european medicines agency bucharest · mihai tudose prime minister of romania “back in 2007, when...

1Relocation of the European Medicines Agency

BucharestRelocation of theEuropean Medicines Agency

emabucharest.ro

Smart Agency in a vivid European city

Mihai TudosePrime Minister of Romania

“Back in 2007, when Romania became a member of the EU, it assumed a trajectory designed to set the premises for dynamic perspectives of unhesitating development on all levels. Now, in 2017, the objectives set back then are ripe for picking. Therefore, a constructive perspective on EU’s future also means fully tapping into the potential of Member States, such as Romania. This potential relies on compelling capabilities, diverse resources, unwavering willingness and profound commitment towards further enhancing the EU project.

This is why Bucharest deserves to host the European Medicine Agency. Thanks to the steady pace of economic and societal progress, as well as to the promising economic projections, Romania enjoys the status of an attractive and favourable setting for EMA’s future operations. Bucharest provides accessible and growing infrastructure, modern headquarters, convenient family opportunities or adequate healthcare facilities. This mix of advantages paves the way to further economic and social development in Bucharest and Romania, to the benefit of the EMA operations and its mission to safeguard the health of EU’s citizens. The speed and pace of Romania’s progress on all stages, ever since its accession to the EU, act as triggers to yield over time better results in achieving a high degree of convergence with EU’s prosperity.

Amid the current business climate and the promising expectations, I pledge with confidence for Bucharest as a friendly, cost-effective and fitting option to relocate EMA. Having said that, the EMA and its staff will find in Romania and in Bucharest not only professional relocation solutions aimed to accommodate their needs, but also innovative, research and development oriented industries, as well as promising life science initiatives. Bucharest reconciles modern with classic, lively reputation with calm getaways, cost effectiveness with high living standards. That is why, all the requirements in place for the continuity and successful performance of EMA meet up in Bucharest. The Romanian Government is looking forward to cooperating in making this transition a success.”

4 Relocation of the European Medicines Agency

Mission statement“A smart Agencyin a vividEuropean city”


Romania is strongly committed to turn its candidacy for the relocation of the European Medicines Agency/EMA into a positive outcome. Romania truly deserves this constructive institutional development, which would allow for its increased contribution to the fulfilment of the EU political objectives, acting in the interest of the EU and its citizens.

Moreover, since Bucharest provides state-of-the-art premises, good logistics and has a proven record of field expertise, EMA’s efficient continuation of operations could only be a natural transition to a new, safe and welcoming EU capital with high development perspectives. Thus, Romania’s candidacy highly responds to the need of ensuring a cost-effective relocation process, as well as to the objective of optimising administrative costs at EU level.

Besides, ever since its 2007 accession to the EU family, Romania has proven its pro-European drive and the bedrock of its society and political actorship relies on the strong attachment to European values and principles. Nevertheless, Romania is amongst the few Member States that do not yet host an European agency.


Starting with the second half of 2016, the Romanian Government, together with regional and local stakeholders, have been working to set up a representative package for the relocation of the European Medicines Agency (EMA) to Bucharest. Our approach to EMA relocation is a flexible and seamless transition for the EMA and its staff to a country with a high potential for development, located within one of the most interesting regions in the EU - Central and Eastern Europe.

The CEE (Central and Eastern Europe) tends to become one of the most attractive regions in terms of active economic growth and highly skilled people, contributing in a representative manner to the scientific environment of the EMA with national leading researchers, students and professors, with scientific collaboration between the healthcare system, the academic sector and the industry. Enjoying stable and reliable macro-economic outlooks, Romania, the 7th largest country in the EU in terms of population, ranks first in the EU in terms of economic growth (5.7%), more than double the EU average (2.4%). Romania offers attractive conditions for Foreign Direct Investments, thus sustaining an economy that generates new jobs at a steady pace, which relies on a multicultural environment with a high percentage of language skilled citizens.

Since its 2007 accession, Romania has demonstrated its clear and steady pro-European orientation and its full commitment towards deepening the EU project. Furthermore, Romania is a pillar of stability in the region and has a unique geostrategic position in the Black Sea area.

Although Romania is among the few EU countries which still do not host any EU agency, here are the main reasons which reflect Romania’s readiness and commitment towards offering to the EMA a new home in Bucharest.

Bucharest, the capital city of Romania, aims at becoming one of the European regional hubs for business and tourism and it represents an important centre for higher education. Taking into consideration the achievement of such goals, local development programs are integrated with the European strategy that aims at providing the appropriate environment for sustainable economic growth. One of the strong points of Bucharest’s communications infrastructure are the widespread optic fibre networks, leading to superior internet access and data transmission rates, the foundation of the future Gigabit society. Bucharest’s NetCity project, the underground infrastructure for optic fibre, is an innovative project and one of the largest investments in the city’s communications infrastructure, in line with the European socio-economic development policy for local communities.

Bucharest hosts several public data centres of a European dimension, able to assure optimal collocation and/or operation of equipment, including back-up and disaster recovery services, as well as high capacity connections with European and global content and connectivity providers.

Executive Summary


Two public internet interexchange points function in Bucharest, ensuring strong connectivity with ISPs active at national level as well as with global carriers; this is helpful in providing reliability and redundancy of communication paths.

1.1. State-of-the-art premises in Bucharest as future EMA headquarters

Romania offers state-of-the-art premises for the future headquarters of the EMA, including attractive financial arrangements for the Lease Contract. The modern real estate concept presents an integrated new concept of work and life in one of the most active parts of Bucharest, the capital city.The proposed EMA building is part of a real estate integrated project of the Global Worth as developer. The project perfectly balances a new concept of office spaces, which combines high technical and environmentally friendly specifications, green areas and a dedicated commercial component, as well as dwellings. A conference centre completes the mix, providing the infrastructure for a continuous learning process for companies and employees alike.

The total Gross Building Area is 36,740.80 sqm with a total office rent area of 27,431.43 sqm. The location is also endowed with highest IT&C and mobile technologies, some of the best in the world and 1st in the EU at the end of 2016. The state-of-the-art IT&C of the building and the area would make it particularly well equipped to provide assistance for the IT requirements of the EMA.Close to the EMA building, the Campus residential complex offers 435 spacious dwellings to rent or buy. Also, family members of EMA staff have

nearby possibilities to work at blue chip tenants in the area.

The Campus provides a private kindergarten and the after-school “Junior School”, as well as onsite amenities such as bank branches, pharmacy, the largest gym / spa in Bucharest, as well as a large variety of restaurants offering local and international cuisine, a supermarket and several coffee shops.

Within walking distance, there are some four star hotels with a total of 606 rooms: the Caro Hotel (184 rooms), the Cristal Hotel (74), the Phoenicia Hotel (348 rooms). Nearby, new hotels are under development, with a potential of another 150 rooms. EMA’s headquarters can be easily reached from the airport in less than 16 minutes. Bucharest Municipality could provide a direct line of transportation between the EMA premises and the destinations required by its personnel, all around Bucharest, including on the route from/to the International Henri Coandă Airport.

1.2. Bucharest - A vivid European city, a safe and cost-efficient place to work and live

Bucharest offers safe and excellent working and living conditions in an open, friendly and welcoming environment. With a population of almost 2 million inhabitants, Bucharest, the capital of Romania, is the 6th largest city in the European Union, after London, Berlin, Madrid, Rome and Paris. Well-connected and accessible, Bucharest serves as the economic, political and social hub of Romania.Bucharest is very well positioned geographically, offering swift access within 2 hours by car, to the Carpathian Mountains, the unique Danube Delta –


the second largest and best preserved of Europe’s deltas – and the impressive Black Sea. Bucharest is one of the safest EU capitals (with less than 1% criminality rate per 100.000 inhabitans), providing a safe place to work and live for its citizens. It has never been a target for terrorist attacks. Romanian citizens perceive as low the risk to national security.The cost of living in Romania – especially in Bucharest – is approximately 50% lower when compared to other EU major cities (Vienna, London, Berlin, Paris) and at least 12% cheaper than other city capitals in the region (Prague, Warsaw or Budapest).Compared to London, the monthly rent price for an excellent IT&C equipped office building in Bucharest is 3 times lower.A new home city cannot be ‘at home’ without proper housing facilities – Bucharest means convenient living costs and high quality of life for expats, including cost efficient housing facilities. Over the past years, the real estate market has experienced a major expansion trend, hence the moderate buying costs and convenient rental prices.

Bucharest is also a place with a rich mix of strong traditional culture, theatres, opera, as well as a large and diverse network of museums completing the picture of a vivid and attractive city. Citizens, expats and visitors of Bucharest are familiar with recreational activities, ranging from traditional “shopping arcades”, cinemas, parks and public gardens, thermal spa facilities or various types of restaurants.Bucharest also offers excellent IT&C services at a high quality/price ratio, as Romania ranks first among European countries with the highest average peak internet connection speed and the communication services tariffs are among the lowest in Europe (Q3, 2016).


1.3. Bucharest - connectivity, easy access, diversity and tailor made approaches

Bucharest Henri Coanda International Airport provides over 220 daily direct and connecting flights to-and-from all EU Member States. Bucharest has direct and connecting flights to 84 European destinations in 29 countries, out of which direct flights to 23 EU capital cities.

TAROM national airline company is ready to provide for excellent corporate commercial offers to EMA staff and visting experts within its entire domestic and international network, at competitive fares.The airport can be reached from downtown in less than 30 minutes and from the EMA headquarters in less than 16 minutes by means of public transportation.

The city’s public transportation network comprises 4 well-connected, secure and accessible subway lines, as well as an extensive network of public bus, trolley bus and tram transportation. Tickets can be purchased at one of the lowest prices in the EU. Bucharest offers friendly bike rental facilities and cycling infrastructure with major expansion prospects.

1.4. Plentiful accommodation

Bucharest offers a wide range of accomodation to ease experts’ and delegates’ travel experience - with over 140 hotels and 10.000 hotel rooms ranging from exclusive to mid-range, major international hotels being present in the city. With plenty of employment possibilities for families and partners of the EMA staff and access to

professional healthcare services, Bucharest offers the largest labour market in the country, enjoying a dynamic and diverse business environment with soaring competitiveness indicators. Bucharest provides a well developed Business Services Sector (BSS), hosting the headquarters of multinational corporations, consulting companies or international law firms, offering a large range of employment possibilities for families and partners of the EMA staff.

Comprehensive and high-quality healthcare services in over 50 public hospitals in Bucharest, as well as a wide range of privately operated clinics and hospitals may ensure proper medical care for EMA employees and their families. Insurance costs are generally covered by the Romanian government, which guarantees access to public healthcare services for all. Besides, citizens can opt for private insurance arrangements, which bear accessible costs and provide access to a wide-range of services in public or private institutions.

1.5. Excellent education facilities for EMA employees’ children

Bucharest offers a wide range of educational institutions for all ages, from nurseries, kindergartens, secondary schools, high schools and universities, teaching in foreign languages.The educational system in Bucharest has evolved taking into consideration the labour market and its modern needs, offering a diverse range of modern curricula and specialities, some of them in foreign languages. Several nurseries operate in Bucharest, offering education in English, German, Finish and other languages. Over 450 public primary and secondary schools operate in Bucharest, out of which over 30 schools - from pre-school to high school - feature


international profiles.In Bucharest, there are 27 public and private universities, offering 75 Bachelor programmes in English, French and German, while 84 master programmes are offered mainly in English. Doctoral studies may be organized in an international language as well. Higher education is free for top students admitted to undergraduate degrees in public universities.

1.6. Smooth transition for staff and their families

The Romanian proposal is based on the relevant EMA management Board decisions and EMA’s Operations and Relocation Preparedness Task Force (ORP) created to ensure a smooth transition through a well-organized process, offering a professional approach to relocation assistance, mechanisms and procedures.

It is based on risk control and management aimed at mitigation of risks through arrangements for the continuation and/or resumption of essential services and ultimately return to “business as usual” in the shortest time possible.

The Romanian Ministry of Health will put in place, immediately after the decision to relocate EMA to Bucharest, an operational Department of Support Relocation Services (DSRS) in order to support relocation of EMA’s activities, experts and their families, from UK to Romania.

The purpose is to relocate EMA with least breaks for work and life. With the support of the Romanian Embassy to the UK, the Romanian Ministry of Health shall assist EMA staff and their families, thus ensuring a smooth and seamless transition.

Apart from the scenarios provided in the EMA/336490/2017 MB document, Romania is ready to cope with the risk of possible EMA staff shortage due to the relocation. The National Agency for Medicines and Medical Devices is a reliable, active partner of the European Medicine Agency, with highly-skilled professionals. It is worth mentioning that Romania ranks tenth as to number of EMA’s employees.

1900 high skilled persons are ready to cope with a possible 25% EMA staff shortage - 300 persons from the National Agency for Medicines and Medical Devices and 1,600 professors from all Universities of Medicines and Pharmacy in Romania. This year, the Agency has signed a partnership agreement with the most prestigious medical university in Bucharest, the “Carol Davila” University, to ensure EMA smooth business continuity, in case of a risk of personnel shortage.With over 170,000 highly-skilled young potential employees yearly, out of which 10,000 medical, dental and pharmacy students in Bucharest, the Romanian market offers concrete possibilities in line with EMA principles to engage young persons in working activities or in a constant dialogue and interaction in a mutually beneficial manner.

Romania ranks high globally in terms of number of medical school graduates – 36 graduates for every 100,000 population, whereas the United States have 6.5 graduates and the UK, 9.3 graduates for every 100,000 population.

Romania has internationally recognised expertise and tradition in the field of medicine and pharmacy education, with more than 70% of foreign students studying medicine and pharmacy here. Furthermore, the Romanian software and IT services sector relies on highly skilled human capital recognised as such at international level.


1.7. The Romanian National Agency for Medicines and Medical Devices has an exceptional track record in modern medicinal product regulation

The National Agency for Medicines and Medical Devices (NAMMD) is a reliable, active partner of the European Medicine Agency. Romania ranks tenth as to number of EMA employees.

It is worth mentioning that Romania has a long and uninterrupted history of modern pharmaceutical market regulators.

For over 50 years, the National Agency for Medicines and Medical Devices (NAMMD) has represented the medicinal product regulatory authority in Romania. The current mission of the Agency includes authorizing the place on the market of good quality, safe and effective human medicines, as well as authorizing the conduct of clinical trials and the clinical trial sites in Romania; safety supervision of medicinal products for human use, through inspection and pharmacovigilance. As of 2014, the NAMMD is also the national competent authority in the field of medical devices and assessment based on scientific criteria adopted through national legislation in force of medical technologies for inclusion into the national healthcare insurance system.

1.8. Recognised Romanian tradition and expertise in the field of medicine and pharmacy

Romania has a long lasting tradition in medical and pharmaceutical research, with bright talented

researchers with tremendous contribution to the development of a wide range of medicine and pharmacy fields. The most representative and brilliant researchers, some of them Nobel Prize laureates, are:

- George Emil Palade, Romanian Nobel Prize laureate, for physiology and medicine awarded in 1974. He is considered to be the father of modern cell biology.- Cornelius Giurgea has revolutionized encephalo-neuro-psycho-tropic therapy by discovering and substantiating the concept of a new therapeutic (pharmacological) class in neuroscience - nootropic medication. Its first representative is piracetam (DCI) - Nootropil® (UCB) - generation I.- Ana Aslan, who developed Gerovital, vitamin H3, patented in 30 countries since 1952. That same year, she established the first geriatric institute in the world, the Geronto-Geriatrics National Institute Dr. Ana Aslan, that represented a model for other countries, through both clinical care and research.- Nicolae Paulescu, the true discoverer of insulin in 1921, secreted by the pancreas, which Paulescu originally called “pancreine”. In his studies, he found out that the hormone regulating the metabolism of carbohydrates is equally involved in lipid metabolism and parotids. The hormone Paulescu discovered has also been shown effective in reducing hyperglycemia and in the treatment of diabetes.

1.9. Strong perspectives of present Romanian R&D in the medicine and pharmacy fields

Nowadays, Romania is a country with high perspectives in the research and development area, counting more than 30,000 people working


in research fields, out of which 18,000 highly skilled researchers.Most of the public hospitals in Bucharest have research departments and clinical training centres belonging to the universities of medicine and pharmacy. In Bucharest, there are 1,600 medical university teaching staff and around 10,000 medical, dental and pharmacy students.

Here are some of the relevant research projects in the Bucharest Ilfov Region:- ELI-NP: The most advanced research facility in the world, focusing on the study of photonuclear physics and its applications is placed in Romania (at only 12 km from Bucharest) – the Extreme Light Infrastructure - Nuclear Physics (ELI-NP). The infrastructure will create a new European laboratory for a broad range of sciences covering frontier fundamental physics, new nuclear physics and astrophysics as well as applications in nuclear materials, radioactive waste management, material science and life sciences. - The „Victor Babes” National Institute - Telocytes

are a new type of interstitial cells, discovered by the famous “telocytes group in Bucharest”, created by Laurentiu M. Popescu, with possible implications in the transmission of signals that initiate regeneration. In 2012, telocytes became an internationally registered brand. The most active countries in telocytes research are: China, Italy, Spain, Germany, Belgium, Singapore or the USA. The role of telocytes is today only surmised, but most likely, their still unknown functions are closely correlated with the particularities of their structure.- Romania is the first country in Europe in terms of telemedicine. The national telemedicine network includes two command centres, at the Floreasca Hospital in Bucharest and the Clinical Emergency Hospital of Târgu Mureș and 56 hospitals in 19 counties. Thus, doctors at the two command centres provide medical support in real time to any of the hospitals in the country and pursue the patient’s vital signs.


Chapters1. Host country – ROMANIA

2. Host city – BUCHAREST

I. Assurance that the Agency can be set up on site and take

up its functions at the date of the UK’s withdrawal from the

European Union

1. Intelligent building in a dynamic market

1.1. Real estate market in Bucharest

1.2. Proposed EMA Office location

1.3. IT&C system of the building

1.4. Proposed financial arrangements for the building

II. The accessibility of the location

2.1. Enabling scientific experts from all EU and third

coutries to meet at EMA in Bucharest- Accessibility of the

new EMA location

2.1.2. Major international airport

2.1.3. Excellent public transport links from the airport

to downtown Bucharest

2.1.4. Means of transportation in the city

2.1.5. Taxi transportation

2.1.6. Bicycle Rental

2.1.7. Other transportation means connecting Bucharest

to EU cities

2.2. Accommodation for experts and delegates

III. Adequate facilities for children of EMA staff

3.1. Strong educational system

3.2. Bucharest’s offer

3.2.1. Nursery and kindergarten

3.2.2. Primary school and secondary school

3.2.3. Higher education schools

IV. Appropriate access to the labour market, social

security and medical care for families

4.1. Brief overview of the Romanian labour market

4.2. How to find a job

4.3. Self-employment

4.4. Romanian Social Assistance Policy

4.5. Employment for families and partners of the EMA

staff

4.6. Secure life for EMA staff, families and children

4.7. Comprehensive and high-quality healthcare

services, public and/or private

V. Business continuity

5.1. Recognised Romanian tradition and expertise in the

field of medicine and pharmacy

5.2. Strong perspectives of present Romanian R&D in the

medicine and pharmacy fields

5.3. Business continuity – Romanian approach

5.4. Enabling staff to relocate with their families

5.5. Covering the possible risk of 25% staff shortage

5.5.1. National responsabilities to support EMA staff

relocation and possible staff shortages

5.5.2. International recognised medical and pharmacy

Romanian universities providing highly skilled young

graduates

5.5.3. Recruiting temporary IT staff at short notice

5.6. Time-plan for EMA relocation

VI. Geographical spread

Annexes

Annex 1 – Romania – general facts and figures

Annex 2 - High quality of life, culture and leisure

Annex 3 - Other communication systems

Annex 4 – Financial arrangements - CONFIDENTIAL

Annex 5 - The 12 public universities in Bucharest offering

foreing language programmes

Annex 6 - The National Agency for Medicines and

Medical Devices activities at EMA level

Annex 7 – Cooperation agreement between NMMDA and

the “Carol Davila“ University of Medicine and Pharmacy

of Bucharest

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List of abbreviations

EMA European Medicines Agency

RMoH Romanian Ministry of Health

NAMMD National Agency for Medicines and Medical Devices

EU European Union

CE European Council

BPO/SSC Business Process Outsourcing/ Shared Service Centre

BSS Business Service Sector

BRP Business Relocation Plan

ARCP Action Relocation Continuity Plan

ESRT EMA Support Relocation Team

RSRT Romanian Support Relocation Team

RSRP Romanian Support Relocation Plan

DSRS Department of Support Relocation Services

RTL Romanian Team Leader

LTL London Team Leader

PS - RSRP Project Schedule

RS Relocation Specialist

ANOFM National Agency for Employment


HostCountryRomania

• An EU member for 10 years already;• A strong pro-European Member State, profoundly attached to EU values and principles

which has constantly proved its openness and dedication to the European project;• The 7th EU largest country in terms of population;• A multicultural country that hosts various ethnic and religious groups• The 2nd longest EU terrestrial external border; • The largest EU harbour at the Black Sea;• Romania – a country that ranks first as economic performance (5.7%), more than double

the EU average (2.4%); • 4th in the EU 28 as lowest level of income tax - 16% income tax and 3rd place in the EU

28 - 19% VAT;• Enjoys stable and reliable macro-economic outlooks, propitious and friendly investment

climate;• A country expats and travellers often consider a place of their own, seamlessly blending

into a modern European lifestyle;• A multicultural country with high openness for ethnic groups, religion and gender, where

one can safely live and work. • Although Romania has an outstanding tradition in multilateral diplomacy, as an EU

Member State it does not host any EU agency.



Romania - an active presence in international organisations – significant elements

Romania has an outstanding tradition in multilateral diplomacy, with highest professional standards set by the Romanian prominent diplomat Nicolae Titulescu, who was twice the President of the League of Nations – in 1930 and 1931. His legacy has been inspirational for many generations of diplomats and ambassadors, who served Romania at the UN, EU or other international organisations, as great professional and intellectual models.Since December 1955, Romania has been a member of the United Nations. Its presence in various bodies of the UN entitles it to be a part of the decision -making process within the world organisation that influences the international situation at global level and in proximal geographical areas.

Romania is a founder member of the World Health Organisation – WHO (1948) and, over the years, has had good cooperation with this esteemed organization. After 1989, the WHO has been the main partner of Romania in the field of the public health and supported the reform of healthcare system.In May 2004, Romania was elected member of the WHO Executive Board for a three years mandate (represented by the minister of health). It is currently presenting a renewed candidature for the same position for another three years mandate starting with May 2018.

Romania has been particularly active within the WHO framework and has co-initiated or joined significant initiatives in this area. Thus, in May 2007, at the World Health Assembly, delegations from Romania and Thailand co-introduced a draft resolution on healthcare systems: emergency-care systems, the first-ever resolution on emergency care services. The Romanian Mobile Emergency Service, for

Resuscitation and Extrication - SMURD has a recognized role in the international healthcare system, thus Romania being one of the co-organisers of an event in May 2013, dedicated to the launch of the WHO Global Alliance for Care of the Injured. In the past three years, Romania’s delegation to the World Health Assembly has been an EU and EURO (region) burden-sharer of a resolution, together with Austria and Monaco, on poliomyelitis.

Currently, there are 84 diplomatic missions in Romania and 13 international organisations have permanent missions in Bucharest. No European agency is currently located in Romania. This prompts us to emphasize that accommodating an EU agency in Romania would meet the objective set in the Conclusions of the December 2003 EU meeting at the level of Heads of State or Government and confirmed in 2008 that observing a geographical spread of the agencies’ seats at the level of the entire European Union is desirable.

Romania – a clear economic outlook

Romania continues its consistent positive economic trend over the past few years. 2016 was an exceptional year for the Romanian economy, as headline growth accelerated to 4.8%. Furthermore, Romania posts highest Q1 2017 economic growth rate in the EU – 5.6%. Recently, the Eurostat has confirmed that Romania registered the highest increases in May industrial production (14.6 percent) in the EU and the second highest quarterly increases in industrial production in the EU (3.5 percent).

In Romania1, the level of taxation is attractive in terms of the single rate of income tax of 16%. Romania ranks 4th in the EU 28 on the lowest level of income tax, after Bulgaria with 10% and the Czech Republic

1 National Prognosis Committee, Romanian Ministry of Public Finance, 2017


and Hungary, with single rates of 15 %. Depending on the number of employees, a special tax rate for SMEs applies - 1% to 3% - for micro-enterprises. Dividents are taxed at 5% final withholding.

At the same time, the consumption tax rate is 19% of the standard VAT rate. Romania ranks 3rd in the EU 28, after Luxembourg, with 17%, Malta, with 18% and at the same level of 19% with Germany and Cyprus.Romanian reduced VAT rates for some categories of goods and services contained in Annex III of VAT Directive 2006/112/EC, to mention the relevant ones, are:

• Foodstuff: 9%• Water Supply: 9%• Pharmaceutical products: 9%• Medical equipment for disabled persons: 9%• Books: 5%• Restaurant and catering services: 9%• Social housing: 5-6%

Indicator 2011 2012 2013 2014 2015 2016 2017

GDP growth 1,1 0,6 3,5 3,1 3,9 4,8 5,2

GDP per capita (euro) 6618 6660 7217 7549 8072 8604 9279

Industrial production growth 7,5 2,4 7,8 6,1 2,7 1,7 5,4

Household consumption 1,0 0,8 2,6 4,2 5,9 7,5 7,3

Current Account (% of GDP) -4,9 -4,8 -1,1 -0,7 -1,2 -2,3 -2,4

Net FDI (% of GDP) 1,4 1,6 1,9 1,6 2,2 2,4 2,5

Budget deficit (% of GDP) -4,2 -2,5 -2,5 -1,72 -1,35 -2,4 -2,96

Inflation rate (end of year) 3,1 5,0 1,6 0,8 -0,9 -0,5 1,9

Inflation rate (yearly average) 5,8 3,3 4,0 1,1 -0,6 -1,6 1,1

Average exchange rate 4,24 4,46 4,42 4,44 4,44 4,49 4,49

Unemployment rate registered 5,2 5,4 5,7 5,4 5,0 4,8 4,3

Budget deficit (ESA) % of GDP -5,4 -3,7 -2,1 -1,4 -0,8 -3,0 -2,9


Location: Southern RomaniaElevation: 55-90 m (190-295 ft)Size: City of Bucharest - 228 sq.km (88 sq. miles); Metropolitan area – 1,521 sq.km (587 sq. miles)Inhabited since: 500 BC First documented: 1459 AD Population: 1,883,425 million as of 2011 Census

In Bucharest, three elements express the city’s specific identity:

1. Its architecture - what people, in their option, have considered valuable for decades and which continues to be the décor of the city today.

2. The urban landscape - resulting from the merging of all the floods and voids in an area, colors, vegetation, heights and construction materials of which the buildings that shine in the sun are built.

3. The contexture of the streets - which gives us direction, momentum and adventure.

In historical areas, the three elements form urban harmonies that express a specific identity. Known for its wide, tree-lined boulevards, glorious Belle Époque buildings and a reputation for the high life (which in the 1900s earned its nickname of “Little Paris”), Bucharest, Romania’s largest city and capital,

is today a bustling metropolis.

Romanian legend tells that the city of Bucharest was founded on the banks of the Dambovita River by a shepherd named Bucur, whose name literarily means “Joy”. His flute playing reportedly dazzled the people and his hearty wine from nearby vineyards endeared him to the local traders, who gave his name to the place.

Bucharest, the capital city of Romania aims at becoming one of the European regional hubs for business and tourism and an important centre for higher education. Taking into consideration the achievement of such goals, local development programs are integrated with the European strategy that aims at providing the appropriate environment for a sustainable economic growth.

The local strategy is focused on five goals: employment, research, education, poverty eradication and energy – climate.

Host CityBucharest

• The 6th largest city in the European Union, after London, Berlin, Madrid, Rome and Paris.

• Lively, well-connected and accessible, it serves as the economic, political and social hub of Romania.

• The concentration of the largest labour market in the country, with a dynamic and diverse business environment with soaring competitiveness indicators.

• A heaven for expats. There are great tips on friendly Mobile Apps, designed to maximize the Bucharest experience.

“Today’s Bucharest is a lively city with remarkable Belle Époque buildings and a reputation for high life” -TeBe



To support the Europe 2020 Strategy, an economic governance system has been established, aimed at coordinating political actions at European and national level. The Europe 2020 Strategy suggests the signing of territorial pacts that can contribute to eliminating disparities and lending a territorial dimension and responsibility.A total of 28 capitals of the European Union, including Bucharest, welcome the European Union’s initiative of giving way to direct dialogue by conferring these cities the status of partners by ratifying the “Smart, sustainable and inclusive growth: EU Capital Cities – essential partners for Europe 2020” declaration at Brussels. This declaration marks the passing to a new level of cooperation in Europe.At present, Bucharest is the most sustainable town in Romania with highly skilled employees working for both national and multinational industries, mainly characterised by high competition. The life quality of the Bucharest population and also of the region has improved year by year due to the city’s investments in transport and traffic for passages, parking lots, the water and sewage network, public lighting, schools and hospitals, theatres and parks.

Housing market and living standards in Bucharest for EMA staff and their families

Characteristics of the Bucharest housing market:• Buying costs are moderate in Romania• Moderate to good rental yields in Bucharest• Romanian law is pro-landlord• Risks: currency risk

• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Bucharest is a bargain. In just few European countries there are affordable houses like in Romania. Even more important, Romania is growing rather rapidly, so there is upside potential. For investors with exposure to Romania, the gross rental yields are good with low to moderate risk. A new home city cannot be ‘at home’ without proper housing facilities – Bucharest means convenient living costs and high quality of life for expats. Over the past years, the real estate market has experienced a major expansion trend, hence the moderate buying costs and convenient rental prices.

http://www.globalpropertyguide.com/Europe/Romania/Landlord-and-Tenant


TRANSACTION COSTS2

Who Pays?

Stamp duty 0.50% - 3% buyer

Notary fee 0.44% - 2.20% buyer

Registration fee 0.50% - 2% buyer

Real Estate Agent´s Fee 3% 3%

buyer seller

Costs paid by buyer 4.44% - 10.20%

Costs paid by seller 4% - 6%

ROUNDTRIP TRANSACTION COSTS 8.44% - 16.20%

As shown in the Table above, houses and apartments are not expensive in Bucharest, at an average of 1,500 euro per square metre (sq. m.), purchase price:• a 120 sq.m. apartment in Bucharest will cost around 190,000 euro• a 70 sq.m. apartment in Bucharest will cost around 106,000 euro

Assumptions for price calculation:• Prices primarily represent very well-kept apartments. • We have used the “useful area” instead of the “built area” computed for sq.m. prices because apartments

situated in old residential buildings were included.

Moderate to good rental yields in Bucharest:

BUCHAREST - flats3

COST (€)

YIELD (p.a.)PRICE/SQ.M. (€)

TO BUY MONTHLY RENT TO BUY MONTHLY RENT

70 sq. m. 106,050 552 6.24% 1,515 7.88

120 sq. m. 190,920 966 6.07% 1,591 8.05

https://www.globalpropertyguide.com/Europe/Romania/Buying-Guide#stamp-duty

https://www.globalpropertyguide.com/Europe/Romania/Buying-Guide#Notary fee

https://www.globalpropertyguide.com/Europe/Romania/Buying-Guide#Registration fee

https://www.globalpropertyguide.com/Europe/Romania/Buying-Guide#Real Estate


High quality of cultural life, entertainment and leisure

Citizens, expats and visitors of Bucharest are no strangers to recreational activities ranging from traditional “shopping arcades”, cinemas, parks and public gardens, thermal spa facilities, or various types of restaurants offering unforgettable culinary experiences.Bucharest hosts 36 museums and public art collections, 2 opera institutions, 23 dramatic theatres, 1 Musical Theatres, Operetta, 1 Puppet Theatres / Animation and 3 Philarmonics.

The Cultural Scene of Bucharest

Bucharest’s cultural life is a rich mix of strong traditional culture, represented by a performing arts sector - theatre, opera, dance and music - as well as a large and diverse network of museums and mass culture, represented by an increasing number of open air festivals, concerts and events and a rapidly developing contemporary arts scene (for details, see Annex 2 –Bucharest, Culture and Leisure). Moreover, there is a growing number of cultural operators from the entrepreneurial sector. These include, besides the traditional areas of cultural industries such as multimedia, cinema, audiovisual, music, publishing, cinema, the more edgy domains of video games, interactive media, design, craftsmanship, architecture etc. Based on recent evaluation of the creative economy sector in Romania, Bucharest is the national leader in cultural entrepreneurship.

The arts and culture sector has different types of cultural structures, each with its own organisational, economic and artistic characteristics: municipal and national cultural institutions, independent organisations and private ones. Although all equally important as part of the cultural ecosystem of the city, they are in fact separate phenomena.

The Bucharest cultural institutions of European fame are: The National Peasant’s Museum — a member of the International Council of Monuments and Sites ICOMOS and the 1996 European Museum of the Year; the Bulandra Theatre — a member of the European Theatre Union since 1992; the Bucharest National Theatre — a founding member of the New European Theatre Action NETA network; the Romanian Youth Cultural Centre — a member of the European Federation of National Youth Orchestras.

The European presence is also felt in the numerous cultural events organised in cooperation with the cultural institutes of other EU states. The French Institute is one of the several cultural agencies promoting foreign culture in Romania, through its network of institutes and cultural centres located in the main cities.The German Goethe Institute, the Italian (Vito Grasso) and Spanish (Cervantes) institutes and the Hungarian Cultural Centre, just to name a few of the cultural institutes present in Bucharest, support cultural life through seminars, conferences, festivals, concerts, exhibitions etc, by funding a variety of independent projects and supporting various programmes and projects, along with public and non-public institutions.


Excellent IT&C for an excellent future of Gigabit society

• Romania ranks first among European countries with the highest average peak internet connection speed (Q3, 2016).

• Bucharest is the largest start-up hub in the country with over 130 start-ups and the home of many tech companies and VC firms as well as universities focused on technology, engineering and software development.

• The Romanian IT&C market has a consolidated value of over 5 bln. EUR, contributing to the dynamic evolution of the GDP.

• Communication services tariffs are among the lowest in Europe, ensuring a high quality/price ratio.

• Mobile voice and data services tariffs are between 2 EUR/month and 9 EUR/month.• Fixed internet tariffs do not exceed 11 EUR/month for services with speeds up to 1000 Mbps

through optic fibre.• Convenient and reliable mobile and data subscriptions are commonplace for those who

live in Romania, as they enjoy some of the most competitive prices for telecommunications in the EU.

The Romanian IT&C market has a consolidated value of over 5 bln. EUR, contributing to the dynamic evolution of the GDP. A number of widely established communication services and connectivity providers as well as local players of regional dimension currently provide services in Bucharest. Some of the names are Orange, Vodafone, Telekom, RCS & RDS, UPC, Euroweb, GTS Telecom and Prime Telecom. The range of services provided is large, covering “traditional” services such as fixed and mobile telephony, internet access,

1119Mbps 106Mbps No.1

Average download speed

Average uploadspeed

Maximum internet speed in EU in 2016

Internet speed in Bucharest

1

Internet servicemaximum cost

(speeds up to 1000 Mbps through optic fibre)

Voice and data servicesmaximum cost

Among the lowest communications services costs in Europe

11Euro/Month 9Euro/Month


broadcasting and video&data transmission as well as added value-services including security or IT support.There are 4 operators providing mobile communications with national coverage: Orange, Vodafone, Telekom, RCS & RDS, ensuring a highly competitive environment for service provision. All have 100% coverage over the city with state-of-the-art 3G and 4G technologies such as HSDPA, HSUPA, LTE and LTE Advanced, helping them sustain high data transfer rates.

The extensive high capacity mobile coverage is doubled by the introduction of advanced service features such as VoLTE – high quality of the voice service and simultaneous voice and high capacity data transfer or WiFi calling – extending indoor mobile coverage via WiFi access.

Romania has already started preparing for 5G, which will add increased transfer capacity and wider range of services. The NRA has launched a public consultation regarding the competitive selection procedure related to award of additional radio frequencies, aiming to allocate them as soon as feasible, to be available for the rollout of 5G mobile networks.

One of the strong points of Bucharest’s communications infrastructure is the wide spread of optic fibre networks, leading to superior internet access and data transmission rates, the foundation of the future Gigabit society. Bucharest’s NetCity project, the underground infrastructure for optic fibre, is an innovative



project and one of the large investments made in the city’s communications infrastructure, in line with the European socio-economic development policy for local communities.

Bucharest hosts several public data centres of European dimension, able to assure optimal collocation and/or operation of equipment, including back-up and disaster recovery services, as well as high capacity connections with European and global content and connectivity providers. Two public internet interexchange points operate in Bucharest, ensuring strong connectivity with ISPs active at national level as well as with global carriers; this is helpful in providing reliability and redundancy of communication paths.

From the perspective of the costs related to provision of communication services, due to the increased competitiveness of the Romanian market, the tariffs of communication services are among the lowest in Europe, ensuring a high quality/price ratio. Thus, on the retail level, usual tariffs for mobile voice and data services are between 2 EUR/month and 9 EUR/month, while usual tariffs for fixed internet do not exceed 11 EUR/month for services with speeds up to 1000 Mbps through optic fibre.

Regarding the quality of the internet access service, international studies place Romania at the top of the world’s high-speed internet. Thus, according to the latest “State of the Internet” connectivity report conducted by the American group Akamai, for the first quarter of 2017, Romania ranked second among European countries with the highest average peak internet connection speed. The average peak speed in Romania was 95 Mbps in the first quarter of this year, up 15% over the same period of 2016.These data are also confirmed by the measurements made using the speed measurement application made available to users by the NRA, Netograf.ro. According to it, in the first quarter of 2017 the average download speed for fixed internet in Bucharest registered 119 Mbps and the average upload speed 106 Mbps. At the same time, the average download speed for mobile internet was 34 Mbps and the average upload speed was 14 Mbps.

It should also be added that fixed internet is provided by the main companies offering services in Bucharest at speeds between 500 and 1000 Mbps.The other communication systems ( WiFi, phone communication, post ) are presented in Annex 3.

• Deliveries of retail, logistic and office spaces stood at 956,000 square meters in 2016, up by 88 percent compared to 2015, marking the best year for the Romanian real estate market since 2008.

• Second cheapest office rental rate in the EU - on average 18 €/sqm41

4 2016 EHL study


1. Intelligent building in a dynamic market

1.1 Real estate market in Bucharest

The year 2016 was one of significant increase in all segments of the real estate market, apart from office space located outside of Bucharest, a segment that had already seen record deliveries in 2015.

Supply52

The stock of modern office spaces in Bucharest has reached 2.1mn sqm, after registering new deliveries of 230,000 sqm during 2016. In fact, the volume of new deliveries marks the fastest pace of expansion since 2009 and is 112% more than the yearly average of deliveries in the post-crisis period. By all means, Bucharest office market is shifting gears. One of the explanations for this increased volume of deliveries is the focus on large projects (with GLAs larger than 25,000 sqm), which accounted for 60% of the total volume of deliveries in 2016. At the same time, there is an increase in the number of pre-lease transactions in the market. During 2016, pre-leased transactions accounted for 82,100 sqm (up by 200% compared to the post-crisis average).

5,6 Colliers market Report, 2017

In terms of geographical distribution, the highest contributors to the stock are Floreasca-Barbu Vacarescu (42% of total deliveries), Dimitrie Pompeiu (26% of total deliveries) and the Central West Area (24% of total deliveries). In total, these zones accounted for 92% of the total deliveries in the market. These areas have developed considerably in the post-crisis years as accessibility, transportation and proximity to amenities started to rank higher in tenants’ requirements. Across all real estate sectors, approximately 60 % of facilities were built in Bucharest and around the capital.

Demand6

Total take-up in the market for 2016 reached 369,000 sqm, up by 52% compared to the previous year. IT and BPO/SSC were the main drivers behind this expansion and accounted for a total of 50% of transactions. In fact, we estimate that more than 20,000 people were hired in these sectors during 2016, which would mean that IT and BPO/SSC are on their way to becoming the largest employers in Bucharest, outpacing employment in retail trade.

Demand for office buildings has been the strongest in already established areas such as: Floreasca Barbu Vacarescu (13% of total demand), Dimitrie Pompeiu (17%) and the Central West part of the city (24%).

Regarding the area between Calea Floreasca and Barbu Vacarescu, the demand is starting to outpace the volume of office space on offer, as the vacancy rate continues to decrease rapidly.Looking at the broader market, it is clear that tenants continue to have the upper-hand. Net take-up during 2016 reached 166,600 sqm, which covers 73% of the area delivered to the market in the same period. It is expected that supply will outpace demand during 2017, which will invariably increase competition in the market.

IAssurance that the Agency can be set up on site and take up its functions at the date of UK’s withdrawal from the Union



1.2. Proposed EMA Office location

Benefits of the offered location:

• Has all legal construction permits and complies with Romanian construction regulations which require, as essential conditions for buildings: mechanical resistance and stability, operational safety, fire safety, hygiene, health and environment, noise protection and sustainable use of natural resources.

• Brand-new building to be completed by the end of 2017, with state-of-the-art IT&C infrastructure, served by local and international well known providers.

• Attractive financial arrangement for the Lease Contract.

• Energy Efficiency: the technical and legal characteristics of the building meet the construction standards for Green Buildings such as BREEAM Excellent.

• No other office space development in Bucharest balances work and life so clearly as the modern concept offered by the Globalworth Campus.

• Residential complex at walking distance, with more than 400 dwellings to rent or buy.

• Excellent access: The airport is located aprox.12 km away and can be reached in 16 min.

• Family members have nearby possibilities to work for some of the selected blue chip tenants in the area: DB Schenker, Deutsche Bank, Deutche Telekom, EFG Eurobank, eValue, Genpact GFK,

Hewlett-Packard, Honeywell, Idea Bank, JTI, Lavalin, Luxoft, NBG Group, Nestle, Netherland’s Embassy, Procter&Gamble, Saipem, Stefanini, Xerox.

• Globalworth Campus is the number one spot in Dimitrie Pompeiu Boulevard, in terms of both business and leisure. It is close to the Herastrau Park, the largest park in Bucharest, to top well-known music clubs, restaurants and other modern amenities.

• Access to a full suite of service providers for the initial implementation phase in case of encountered limitation or deliver a full working new EMA building in time: accross the street, Regus type services are offered on Dimitrie Pompeiu 5-7 and Dimitrie Pompeiu 9-9A, only in exceptional cases there are delays in time building delivery or relocation process.

DESCRIPTION OF THE LOCATIONAddress: 4-6 Dimitrie Pompeiu Boulevard, 1st District. Situated in the Northern part of the capital city of Romania, Bucharest, with excellent access to all types of transports: subway, tramway, car, bycicle.

ToGovernment

10’To

City Centre

15’To

Airport

16’


Globalworth Campus is located at the heart of the most dynamic business district in Bucharest. The new up-and-coming Floreasca – Dimitrie Pompeiu area is situated in the northern part of the city, in the traditional corporate zone of the Romanian capital. With a rich history in attracting and retaining blue chip tenants such as Honeywell, Deutsche Bank or Hewlett Packard, Bayer, Abbott, Sanofi, Merck, Dimitrie Pompeiu has risen to prominence as one of the first choices for multinationals in Bucharest.

A state-of-the-art development, the real estate project Globalworth Campus perfectly balances office, retail and other supporting amenities. The project effortlessly brings in a new concept of office spaces, which combines high technical and environmentally friendly specifications, green areas and a dedicated commercial component and residential. A conference centre completes the mix, providing the infrastructure for a continuous learning process for companies and employees alike.

The Globalworth Campus is an integrated real estate project and is the result of the convergence of commercial excellence and modern hardscapes softened by green areas and water features. There are numerous opportunities for relaxation or network building in the project’s bistros, cafes, or shopping areas.


Campus facilites: The Campus enjoys a large variety of restaurants offering local and international cuisine as well as several coffee shops (including Paul, Starbucks or similar). The onsite amenities include the largest gym/spa in Bucharest (Worldclass), a supermarket (Mega Image), bank branches, private kindergarten and after shool „Junior School”, pharmacy (Sensiblu) etc.Globalworth Residence: Upground Towers is a modern residential compound located within walking distance from Globalworth Campus. With a height regime (GF+16F), GLA (sqm) 58,913 comprising 571 units, the project offers for sale and for renting 435 spacious apartments (on average 120 sqm per dwelling), with underground parking spaces for 617 vehicles.

Nearby facilities:Retail: A short journey west of the property lies Promenada Mall, a 36,000 sqm shopping centre catering to the needs of the individuals working in the area.Hotel accomodation: 5-15 walking minutes distance from the Dimitrie Pompeiu building location there are some 4 star hotels with a total of 606 rooms: the Caro Hotel (184 rooms), the Cristal Hotel (74) , the Phoenicia Hotel (348 rooms). New hotels are under development such as the Europa Royal on Dimitrie Pompeiu Boulevard.

CAMPUS PROPERTY DESCRIPTIONThe project perfectly blends in office, retail and other functions in an 88,000 sqm GLA (Gross Lettable Area) development. Built in 2 phases, Globalworth Campus will incorporate the latest technologies and flawless functionality, in order to deliver the very best of office experiences. With a 2,400 sqm floor plate, the development will have a 320 employee floor efficiency and a 1 to 80 parking ratio. It will be anchored by a 3,000 sqm retail gallery and a 720 seat conference centre which, combined with its unique running trail, will make it the focal point of Bucharest’s new CBD. At the end of the construction, Globalworth Campus aims to achieve a BREEAM Excellent certification.



TECHNICAL DESCRIPTION OF THE PROPOSED EMA BUILDINGBuilding at a glance:

Building management system with full control of the equipment and billing system for utilities, parking with controlled access

Four pipes independent HVAC system with fan-coils mounted on the ceiling

2.8m clear height with built-in HVAC systems,

Emergency generator for the vital systems and common areas of the building

Telecom and internet services

24h/7 days security and safety

Control access and video surveillance system

Interior hydrants and sprinkler system

Public announcement system

Energy-saving heating plant (boilers with condensation)

Energy saving Air Handling Units with heat recovery and free cooling

Dedicated chiller backed up by generator for server rooms

Sprinkler system in all common

Easy orientation by proper signalling of the parking, entrances, lobbies, common spaces, elevators and exits

ALL COMMON AND TECHNICAL AREAS USE MODERN SYSTEMS THAT COMBINE HIGH PERFORMANCE AND EASY MAINTENANCE WITH ADEQUATE STANDARDS AND ARCHITECTURE

of common spaces

partitioning and the decorating of the

requirements of each tenant

High performance solar control panes with advanced thermal insulation properties (SGG Cool-Lite ST 120)

Efficiently organized areas with very few waste

Central lobbies and staircases efficiently


DIMITRIE POMPEIU BLVD.

TOWER 3CONFERENCE

HALL

PIPERA

TOWER 22S + P + 12E + Th

2S + P + 12E + Th

2S + P + 12E + Th

TOWER 1

UNDERGROUNDCAR ACCESS

PUBLICACCESS

ACCESS

ACCESS ACCESS ACCESS

ACCESS

PUBLICACCESS



FIRE TRUCKACCESS

FIRE TRUCKACCESS

FIRE TRUCKACCESS

FIRE TRUCKACCESS

(COVERED WITH GREEN AREAS)

The project is designed to incorporate the latest workspace technologies. Globalworth Campus has a flexible layout all the while implementing state-of-the-art technology. The property can accommodate multiple tenant requirements, on site facilities and activities.The proposed building is Tower 2 on the Site Plan below and is part of the already mentioned integrated development project, “Globalworth Campus” consisting of : 3 Class A office buildings; one Conference Hall for 720 seats, parking – under and on the ground parking lots, commercial spaces, green spaces and within walking distance, the residential complex with more than 400 dwellings.

SITE PLAN



STRUCTURAL SYSTEM FEATURESThis office building is located in the northern part of Bucharest, with a height of maximum 60m. The structure has two basement levels, ground floor, 12 floors and one technical floor.

It is a well-balanced, reinforced concrete structural system, with a central shear wall tube and ductile frames. The structural system will allow large openings and provide maximum flexibility for interior design and partitioning.

Seismic resistance: The building is designed for a ground acceleration of 0,24g, in accordance with Romanian Legislation regarding such type of building.

The total Gross Building Area is 36,740.80 sqm with a total office area of 27,431.43 sqm.73

Floor Gross Building Area (sqm) Total rentable area (sqm)

Technic Floor 250.00 0.0012 Floor 2,265.90 2,215.0911 Floor 2,265.90 2,215.0910 Floor 2,265.90 2,215.09 9 Floor 2,265.90 2,215.09 8 Floor 2,265.90 2,215.097 Floor 2,265.90 2,215.09 6 Floor 2,265.90 2,215.095 Floor 2,265.90 2,215.094 Floor 2,265.90 2,215.093 Floor 2,265.90 2,215.092 Floor 2,265.90 2,215.091 Floor 2,265.90 2,215.09Lobby 1,529.00 695.45

-1 Floor 3,885.50 79.89-2 Floor 3,885.50 74.99TOTAL 36,740.80 27,431.43

7 Based on BOMA measurements. Apart from the rented offices, the final rented surface consists also from the added underground car park (about 7.500 sqm), the reception and commercial spaces.


Floor loads:

Romanian legal provisions are aligned with the Eurocode and the design floor loads for offices are: - LIVE LOAD: 3.00kN/sqm - Special loads are taken into consideration for the design of technical rooms – live loads of 7.50 kN/m2 (specific area designated for this purpose on the current floor with an area of max 5% of the total floor rentable area).

MECHANICAL & ELECTRICAL FEATURES

HVAC SYSTEM DESCRIPTION

Heating and cooling: Heating and cooling of the building is achieved with a 4 pipe system with fan coils placed above the suspended

ceiling supplied with chillers and boilers. The system allows flexibility to distribute heating and cooling loads in the building as per tenant requirements and also allows heating and cooling at the same time for the intermediate seasons of spring and autumn. The boilers will be made of stainless-steel with pressurized fireplace, mounted on a chassis, connected in cascade, using the benefit of condensing technology for better efficiencies and will produce thermal agent, by LowNOX modulated burner, functioning with natural gas. The cooling plant consists of two air-cooled chillers (2 screw chillers) and one drycooler. The cooling plant is capable of supplying proper cooling agent to the tenant terminal units to assure cooling needs in winter time by means of freecooling using the drycooler. Additional to these chiller units, the buildings provides a dedicated chiller for IT equipment cooling that will

6 high speed elevators servicing the office tower and two basement elevators

Four pipe HVAC system with a fresh air supply of

7.5 mc / h / sqm

Highly flexible fit-out

Clear height of 2.8m

Openable windows


be able to run in winter conditions (it’s equipped with low ambient kit) to assure the base cooling of small IT rooms.HVAC PARAMETERS (DRAFT)

External design conditions: Winter: temperature -15°C Winter: relative humidity 90% Summer: temperature +35°C Summer: relative humidity 38% Internal design conditions: Winter: temperature +22°C±2°C Winter: relative humidity 30% - 50% Summer: temperature +24°C±2°C Summer: relative humidity 40%-60% Design Occupancy: Open space: 1 person/6 mp (for max 80% of carpet area) Meeting rooms: 1 person/3mp (for max 20% of carpet area) Fresh air: 7.5mc/h/mp (carpet area)

ELECTRICAL SYSTEM DESCRIPTION

Electrical supply distribution:

The electrical power is distributed from the main electrical panel through vertical electrical bus bars providing flexibility and allowing easy match with specifications and power requirements of every client.

Generators&UPS:

The building is provided with 2 back-up generators working in parallel and synchronized that can sustain the vital systems of the building as per local legal requirements. The electrical back-up supply will be designed to cover the following: emergency lighting, 30% of the lighting of the building, 2 plugs per person in the office areas (assuming occupancy of 1person per 8sqm), fire detection system, pumping stations for sprinklers and hydrants, emergency elevators, smoke

exhaust, access control and anything else required by local laws and regulation. UPS will be available for uninterrupted operation of the fire detection and access control. Provisions will be available for the tenants to install their own UPS.

Lighting Design:

For the office areas, high class lighting fixtures are used, designed for mounting into ceiling grids (600 x 600 mm), with florescent tubes and electronic ballast. Decorative lighting of various types plus recessed lighting will be used for reception areas, lobbies and other common spaces.

The lights for the common areas are controlled by BMS double with motion sensors and in the office area are controlled by traditional switches and by light sensors (first row near the façade) based on green accreditation requirements.

The interior lighting is designed with the following parameters (average lighting Em) General offices: 500 lux at 0.8mLift lobbies: 250 lux at 0.0 m Toilets & staircases: 150 lux at mirror / at 0.0 m for staire case Storage rooms & parking: 100 lux at 0.0 m

SANITARY SYSTEM FEATURES

Hot and cold water; sewage and drainage: Preparation of hot water is done through the locally placed boilers. All toilets are equipped with high quality sanitary objects, all with incorporated water tank “type Geberit”. All taps are provided with motion sensors for reduced water consumption. All the fixtures will have low flow or low flush feature. For sewage and rain water drainage systems, high quality PE are used to ensure durability and noise reduction.


Hydrants and sprinklers:Fire protection of the building is achieved through hydrants, dry risers and dual layer sprinkler systems that are covering all offices and common areas.

BUILDING’S SECURITY FEATURES

Access control: The access control system in the building is provided with turnstiles at the reception area ensuring restricted access to office areas. The system is

modular. All technical spaces are access-controlled and secured and evacuation staircases are open only in emergency. A special security control room, close to the lobby entrance, will be put in place for the access control system and CCTV system control office.According to the EMA requirements provision of natural or build barriers shall be placed in the building perimeter.

Building management system:

The building is provided with automated building management system that integrates and monitors the building systems and controls the energy consuming systems such as heating and cooling, generators, pump stations, emergency systems, AHU.

CCTV The building common areas and exteriors are monitored through video surveillance system with

latest technology cameras placed on all entrances, ramps, basements, exterior etc. with high area coverage and very detailed information that is stored in NVR devices. The CCTV system complies with the EDP (28 days retention capacity).

Fire detection alarm: A fully addressable fire detection system will be available, with battery back-up in all areas in


accordance to fire legislation in force.Public address system: For the efficiency and operation of the building a modern public address system is installed in all public areas for all kind of announcements.

TELEPHONE AND INTERNET PROVIDERS Access for all local telephone and internet providers will be available in the building by means of two connections to the NetCity network. The building has UPS power for all technical rooms, able to support all IT equipment for 60 minutes.The building has the technical posibility for IT network in all offices and meeting rooms with 2 connections for each workstation for redundancy. WiFi on all floors throughout the premises.

FINISHES & ARCHITECTURE FEATURESBuilding envelope: All office spaces are provided with natural light as all the building is surrounded with curtain wall façade. The curtain wall is designed to build a more sustainable and low-energy building using semi-structure high thermo-insulation Aluminium system at the same time insuring maximum resistance to wind loads. The system selected is modular, the most suitable for high rise buildings that allows quick installation, easy maintenance and durability. The glass used is sun reflective in order to ensure maximum thermo-insulation and improved thermal coefficient at the maximum extent. Materials used: modular facade Schuco UCC 65 SG; glass: Saint Gobain Cool Lite ST 120.

Ceiling finishes&free floor height:Suspended ceiling system with tiles 600x600mm in the office space with normal level of acoustic absorption and attenuation and variable sizes for common space with high level of acoustic absorption and attenuation.

The free floor heights are set as follows: - Ground Floor - minimum 4.30m - Floors and office areas: minimum 2.80m

Raised floor: For the accommodation of under floor cabling and floor boxes, raised floor will be provided for all office areas. Raised floor will be medium duty, H=15cm calcium sulphate incombustible as per requirements of local legislation.

Lifts:The building is provided with 8 lifts as follows: - 6 high speed lifts of 24 persons (1800kg) capacity for the office tower, out of which 2 are for firefighters in emergency cases, speed 2.5m/s - 2 lifts exclusive for the parking levels (1, 2) - the lifts are low voltage, to assure energy efficiency of the building.

Entrance/ground floor: The main lobby of the office building is easily accessible from a large platform connected with Dimitrie Pompeiu Boulevard and George Constantinescu Street through a large entrance with revolving door and two adjacent escape doors. This space is also accessible by two escape doors on the secondary façade, in direct relation with the green spaces and the interior street of the ensemble. Depending on the tenants’ requests, the main lobby will be furnished with modern high quality materials: special lighting, large ceramic/ glass panels and metalic perforated panel - cladding on the walls, high quality ceramic on the floor, elegant reception front desk, all the security requirements.The Ground Floor of the building could accommodate different dedicated spaces, according to the final specification, with different access door from those of the lobby. The areas between the exterior sidewalks and the interior parking or car routes are covered with green grass and trees.


Tenant facilities:On each floor, the common spaces are provided with two groups of restrooms and one restroom for disabled persons. There is a waste management system in place with recycling system throughout the building.There is provision for one kitchenette on each floor with direct access from the office areas with totally independent ventilation system. There is an area dedicated for server/storage/archive room on each floor with direct access from the office areas and with all the requested provisions (increased loading capacity, provisions for cooling from separate chiller). The lighting of the common spaces as well as the water supply from sink taps are provided with motion sensors, energy efficient, equipped with low flow equipment. Additional fire security through dual layer sprinkler system is provided. The parking area has a specialy equiped area for bicycles for sole use for : 100 spaces, 7 showers, 2 changing rooms.Provisions for the disabled: The building is equipped with all necessary items for disabled persons: - There is one toilet for disabled persons on each floor;- There are special parking places dedicated to disabled persons;- The access in the building is easy as the Ground Floor level is connected with the exterior level through a dedicated ramp.EXTERIOR The exterior of the building meets a nice environmental landscape with great access organization both for car access and for pedestrians, lots of green areas, benches etc. There is easy access from Dimitrie Pompeiu Blvd as well as from George Constantinescu Street. Car access is controlled with barriers. The exterior lighting offers nice exterior environment and safety. GREEN CERTIFICATION The building is designed and constructed to be one of the most environmentally friendly buildings in Bucharest.The project boasts with being one of the buildings in Romania candidate for achieving BREEAM Excellent Certification. This target was set from the design stage with high end furnishings, façade and installations and using innovative design solutions.ACCESS TO THE BUILDINGIn time, the Central Business District of Bucharest (further mentioned as CBD) has evolved from Victoriei Square (now considered old CBD), to the current location due to the development of new and modern logistics, especially easy access to all means of transportation. Among multinational companies relocated to the same area, we can mention: Honeywell, Vodafone, Bayer, Orange, Schnider, Carrefour etc.Globalworth Campus and the porposed Tower 2 EMA building is located only 3 metro stops away from Victoriei Square and is easily accessible by over-the-ground means of public transportation (trams 5 and 16). The Pipera metro station sits directly in front of the property, while car access is via Dimitrie Pompeiu Boulevard. The Campus also celebrates sustainable and green commute options, offering secure bike storage, changing rooms and lockers.


The underground transportation map

HIGH STANDARD MEETING FACILITIESApart from the specific meeting requirements for the EMA building, the Globalworth Campus offers a 720 seat conference hall, one of the highest standard meeting facilities. The conference hall is a sound proof space with state-of-the-art equipment such as: audio and video recording facilities, input for laptop, equipment to generate broadcast, UPS power and cetral air conditioning system. Special security arrangements will be put in place considering the client’s requirements.

Piaţa Unirii

Universitate

Piaţa Romană

Aviatorilor

Piaţa Victoriei

Tineretului

Piaţa Sudului

M2 Metro Line

GLOBALWORTHCAMPUS

LEGEND

PIPERA

M

OLD CITY CENTER

Triumph Arch

Promenada Mall

Herastrau Park

RomanianGovernment

Bucharest Universityof Economic Studies

Romanian Athenaeum

University of Bucharest

Bucharest National Theatre

The Palace of Parliament

Unirea Shopping Center

Sun Plaza Mall

Tineretului Park

EDUCATIONAL

LANDMARK BUILDINGS

RETAIL

PARK


1.3. IT&C of the building

• Excellent telecommunications network with high capacity digital network provided using two secured underground connections viaMetropolitan Network (Netcity8).4The network can support any speed transfer.

• Connectivity: mobile cellular communications of the building, including Internet access, are covered by

indoor 4G signal repeaters; superfast broadband fixed and Wi-Fi Internet access are also available via optic fibre in-house wiring and indoor Wi-Fi access network. We can also provide indoor wireless network coverage for LAN infrastructure.

• International (and local) IT provision of Data Centre facilities is supported by at least 5 different IT providers of Tier 3 or above data centres in Bucharest (i.e. IBM, CloudFlare, M247, Telekom, Omnilogic, StarStorage, etc.). They can provide a main and a backup data centre for disaster recovery, both to be accessed from the EMA premises via a fast high volume Internet access fibre connection.

• Minimum two Tier 3 data centres (with collocation options) in geographically independent locations (power grid, flood zones).

• Green energy standards ISO 14001, 50001 are available and subject to the EMA selection process of suppliers for the data centre.

• Security&operational standards ISO 27001, 9001, SSAE16, PCI-DSS: most suppliers are fully compliant with mentioned standards, the suppliers’ selection process will consider the mentioned standards.

• Ideally, Microsoft ExpressRoute & Direct Connect connectivity: the mentioned requirement is on request at

8 NetCity is the Bucharest City Hall project to help digitize the capital city of Romania. It provides for the transfer of underground cables within the project area (final projected length of around 1,400km)


Microsoft. The building is located 200 m away from the two most important Romanian neutral collocation centres, NX Data 1 and NX Data 2. They can provide direct circuit connections, considering Microsoft has the mentioned service. Other 5 data centres are located within 800 m.

• Adequate carrier infrastructure, both for campus, data centre and home working facilities (may require selection of Tier 1 carriers): two internal optic fiber rings and two different underground entrances, secured, for providers. Each entrance comes from a different street, from different points of the metropolitan undergrounded network.

• Ability to cater for a disaster recovery site requirement in a geographically independent location (power grid, flood zones) from the main campus: the location has the possibility to implement such a requirement, based on more detailed EMA specifications.

1.4. Proposed financial arrangements for the building

In Annex 4 to the present document, subject to confidentiality, are presented the main commercial terms proposed for the Lease Contract. The information and prices are subject to final arrangements with EMA representatives. Apart from the Lease Agreement, the mentioned Annex 4 includes also the Romanian Goverment’s commitment to support the EMA.


II2.1. Enabling scientific experts from all EU Member States to meet at EMA in Bucharest

Major international airport hub – Henri Coanda Airport Bucharest (OTP) located at 12 km from EMA headquartes and serving all EU Member States within 3-4 hours flight time, with over 220 direct and connecting flights per day

The Henri Coanda International Airport will be connected to the existing Metro network, by completion of Line VI running from Bucharest - Otopeni - Henri Coandă International Airport, the Line providing for a transport capacity of 50,000 passengers/hour/direction.

Special dedicated line of transportation for EMA staff and delegates

The Municipality, through the Autonomous Public Entity for Transportation, can provide, using its own means of transportation, a special dedicated line of transportation between the new EMA location and the destinations required by its personnel, all around Bucharest, including on the route from/to the International Henri Coandă Airport.

There are 4 well-connected, secure and accessible subway lines with modern trains and stations provided with safety and comfort facilities (waiting

time electronic display, accessibility for passengers with disabilities) – fare for 2-trips: approx. 1.1 €Competitive taxi services - Average Taxi Fare: 0.45 €/kmExtensive network of public bus, trolley bus and tram transportation – fare for one-trip: approx. 0.30 €.

2.1.1. Major international airport hub serving all EU Member States (MSs) in maximum 3-4 hours flight time, with high flight frequency and carrier choice.

• International Henri Coanda Airport provides multiple daily flight connections which will allow EMA experts and visitors to travel to-and-from all EU Member States to Bucharest

• Perspectives to relaunch direct long haul services from Bucharest to destinations in North America and Asia, operated by the Romanian national air carrier, TAROM

• Excellent corporate commercial offers provided by TAROM, in its entire domestic and international network, at competitive fares

• Within 3-4 hours flight time, direct or connecting regular flights operating from the “Henri Coanda” International Airport Bucharest to 84 European destinations in 29 countries, out of which 23 European capital cities.

There are non-stop flights to Bucharest from most major European cities and in the Middle-East and connecting flights from the United States, Canada, Australia and New Zealand through various European and Middle Eastern Hubs. Apart from international air carriers, Romania’s national air carrier TAROM has concluded commercial agreements with major airlines in Europe and the Middle East. On top of that, due to its recent shift in strategy, TAROM is negotiating the opportunity of re-launching its direct long haul services from its Hub in Bucharest to destinations in North America and Asia, with a possible start of operations from 2018.

The accessibility of the location


The information below shows flight frequency and carrier choice for EU capital cities.

Nr.crt.

City Number of direct/ connecting flights/day Carrier

Average price in Euro (for economy

class)1. Amsterdam 14 KLM, TAROM, LOT, LUFTHANSA 60 - 200

2. Athens 5 TAROM, AEGEAN AIRWAYS, RYANAIR, BULGARIA AIR 33 - 141

3. Berlin 9 TAROM, BLUE AIR, GERMANWINGS, AUSTRIAN, AIR SERBIA, LUFTHANSA, SWISS, KLM, EUROWINGS 63 - 256

4. Brusselles 5 TAROM, BLUE AIR, LOT, KLM, LUFTHANSA 57 - 200

5 Budapest 3 TAROM, WIZZ AIR 32 - 286

6. Copenhagen 10 SAS, AUSTRIAN, LOT, LUFTHANSA, 66 - 210

7. Dublin 7 BLUE AIR, RYANAIR, LUFTHANSA, KLM, BRITISH AIRWAYS 41 - 277

8. Helsinki 6 BLUE AIR, LUFTHANSA, KLM 107 - 242

9. Larnaca 3 TAROM, BLUE AIR, WIZZAIR 47 - 283

10. Lisbon 9 BLUE AIR, TAP PORTUGAL, WIZZAIR, AIR FRANCE, LUFTHANSA, KLM, 73 - 324

11. London 9 TAROM, BRITISH AIRWAYS, RYANAIR, SWISS, LUFTHANSA, KLM, AUSTRIAN 84 - 407

12. Madrid 8 TAROM, WIZZAIR, BLUE AIR, LURTHANSA, KLM, AUSTRIAN 42 - 205

13. Malta 3 WIZZAIR, AUSTRIAN, AIR MALTA, TAROM 82 - 195

14. Oslo 7 BLUE AIR, LUFTHANSA, KLM, AUSTRIAN, RYANAIR 101 - 381

15. Paris 4 TAROM, AIR FRANCE, AIR EUROPE, VUELING AIRLINES, 59 - 37716. Prague 2 AUSTRIAN, LUFTHANSA 63 - 18617. Rome 4 TAROM, BLUE AIR, LUFTHANSA, TURKISH AIRLINES 38 - 15118. Sofia 2 TAROM, 47 - 223

19. Vienna 7 TAROM, LUFTHANSA, LOT, AUSTRIAN 62 – 192

20. Stockholm 8 SAS, LOT, AUSTRIAN, LUFTHANSA 58 – 166

21. Warsaw 3 TAROM, LOT 57 – 21022. Zagreb 3 CROATIA AIRLINES, AUSTRIAN, LUFTHANSA 102 - 452

23. Riga 3 LUFTHANSA, AEROFLOT, LOT 91 - 212

24. Tallin 6 LOT, LUFTHANSA, AIR BALTIC, KLM, AEROFLOT 82 - 294

25. Vilnius 6 KLM, LOT, RYANAIR, WIZZAIR, AIRBALTIC AUSTRIAN, LUFTHANSA 91 – 182

26. Luxemburg 10 AUSTRIAN, LUXAIR, LUFTHANSA, KLM, AIR FRANCE, TAROM, RYANAIR 93 - 234

27. Ljubljana 6 ADRIA AIRWAYS, LUFTHANSA, AUSTRIAN, SWISS, 111 – 492

28. Bratislava 7 LUFTHANSA, AUSTRIAN LOT, TAROM, 59 - 199

TOTAL 220 -----


• Henri Coanda International Airport95 (OTP)Henri Coandă Airport is located 18 km (11 miles) from downtown Bucharest. Most international flights arrive at Henri Coandă (Otopeni) Airport.Airport facilities include ATM, currency exchange office, Taxi Desk and cell phone rentals. Major car rental companies have offices located on the arrivals/ baggage claim level. Domestic Flights: Scheduled domestic flights from/to Cluj-Napoca (CLJ), Iasi (IAS), Oradea (OMR), Satu Mare (SUJ), Sibiu (SBZ) and Timisoara (TSR) also depart from/ arrive to Henri Coandă Airport.Direct airlink with European capital cities: Within 3-4 hours flight time, direct, regular flights operate from the “Henri Coanda” International Airport Bucharest, to 84 European destinations in 29 countries, out of which 23 EU capital cities

• Baneasa AirportBaneasa Airport, located 8,5 Km (six miles) from downtown Bucharest, is the second airport in Bucharest, mostly used for private planes, or sport activities

2.1.2. Excellent public transport links from airports to downtown Bucharest

• Transportation between Henri Coandă International Airport and city centre

• Bucharest city centre can be reached by bus, taxi or train connections, directly from the airport

By taxi - Cheap taxi fares, with rates/km starting from 1.39 RON to 3.50 RON (the equivalent of 0.31 eurocents to 0.78 eurocents at the exchange rate of 1Euro=4,50 lei).

By bus: Connections with the city centre and the main train station are ensured by two express buses, 780 and 783. The journey to downtown takes

9 Henri Coandă (1886–1972), aviation pioneer and inventor of the jet engine

approximately 40 minutes. A roundtrip ticket costs 7.00 Lei (about 1.56 Euro at the exchange rate of 1 Euro=4.50 lei).

By train: Henri Coanda Express Trains offer daily service from Balotesti (0.5 miles from the airport) to the main train station (Gara de Nord) with one stop at Mogosoaia. Trains run hourly from 5:56 a.m. to 9:00 p.m. The journey from the airport to the main train station takes about one hour and 10 minutes. One-way ticket costs 6 Lei (about 1.34 Euro at the exchange rate of 1 Euro=4.50 lei). Transfer from Balotesti train station to the International Arrivals Terminal is included10.6

Railway connection For better railway connections with the Henri Coanda International Airport, the General Transport Master Plan of Romania also includes a project related to achievement of the railway connection between the North Railway Station and the Henri Coanda Airport, running 19.6 km in length and estimated at 97.15 million Euro.Currently, the CFR Călători company operates 34 daily trips from the “Henri Coandă” Bucharest International Airport to the North Station in Bucharest, combined with transshipment by road transport (using CFR Călători owned vehicles) to the “PO Otopeni Airport” hub.To facilitate travellers’ access from the airport to the trains, transfer minibuses are boarded at the 1st floor bridge, the international arrivals area, where the ticket stand is also located.

Express trains run according to the following hourly timetable:Airport - Bucharest North Station: first trip 05:44 to 19:59, the last trip;Bucharest North Station - Airport: first trip 05:40 to 19:50, last trip (37 trips in total).

10 Tickets can be purchased at the CFR booth International Arrivals Terminal

https://en.wikipedia.org/wiki/Henri_Coand%C4%83

https://en.wikipedia.org/wiki/Jet_engine


From the Bucharest North Railway Station, connections to all city areas are provided by both metro and public transport, ensuring night-time routes as well.

Bus transportation between Baneasa airport and city centre Bus #131 and #783 to downtown Bucharest Bus #205 and #780 to the main train station (Gara de Nord) The express bus system is more useful for reaching destinations outside the city centre, as only a few express buses actually pass through the centre itself. Two- or 10-journey tickets, as well as monthly passes, are available for these buses.

Car RentalAll major international and local car rental companies are represented in Romania’s capital city. On average, the car rental per day in Bucharest is 20 lei or about 4.45 Euro.

2.1.3. Means of transportation in the capital city

• Bucharest’s public transportation network includes: subway, bus, trolley bus and tram

• 4 well-connected, secure and accessible subway lines with modern trains and stations provided with safety and comfort facilities (waiting time electronic display, accessibility for passengers with disabilities) – fare for 2-trips: approx. 1.1 €

• Competitive taxi services - Average Taxi Fare: 0.45 €/km

• Extensive network of public bus, trolley bus and tram transportation – fare for one-trip: approx. 0,30 €

• Of utmost importance for public transportation

in Bucharest is the high level of security for the people. Passenger security in the Bucharest subway is high standard and comprises video surveillance of passenger flows (CCTV), security personnel for access to the paltforms and security personnel in the subway trains.

The Plan for Sustainable Urban Mobility 2016 – 2030 for the Bucharest – Ilfov Region is a strategic development document that uses a software, IT application, for simulating and planning transports and aims at meeting the mobility needs of the people and businesses in this area in order to improve the quality of life, at the same time contributing at reaching European targets regarding environment protection and energy efficiency. Thus, the development vision of the Plan is to build an efficient, integrated, sustainable and safe transportation system promoting economic, social and territorial development and providing a good quality of life.The Autonomous Transportation Enterprise of Bucharest (RATB), entity under the subordination of Bucharest Municipality, provides public transportation and has a total fleet of 1,929 units formed of buses, trolleybuses and trams and 155 routes. There is a bus route that provides a permanent link between the centre of the city and the International Henri Coandă Airport.

There are four subway lines (M1, M2, M3 and M4). Subway stations are indicated with the letter “M” (blue, on a white board). At present, the fifth main line, M5, is under construction and has a length of 6.5 km and 10 stops.At the end of 2022, the Henri Coanda International Airport will be connected to the existing Metro network, by completion of Line VI running from Bucharest - Otopeni - Henri Coandă International Airport, the Line providing for a transport capacity of 50,000 passengers/hour/direction.

http://romaniatourism.com/bucharest.html#carrental


The metro provides fast, proper and economical transportation and maintains its market share. The number of passengers transported by metro is about 20% of the total number of those using public transport, whereas the length of the metro network is approximately 4% of the total public transport network of Bucharest. The Romanian metro is placed in the first half of the ranking of European countries, displaying an obvious upward trend in that respect.

Subway fares (at the exchange rate of 1 Euro=4.50 lei):2-trip metro card: 5 Lei (about 1.1 Euro) 10-trip metro card: 20 Lei (about 4.5 Euro )1-day unlimited pass: 8 Lei ( about 1.78 Euro) - unlimited rides during one day7-day unlimited pass: 25 Lei (about 5.56 Euro) - unlimited rides during one week

month unlimited pass: 70 Lei (about 15.6 Euro) - unlimited rides/calendar month

Access in all 51 stations is provided by 100 elevators and through special gates that allow use by people with physical disabilities as well. Also, all cabin trains are equipped for people with disabilities, children and elderly persons.

The subway operates from 5:00am until 11:00pm.RATB maps can be found at stands near bus and tram stops or online at http://www.ratb.ro/eng/index.php

Starting with 2007, the RATB has introduced low floor tram carriages and Euro 4 Mercedes Citaro buses.

To find the best options for point to point public

2h

3h


http://www.ratb.ro/eng/index.php


Bucharest

Chisinau

Kiev

Sofia

Belgrade

Athens

Heraklion

Thessaloniki

Rome

Alghero

Perugia Pescara

Bari

MilanVerona

Florence

Venice

Pisa

BolognaTurin

Hamburg

Hannover

Stuttgart

Zurich

Berlin

Nuremberg

Munich

Prague

Warsaw

Moscow

Vienna

Budapesta

Zagreb

Cologne Bonn

FrankfurtLondonBristol

BirminghamLiverpool

Doncaster SheffieldDublin

Glasgow

Larnaca

Antalya

İstanbul

Tel Aviv

Beirut

Amman

Paris

Bordeaux

Bilbao

Lyon

Geneva

Basel - Mulhouse

Nice

Barcelona

Zaragoza

Valencia

Alicante

Malaga

Castellon

Lisbon

Naples

Lamezia Terme

Catania

Malta

Palermo

Brussels

AmsterdamEindhoven

Dortmund

DusseldorfLiege

Tenerife

CopenhagenBillund

Stockholm

Malmo

Oslo

Madrid

Helsinki

Bucharest ›• Alghero • Alicante • Amman • Amsterdam • Antalya • Athens • Barcelona • Bari • Basel – Mulhouse • Beirut • Belgrade • Berlin • Bilbao • Billund • Birmingham • Bologna • Bordeaux • Bristol • Brussels • Budapesta • Castellon • Catania • Chisinau • Cologne-bonn • Copenhagen • Doha • Doncaster-sheffield • Dortmund • Dubai • Dublin • Duesseldorf • Eindhoven • Florence • Frankfurt • Geneva • Glasgow • Hamburg • Hannover • Helsinki • Irakleion • Istanbul • Kiev • Lamezia terme • Larnaca • Liege • Lisbon • Liverpool • London • Lyon • Madrid • Malaga • Malmo • Malta • Milan • Moscow • Munich • Naples • Nice • Nuremberg • Oslo • Palermo • Paris • Perugia • Pescara • Pisa • Prague • Pune • Rome • Sofia • Stockholm • Stuttgart • Tel aviv-yafo • Tenerife • Thessaloniki • Turin • Valencia • Venice • Verona • Vienna • Warsaw • Zagreb • Zaragoza • Zurich


transportation or to locate a street in Bucharest, there is a free Internet option: www.transporturban.ro/en. Buses, trams and trolley buses operate between 5:00am and 11:59pm.

Tickets/cards must be purchased beforehand and validated upon boarding.Tickets or passes can be purchased at any stand displaying the RATB logo (The Autonomous Transportation Enterprise of Bucharest).Travellers may be required to show the validated ticket/card during the trip.

Bus / tram / trolley bus fares11:7magnetic travel card (electronic wallet): 3.70 Lei (Euro 0.82) one-trip ticket or one-trip-fare: 1.30 Lei (Euro 0.30)day pass: 8.0 Lei (Euro 1.78)week pass: 17.0 Lei (Euro 3.78)two-week pass: 25.0 Lei (Euro 5.56)month pass: 50 Lei (Euro 11.20)

Tickets are interchangeable for the bus, tram and trolley bus, with the exception of express buses.

11 Exchange rate used is: 1Euro = 4.50 lei

http://www.transporturban.ro/en


2.1.4. Taxi transportation

Numerous taxi companies operate in the city at one of the lowest fares in Europe.

2017 Average Taxi Fares in Euro, in some EU cities12:8

No City Taxi start Taxi 1 km Range 10 Km

1. Bucharest 0.45 0.45 4.95

2. Budapest 1.46 0.91 10.56

3. Vienna 3.85 2.18 25.65

4. Berlin 3.90 2.00 23.90

5. Amsterdam 3.95 2.18 25.75

6. Milan 5.00 1.09 15.90

7. Tallin 2.50 0.50 7.50

8. Lille 5.00 1.90 24.00

2.1.5. Bicycle rental

Friendly bike rental facilities and cycling infrastructure with major expansion prospectsThe General Council of Bucharest has passed a project for construction of 42 bicycle circuits in Bucharest, besides those already existing.

All major cities in Romania, including Bucharest, have their local or national bicycle rental companies. On average the bicycle rental per day in Bucharest is between 5 lei and 80 lei, or 1.12 euro and 17.78 euro at1 euro = 4.50 lei.

For the first time in Bucharest, the first automatic stations for renting bicycles have been launched, I’Velo Urban. These bicycles will provide better mobility for the citizens, being placed in the most important places in Bucharest, on the routes with the highest inflow of public transportation travellers. The automatic bike-sharing stations are: Piața Universității, Piața Revoluției, Piața Romană, Piața Victoriei, Piața Charles de Gaulles, Kaufland Barbu Văcărescu, near the subway stations.

12 https://www.numbeo.com/taxi-fare/in

http://romaniatourism.com/bucharest.html#bicycle

https://www.numbeo.com/taxi-fare/in


2.1.6. Other transportation means connecting Bucharest to EU cities

The Romanian railway network covers the entire country, with 10,632 km length of routes and a 19,868 km developed length. In 2011, the Romanian railway network was the eighth largest network in the European Union. The Romanian railway network has a density of 533.5 km / 1,000,000 inhabitants, exceeding the European Union average of 429.4 km network per million inhabitants.

The national company operates several trains providing direct connections to the following European cities: Vienna, Budapest, Istanbul, Chişinău, Sofia and Tessaloniki. Connection trains are provided to the other European cities.

At the same time, according to the Master Plan of General Transport in Romania, preparation of a range of projects for high-speed railway, successive schedule and rail services are starting this year, including a set of projects and investments related to both the railway and railway services, in order to capitalize on the socio-economic potential of certain development regions in Romania.

The proposed project package aims to increase the attractiveness of rail passenger transport (with immediate favourable effects for freight transport), by decreased journey time, increased safety and comfort, as well as by introducing certain railway services. The railway-directed projects and investment package will be implemented for railway sectors with a higher potential for attracting passengers and serving economically and socially attractive areas.


There are a number of concessionary fares for passengers travelling by train, local buses or inter-county buses. For example, in Bucharest, the following persons are exempt from fares: children under the age of 7, war veterans, persons with disabilities and all categories of pensioners. High school and university students attending day classes benefit from discounts of 50% of the monthly transport card. In the case of train transport on SNCFR trains, primary and secondary school students, as well as full-time university students at public universities or at accredited private universities benefit from 50% discounts for ‘regio’ train fares in second class, whereas pensioners benefit from 6 one-way second-class tickets at a 50% discount for ‘regio’ and ‘interregio’ train fares in second class. Private railway companies also offer discounts of 50% on fares for pupils/students/pensioners.Several international bus companies operate regular transport to most EU countries destinations.

2.2. Accomodation for experts and delegates

Convenient accommodation for delegates and experts in over 140 hotels and 10.000 hotel rooms ranging from exclusive to mid-range

Bucharest offers a range of hotels to ease travel experience of experts or delegates in order to maximize their productivity at the EMA headquarter. The price boundaries are consistent with the offered services and number of stars. The star system in Bucharest is consistent with the European one, with major international hotels present in the City.The table below shows all Bucharest hotels ranked by stars, including number of rooms and number of beds.

Bucharest Hotel Industry In Numbers as of March 2017139

HOTEL STARS NUMBER OF HOTELS NUMBER OF ROOMS NUMBER OF BEDS

5 stars 10 1,940 3,854

4 stars 49 5,092 9,968

3 stars 56 2,235 4,364

2 stars 20 807 1,499

1 star 5 297 566

TOTAL 140 10,371 20,251

Hotel accommodation: 5-15 minutes walking distance from the Dimitrie Pompeiu’s building location, there are some 4 star hotels with a total of 606 rooms: the Caro Hotel (184 rooms), the Cristal Hotel (74) , the Phoenicia Hotel (348 rooms). New hotels are under development such as, the Europa Royal on Dimitrie Pompeiu Boulevard.

13 Source: 2017, Ministry of Tourism monitoring system.


III3.1. Strong Educational System

• The Romanian educational system is based on strong European traditions and a multilingual environment of education for both children and adults;

• It has evolved taking into consideration the labour market and its modern needs, offering a diverse range of modern curricula and specialities;

• Education in Romania is based on a free-tuition, egalitarian system;

• EU-recognition of diplomas;• Bucharest offers a wide range of educational

institutions for all ages, from nurseries, kindergartens, secondary schools and high schools;

• Over 450 public primary and secondary schools, while over 30 schools (from pre-school to high-school) feature international profiles. In most of those schools, the language used is English, although international schools with German, French, Spanish and other non-EU languages also operate in Bucharest;

• 3 public schools with education provided in mother

tongues (Bulgarian, German or Hungarian);• 6 private schools in Bucharest registered as

operating according to the rules and principles of different education systems (3 UK, FR, EL, US);

• Higher education offer in Bucharest is free for top students admitted to undergraduate degrees in public universities;

• 12 public universities and 15 private universities, offering 50 Bachelor programmes in English, 17 Bachelor programmes in French, 8 Bachelor programmes in German;

• 84 Master programmes offered mainly in English;• Doctoral studies are in Romanian, with the

possibility to be organized in an international language as well, upon student’s request.

A high percentage of language skilled citizens. 97% of Romanian high school students study two or more foreign languages. The predominant languages are English, French, German and Spanish, yet initiatives for teaching Japanese, Nordic languages or the entire Latin language family (Spanish, Italian, French) exist.

FacilitiesAdequate facilities for children of EMA staff


In order to match the needs of the EMA staff and their families, the Romanian proposal presents its international school offer for the children of the EMA staff.

Education in Romania is based on a free-tuition, egalitarian system. Access to free education is guaranteed by Article 32 of the Romanian Constitution, based on one of the main humanitarian European principles formulated by Immanuel Kant in the 18th Century: proclaim the natural dignity and inherent worth of all human beings. Education is regulated and enforced by the Ministry of National Education. Each step has its own form of organization and is subject to different laws and directives.

The national educational system:• has open character, allowing for the mobility of pupils, by transfer from one school unit/form/field of

study/pathway to another;• has pluralistic character (public or private schools, in educational alternative systems such as Step by

Step, Waldorf, Freinet, Montessori etc.) and provides schooling methods in the official state language (Romanian), in the native languages of pupils from national minorities or in languages of international circulation.

3.2. Bucharest offer

3.2.1. Nurseries and kindergartens (age group 0-3 years and 3-6 years) Early childhood (0-6 years old) education includes before preschool level (0-3 years) and preschool (3-6 years) and is organized in younger/toddler group, middle group and pre-schoold proper group.1411

Before preschool early education can take place in nurseries, kindergartens and day care centres, public or private, according to the same educational content and in compliance with the same national standards.

Preschool education is conducted in kindergartens and schools (public or private) with pre-school education forms, according to the same curriculum and following the same national standards.

Children are organized, on a regular basis, by homogeneous age groups.

14 Guide for enrollment in kindergarten (ARACIP - 2016)

“We express our commitment to ensure that all the requests on the schooling of the 648 EMA’s staff children are met in due time and confirms the availability of the international, private and public schools from Bucharest to enroll the children.”

-The Romanian Ministry of National Education

https://en.wikipedia.org/wiki/Romania

https://en.wikipedia.org/wiki/Ministry_of_Education_(Romania)

http://www.edu.ro/sites/default/files/_fi%C8%99iere/Invatamant-Preuniversitar/2016/prescolar/ghiduri/Ghid ARACIP inscriere gradinite 9 apr 2016.pdf


The table below gives examples of private kindergartens in Bucharest with teaching languages other than Romanian.

No Name of the school Adress Status Teaching language, other than Romanian

1 The Educational „Lauder - Reut” 15 Iuliu Barash St, sector 3, AccreditedBy MEN English

2 ”FRIDOLIN” Kindergarten 9-13 Făgăraș Street, Sector 1 AccreditedBy MEN

German, as a native language

3 Adiwelt Kindergarten Str. Elena Cuza nr. 55 – 57, sector 4 AccreditedBy MEN

German, as a native language

4 "SOS Satul Copiilor" Kindergarten Calea Floreasca nr. 165, sector 1 AccreditedBy MEN English

5 Primary School ”Romania-Finish” Municipiul București, str. Răsăritului nr. 59

AccreditedBy MEN Finish

6 „Happy Planet Kids” Kindergarten Str. Lt. col.C-tin Marinescu nr.17, sector 6

AccreditedBy MEN English

7 "Olga Gudynn International School" Kindergarten Str. Băneasa Ancuța nr. 8, sector 2 AccreditedBy MEN English

8 „Sfântul Andrei ” Kindergarten Str. Bulgăruş nr. 44, sector 5 AccreditedBy MEN English

9 King s Oak British International School Str. Petre S. Aurelian nr 66, sector 1 AccreditedBy MEN English

10 Verita International School Bd. Dacia nr 79, sector 1 AccreditedBy MEN English

With a flexible payment system, the average yearly costs/child in private kindgergartens are: for a half day nursery – an average of 6,000 euro/year; for a full day nursery – an average of 7,800 euro/year.

3.2.2. Primary and secondary school

Compulsory schooling usually starts at age 6, with the “preparatory school year” (clasa pregătitoare), which is mandatory for enrolment in the first grade. In Romania, high school starts in the 9th grade and generally takes 4 years to complete; vocational high schools take 5 years. Public institutions do not charge tuition fees and offer scholarships to students with


academic merit or/and underprivileged.

The Romanian secondary education system includes:• National colleges: the most prestigious, well equipped and internationally-connected secondary-school

institutions in Romania;• Economic and technical colleges: both offer academic programs geared towards technical/service

industry training;• High schools: usually a high school’s name is indicative of its academic focus: theoretical high schools,

economic high-schools etc.;• School groups: two schools that have teamed up, generally a high school offering technical or service

industry programs and a School of Arts and TradesSchooling is d until the tenth grade (Lower Secondary), which corresponds to the age of sixteen or seventeen.

The school educational cycle ends in the twelfth grade (Upper Secondary), when students graduate the baccalaureate.

Relevant public schools in Bucharest teaching in languages other than Romanian In Bucharest, there are public schools where teaching is in Bulgarian, German or Hungarian, as mother tongues, education being offered from pre-school to high-school.

Public Schools teaching in Bulgarian, German and Hungarian

No School Name Teaching regime/program

1 Goethe National German College (from pre-school to high school) German, mother tongue

2 Ady Endre Theoretical High School Bucharest (from pre-school to high school) Hungarian, mother tongue

3 Hristo Botev Theoretical High School ( from primary to high school) Bulgarian, mother tongue

https://en.wikipedia.org/wiki/Romanian_Baccalaureate


Bilingual education is offered in English, French, German, Italian, Spanish and Portugues in a number of public schools in Bucharest, presented in the table below.

List of public schools providing bilingual education divided by Bucharest administrative districts according to the rules and principles of the Romanian education system

District School Name Level Teaching regime/program

1 National College "I.L.Caragiale" Upper Secondary English - Bilingual

1 National College "I.L.Caragiale" Upper Secondary German - Bilingual

1 National College "Ion Neculce" Upper Secondary Italian - bilingual

1 National College "Sfântul Sava" Upper Secondary English - Bilingual

1 High School "Alexandru Vlahuţă" Upper Secondary German - Bilingual

1 High School "Nicolae Iorga" Upper Secondary English - Bilingual

1 Bilingual High School "Miguel de Cervantes" Upper Secondary Spanish - bilingual

2 National College “Şcoala Centrală” Upper Secondary French - bilingual

2 National College "Cantemir Vodă" Upper Secondary English - Bilingual

2 National College "Iulia Haşdeu" Upper Secondary English - Bilingual

2 National College "Iulia Haşdeu" Upper Secondary Spanish - bilingual

2 National College "Spiru Haret" Upper Secondary English - Bilingual

2 National College Bilingv "George Coşbuc" Upper Secondary English - Bilingual

2 High School Bilingv "Ita Wegman" Upper Secondary German - Bilingual

3 High School "Dante Alighieri" Upper Secondary Italian - bilingual

4 National College "Ion Creangă" Upper Secondary English - Bilingual

6 National College "Elena Cuza" Upper Secondary English - Bilingual

6 High School "Eugen Lovinescu" Upper Secondary Portuguese - bilingual

Additionally, there are a number of private international schools teaching in English, French, Greek or German.


International Private Schools in Bucharest

No School Name Teaching regime/program

1 International British School of Bucharest English - Bilingual

2 Bucharest Beirut International School Lebanese, English

3 The American International School of Bucharest English

4 The British School of Bucharest English

5 Lycée Français Anna de Noailles French

6 Verita International School English

7 „Athena” Helenic School Greek

8 King's Oak British International School English

9 The Mark Twain International School English IBO Educational Programme

10 EUROPEAN SCHOOL OF BUCHAREST English IBO Educational Programme

There are a number of private schools with teaching language in English or German:

Name of the school Level of education Teaching language, other than Romanian

The Lauder- Reut Educational Complex

Primary education English language

Secondary education English language

High-school education The bilingual program - English language

Primary School „FRIDOLIN” Primary education German, as a native language

Secondary School „FRIDOLIN” Secondary education German, as a native language

Secondary School ”Zeppelin Schule”Primary education German, as a native language

Secondary education German, as a native language


Some of these international private schools are registered as operating according to the rules and principles of different education systems (EU Countries mainly):

Private schools in Bucharest according to the rules and principles of different education systems (EU Countries mainly)

Name of the school Address Educational system Curricula Education documents

issued by the school

Lycée Français Anna de Noailles

Șos. București-Ploiești, nr. 160A, DN1

The education system of the French Republic

Curriculum corresponding to the educational system of the French Republic

Diplôme national du brevet, Diplôme du baccalauréat general.

Şcoala Elena „Athena”

Str. Parfumului nr. 9, sector 3

The educational system in the Republic of Greece

Curriculum of the educational system in the Hellenic Republic

Graduation diplomas, Education certificates Transfer certificate

The British School of Bucharest

Str. Erou Iancu Nicolae nr. 42 - 42A, Oraşul Voluntari, Pipera

The educational system in the United Kingdom of Great Britain and Northern Ireland

Curriculum corresponding to the educational system of the United Kingdom of Great Britain and Northern Ireland

Cambridge University (CIE) CIE-IGCSE, EDEXCELL-IGCSE/GCSE, Edexcel-AiDA

The International School of Bucharest

Şos. Gării Căţelu nr 1 R, sector 3



Portfolio of diplomas (Cambridge IGCSE, Cambridge AL) on the passing of specific exams

International British School of Bucharest

Str. Agricultori nr. 19 A -25, sector 2



Graduation of diploma and portfolio of diplomas (Cambridge Checkpoint, Cambridge IGCSE, Cambridge AS, Cambridge AL) on the passing of specific exams

The American International School of Bucharest, LLC

Șos. Pipera-Tunari, No 196, Orașul Voluntari,

The educational system in the United States of America Primary Years Programme of IBO (PYP), Middle Years Programme of IBO (MYP), Diploma Programme of IBO (DP)

Curriculum corresponding to the educational system in the United States of America IBO Primary years programe, IBO Middle Years Programme, IBO Diploma Programe

Diploma for graduation of an US High-School International Baccalaureate Diploma

The average costs of studies in private educational system in Bucharest are: for primary school – an average of 9,955 euro/year; for secondary education – an average of 11,000 euro/year for tuition only. As for the payment system, is flexible like the other mentioned forms of education.


3.2.3 Higher education degrees

Passing the Baccalaureate exam is a prerequisite for admission to higher education. Students apply to a school or department within a university. Admissions usually depend on one’s Baccalaureate grade and yearly GPA in secondary education, the student’s score in the university-organized admissions exam, an interview and more (usually a mix of the above).

Most Bachelor’s programs in Romania take 3 years to complete. However, some programs take longer to complete, for example those in some technical fields, medicine and architecture.

Master’s programs (MA) take 2 years beyond the Bachelor’s degree. Master’s programs are a prerequisite for admission to PhD programs.PhD programs usually take 3 years to complete. Under special circumstances, the duration of study may be extended by 1 or 2 years.

The European Credit Transfer System (ECTS) is compulsory in Romanian universities. For each year of study, the student receives 60 ECTS (slightly more if they take on, say, all electives instead of just picking the compulsory amount; also if they take teacher training modules), an average of 30 ECTS per semester. The undergraduate program will have from 180 to 240 ECTS and the MA program from 90 to 120 ECTS.

Romanian students are eligible for the Erasmus + program and can study for one or two semesters at a wide range of universities in the European Higher Education Area. Education is free for top students admitted to undergraduate degrees at public universities. By law, these top students are waived the tuition fees for a BA, an MA and a PhD.

There are 12 public universities in Bucharest and 15 private universities, offering 50 Bachelor’s programmes in English, 17 Bachelor’s programmes in French, 8 Bachelor’s programmes in German. As regards the Master’s degrees, for the academic year 2017-2018, in Bucharest there are 84 Master’s programmes offered mainly in English. Doctoral studies are in Romanian with the posibility to also be organized in an international language, upon students’ request.Should a student decide to continue her/his studies in Bucharest, it is worth mentioning that, while maintaining academic standards, tuition and living costs for students are low.

A brief description of the 12 public universities in Bucharest offering foreing languages programmes is available in Annex 5.

Equivalence of diplomas in Romania The National Centre for Recognition and Equivalence of Diplomas (NCRED), member of the ENIC-NARIC networks of National Centres for academic information and recognition abroad, recognizes education documents of pre-university level acquired abroad, through evaluating and establishing the level, the field/specialization, in relation to the Romanian educational system, in keeping with international norms and good practices in the field of recognition.

Subsequently to evaluation, the NCRED may recognize the level, the field of studies and/or the specialization, automatically or by taking equivalency examinations or other compensatory measures. With the aim to implement the compensatory measures, the NCRED collaborates with the County School Inspectorates and with the School Inspectorate of Bucharest Municipality.This procedure is implemented for the continuation of studies in Romania, as well as for access to the labour market.


The NCRED recognizes education documents that prove graduation of XI-XII grades and graduation from upper-secondary studies at Baccalaureate level, from professional schools and the post-secondary schools.

Starting with 2015, by Minister Decree no. 5268/2015, files submitted for validation of the study periods carried out abroad and within education-providing organizations, corresponding to an educational system from another country (grades I-X), are received and evaluated by the local School Inspectorates.

The NCRED recognizes educational activities in Romania corresponding to an education system from another country.Aiming at maintaining the right to free practice for bearing a regulated profession in Romania, the NCRED recognizes (in keeping with the 2005/36/CE Directive) diplomas acquired within EU member-states, within the European Economic Area and within the Swiss Confederation, which give access to regulated professions, wherever the regulatory acts concerning the profession do not require otherwise.


IVAppropriate AccessAccess to the labour market, social security and medical care for both children and spouses/ partners

The cost of living in Romania – especially in Bucharest – is approximately 50% lower compared to other important western cities in EU Member States (Vienna, London, Berlin, Paris) and at least 12% cheaper than other capitals of CEE countries (Prague, Warsaw or Budapest).15

According to the structure of total consumption expenditure in the first quarter of 2016, housing and water, electricity and natural gas accounted represent 19.6 % of household consumption. Other household expenses cover leisure and culture (3.1 %), transportation (5.9 %), healthcare (5.3 %), communications (5.1 %), clothing and footwear (5.2 %), home furnishings and maintenance (4.5 %), etc.

Bucharest offers the largest labour market in the country, with a dynamic and diverse business environment with soaring competitiveness indicators. All branches of industry are present in the Bucharest-Ilfov region, as this is the main industrial agglomeration in the country.

In the past few years, the workforce has reoriented massively towards the services sector, which at present is the main contributor to this region’s economy. This region also has the fastest growth rates in sectors such as the building and real estate sector. Other highly dynamic sectors are the retail, distribution and management sectors.

The economic environment in this region is highly attractive, as a result of direct investments, the existing institutional structure, a skilled workforce and a communications system.

15 Source: Invest Romania 59Relocation of the European Medicines Agency


4.1 Brief overview of the Romanian labour market

The main types of enterprises present on the labour market are companies - limited liability companies (SRL), joint-stock companies (SA), partnerships (SNC), simple partnerships (SCS), joint-stock partnerships (SCA), sole traders (PFA) and family associations.The main categories of employers are multinational companies, profit/non-profit state-owned companies, private companies and NGOs. According to the 2016 Coface CEE Top 500 Companies study, the largest companies in Romania in terms of turnover are: Automobile Dacia SA, OMV Petrom Marketing SRL, OMV Petrom SA, Rompetrol Rafinare SA, Kaufland România, Rompetrol Downstream SRL, British American Tobacco Trading SRL, Lukoil Romania SRL, Carrefour România SA, EON Energie România SA and Transgaz SA. The main types of employment contract are contracts which may be fixed-term or permanent, with full-time or part-time working hours. Certain jobs require specific qualifications and/or experience.

Romanian labour market – ANOFM key figures (as of 1 January 2016) • active population - 8 776 800 persons;• 54.1 % men and 45.9 % women in the total active population;• most employees work in the services sector (3,100,200 people);• 1,821,800 persons are employed in the industrial and construction sectors;• the employment rate of the working age population (15-64 years old) was 61.8 %, with a higher rate for men (70.0 %, compared to 53.4 % for women).

Bucharest labour market – ANOFM key figures (as of 1 January 2016)• active population - 1,533,700 persons (44.4 % of the country’s total population);• unemployment rate (as on 31 December 2016) - 1.4 % – the lowest at national level (only 20 600 unemployed per-sons);• the employed population tends to have a high level of training and qualifications;• the main economic sector in which the population is employed is the services sector (71.3 %), followed by industry and the construction sector (26.2 %), while agriculture accounts for only 2.4 %. Services generate the largest num-ber of jobs.



4.2. How to find a job

Jobseekers who are EU or EEA citizens have free access to the Romanian labour market. Nationals of other Member States of the European Union are employed in the same conditions as Romanian nationals and have to complete all the employment formalities. It is recommended that sufficient time be allowed between the signing of the individual employment contract and the start of work at the Romanian employer, so as to enable the EU national to complete all the required formalities.

Interested persons may contact and register with one of the 41 employment agencies in the counties or in Bucharest, or with one of the 70 local employment agencies spread throughout the country.

County agencies provide information, counselling and mediation services for jobseekers or unemployed persons, as well as information and mediation services for potential employers. The services offered are free of charge.

A database is available, at both county and national level, containing all the jobs offered by Romanian employers, who are required by law to declare all their vacancies to the National Employment Agency (ANOFM). Job vacancies can be found under the ‘Locuri de muncă’ (Jobs) section on the ANOFM’s website. Details of the vacancies are displayed in Romanian.

EU/EEA citizens who are unemployed persons receiving unemployment benefits in another EU/EEA state and who are seeking a job in Romania may export their unemployment benefits (for a maximum period of 3 to 5 months), provided that they register as jobseekers with the county employment agency covering the area where they have established their residence in Romania. On the national labour market there are also private

providers (Romanian or from other EU/EEA countries) of specialised services aimed at stimulating the labour market. The list of private providers of employment services authorised to operate on the domestic market can be found on the individual websites of the county employment agencies.

4.3. Self-employment

Natural persons who are EU/EEA citizens may carry out business activities in Romania, as follows: as sole traders, individually and on a self-employed basis; as entrepreneurs owning an individual undertaking; as members of a family enterprise, in accordance with the national legislation in this area.

Sole traders and individual or family enterprises may be authorised to carry out business activities in any field, trade or profession, with the exception of those governed by special laws, but they must be residents in Romania. Registration in the Trade Register and an operating permit are mandatory. Sole traders carrying out independent business activities are


regarded as self-employed. Self-employment status refers to the right to benefit from the public pension scheme and other social insurance schemes, the social healthcare insurance system and the unemployment insurance system, in accordance with relevant laws.

Sole traders may not employ other persons on the basis of individual employment contracts to carry out the activities for which the legal authorisation for self-employment has been obtained. Owners of individual undertakings may employ other persons under an individual employment contract, may collaborate with other sole traders, with other owners of individual undertaking, with representatives of a family enterprise or with other legal persons. Family enterprises have two or several members of the same family. Members of a family enterprise are insured under the state social insurance system (pensions, unemployment and healthcare).

4.4. Romanian Social Assistance Policy

The Romanian law of social assistance, respectively Law no.292/2011, stipulates that social assistance benefits are granted to all categories in vulnerable situations, without discrimination.

The right to social assistance measures is guaranteed for all Romanian citizens, as well as to citizens of other countries, stateless persons and any other person who has acquired a form of protection and resides in Romania, without any discrimination.

Social assistance benefits granted in Romania are financial transfers granted for:

• family and children (family benefits); • preventing poverty and social exclusion risk (means tested benefits); • persons with special needs (disability benefits);• other types of benefits and facilities (emergency aids).

4.5. Employment possibilities for families and partners of the EMA staffForeign nationals are mostly employed in the Business Services Sector (BSS), the headquarters of multinational corporations, consulting companies or international law firms; were at the end of 2016, BSS foreign employees, around 150,000 persons, 20% increase over 2015.

BSS centres provide IT, HR, Finance & Accounting, Marketing, Legal, Research & Analysis and R&D services in a multitude of different languages to all parts of the world.



Top employers in the BSS sector:

OMV PETROM SA, Kaufland Romania SCS, Auchan Romania SA, Carrefour Romania SA. Mega Image SRL, Addeco Human Reources SRL, Telekom Romania Communication SA, Romania Hipermarche SA, Metro Cash & Carry SRL, Lugera&Makler SRL, Mercer, Accenture, GSK, Pfizer, Novartis, Abbvie, Abbott, Roche, MSD, Merk, Microsoft Romania, IBM Romania, Daimler Benz Romania.

Major consulting companies:

Ernst & Young, Accenture, Deloitte, KPMG, PwC, McKinsey, BCG, Roland Berger, Colliers, Cushman & Wakefield

Major international law firms:

Allen & Overy LLP, Martinez-Echevarría, Perez & Ferrero Lawyers, Squire Sanders, White & Case, Dessewffy, Dávid and Partners Law Office, Rokas Law Firm, Eversheds Sutherland, DLA Pipers Dinu SCA, Dentons, Wolf Theiss, Noerr Finance&Tax SRL, Clifford Chance, Kinstellar SCA, Leroy&Asociates.



Bucharest is one of the safest EU capitals (with less than 1% criminality rate per 100,000 inhabitants) providing a safe place to work and live for its citizens.

4.6. Secure life for the EMA staff, families and children

It has never been a target for terrorist attacks, being very well placed in the international ranking statistics - 0.2 score in the Political Stability and Absence of Terrorism index by the World Bank (2015).

According to the EB-86 Standard Eurobarometer, published in November 2016, Romanian citizens perceive as low the risk to national security referring to the main indicators, namely criminality, immigration and terrorism.

The level of the terrorist alert is BLUE-CAUTION (level 2 of 5). The European Medicines Agency and its staff shall benefit from the privileges and immunities established in Protocol (No 7) to the EU Treaties.

Romania is committed to other possible complementary provisions in a headquarters agreement specifying the detailed provisions with regard to application of the protocol.

Preserving privileges and immunities – first level of security for EMA staff in Bucharest

The European Medicines Agency and its staff shall benefit from the privileges and immunities established in Protocol (No 7) on the privileges and immunities of the European Union no. C 83/266 published in the Official Journal of the European Union on March 30, 2010, enjoying the usual immunities and inviolabilities provided by this Protocol. Similar measures as those adopted for other European or international organisations’ branches based in Romania would be applied. According to the Protocol, national staff working for the European Medicines Agency shall enjoy only functional immunities and privileges.

The Ministry of Foreign Affairs (MFA) ensures the application of provisions of the above mentioned Protocol, thus the Agency and its staff only has to register with the Protocol Directorate in order to benefit from these privileges and immunities. One of the responsibillities of the EMA Human Resources Department in Bucharest will be registration of EMA staff with the MFA.

Upon a final decision regarding the future location of the European Medicines Agency, Romania is committed to other possible complementary provisions in a headquarters agreement specifying the detailed provisions with regard to application of the protocol.


Safe life for EMA staff in Bucharest – national security and stability

Romania is a pillar of stability in the region and has a unique geostrategic position in the Black Sea area, in the present context, able to set up a security platform in the Black Sea, the Balkans, Central Asia and the Middle East area.Guaranteeing the safety of citizens, protecting their rights and fundamental freedoms represent national objectives, besides those that define and outline Romania’s strategic credibility, at international level.

The present system of public order and national security in Romania has proved its viability, being appreciated as one of the most efficient in Europe, the criminal phenomenon being very well managed by the Romanian authorities.

Internally, a high level of security and safety is maintained, the existing crimes being on a downward trend over the past 4 years, this way reaching the lowest value of the last 10 years.

Citizen safety is at the highest level. Criminal behaviour is kept under control, with no special events registered.

Crime prevention activities carried out by Romanian authorities are targeted largely towards issues that citizens consider priorities for improvement of safety problems. In the prevention area, special attention is paid to the education environment.


The rate of serious violent crime, is low (only 0.2% of all notified offences) and it is not characterized by severe forms of manifestation.

According to the EB-86 Standard Eurobarometer, published in November 2016, the population of ROMANIA perceives as low the risk to national security, referring to the main indicators, namely criminality, immigration and terrorism.

The same study appreciates that Romanian citizens did not consider criminality as one of the main factors that could affect them individually, this being only on the 12th place of 15. One of the study conclusion mentions that Romanian citizens do not consider criminality one of the major problems that concern them, this perception being widely due to the increase of citizens’ safety.

The results registered as regards the constant decrease of crime at national level is also due to the excellent cooperation of law enforcement institutions with similar international agencies, namely the INTERPOL, the EUROPOL and the US law enforcement agencies.

Against the background of the restricting law regarding arms and ammunition, Romania efficiently manages this issue, not registering significant incidents affecting the safety of citizens or disturbing public order and safety.

The activities developed for preventing crime around education areas are in compliance with the objective assumed in the “National Strategy of public order and safety 2015 - 2020”, regarding the creation of a safe environment for education, by constantly involving competent institutions in increasing the degree of safety within the education institutions.

Starting with July 2016, a new common national action plan has been implemented for increasing the degree of safety of students and teachers, as well as for preventing juvenile delinquency within and around pre-university education units.

The dynamic of traffic accidents has recorded lower figures, scoring lower than foreseen by Romania to its European partners according to the European Road Safety Action Programme.

Regarding the prevention and countering terrorism, efficient coordination of law enforcement agencies from the National System for Prevention and Terrorism Countering, based on concrete measures, allowed early warning identification of any form of (self) radicalisation or intentions to support or execution of terrorist attacks on national territory, the level of the terrorist alert being BLUE-CAUTION (level 2 of 5).

On the grounds of terrorist attacks multiplying, raising of their scale and diversity of attack patterns, the need has been highlighted for identification of adequate answers for limitation of this phenomenon,


irrespective of manifestation form. In this regard, Romania has proposed to set up an International Court Against Terrorism, designed as an International Penal Law Organism, which should have as main goal deterring terrorism acts and conviction of perpetrators, wherever the crime may have been commited.

In regard of countering trafficking of human beings, according to the Annual Report of the US State Department, published in June 2017, Romania has made increasing efforts to enforce the rule of law, cooperation with NGO’s and developing their financial mechanisms. In this regard, Romania ranked 2nd of 4 tiers.Against the European trend of evolution with regard to migration, especially on the Western Balkans route, in result of implementation of the mechanisms for countering illegal migration and illegal staying, the illegal migration phenomenon is efficiently dealt with by the Romanian authorities, ranking low in relative numbers.

Although not yet full a Member of the Schengen area, Romania currently applies most of the provisions of the Schengen acquis and acts as a de facto Schengen member with a significant contribution to EU internal security, responsibly and efficiently managing over 2000 km of external border of the European Union.

Romania fulfils all technical criteria for joining the Schengen Area, having succesfully completed evaluation of the 7 fields of interests (police cooperation, data protection, consulates, maritime, air and land borders, SIS/SIRENE), as also ackonowledged at EU level (the EU Council).

Excellent IT&C systems for an excellent future of Gbit societyOne of the strong points of Bucharest’s communication infrastructure is the wide spread of optic fibre networks, leading to superior internet access and data transmission rates, the foundation of the future Gigabit society. Bucharest’s NetCity project, the underground infrastructure for optic fibre, is an innovative project and one of the large investments made in city’s communication infrastructure, in line with the European socio-economic development policy for local communities.

Bucharest hosts several public data centres of European dimension, able to assure optimal collocation and/or operation of equipment, including back-up and disaster recovery services, as well as high capacity connections with European and global content and connectivity providers. Two public internet interexchange points operate in Bucharest ensuring strong connectivity with ISPs active at national level as well as with global carriers; this is helpful in providing reliability and redundancy of communication paths.

From the perspective of costs related to provision of communication services, due to the increased competitiveness of the Romanian market, tariffs of communication services are among the lowest in Europe, ensuring a high quality/price ratio. Thus, on the retail level, usual tariffs for mobile voice and data services are between 2 EUR/month and 9 EUR/month, while usual tariffs for fixed internet do not exceed 11 EUR/month for services with speeds up to 1000 Mbps through optic fibre.


Regarding the quality of the internet access service, international studies place Romania at the top of the world’s high-speed internet. Thus, according to the latest “State of the Internet” connectivity report conducted by the American group Akamai, for the first quarter of 2017, Romania ranked second among European countries with the highest average peak internet connection speed. The average peak speed in Romania was 95 Mbps in the first quarter of this year, up 15% over the same period of 2016.

These data are also confirmed by the measurements made using the speed measurement application made available to users by the NRA, Netograf.ro. According to it, in the first quarter of 2017 the average download speed for fixed internet in Bucharest registered 119 Mbps and the average upload speed 106 Mbps. At the same time, the average download speed for mobile internet was 34 Mbps and the average upload speed was 14 Mbps.

It should also be added that fixed internet offers of the main providers offering services in Bucharest usually mention connections at speeds between 500 and 1000 Mbps.

4.7. Comprehensive and high-quality healthcare services, public and/or private

Access to healthcare is guaranteed by Article 34 in the Constitution of Romania, which specifies that the state is obliged “to guarantee the sheltering of healthcare”.Every citizen of Romania is entitled to cost-free, unrestricted medical procedures, as established by a physician. Citizens of the European Union have the right to free emergency medical assistance.

Romania offers benefits of an universal healthcare system. The state finances primary, secondary and tertiary healthcare. Public health campaigns are financed by the Government of Romania. The Ministry of Health of Romania is required to manage and supervise the public healthcare sector.

The Romanian healthcare system has turned from a centralized model, in which healthcare providers were directly employed by the Romanian Ministry of Health (RMoH), to a contract model in which healthcare providers in the healthcare system are independent and in contractual relationships with the insurance fund.

Health insurance costs are generally covered by the Romanian government, which guarantees access to public healthcare services for all.

Besides, citizens can opt for private insurance schemes, which bear accessible costs and provide access to a wide-range of services in public or private institutions.

There are currently over 50 public hospitals in Bucharest, as well as a wide range of private operated clinics and hospitals.

Hospital infrastructure development is a major priority in Romania, as there are several ongoing initiatives to fund the construction and equipment of new and existing facilities.


The RMoH is responsible for providing preventive services at both the individual and population level. At local level, preventive activities are organized and supervised by the District Public Healthcare Authorities.

For 2017, the budget allocated for the healthcare sector is 33. 8 billion lei (approx. 800 million euro) or 4.15% of GDP, with 3.5 billion lei (78 million euro) more than in 2016, plus 3. 9 billion lei (80 million euro), commitment appropriations.

Main objectives funded for 2017 are:• Compensated and free medicines (155.5 million

euro additionally allocated) • Construction of regional hospitals and

providing each county hospital with a tomography computer

• Purchase of mandatory vaccines for children (172 million euro)

• Providing seven hospitals with linear

accelerators for cancer treatment• Funding the 15 percent increase of the

healthcare system salaries

Facilities and equipment

Healthcare services in Romania have evolved during the past few years and especially since the country joined the European Union in 2007. The government has been taking strict measures to ensure that all citizens have access to healthcare facilities and services. It is also securing and deploying funds to improve the current state of healthcare in Romania, in both the private and public systems, so as to continue the improvement of healthcare systems.

The Ministry of Health regulates the healthcare sector in Romania. The governmental bodies in Romania are working towards setting up quality management system in the healthcare sector, to review the standards of healthcare facilities.


A National Agency for Quality Control in the Healthcare Sector was set up in 2015 by the Government of Romania to determine, through standardization, quality assurance and continuous quality improvement of healthcare services, patient safety, healthcare services assessment and accreditation of healthcare facilities and change of the organizational culture for implementing the quality management system. The entire process is meant to ensure the international recognition of the quality of Romanian healthcare services.

In 2014, the Romanian Government signed an Agreement with the World Bank for the approval of 250 million-euro for the purpose of improving the infrastructure of the healthcare system in the country, such as modernization of healthcare facilities, improvement of healthcare governance bodies and fight diseases such as cancer. Additionally, a new metropolitan hospital is planned to be built by the local Administration of Bucharest, with a total number of 2000 beds.

In 2016, according to the National Statistics Institute, there were 366 public hospitals and 201 private hospitals in Romania.

Since 2008, the number of private hospitals has increased over four times. Overall, the total number of hospitals increased by 15% between 2008 and 201716.2

In 2017, the Romanian Ministry of Health has approved a total number of 119,579 beds funded by the state (public and private), of which more than 20,331 beds were in Bucharest.

Currently, Bucharest has a considerable number of hospitals comprising all specializations, intensive care units and outpatient cabinets for all sections, with highly specialized staff and top performance medical equipment. We can mention the university hospitals Floreasca Emergency University Hospital, the Bucharest University Emergency Hospital and the Fundeni Clinical Institute, facilities comprising more than 800 beds, the Coltea Hospital, all with highly specialized medical teams with European and worldwide recognition.

Bucharest offers excellent public childcare facilities such as the paediatric Hospitals-Marie Curie and Grigore Alexandrescu, with a capacity of 500 and 400 beds respectively, alongside with specialized departments for paediatric care within each public hospital in the capital, as well as a number of 9 public maternities, most of them recently modernized through state funds or European and World Bank funds.

Romania is the first country in Europe in terms of telemedicine. The national telemedicine network includes two command centres, at the Floreasca Hospital in Bucharest and the Clinical Emergency Hospital of Târgu Mureș and 56 hospitals. Thus, doctors at the two command centres provide medical support to any of the hospitals in the country and pursue the patient’s vital signs in real time.

There is also a large number of private operated clinics and hospitals, all with experienced and trained staff, the annual growth rate of the private medical services market being approximately 12 percent.

16 National Institute of Statistics, 2017


The private system is attractive to expats, as these hospitals boast the very latest, state-of-the-art equipment and technology and have modern facilities. Most medical staff in private facilities can communicate fluently in English.

Prices for private healthcare in Romania are significantly lower than in other European countries or in the United States, with the total cost of treatment less than half of the cost of treatment alone in many countries. Thus, Bucharest is becoming more and more attractive for medical tourism, especially in niche specializations (e.g. dentist treatment).

In 2015, Fiscal legislation was amended so as to stimulate private insurance benefit packages for the private sector. As such, the deductibility thresholds for expenses incurred on behalf of an employee in relation to voluntary pension schemes (i.e. EUR 400/year/employee) and for expenses for voluntary healthcare insurance premiums (i.e. EUR 250/year/employee) have been eliminated; these expenses are to be taxed at the level of the employer, with the threshold being EUR 400/year/employee for each type.

There is a high number of private hospitals and networks, such as: Monza, Sanador, Regina Maria, Ponderas, Metropolitan, Neolife, Medlife, Polisano, Oncofort, Medicover, West Eye Hospital, Pelicanul. The top five players on the private healthcare services market, Medlife, Regina Maria, Medicover, Sanador and Gral, had a total business of about 1.3 billion lei (288 million euro) in 2015, according to public available data. At a total level, the medical services market amounts to about 6 billion lei (about 1,35 bn. euro), according to the same public source.

The Regina Maria Private Healthcare Network, one of the two largest private healthcare networks in Romania, offers 33 polyclinics (16 in Bucharest), 4 hospitals (3 of which in Bucharest-Euroclinic, Ponderas, Baneasa Hospital), 8 Medical Centres and over 180 partner clinics across the country, 1,700 medical staff, 22 medical specialities.

The Life Memorial belonging to the MedLife medical network, represents an investment of 17 million euro, the unit having 150 beds. The hospital, which spans an area of 12,500 square meters, comprises an operator block consisting of 5 operating rooms, an IC section, as well as obstetrics-gynecology, neonatology, surgery, internal diseases, cardiology, oncology and paediatrics. Apart from the Life Memorial, MedLife also owns two more hospitals: a paediatric hospital in Bucharest and another in Arad, operated in collaboration with the Genesys Medical Clinic in Arad. Currently, the MedLife network includes 9 hyperclinics, 8 medical analysis laboratories, 28 general medical centres and 7 monodisciplinary centres. Since 2010, MedLife has also operated a pharmacies network, PharmaLife.With a total area of 23,000 square meters and a capacity of 402 beds, the Sanador Hospital includes all the medical and surgical specialties and is unique from this point of view on the Romanian market. The hospital is serviced by 7 lifts, it has 125 paid parking spaces in the 3 basements. Parking is managed by Parc Med Logistics.


In Romania, Medicover has a network of 19 clinics in Bucharest and Timisoara, Cluj-Napoca, Constanta, Iasi, Ploiesti, Brasov, Galati, Pitesti and a general hospital - the Medicover Hospital located in Bucharest. The network offers integrated services: complete outpatient care, the first provider in Romania to introduce the concept of healthcare subscription. The Medicover Hospital in Romania includes all departments: outpatient, day hospital and a wide range of medical and surgical specialties.

The Synevo, part of the Medicover Group, is the largest and most advanced laboratory network in Romania, present in 11 countries, with over 80 laboratories and over 400 harvesting centres. The central laboratory was in Bucharest and claimed an investment of 10 million euro

Dental careAccording to the National Institute of Statistics, the number of private dental clinics in Bucharest has increased by 27%, reaching 2,894 in 2015 and it continues to expand.

Emergecy care: one of the best in Europe

Emergency care is available free for everyone including those without state healthcare insurance. However, once the condition is stabilized there is need for proof of the insurance status. Emergency treatment is provided at patient’s emergency rooms in all hospitals, which are open non-stop all year round.

The Emergency Healthcare Information System (EHCIS) in Bucharest provides information about the whole activity of Dispatch Emergency Ambulance Service and Emergency Admissions of the 7 Hospitals providing emergency healthcare in Bucharest over a MAN (Metropolitan Area Network). The data are registered in the ORACLE database on the central server. The client/server architecture assures real time communication among all these locations. The system works 7 days/week, 24 hours/day.

The pharmaceutical industry in Romania is prosperous, with an average revenue of aprox. 2 billion euro per year.

The value chain in the pharmaceutical industry has increased significantly in the past decade in all segments, contributing with over 1% to the GDP. There are 43 production plants, 5 packaging plants and 8 manufacturers of substances.

In 2014, Romania’s market size increased by a full 6.8 % to EUR 2.76 billion with Romanians purchasing OTCs to the tune of some EUR 755 million in the final quarter alone, reflecting an 11.8% year-on-year rise, according to market research conducted by Cegedim.1,051 pharmacies are located in Bucharest with the approval of the Ministry of Health.


The SMURD is an emergency rescue service, one of the top in Europe. The first SMURD unit was created in 1990, in Târgu Mureș, a city in the centre of Romania and an important medical centre. In October 1996, the service received legal recognition under the Military Firemen Corps Law no.121.

Now the SMURD is a complementary service, with bases covering many parts of the country, still expanding. It deals with the worst emergency cases, all in a very good collaboration with the regular Ambulance Service (Serviciul de Ambulanţă). Also, HEMS (helicopter emergency medical system) was enforced in six cities (Târgu Mureș, Bucharest, Iaşi, Arad, Craiova and Constanţa), while in other cities the system is only ambulance based. Depending on the situation, police and army helicopters are also used.The emergency system used by this service is based on the European 112 emergency phone number, now also used in Romania for all the emergencies (police, firefighters, ambulance). Altogether (including the fleet of the Internal Affairs and SMURD), Romania has a fleet of 32 aircraft equipped for medical emergencies.

Pharmaceutical sector in Romania

Based on turnover,the biggest player in distribution of drugs is Mediplus. The company is part of the A&D Pharma group, founded in 1994, which also controls the network of pharmacies Sensiblu. The Mediplus logistic network consists of 10 regional warehouses and a national logistics centre.

Over-the-counter and prescription medicines

All citizens are entitled to receive financial aid for prescriptions, regardless of their financial status. The only required condition is contribuition to the National Healthcare Insurance House.. Any medicine (except for generic medicines) can be obtained with a discount. The discount is obtained by getting a medical prescription. The deduction is made right at the paying point and pharmacies further obtain their money back from the Ministry of Healthcare.Furthermore, there are medicines given out for free. Medicines for diseases included in National Healthcare Programs are free for anyone, regardless of their financial status. Diseases usually covered are chronic diseases. Starting with July 2012, all prescriptions have to be issued in digital format only.



V5.1. Recognised Romanian tradition and expertise in the field of medicine and pharmacy

BusinessContinuity

Research conducted by Romanian specialists has had tremendous contribution to the development of a wide range of medicine and pharmacy fields, such as:- the first treaty of bacteriology in the world- the Pathological Histology Atlas of the Nervous System- the discovery of insulin- the first geriatric institute in the world - improving age-related dystrophic disorders- the revolution of encephalo-neuro-psycho-tropic therapy, by discovering and substantiating the concept of a new therapeutic (pharmacological) class in neuroscience- the discovery of humoral and cellular immunity- the lack of sensitivity and immunity of the body against scarlet fever. - the great Romanian experience on massive cholera vaccination in 1913 - the setting up of ophthalmology procedures with a wide international spread- introducing high rachianesthesia and new techniques in the surgery of uterine cancer, the sympathetic nerve and hernias.- among the founders of modern infra-microbiology The Romanian Nobel prize winner in the field of physiology and medicine (1974), George Emil Palade (1912-2008) is considered the father of modern cell biology.



Carol Davila (1828-1884) and Nicholas Kretzulescu (1812-1900) are the main founders of Romanian medical education - the Medical Society (1857), the Red Cross Society (1876), the Society of Natural Sciences (1876) - as well as of two medical magazines.

Victor Babes (1854-1926) was a physician, professor, academician, member of the Academy of Medicine in Paris, an officer of the Legion of Honour, the founder of the Romanian school of microbiology. In 1885, in collaboration with Andre Victor Cornil, he conducted the first treaty of bacteriology in the world, laying the foundations of modern sciences and, in 1892, together with Gheorghe Marinescu and Paul Blocq, he published a Pathological Histology Atlas of the Nervous System. His research has led to discoveries in a wide range of fields, such as tuberculosis, leprosy, rabies vaccination and serotherapy of diphtheria, the discovery of novel microorganisms, with classification of an entire class of parasites, in 1900, at the International Congress of Zoology in London, called the Babesia.

Ioan Cantacuzino (1863-1934) was the founder of the Romanian school of experimental immunology and pathology, a internationally recognized physician, microbiologist, professor, academician, member of the Paris Academy of Sciences, Doctor Honoris Causa of the Universities of Lyon, Brussels, Montpellier, Athens and Bordeaux. He is the author of fundamental works on phagocytic functions in animal behaviour, electrophysiological phenomena role in immune mechanisms, on discovery of humoral and cellular immunity, lack of body sensitivity and immunity against scarlet fever. He created the notion of immunity by contact and set up cholera vaccination, called the Cantacuzino Method, still used today. The massive cholera vaccination in 1913 made him known as the Great Romanian experience. In 1921, he legally founded The Institute for Serums and Vaccines Dr. I. Cantacuzino, still operating today.

The Romanian Ophthalmology School was founded by Nicolae Manolescu (1850-1910), who set up a series of procedures with a wide international spread after presentation at the International Congress of Medicine in Lisbon.

Thoma Ionescu (1860-1926), surgeon and anatomist, professor in Bucharest and Paris, honorary member of the Romanian Academy, one of the founders of the Romanian School of Surgeons and Topographic Anatomy. Founder, in 1897, of the Surgery Society and the Surgery Journal he was recognized for the great merit of introducing high rachianesthesia and new techniques in the surgery of uterine cancer, the sympathetic nerve and hernias.



In the field of physiology, one may also mention Ioan Athanasiu (1868-1926), one of the founders of modern Romanian physiology and author of several articles on the scientific bases of physical education, professor and correspondent member of the Romanian Academy.

An exceptional personality was Constantin Levaditi (1874-1953), born in Galati and naturalized in France, one of the founders of modern infra-microbiology. Graduate of the Faculty of Medicine in Bucharest, he was an honorary member of the Romanian Academy and the French Academy of Medicine.

Nicolae Paulescu (1869-1931), the true discoverer of insulin, secreted by the pancreas and originally called “pancreine” by Paulescu. In his studies he found that the hormone regulating the metabolism of carbohydrates is equally involved in lipid metabolism and parotids. The hormone discovered by Paulescu has also been shown effective in reducing hyperglycemia and in the treatment of diabetes.

A totally exceptional name is Ana Aslan (1897-1988), academician, specialist in gerontology. From procaine, an important substance in improving age-related dystrophic disorders, she developed Gerovital, vitamin H3, patented in 30 countries since 1952. That same year, she established the first geriatric institute in the world, Geronto- Geriatrics National Institute Dr. Ana Aslan, that would represent a model for other countries for both clinical care and research.

George Emil Palade (1912-2008), a Romanian Nobel Prize laureate for physiology and medicine in 1974, considered the father of modern cell biology, and received the National Medal of Science of the United States of America in 1986.

Prof. dr. Cornelius Giurgea (1923, Bucharest - 1995 Brussels) has revolutionized encephalo-neuro-psycho-tropic therapy, by discovering and substantiating the concept of a new therapeutic (pharmacological) class in neuroscience - nootropic medication (nootropics, memory and cognitive enhancers, anti-hypoxic agents, cerebral metabolism activators, smart drugs). The first representative such medicine is piracetam (DCI) - Nootropil® (UCB) - generation I.

A cyclic derivative of gamma amino butyric acid (GABA) - amino acid neurotransmitter from the brain, piracetam - due to lack of toxicity, outstanding efficacy and wide use is produced in many countries around the world and registered (®) under over 50 names, of which the most popular are: Nootropil®, Braintop®, Cerebroforte®, Gabacet®, memo Puren®, Nootrop®, Normabrain®, Piracebral®, Psychoton®, Sinapsan®.


5.2 Strong perspectives of present Romanian R&D in medicine and pharmacy

A country with high perspectives in the research and development area, Romania counts more than 30,000 people working in research fields, out of which 18,000 highly skilled researchers. The Extreme Light Infrastructure - Nuclear Physics (ELI-NP), the most advanced research facility in the world, focusing on the study of photonuclear physics and its applications, is placed in Romania (only 12 km outside Bucharest). The infrastructure will create a new European laboratory with a broad range of sciences covering frontier fundamental physics, new nuclear physics and astrophysics as well as applications in nuclear materials, radioactive waste management, material sciences and life sciences. The “Victor Babes” National Institute - the “telocytes group in Bucharest” has discovered a new type of interstitial cells - the telocytes, with possible implications in transmission of signals initiating regeneration.Romania is the first country in Europe in terms of telemedicine.

Most public hospitals in Bucharest have research departments and clinical training centres belonging to the universities of medicine and pharmacy.

In Bucharest, there are 1,600 medical university staff and around 10,000 medical, dental and pharmacy students. ELI-NP - a very high intensity laser system, with two 10 PW laser arms able to reach intensities of 1023 W/cm2 and electrical fields of 1015 V/m, is going to be the most advanced research facility in the world, focusing on the study of photonuclear physics and its applications and the most brilliant tunable gamma-ray beam. Situated in Magurele, only 12 km from downtown Bucharest, the users of the ELI-NP facility benefit from all infrastructure and services provided within the metropolitan area.The “Victor Babes” National Institute – The “telocytes group in Bucharest”, created by Laurentiu M. Popescu, has discovered a new type of interstitial cells, the telocytes, with possible implications in transmission of signals that initiate the regeneration.In 2012, telocytes became an internationally registered brand. Studies published in prestigious international journals (indexed by ISI) highlighted Romania’s contribution to the the international scientific community. Today, telocytes are recognized in more than 40 laboratories on the five continents. The most active countries in telocyte research are: China, Italy, Spain, Germany, Belgium, Singapore or the USA.

Nowadays, studies carried out at the Department of Cell Biology, Molecular and Histology of the Bucharest Medical and Pharmacy University, in collaboration with the Fudan University and Shanghai Regeneration and Aging Laboratory in China, intend to decipher the function of these cells. As a result of this collaboration, the genomic and proteomic characterization of telocytes isolated from the lungs has been obtained and further evidence of their regenerative potential cells has been provided.In collaboration with Fudan University, the book entitled “Telocytes: connecting cells” has been published by the renowned Springer publisher including the contributions of 30 laboratories around the world.


Today, the role of telocytes is only surmised, but their yet unknown functionas are most likely closely correlated with the particularities of their structure. Therefore, there are projects funded by the Executive Agency for Higher Education, Research, Development and Innovation Funding (UEFISCDI) that aim to discover the functions of telocytes by developing bioinformatics and information processing systems. It is very important to determine the constitutive properties of the telocytes for the study of the signalling mechanisms between them and the surrounding cells, with possible implications in the transmission of signals that initiate the regeneration.

Exemples of R&D Centres in Romania:• Centre for Gene and Cellular Therapies in the Treatment of Cancer (OncoGen), Timisoara• Institute of Cellular Biology and Pathology “Nicolae Simionescu”• Institute for Macromolecular Chemistry “Petru Poni”, Iasi Major R&D regional centres in Romania:1. Renault Technology Romania, Bucharest2. Regional R&D Center Ixia (IT), Bucharest3. Cisco Academic Training Regional Center, Bucharest4. Regional R&D Center Renault, Titu5. Regional R&D Center Continental (IT), Timisoara6. Regional R&D Center Siemens, Cluj-Napoca

Romania is the first country in Europe in terms of telemedicine. The national telemedicine network includestwo command centers, at Floreasca Hospital in Bucharest and Clinical Emergency Hospital of Târgu Mureșand 56 hospitals in 19 counties. Thus, doctors at the two command centers provide medical support in realtime to any of the hospitals in the country and pursue the patient’s vital signs.

5.3. Business Continuity – Romanian approach

The Romanian candidacy offers a professional approach to relocation assistance, mechanisms and procedures, based on the hypothesis that EU Council’s decision is favorable to Romania.Immediately after the decision for the EMA relocation to Bucharest, the Romanian Ministry of Health (RMoH) will put in place an operational department of Support Relocation Services (DSRS) in order to support relocation of activites, experts and their families from the UK. The purpose is to relocate the EMA with least brakes.



During the relocation process of an organization, the most important element is the continuity of the main activities so that both employees and clients can be assured that the core activities are carried out continuously and the risks of interruption are controlled and at minimum levels.

The proposed EMA business relocation is based on a risk control management mitigated by the arrangements in place for the continuation and/or resumption of essential services and ultimately returns to business as usual. (Phase 1 of the EMA Brexit Preparedness Business Continuity Plan approved at the management Board Meeting).The Romanian approach considers the relevant EMA management Board decisions and EMA’s Operations and Relocation Preparedness Task Force (ORP) created to ensure a smooth transition of the organization through a well-organized process.

From the organizational point of view, the following three components are essential: 1. Overall Management 2. Coordination3. Implementation

1. EMA Governance: - Establishes authority and responsibility for the ORP dealing with the final and approved EMA Brexit Preparedness Business Continuity Plan , Employee policy document for relocation and a final Communication Plan of support internal and external communication in the relocation process.- Approves and selects a well known relocation company that will develop and implement the Business Relocation Plan (BRP) and Action Relocation Continuity Plan (ARCP) accordingly; the required services should be developed considering the risks and scenarios identified in the final or updated version of the EMA Brexit Preparedness Business Continuity Plan.- Approves the Space Plan to be developed, BRP and the ARCP and the EMA Support Relocation Team (ESRT).

Since all resources cannot be replaced immediately, a Business Relocation Plan (BRP) and the Action Relocation Continuity Plan (ARCP) should be endorsed/approved by the EMA Board members with final estimates. The ARCP includes the needed resources (budget, equipment and people) in hours, days and weeks following the beginning of the relocation process.

Business Relocation Plan requires high-level detail planning. Relocating EMA office needs the protection of the business from unplanned events that may arise during office relocation (comprising people, IT&C resources, documents, office space, furniture and equipment). Romania is fully engaged to develop a Space planning document immediately after the Council’s decision with respect to the next EMA stop in order to support too the BRP and ARCP.

The Business Relocation Plan (BRP) and the Action Relocation Continuity Plan (ARCP) should be as practical and flexible as possible to allow effetive regional and local adaptation to minimize potential EMA’s exposure


to business gaps and to mitigate the risks.

2. Relocation team’s coordination and competences:

- Deals with exceptional situations and events, such as the international relocation of the European Medicine Agency, in its capacity as European regulator. Always focuses on coordination and control of people and resources.

- Tests, plans, measures and arrangements among Relocation Teams for better coordination for the relocation.

- Ensures implementation of the BRP and ARCP by providing availability of critical services and assets and of any other service or asset when warranted by a possible threat during the implementation of the ARCP.

- Allocates executive responsibility for managing the relocation. It is advisable to select and appoint a leader to take overall project management responsibility and appoint representatives in each three proposed relocation teams to liaise with the leader. Also, it is important to prepare checklists of responsibilities for team members, so everyone is aware of key dates and tasks.

- As the Relocation Teams’ main offices should be considered, at first, the present EMA headquarters in London. It is considered that in case of an event, the risks and their mitigation would be properly managed from the current premises on a case-by-case basis. At the current EMA premises, special arrangements will be made for the necessary rooms equiped with the required IT&C and support staff (i.e. secretary, assistant for the TL etc.). When 80% of the relocation is finalized, the EMA relocation team should gradualy move to the new premises. The EMA Support Relocation Team (further refered as ESRT) and The Romanian Support Relocation Team (further refered as RSRT) will be revoked when the underlying activities take place as before („business as usual“).

Relocation Teams:

- Relocation team from a well known, reliable relocation company: to ensure an effective relocation process, services are outsourced to a well-known relocation company who can develop, test and implement a Business Relocation Plan (BCP) and an Action Relocation Continuity Plan (ARCP) on EMA’s behalf. We consider that the EMA’s core business


teams and other process teams, with the Romanian Support Relocation Team (RSRT) are not in the position to allocate sufficient professional resources to support an international relocation process with no or limited interruptions; it is not their core business. The risks of such relocation should be mitigated by an outsourced specialized company offering a professional relocation team supported by the EMA and the Romanian Support Relocation Teams.

- The Romanian Support Relocation Team (RSRT): is coordinated by a professional Romanian Team Leader (RTL), hired by the Romanian Ministry of Health with professional experience and expertise in business relocation. Details of the RSRT coordination and competences are presented in section 5.3;

- The EMA Support Relocation Team (ESRT): the main knowledge support from the EMA team is provided by: Architect, IT Business Continuity Leader, Business Continuity Facilities &Vendors Leader and Business Continuity Human Resource Leader under the co-ordination of a London Team Leader (LTL). The team is supported by heads of line managers for business-specific changes during the tests or relocation activities;

3. Implementation of the relocation deals:

- Provides support for space planning, involving architect and/or installation engineers;

- The relocation company undertakes the development of the BRP and ARCP;

- Implementation of the approved relocation BRP and ARCP;

- Coordinates its relocation with the ESRT and RSRT support teams;

- Monitoring of activities and continuous review and control of critical actions during relocation;

- Approval of resources needed in the hours, days and weeks following the beginning of the relocation process (i.e. supplementary resources in special circumstances, level of approval etc).

The development of the BRP and ARCP will consider maintaining EMA essential activities during relocation, based on principles and methodology of the approved EMA Preparedness Business Continuity Plan. This way, the EMA can continue to provide customers with the


right level of service with minimal disruption.

The implementation phase of the approved ARCP comprises all the planned relocation activities which are under the responsibility of the selected relocation company that shall coordinate its steps with the support of the EMA and the Romanian Support Relocation Teams (ESRT and RSRT).

The next section gives information about the Romanian support for EMA relocation to Bucharest, in terms of people and organizations involved in order to offset possible risks of EMA staff shortages and other potential relocation events.

The Romanian Support Relocation Plan (RSRP) aims to support the EMA relocation of activities and staff with their families.

The Romanian Ministry of Health (RMoH) shall put in place, immediatley after the decision to relocate the EMA to Bucharest, an operational Department of Support Relocation Services (DSRS) in order to support relocation of activities and experts and their families, from UK. The purpose is to relocate EMA with at least breaks for work and life.

A web page is created with a full range of necessary information, such as: accommodation, schooling for the whole range of educational levels for EMA staff’ children; employment possibilities; taxes and other fiscal information, means of transportation etc.

The organizational strucuture of the DSRS comprises

a Romanian Team Leader (RTL), with relevant professional experience and expertise in business relocation and a team of 6 key experts (RS) to support the EMA relocation process. The DSRS shall be under the direct responsibility of the General Secretary of the Romanian Ministry of Health (RMoH).

The main responsibilities of the RomanianTeam Leader (RTL) are:

- To support the whole relocation process, with emphasis on experts and their families;

- Support the space planning of the new building, if the case;

- To ensure that staff responsibilities are met as for time and quality;

- Select the best method of internal and external communication considering how the RTL will distribute information to management, staff and service providers and how often;

- Agree together with his/her counterpart in London the target dates and timeline of activities;

- Develop together a project schedule with own staff and in agreement with the London counterpart;

- Coordinate all resources and assign responsibilities: resource people to be responsible for certain tasks, as well as sector service providers and contractors, in case of need.

The RTL develops a comprehensive document called “Romanian Support Relocation Plan - Project Schedule” and coordinates its tasks together with the London-based teams. The document shall prioritise support tasks with the aim to ensure work continuity for the EMA in the relocation process.

To achieve the operational objective of the “Romanian Support Relocation Plan - Project Schedule” (PS) the following tasks are envisaged:

5.4. Enabling staff to relocate with their families


1. Cross-cultural training in advance of EMA staff moving to Bucharest: 2 months prior to the relocation process, the EMA staff moving to Romania may be offered training by Romanian trainers on topics such as specific customs, language, habits&behaviours, social norms etc.

Responsibile: Trainers in cross-cultural aspects from the DSRS in the RmoH with support from the Risk Management Expert (on insurance issues)

2. Develop a local Romanian plan for internal and external communication coordinated with the EMA communication plan in the UK with the goal to support employees and provide them with information on essential location aspects such as house prices, schools and colleges, medical facilities, local stores, culture and sports. Also the plan informs customers of the relocation dates and arrangements for delivery during the transition period; it sets the potential benefits of the move in terms of improved customer service. It provides customers and suppliers with essential location information including address, telephone and other contact details.

Periodically informs customers, experts and suppliers of the relocation. Explains how and where to obtain services during the move to Romania. A special English language Call Centre is put in place to better communicate with experts or clients.

At the same time, a group of RS (2 to 3 persons) shall be established, with support of the Romanian Embassy in the UK, to assist EMA staff, their families and business in the process of relocation from UK.

Responsible: EMA London teams and the Romanian RSRT

3. Specific support for other EMA relocation activities: space planning support offered to the Romanian Developer, if the case.

Responsible: ESRT and RSRT

4. Experts and family installation in their new dwellings.

Tasks to be followed:

1) The project schedule shall be coordinated with the London Teams in order to determine their final sequences, duration and assigned support.

2) About 100 temporary hotel apartments/ rooms shall be made available for the EMA staff. Temporary stay for the staff and families will be correlated with the move of their personal belongings.

3) The RTL shall assign a RS for each expert/group of experts and family/families in order to support the EMA staff in case of international moving disruptions. On arrival in Romania, staff members shall be provided the contact of the assigned RS.

4) The RS shall support the EMA expert/group of experts in identifying appropriate dwellings according to the needs of the expert and their family.

5) On a case-by-case basis, the RS shall identify a list of tasks, with start and finish dates, for each


particular relocation of each/group of EMA staff and their families.

6) The RTL and RS should agree with key stakeholder on the sequences, duration and assigned responsibilities.

7) Regular meetings provided in the project schedule for the entire project relocation to update the schedule and responsibilities: develop a contact sheet for all meeting attendees; distribute agendas of the meetings in advance.

8) Final move of EMA staff in their new living places Feedback to RS from EMA staff.

Responsible: Relocation Specialists (RS) from the Department of Support Relocation Services (DSRS) in the RMoH and London Teams.


Established set of competences of the Relocation Support specialists ( RS) assisting the relocation process of EMA staff and their families are:

DSRS staff to assist EMA staff and families

Relocation Specialist

- Supports the relocation with the outsourced selected company- Assists EMA staff and their familyes in the relocation process- Follow up activities.

Real Estate Specialist

- Supports the finding of the right location and space for specific needs. - Support and advise the staff and their families in their decision to rent or buy a living place.

Construction Expert / Architect

Construction specialists are speifically assigned to: - Provide support for coordination on space planning, office facilities and parking - Provide support for construction oversight of new dwellings, renovations and upgrades.

IT&C Specialists Delivery

- Assists EMA staff in arranging for the installation of low voltage telephone, data and video wiring and other IT&C services needed in their new facilities.

Risk Management Expert

- Identifies and mitigates risks and provides support for additional insurance coverage- Provides expertise on safety measures, ergonomics, emergency preparedness etc.

Trainers on cross-cultural themes

- Conducts training on specific customs, beliefs, languages, dress, habits&behaviour, ideology and social norms.

5.5. Covering the possible risk of 25% staff shortage

5.5.1. National responsibilities to support EMA staff relocation and possible staff shortages

The National Agency for Medicines and Medical Devices (NAMMD) is a reliable, active partner of the European Medicines Agency Romania ranks tenth EMA employees.

Romania is ready to cope with the risk of a possible EMA staff shortage due to the relocation. In 2017, the Agency has signed a partnership agreement with the most prestigious medical university in Bucharest, the “Carol Davila” University to ensure EMA smooth business continuity, in case of a possible risk of personnel shortage.

The total highly skilled persons, to support an EMA 25% staff loss scenario, are 1,900 (300 persons from the NAMMD and 1,600 proffessors from all universities of medicines and pharmacy in Romania).


The NAMMD and the Romanian Ministry of Health have full capacity to serve as a quick reference to cope with a possible risk of staff loss due to relocation. Apart from the scenarios foreseen in the EMA/336490/2017 MB document, Romania provides its support for the possible loss of staff and assures that this can be mitigated with aid of NAMMD personnel, which could replace shortly the critical position holders from EMA vacancies, until the hiring process of new employees is finalized.

This is supported by the following facts:Romania has a long and uninterrupted history of modern pharmaceutical market regulators. For over 50 years, the National Agency for Medicines and Medical Devices (NAMMD) has represented the medicinal regulatory product authority in Romania.

It was the first institution in Romania to comply with the modern definition of a medicines regulatory authority, where main responsibilities were: authorisation and registration of medicinal products, yearly development of the Product Index, complex control of medicinal products manufactured nationally and abroad, pharmaceutical inspection, development of the Romanian Pharmacopoeia and its Supplements, development of national standards and reference materials etc.. The Romanian Pharmacopoeia has been considered a reference worldwide for many years.

The current mission of the Agency includes assessment of dossiers for authorisation for the marketing of good quality, safe and effective human medicines, assessment of dossiers for authorisation of conduct of clinical trials in Romania and of clinical trial sites; surveillance of human medicinal product safety in therapeutic circuit through inspection and pharmacovigillance.

As of 2014, the NAMMD is also the national competent authority in the field of medical devices and of assessment based on scientific criteria adopted by national legislation in force of medical technologies for inclusion into the national healthcare insurance system.

One important point to note is increased involvement of NAMMD specialists in activities of committees and working groups of the European Medicines Agency’s (EMA) and of the Heads of Medicines Agencies (HMA) (Annex 6).


In the context of the Brexit process, the NAMMD will also have to cope with this challenge without disregarding achievement of its current mission. In that respect, it is worth highlighting that, at EU, EMA and HMA committees and working groups’ level, aiming to create a frame of work allowing for coordinated approach to smooth transfer of UK responsibilities to the Member States remaining in the European Economic Area, the NAMMD will be directly involved in taking over redistributed responsibilities assigned. NAMMD specialists assigned as representative participants in these committees and working groups constantly prove their expertise in their area of competence through direct and ever more active involvement in the work of the respective committee / working group.

In 2017 the NAMMD has signed a partnership agreement with the most prestigious medical university in Bucharest “Carol Davila” University to ensure smooth EMA business continuity, in case of a possible risk of personnel shortage. Also, the agreement is an exemple of NAMMD cooperation with the relevant local actors (Annex 7). The total number of highly skilled persons, able to support the EMA in case of 25% staff loss scenario, is 1,900 (300 persons from the NAMMD and 1,600 proffessors from all universities of medicines and pharmacy in Romania).

5.5.2. International recognised medical and pharmaceutical Romanian universities providing highly skilled young graduates

Bucharest is a university centre with a long-lasting tradition – 12 public universities and 15 private universities, overall 159 faculties supply the market with highly skilled young people.

In the 2012 QS World University Rankings, the University of Bucharest was ranked in the Top 700 universities of the world. There is a constant increase of foreign students enrolled in its universities.

Romania ranks highl globally, in terms of number of medical school graduates - 36 graduates for every 100,000 population. By comparison, the United States have 6.5 graduates and the UK, 9.3 graduates.Bucharest counts for more than 1,600 medical university staff and around 10,000 med-ical, dental and pharmacy students.14,000 specialists in medicine and pharmacy trained in Romanian medical universities are currently working in other EU countries.More than 70% of foreign students studying in Romania (5.678) are enrolled in univer-sities of medicine and pharmacy.


Students enrolled in the medical and support areas in Bucharest for 2016-2017 educational year:

No17 Areas of study Total graduates LMPhD Bucharest (end education 2016) Bachelor’s Master’s PhD

1 Mathematics 105 63 39 3

2 Physics 126 41 55 30

3 Chemistry 66 31 26 9

4 Chemical engineering 210 108 98 4

5 Computer Science 362 234 127 1

6 Computers and information technology 621 437 170 14

7 Cybernetics, statistics and economic informatics 755 440 309 6

8 Veterinary medicine 228 220 0 8

9 Pharmacy (sectoral, 5 years) 267 266 0 1

10 Pharmacy (general, 3 years) 0 0 0 0

11 Medicine (sectoral, 6 years) 876 863 0 13

12 Medicine (sectorial, 4 years) 151 71 80 0

13 Medicine (general, 3 years) 29 29 0 0

14 Dental Medicine (sectoral, 6 years) 275 275 0 0

15 Dental Medicine (general, 3 years) 44 44 0 01

With over 170,000 highly-skilled young potential employees yearly, the Romanian market offers concrete possibilities in line with EMA principles to engage young persons in working activities or in constant dialogue and interaction in a mutually beneficial manner (e.g: young science researcher that could develop or support scientific opinions; inclusion of the views of young patients/consumers and their carers, wherever it may be appropriate).

Early involvement of young people in this kind of European regulatory Agency has proved to have a positive impact. On one hand, it fuels the Agency with young and very flexible highly-skilled work force adapted to short or long term assignments, with modern views of the global labour market. The freshness of their approach could be benefic for the constant improvement of the Agency, adapting it to future changes or market requirements.

17,18 Source: January 2017, Ministry of National Education, Monitoring System


Data regarding the students enrolled in Bachelor’s, Master’s and PhD programmes in the universities of Bucharest for the educational year 2016-2017:

Students enrolled in the Universities

of Bucharest18

Total number of students in Bucharest

Of which

Total number of students (BMPhD)

Of which Post graduate medical stud-

ies

P re p a ra t o r y year of Roma-nian language

Post graduate programmes

Bachelor Master PhD

1. Romanian stu-dents 175.454 169.609 124.938 36.952 7.719 4.495 21 1.329

2. Other EU Member States

students766 710 563 49 98 10 46

3. Non-UE stu-dents 4.783 4.254 3.331 674 249 218 311

4. Total students other EU and

non-EU (2+3)5.549 4.964 3.894 723 347 228 357 0

5.5.3.Recruiting temporary IT staff at short notice

Due to the high number of public and private universities (159 faculties in 27 universities), Bucharest offers a wide range of possibilities for short notice recruitment of multilingual temporary staff. The Bucharest IT market is mainly supplyed by the Politechnic University, University of Bucharest (Mathematics & IT Faculty), the Academy of Economic Studies (Cybernetics Faculty) and a range of new entry private universities which provide for key skills in infrastructure (i.e. systems, middleware); IT architecture (i.e.: security, software); systems development (i.e. developers, testers); management (i.e. project, ITSM).

Ability to recruit highly skilled IT and data management human resources (contractors):

The Romanian software and IT services sector relies on its highly-skilled human capital, recognised at international level. Romania ranks 4th worldwide in terms of medals obtained in all times International IT Scholar Competition - 99 medals in total, out of which 28 gold medals, 45 silver medals and 26 bronze medals.


It is estimated that the software and IT services industry will generate more than 3% of Romania’s GDP in the next 3 years, provided the industry manages to leverage and compensate for a legacy education system and keep a low rate of highly IT skilled foreigners (especially from Ukraine, Bulgaria, Serbia etc.) who might be attracted to the country.

On the mid-term, the trend of increasing the value added to IT services provided from Romania is visible, while still focusing on growing the junior workforce, On the longer term, Romania’s positioning is expected to consolidate as a target market for higher value-added services, R&D centres and significant domestic market projects that would include high-end solutions and technologies.

Strong international IT providers (people&skills&accessibility)19162

The local private market is concentrated around multinationals. For 2017, there are clear signs of an increasing local IT market maturity, increasingly educated IT managers/CIOs, as well as top executives. The types of solutions and IT tools required show growing interest in business-oriented technologies, with lower TCO and faster ROI.Looking at the ownership structure of the software and IT services companies in Romania, it results that strategic investors (IT corporations) and entrepreneurs have been the most active during the past 10 years. Investment funds and “business angels” are increasingly visible on the market, analyzing different opportunities to enter the capital of high-potential local IT companies.

19 Source: “Software & IT Services in Romania - 2017 “commissioned by ANIS Romania

46.4%

18.8%12.1%

6.5%

6.4%

5% 2.4%2.3%

București Cluj Timiș Iași Brașov Bihor Dolj Alții

Distribuition of IT companies in Romania


Based on the number of employees and turnover, the first 5 IT companies in Bucharest and Romania are multinationals such as Oracle, IBM, Ericsson Telecommunications, Microsoft, Atos IT Solutions and Services.

More than 75% of the companies in the field are located in areas with university centres and have attracted foreign investments in recent years: 46.4% in Bucharest, 12.1% in Cluj, 6.5% in Timis, 6.4% in Iasi and 5% in Brasov.

5.6. 2018 TIME-PLAN FOR EMA RELOCATION

Timing Key Milestones ResponsibilityNovember 2017 CE decision on the new seat for the EMA

in another EU member state EU Council

December 2017 Space planning in accordance with detailed EMA requirements and Romani-an regulations in construction: structure&

enclosure of the building.

Responsible arhitect working with/for EMA

December 2017 Base-building construction completed Romanian Developer Dec. 2017-Jan. 2018 Tender for selection and approval

of the relocation company. Signing of the contract with the relocation company.

Lease contract approval by the MB and signing of contract.

European Medicine Agency (EMA) desig-nated staff

EMA and Romanian Developer

Feb.-March 2018 Business Relocation Plan and Action Con-tinuity Relocation Plan: development and

approval

Relocation company and EMA

Jan.-Feb.2018 New building: space design based on de-tailed space planning

Romanian Developer as per Contract schedule

Phase I: March-May 2018

Phase II:June-August 2018

Fit-out works’ completion:Phase I: first 6 floors, basement and

ground floorPhase II: remaining floor spaces

Romanian Developer as per contract schedule

Support: RTL, LTL

May- June 2018 Testing, commission and preparation for the move

LTL, RTL and Relocation Company

June 2018 Early access by services after phase I, fit-out work completion.

Relocation CompanySupport: RTL, LTL

July-Sept. 2018 Staff moves: first phase based on planned staff move.

Relocation CompanySupport: RTL, LTL

Sept.-Nov.2018 Staff moves: second phase, after phase II fit-aut works completion and based on

planned staff move.

Relocation Company Support: RTL, LTL

December 2018 First committee meeting (CVMP) at the new Bucharest location.

EMA

December 2018 Formal change of EMA address EMA


VIGeographicalSpread

After 10 years of EU membership, Romania is among the few EU countries not yet hosting any EU agency.

During the 10 years of EU membership, Romania has demonstrated its full commitment towards deepening the EU project and promoting European values, fundamental principles and objectives set out during this period. Romania has a clear and steady pro-European orientation, as also shown by the results of Eurobarometer surveys issued on the EU public support in MS countries.

Romania is a pillar of stability in the region and has a unique geostrategic position in the Black Sea area, able in the present context to set up a security platform in the Black Sea, Balkans, Central Asia and Middle East area.

Romania’s strong commitment towards the EU is supported by good economic perspectives. This is exemplified by the fact that 2016 was an exceptional year for the Romanian economy, as headline growth accelerated to 4.8%. Romanian economy is expected to continue growing in the current year.

Romania provides a favorable location, a friendly investment climate as an attraction tool for investors worldwide. Romania remains very well positioned to attract new investments due to its historical support for its high level of education.

As an important player in the region, Romania has an economic impact due to its crucial structural shift in the economy: the emergence of the BPO/SSC and IT sector as powerhouse for growth and employment. Output in the sector has increased by 12% during 2016, making it the second contributor to GDP expansion after consumer spending and ahead of industrial production. Furthermore, the sector has consistently recorded growth rates above 7% p.a. during the past five years.

The two reasons to consider Romania as a regional potential hub in the service sectors are:

i) demand for services is expanding at a global level and

ii) Romania has a significant potential for development in this area.



At global level, multinational companies have seen an increased benefit from constructing Shared Service Centres as a means to reduce costs and are set to continue implementing these solutions as key components of a new business model. The CEE region has been at the forefront of this boom, with Romania closely following up, as it currently employs approximately 100,000 people in the SSC/BPO sector. Furthermore, the prominence of the already existing companies should help boost demand not only during 2017, but also in the years ahead.

Bucharest, the capital city of Romania, aims at becoming one of the European regional hubs for business and tourism and an important centre for higher education. Taking into consideration the achievement of such goals, local development programs are integrated with the European strategy that aims at providing the appropriate environment for sustainable economic growth.

The Bucharest local strategy is focused on five goals regarding employment, research, education, poverty eradication and energy – climate.

Criminal behavior is kept under control, up to now, no special events having been registered. Citizen safety has been highest over the past ten years. Crime prevention activities carried out by the Romanian authorities are targeted largely towards issues that citizens consider priorities for improvement of safety problems in the towns where crime occurs most frequently. In the prevention area, special attention is paid to the education environment.

Finally, in choosing Romania as the next stop for the EMA, it is important to stay focused on benefits offered to the European people, in a dynamic world in real time, by a country with:

1. European tradition

2. Minor Brexit impact on the National economic stability2019163

3. An important geostrategic regional hub

4. Skilled population

5. Friendly social, economic and cultural conditions

6. State-of-the-art IT&C technologies

7. Secure life

8. European excellent and affordable living condition

Accommodating the European Medicines Agency in Bucharest would meet the objective set out in the Conclusions of the December 2003 EU meeting at the level of Heads of State or Government and confirmed in 2008, that observing a geographical spread of the agencies’ seats at the level of the entire European Union is desirable.

20 2016 Report, Romanian Ministry of Economy: Romania’s total exports and imports to the EU, at the end of 2016, ammounted to EUR 95.029 billion, out of which EUR 4.027 billion (4.23%) represented trade relations with the UK


Vote Romania for EMA


Romania – country general fact and figures

Official Name: Romania

Location: (Southeastern) Central Europe

Climate: Temperate, four distinct seasons

Time Zone: GMT + 2

Official Language: Romanian

Area: 92,043 sq. miles (238,391 sq. km)

Flag: Three vertical stripes: blue, yellow and red.

Capital: Bucharest (București)

Currency: Leu

Population: Based on the latest United Nations estimates, the current population of Romania1 is 19,270,127 as of Monday, April 3, 2017 or, 3.9% from the total EU population, equivalent to 0.26% of the total world population. Romania population ranks number 59 in the list of UN countries (and dependencies) by population and 7th in The EU.

Largest cities2: Bucharest (1,883,425), Iasi (322,000), Cluj Napoca (309,000), Timisoara (303,000), Constanta (298,000), Craiova (295,000), Galati (286,000), Brasov (275,000), Ploiesti (224,000), Braila (205,000), Oradea (196,400). Romania’s population lives in 320 cities and towns and 12,956 villages, with 61.3% of the Romanian population in urban areas (11,785,372 people in 2017).

Ethnic groups: Romanian 83.04%, Hungarian 6.5%, Rroma 3.3%, Ukrainian 0.3%, German 0.2%, other 0.7%, unspecified 5.9%.

1 Source: Worldometers (www.Worldometers.info). Elaboration of data by United Nations, Department of Economic and Social Affairs, Population Division.2 2011 Romanian Census

Religious affiliation: Eastern Orthodox (including all sub-denominations) 86.5%, Protestant (various denominations including Reformed and Pentecostal) 5.1%, Roman Catholic 4.6%, other (includes Muslim) 0.4%, none or atheist 0.2%, unspecified 0.1%.

Form of State: Romania is a semi-presidential democracy based on a bicameral Parliament: the Chamber of Representatives or „Chamber of Deputies” (Camera Deputatilor) and the Senate (Senat). All members of the legislature are directly elected.

Under the semi-presidential system, the president is responsible for foreign and defense policy.

Legal system: Constitution of 1991 amended and completed by the Law No. 429/2003 on the revision of the Constitution of Romania.

Electoral System: Universal direct suffrage over the age of 18. Parties must win at least five percent of the national vote to gain representation in the Parliament. Organizations of citizens belonging to national minorities, which fail to obtain the number of votes for representation in Parliament, have the right to one Deputy seat each, under the terms of the electoral law. Citizens of a national minority are entitled to be represented by one organization only.

National Elections: Fall 2019 (presidential), Fall 2020 (parliamentary)

Head of State: President of the Republic, currently Mr. Klaus Werner Iohannis (elected on November 16, 2014). Romania’s president can serve two consecutive five-year terms.

National Government: The government is led by the Prime Minister, nominated by the political party - or political alliance - with parliamentary majority, approved by the President of Romania and confirmed by the Parliament.

Head of the Government: the Prime Minister, currently Mr. Mihai Tudose (appointed on June 26, 2017).

Annex 1

http://www.worldometers.info/world-population/

http://www.worldometers.info/world-population/

http://www.worldometers.info/world-population/population-by-country/

http://www.worldometers.info/world-population/population-by-country/

http://www.worldometers.info/

http://www.cameradeputatilor.ro/pls/dic/site2015.home?idl=2

http://www.senat.ro/

http://www.presidency.ro/

http://www.gov.ro/en


Main political parties, represented in Romania’s Parliament following the December 11, 2016 elections: Social Democratic Party (PSD), National Liberal Party (PNL), The Union for Romania (USR), Democratic Union of Hungarian Ethnics in Romania (UDMR), Liberal-Democratic Alliance (ALDE), Popular Movement Party (PMP).

Local Administration: Forty-one County Councils (Consiliul Judeţean) and the Bucharest capital city .

Romania is a member state of the European Union (EU) and North Atlantic Treaty Organization (NATO), apart from being member of all major international organizations.

Romania: Economic freedom rating is 65.663

Scores are from 0 to 100, higher scores are more desirable i.e. more conducive to economic growth. The lower the score, the greater the level of government interference in the economy and the less economic freedom a country enjoys.

o Free 80 - 100;

o Mostly Free 70 - 79.9;

3 Source: The Heritage Foundation and the Wall Street Journal

o Moderately Free 60 - 69.9;

o Mostly Unfree 50 to 59.9; and

o Repressed 0 - 49.9.

The Romanian score is better compared to other, more advanced economies in the EU.

Romania: Economic growth competiveness index is 4.324

The Growth Competitiveness Index (GCI) aims to quantify the quality of the macroeconomic environment, the state of country public institutions and its level of technological readiness.

Higher competitiveness scores are more desirable:

- Very High 5.51 to 7

- High 4.51 to 5.50

- Moderate 3.51 to 4.50

- Low - 3.01 to 3.50

- Very Low 0 to 3.00

4 Source: World Economic Forum

Romania Slovenia65.60 60.60

65.10 59.10

62.30 53.20

61.20

Portugal Croatia

France Greece

Italy

Romania Cyprus4.32 4.23

4.32 4.22

4.28 4.07

4.024.25

Bulgaria Slovak Rep.

Slovenia Croatia

GreeceHungary

Religions in Romania

Orthodox

Romano-CatholicReformed

Pentecostal

Greek-Catholic

Muslim

Unitarium

Old Rite ChristianSynod-PresbyterianLutheran Evangelic

Source: Romanian 2002 Census

http://www.heritage.org/research/features/index/

http://www.weforum.org/en/initiatives/gcp/index.htm


Romania: Taxes on residents is -10,16%5

The percentage of gross earnings given up in tax, including any social security contributions. Calculated for a single worker without children, earning 100 % of the average wage, for selected countries.

Ratio/Capital city BucharestAverage salary (Euro/month) 572

Rent for a studio (Euro/month) 150

Hotel room (3 stars) (Euro/day) 45

Utilities (Euro/month) 70

Gasoline (Euro/liter) 1.1Urban transport ticket (Euro) 0.6

5 Source: OECD Tax Database

Ireland

Hungary

Slovak Rep.

Estonia

10.09% -13.80%

-10.09% -13.80%

-10.40% -14.21%

-11.12% -14.21%

-12.62% -14.25%

-12.84% -14.42%

-13.11 % -14.58%

-13.11% -14.66%

-13.22% -15.16%

-13.23% -15.23%

-13.73% -15.73%

Malta

Poland

Latvia

Slovenia

Germany

Netherlands

Romania

Bulgaria

Spain

Lithuania

Sweden

Austria

Croatia

Belgium

Denmark

Czech Rep.

Luxembourg

Portugal

http://www.oecd.org/document/60/0,2340,en_2825_495698_1942460_1_1_1_1,00.html


Annex 2

High quality of life, culture and leisure

The Cultural Scene of BucharestBucharest’s cultural life is a rich mix of strong traditional culture, represented by a performing arts sector - theatre, opera, dance and music - as well as a large and diverse network of museums and a mass culture, represented by an increasing number of open air festivals, concerts and events and a rapidly developing contemporary arts scene. Moreover, there is a growing number of cultural operators from the entrepreneurial sector. These include, besides the traditional areas of cultural industries such as multimedia, cinema, audiovisual, music, publishing, cinema, the more edgy domains of video games, interactive media, design, craftsmanship, architecture, etc. Based on recent evaluation of the creative economy sector in Romania, Bucharest is the national leader in cultural entrepreneurship.

The arts and culture sector has different types of cultural structures, each with its own organisational, economic and artistic characteristics: municipal and national cultural institutions, independent organisations and private ones. Although they are all equally important as part of the cultural ecosystem of the city, they are in fact separate phenomena. The independent sector’s rapid growth over the past 15 years is also the result of the annual incorporation of a high number of young arts graduates coming from all over the country, making it the most active and innovative part of the local cultural scene.

The Bucharest cultural institutions with European recognition are: The National Peasant Museum — a member of the International Council of Monuments

and Sites ICOMOS and the 1996 European Museum of the Year; Bulandra Theatre — a member of the European Theatre Union since 1992; Bucharest National Theatre — a founding member of New European Theatre Action NETA network; Romanian Youth Cultural Centre — a member of the European Federation of National Youth Orchestras.

The European presence is also felt in the numerous cultural events organised in cooperation with the cultural institutes of other EU states. The French Institute is one of the several cultural agencies promoting foreign culture in Romania, through its network of institutes and cultural centres located in the main cities. The German Goethe Institute, the Italian (Vito Grasso) and Spanish (Cervantes) institutes and the Hungarian Cultural Centre, just to name a few of the cultural institutes present in Bucharest are supporting the cultural life through seminars, conferences, festivals, concerts, exhibitions etc, by funding a variety of independent projects and support various programmes and projects, along with public and non-public institutions.

Bucharest has the highest number of Art Universities in the country (seven), with more than 7,000 art students. In recent years, there have been some successful attempts to improve the collaborative aspects of the, otherwise, traditional institutions with research and experiment platforms.Some notable examples are the Centre for Electroacustic Music and Multimedia at the National Music University, which works with cuttingedge technologies in aural and visual arts and the CINETIC international research centre in creative technologies at the University of Theatre and Film.The Bucharest diverse networks of museums and public libraries produce more than half of the city’s cultural output, comprising theatre, dance and music performances, as well as exhibitions, conferences and arts driven education events.


Bucharest’s Cultural Infrastructure6

Libraries Number

National Libraries 3

Specialized Libraries 58

School Libraries 264

Libraries of Academic Institutions 28

Museums and Public Art Collections 36

Theatres, Show and Concert Companies

Dramatic Theatres 23

Opera Institutions 2

Musical Theatres, Operetta 1

Puppet Theatres / Animation 1

Philarmonics 3

Popular Orchestras 1

Artistic Ensembles 13

Cultural Centres 7

Cinemas 17

Circus 1

Cultural Heritage

Historic monuments 2.651

Treasure Goods 12.191

Museums• Art Collections MuseumAddress: 111 Calea Victoriei Founded in 1978, the Art Collections Museum, a branch of the National Art Museum, houses private collections donated over the course of time. Collections include European as well as Oriental art works.

• Bucharest History & Art Museum Address: 2 I.C.Bratianu BoulevardHoused in the neoclassical Sutu Palace (1834), the museum features some 300,000 artifacts, from

6 Data provided by the National Institute for Statistics, the National Institute for Cultural Research and Training, the National Institute for Heritage

coins, books, maps, engravings, paintings, arms and furniture to old traditional costumes. Among the most valuable exhibits are the document attesting for the first time the name of the city of Bucharest, issued by Vlad Tepes in 1459 and a sword set in precious stones that belonged to Prince Constantin Brancoveanu (1688-1714).

• George Enescu National MuseumAddress: 141 Calea Victoriei The museum, housed in the Cantacuzino Palace, displays documents and various objects that belonged to the great Romanian composer and violinist George Enescu (1881-1955), including a Bach music collection he received as a gift from Queen Elisabeth of Romania. A world-class violinist, Enescu studied at the Vienna Conservatory, where he met German composer Johannes Brahms and where he also gave his first concerts. In Paris, Enescu graduated from the French Conservatory in 1899. His best-known works, the Romanian Rhapsodies, earned him national and international fame. In 1936, his Oedipe tragic opera premiered in Paris and Enescu was awarded the French Legion of Honor award for the composition. A member of the Romanian Academy and corresponding member of the Institute of France, George Enescu was the teacher of renowned violinist Yehudi Menuhin. Every two years, the Romanians celebrates the maestro by hosting the George Enescu International Classic Music Festival.

http://romaniatourism.com/george-enescu-music-festival.html

http://romaniatourism.com/george-enescu-music-festival.html


• Cotroceni Palace & Museum Address: 1 Geniului Street

A former royal residence built between 1679 and 1681 by Prince and ruler Serban Cantacuzino, the palace was home to King Carol I, who made important changes in its architecture. At the end of the 19th century, Heir-to-the-Crown Ferdinand ordered the partial demolition of the palace, which was later reconstructed by French architect Paul Gottereau in neoclassical style. In 1977, Nicolae Ceausescu transformed it into an official guesthouse with the addition of a new wing. After 1990, the old wing of the palace became a museum. The Oriental Hall, the Norwegian Hall and the Queen’s Chamber are almost unchanged from the original design and are worth visiting. Very important collection of medieval art also can be seen here. Nowadays he new wing serves as the seat of the Romanian Presidency.

• Museum of the Romanian PeasantAddress: Sos. Kiseleff 3 Opened in 1906, the museum features the richest folk art collection in Romania, with over 90,000 artifacts that trace the colorful and diverse cultural life of the Romanian people. The Pottery Collection includes some 18,000 items, representative of the most important pottery centres in the country. The oldest ceramic item found in the museum bears the inscription 1746. Equally impressive, the Costume Collection comprises almost 20,000 traditional folk costumes, some dating from the beginning of the 19th century, giving visitors insight into the styles and traditions of the Romanian peasants.

The displays dip into all aspects of life in the Romanian countryside. Exhibits of agricultural tools, carpets,

icons, furniture, photographs and films build up a complete picture of Romanian folk culture. In one of the galleries, you can see a wooden church and in another, a wooden peasant house. Four more wooden churches stand in the outdoor museum area. In 1996, the museum was named European Museum of the Year. Visitors can buy regional handcrafts and textiles in the museum’s extensive gift shop.

• National Art Museum Address: Calea Victoriei 49-53

Romania’s leading art museum was founded in 1948 to house the former Royal Collection, which included Romanian and European art dating from the 15th to the 20th century. Located in the neoclassical former Royal Palace, set amid a wealth of historic buildings such as the Romanian Athenaeum, Kretzulescu Church and the Hotel Athenee Palace-Hilton, the museum

currently exhibits over 100,000 works divided into two major sections. Its National Gallery features the works of major Romanian artists, including Grigorescu, Aman and Andreescu. There is also a roomful of early Brancusi sculpture, such as you won’t find anywhere else, demonstrating how he left his master, Rodin, behind in a more advanced form of expression.

The European Gallery, comprising some 15 rooms,


displays little-known art gems from the likes of El Greco, Monet, Rembrandt, Renoir, Breughels (father and son) Cezanne and Rubens. If you only have time to visit one gallery, make it the Romanian one. It is the most complete collection of Romanian works of art in the country and quite possibly, the world.

• National History Museum Address: Calea Victoriei 12

Housed in a 1900s neoclassical building that once served as the city’s main post office, the museum offers a great introduction to the exciting history of Romania. Spread throughout 41 rooms, the exhibits recount the country’s development from prehistoric times to the 20th century. The highlight is the National Treasury Hall where visitors can enjoy a dazzling display of some 3,000 gold items, including jewelry and valuable Neolithic artifacts. Among the displays are the 12 pieces of the 4th century Pietroasele Treasure Collection. First presented at the 1867 World’s Fair in Paris, it was considered the most valuable treasure collection in the world (the tomb of Tutankamon had not yet been discovered). One year later, the collection was displayed at the Second Annual International Exhibition in London and in 1872, at the International Exhibition in Vienna. • National Museum of Contemporary Art Address: Calea 13 Septembrie 1, entrance E4

Bucharest’s newest museum, the MNAC, as it is often called by museum-goers, displays works of Romania’s contemporary artists as well as many temporary exhibits by international artists. The museum is housed in a wing of the Palace of Parliament, the space which would have served as Nicolae and Elena Ceausescu’s private apartment (where just the bathroom occupied 680 square feet, while the adjoining boudoir was three times that size).

• Theodor Pallady Museum Address: Str. Spatarului 22

Housed in the beautifully restored Melik house, built around 1750 by the rich Armenian Hagi Kevork Nazaretoglu and currently, the oldest house in Bucharest, the museum features six Pallady paintings, a couple of his sketches and various other art objects. Zambaccian Museum (Muzeul Zambaccian)Address: Str. Zambaccian 21A

The museum possesses the private art collection of Krikor Zambaccian (1889-1962). Names such as Andreescu, Grigorescu, Luchian, Pallady and Tonitza are famous in Romania, albeit less known outside the country, but the works, mainly following the Impressionist school, are of the highest quality. There are also several small sculptures that complement the canvases. Although Zambaccian was a big patron of the art of his home country, he also collected European works from artists such as Cezanne, Renoir, Delacroix, Corot, Derain, Matisse, Pissaro, Bonnard, Utrillo and Picasso. The museum preserves the initial display as it was conceived by the art collector himself.

Performing ArtsBucharest’s performing art sector is historically


strong with the National Theatre at its core. Its diverse networks of theatre, dance and music performances produce more than half of the city’s cultural output, as well as exhibitions, conferences and arts-driven education events.

Bucharest has numerous drama theatre and concert venues. Tickets can be purchased on-line or directly at the venue’s box office.The vibrant cultural life is also supported by a great number of foundations implementing artistic and cultural projects. These projects have led to the creation of an independent artistic scene, especially as regards theatre, visual arts, contemporary dance, a scene that becomes more and more visible to the public.

Theatre performances are very popular in Romania and for most shows tickets sell-out within hours.While most theatre productions are performed in Romanian, sometimes, it is possible to find performances in German or English at various small theatres.There are 16 major theatres in Bucharest offering performances for all ages. The theatre season closes during the summer, from July to September, although some small student and underground theatres do remain open.

The notable theatres in Bucharest are:

• National TheatreAddress: Blvd Nicolae Balcescu 2

Three auditoriums host professional domestic and foreign plays by a broad selection of both classical and contemporary Romanian playwrights. The theatre’s Great Hall (Sala Mare), hosts the grand productions, while the Amphitheatre (Sala Amfiteatru) shows smaller productions and TV shows and the Studio Hall (Sala Atelier) gets a mix of lower-key shows and

presentations.

• National Jewish Theatre Address: Str. Dr. Iuliu Barasch 15The Jewish Theatre offers performances in Yiddish, Hebrew and Romanian (translation into Yiddish and Hebrew available).

• The Comedy TheatreAdress: 2 Sf. Dumitru Street Sala Nouă: 11 Sf. Vineri Street

With a repertoire dedicated to comic genre in its rich diversity, from Shakespeare, Chekhov and Gogol boulevard comedy, theater of the absurd and black comedy, Comedy Theater is unique in Romania.In the 60s the Comedy Theater went through a period of artistic synchronization with global theatrical movement, as evidenced by Nations Theater Award for “Best National Participation” made in Paris in 1963 with the play “Rhinoceros” by Eugène Ionesco, directed by Lucian Giurchescu, followed by “Shadow” by Evghenii Svartz and “Troilus and Cressida” by William Shakespeare, both directed by David Esrig, the last one also getting the award for best performance.

• Odeon TheatreAddress: Cal. Victoriei, 40-42

The Odeon Theatre, located in a splendid building which is a historical monument which centenary was celebrated in 2011, has been invited to be part of the Black Sea Route, within the project called The European Route of Historical Theatres.

This new route was launched on March 3rd, 2017, at a press conference that took place at the National Theatre in Iași. Among the participants were representatives of the theatres that are part of the Black Sea Route and also members of Perspectiv


– The European Association of Historical Theatres, located in Berlin, the originator of this pan-European project, brought to life with the support of the European Union’s Culture Programme.

• Bulandra TheatreAddress: 1Schitu Măgureanu Bulevard

The Bulandra Theatre was founded in 1947 as Teatrul Municipal; its first director was Lucia Sturza Bulandra, one of the leading Romanian stage actresses of her generation.

Since 1991, the Bulandra Theatre has been a member of the Union of European Theatres, which was founded in March 1990. The theatre currently has two stages, located about 1.5 kilometers apart from one another, Sala Izvor (renovated 2002) near the Dambovita River, not far from the southwest corner of Cismigiu Garden and Sala Toma Caragiu(renovated 2003), about half a kilometer southeast of Piata Romana, just east of the Gradina Icoanei park.

Opera & Ballet

• National Opera & Ballet Address: Mihail Kogalniceanu Boulevard 70 – 72The city’s artistic life stood up to its Parisian nickname in the 1930s and today, is as vibrant as ever. The Opera House, completed in 1953, is worth visiting, not only for its brilliant performances but also for the lavish interior design. The world-renowned Romanian Opera performs in Romanian as well as Italian and German. You will be able to enjoy the classic repertoire - Puccini, Verdi, Rossini, Mozart -, innovative staging, lavish costumes, seasoned performers and choreographers. The Romanian National Ballet also performs in this theatre. Performances are held Wednesday through Sunday evenings, except during July and August.

Symphonic Music

• The Romanian AthenaeumAddress: 1 Benjamin Franklin Street

The work of French architect Albert Galleron, who also designed the National Bank of Romania, the Athenaeum was completed in 1888, financed almost entirely with money donated by the general public. One of the preeminent public fundraising campaigns ever in Romania, the “Give a penny for the Athenaeum” campaign saved the project after the original patrons ran out of funds. With its high dome and Doric columns, the Athenaeum resembles an ancient temple. The lobby has a beautifully painted ceiling decorated in gold leaf, while curved balconies cascade in ringlets off a spiral staircase.A ring of pink marble columns is linked by flowing arches where elaborate brass lanterns hang like gems from a necklace. Inside the concert hall, voluptuous frescoes cover the ceiling and walls. Renowned worldwide for its outstanding acoustics, it is Bucharest’s most prestigious concert hall and home of the Romanian George Enescu Philharmonic.


Entertainment

CinemasForeign movies are generally shown in the original language with Romanian subtitles. Current film listings are available online www.sapteseri.ro

CircusBucharest Globus Circus Address: Aleea Circului 1

Built in 1960, the enormous, permanent big-top circus is the centrepiece of a small but lovely park. With seating for more than 3,500 spectators, Bucharest’s circus continues to host excellent performances, put on by both local and touring companies.

Festivals & EventsOver the past 20 years, Bucharest has hosted a large number of festivals. Industry professionals promoted an increasing number of film festivals in response to the dramatic decrease of the 1990s in film audiences and the lack of an European film distribution network. Independent events and festivals such as Bucharest Design Week (20,000 visitors) and visual arts fair Art Safari (19,000 visitors in 2015) have educated and drawn new audiences, while network-type events such as the White Nights format have proven to be the most popular.

Music festivalsOne of the country’s most important and popular music events is the George Enescu International Festival, held in honour of the famous Romanian composer George Enescu. The first official opening day of the festival took place on September 4th 1958, merely three years after George Enescu’s passing, thus marking the official debut of the most important


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international musical manifestation hosted. Each edition brings to Bucharest some of the world’s most famous musicians worth mentioning Yehudi Menuhin, Sviatoslav Richter, Ion Voicu, Valentin Gheorghiu, Rostropovich performed on the stages of the Athenaeum, the Palace Hall and the Radio House and the most recent edition of the Enescu Festival (30 August – 20 September 2015, Bucharest) brought on stage George Enescu’s works by record-breaking German violinist David Garrett, San Francisco Symphony Orchestra (Pulitzer Prize for Music), or Israel Philharmonic Orchestra under Zubin Mehta.Conceived as a yearly event, Bucharest Jazz Festival is intended to be the major jazz event of Romania’s Capital, aiming to become fully integrated in the national and European contexts. Placing a strong accent on supporting the local Romanian jazz scene, Bucharest Jazz Festival is also a bridge for world class jazz and a platform for the latest trends in contemporary jazz.

Launched in 2006, the SoNoRo International Chamber Music Festival brought chamber music to the forefront of Romanian cultural life and included the Romanian musical scene in a network of high-profile European festivals. In addition to regular partnerships with festivals in Italy, Latvia, Germany, England, Israel and Japan, SoNoRo has performed in some of the most famous halls in the world, such as Wigmore Hall in London, Konzerthaus in Vienna, YMCA in Jerusalem and Carnegie Hall in New York.

Contemporary art and designBucharest hosts every year the Romanian Design Week Festival, as a city highly promoting creative industries. Staged every year in May, Romanian Design Week is a 10-day festival that promotes design as a pad for cultural, social and economical growth. Events and showcases focus on product and industrial design, furniture, graphics, fashion, architecture and interior design. The main exhibition includes, every year, over 150 projects of more than 100 designers, design and architecture studios. A board of curators selects the participants of the main exhibition, gathering under the same roof the best creative work developed by Romanian designers, artists and architects. The festival’s international flair is reinforced by the introduction of a guest country. Up until now, these have included Netherlands (2014) and Denmark, Finland, Island, Norway and Sweden with a common project (2015).

The Art Safari Pavilion, organized by the Arts Society Cultural Centre Foundation, is an annual event devoted both to Romanian and regional art, with an emphasis on its recent developments. Designed to offer a comprehensive presentation of Romanian art, Art Safari features a wide range of artworks from heritage art to contemporary art. Over 100 galleries, museums and cultural institutions attend the event, mostly Romanian, along with participants from other countries.

Book fairsAnother very important event is the Gaudeamus International Book and Education Fair, which gathers a very impressive number of publishing houses, as well as visitors. The Gaudeamus Fair is part of the READING Program initiated and organized by Radio Romania since 1994. Some of the highlights of the 2016 edition are: 125,000 visitors, 300 exhibitors from five countries: Romanian and foreign publishing houses, book distribution agencies, educational institutions, professional associations, cultural and educational non-governmental organizations, museum, libraries, 850 accompanying events – book launches, book signing


sessions, professional debates and forums, creative workshops etc.

Film Festivals Awarded by the most important international film festivals, the Romanian New Wave films influenced the number and reputation of the film festivals. Bucharest International Film Festival is a competitive festival dedicated to feature films only; is organized by Charta Foundation. The objective of the festival is to promote international independent film, supporting the production and distribution of Romanian film as well. The festival aims to create a platform for the international cinema industry.

The anim’est International Animation Film Festival, established in 2006, has become Bucharest’s most loved film festival and a recognized event on the international animation scene. The festival’s programme consists of six competitive sections (international feature film, international short film, Romanian film, student film, video, Minimest), the Mozaic section – presenting the hottest animation short & feature animations in international film festivals and also special sections & retrospectives dedicated to important animation studios, directors, film schools and festivals. Workshops, masterclasses, special parallel events, concerts and parties open to the festival guests and audience. The anim’est Trophy is presented every year to one of the films competing in the short film competition.

One World Romania is the biggest documentary festival dedicated to human rights in Romania and which presents cutting edge films addressing urgent political and social issues confronting today’s Europe. Starting 2017, One World will curate a special section within the festival, consisting of film showcases and collaboration programmes between documentary filmmakers and activists, providing a solid base for highly debated subjects such as the European refugee crisis, political views in the Orient, corruption and future world scenarios. Parallel, One World Association organises the educational programme One World Romania at School, which aims to introduce human rights debates and documentary film screenings in high schools from Bucharest.

Les Films de Cannes à Bucarest came into being in 2010 at the initiative of director Cristian Mungiu, with the support of Thierry Frémaux, General Delegate of the Cannes Film Festival. Their idea generated a trend, the festival spreading as far as Buenos Aires in 2014, under the name of Semana de Cine del Festival de Cannes.

Street festivals B-FIT in the Street!, the only international street theatre festival in Bucharest, is organised by ARCUB, the Cultural Centre of the Bucharest Municipality. During the festival, Bucharest becomes a fantastic setting, inhabited by unexpected characters blending in the crowd and interacting with the passers-by. Austria, Spain, UK, Germany and Italy were some of the countries that attended the 2016 edition of B-FIT in the Street!, an event with various dumb shows, circus, comedy, dance, acrobatics, street music and parades.

The Bucharest International Light Festival Spotlight restores public space to its traditional role as a set up for the rituals of communication by treating the architectural dimension of the city as a living structure


that auto generates. Artists and architects working with light are challenged to use the rich symbolism of Romanian folklore and translate it into digital art collaborative projects, to explore the superposition of spaces, experiment with the architectural dimension of the city as media carrying connections, rather than as static object and eventually use the public space of the city as a temporary museum.

Another interesting street festival held in Bucharest is called Femei pe Matasari (Women on Matasari) and brings together creative projects in the area of theater, music and fashion. The name comprehensively covers the event’s ideology: taking place in and around Matasari Street, organised by women, it’s designed to showcase local arts and culture groups through live music, fashion and theatre. The name of the street reminds of the old craft of working with silk (matase is the Romanian word for silk, matasar was the person working with silk).

Drawing huge number of persons, The European Night of Museums, the White Night of Galleries, as well as the White Night of Cultural Institutes has become a landmark for celebrating culture across the continent and these events have proven spectacularly popular in Bucharest.

The festival schedule during the year:• George Enescu Music Festival (September- every two years), the biggest international event• Masters of Lyrical Art (March)• Easter Gifts National Arts & Crafts Fair (April)• ‘Next’ International Film Festival (April)• Bucucuresti International Film Festival (B-EST IFF) (April)• Bucharest International Jazz Competition (May)• Bucharest International Music Festival ‘EuropaFest’ (May)• ‘GayFest’ Gay Pride Festival (June)• OstFest Music Festival - (June)• Rock The City - Music Festival (June) • B’ESTFEST top international dance, indie and world music acts (July)• ‘Proms of Delight’ - The Romanian Symphony Orchestra at

Bucharest’s National Art Museum (August)• ‘Little Paris’ International Music Festival - (August)• International Festival of Radio Ensembles “RadiRo” (September)• Romania Tennis Open - an ATP event (September)• Romanian National Theatre Festival (October)• ‘Kinofest’ - cutting-edge short films and new media (October)• St Nicholas Fair at Bucharest’s Museum of The Romanian Peasant (December)• Winter Gifts Arts & Crafts Fair - Museum of the Romanian Peasant (December)

http://www.festivalenescu.ro/

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http://www.nextfilmfestival.ro/en/

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Healthy LeisureNearby Attractions:

Nature, outdoor activities for adults and children - bike ride, climbing courses in the trees, horse riding, airsoft, archery or paintball - , relaxation and fun are ideally melt in some adventure parks which are also very easy to access from Bucharest. Balotesti, Comana and Cernica are close to the city and well known for the tourits they attract for a day or even a night stay over in the forest.

• Therme Bucharest, the largest thermal water park in Europe

Where: 10 Km North of BucharestAccess: car, taxi, Therme buses

Located in the Balotesti village, Therme Bucharest is the perfect place to bring the entire family for fun and recreation, bringing together the wonders of nature and the convenience of modern lining in an exceptional setup. It is the largest thermal park in Europe, with a covered area of 30,000 sq. meters and a total of 250,000 sq. m. It has palm trees, pools at 33 degrees Celsius and operates 365 days.The total capacity is 4000 visitors at the same time, pools are fueled exclusively by thermal waters

extracted from 3 km deep, 1,800 parking spaces, 1,200 trees planted outdoors, 500 palms and exotic plants, the largest retractable roof with a front opening of 36 meters without pillars, the water is extracted at 85 degrees Celsius, coated, cooled and changed once in 4 hours. The building uses mostly thermal energy supply.

• Snagov MonasteryWhere: 41 km (25 miles) north of BucharestAccess: car, bus, taxi

In 1458 - more than one hundred years after the church was built (1364) - Romanian prince Vlad Tepes (Vlad the Impaler) added thick defending walls and a dungeon. A plaque on the floor inside the church marks the grave with the presumed remains of the world-known count. The monastery is located on an island on lake Snagov and can be accessed on a pedestrian bridge or by boat.

Sports

Football is the most widely followed sport in Bucharest, with the city having numerous club teams, some of them being known throughout Europe: Steaua, Dinamo, or Rapid.


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Arena Națională, a new stadium inaugurated on 6 September 2011, hosted the 2012 Europa League Final and has a 55,600-seat capacity, making it one of the largest stadiums in Southeastern Europe. Sport clubs have formed for ice hockey, rugby union, basketball, handball, water polo and volleyball. The majority of Romanian track and field athletes and most gymnasts are affiliated with clubs in Bucharest.

The Athletics and many Gymnastics National Championships are held in Bucharest at the Polyvalent Hall, which is also used for other indoor sports such as volleyball and handball.

The largest indoor arena in Bucharest is the Romexpo Dome with a seating capacity of 10,000. It is used for tennis, boxing and kickboxing.Every year, Bucharest hosts the BRD Năstase Țiriac

Trophy international tennis tournament, which is included in the ATP Tour. The outdoor tournament is hosted by the tennis complex BNR Arenas.

Rugby games are held in different locations, but the most modern stadium is Arcul de Triumf Stadium, which is also home to the Romanian national rugby team.Other Romanian turistic attractions with starting point in Bucharest

Parks & Gardens

• Cismigiu Garden Address: Regina Elisabeta Boulevard Designed in 1845 by the German landscape architect Carl Meyer, the garden opened to the public in 1860. The name, Cismigiu, comes from the

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https://en.wikipedia.org/wiki/Team_handball

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https://en.wikipedia.org/wiki/Sala_Polivalent%C4%83_(Bucharest)

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Turkish cismea, meaning “public fountain.” More than 30,000 trees and plants were brought from the Romanian mountains, while exotic plants were imported from the botanical gardens in Vienna. Cismigiu is Bucharest’s oldest park and a great place to stroll and enjoy a break from the hectic city. Set amid green lush lawns and winding paths, the park offers a lake with rowboat rentals, a beer garden, a playground for children, a chess area for amateurs and plenty of park benches for relaxing and people-watching.

• Botanical Garden Address: Sos. Cotroceni 32 (across from Cotroceni Palace)

The huge greenhouses are open Tue, Thu, Sat, Sun, 9am - 1pm.Opened in 1891, the garden features over 5,000 varieties of plants from Romania and around the world.

The garden also encompasses a beautiful building in the Brancovenesc architectural style, housing the Botanical Garden Museum. Here, you can peruse manuscripts, old botanical research devices and a collection of artifacts made of vegetal materials. Locals treat the gardens as a park and on warm afternoons, you may see more young lovers than plants.

• Herastrau ParkAddress: 32 Soseaua Kiseleff

Spread over some 400 acres, from the Arch of Triumph to the Banesa Bridge, the park is home to numerous attractions, including a boat rental complex, tennis courts and fairground. In the summertime, many terraces open up on the shores of the lake.

For an overview of the park, take a ride around the lake on the ferry or rent your own boat. The park is also home to the Village Museum. The area surrounding the park holds even greater treasures. The streets between Bulevardul Mircea Eliade and Soseaua Kiseleff contain extraordinarily beautiful houses in architectural styles ranging from 19th century neoclassical to 20th century art nouveau and modern luxury villas.

Painted Churches

• Voronet MonasterySmall but extremely beautiful, the Voroneţ Monastery was nicknamed the Oriental Sistine Chapel and the shade of blue that permeates the wall paintings is famous all over the world.

Close to the city Gura Humorului, the Voroneţ Monastery is one of the few historic religious establishments which has, for the most part, retained its original form.Most of the interior paintings date from the reign of Stephen the Great. The exterior paintings were added later, during the reign of Petru Rareş, Stephen the Great’s son.The church was extended and painted on the outside by metropolitan Grigore Roşca, in 1547.The church’s artworks are considered the best representation of Moldavian feudal art.Three months, three weeks and three days. That i how long it took to build Voronet, perhaps Moldovia’s most precious jewel.The church of Voroneţ Monastery was included in the UNESCO World Heritage List in 1993.

• Sucevița Monastery”Învierea Domnului” Church of Suceviţa MonasteryIt was founded by metropolitan Gheorghe Movilă and ruler Ieremia Movilă. The church was painted during 1596-1602.


Built in the 16th century and combining Gothic and Byzantine artistic elements with the style established during the reign of Stephen the Great and that of the wooden churches of the Maramureş area, Suceviţa has a special value, being included in the UNESCO World Heritage List in 2010.(Year of construction: 1582. Suceviţa Commune, Suceava County).

• Moldovita Monastery”Buna Vestire” Church of Moldoviţa MonasteryIt was built by ruler Petru Rareş, near an ancient foundation of Alexandru cel Bun. The interior and exterior paintings in Moldoviţa Monastery’s church date back to 1537. Moldoviţa’s exterior paintings are true masterpieces whose remarkable preservation over the centuries has left their splendour undimmed by time.The church of Moldoviţa Monastery was included in the UNESCO World Heritage List in 1993.(Year of construction: 1532. Vatra Moldoviţei Commune, Suceava County)

• Horezu MonasteryHorezu - UNESCO monumentThe ensemble of the Monastery of Horezu is situated in a picturesque landscape of the sub-Carpathian wooded hills and in the proximity of the Romanilor stream. It is the most important foundation of the Cantacuzene Prince Constantin Brancoveanu, the ruler of the Romanian principality of Wallahia between 1688 -1714.

The catholicon of the Monastery of Horezu, dedicated to Saints Constantine and Helena, was built between 1690-92 and the interior decoration was completed two years later by the work of the Greek artist Constantinos, who founded the school of mural and icon painters of Hurezi.The Horezu Depression was in 2008 designated a `European Destination of Excellence’, along with 19 other destinations in Europe, as part of the European Destinations of Excellence project, whose themes were tourism and hidden local heritage. Launched by the European Commission, the project was implemented by national tourism authorities in each participating country.

Sfânta Ana - the only volcanic lakeSfânta Ana is Romania’s only volcanic lake. It lies in the Harghitei Mountains, on the left bank of the Olt River near Tuşnad.

At 946 m, the lake occupies the bottom of an extinct volcano, named Ciomatu, from the volcanic massif Puciosu, of which 1,301m summit was the location of the most recent volcanic eruption in the Carpathians and indeed Central Europe, several thousand years ago.Almost circular, it is 620m long and 460m wide at its widest point, has a surface of 0.2 km2 and a maximum depth of 7m.With no springs feeding it, the lake is replenished only by rain and its water’s purity comes close to that of distilled water, containing only 0.0029ml minerals per liter. Extremely poor in oxygen, the lake permits no animal life.


A reserve on account of its natural, geological, floral and wildlife riches, Sfânta Ana Lake is linked to Băile Tuşnad resort by tourist paths and a road.

Bukovina - a country of painted monasteries, impressive landscapes, old traditions, decency and hospitality. Small churches or real fortresses, lofty or well behaved, located in past mysterious places, enhance the charm of the landscape.

Speaking of Bukovina, one instantly thinks about great masterpieces of the painters of the Middle Ages: Voroneț with the impressive Judecata de Apoi (“Doomsday”), Pătrăuți with graceful “Cavalcade of Emperor

Constantine the Great”, Moldovița with the unique “Siege of Constantinople”, Probota with ecumenical councils and the gorgeous “Pantocrator” dominating majestically the drum tower, Suceviţa with its “Ladder of Virtues” or Arbore with St. Marina, reprinting a new way of “Cavalcade of Emperor Constantine the Great” and the Gothic canopy of the founder.

Among the many masterpieces existing in Bucovina, eight have received international recognition from UNESCO:

• “Beheading of St. John the Baptist” Church - Arbore• Church “Ascension of St. Cross” - Pătrăuți• Moldovița Monastery• Humor Monastery• Voroneț Monastery


• “St. John the New” Suceava• Probota Monastery• Danube Delta

Danube Delta - Part of UNESCO Natural HeritageDanube Delta, with an area of 5,800 square kilometers, is the second largest and best preserved of the European deltas and is mostly located in Romania.

It was included in the UNESCO World Heritage in 1991.

Earlier, Jacques-Yves Cousteau, a key figure of the 20th century, had made a television film, in four episodes and the intervention of the famous French was crucial in the decision to classify the Danube Delta as a Biosphere Reserve in Romania.The Danube Delta Biosphere ReservationThe Danube Delta Biosphere Reservation is the third-richest biosphere reservation in the world in terms of biodiversity, after Australia’s Great Barrier Reef and Ecuador’s Galapagos Islands.

It is home to more than 7,000 known species of plants and animals known and, scientists believe, still more as yet unknown.

This feature of the Danube River is the only delta in the world with biosphere reservation status. Its area accounts for 2.5% of Romania’s surface and is the third largest delta in Europe, after those of the Volga and the Kuban and it is the 22nd largest in the world.

It shelters the largest compact area of reed beds on the planet and supports 30 types of ecosystem. Thanks to all these factors, the Danube Delta is a unique treasure of the planet’s natural heritage.

Besides the actual delta’s 3510 km2, Danube Delta Biosphere Reservation’s other remarkable features includes the Razim – Sinoe complex of lakes (1145 km2), the Black Sea beach strip (1030 km2), the Danube riverbank between Cotul Pisicii and Isaccea (13 km2) and the Danube flood-meadow between Isaccea and Tulcea (102 km2 ).

Dacian Fortresses

Dacian Fortresses - UNESCO’s Cultural World HeritageThe fortified complex also known as Dacian fortresses in Orăştie Mountains, is located in the central and western sector of the geographic unit with the same name, concentrated around the river known as Apa Oraşului (Grădiştea river), which springs from Godeanu Mount and flows into the Mureş river at Orăştie.

Scattered along the many valleys of the mount, arrayed on high platforms, on natural or artificial terraces varying in altitude from 500 to 950 m, we can find here a number of habitats, most of them fortified, having


characteristics and shapes of a surprising consistence, dominating the access ways and the main habitat, Sarmizegetusa, from the top of Grădiştea Hill (a branch of Godeanu Mount), at 1200 m altitude.The series of fortresses and defence towers of Sarmizegetusa start with the main access way to the capital of the Dacian kingdom, which ascended from Mureş Valley upstream to the river Apa Grădiştei, defended at the bottleneck point of the valley by the fortresses at Costeşti-Cetăţuie and Costeşti-Blidaru, as well as by the system of towers and small fortifications, such as Făeragul or Cetăţuia Înaltă.Built in the 1st centuries B.C. and A.D. under Dacian rule, these fortresses show an exceptional and unusual fusion of military and religious architectural techniques and concepts from the classical world and the late European Iron Age.The six defensive works, the nucleus of the Dacian Kingdom, were conquered by the Romans at the beginning of the 2nd century A.D.; their extensive and well-preserved remains stand in spectacular natural surroundings and give a dramatic picture of a vigorous and innovative civilization.

The Dacian civilization, as we know it today due to the systematic research undertaken by Romanian archaeologists, reveals the exceptional historical value (the concept of fortified mountains) and exceptional aesthetical value (the remarkable suggestion of the sacred and impenetrable space of the divine) of the fortresses from the Orăștie Mountains: a grandiose, imposing architecture which used refined decorative effects, a monumental architecture carved in stone, wood and as well other materials (clay, for example).The sophisticated rhythm of the columns of the sanctuaries, the dwelling towers located at the highest places of the fortresses, in perfect resonance with the spirit of the natural environment, single out this ancient civilization, faithful to its interior spirit and traditional materials.Sarmizegetusa Regia Fortress on Grădiştei HillSarmizegetusa Regia Fortress was the capital of pre-Roman Dacia, reaching its peak during the reign of Decebal and is the largest of the Dacian fortifications.

Located on the top of a cliff, at 1,200 metres altitude, the stronghold was the strategic centre of the Dacian defensive system of Orăştiei Mountains and consisted of six fortresses.The stronghold, a quadrilateral formed of massive blocks of stone (murus dacicus), is estimated to have been built in the 3rd-2nd centuries BC, being located on an area of approximately 30,000 square metres.



Annex 3

Other communication systems

WiFi / Getting OnlineBucharest offers numerous WiFi hotspots and many are free. Usually, all you will need is a password (divulged to you when you order something) though in many venues in Old Town or in Metro you can simply sit down and start surfing away.

Bucharest free Wi-Fi /HotSpots imply public spaces & parks:- Piata Universitatii (University Square) at La Biblioteca (The Library);- Orange Concept Shop at Calea Victoriei;- Orange Studio at Piata Victoriei (Victoriei Square);- Parcul Herastrau (Herastrau Park) at Gradina Japoneza (The Japanese Garden);- Expres Olimp at Bulevardul Iuliu Maniu 1 – 3- Lacul Tei at Strada Inginerilor;- Strandul Moghioros at Moghioros Pool- Most Cafés, Restaurants and Clubs- Shopping Malls: Carrefour Orhideea Mall, CityMall, Auchan – Titan- Fast Food Restaurants: McDonalds (All McDonalds in Bucharest), K F C (all KFC), Pizza Hut,Pizza Maxx (splaiul Independentei 290 - Complex Regie),WiFi hotspots in the Old Town Bucharest (Centrul Vechi).

Telecommunication The city is well-served by a modern landline and mobile network (4 mobile phone operators at national level). The telecom system in Bucharest has a reliable and modern communication infrastructure with the following main operators:

GTS Telecom, part of GTS Central Europe and owned by Deutsche Telekom AG is one of the main infrastructure-based provider of telecommunications services in Romania and is positioned as a quality leader in the communications segment for medium and large companies. The company is one of the founding members RoNIX (Romanian Network for Internet eXchange) and is certified ISO 9001, ISO 14001, OHSAS 18001 and ISO 27001.GTS provides national and international transport solutions for data, voice, internet access, cloud services and collocation in its own data centres in Bucharest.The company operates an extensive Ethernet and MPLS network built on a resilient fiber optic infrastructure.

Orange Romania is the brand under which France Telecom provides mobile, Internet and television services. The France Telecom Group is one of the world’s leading telecoms services with over 183 million customers on five continents. Orange Romania has implemented a quality management system certified according to ISO 9001.With the 4G Orange Network, it is possible to access the information you need and send large files faster than ever. In addition, you can make video conferencing or Full HD video streaming easier and for children quick access to online games. Starting with May 2017, Orange Romania offer for the first time, 4G coverage in all cities in Romania.

Vodafone Romania is the first company that implemented the GSM network in Romania in April 1997. Also the first operator to launch 3G services on the Romanian market in April 2005 and then the superior level of HSDPA 3G broadband performance. In October 2012,Vodafone Romania is the first operator that launched the first 4G


mobile data network in Romania.For three consecutive years, Vodafone Romania have been certified P3 Communications as “The Most Powerful Mobile Network in Romania”.Vodafone Romania was the first telecom company in Romania certified according to ISO27001 by KPMG UK in 2005, renewed certification in 2014. ISO27001 is the most recognized standard for information security. The company is also certified ISO 22301 Certification - Business Continuity Management; ISO 9001 Certification - Quality Management; ISO 14001 certification - Environmental management.

Postal Services & TelephoneOffices of Poșta Română, the national postal operator, are spread throughout the city, with the central post office (Romanian: Oficiul Poștal București 1) located at 12 Matei Millo Street. Public telephones are located in many places and are operated by Telekom Romania, a subsidiary of Deutsche Telekom and successor of the former monopoly Romtelecom.Post offices display a postal horn symbol and the word Posta.Main Post & Telephone OfficeAddress: Str. Matei Millo 10 (off Calea Victoriei)Open: Mon. - Fri. 7:30am - 8 pm; Sat. 8 am - 2 pm; Closed Sun.Telephoning Bucharest from AbroadInternational Access Code +40 (country code) + 21 or 31 (area code) + telephone number (seven digit number).Poșta Română provide solutions specially tailored for businesses needs, whether it’s about sending parcels, express services, e-commerce solutions, direct marketing, flyers distribution, money orders or printing solutions.

Special delivery:Collecting, processing and delivery of postal parcels

at sender’s location of choice. The handover takes place at sender’s location of choice, date and time being established by the sender also.This service implies preliminary communication between the sender and the final addressee regarding the time of the arrival.Collecting and processing operations are simplified thanks to processes informatization.Returning undistributed mail items at sender’s location of choice. Mail items are being monitored through the entire techological flow using the Track & Trace system.

Express services:

Prioripost Business – addressed to companies that use direct sales (multilevel marketing); direct marketing companies that manage monthly a significat number of mail items; companies that use the mail order channel or other categories of alternative commerce.

Prioripost - fixed insured value - the service addresses both to individuals and legal persons, the delivery being distributed within the express mail system - PRIORIPOST. It is a fast and convenient system to send financial and fiscal documents or reports to public institutions (tax on income statements, balance sheets, wages tax statements, VAT deduction sheets, VAT refund applications etc.).

Prioripost – invoices - this service ensures collection, transportation and delivery of mail items containing documents (invoices, waybills) or Prioripost merchandise items that circulate accompanied by invoices and/ or waybills.The service also ensures the return of signed and stamped fiscal documents to the sender and other specific services.


Annex 4

Financial arrangements for the EMA building

CONFIDENTIAL INFORMATION, TO BE SUBMITTED SEPARATELY


Annex 5

The 12 public universities in Bucharest offering foreing languages programmes- a brief description -

1. The University POLITEHNICA of Bucharest is the oldest and most prestigious engineering school in Romania, with a tradition of more than 190 years made possible by the efforts of some of the greatest Romanian professors. Its specificity relies in creating knowledge through research and technological innovation, as well as through its implementation by means of education and professional training at a European level.University POLITEHNICA of Bucharest welcomes foreign applicants, offering a number of 20 B.Sc. and 25 M.Sc. programs taught in English, French or German.

2. The Technical University of Civil Engineering of Bucharest is a technical university that trains higher education specialists in the fields of civil engineering, building services engineering, mechanical engineering/technological equipment and machines, environmental engineering, geodesic engineering, management and engineering and systems engineering.The Technical University of Civil Engineering of Bucharest includes seven faculties, of which six provide tuition in Romanian and one in foreign languages (English and French). In addition, there is a Department of Foreign Language Studies.

3. The “Ion Mincu” University of Architecture and Urbanism in Bucharest is the oldest and most important academic institution in this field in Romania. It continues a long tradition of local architectural higher education, the foundation of which is closely linked with the rise of modern

Romania and the setting of its new institutional structure and culture, during the second half of the 19th century.

4. The University of Agronomic Sciences and Veterinary Medicine of Bucharest (USAMV B, for its acronym in Romanian) is the result of the academic, scientific and administrative process supported by great names of Romanian agronomic education and science, which began with the first Agronomic School in Romania (The Pantelimon School), established 163 years ago.The fields of study covered by USAMV B are: Agronomy, Biology, Forestry, Horticulture, Animal Science, Veterinary Medicine, Food Engineering, Civil Engineering, Environmental Engineering, Geodetic Engineering, Biotechnologies, Applied Engineering Sciences, Engineering and Management, Engineering and Mmanagement in Agriculture and Rural Development. USAMV B currently operates seven (7) faculties in Bucharest, two (2) branches across the country and fifteen (15) departments.

5. The University of Bucharest is one of the oldest institutions of higher education in Romania, hence it bears the responsibility and the duty to be a pioneer and a model of academic integrity. In its 150 years of existence, the University of Bucharest has gained solid national and international prestige, being the first Romanian academic institution in the QS World University Rankings.The University of Bucharest offers numerous study programmes, from Bachelor Degress to PhD programmes, as well as other academic programmes, such as Erasmus and long life learning. The University constantly collaborates with more than 100 prestigious universities from 40 different countries. The degrees granted by the University of Bucharest are recognized in most countries in the world.The University of Bucharest


covers the fields of Human and Social Sciences, Natural Science and Engineering, Exact Sciences (Mathematics and Computer Science) and offers numerous undergraduate, graduate and PhD study programmes, as well as numerous other higher postgraduate programmes. The degree granted by the University of Bucharest after final examinations is recognised all over the world and recommends graduates as being thoroughly trained in the field of study of their choice.

6. “Carol Davila” University of Medicine and Pharmacy Bucharest (CDUMO) is the first University of medicine and pharmacy from Romania, that enjoys today a well deserved prestige and recognition in national and international academic environment, a true leader of the Romanian medical education.At 160 years of existence, the fundamental objective of CDUMP is to accelerate the efforts to transform the institution into a University of elite worldwide, one of the top 500 universities of the world.The University proposes a high quality education, focused on student, a continuous improvement of the educational process through modern teaching methods, fair didactic relationships with students, encouraging initiative, creativity, dialogue and effective and active involvement of students in the educational process both in theory and practice.

7. The Bucharest University of Economic Studies in Bucharest is a research intensive university that organizes study programs and scientific research in the fields of Economic Sciences, Administrative Sciences, Sociology and Humanities. ASE is considered the most important economic higher education institution from Romania and one of the most renown economic universities in South‐Eastern Europe. Students are offered the opportunity to pursue a full academic path

by attending Bachelor’s, Master’s, Doctoral and Postdoctoral study programs. In addition, ASE organizes continuing training programs, teacher training programs, postgraduate programs, as well as MBA and EMBA study programs. ASE has 12 Faculties, whose nealry 22,000 students can attend study programs in Romanian, English, French or German: 24 Bachelor’s programs, 87 Master’s programs, Doctoral studies in 10 fields and more than 145 postgraduate continuing education programs.

8. National University of Physical Education and Sports (UNEFS) develops 5 study programs for the bachelor university cycle and 7 study programs for the master university cycle.

9. National University of Political Studies and Public Administration (SNSPA) is a public higher education institution, which includes all three cycles of education: bachelor, master, doctorate. SNSPA has a complex portfolio of 9 undergraduate programs, 52 master programs and 4 doctoral schools. SNSPA underlie a wide range of academic activities: research, academic education, postgraduate education, the projects realized in SNSPA with transnational partners, students’ activity, teachers’ and researchers’ activity, library endowment, academic management activity.

10. National University of Music Bucharest is a Romanian professional institution of higher education, research and music creation, founded in 1864.National University of Music Bucharest has two faculties focused on higher music education process:• Faculty of Musical Performance (all classical instruments and singing)• Faculty of Composition, Musicology and Music Pedagogy (composition, musicology, music


pedagogy, orchestral and choir conducting, jazz-pop music and sacred music)The research and advanced research are organized within the frame of a Doctoral School, a Post-Doctoral Institute and a Research, Innovation and Information Unit.

11. The National University of Arts (UNArte) in Bucharest is an establishment of education and artistic creation, rated Highly Trustworthy by ARACIS subsequent to the institutional evaluation, which includes study programs accredited for the ranking field “Visual Arts”. The University comprises the Faculty of Fine Arts, which includes the Departments of Painting, Graphic Arts, Sculpture, Photo-Video-Computerized Image Processing and the Master’s program Education through Visual Arts; the Faculty of Decorative Arts and Design, with the Departments of Design. Fashion – fashion design, Mural Art, Textile Arts – textile design, Ceramics-Glass-Metal, Scenography and Artistic Event; the Faculty of Art History and Theory, which organizes the study programs of Art History and Theory and Conservation and Restoration.

12. The National University of Theatre and Film I.L. Caragiale (UATC) begun its activity in 1834, as the first theatre FACULTY IN Romania within the Philharmonic School. Since 1990, the Academy of Theatre and Film has undergone a continuous reform process. New specializations have been added, such as Audiovisual Communication and Multimedia: Sound-Editing (both at the Film Faculty), Puppets-Marionettes, Choreography and Scenography (at the Theatre Faculty). The number of students has gone up, while the curricula and study programs have been continuously improved and diversified.

Annex 6

The National Agency for Medicines and Medical Devices in support of EMA relocation to Bucharest

The National Agency for Medicines and Medical Devices (NAMMD) is the national authority competent in the fields of medicine, medical devices and health technology assessment. The current mission of the Agency includes assessment of dossiers for authorisation for marketing of good quality, safe and effective human medicines, assessment of dossiers for authorisation of conduct of clinical trials in Romania and of clinical trial sites; surveillance of human medicinal product safety in therapeutic circuit through inspection and pharmacovigilance. As of 2014, the NAMMD has also the national competent authority in the field of medical devices and assessment based on scientific criteria adopted by national legislation force of medical technologies for inclusion the national healthcare insurance system.

One important point to note is increased involvement of NAMMD specialists, since 2016, in activities of committees and working groups of the European Medicines Agency’s (EMA) and of the Heads of Medicines Agencies (HMA).

In the context of the Brexit process, the NAMMD will also have to cope with this challenge without disregarding achievement of its current mission. In this respect, it is worth highlighting that, at EU, EMA and HMA committees and working groups level, aiming to create a frame of work allowing for coordinated approach to smooth transfer of UK responsibilities to the Member States remaining in the European Economic Area, the NAMMD will be directly involved in taking over redistributed responsibilities assigned. NAMMD specialists


assigned as representative participants in these committees and working groups constantly prove their expertise in their area of competence through direct and ever more active involvement in the work of the respective committee / working group.

Special emphasis should be placed on the fact that, in case of EMA relocation to Bucharest, the expertise of the NAMMD staff, of its highly qualified specialists particularly, will allow conduct of activities formerly performed by certain EMA staff members who might decide not to relocate.

A few concrete examples of involvement in the scientific work of the European Network are highlighted in what follows:

• Regarding the centralised procedures with RO already assigned as co-rapporteur, rapporteur or peer-review, to be started in the next period:

1) Co-rapporteurs for pegfilgrastim – bio similar (application 10.4). Nomination May 2017; 2) Co-rapporteurs for Ioflupane (123I) - CIS bio international (IOFLUPANE (123I)), generic of DATSCAN of Amersham (application generic 10.1) Nomination March 2017;3) Rapporteurs for Tadalafil Mylan (application generic 10.1), following resuming of the bioequivalence study and return to the EMA with related documentation;4) Peer-review in the multi-national team (RO/SE) – Cerepro (SITIMAGENE CERADENOVEC), (Advance therapy medicinal product – Application complete 8.3 new active substances). Nomination April 2017; 5) Peer-review in the multi-national team (RO/NO) – Voretigene Neparvovec (voretigene neparvovec), (Advance therapy medicinal product – Application complete 8.3 new active substance). Nomination

July 2016;

• Romania’s activity (March 2016 – June 2017) in the EMA Committee for Orphan Medicinal Products (COMP), based on reports prepared by the assigned NAMMD representative:

1. 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide (F901318) for treatment of invasive aspergillosis (orphan designation no. EU/3/16/1738, on 14 October 2016);2. N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide (CM4620) for treatment of acute pancreatitis (orphan designation no. EU/3/16/1783, on 18 November 2016);3. Udenafil for treatment of functional single ventricle congenital heart disease (orphan designation no. EU/3/16/1807, on 12 December 2016);4. Fluticazon propionate for treatment of eosinophilic esophagitis (orphan designation no. EU/3/16/1815, on 12 January 2017);5. Synthetic composition of Trans-cinnamic aldehyde, Trans-2-methoxy-cinnamaldehyde, Cinnamyl acetate, Linalool, Beta-caryophyllene, Cineol and Benzyle benzoate (CTCLBCB) for treatment of invasive aspergillosis (not granted orphan designation after assessment and presentation; withdrawal of application by the sponsor in December 2016);6. Emeramide for prophylaxis of mercury toxicity (orphan designation no. EU/3/17/1864, on 20 April 2017);7. Tripotassium citrate monohydrate and potassium hydrogen carbonate for treatment of renal distal tubular acidosis (orphan designation granted by the COMP in June 2017, official designation by the European Commission pending);8. Retinol for treatment of retinopathy of


prematurity (orphan designation granted by the COMP in June 2017 official designation by the European Commission pending);9. L-citrulline for treatment of cardiopulmonary by-pass (assessed in June, requesting supplementations in the presentation stage);10. Emeramide for treatment of Neurodegeneration with brain iron accumulation (assessment report for July 2017);11. Synthetic composition of Trans-cinnamic aldehyde, Trans-2-methoxy-cinnamaldehyde, Cinnamyl acetate, Linalool, Beta-caryophyllene, Cineol and Benzyle benzoate (CTCLBCB) for treatment of invasive mucomycosis (under validation);12. Film-coated fibrinogen in albumin spheres for treatment of radiotherapy - induced skin ulcers (under validation). • Regarding the Paediatric Committee (PDCO), since 2012, work has consisted in assessment of 50 Paediatric Investigation Plans (PIP), of which 9 assessments are currently in progress.

At the same time, 4 paediatric work-sharing procedures have been completed, where RO acted as rapporteur.

• In the Committee for Medicinal Products for Human Use (CHMP), Romania was a co-rapporteur in a review procedure based on Art 31 for Tolperisone in September 2012 and co-rapporteur la in a review procedure for Raxone (idebenone) in 2013.

• As an observer, as of June 2016, in the CHMP Biostatistics Working Party Romania has been distributed 5 scientific advice applications for determination of statistic problems.

• As regards EMA-coordinated pharmacovigilance

work, the NAMMD has managed 8 PSUSA procedures so far, 2 other procedures being in progress, as follows: In 2015 – 1 PSUSA procedure for tenonitrozole.In 2016 – 5 PSUSA procedures: - Asparaginase PSUSA/00003161/201508 (17.12.2015 - 14.04.2016);- Hexoprenaline sulphate PSUSA/00003170/201508 (17.12.2015 - 14.04.2016);- Chlorquinaldol (vaginal tablet)/promestriene PSUSA/00009272/201509 (15.01.2016 - 13.05.2016);- Bilastine PSUSA/00003163/201603 (02.06.2016 - 29.09.2016);- N ( 2 ) - L - a l a n y l - L - g l u t a m i n e PSUSA/00003158/201603 (04.08.2016 - 01.12.2016).

In 2017 - 2 completed PSUSA procedures for midodrine and chlorquinaldol (vaginal tablet)/promestriene. Currently, one procedure is in progress for bilastine and a new one is to be started soon, for lantahnum.

• As regards participation of NAMMD representatives in the Committee for Advanced Therapies: Romanian CAT members have been involved in preparation of 25 scientific recommendations on classification of advanced therapy medicinal products (ATMPs), in 21 CAT Clinical Reports to the Scientific Advice Working Party and in drafting groups of scientific guidelines on investigational ATMPs, GCP specific aspects for investigational ATMPs.

• Concerning participation in work of the Committee on Herbal Medicinal Products (HMPC), Romania has been a rapporteur for 6 monographs:


- Camellia sinensis (L.) Kuntze, non fermentatum folium- final;- Ricinus communis L., oleum – final;- Harpagophytum procumbens DC and/or Harpagophytum zeyheri Decne, radix – final;- Piper methysticum G. Forst., rhizome – now in the post - public consultation stage;- Calendulae flos – work in progress;- Species amarae – work in progress.

Romania is a peer-review for one monograph: POLYPODIUM VULGARE L., RHIZOMA – work in progress

• As regards work in the CHMP Quality Working Party (QWP), here are the titles of the scientific guidelines, reflection papers and concept papers developed with Romania’s participation during 2013- 2017

2013

- Revision of the Guideline EMA/CHMP/CVMP/QWP/99738/2013, “Process Validation”;- Revision of the Guideline CHMP/CVMP/QWP/199250, “Setting Specifications for Related Impurities in Antibiotics”;- Revision of the Guideline EMA/CHMP/QWP/811210/2009, “Real Time Release Testing”;- Revision of the Guideline EMEA/CHMP/CVMP/QWP/17760/2009 Rev 2, “Use of Near Infrared Spectroscopy (NIRS) by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations”;- Revision of the Guideline EMA/CHMP/QWP/911254/2011, “Quality of Transdermal Patches”;- Revision of the Guideline EMA/492713/2012, “Quality of Oral Modified Release Products”.

2014

- Participation in revision of the Guideline EMA/CHMP/CVMP/QWP/BWP/70278/2012 Rev. 1, “Process Validation”; - Participation in conclusion of the EMA reflection paper EMA/448443/2014 on requirements for selection and justification of starting materials for the manufacture of chemical active substances;- Participation in conclusion of the EMA reflection paper CHMP/CVMP/QWP/136250/2014 on the use of cocrystals and other solid-state forms of active substances in medicinal products;- Participation in conclusion of the EMA document EMA/334808/2014, Template for the qualified person’s declaration concerning GMP compliance of active of active substance manufacture, The QP declaration template; - Participation in revision of the Guideline EMEA/CHMP/CVMP/QWP/17760/2009 Rev 2, on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations; - Participation in revision of the Guideline EMA/CHMP/CVMP/QWP/441071/2011 Rev 2, on stability testing for applications for variations to a marketing authorisation;- Participation in conclusion of the EMA concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products;


- Participation in conclusion of the EMA reflection paper EMA/HMPC/95714/2013 on microbiological aspects of herbal medicinal products and traditional herbal medicinal products; - Participation in revision of the EMA Guideline EMA/CHMP/QWP/608924/2014 on quality of transdermal patches;- Participation in revision of the EMA Guideline EMA/CHMP/QWP/428693/2013 on quality of oral modified release products;

2015

- Participation in conclusion of the EMA reflection paper EMA/CHMP/QWP/104223/2015, “Chemical Structure and Properties Criteria to be Considered for the Evaluation of New Active Substance (NAS) Status of Chemical Substances”;- Participation in conclusion of the EMA reflection paper CHMP/CVMP/QWP/284008/2015, “Use of Cocrystals of Active Substances in Medicinal Products”;- Participation in proofing of the draft Guideline, “Chemistry of Active Substances” EMA/CHMP/QWP/96664/2015; - Participation in proofing of the draft Guideline, “Manufacture of the Finished Dosage Form” CHMP/QWP/245074/2015;- Participation in proofing of the draft Guideline, “Q 3 D Impurities: Guideline on Elemental Impurities” CHMP/ICH/353369/2013, in the CHMP Quality Working Party- Participation in conclusion of the EMA concept paper /CHMP/QWP/558185/2014, “Development of e Guideline on Quality and Equivalence of Topical Products”;- Participation in conclusion of the EMA concept paper EMA/CHMP/QWP/126334/2015, “Need for Revision of the Guideline on the Requirements

to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials”; - Participation in conclusion Of the EMA Guideline EMA/CHMP/QWP/608924/2014, “Quality of Transdermal Patches”;- Participation in conclusion of the EMA reflection paper EMA/448443/2014 on requirements for selection and justification of starting materials for the manufacture of chemical active substances;- Participation in conclusion Of the EMA Guideline EMA/CHMP/QWP/428693/2013 (approved in 2015), “Quality of Oral Modified Release Products”; - Participation in conclusion of the EMA reflection paper CHMP/CVMP/QWP/136250/2014 on the use of cocrystals and other solid-state forms of active substances in medicinal products.

2016

- Participation in conclusion of the EMA reflection paper EMA/CHMP/QWP/104223/2015, “Chemical Structure and Properties Criteria to Be Considered for the Evaluation of New Active Substance (NAS) Status of Chemical Substances”;- Participation in conclusion of the EMA draft Guideline EMA/CHMP/CVMP/QWP/BWP/850374/2016, “Sterilisation of the Medicinal Product, Active Substance, Excipient and Primary Container”;- Participation in conclusion of the EMA Guideline EMA/CHMP/ICH/83812/2013 on ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk”;- Participation in conclusion of the EMA concept paper EMA/CHMP/QWP/126334/2015, “Need for revision of the guideline on the requirements


to the chemical and pharmaceutical quality documentation”;- Participation in conclusion of the EMA reflection paper EMA/CHMP/QWP/104223/2015, “Chemical Structure and Properties Criteria to Be Considered for The Evaluation of New Active Substance (NAS) Status of Chemical Substances”; - Participation in proofing of the draft Guideline, “Chemistry of active substances” EMA/CHMP/QWP/96664/2015”;- Participation in conclusion of the EMA reflection paper Dissolution specification for generic oral immediate release products, “Dissolution specification for generic oral immediate release products”;- Participation in conclusion of the EMA reflection paper CHMP/CVMP/QWP/284008/2015, “Use of Cocrystals of Active Substances in Medicinal Products”;- Participation in conclusion of the EMA reflection paper EMA/CHMP/QWP/BWP/661488/2016, “Development of a Guideline on Quality Requirements of Medicinal Products Containing a Device Component for Delivery or Use of the Medicinal Product”.

2017

- Guideline on the selection of sterilisation processes for active substances, drug products and primary packaging (Human and Veterinary);- Guideline on Manufacture of the Finished Dosage Form;- Guideline on Drug Device Combinations;- Guideline on quality of water for pharmaceutical use;- Guideline on the pharmaceutical quality of inhalation and nasal products;- Reflection Paper on Quality aspects of medicines for older people;- Reflection Paper on Dissolution specification for

immediate release products;

• In the CHMP Name Review Satellite Group (NRG), the NAMMD has taken part in development of the EMA Guideline EMA/CHMP/287710/2014 – Rev. 6 on the acceptability of names for human medicinal products processed through the centralised procedureNAMMD endeavours to be directly involved in addressing the new challenges that will be supported by additional, highly skilled human resources. In this context, it is worth mentioning that, starting 2016, efforts have been made to increase the capacity of human resources allocated to the Agency through collaboration with the medical and pharmacy institutions in Romania, as a measure designed to facilitate the undertaking of responsibilities redistributed by Brexit and assumed by the Agency in the event of EMA relocation to Bucharest. The partnership with the most prestigious medical university in Bucharest is a proof of practical cooperation among the relevant local actors in support of the smooth relocation, in case of human resource risk. The NAMMD will carry out the additional work in all its areas of competence, in line with the new procedural guidelines adopted at EU27 level.


Annex 7

Relocation of theEuropean Medicines Agency

emabucharest.ro

The Ministry of Health of Romania

Address:1-3 Cristian Popişteanu Street, Sector 1, Postal Code 010024, Bucharest

Telephone:+4021 3072 500+4021 3072 600

Website:www.ms.ro

The National Agency for Medicines and Medical Devices

Address:48 Aviator Sanatescu Street, Sector 1, Postal Code 011478, Bucharest

Telephone:+4021 317 11 00+4021 317 11 01

Website:www.anm.ro

european medicines agency bucharest · mihai tudose prime minister of romania “back in 2007, when...

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