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European Medicines Agency in Zagreb ——— Zagreb A safe place for EMA A good life for you Offer of the Republic of Croatia for the seat of the European Medicines Agency (EMA) July 2017

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Page 1: European Medicines Agency in Zagreb · Zagreb is an open, multi-cultural metropolitan city and a popular tourist destination The staff of the European Medicines Agency in Croatia

European Medicines Agency

in Zagreb

———

Zagreb

A safe place for EMA

A good life for you

Offer of the Republic of Croatia for the seat of the

European Medicines Agency (EMA)

July 2017

Page 2: European Medicines Agency in Zagreb · Zagreb is an open, multi-cultural metropolitan city and a popular tourist destination The staff of the European Medicines Agency in Croatia

Offer of the Republic of Croatia for the seat of the European Medicines Agency

2

Table of Contents

Introduction ................................................................................................................................ 3

Zagreb, city of the future, and the European Medicines Agency .................................................. 5

Six principal reasons in favour of Zagreb as the new seat of the European Medicines Agency ... 10

1. The state guarantees conditions for EMA's presence at the new location ........................... 11

2. Croatia will facilitate the relocation of staff, thus ensuring business continuity ................... 14

3. The selected location is easily accessible and well connected ............................................ 23

4. Adequate education facilities are available for children ..................................................... 26

5. Children and spouses have guaranteed access to the labour market and quality medical care

...................................................................................................................................... 31

6. Zagreb satisfies the criterion of geographical spread ......................................................... 32

Page 3: European Medicines Agency in Zagreb · Zagreb is an open, multi-cultural metropolitan city and a popular tourist destination The staff of the European Medicines Agency in Croatia

Offer of the Republic of Croatia for the seat of the European Medicines Agency

3

Introduction

The Republic of Croatia is aware of the importance of the European Medicines Agency for the

preservation of public health in the European Union. It is for this reason that Croatia is very

pleased to apply to become the new seat of the European Medicines Agency. Croatia meets

all the conditions for ensuring the business continuity of the European Medicines Agency at a

high level both during and after its relocation. Currently, Croatia does not host the seat of any

institution of the European Union, although it is fully ready to embrace such a highly

responsible task.

Croatia is both a Mediterranean and Central European country with an exceptionally

favourable geographic position at the heart of Europe. Its excellent transport connections

enable fast and easy access to experts taking part in the work of the European Medicines

Agency from all other parts of Europe and the world.

Zagreb, the capital, is an ideal new address for the European Medicines Agency. The imposing

business building of Sky Office, located on one of Zagreb's main roads, offers all the amenities

to satisfy the current operating needs of the European Medicines Agency, while its technical

and spatial features offer opportunities for the future further strengthening of the capacities

of the European Medicines Agency. Zagreb also has an excellent ICT infrastructure and

logistics with the capacity to adequately support the implementation of the business

processes of the European Medicines Agency. In addition to its strong ICT sector, Croatia also

has a successful research and development sector, a prominent scientific community, a

developed pharmaceutical industry, and a large number of experts in the field of biomedicine

and health.

In terms of numerous amenities relating to the quality of life in Croatia and Zagreb, we should

single out the high level of health care and education systems, the outstanding and diverse

accommodation available for staff and their families, accessible public transport and good

transport connections, and an extremely high level of security and openness towards other

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Offer of the Republic of Croatia for the seat of the European Medicines Agency

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cultures, thanks to the unique position of Croatia and Zagreb at the crossroads of the Romanic,

Germanic, and Slavic cultural spheres.

Below, we present in more detail the key advantages that Croatia can offer to meet the criteria

for the new seat of the European Medicines Agency.

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Offer of the Republic of Croatia for the seat of the European Medicines Agency

5

Zagreb, “city of the future”,1 and the European Medicines

Agency

Croatia can provide optimal conditions for the everyday life and work of the staff of the

European Medicines Agency and their families. It also offers a superb quality of life and a high

level of security and openness in society.

Source: FLASH EUROBAROMETER 419, Quality of life in European cities 2015, January 2016

Zagreb offers a high quality of life

a much lower cost of living than other Member States

a rich provision of cultural and social events

infrastructure for sports and recreation

high air quality, good quality drinking water, and a mild climate

a large number of parks and green surfaces.

1 http://www.fdiintelligence.com/Rankings/European-Cities-and-Regions-of-the-Future-2016-17?ct=true

http://www.croatiaweek.com/zagreb-in-financial-times-top-10-european-cities-regions-of-the-future

90 8980 79 78 77 77 74

70 67 66

0

10

20

30

40

50

60

70

80

90

100

Percentage of citizens who hold that the presence of foreigners is good for the city

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Offer of the Republic of Croatia for the seat of the European Medicines Agency

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Zagreb is an open, multi-cultural metropolitan city and a popular tourist destination

The staff of the European Medicines Agency in Croatia can expect a multi-ethnic, multi-

cultural, and multi-confessional environment in which diversity and openness are

encouraged.

Croatia has more than twenty national minorities with different ethnic, religious,

cultural and linguistic characteristics, whose diversity is recognised as an added value

in Croatian society and protected by its Constitution. National minorities have their

members in representative bodies at both national and local levels.

Thanks to its rich culture, in recent years Zagreb has become a very popular tourist

destination, which in 2016 recorded 1.1 million tourists and 2 million overnight stays,

while Advent in Zagreb has been declared the best in Europe for two years in a row.

In view of the growing economic openness and business connections with other

European centres, experts from other countries are moving into Croatia in ever rising

numbers. As an energetic tourist venue and one of the leading Mediterranean

destinations, Croatia attracts a large number of tourists from all parts of the world: in

2016 alone, there were 15.6 million tourist arrivals and 78 million overnight stays.

The growing presence of foreigners in Croatia promotes the openness of society,

resulting in ever richer business, cultural, sporting, and culinary choices. In the very

centre of Zagreb, at a short distance from each other, there is a Catholic, Orthodox,

and Protestant church, and a synagogue.

Zagreb is a safe city

Comparative statistics show that Zagreb has a very low crime rate.

Citizens of Zagreb enjoy a high level of security.

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Source: FLASH EUROBAROMETER 419, Quality of life in European cities 2015, January 2016

A multi-lingual environment

Since all employees of the European Medicines Agency, delegates and experts must actively

use the English language in the performance of their jobs, a high level of fluency in English in

a state that could be the new host of the European Medicines Agency is highly desirable. In

view of the heterogeneous nationality structure of the staff of the European Medicines Agency

and their families, it is extremely important to ensure access to a multi-lingual environment.

In this sense, Croatia offers:

an extremely high level of knowledge of the English language;

compulsory learning of a second language from the first grade of primary school

onwards;

various opportunities for education in English bilingual gimnazija (academic secondary

schools) and bilingual university faculties, as well as private universities and schools);

numerous schools for learning Croatian as a second and foreign language for non-

native speakers in Croatia (for example, Croaticum – Centre for Croatian as a Second

and Foreign Language at the Faculty of Humanities and Social Sciences of the

University of Zagreb);

9591 89 86 83 81

74 71 71 68 66

0

10

20

30

40

50

60

70

80

90

100

Percentage of people who feel safe in the city

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Offer of the Republic of Croatia for the seat of the European Medicines Agency

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a large number of institutes and institutions for foreign languages in Zagreb that offer

cultural programmes and events in foreign languages (such as: the Goethe-Institut

Kroatien, Institut Français de Croatie, Alliance Française, British Council in Croatia,

Istituto Italiano di Cultura di Zagabria, Centro de Língua Portuguesa/Camões em

Zagreb, Instituto Cervantes de Zagreb, Hungarian Institute Balassi, and many others).

Source: Gfk Hrvatska

Safe, good, and accessible life in Zagreb

The cheapest capital in the EU

Of all the EU Member States, Croatia's capital has the lowest cost of living, while Croatia in its

entirety ranks eighth among the Member States as the most affordable place to live. In

comparison to the reference value of Brussels, according to Eurostat, the cost of living in

Zagreb is at the level of 73.5 (in comparison to Brussels, where the cost of living is at the level

of 100). The highest cost of living in a capital among all Member States of the European Union

is recorded in the United Kingdom—where the current seat of the European Medicines Agency

is located—and it stands at 141.8. It follows that, in Zagreb, the staff of the European

Medicines Agency would cut their current cost of living by half.

96

44

24

159 7

0

10

20

30

40

50

60

70

80

90

100

Percentage of ciitzens who know this language well / fluently

English German Italian Spanish French Russian

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The cheapest apartments in the EU

In terms of the price for purchasing an apartment, Croatia ranks first among all Member States

of the European Union with the lowest price of EUR 1,051 per m² (the average price for an

apartment with a surface area of 120 m² in the centre of the capital) and also ranks first in

terms of the lowest price of rent, i.e., EUR 592 monthly. Further, 50% of the total population

believe that it is easy to find a good apartment at an acceptable price in their city, which places

Croatia in second place among all Member States of the European Union.

The safest Member State of the EU

In terms of safety in the country, Croatia is ahead of all Member States of the European Union

with only 2.8% inhabitants in the total population who have faced crime, violence or

vandalism. In terms of safety in towns (urban areas) defined in the same way, Croatia ranks

second with 7.6% (immediately after Lithuania with 7%).

The second ecologically least polluted EU Member

Regarding the criterion of pollution in the country, Croatia is one of the least polluted EU

Member States and it holds second place (6% of the total population believe that there is a

problem of pollution, smog, or other ecological problems) and, according to the same

criterion, it ranks fourth in terms of pollution in towns (10.1%).

Croatia is proud of its access to high quality tap water and is one of few countries that

guarantee and provide safe drinking water to its citizens from the public water supply system.

With the largest reserves of renewable drinking water per capita in the European Union,

Croatia is one of the richest countries in terms of the quantity of natural resources in the form

of drinking water and, according to UNESCO's report on water reserves, it holds an extremely

high position not only among European countries but also in the world.

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Six principal reasons in favour of Zagreb

as the new seat of the

European Medicines Agency

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Offer of the Republic of Croatia for the seat of the European Medicines Agency

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1. The state guarantees conditions for EMA's presence at the new

location

The Sky Office building in Zagreb is an ideal seat

The Sky Office building in Zagreb (at 9 Roberta F. Mihanovića Street) is positioned along Zagreb Avenue, only 15 minutes away from the heart of the city. (Source: Croatian Chamber of Architects)

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Exceptional and state of the art conditions for EMA

The Sky Office building is a modern building with superb characteristics that meets and

surpasses the requirements set for the location of a new seat of the European Medicines

Agency.

The Sky Office business building was built in 2012, and prior to the European Medicines

Agency’s moving in, it will undergo further adjustments according to the Agency’s needs. The

building meets all the conditions to satisfy the current needs of its operation, while its

technical and spatial features even leave room for the further strengthening of the EMA's

capacities in the future. In addition to the available on-site archive facilities at the location of

the Sky Office, EMA will also be provided with an adequate off-site archive.

Main features of the building

an impressive business space with a total surface area of 32,000 m²

dominant position on the city's main road

flexible spatial layout

latest standards in energy efficiency

two 22-storey towers connected in the lobby and from the 2nd to the 14th floors

two vertical communication cores with 12 fast modern lifts and four staircases

interconnecting all floors

horizontal communication on each floor organised around a central core

isolation from outside influences with effective protection against noise, heat, and

direct sunlight.

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ICT infrastructure support and ICT expertise

The ICT infrastructure, support, and highly skilled ICT staff are essential conditions to ensure

continuity in the operation of the European Medicines Agency. The ICT sector in Croatia is

32,000 strong and generates an income of HRK 31 billion. Consolidated exports in the industry

in 2015 exceeded a growth rate of 12%.2

Croatia offers:

the possibility of hiring highly skilled ICT workers

high Internet and 4G network coverage in Zagreb and throughout Croatia

a large number of ICT and mobile services providers

availability of data centres

very high level of information security

top ICT companies and innovative industries (such as Ericsson Nikola Tesla, a regional

leader in the ICT industry supporting and directing the development of

communications, and Rimac Automobili, producing some of the fastest electric sports

cars in the world).

Accommodation capacities in Zagreb

International experts participating in working meetings at the European Medicines Agency will

find a wide range of accommodation that can satisfy the daily peak demand of the European

Medicines Agency of 350 rooms.

Hotel categories Number of hotels Number of rooms Number of beds

High-end categories 22 2,686 4,786

Mid-range categories 32 1,289 2,342

2 Analysis of Croatia's ICT industry: http://www.konkurentnost.hr/Default.aspx?art=596&sec=2

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2. Croatia will facilitate the relocation of staff, thus ensuring

business continuity

Setting up an operational office for executing the relocation

Croatia will set up an operational office that will be available for non-stop communication with

the European Medicines Agency. In cooperation with the European Medicines Agency, the

Office will draw up a plan for business continuity and ensure its successful implementation.

Assistance programme for staff of the European Medicines Agency during relocation

In order to ensure continued functionality of the European Medicines Agency during the

relocation and in order to facilitate the beginning of work and life in a new country for its staff,

the Croatian state will set up a service intended for providing support to the staff of the

European Medicines Agency and its partners/families during the relocation, the so-called One-

Stop Service.

Assistance for staff and their families includes a wide spectrum of services and involves all

institutions and procedures that the staff of the European Medicines Agency might need

following their relocation to Croatia. For example, this includes:

assistance in obtaining stay permits and social insurance registration for family

members;

assistance in completing tax returns, information on the method and possibilities

available for physical relocation;

assistance in collecting information connected with housing and contacts with

agencies engaged in such activities;

assistance in selecting and registering with the system of primary health protection,

information on the education system and on possibilities that the Croatian state

provides for family members in this segment;

assistance in finding employment for partners/family members;

assistance in integrating into society through

associations/institutions/chambers/projects connected with hobbies, the local

community or professional training;

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information on opportunities available during leisure time and to become acquainted

with Croatia and neighbouring countries;

support in all other aspects of life in the new country.

Privileges and immunities for the staff of the European Medicines Agency

The staff of the European Medicines Agency in Croatia will be granted all privileges and

immunities stipulated in Protocol (No. 7) on the privileges and immunities of the European

Union. In line with this framework, the European Medicines Agency in Croatia is guaranteed,

inter alia:

inviolability of premises and archives;

exemption of its assets, revenues and other property from all direct taxes;

exemption from all customs duties;

exemption from prohibitions and restrictions on imports and exports in respect of

articles intended for official use;

exemption from any restrictions on imports and exports in respect of its publications.

The staff of the European Medicines Agency will enjoy functional immunity and privileges that,

among other things, include exemption from national taxes on salaries, wages and

emoluments paid by the European Union and other benefits usually awarded to officials of

international organisations in connection with monetary or foreign currency legislation.

The Croatian state is also prepared to provide certain special conditions for the European

Medicines Agency and its staff within the Agreement on the Seat of the European Medicines

Agency.

The staff of the European Medicines Agency will have opportunities to participate in the

work of the academic community.

Croatia offers:

access to the available infrastructure and expertise of the University of Zagreb;

the opportunity for staff of the European Medicines Agency to take part in the work of

the academic community (publishing articles, attending classes...).

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For illustration, the staff of the Croatian Agency for Medicinal Products and Medical Devices

cooperate with the University of Zagreb and other Croatian universities and take part in the

implementation of a large number of study courses.

Institutional cooperation for supporting the European Medicines Agency in finding high-

quality professional staff

If there is a lack of experts, thanks to its experience and knowledge in the area, Croatia will

set in motion appropriate mechanisms to support the European Medicines Agency in finding

high-quality professional staff and thus secure the required number of experts. Experts from

the Croatian Agency for Medicinal Products and Medical Devices and representatives of the

relevant professional chambers and associations of health workers have so far experienced

good cooperation in areas of mutual interest. Such cooperation will continue in order to

ensure timely recruitment of eligible high-quality professional staff to work in the European

Medicines Agency. The process will take into consideration the structure of the staff

(specialised and experienced doctors, pharmacists, and veterinarians as well as experts in the

fields of law and finance) and data from the survey on the readiness of the staff of the

European Medicines Agency for relocation and key data from its work in 2016. The experience

of cooperation of the Croatian Agency for Medicinal Products and Medical Devices with

external experts and their availability via a database that includes data on potential conflicts

of interest may be applied to a much wider circle of potential experts.

Expertise in the research and development sector and in the scientific community

The research and development sector and the scientific community in the Republic of Croatia

are a rich source of potential highly qualified experts who can take part in the work of the

European Medicines Agency or provide support through their expertise.

Institutions from the said sectors also provide an opportunity for the employment of partners

or family members of the staff of the European Medicines Agency.

Croatia is home to renowned institutions and many acclaimed scientists and experts who

contribute considerably to European and international scientific research and development in

the field of biomedicine and health. The following institutions should be singled out in

particular:

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"Andrija Štampar" School of Public Health

the leading scientific-teaching institution for public health in Croatia with a

tradition of more than ninety years;

within the school there is the Collaborating Centre of the World Health

Organisation for HIV Surveillance and the Collaborating Centre of the World

Health Organisation for Occupational Health.

"Ruđer Bošković" Institute

a pivotal scientific institution in Croatia in the field of natural and biomedical

sciences, as well as for research of the sea and the environment;

the leading and internationally most competitive national institution in view of

its participation in international research projects of various institutions, such

as IAEA, NATO, NSF, SNSF, DAAD, and in the programme of the European

Commission EC FP5-7, as well as in programmes of many other foreign scientific

foundations;

it gathers more than five hundred scientists and researchers in over eighty

laboratories engaged in research pertaining to physical and organic chemistry

and biochemistry, molecular biology and medicine, the sea and the

environment, theoretical and experimental physics, physics and chemistry of

materials, electronics, information and computer science, as well as laser and

atomic research and development.3

Other important institutions engaged in research in Zagreb and Croatia that should be singled

out include the Institute for Medical Research and Occupational Health, the Croatian Institute

for Brain Research, BIOCentre, the Croatian Veterinary Institute, and the Energy Institute

"Hrvoje Požar".

Scientific activity in Croatia, besides universities and their component parts, is conducted by

scientific institutes, the Croatian Academy of Medical Sciences, and the Croatian Academy of

Sciences and Arts, founded in 1866.

3 http://www.irb.hr/O-IRB-u

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The activity of public scientific institutes in the field of

biomedicine and health

Field of biomedicine and health

Croatia has three public scientific institutes in the field of biomedicine and health: the Institute

for Medical Research and Occupational Health, the Croatian Veterinary Institute, and the

"Ruđer Bošković" Institute, with over 1,000 researchers.

In 2014, three scientific centres of excellence in the field of biomedicine and health were

founded.

In the academic year 2015/2016, around 1,800 students graduated in the field of biomedicine

and health.

Long-running scientific tradition

Many prominent scientists from various fields of work have their origins in Croatia. We

could single out Lavoslav Ružička, winner of the Nobel Prize in Chemistry in 1939, Vladimir

Prelog, winner of the Nobel Prize in Chemistry in 1975, and Nikola Tesla, renowned

scientist and innovator.

We should also mention Dr Andrija Štampar, former dean of the School of Medicine in

Zagreb, who, among many of his contributions in the field of public health, was one of the

founders of the World Health Organisation and who presided over the first World Health

Assembly in Geneva in 1948. He was the first vice-president of the United Nations

Economic and Social Council.

The University of Zagreb is the oldest, largest and, in the academic and research sense,

leading university in Croatia. It was founded in 1669, which makes it the oldest university

with academic continuity in Croatia and one of the oldest universities in Europe.

Expertise and experience of the pharmaceutical industry

The pharmaceutical industry in Croatia brings together a large number of highly qualified

experts and provides valuable experience in the field:

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Croatia has a long tradition in the development and production of human and

veterinary medicinal products.

Traditional Croatian excellence in the pharmaceutical industry provides for the

continued development of medicinal products and of the pharmaceutical profession

and contributes to the finding of more effective and faster-acting therapy for patients.

The know-how and experience of the labour force guarantee the successful

development of this industry and related sectors. Further, the pharmaceutical industry

is one of Croatia's economic sectors that intensively invests in research and

development.

Croatia has a long tradition in the pharmaceutical industry. The discovery of an

innovative antibiotic, Azithromycin, put Croatia in the ranks of only ten countries in

the world that can boast to have developed a completely new medicinal product.

Many European and global pharmaceutical industries have representative offices and

branch offices in Zagreb and Croatia.

The pharmaceutical industry is one of the strongest sectors in Croatia, with the highest

level of investment in capacities and in research and development, and of exports:

its core of employees is 5,000, with highly educated experts accounting for a large

share;

it records large investments in production facilities;

it directly creates added value in the amount of HRK 2 billion a year;

it generates income exceeding HRK 6 billion, of which two-thirds through exports,

mostly to the markets of the European Union, the Russian Federation, and the

United States;4

generic medicinal products account for 42% of the market;5

Croatia is host to 37 pharmaceutical companies;

in relation to other countries in its surroundings, Croatia is competitive in terms of

the average hourly labour costs of EUR 9.2;6

in Croatia, there are two strong pharmaceutical associations:

4 https://izvoz.gov.hr/vijesti/hrvatska-farmaceutska-industrija-jedan-od-najsnaznijih-izvoznih-sektora/990 5 Percentage for 2015, source: The European Federation of Pharmaceutical Industries and Associations (EFPIA), https://efpia.eu/media/219735/efpia-pharmafigures2017_statisticbroch_v04-final.pdf 6 http://www.aik-invest.hr/sektori/farmacija/

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Innovative Pharmaceutical Initiative – iF! The association embraces 23

innovative pharmaceutical companies that have 870 members of staff and

secure 60% of medicinal products in Croatia. It is a member of EFPIA – The

European Federation of Pharmaceutical Industries and Associations.

Croatian Association of Employers – Association of Producers of Medicinal

Products and the Association of Producers of Generic Medicinal Products.

Expertise from the system of the health care system and the system of veterinary protection

The Croatian health care system and the system of veterinary protection recruit a large

number of highly qualified experts who, thanks to their knowledge and professional

qualifications, can be a potential source of new staff for the European Medicines Agency in

the event of a shortage of human resources.

At the moment, the Croatian health care system has 68,411 employees, of whom:

14,427 doctors of medicine, including 9,443 specialists

3,615 doctors of dental medicine

2,848 pharmacists

484 medical biochemists.7

The Croatian system of veterinary protection currently employs around 1,800 doctors of

veterinary medicine.

Comprehensive support by the Croatian Agency for Medicinal

Products and Medical Devices

The Croatian Agency for Medicinal Products and Medical Devices is a national agency

regulating the field of human medicinal products and medical devices in Croatia. In its

operation, it continues to re-assert itself as a competent partner of the European Medicines

Agency, the pharmaceutical industry, and patients. On the basis of its professional knowledge

and logistics, the Croatian Agency for Medicinal Products and Medical Devices can secure

7 Croatian Health Statistics Yearbook for 2016 https://www.hzjz.hr/wp-content/uploads/2017/05/03_KADR_2016.xlsx

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adequate support for the European Agency for Medicinal Products in the performance of its

activities during and after the relocation process:

Excellence of the Croatian Agency for Medicinal Products and Medical Devices. The

Croatian Agency for Medicinal Products and Medical Devices received an exceptionally

high total rating of 4.14 out of 5 in the medicines agencies’ valuation programme of

the Benchmarking of European Medicines Agencies (BEMA), thus falling in the group

of top agencies in the medicines regulatory network of the European Union. The

Croatian Agency for Medicinal Products and Medical Devices received more ratings of

5 than any other medicines agency so far, while many of its indicators of operation

were appraised as best practice at the EU level.

Recognised expertise by Croatian experts. Of the 45 national experts currently

seconded to a position in the European Medicines Agency, three experts belong to the

staff of the Croatian Agency for Medicinal Products and Medical Devices, which is twice

the "quota" for a Member State, thus confirming that the expertise of the staff of the

Croatian Agency for Medicinal Products and Medical Devices is also recognised by the

European Medicines Agency.

Excellent co-operation with EMA. The Croatian Agency for Medicinal Products and

Medical Devices has fostered successful and proactive partnership cooperation with

the European Medicines Agency since its establishment. Thanks to timely and

extensive preparations immediately after Croatia's accession to the European Union in

2013, it has successfully assumed its tasks in the regulatory network of the European

Union. It takes a full and active part in the work of the committees and working parties

of the European Medicines Agency with more than forty

members/alternates/observers and contributes to the appraisal of medicinal products

for the European market with its team of experts. As members of the committees of

the European Medicines Agency, Croatia's representatives take part in the evaluation

of the safety, effectiveness and quality of medicinal products available to patients in

the European Union and ensure that only medicinal products that meet the high

requirements prescribed in the legislation of the European Union are available to

patients in the Republic of Croatia and other Member States.

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High qualifications of Croatian experts. The staff of the Croatian Agency for Medicinal

Products and Medical Devices are highly qualified experts: more than 70% of the staff

have higher education qualifications, of whom more than 10% have PhDs or are

masters of science. Pharmacists, doctors of medicine, graduate chemical engineers

and doctors of veterinary medicine account for the largest share of the staff with

higher education qualifications, closely followed by related professions in the field of

biomedicine and health, and biotechnical and natural sciences. The staff of the

Croatian Agency for Medicinal Products and Medical Devices continuously improve

their skills and professional abilities. Intensive investments are made in the relevant

forms of professional and scientific development of the staff, so that the quality of

work and expertise is maintained at a high level.

Developed international cooperation. The Croatian Agency for Medicinal Products

and Medical Devices fosters successful cooperation with all relevant European and

international bodies in the field of its activity, in particular WHO, EDQM, EC, HMA and

other national medicines agencies.

Successful regional cooperation. The Croatian Agency for Medicinal Products and

Medical Devices is also active in inter-regional cooperation, where it provides practical

assistance, education, and transfer of European standards to the staff of regional

agencies that wish to become involved in European affairs.

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3. The selected location is easily accessible and well connected

Zagreb has daily connections with most seats of the Member States of the European Union

and with all major metropolitan cities via "Franjo Tuđman" Airport. Recent full modernisation

of the airport will enable Zagreb to soon become a regional air hub; it has also created

conditions for a significant increase in the number of international lines and passengers, and

an even better reception of passengers.

Good connections with Europe

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For example, there are several flights each day between Zagreb and Brussels, as well as

Frankfurt, Munich, and Vienna, which provide further connections with almost all destinations

in Europe.

Zagreb is also connected via direct and frequent daily flights with London, Paris, Amsterdam,

Berlin, Lisbon, Rome, Stockholm, Zurich, Copenhagen, Bucharest, Moscow, Istanbul, etc.

Presence of major airline companies

Along with Croatia Airlines, Zagreb is host to almost all major air carriers whose wide network

of routes ensures effective and excellent connections between Zagreb and destinations within

the European Union but also all over the world. We should like to single out Lufthansa, British

Airways, KLM/Air France, Austrian Airlines, Emirates, Turkish Airlines, Swiss, Eurowings,

Aeroflot, etc.

Connections during the summer season are even more intensive in view of heightened tourist

demand, which is an indicator of the potential of this market for further development and

progress.

New passenger terminal

A big step forward regarding infrastructure has been made at Zagreb's airport with the

opening of a new passenger terminal at the "Franjo Tuđman" Airport, worth EUR 331 million,

thus considerably boosting the level of services and transport capacities of "Franjo Tuđman"

Airport.

Excellent connection with Zagreb

The "Franjo Tuđman" Airport has excellent connections with Zagreb and is a twenty minutes'

car drive from the centre of the city. There is a commercial connection between the bus

station and the airport (tickets in one direction cost HRK 30) and a regular city bus line

between Zagreb and the airport is currently being set up. Buses on the line drive every day at

30-minute intervals from 4:30 (7:00) to 20:00 (20:30). The schedule was fixed in line with the

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arrival times of regular airlines.8 It is also planned to set up connections with the airport via

light rail or tram.

Connections with all parts of Croatia

Should the staff of the European Medicines Agency have to travel by other means of transport,

Zagreb has regular bus lines connecting it to all parts of Croatia but also to many European

cities and towns.

In the case of a journey by car, bus or train, you can reach any major destination relatively

quickly and cheaply.

Well-developed motorway network

The Croatian long distance road transport system (international transport) is well connected

with neighbouring countries. Croatia has an extensive network of motorways and state roads

yielding a high-quality service, which ranks Croatia as the fourth country in the European

Union based on the number of kilometres of motorways per 1,000 inhabitants.

Frequent bus and tram transport

In terms of the micro-location of the offered seat of the European Medicines Agency, Zagreb

provides a network of tram lines operated by Zagreb Electric Tram (ZET), which includes

almost 120 kilometres of tram lines, with a tradition of more than a century. The ZET network

was formed in line with the spatial distribution of the population and is dependent on total

transport demand. In the central part of Zagreb, in the area where passenger turnover is most

intensive, there is a network of tram and bus lines, while in the less densely populated

periphery there is only bus transport. Fifteen day lines and four night lines transport more

than 200 million passengers annually.

8 http://www.croatiaairlines.com/hr/Informacije-o-putovanju/U-zracnoj-luci/prijevoz-do-zracne-luke

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4. Adequate education facilities are available for children

Excellent education opportunities for the children of agency staff

Croatia offers:

a diverse range of public and private kindergartens, schools, and universities,

international schools as well as national schools and universities that provide

schooling/education in a foreign language;

sufficient capacity and accessible prices in nurseries, kindergartens, schools, and

universities;

long-standing academic excellence.

International education programmes in Zagreb

The City of Zagreb offers places for pre-schoolers (from three years to primary school age) in

12 kindergartens which, in addition to regular programmes in the Croatian language, also have

a 10-hour programme in English, French, Italian or German (enrolling children of foreign

nationals, diplomats, etc.) and in kindergartens with full-day programmes in English, German,

French, and Italian (attended by the children of foreign nationals and diplomats). At the

moment, there is no international programme for children aged 0 to 3, but such children can

be enrolled in any kindergarten with programmes in the Croatian language.

Zagreb offers opportunities for education in English:

based on the Croatian National Curriculum from grade one through five;

based on the international programme IBO (International Baccalaureate

Organization), which offers education programmes for students in the age range from

three to 19. Overall education in English includes three primary and secondary

education programmes:

for students in the age range from three to 12 (Primary Years Programme –

PYP)

for students in the age range from 11 to 16 (Middle Years Programme – MYP)

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for students in the age range from 16 to 19 (Diploma Programme – DP)

based on the British National Curriculum (The British International School of Zagreb)

for preschool, primary school, and the “international gimnazija" programme

based on the American National Curriculum (American International School of Zagreb)

for:

preschool education:

for children from three to four years of age (Pre-Kindergarten)

for children of five years of age (Elementary School Program Kindergarten)

primary and secondary school program for children:

from grade 1 through 5 (Elementary School)

from grade 6 through 8 (Middle School Program)

from grade 9 through 12 (High School Program).

There are also international schools in Zagreb in:

French (French School in Zagreb – École française de Zagreb) for preschool and primary

school education programmes, and

German (German International School in Zagreb) for:

preschool education programme

primary and secondary school programme for children:

from grade 1 through 4 (Grundschule)

from grade 5 through 9 (Gymnasium).

Instruction in English, German, Italian, and French

Other than in the Croatian language, it is possible to attend some secondary school classes in

a foreign language, primarily English, German, Italian and French, in five secondary schools in

the City of Zagreb (The IV Gimnazija, The X Gimnazija "Ivan Supek", The XVI Gimnazija, The

XVIII Gimnazija, and the "Vladimir Prelog" Science School, which offers a science "gimnazija"

curriculum).

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Establishing new educational institutions

As the Ministry of Science and Education has extensive experience in founding new

educational institutions, we should mention some other possibilities to meet the criteria, i.e.,

capacities for accommodating the staff of the European Medicines Agency:

establishing a corporate kindergarten within the premises of the European Medicines

Agency, which could offer international programmes;

in cooperation with the City of Zagreb, introducing an international programme in

additional primary schools in Zagreb;

establishing a new school facility in conformity with the legislation governing primary

and secondary education.

Higher education

Integration in the European higher education area

Croatia plays an active role in the Bologna Process, regularly performs activities to ensure

stronger inclusion in the European area of higher education, and aims to create a multi-

cultural, multi-lingual, and international atmosphere in higher education in Croatia. The

Strategy of Education, Science, and Technology that the Croatian Parliament adopted in 2014

(Official Gazette 124/14) as the main strategic document for all segments of the educational

process in Croatia lists the internationalisation of higher education and its stronger integration

in the European and global higher education area as one of the main goals in higher education.

Multi-annual action plans for the internationalisation of education are adopted and

implemented within the framework of the said goal.

Studies in foreign languages

In Croatia, there are 31 study programmes in foreign languages, mostly in English, including at

undergraduate, graduate, and postgraduate levels. Some study programmes are conducted in

cooperation with foreign universities.

The University of Zagreb has 14 study programmes in the English language, the University of

Zadar has two, while the "Juraj Dobrila" University in Pula has three study programmes in

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Italian and one in English. Both the University of Rijeka and the University of Split have one

study programme in English respectively. The private university "Libertas" has two study

programmes in the English language. Polytechnics and colleges for professional (applied)

education organise seven study programmes in the English language.

"Study in Croatia"

A list of the mentioned study programmes, links to the higher education institutions

conducting them, and further information on other options for foreign students are available

in the publication entitled "Study in Croatia", issued by the Ministry of Science and Education

in 2016:

http://www.studyincroatia.hr/download/files/study_in_croatia_brochure.pdf

The same rights for Croatian and European students

Students from the Member States of the European Union have the same rights and obligations

when enrolling as Croatian citizens. They exercise their right to subsidies in tuition fees at

public higher education institutions, subsidised accommodation in student halls of residence,

subsidised meals in student restaurants, and to state scholarships. Enrolment in

undergraduate studies is centralised and is conducted by the Agency for Science and Higher

Education. Students who have completed secondary education abroad do not have to pass

the Croatian state graduation exam for access to higher education.

In terms of the children of the staff of the European Medicines Agency who are to proceed

with higher education, the Ministry of Science and Education will propose to the Croatian

Rectors' Conference facilitated access to higher education institutions in connection with the

recognition of periods of study abroad.

Increase in the number of study programmes in foreign languages

Considering that study programmes in foreign languages are a key condition for the further

internationalisation of the system of higher education in Croatia and for improving the quality

of higher education through internationalisation, it is planned to increase the number of study

programmes in foreign languages within the project of the European Social Fund. The

academic year 2018/2019 or 2019/2020 will mark the beginning of implementation of study

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programmes to be funded through the European Social Fund. Fields chosen for funding are

STEM (natural sciences, technology, engineering, mathematics), ICT (information-

communication technologies), fields from the "Smart Specialisation Strategy of the Republic

of Croatia 2016 – 2020" and the "Industrial Strategy of the Republic of Croatia 2014 – 2020".

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5. Children and spouses have guaranteed access to the labour

market and to quality medical care

Employment

Working within the framework of positive Croatian legislation governing this area, Croatia will

offer institutional support to family members of EMA staff regarding employment and access

to the Croatian labour market.

In accordance with Article 75 of Regulation (EC) No. 726/2004 of the European Parliament and

of the Council of 31 March 2004 laying down Community procedures for the authorisation and

supervision of medicinal products for human and veterinary use and establishing a European

Medicines Agency, the staff of the European Medicines Agency are subject to the rules and

regulations applicable to officials and other staff of the European Union. This includes

implementation of the Protocol on the privileges and immunities of the European Union.

A reliable and comprehensive health care system

The staff of the European Medicines Agency and their families will have access to Croatia's

reliable health care system, which is characterised by:

high-quality comprehensive health care;

a wide spectrum of services within compulsory health insurance;

exceptionally competitive prices of health care services;

established e-services (e-records, e-prescriptions, e-appointments, etc.),

availability of a large number of public and private medical institutions and polyclinics.

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6. Zagreb satisfies the criterion of geographical spread

Considering that from its accession to the European Union on 1 July 2013 Croatia does not

host any EU agency, Croatia's application fully meets the criterion of the desirability of

geographical spread of agencies. We expect that the mentioned key criterion will be given due

weight, taking into consideration the political will of the heads of states and governments of

the Member States of the Union expressed in the decision of December 2003.

This offer was adopted by the Government of the Republic of Croatia. The conditions set will

be further elaborated in a headquarters agreement, in case Zagreb is selected as a new

headquarters for the EMA.