published by - .: mida · 2018-02-12 · published by: malaysian investment development authority...

Published by:

Malaysian Investment Development AuthorityMIDA Sentral, No.5, Jalan Stesen Sentral 550470 Kuala Lumpur, MalaysiaTel: (603) 2267 3633 Fax: (603) 2274 7970Website: www.mida.gov.myE-mail: [email protected]

Malaysia

Your Profit Centre in Asia

Kuala Lumpur

www.mida.gov.my

This guidebook for the pharmaceuticalindustry in Malays ia serves as animportant source of in format ion forinvestors intending to invest in th isi n d u s t r y. I t a l s o s p e l l s o u t t h eprocedures and requirements for thevar ious appl icat ions for l icences andpermits for the setting up of a businessin the pharmaceutical industry.

The Malaysian Investment DevelopmentAuthor i ty (MIDA) is the Government'sprincipal agency under the Ministry ofInternational Trade and Industry (MITI)responsib le for the promot ion andcoordination of industrial developmentin Malaysia. MIDA assists companiesw h i c h i n t e n d t o i n v e s t i n t h emanufacturing and services sectors inthe country. MIDA has a global networkof 24 overseas off ices covering NorthAmerica, Europe, Asia Pacific and Africato ass ist investors. W ith in Malays ia,MIDA has 12 branch off ices in thevarious states to faci l i tate investors inthe implementat ion and operat ion oftheir projects.

For more informat ion on investmentopportunit ies in Malaysia and contactdetails of MIDA, visit www.mida.gov.my.

Published by

Preface

ContentsFact Sheet of Malaysia 2- Background of Malaysia- Key Economic Indicators

Healthcare in Malaysia 3- The Pharmaceutical Industry in Malaysia- Investment Opportunities- Infrastructure Support- Intellectual Property (IP) Protection

Why Malaysia 12

Getting Started in Malaysia 13- Starting a Business - Taxation- Approval of Manufacturing Projects - Approval of Expatriate Posts

Incentives for Investment 18- Incentives for Manufacturing Companies- Incentives for High Technology Companies- Incentives for Strategic Projects- Incentives for Research & Development (R&D)- Incentives for Operational Headquarters (OHQ)- Incentives for International Procurement Centres (IPC) /

Regional Distribution Centres (RDC)- Other Incentives

Regulatory Control in the Pharmaceutical Industry 21- Regulatory Agency - Drug Control Authority- Product Registration - New Application Processing Procedures - Application Formalities - Application Processes - Regulatory Outcome - Registration Maintenance - Online Registration System - Licence Issued for Registered Products - Manufacturer’s Licence Application Procedures - Bioavailability and Bioequivalence Study for

Pharmaceutical Products

Useful Contacts 45- MIDA Overseas Offices- MIDA State Offices- MITI Overseas Offices- MATRADE Overseas Offices- MATRADE State Offices- Ministry of Health and Relevant Division/Agencies

KUALA LUMPUR

PERLIS

KEDAH

PULAU PINANG

PERAK

SELANGOR

MELAKA

JOHOR

KELANTAN

PAHANGNEGERI

SEMBILAN

TERENGGANU

SABAH

SARAWAK

U PINPULA NG KE

AH

GG ANKE NNANN

ERLE L

KELANT IN N N

PE LI

KED

MEL

K ANK

TERENGGANUERENGGANURENGGANU

JOHOR

SEMBILANN

ELAKAEL A

SS

AHANGN

NN

NEGERIRI

GOR

N

G

P

KELANT

PERAK

A

SELANG

KUALA LUMPUR PU PU

AH

AKWSARA

SAB

2 Fact Sheet of Malaysia

Malaysia covers an area of about 330,252 square kilometres, consisting of13 states, namely Johor, Kedah, Kelantan, Melaka, Negeri Sembilan,Pahang, Perak, Perlis, Penang, Sabah, Sarawak, Selangor and Terengganu.Apart from the 13 states, there are three Federal Territories, which are KualaLumpur, Putrajaya and Labuan. Kuala Lumpur is the capital of Malaysia.Malaysia l ies entirely in the equatorial zone and the average dailytemperature throughout Malaysia varies from 21°C to 32°C.

Malaysia is a multi-ethnic country. The principal ethnic groups are Malays,fol lowed by Chinese and Indians. Other signif icant groups are theindigenous people of Sarawak and Sabah, including the Dayaks, Kadazans,Bajaus, Melanaus and Muruts.

Major exports of Malaysia are manufactured goods such as electrical andelectronics products, machinery and appliances, chemicals, plasticproducts, iron, steel and metal products, and petroleum-based products.In the year 2010, the share of exports of manufactured goods to totalexports is 72%. Imports comprise mainly intermediate goods such asprimary and processed industrial supplies, thermionic valves and tubes,parts and accessories of capital goods, primary and processed fuellubricants, and parts and accessories for transport equipment.

Background of Malaysia

Key Economic Indicators

f: forecastSources: Economic Report 2012/13Exchange rate: USD1 = RM3.09 (as at January 2013)

2013 f

Population 29.71 million

Labour force 13.2 million

Unemployment rate 3.1%

GDP RM780.98 billion (USD253.56 billion)

GDP growth 4.5% - 5.5%

Per capita income RM32,947 (USD10,662)

Inflation rate (CPI) 1.9% (2012)

Total export (f.o.b.) RM740.7 billion

Total import (c.i.f.) RM639.9 billion

Healthcare in Malaysia 3

Malaysia’s primary care model has been acknowledged by the World HealthOrganisation as a viable system to achieve “Health for All”. The demand forquality healthcare continues to rise in Malaysia with increasing affluence andrising consumer awareness. Currently, about 7.25% of the country’s GDP isexpected to be spent on healthcare. This is expected to increase with thegrowing population and a longer life expectancy, as well as the Government’sincreasing expenditures on provision of better healthcare facilities and services.

Healthcare remains a priority of the Malaysian Government. For 2012, theGovernment had increased the budget allocation for healthcare to RM16.87bi l l ion. A total RM1.87 bi l l ion for the budget wi l l be spent on healthcaredevelopment to enhance health faci l i t ies and provide medical equipment,increase supply of medicines, develop human resources, intensify research andenforcement activities, as well as to build more hospitals, clinics and quarters.

Crude Birth Rate (per 1000 population) 17.5*

Crude Death Rate (per 1000 population) 4.8*

Infant Mortality Rate (per 1000 live births) 6.8*

Life Expectancy - Male (age in years) 71.9*

Life Expectancy - Female (age in years) 77.0*

Healthcare in Malaysia

Demographics - 2011

Number of registered doctors (Government & Private) 36,607

Population per doctor 791

Number of hospitals 366*

Number of clinics 11,212**

Number of beds 55,923

Number of dental chairs 486***

Health Facts

* Includes Government hospitals, special medical institutions, non-MOH Government hospitals& private hospitals.

** Includes MOH dental clinics, MOH mobile dental clinics (including mobile and pre-schoolteam); MOH Health Clinics, MOH Community Clinics, MOH maternal & child health clinics,MOH mobile health clinics, private medical clinics & private dental clinics.

***Includes MOH dental clinics and MOH mobile dental clinics.

Source: Ministry of Health Malaysia, (as at July 2012)

* Provisional/Preliminary data (as of 2010)

4 Healthcare in Malaysia

The pharmaceutical industry is one of the new growth areas targeted forpromotion and development by the Government. The products manufacturedby the Malaysian pharmaceutical industry are broadly categorised into fourcategories, i .e prescript ion medicines, over-the-counter (OTC) products,tradit ional medicines and health/food supplements. The pharmaceuticalcompanies are mainly small and medium-sized companies engaged in theproduction of generic drugs, traditional medicines and herbal supplements aswell as contract manufacturing for foreign multinational corporations (MNCs).

According to the Drug Control Authority (DCA) ofthe Ministry of Health, as of October 2012, thereare 259 manufacturing companies licenced byDCA compris ing 182 tradit ional medicinecompanies, 75 pharmaceutical companies and3 veterinary product companies.

Among the major local companies arePharmaniaga Manufactur ing Berhad, HovidBerhad, CCM Duopharma Biotech Sdn Bhd, andKotra Pharma (M) Sdn Bhd. These companiesfocus mainly on generic drugs, part icular lyan t ib io t i cs , pa ink i l l e rs , hea l th supplementsand injectables. Some of the foreign-ownedcompanies with manufacturing presence in thecountry include Y.S.P. Industries (M) Sdn Bhd(Taiwan), Ster l ing Drug (M) Sdn Bhd (themanufacturing arm of GlaxoSmithKline from UK),Ranbaxy (M) Sdn Bhd ( India), Xepa-SoulPatt inson (M) Sdn Bhd (Singapore) and SMPharmaceutical Sdn Bhd (India).

The large MNCs such as Pf izer, Schering Plough, Novart is, El i Li l ly, AstraZeneca are mainly l icenced importers. Their products, which are most lybranded drugs, are distributed by locally incorporated companies.

The Malaysian pharmaceutical industry has the capability to produce almost alldosage forms, including ster i le preparat ions such as eye preparat ions,injections, soft gelatine capsules and time release medications. In January2002, Malaysia was admitted as the 26t h member of the PharmaceuticalInspection Cooperation/Scheme (PIC/S)*. This would faci l i tate exports ofMalaysian pharmaceutical products to the member countries which include EU,Australia and Canada.

The Pharmaceutical Industry in Malaysia

* The PIC/S provides an active and constructive co-operation in the field of GoodManufacturing Practice(GMP) between countries and pharmaceutical inspection authorities.It leads the international development, implementation and maintenance of harmonised GMPStandards and Quality System of Inspectorates in the field of medical products.


Biopharmaceuticals / Biogenerics (Biosimilars)The potential expansion of biosimilars is expected to have a major implicationon the biopharmaceutical industry. The impact of biosimilars on thebiopharmaceutical industry is expected to be similar if not greater than the impactof generics on the pharmaceutical industry. Currently biopharmaceuticals areconsiderably more expensive than conventional medications. However, Malaysiaoffers a more competitive cost option to investors due to the available ecosystem.

A large number of first generation biopharmaceutical products are nearing maturityand major biopharmaceutical companies are likely to move these out to countrieslike Malaysia that offer a good value preposition.

Currently, in Malaysia, local and foreign players arealready engaged in activities like biopharmaceutical APIs,FDA / EMEA cGMP compliant services, specialising inmonoclonal antibodies and recombinant proteins. Inaddition, special ised research, development andcommercialisation of biopharmaceutical products is on-going. The government is further encouraging potentialinvestors to move up the value-chain.

Contract ManufacturingThe current trend among the major global drug companies is to outsource theirmanufacturing operations to enable them to concentrate on time consuming andcostly `gene hunting’ methods of R&D for new drug discovery. The pharmaceuticalindustry in Malaysia could capitalise on this development by manufacturing genericand patented products of these companies on contract basis. A number of localcompanies are keen to provide contract manufacturing services to interested parties.

Generic DrugsForeign pharmaceutical companies are encouraged to set up faci l i t ies inMalaysia to manufacture off-patented drugs.

Herbal MedicinesForeign pharmaceutical companies could enter into collaborations with localcompanies and research institutions to produce new medicinal drugs.

Manufacturing of Active Pharmaceutical Ingredients (API)There is huge demand for API to be used in the manufactur ing of localpharmaceuticals as well as for export.

Other higher value-added products and servicesThe products include innovator drugs, vaccines, biopharmaceuticals, inhalationproducts drug discovery activit ies or new chemical entity (NCE) and noveldelivery systems.

Investment Opportunities


Infrastructure Support

Efficient Logistics and Well-DevelopedInfrastructureThe pr ime advantage to

manufacturers in Malaysia has

been and continues to be the

nat ion's persistent dr ive to

develop and upgrade i ts

infrastructure. Integrated

logist ics have ensured that

Malaysia's pharmaceutical

products reach markets in Asia

and worldwide on time, enabled by the extensive infrastructure that includes

world-class airports, seaports and sophisticated telecommunications network.

Availability of IndustrialEstates and SpecialisedParksIndustries in Malaysia are mainly

located in over 200 industr ia l

estates or parks and 13 Free

Industr ial Zones (FIZs) developed throughout the country. FIZs are export

processing zones which have been developed to cater to the needs of export-

oriented industries such as pharmaceutical industry. Companies in FIZs are

allowed duty free imports of raw materials, components, parts, machinery and

equipment directly required in the manufacturing process. In areas where

FIZs are not avai lable, companies can set up Licenced Manufactur ing

Warehouses (LMWs) which are accorded facilities similar to those enjoyed by

establishments in FIZs.

Malaysia has also developed specialized parks to cater to the needs of specific

industries which are technology-intensive and research-intensive. Examples of

these parks are the Technology Park Malaysia in Bukit Jal i l , Kuala Lumpur

and the Kul im Hi-Tech Park in the northern state of Kedah. These parks

comprise state-of-the-art buildings with specific functions and fully-integrated

high technology park.


Other specialised parks developed by the Malaysian Government agencies are

as follows:

Bio-XCell MalaysiaBio-XCell is a premier biotechnology park and ecosystem dedicated to healthcare

and industrial biotechnology developed by Malaysian Bio-XCell Sdn. Bhd. (a joint

venture company formed between BiotechCorp and UEM Land Berhad).

Bio-XCell is strategically located on 160 acres in Nusajaya, within the Iskandar

region of Johor, Malaysia, and close to the border with Singapore providing global

connectivity through a network of five seaports and two international airports,

all within 59 km. Bio-XCell offers an environment conducive for the development

and manufacturing of biologics, pharmaceuticals, bio-based/green chemicals and

other solutions to heal, fuel and green the world. As a managed park, Bio-XCell

provides its clients and investors with a range of value added benefits including

comprehensive infrastructure, high speed internet access, park maintenance and

security as well as core facilities to nurture the ecosystem.

Key facilities of the park include:

Central Hub: A multipurpose complex with a variety of office and lab space

for rent. The focal point of the park providing amenit ies such auditor ium,

business centre, training facilities, Food & Beverage and retail outlets.

Central Utilities Facility: Providing uti l it ies for biomanufacturing such as

industrial steam, chil led water and waste water treatment service to clients

on a user pays basis.

Perlis

Kedah

Penang

KelantanPerak

Terengganu

Enstek

Nusajaya

M A L A Y S I APahang

Selangor

Kuala Lumpur

N. Sembilan

MelakaJohor Sarawak

Sabah

TechnologyPark Malaysia

Kulim Hi-TechPark

For further information on Bio-XCell,visit www.bio-xcell.my


Standard Shells: These buildings providing 20,000 sq. ft. of space, can be

fit-out to clients’ needs and are available for rent or purchase.

Plots of freehold land: Available for sale, enabling clients to build their own

customised facilities.

Penang Science ParkPenang Science Park is designed with good infrastructure and amenities to

cater for strategic industries such as high technology, biotechnology, halal

industries and SMI park.

The park consists of 3 phases;

• The first phase spans with an area of 121 hectares at Batu Kawan and has

been completed with infrastructure and amenities,

• The second phase will cover an area of 121 hectares at Bukit Minyak and

the infrastructure is expected to complete by mid 2013.

• The final phase is scheduled to be ready in the year 2014.

A total of 48 acres has been allocated for

the biotechnology and pharmaceutical

industries.

Kulim Hi-Tech Park (KHTP)The Kulim Hi-Tech Park (KHTP), officially opened in 1996, is the first Hi-Tech Park

in Malaysia. The KHTP is situated in the district of Kulim, in the state of Kedah, in

the north-west of Peninsular Malaysia. Currently, the development of KHTP covers

an area of approximately 1,700 hectares (approximately 4,000 acres).

For further information onPenang Science Park, visit www.pdc.gov.my

Facilities / Centres Distance / Driving Time

Penang International Airport 42 km (40 minutes)

Penang Port (Butterworth) 23 km (20 minutes)

North-South Highway 5 km (5 minutes)

Urban centres 19 km (20 minutes)

Butterworth 10 km (15 minutes)

Seberang Jaya 5 km (5 minutes)

Batu Kawan (new township)

University Technology Mara 10 km (10 minutes)

University Science Malaysia 20 km (25 minutes)

Japan Malaysian Tech. Institute within the park


The KHTP is conceived and developed as one of the national strategies of

Vision 2020 for Malaysia to become a ful ly- industr ial ised nation by 2020.

Envisioned to be the ‘Science City of The Future’, the KHTP has continually

being developed and promoted as an integrated science park targeting clean,

capital-intesive, and high value-added technology-related industries primarily

in the f ie lds of advanced electronics, mechanical e lectronics,

telecommunicat ions, semiconductors, optoelectronics, biotechnology,

advanced materials, research and development and emerging technologies.

Right from the onset, the development of KHTP incorporates 6 elements or

Zones, namely:

• industrial;

• R&D and training;

• amenity;

• housing;

• urban; and

• institutional.

Kulim Technology Park Corporation Sdn Bhd (D-44351), a whole-subsidiary of

the Kedah State Development Corporation, is the developer and manager of

the KHTP; while the Malaysian Federal Government fully supports the KHTP

development by way of dedicated

development funds, as well as, other

cr i t ical advisory and promotion

support.

Enstektechpark@enstek is current ly the

technology park with the highest number

of Biotechnology and Medical Industrial

Companies in Malaysia.

Located within the township of Bandar

Enstek, techpark@enstek is just 10 minute

away from Kuala Lumpur Internat ional

Airport (KLIA) and only 38 minutes from

downtown Kuala Lumpur via the Express

Rail Link (ERL).

Bandar Enstek consists of 4 main components; residential area, technology

land park, commercial hub and institutional zones.

SELANGOR

MELAKA

JOHOR

PAHANG

NEGERISEMBILAN

ENSTEK Technology Park

For further information on Kulim Hi – Tech Park, visit www.khtp.com.my


techpark@enstek is envisaged to become a world-class technology hub catering

for the need of high technology and eco-conscious industries such as

biotechnology, green technology

and information technology (ICT)

industries. It is also endowed with

ready infrastructure and amenities

to support such sectors.

Availability of Clinical Trials and Bioequivalence CentresThe Clinical Research Centre (CRC), comprising a network of 17 centres aroundthe country, acts as a one-stop-centre by providing a single point of contact toaccess all Ministry of Health hospitals and clinics to conduct clinical trials inMalaysia. These clinical trial centres have linkages to more than 50 general anddistrict hospitals, and more than 100 health clinics as potential sites for clinicaltr ials with access to 550 cl inical investigators and 17 mil l ion patients fromdiverse therapeutic areas in the public healthcare system in Malaysia.

The private entities which conduct clinical trials are as follows:-

• Infokinetics Research Centre Sdn. Bhd.

• International Medical University

• University Malaya Medical Centre

• NCI Hospital

• Universiti Kebangsaan Malaysia Medical Centre

• Hospital Universiti Sains Malaysia

• Sunway Medical Centre

• Universiti Teknologi Mara, Selayang and Sungai Buloh

• Mahkota Medical Centre

• Lam Wah Ee Hospital

• Mount Miriam Cancer Hospital

• Gleneagles Medical Centre

• Columbia Asia Medical Centre

• Island Hospital

• Penang Adventis Hospital

• Pantai Hospital Penang

• Loh Guan Lye Specialist Centre

• Monash University Sunway Campus & Johor Bahru Campus

Bioequivalence Centres

• University Malaya Medical Centre

• School of Pharmaceutical Sciences,

Hospital Universiti Sains Malaysia

• Infokinetics Research Centre Sdn Bhd

For further information on Enstek, visitwww.techpark.enstek.com


Intellectual Property (IP) Protection

Malaysia has strong IP protection in place and is committed to safeguarding IPon inventions. To ensure IP protection in Malaysia is in line with internationalstandards and provides protection for both local and foreign investors, Malaysiais a party to the following treaties:

• World Intellectual Property Organisation (WIPO), 1967;

• Paris Convention for the Protection of Industrial Property 1883;

• Berne Convention for the Protection of Literary and Artistic Works (1886);

• Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement;

• Patent Cooperation Treaty (PCT) 1970

For further informationon IP protection inMalaysia, visitwww.myipo.gov.my

IP in Malaysia comprises:

• Patents

• Trade Marks

• Industrial Designs

• Copyrights

• Geographical Indications

• IC Layout Designs

12 Why Malaysia

“Why Malaysia”

An Educated Workforce

• Talented, young, educated andproductive workforce

• Multilingual workforce speaking twoor three languages, including English

• Comprehensive system of vocationaland industrial training, includingadvanced skills training.

• Harmonious industrial relations withminimal trade disputes

Developed Infrastructure

• Network of well-maintained highways

and railways

• Well-equipped seaports and airports

• High qual i ty te lecommunicat ions

network and services

• Fully developed industrial parks,

including free industrial zones,

technology parks and Multimedia

Super Corridor (MSC)

• Advanced MSC Malaysia Cybercities

and Cybercentres

Vibrant Business Environment

• Market-oriented economy

• Well-developed financial and banking

s e c t o r, i n c l u d i n g t h e L a b u a n

International Financial Exchange

• Wide use of English, especially in

business Legal and account ing

practice based on the British system

• Large local business community with

a long history in international

business links

• Large foreign business community in

all business sectors

• Extensive trade links - country's total

trade was valued at RM1.31 trillion

(2012)

Supportive Government Policies

• Pro-business policies

• Responsive government

• Liberal investment policies

• Attractive tax and other incentives

• Liberal exchange control regime

• Intellectual property protection

Quality of Life

• Friendly and hospitable Malaysians

• Safe and comfortable living

environment

• Excellent housing, modern amenities,

good healthcare and medical

facilities

• Excellent educational institutions

including international schools for

expatriate children

• World-class recreational and sports

facilities

• Excellent shopping with goods from

all over the world

Getting Started in Malaysia 13

Getting Started in Malaysia

Starting a BusinessIn general, the overall cost of doing business in Malaysia is competit ive. InMalaysia, the process is facilitated by experienced and reputable agencies thatexist both within and outside the Federal and local governments. For startinga business in Malaysia, the main fees which need to be paid are fees to theCompanies Commission of Malaysia (SSM) and fees for company secretarialservices.

Main fees to be paid to the Companies Commission of Malaysia

USD1 = RM3.08 (As at January 2013)Source: Companies Act, 1965 (Act 125) & subsidiary legislations.For the full range of fees, please visit SSM website at www.ssm.com.my

Other costs of doing business in Malaysia that investors need to know are rentalrates for prime office space, cost of industrial land, cost of ready-built factoryand average construction costs of factory building. The costs will depend onthe business location selected by the investors. For example, if it is in KualaL u m p u r, t h e r e n t a l r a t e f o rp r i m e o f f i ce space i s i n therange of RM64.60 - RM102.25(USD20.77 – USD32.88)/squaremetre/month.

RM USD

Reservation of a name 30 9.74

For registration of a company, fees range according to nominal share capital, e.g.:

- Below RM100,000 1,000 324.68

- RM100,001 - RM500,000 3,000 974.03

- RM500,001 - RM1,000,000 5,000 1,623.38

- RM1,000,001 - RM5,000,000 8,000 2,597.40

- RM5,000,001 - RM10,000,000 10,000 3,246.75

- RM10,000,001 - RM25,000,000 20,000 6,493.51

- RM25,000,001 - RM50,000,000 40,000 12,987.01

- RM50,000,001 - RM100,000,000 50,000 16,233.77

- Exceeding RM100 million 70,000 22,727.27

For more details on these costs,visit www.mida.gov.my

14 Getting Started in Malaysia

Registration of Business/Incorporation of Company

• Sole proprietorships • Partnerships• Company

Companies Commission ofMalaysia (SSM)www.ssm.com.my

Application for ManufacturingLicences and/or Tax Incentives

Malaysian InvestmentDevelopment Authority (MIDA)www.mida.gov.my

Application for Other Approvals and Permits

Approvals at the Level of Federal Ministries / Departments / Agencies

• Good Manufacturing Practice(GMP) & Registration ofProducts from NationalPharmaceutical ControlBureau (NPCB), Ministry of Health(www.bpfk.gov.my)

• Department of OccupationalSafety and Health(www.dosh.gov.my)

• Fire and Rescue Department (www.bomba.gov.my)

• Department of Environment(www.doe.gov.my)

Approvals at the Level of State Governments and Local Authorities

• Acquire land and premise(Industrial land /Premise /Factory Approval)

• No Objection Letter (NOL) forlocation of projects

• Planning Permits

• Building Plans

• Certificate of Fitness (CF)

• Business Licence

• Electricity supply - Tenaga Nasional Berhad(www.tnb.gov.my)

• Water supply - Local Water Authority

(www.jba.gov.my)

• Telecommunication - Telekom Malaysia Berhad(www.tm.com.my)

Utilities

• Expatriates - MIDA (www.mida.gov.my) or

Immigration Department (www.imi.gov.my)

• Foreign Workers - Immigration Department

(www.imi.gov.my)

Immigration


Taxation

Generally, all income of companies and individuals accrued in or derived fromsources outside Malaysia and received in Malaysia is liable to tax. However,effective from the year of assessment 2004 income remitted to Malaysia byresident companies (other than companies carrying on the business of banking,insurance, air and sea transportat ion), resident indiv iduals, non-residentcompanies and non-resident individuals are exempted from tax.

Income tax in Malaysia is assessed on income earned in the current year. Theself-assessment system was implemented for companies, sole proprietors,partnerships, cooperat ives and salar ied groups to streamline the taxadministration system.

Source: Inland Revenue Board – www.hasil.org.myUSD1 = RM3.08 (As at January 2013)

Corporate Tax

Resident and non-resident companies 25%

Resident companies with paid-up capital of RM2.5 million (USD811,688.31) and less at the beginning of the basis periodfor a year of assessment

• on the first RM500,000 (USD162,337.67) chargeable income 20%

• on subsequent chargeable income 25%

Personal Income Tax

Resident individuals with chargeable income of RM16,667 1%-26%

(USD5,411.36) and above per annum (after deduction of personal reliefs)

Non-resident individuals (not entitled to any personal reliefs) 26%

Withholding Tax (Non-resident persons)

Special classes of income (use of moveable property, technical 10%

services, installation services on the supply of plant and machinery, etc.)

Interest 15%

Royalty 10%

Contract payment on:

- account of contractor 10%

- account of employee 3%Other income such as commission, guarantee fees, 10%agency fees, brokerage fees, introducers fees etc.

16 Getting Started in Malaysia

Sales Tax

Sales tax is imposed on certain imported and locally manufacturedgoods under the Sales Tax Act, 1972. The tax rate ranges from 5 - 10%for majority of the goods except for food preparations other thanalcoholic and non-alcoholic compound preparations (other than thoseof heading No. 33.02) used for making beverages which falls under thetariff code 2106.90.490 with a tax rate of 20%. Sales tax is also imposedon petroleum and petroleum products according to specific rates.

5%-10%

Service Tax

Service tax is imposed on taxable services provided by taxable personsunder the Service Tax Act, 1975. Services include services provided byprofessionals (such as lawyers, engineers, architects, surveyors,consultants), advertising firms, private hospitals, insurance companies,communication companies, hotels and restaurants.

6%

Rates of Capital Allowances

Capital a l lowances are given on qual i fy ing capital expenditure. In i t ia lallowances are given only once while annual allowances are given every yearby the straightline method. Some of the items accorded allowances are shownbelow. For plant and machinery, companies are advised to verify with theInland Revenue Board on the specific items which qualify.

Initial Allowance Annual Allowance

Industrial buildings 10% 3%

Plant and machinery 20% 14%

Heavy machinery and motor vehicles 20% 20%

Computer and IT equipment 20% 40%

Environmental control equipment 40% 20%

Others 20% 10%

Source: Royal Malaysian Customs - www.customs.gov.my

Source: Inland Revenue Board - www.hasil.org.my


Approval of Manufacturing Projects

The Industrial Co-ordination Act 1975 (ICA) requires companies manufacturingpharmaceutical products with shareholders' funds of RM2.5 million and aboveor engaging 75 or more full-time paid employees to apply for a manufacturinglicence for approval by the Ministry of International Trade and Industry (MITI).

Foreign investors can now hold 100% of the equity in all investments in new projects,as well as investments in expansion/diversification projects by existing companies.

Malaysia's commitment in creat ing a safe investment environment hasconvinced more than 4,000 international companies from over 50 countriesto make Malaysia their offshore base.

A company whose equity participation has been approved will not be required torestructure its equity at any time as long as the company continues to complywith the original conditions of approval and retain the original features of the project.

Approval of Expatriate Posts

Manufacturing companies are allowed to bring in expatriate personnel where there is ashortage of trained Malaysian is well to safeguard their investment in the country. i.e“time posts” and “key posts”. Key posts refer to posts that are permanently filled byforeigners. The current guidelines on the employment of expatriate personnel formanufacturing companies are as follows:

Foreign paid-up capital of USD2 million and above:

• A maximum of 10 expatriate posts, including five key posts.• Can be employed for up to a maximum of 10 years for executive posts*, and 5 years

for non-executive posts**

Foreign paid-up capital of more than USD200,000 but less than USD2 million:

• A maximum of five expatriate posts, including at least one key post.• Can be employed for up to a maximum 10 years for executive posts*, and 5 years

for non-executive posts**

Foreign paid-up capital of less than USD200,000:

• Key posts can be considered where the foreign paid-up capital is at least RM500,000.• Time posts can be considered for up to 10 years for executive posts* and 5 years for

non-executive posts**• The number of key posts and time posts allowed depends on the merits of each case

* that require professional qualifications and practical experience** that require technical skills and experience.

18 Incentives for Investment

Incentives for Investment

The manufacturer of pharmaceuticals and related product is categorised as “promotedactivities” or “promoted products”. The list of promoted activities and products isavailable in MIDA website at www.mida.gov.my

Some of major tax incentives available for the pharmaceutical industry are as follows:-

• Incentives for Manufacturing Companies

• Incentives for High Technology Companies

• Incentives for Strategic Projects

• Incentives for Research & Development (R&D)

• Incentives for Operational Headquarters (OHQ)

• Incentives for International Procurement Centres (IPC) / Regional Distribution Centres(RDC)

• Other incentives

Incentives for Manufacturing Companies

• Pioneer Status with income tax exemption of 70% or 100% on statutory income fora period of 5 years, or

• Investment Tax Allowance (ITA) of 60% or 100% on qualifying capital expenditureincurred for a period of 5 years, or

• Reinvestment Allowance (RA) of 60% on qualifying capital expenditure (to be offsetagainst 70% or 100% of statutory income) for 15 consecutive years

Incentives for High Technology Companies

• Pioneer Status with full income tax exemption on statutory income for 5 years, or

• ITA of 60% on qualifying capital expenditure for 5 years to be offset against 100% ofstatutory income

Incentives for Strategic Projects

• Pioneer Status with full income tax exemption on statutory income for 10 years, or

• ITA of 100% on qualifying capital expenditure for 5 years to be offset against 100%of statutory income

Incentives for Investment 19

Incentives for Research & Development (R&D)

Contract R&D Company

• Pioneer Status with 100% income tax exemption on statutory income for 5 years, or

• ITA of 100% on qualifying capital expenditure for 10 years to be offset against 70%of statutory income

R&D Company

ITA of 100% on qualifying capital expenditure for 10 years to be offset against 70% ofstatutory income

In-house Research

Investment Tax Allowance of 50% on qualifying capital expenditure for 10 years to beoffset against 70% of statutory income

Incentives for Operational Headquarters (OHQ)

• 100% income tax exemption for a period of 10 years for income derived from business,interest and royalties

• Dividends paid from the exempt income will be exempted from tax

• The income generated by an OHQ company in providing qualifying services to itsrelated companies in Malaysia will not be taxed during its tax-exempt period, providedsuch income does not exceed 20% of its overall income derived by providing qualifyingservices

• Expatriates working in OHQ companies are taxed only on the portion of theirchargeable income attributable to the number of days that they are in Malaysia

• Import duty and sales tax exemption

Incentives for International Procurement Centres (IPC) /Regional Distribution Centres (RDC)

• Full tax exemption of statutory income for 10 years

• Dividends paid from the exempt income will be exempted from tax in the hands ofshareholders

• Expatriates working in IPC/RDC companies are taxed only on the portion of theirchargeable income attributable to the number of days that they are in Malaysia

20 Incentives for Investment

Other Incentives

i. Incentives for Export

• Double Deduction for the Promotion of Export

• Single Deduction for the Promotion of Export

• Double Deduction on Export Credit Insurance Premium

• Special Industrial Building Allowance for Warehouses

• Double Deduction on Freight Charges

• Incentive for the Implementation of RosettaNet

• Double Deduction for the Promotion of Malaysian Brand Names

ii. General Incentives

• Exemption from Import Duty on Raw Materials/Components

• Exemption from Import Duty and Sales Tax on Machinery/Equipment, Spare Parts and Consumables

For further information on incentivesfor investment, visitwww.mida.gov.my

REGULATORY CONTROL INTHE PHARMACEUTICAL INDUSTRY

21

22

Regulatory Agency

National Pharmaceutical Control Bureau (NPCB)

The regulatory control of pharmaceutical products and traditional medicines inMalaysia is carried out by the National Pharmaceutical Control Bureau (NPCB),an institution under the Pharmaceutical Services Division (PSD) Ministry ofHealth, which ensures the qual i ty, eff icacy and safety of pharmaceuticalproducts as wel l as the qual i ty and safety of tradit ional medicines andcosmetics marketed in the country.

The NPCB, formerly known as the National Pharmaceutical Control Laboratory,was set up in October 1978 to implement quality control on pharmaceuticalproducts. The infrastructure and faci l i t ies were designed to meet therequirements for testing and quality control activities.

The NPCB has in place a well-structured and comprehensive regulatory system.This system handles the registration of pharmaceutical products and traditionalmedicines as well as the notification of cosmetic products under the Control ofDrug and Cosmetics Regulations 1984.

The introduction of these regulations in June 1984 was an important milestonein the history of drug regulatory activit ies in Malaysia as it provides for theestabl ishment of the Drug Control Author i ty (DCA) to regulate thepharmaceutical industry. The DCA, an executive committee which is responsiblefor product registrat ion and l icensing of manufacturers, importers andwholesalers was establ ished in 1985, whereby the NPCB functions as theoperational arm and the secretariat to the DCA.

Regulatory Control in Pharmaceutical Industry

Regulatory Control in Pharmaceutical Industry 23

Since 1985, the NPCB has been given the task of ensuring the quality, efficacyand safety of pharmaceuticals through the registration and licensing scheme.This is achieved through evaluation of scientific data and laboratory tests on allproducts before they are marketed. A system to monitor products in the marketwas also setup. In addit ion, the Adverse Drug Reactions (ADR) monitoringprogram was launched in Malaysia in 1987 to carry out pharmacovigi lanceactivities. Under the surveil lance program, registered products are routinelysampled to ensure compliance with regulatory requirements.

Under the ASEAN Technical Co-operation among Developing Countries (ASEANTCDC) Program, the NPCB has been chosen and recognised by the ASEANcountries as the regional training centre for quality control of pharmaceuticals. NPCBhas been the host for various training programs in quality control and hassuccessfully conducted such trainings since 1986. In addition, the NPCB has alsobeen receiving trainees from ASEAN countries as well as various other countries.

In view of the technical expertise and training capabilities of NPCB, it receivedthe recognition as a "WHO Collaborating Centre in the Regulatory Control ofPharmaceuticals" on 10th May 1996. As a WHO Col laborat ing Centre forRegulatory Control of Pharmaceuticals, the NPCB wil l continue to providetraining in pharmaceutical quality assurance and regulatory affairs to fellowsfrom other countr ies. Due to its commitment and technical expert ise, thisinstitution is redesigned as WHO collaborating centre effective 1st August 2011for a period of 4 years.

In Addition, the NPCB successfully gained accession as the 26th member ofthe Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January2002. Since then, NPCB has been activety involved in International GoodManufacturing Practice (GMP) and Quality Assurance programmes.

Drug Control Authority (DCA)

The Drug Control Authority (DCA) is the executive body established under theControl of Drugs and Cosmetics Regulat ions 1984. The main task of thisAuthority is to ensure the safety, qual i ty and eff icacy of pharmaceuticals,traditional medicines, health supplements, veterinary products and personalcare products that are marketed in Malaysia.

This objective is being achieved through the following:

• Registrat ion of pharmaceutical products, natural products ( tradit ionalmedicines) and veterinary products

• Licensing of premises for importers, manufacturers and wholesalers

• Monitoring the quality of registered products in the market

• Adverse Drug Reaction Monitoring

NATIONAL PHARMACEUTICAL CONTROL BUREAUMINISTRY OF HEALTH MALAYSIA

CENTRE FORCOMPLIANCE &

LICENSING

GMP Section(Pharmaceutical)

GMP Section(Complementary)

Licensing andCerti�cation Section

Quality and IndustrialDevelopment Section

GDP Section

CENTRE FORQUALITY CONTROL

Bio-PharmaceuticalTesting Section

LaboratoryServices Section

Standards andQuality Section

Natural ProductsTesting Section

PharmaceuticalChemistry Testing

Section

Research andDevelopment

Section

VariationsSection

CENTRE FORADMINISTRATION

Finance Unit

Development Unit

Administration Unit

Asset Management/Store Unit

CENTRE FOR PRODUCTREGISTRATION

TherapeuticMedical Section

VeterinaryMedicine Section

Active PharmaceuticalIngredient (API)

Section

RegulatoryCoordination Section

Biologics andComplementary

Section

CENTRE FORPOST REGISTRATION

PharmacovigilanceSection

Surveilance andProduct Complaints

Section

CosmeticsSection

CENTRE FORORGANISATIONAL

DEVELOPMENT

InformationCommunication

Technology Section

Interrelations andPolicy Section

GCP CompianceSection

GLP ComplianceSection

Human Resource andQuality Coordination

Section

CENTRE FORINVESTIGATIONAL

NEW PRODUCT

InvestigationalProduct Evaluation

Section

InvestigationalProduct Safety

Monitoring Section

DIRECTOR OF REGULATORY PHARMACY

MINISTRTIONAL PHA NAATIONAL PHARMACEUTICAL CONTROL BUREAU

YTH MALA AYSIAY OF HEAL LTH MALAMINISTRTIONAL PHARMACEUTICAL CONTROL BUREAU

YSIATIONAL PHARMACEUTICAL CONTROL BUREAU

REGISTRACENTRE FOR PRODUCT

Therapeutic

TIONSTRAATIONCENTRE FOR PRODUCT

Therapeutic

DIRECTOR OF REGULA

TIONPOST REGISTRA ATIONCENTRE FOR

Pharmacovigilance

Y PHARMACYTOR OF REGULA ATOR

LICENSINGCOMPLIANCE &

CENTRE FOR

GMP Section

Y PHARMACY

LICENSINGCOMPLIANCE &

CENTRE FOR

GMP SectionMedical Section

Medicine Section eteVVe

Sectionedient (API)Ingr

Active Pharmaceutical

Medical SectionTherapeutic

Medicine Section eterinary

Sectionedient (API)

Active Pharmaceutical

SectionPharmacovigilance

Sectionoduct ComplaintsPrSurveilance and

SectionCosmetics

(Pharmaceutical)GMP Section

(Complementary)GMP Section

Certi�cation SectionLicensing and

(Pharmaceutical)GMP Section

(Complementary)GMP Section

Certi�cation SectionLicensing and

QUALITY CONTROLCENTRE FOR

dination SectionCoorRegulatory

SectionComplementaryBiologics and

QUALITY CONTROLCENTRE FOR

dination SectionRegulatory

SectionComplementaryBiologics and

SectionariationsVVariations

DEVELOPMENTTIONALORGANISAATIONAL

CENTRE FOR

echnology SectionTTechnology SectionCommunication

Information

Development SectionQuality and Industrial

GDP Section

TADMINISTRAATIONCENTRE FOR

Development SectionQuality and Industrial

GDP Section

TIONCENTRE FOR

QUALITY CONTROL

esting TTesting SectionBio-Pharmaceutical

esting TTesting SectionNatural Pr

Pharmaceutical

QUALITY CONTROL

esting SectionBio-Pharmaceutical

esting SectionoductsNatural Pr

Pharmaceutical

echnology Section

Policy Sectionelations andInterr

SectiondinationQuality Coor

ce andHuman Resour

CENTRE FOR

TADMINISTRAATION

Finance Unit

Development Unit

TION

Finance Unit

Development Unit

Services SectionLaboratory

SectionChemistry T

SectionDevelopmentResear

Services SectionLaboratory

Sectionestingstry T Testing

SectionDevelopment

ch andResear

NEW PRODUCTTIONALINVESTIGAATIONAL

Sectionoduct EvaluationPrInvestigational

Monitoring Sectionoduct SafetyPr

Investigational

Administration Unit

e UnitStorAsset Management/

Administration Unit

Asset Management/

Quality SectionStandarQuality Section

ds andStandarSection

GCP Compiance

SectionGLP Compliance

24 Regulatory Control in Pharmaceutical Industry


Product Registration

Introduction

The guidelines outlined in the Drug Registration Guidance Document (DRGD)primarily drawn up in accordance with the legal requirements of the Sale ofDrugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984.Although the legal requirements of other related legis lat ions have beenincluded, applicants are reminded that it is their responsibility to ensure thattheir products comply with the requirements of these legislations, namely:

• Dangerous Drugs Act 1952;

• Poisons Act 1952;

• Medicine (Advertisement & Sale) Act 1956;

• Patent Act 1983; and

• any other relevant Acts.

Definition of a Product

Under the Control of Drugs and Cosmetics Regulations 1984, a ‘product’ asdefined in the Regulations, means a ‘drug’ in a dosage unit or otherwise, foruse wholly or mainly by being administered to one or more human beings oranimals for a medicinal purpose. Under the Sale of Drugs Act 1952, ‘drug’includes any substance, product or article intended to be used or capable, orpurported or claimed to be capable of being used on humans or any animal,whether internally or externally for a medicinal purpose used in humans (andanimals).

Drug Registration

• Regu la t ion 7 (1 ) (a ) o f the Cont ro l o f Drugs and Cosmet ics 1984(Amendment 2006) requires al l products to be registered with the DCAprior to being manufactured, sold, supplied, imported or prossessed oradministered, unless the product is exempted under specif ic provision ofthe Regulations.

• Any drug in a pharmaceut ica l dosage fo rm in tended to be used, o rcapable or purported or claimed to be capable of being used on humansor any animals, whether internal ly or external ly for a medical purposes isrequired to be registered with the DCA.


• Medicinal purpose means any of the following purposes:

- Al leviat ing, treat ing, cur ing or prevent ing a disease or a pathological condition, or symptoms of a disease

- Diagnosing a disease or ascertaining the existence, degree or extent of a physiological or pathological condition;

- Contraception;

- Inducing anaesthesia;

- Maintaining, modifying, preventing, restoring or interfering with, the normal operation of a physiological function;

- Controlling body weight;

- General maintenance or promotion of health or well-being

• The Regulations do not apply to the following products:

- Diagnostic agents and test kits for laboratory use;

- Medical devices:

i. Non-medical medic and contraceptive devices;

ii. Non-medical bandages, surgical dressing, plaster, dental fillings;

iii. Instruments apparatus, syringes, needles, sutures, catheters;

- Food, (as def ined under Food Act 1983 and Food Regulat ions 1985, includes every article manufactured, sold or represented for use as food or dr ink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances. This includes food for special dietary use for persons with a specif ic disease, disorder or medical condit ion, and food which contain quantities of added nutrients allowable under the Food Act and Regulations).

- Cosmetics, (in conformance with the harmonisation of cosmetic regulationsin the ASEAN region and in compliance to the ASEAN Cosmetic Directive, cosmetics are regulated via the notif ication process starting 1 January 2008).

• Products which are not registered with the DCA and are intended to be imported for the purpose of cl inical tr ial shal l have a Clinical Trial Import Licence (CTIL).

• Products which are not registered with the DCA and are intended to bemanufactured local ly for the purpose of cl in ical tr ia l should apply forexemption by the DCA (Cl in ical Tr ia l Exemption) from Director ofPharmaceutical Services.

• Any person who wishes to manufacture any product solely for the purpose ofproducing a sample for the sole purpose of registration should apply for anexemption for manufacture of sample (Appl ies to local ly manufacturedproducts only).


Application TypeApplication for a new product registration may be categorised as follows:

i. Application for an innovator product (NCE/Biotech)

ii. Application for a generic product (Controlled Poisons & Non-Controlled Poisons)

[a generic product is a product that is essentially similar to a currently

registered product in Malaysia. The term generic is not applicable to

biological and biotech products]

iii. Application for product registration via the abridged procedure (for

certain categories of OTC products and traditional medicines)

A

Data Requirements

The data required to support an application is divided into:

i. Administrative data (Part I)

ii. Data to support product quality (Part II)

iii.Data to support product safety (Part III)

iv. Data to support product efficacy (Part IV)

Applicants are advised to read the explanatory notes in Section 2 of Drug Registration Guidance Document, and also the relevant ASEAN or ICH Guidelines (www.ich.org) and checklists, for full information on product data requirement. The DCA may request for supplementary information.

B

Data Submission

Data to be submitted will be based on the application type:

i. Innovator product – Parts I to IV (For existing chemical or biological entity(s) in a new dosage form, only Parts I and II, together with pharmacokinetic data will be required)

ii. Generic product – Parts I & II onlyiii. Abridged procedure – Part I only

The applicant should make available the requested information within

the specified period. Failure to do so may result in the rejection

of the application.

C

New Application Processing Procedures


Application Formalities

The DCA only accepts applications which are being submitted through web-based online system at http://www.bpfk.gov.my. The applicant for productregistration must be registered with Malaysian Registrar of Business (ROB) orCompanies Commission of Malaysia (SSM). The applicant, (if the said companyis not the product owner) should be authorised in writing by the product ownerto be the holder of the product registration certificate and be responsible forall matters pertaining to the registration of the product.

a. Responsibility of Marketing Authorisation Holder (i.e. the applicant for product registration)

• The applicant shall be responsible for the product and all information supplied in support of his application. He shall be responsible for updating any information relevant to the product/application during the course of evaluation and after product registration.

• Any person who knowingly supplies any false or misleading information in connection with his application commits an offence under the Control of Drugs and Cosmetics Regulations 1984.The applicant is responsible for the quality, safety and efficacy of his products.


b. Application Fee

Every application for registration shall incur a processing fee:

* The DCA will charge the applicant such costs as it may incur for the purpose of carrying outlaboratory investigation relating to the registration of any product. (Any payment made is notrefundable once an application has been submitted and payment confirmed)

Product Category Processing Fee Laboratory Fee *

Traditional Product/ Traditional RM500 RM700 for

Health Supplement (each product) laboratory tests

Pharmaceutical Product/ RM1,000 RM1,200

Pharmaceutical Health (1 active ingredient) or

Supplement RM2,000

(2 or more active

ingredient) as fee for

analytical validation

evaluation method

New Chemical Entities/Biotech RM1,000 RM3,000

(1 active ingredient) or

RM4,000

(2 or more active

ingredient) as fee for

analytical validation

evaluation method

Veterinary Product RM1,500 Not applicable

(each poison /

OTC product, inclusive

of laboratory tests)

RM1,200

(each natural product,

inclusive of laboratory

tests)

Cosmetic Product RM50 Not applicable

(each product)


c. Accompanying Documents

i) The following documents are to be submitted together with the application:

• Authorisation from the product owner

• Letters of authorisation of contract manufacture and acceptance as wellas from the manufacturer and also each sub-contractor, where a product is contract manufactured, if applicable (e.g. repacker).

ii) The letter of authorisation or acceptance from the manufacturer should beon the product owner’s original letterhead and be dated and signed by theManaging Director, President, CEO or an equivalent person who has overallresponsibility for the company or organisation

iii) The letters should state the name of the product concerned, name andactual plant address of the manufacturer(s) involved in the manufacture ofthe product.

iv) Imported products will also need to be accompanied with either:

• Certificate of Pharmaceutical Product (CPP) from the competent authorityin the country of origin; OR

• Certification for Free Sales (CFS) and Good Manufacturing Practice (GMP)from the relevant authorit ies for tradit ional medicines and dietarysupplements

For more information, please referto the ‘Drug Registration GuidanceDocument’ in the NPCB’s websiteat www.bpfk.gov.my


Application Process

a. Initiation of Review

Review of appl icat ions wi l l fol low a queue system. There wi l l be separatequeues for the different categories of products:

• New Chemical Entity (NCE)

• Biotech

• Generics (full evaluation procedure)

• Abridged Evaluation Procedure Pharmaceuticals (OTC)

• Traditional Products

b. Time Frame

The time frame for registration of products:

• The t ime frame for each product is calculated from the date of f inal andcomplete submission.

• Priority review may be granted where the product is intended for treatmentof a ser ious or l i fe-threatening disease (where the l ikel ihood of death is high unless the course of the disease is interrupted).

Full Evaluation Timeline

Prescription Drugs (Poison) 210 working days

Non-prescription (Non-poison) Drugs 210 working days

NCE 245 working days

Abridged Evaluation Timeline

Health Supplement Products

Natural Products (Traditional)

Cosmetic Products (Notification Note)

- Single active ingredient: 60 working days

- 2 or more active ingredients:80 working days


Regulatory Outcome

a. Decisions of the DCA

An application may be approved or rejected and the DCA decision will be sentvia e-mail to the marketing authorisation holder.

b. Product Registration Number

• A Registration Number, which is specific for the product registered, will begiven via e-mail when an application is approved by the DCA. Registrationis valid for a period of 5 years.

• Product Notification Number will be given to a cosmetic product after thenotification process.

c. Rejection, Cancellation, Suspension of Registration

The DCA may reject, cancel or suspend the registrat ion of any product i fthere are deficiencies in safety, quality or efficacy of the product or failure tocomply with conditions of registration.

d. Appeal against DCA decisions

Any applicant aggrieved by the decisions of the DCA may make a written appealto the Minister of Health. Appeals MUST be made within fourteen days from thedate of the DCA notification. A period of 180 days from the date of appeal isgiven for submission of any support ing data or documents for NCE andbiotechnology products and 90 days for other products. The appeal is closedif all the required information is not submitted within the stated time given.

e. Decision of the Minister

The decision made on any appeal is final.


Registration Maintenance

a. Conditions for RegistrationThe affixing of the security device, one of the conditions for product registration,to product labelling has been identified as a means to verify and authenticatethat the product has been duly registered with the DCA.

The DCA may specify certain conditions for registration for a particular group,amend any condit ions for registrat ion and may lay down specif ic productlabelling requirements.

The DCA may cancel theregistrat ion of any product i fthe conditions for registrationare not complied with.

b. Validity Period

The registration of a product is valid for 5 years or such period as specified inthe registration certificate.

For cosmetic products, the Notification Note is valid for 2 years or such periodas specified in the Notification Note.

Renewal of product registration should be done six months prior to the expiryof the validity period of product registration. Upon expiry of the validity periodof registration, the module for renewal of product registration will no longerbe accessible and application for re-registration of the product can no longerbe submitted.

c. Change In Particulars of Registered Products

Changes in particulars of a Registered product require DCA approval. Changesrefer to any changes in product name, product specif icat ions, packing,indications, contents of product label, package insert, or product literature,or any relevant particulars of the registered product.

• Any changes in excipients, such as change in lubricant, preservative, solventin film coating, etc to improve product formulation requires prior approval ofthe DCA.

• Explanation/reason for the changes should be given. All relevant supportingdata related to the above changes should be updated accordingly.

• The registration of a product may be cancelled if changes are made withoutprior approval of the DCA.

For information on product conditionsfor reg is t ra t ion , p lease re fe r toAppendices 1, 1.1, 2 & 3 of the DrugRegistration Guidance Document fromwww.bpfk.gov.my.


• The market ing author isat ion holder mustensure that all the necessary validation hasbeen conducted to demonstrate that thechange does not reduce the quality, safety oreff icacy of the product and submit al lnecessary documents.

d. Reporting Problems with Registered Products

i. Adverse Drug Reactions (ADR)

• All market authorisation holders (MAH) must ensure that an appropriatesystem of pharmacovigilance is in place in the company order to accentresponsibility and liability for its products on the market and ensure thatappropriate action can be taken, when neccessary.

• MAH sould inform the pharmacovigi lance sect ion of Nat ionalPharmaceutical Control Bureau, in writ ing of al l matters pertaining tothe safety of the products.

• All report of adverse reaction associated in the use of registered productoccuring in Malaysia must be reported to the NPCB within the stimulatedtimeline.

• MAH who have registered a product containing new chemical entity mustroutinely submit periodic safety updates reports (PSUR) on that product6 monthly for the first 2 years after approved in Malaysia and annuallyfor the subsequent 3 years.

• All labels and package inserts must be amended to include any new ADR,warning, precautions, etc. within the time frame given by the DCA.

ii. Market Surveillance of Registered Products

• Samples of registered products may be tested for compl iance withstandards or specif icat ions and i f they fai l to meet adequatespecifications, the marketing authorisation holder will be issued a warningand has up to 30 days to identi fy the source of qual i ty defect(s) andactions taken to improve quality unless the failure is serious enough tojustify recall of the product.

iii. Product Complaints

• The market authorisation holder should notify the DCA of any productquality related problems that the holder is aware of.

• Complaints submitted to the DCA by health care professionals,consumers, and patients will be investigated. Based on the outcome ofthese investigations, appropriate action will be taken which may includeproduct/batch recalls, cancellation/suspension of product registrationsor other regulatory action as deemed necessary.

F o r m o re i n f o r m a t i o n ,please refer to Appendix 4o f D r u g R e g i s t r a t i o nGuidance Document fromwww.bpfk.gov.my


iv. Product Recalls

• The decision for recall shall be made when there is or may cause potentialrisk to the user of the products. Recall may be done voluntanly by theproduct registrat ion holder or directed by the Senior Director ofPharmaceutical Services, Ministry of Health Malaysia.

• The product registration holder is responsible for conducting recalls ofdefect or unsafe product. No recal l should take place without f i rstconsulting or informing the Senior Director of Pharmaceutical Services.

e. Termination of Registration by Marketing Authorisation Holder

The marketing authorisation holder shall inform the DCA of decision to terminatethe registration of a product before the end of the validity of such registrationand surrender the product registration certificate immediately to the DCA.

f. Change in Manufacturing Site

• Applies to change of manufacturing site for part or all of the manufacturingprocess of the product but does not cover changes related to a new sitewhere only batch release takes place or to a new packager as these changesare covered under appl icat ions for amendments to the part iculars of aregistered product (variation).

• The new manufactur ing site should comply with the current GoodManufacturing Practice (GMP). Local manufacturing sites are subjected topre-licensing inspections and for sites outside Malaysia, certification by acompetent authority is sufficient. However, the DCA reserves the right toconduct an inspection on any manufacturing site.

• This procedure is applicable for:

- Change in the manufactur ing site for the same company, including rationalisation in the event of mergers; and

- Where a company which previously contracts out the manufacture of its product transfers the manufacture to its own premises

• A change in manufactur ing site between contract manufacturers is not routinely allowed but may be considered in a crisis situation.

• There are 5 different types of site change, hence require different sets ofaccompanying documents.


Type I : Change of Manufacturing Site Within Malaysia

Type II : Change of Manufacturing Site from ForeignCountry to Malaysia

Type III : Change to Manufacturing Site Located OutsideMalaysia

Type IV : Change o f Manufactur ing S i te for Spec ia lCategory Products

Type V : Crisis Situation

g. Other Information

i) Products for Export Only

• The DCA may register the following locally manufactured products forexport only:

- Product(s) registered by the DCA but sold in a di fferent colour (formulation), shape and strength;

- Products which contain ingredients not allowed by the DCA for local use (terms and conditions apply), provided that confirmation in writing is obtained from the competent authority of the importing country that there is no objection to the importation and sale of the formulation in quest ion. Evidence of registrat ion of sol id formulat ion with the competent author i ty in import ing country may be accepted as supporting data.

• If there is no change in the formulation or appearance of the product,registration for export purposes is not necessary.

• An “export notification” procedure allows an applicant to apply for FreeSale Certif ication (CFS) of the product whereby the applicant need todeclare to the DCA the differences in the product for export comparedto the registered product marketed in Malaysia.

• A Certificate of Pharmaceutical Product will be issued to the applicant forthe registered product.

For the description of each category, please refer to DrugRegistration Guidance Document in the NPCB website atwww.bpfk.gov.my


ii) Combination Packs

• Products which are packed together in combination for a therapeuticregimen can be registered as a single product.

• Where the combinat ion pack product consists of registered andunregistered products, the unregistered product needs to be registeredbefore submitting the registration application for the combination pack.

• Where the combination pack consists of registered products which aresourced from different product owners, letters of authorisation from theproduct owners shall be submitted, together with the following productdetails :-

- Product Name;

- Product Registration Number.

iii) Use of HALAL logo

The use of HALAL logo on the labels of pharmaceutical products wil l notbe al lowed except for t radit ional products, dietary supplements anda lso cosmetics providedthat such products havebeen cert i f ied andapproved as HALAL byDepartment of Is lamicDevelopment Malaysia(JAKIM)

iv) Product Labelling, Bioequivalence, New/Additional IndicationPlease refer to the Drug Registration Guidance Document in NPCB website

for details.

For details, please visit the HalalIndustry Development Corporationwebsite at www.halal.gov.my


Online Registration System

Quest is an online submission system for the product licence holder to conductsecured online transactions on registration, change request, market sampling,renewal and other transactions

Note:The public can access the product search on both QUEST 2 and QUEST 3 tosearch for registered products, product registration holders as well as productmanufacturers.

Quest 3 Customer Support Number

603-7883 5400 extension: 5560/ 5561/ 5562

USB Token System Customer Service Department

Tel: 603-8992 8888URL: http://www.digicert.com.myE-mail:[email protected]

Payment received by Digicert

Evaluation of applicationby BPFK Officer

Send payment+ slip asadviced in the slip (toDigicert Sdn. Bhd.)

Pin number will be send

separately via POSLAJU

USB Token will be sentwithin 7 working daysby Digicert Sdn. Bhd.

via POSLAJU

Password will beemailed to the emailaddress specified in

the application


USB TOKEN/MEMBERSHIP APPLICATION FOR FIRST TIME USER

www.bpfk.gov.my

First time user registration

Applicant mustremember the

chosenUsername

Membership registration form

Fill in company and membership details (All fields are compulsory)

Scan and attach documents: 1. Company Registration Form 2. Company Authorisation Letter 3. Identity Card (Front Only)

Submit application

Login to QUEST3 and proceed with Product Registration/Cosmetic Notification

Print membership slip

Print membership slip

Correspondence through email

Quest 3

Application rejected Satisfactory

Not satisfactory

Res

ub

mit

ap

plic

atio

n

No response


Licence Issued for Registered Products

NPCB processes the application and issues the following licences:

• Manufacturer’s Licence (Form BPFK-426.3_LK)

• Importer’s Licence (Form BPFK-424.3_LI)

• Wholesaler’s Licence (Form BPFK-422.3_LB)

Licensing FeesThe licensing fees for the application for the various licences are as follows:

Licence ApplicationThe Application for the above licences can be submitted manually or onlinethrough the NPCB QUEST 3 Online Submission System. Application forms mustbe accompanied with the following documents:

i) New Application:

• Organisation chart of the company (including names of the staff)

• Premises location plan (A4 size)

• Floor plan for premises (A4 size)

• List of storage, manufacturing and quality control facilities

• Products recall procedure

• List of other products (non-registered products) stored in the same premises

• Copy of Registration of Company (ROC) or Registration of Business (ROB) certificate

• Copy of Business Licence (Issued by the State Local Authority)

• Copy of identity card of applicant/licence holder

• Copy of Retention of Pharmacist Certificate*

• Copy of Annual Registration Certificate*

• Copy of Type A Licence*

Licence Registration Fee Timeline Validity Renew Before

Manufacturer’s Licence RM 1000 10 working days 1 year December

Importer’s Licence RM 500 10 working days 1 year December

Wholesaler’s Licence RM 500 10 working days 1 year June

ii) Application Renewal:

• Copy of Business Licence (Issued by the State Local Authority)

• Copy of identity card of applicant/licence holder

• Copy of Type A Licence*

• Copy of previous licence

*Note: If applicant is a registered pharmacist


Application forms for Manufacturer’sLicence, Importer’s Licence andWholesaler’s Licence can bedownloaded from NPCB’s website atwww.bpfk.gov.my

Manufacturer’s Licence Application Procedures

The layout plan must be submitted to the Centre for Compliance and Licensingof National Pharmaceutical Control Bureau for evaluation. At the same time, anapplicant may register the company with SSM.

The layout plan and design shall fulfil the following:

• Premise should be of suitable size, design, construction and its location.

• Have sufficient working area for the placement of equipment or machines andother materials for operational purposes.

• Able to avoid cross over between material flow personnel flow, and storageof materials.

• Once the plan has been approved, applicant shall seek additional advice/approval from the Fire Department and Department of Environmental prior toconstruction.

• Applicant shall prepare a complete documentation system that comprisesof directions, explanations, specif ications and records pertaining to theoperation.

• Once the construction of manufacturing facilities is completed, the applicantshall seek an appointment with the GMP auditor to inspect the premise forpre-licensing purpose.

• Applicant may also apply for Business Licence from local state authority.

• The report of the findings will be delivered 14 working days after the date ofinspection and Letter of Confirmation (LOC) will be issued by the Centre forCompliance and Licensing once approved.

• During product registration, if the Centre for Product Registration requiressamples for testing purposes, applicant may write an official letter to permitthe manufacturing of that particular product.

• Once product has been registered, applicant may apply for manufacturer’slicence.

• Appl icat ion wi l l only be processed once payment has been made to theCentre for Administration.

• Once approved, the manufacturer’s l icence can be collected from Centrefor Compl iance And Licensing or i t wi l l be posted to the manufactur ingaddress.



Application Process to Obtain Manufacturing Licence

Corrective Action

Floor plan does notcomply with

GMP requirement

Premise does notcomply with

GMP requirement

Send Floor Plan to CGMP for Evaluation

Floor Plan Approved

Invite GMP Auditor to PerformPre-licensing InspectionCorrective Action

Premise Approved

Issuance of Letter of Confirmation (LOC)

Product Registration Process

Registration Number Confirmed(MAL Number)

Application for Manufacturer’s Licence

Manufacturer’s Licence Issued


Bioavailability and Bioequivalence Study forPharmaceutical Products

IntroductionBioavai labi l i ty (BA) test ing of drug products in humans provides the mostappropriate method available for determining bioequivalence. Demonstrationof bioequivalence (BE) is general ly the most appropriate method ofsubstantiating therapeutic equivalence between medicinal products.

Bioavailability:Bioavailabi l i ty means the rate and extent to which the active substance ortherapeutic moiety is absorbed from a pharmaceutical form and becomesavailable at the site of action.

Bioequivalence:Two medicinal products are bioequivalent if they are pharmaceutical equivalentsor alternatives and if their bioavailabilities (rate and extent) after administrationin the same molar dose are similar to such degree that their effects, with respectto both efficacy and safety, will be essentially the same.

Effective 1st January 2012, the DCA had imposed on Bioequivalence (BE)studies requirement for all immediate releases oral, solid dosage form genericproducts containing scheduled poison as Act ive Ingredients as wel l asaccreditation of BE research centres.

Generic Product List and Guidelines for BioequivalanceStudiesA list of drug substances which, when formulated in oral solid dosage forms,require BE data as a prerequisite for registration, has been established by theDCA. The l ist and guidel ines can be found in the NPCB website atwww.bpfk.gov.my .

USEFUL CONTACTS

45

46 Useful Contacts

MALAYSIAN INVESTMENT DEVELOPMENT AUTHORITY (MIDA)

MIDA SentralNo. 5, Jalan Stesen Sentral 5Kuala Lumpur Sentral50470 Kuala Lumpur, MalaysiaTel: (603) 2267 3633 Fax: (603) 2274 7970E-mail: [email protected]: www.mida.gov.my

ASIA-PACIFIC

AUSTRALIAConsul-Investment/DirectorConsulate of MalaysiaMalaysian InvestmentDevelopment AuthorityLevel 6, MAS Building16 Spring StreetSydney, NSW 2000, AustraliaTel: (612) 9251 1933 Fax: (612) 9251 4333E-mail: [email protected]

JAPANTokyoDirectorMalaysian InvestmentDevelopment Authority32F, Shiroyama Trust Tower4-3-1, Toranomon, Minato-kuTokyo 105-6032, JapanTel: (813) 5777 8808Fax: (813) 5777 8809E-mail: [email protected]: www.midajapan.or.jp

OsakaDirectorMalaysian InvestmentDevelopment AuthorityMainichi Intecio 18F3-4-5 Umeda, Kita-kuOsaka 530-0001, JapanTel: (816) 6451 6661Fax: (816) 6451 6626E-mail: [email protected]

PEOPLE’S REPUBLIC OFCHINAShanghaiConsul (Investment)Consulate General of Malaysia(Investment Section)Malaysian InvestmentDevelopment AuthorityUnits 807-809, Level 8Shanghai Kerry CentreNo. 1515, Nanjing Road (West)Shanghai, 200040People’s Republic of China Tel: (8621) 6289 4547/5298

6335Fax: (8621) 6279 4009E-mail: [email protected]

GuangzhouDirectorMalaysian InvestmentDevelopment AuthorityUnit 1804B-05CITIC Plaza Office Tower233 Tianhe Be RoadGuangzhou, 510610People’s Republic of ChinaTel: (8620) 8752 0739Fax: (8620) 8752 0753E-mail: [email protected]

TAIWANDirector (Investment Section)Malaysian Friendship & TradeCentreMalaysian InvestmentDevelopment Authority12F Suite A, Hung Kuo BuildingNo. 167, Tun Hua North RoadTaipei 105, TaiwanTel: (8862) 2713 5020/

2718 6094Fax: (8862) 2514 7581E-mail: [email protected]

KOREA, REPUBLIC OFCounsellor (Investment)Embassy of Malaysia (Investment Section)Malaysian InvestmentDevelopment Authority17th Floor, SC First Bank Building100, Gongpyung-dong, Jongro-guSeoul 110-702, Republic of Korea Tel: (822) 733 6130/6131Fax: (822) 733 6132E-mail: [email protected]

UNITED ARAB EMIRATESDirector/Consul InvestmentMalaysian InvestmentDevelopment AuthorityConsulate General of Malaysia(Investment Section)Unit 2205, 22nd Floor, Tower ABusiness Central Tower, DubaiMedia City(P.O. Box: 502876) DubaiUnited Arab EmiratesTel: (9714) 4343 696/697Fax: (9714) 4343 698E-mail: [email protected]

INDIADirector/Consul InvestmentMalaysian InvestmentDevelopment AuthorityConsulate General of Malaysia (Investment Section)81 & 87, 8th Floor, 3rd NorthAvenue Marker MaxityBandra Kurla Complex,Bandra (E)Mumbai 400051, IndiaTel: (9122) 2659 1155/1156Fax: (9122) 2659 1154E-mail: [email protected]

SINGAPOREDirector/Consul InvestmentMalaysian InvestmentDevelopment AuthorityNo. 7, Temasek Boulevard 26-01, Suntec Tower One Singapore 038987 Tel: (65) 6835 9326/

9580/7069Fax: (65) 6835 7926E-mail: [email protected]

THAILANDDirector/Investment CounsellorMalaysian InvestmentDevelopment Authority3601, 36th Floor, Q. HouseLumpini Building South Sathorn Road Tungmahamek, Sathorn Bangkok 10120, ThailandTel: (66) 2677 7487Fax: (66) 2677 7488E-mail:[email protected]

MIDA’S OVERSEAS OFFICES

Useful Contacts 47

EUROPE

SWEDENEconomic CounsellorEmbassy of MalaysiaKarlavägen 37, P.O. Box 26053S-10041 Stockholm, SwedenTel: (468) 791 7942/


UNITED KINGDOMDirectorMalaysian InvestmentDevelopment Authority17 Curzon StreetLondon W1J 5HR, United KingdomTel: (4420) 7493 0616Fax: (4420) 7493 8804E-mail:[email protected]

GERMANY, FEDERALREPUBLIC OFFrankfurtDirector/Consul InvestmentMalaysian InvestmentDevelopment AuthorityConsulate General of Malaysia(Investment Section)17th Floor, Frankfurt KastorPlatz der Einheit 160327 Frankfurt am Main,GermanyTel: (4969) 7680 7080Fax: (4969) 7680 708-20E-mail: [email protected]

MunichDirectorMalaysian InvestmentDevelopment Authority6th Floor, BurkleinhausBurkleinstrasse 1080538 Munich, GermanyTel: (4989) 2030 0430Fax: (4989) 2030 4315E-mail: [email protected]

FRANCEDirectorMalaysian InvestmentDevelopment Authority42, Avenue Kleber75116 Paris, FranceTel: (331) 4727 3689/6696Fax: (331) 4755 6375E-mail: [email protected]

ITALYConsul-InvestmentConsulate of Malaysia(Investment Section)Malaysian InvestmentDevelopment Authority5th Floor, Piazza Missori 320123 Milan (MI), ItalyTel: (3902) 3046 521Fax: (3902) 3046 5242E-mail: [email protected]

NORTH AMERICA

LOS ANGELESConsul (Investment)Consulate General of Malaysia(Investment Section)550, South Hope Street, Suite 400Los Angeles, California 90071United States of AmericaTel: (1213) 955 9183/

9877Fax: (1213) 955 9878E-mail: [email protected]

SAN JOSEMalaysian InvestmentDevelopment Authority226, Airport Parkway, Suite 480San Jose, California 95110United States of AmericaTel: (1408) 392 0617/8Fax: (1408) 392 0619E-mail: [email protected]

NEW YORKConsul (Investment)Consulate General of Malaysia(Investment Section)313 East, 43rd Street, NewYorkNew York 10017United States of AmericaTel: (1212) 687 2491Fax: (1212) 490 8450E-mail: [email protected]

BOSTONDirectorMalaysian InvestmentDevelopment AuthorityOne International Place, Floor 8Boston, MA 02110United States of America Tel: (1617) 338 1128/


CHICAGODirectorMalaysian InvestmentDevelopment AuthorityJohn Hancock Center, Suite 1515875, North Michigan AvenueChicago, Illinois 60611United States of AmericaTel: (1312) 787 4532Fax: (1312) 787 4769E-mail: [email protected]

HOUSTONDirectorMalaysian InvestmentDevelopment Authority6th Floor, Suite 630 Lakes on Post Oak 3050 Post Oak Boulevard Houston, TX 77056 United States of AmericaTel: (1713) 979 5170 Fax: (1713) 979 5177/78E-mail: [email protected]

AFRICA

JOHANNESBURG

REPUBLIC OF SOUTH AFRICAEconomic CounsellorHigh Commission of MalaysiaGround Floor, Building 5Commerce Square Office Park39 Rivonia Road, SandhurstSandton, JohannesburgRepublic of South AfricaTel: (2711) 268 2307/


48 Useful Contacts

KEDAH & PERLISDirectorMalaysian Investment DevelopmentAuthorityLevel 4, East Wing, No. 88Menara Bina Darulaman BerhadLebuhraya Darulaman05100 Alor Setar Kedah Darul AmanMalaysia Tel: (604) 731 3978Fax: (604) 731 2439Email: [email protected]

PENANGDirectorMalaysian Investment DevelopmentAuthority4.03, 4th FloorMenara Boustead Penang39, Jalan Sultan Ahmad Shah10050 Pulau Pinang Malaysia Tel: (604) 228 0575Fax: (604) 228 0327E-mail: [email protected]

PERAKDirectorMalaysian Investment DevelopmentAuthority4th FloorPerak Techno Trade Centre (PTTC)Bandar Meru RayaOff Jalan JelapangP.O. Box 210, 30720 IpohPerak Darul RidzuanMalaysia Tel: (605) 5269 962 / 961Fax: (605) 5279 960E-mail: [email protected]

MELAKADirectorMalaysian Investment DevelopmentAuthority3rd Floor, Menara MITCKompleks MITCJalan Konvensyen75450 Ayer Keroh MelakaMalaysia Tel: (606) 232 2876/78Fax: (606) 232 2875E-mail: [email protected]

NEGERI SEMBILANDirectorMalaysian Investment DevelopmentAuthority Suite 13.01 & 13.0213th Floor, Menara MAA70200 SerembanNegeri SembilanMalaysiaTel: (606) 762 7921/7884Fax: (606) 762 7879E-mail: [email protected]

JOHORDirectorMalaysian Investment DevelopmentAuthorityNo.5, Level 13Menara Tabung HajiJalan Ayer Molek80000 Johor Bahru, Johor MalaysiaTel: (607) 224 2550/ 5500Fax: (607) 224 2360E-mail: [email protected]

PAHANGDirector Malaysian Investment DevelopmentAuthoritySuite 3, 11th FloorKompleks TeruntumP.O.Box 178,25720 Kuantan, Pahang MalaysiaTel: (609) 513 7334Fax: (609) 513 7333E-mail: [email protected]

KELANTANDirector Malaysian Investment DevelopmentAuthorityAras 5-CMenara Pejabat KelantanTrade CentreJalan Bayam15200 Kota Bharu, Kelantan MalaysiaTel: (609) 748 3151Fax: (609) 744 7294E-mail: [email protected]

SELANGORDirector Malaysian Investment DevelopmentAuthority 22nd Floor, Wisma MBSAPersiaran Perbandaran40000 Shah AlamSelangor Darul EhsanMalaysiaTel: (603) 5518 4260Fax: (603) 5513 5392E-mail: [email protected]

TERENGGANUDirectorMalaysian Investment DevelopmentAuthority5th Floor, Menara Yayasan IslamTerengganuJalan Sultan Omar20300 Kuala Terengganu, TerengganuMalaysiaTel: (609) 622 7200Fax: (609) 623 2260E-mail: [email protected]

SABAHDirectorMalaysian Investment DevelopmentAuthorityLot D9.4 & D9.5, Tingkat 9 Block D, Bangunan KWSPKaramunsing 88100 Kota Kinabalu SabahTel: (6088) 211 411Fax: (6088) 211 412Email: [email protected]

SARAWAKDirectorMalaysian Investment DevelopmentAuthority Room 404, 4th FloorBangunan Bank NegaraNo.147, Jalan Satok, P.O.Box 71693714 KuchingSarawakMalaysiaTel: (6082) 254 251/237 484Fax: (6082) 252 375E-mail: [email protected]

MIDA STATE OFFICES

Useful Contacts 49

MINISTRY OF INTERNATIONAL TRADE & INDUSTRY (MITI)Block 10, Government Offices Complex, Jalan Duta 50622 Kuala Lumpur, MalaysiaTel: (603) 6203 3022 Fax: (603) 6203 2337/ 6203 1303 Website: www.miti.gov.my E-mail: [email protected]

MITI OVERSEAS OFFICES

BELGIUMMinister Counsellor (Economy)Mission of Malaysia to the EUEmbassy of Malaysia in BelgiumAvenue de Tervuren 414A1150 BrusselsBelgiumTel: (322) 776 0340/762 5939Fax: (322) 771 2380Email: [email protected]/

[email protected]

CHINA, PEOPLE’S OF REPUBLIC OFMinister Counsellor (Economy)Embassy of Malaysia (Economic Section)No.2 Liang Ma Qiau Bei JieChaoyang District, 100600 BeijingPeople’s Republic of ChinaTel: (8610) 6532 2533/7990Fax: (8610) 6523 3617Email: [email protected]

INDIA, REPUBLIC OFMinister Counsellor (Economy)High Commission of Malaysia in New Delhi50-M, Satya MargChanakyapuriNew Delhi 110021Republic of IndiaTel: (91-11) 2611 1291/1292/

1293/1297Fax: (91-11) 2688 1538Email: [email protected]

INDONESIACounsellor (Economics)Embassy of Malaysia(Commercial Section)Jalan H.R. Rasuna Said, Kav X6No.1-3, KuninganJakarta 12950IndonesiaTel: (6221) 522 4947/522 4962Fax: (6221) 522 4963Email: [email protected]

JAPANMinister Counsellor (Economy)Department of Trade AffairsEmbassy of Malaysia20-16 Nanpeidai-ChoShibuya-ku, Tokyo 150-0036JapanTel: (813) 3476 3844Fax: (813) 3476 4972E-mail: [email protected]

SINGAPORECounsellor (Economics)Malaysian Trade Commission80 Robinson Road #01-02Singapore 068896Tel: (0265) 6222 0126/1356/1357Fax: (0265) 6221 5121Email: [email protected]

SWITZERLANDPermanent Mission of Malaysia to the WTOInternational Centre Cointrin (ICC)3rd Floor, Block C20, Route de Pre-BoisCase Postale 1909CH 1215, Geneva 15SwitzerlandTel: (4122) 799 4040Fax: (4122) 799 4041E-mail: [email protected]

THAILANDCounsellor (Economics)Embassy of Malaysia (Trade Office)35, South Sathorn RoadTungmahamek, SathornBangkok 10120ThailandTel: (662) 679 2190-9

Ext. 2303/ 2304/ 2305Fax: (662) 679 2200E-mail: [email protected]

UNITED STATES OF AMERICAMinister Counsellor (Economy)Embassy of Malaysia3516 International Court NWWashington DC 20008United States of AmericaTel: (1202) 572 9700/10/34Fax: (1202) 572 9782/882E-mail: [email protected]

50 Useful Contacts

MALAYSIA EXTERNAL TRADE DEVELOPMENT CORPORATION (MATRADE)Menara MATRADE, Jalan Khidmat Usaha, Off Jalan Duta, 50480 Kuala Lumpur, MalaysiaTel: (603) 6207 7077 Fax: (603) 6203 7037 Toll Free: 1800-88-7280 Website: www.matrade.gov.my E-mail: [email protected]

EAST - ASIA CHINA, PEOPLE’S REPUBLIC OFBeijingTrade CommissionerEmbassy of Malaysia (Trade Section)Unit E, 11th Floor, Tower BGateway Plaza18, Xiaguangli, North RoadDongsanhuanChaoyang District, Beijing 100027People’s Republic of ChinaTel: (8610) 8451 5109/5110/1113Fax: (8610) 8451 5112E-mail: [email protected]

Chengdu DirectorMalaysia External Trade DevelopmentCorporation (Chengdu Representative Office)Level 14, Unit 1402-1404The Office TowerShangri-La Centre9 Binjiang Road EastChengdu 610021, Sichuan ProvincePeople’s Republic of ChinaTel: (8628) 6687 7517Fax: (8628) 6687 7524E-mail: [email protected]

GuangzhouTrade CommissionerConsulate General of Malaysia (Trade Section)Unit 5305, Citic Plaza Office Tower233, Tianhe Bei RoadGuangzhou, 510610 GuangdongPeople's Republic of China Tel: (8620) 3877 3865/ 3975Fax: (8620) 3877 3985E-mail: [email protected]

Hong KongTrade Commissioner/ConsulConsulate General of Malaysia(Trade Section)19th Floor, Malaysia Building50 Gloucester Road, WanchaiHong Kong Special AdministrativeRegionRegion of the People’s Republic ofChinaTel: (852) 2527 8109Fax: (852) 2804 2866E-mail: [email protected]

ShanghaiTrade Consul Consulate General of Malaysia (TradeSection)Unit 807-809, 8th FloorShanghai Kerry Centre1515, Nanjing Road WestShanghai, 200040 People’s Republic of ChinaTel: (8621) 6289 4420/4467Fax: (8621) 6289 4381E-mail: [email protected]

TAIWANDirectorMalaysian Friendship & Trade Centre(Trade Section)10F-D, Hung Kuo Building167 Dun Hwa North RoadTaipei 105, TaiwanTel: (8862) 2545 2260Fax: (8862) 2718 1877E-mail: [email protected]

MATRADE’S OVERSEAS OFFICES

AUSTRALIATrade CommissionerConsulate of Malaysia (Commercial Section)Level 4, Malaysia Airlines Building 16, Spring Street, SydneyNSW 2000, AustraliaTel: (612) 9252 2270Fax: (612) 9252 2285E-mail: [email protected]

CENTRAL ASIAUZBEKISTANMarketing OfficerTrade Office (MATRADE)Embassy of Malaysia28, Maryam Yakubova Street, Yakkasaray District100 031 Tashkent, Republic of UzbekistanTel: (99871) 256 67 07Fax: (99871) 256 69 09Email: [email protected]

Useful Contacts 51

SOUTH EAST ASIA

CAMBODIAMarketing OfficerMalaysia External Trade DevelopmentCorporation (MATRADE)No. 222, Preah Nurodorn BoulevardSangkat Tonle Bassac KhanChamkarmornPhnom PenhCambodiaTel: (855) 2372 1224Fax: (855) 2372 1225E-mail: [email protected]

INDONESIATrade Commissioner Embassy of Malaysia (Trade Section)12th Floor, Plaza Mutiara Jln. Lingkar Kuningan Kav E.1.2. No1 & 2Kawasan Mega KuninganJakarta 12950Indonesia Tel: (6221) 576 4297/ 4322Fax: (6221) 576 4321E-mail: [email protected]

PHILIPPINESMarketing OfficerEmbassy of Malaysia Trade Office (MATRADE)10/F, The World Trade Centre330 Sen, Gil Puyat AvenueMakati City, PhilippinesTel: (632) 864 0761Fax: (632) 891 1695E-mail: [email protected]

SINGAPOREDirectorMalaysia External Trade DevelopmentCorporation#33-01/03, Shaw Towers 100Beach Road, Singapore 189702Tel: (0265) 6392 2238Fax: (0265) 6392 2239E-mail: [email protected]

THAILANDMarketing OfficerEmbassy of Malaysia (Trade Section)35, South Sathorn RoadTungmahamed, SathornBangkok, 10120, ThailandTel: (662) 679 2190-9 ext 2209

(662) 679 2200/ 2131Fax: (662) 679 2200E-mail: [email protected]

VIETNAMHo Chi Minh CityTrade CommissionerConsulate General of Malaysia (Trade Section)1208, 12th FIoor, Me Linh Point Tower2, Ngo Duc Ke Street, District 1Ho Chi Minh CityVietnamTel: (848) 829 9023/ 8256Fax: (848) 823 1882E-mail: [email protected]

HanoiMarketing OfficerEmbassy of MalaysiaTrade Office (MATRADE)45-46 Dien Bien Phu StreetBa Dinh District, HanoiVietnamTel: (844) 734 7521Fax: (844) 734 7520Email: [email protected]

JAPANTokyoDirectorMalaysia External Trade DevelopmentCorporation6th FIoor, Ginza Showadori Building 8-14-14, Ginza Chuo-kuTokyo 104-0061, JapanTel: (813) 3544 0712/ 0713Fax: (813) 3544 0714Email: [email protected]

OsakaMarketing OfficerMalaysia External Trade DevelopmentCorporation Mainichi Intecio 18F3-4-5, Umeda, Kita-kuOsaka 530-0001 JapanTel : (816) 6451 6520Fax : (816) 6451 6521E-mail: [email protected]

KOREA, REPUBLIC OF Trade CommissionerEmbassy of Malaysia (Trade & Investment Section)17th Floor, SC SC Bank Korea Limited47, Chongro, Chongro ruSeoul 110-702Republic of Korea Tel: (822) 739 6813/ 6814/ 6812Fax: (822) 739 6815E-mail: [email protected]

SOUTH ASIA

INDIAChennaiTrade CommissionerConsulate General of Malaysia (Trade Section)Capitale 2A, 2nd Floor554 & 555, Anna SalaiTeynampet, Chennai-600018IndiaTel: (9144) 2431 3722 / 3723Fax: (9144) 2431 3725E-mail: [email protected]

MumbaiConsulConsulate General of Malaysia Trade Section (MATRADE)Suite 301, 3rd Floor, Noman CentreBlock GBandra Kurla Complex, Bandra (E)Mumbai 400051IndiaTel: (9122) 2659 7272 / 3Fax: (9122)2695 7274E-mail: [email protected]

52 Useful Contacts

EUROPE

FRANCETrade CommissionerService Commercial De MalaisieDe L’ Ambassade De Malaisie90, Avenue Des Champs Elysees75008 Paris, FranceTel: (331) 4076 0000/0034Fax: (331) 4076 0001E-mail: [email protected]

GERMANY Trade Commissioner / ConsulConsulate of Malaysia (Trade Section)MATRADEKastor-Hochhaus (Commerzbank)17th Floor, Platz der Einheit 160327 Frankfurt am MainGermanyTel: (4969) 247 5015-10Fax: (4969) 247 5015-20Email: [email protected]

HUNGARYTrade CommissionerEmbassy of Malaysia (Trade Section)Ground Floor, Museum AtriumDozsa Gyorgy ut 84/b1068 BudapestHungaryTel: (361) 461 0290Fax: (361) 461 0291E-mail: [email protected]

ITALYConsul and Trade CommissionerConsulate of Malaysia (CommercialService)5th FIoor, Via Vittor Pisani 3120124 MilanoItalyTel: (3902) 669 0501Fax: (3902) 670 2872E-mail: [email protected]

THE NETHERLANDSTrade CommissionerEmbassy of Malaysia (CommercialSection)Rustenburgweg 2 2517 KE The HagueThe NetherlandsTel: (31010) 462 7759Fax: (31010) 462 7349E-mail: [email protected]

RUSSIATrade CommissionerEmbassy of Malaysia (Trade Section)Mosfilmovskaya Ulitsa 50Moscow 117192Russian FederationTel: (7495) 147 1514/ 1523Fax: (7495) 143 6043E-mail: [email protected]

UKRAINEMarketing OfficerTrade Office (MATRADE)Embassy of MalaysiaNo. 25 Bulivska StreetPerchersk, Kiev 01014UkraineTel: (38044) 286 7128Fax: (38044) 286 8942Email: [email protected]

UNITED KINGDOMTrade CommissionerMalaysian Trade Commission(Commercial Section)3rd & 4th Floor, 17 Curzon StreetLondon W1J 5HRUnited KingdomTel: (4420) 7499 5255/4644Fax: (4420) 7499 4597E-mail: [email protected]

UZBEKISTANEmbassy of Malaysia28, Maryam Yakubova StreetYakkasaray District100 031 TashkentRepublic of Uzbekistan Tel: (99871) 256 6707Fax: (99871) 256 6909Email: [email protected]

WEST ASIA

SAUDI ARABIATrade CommissionerConsulate General of Malaysia(Commercial Section)14th Floor, Saudi Business CentreMadina RoadP.O.Box 20802Jeddah 21465Saudi ArabiaTel: (9662) 653 2143/ 98Fax: (9662) 653 0274E-mail: [email protected]

UNITED ARAB EMIRATESConsul General / Trade CommissionerConsulate General of MalaysiaMalaysia Trade CentreLot 1-3 Ground Floor & 6-10 Mezzanine FloorsAl-Safeena Building Near Lamcy PlazaZaabeel RoadP.O.Box 4598, DubaiUnited Arab EmiratesTel: (9714) 335 5528/38Fax: (9714) 335 2220E-mail: [email protected]

Useful Contacts 53

NORTH AMERICA

CANADATrade CommissionerConsulate of Malaysia (Trade Office)First Canadian PlaceSuite 3700100 King Street WestToronto, Ontario M5X 1E2CanadaTel: (1416) 504 6111Fax: (1416) 504 8315E-mail: [email protected]

LOS ANGELES, THE USATrade CommissionerConsulate General of Malaysia(Commercial Section)550 South Hope StreetSuite 400, Los Angeles, CA 90071United States of AmericaTel: (1213) 892 9034Fax: (1213) 955 9142E-mail: [email protected]

MIAMI, THE USADirectorMalaysia Trade Centre703 Waterford Way, Suite 150Miami, Florida 33126United States of AmericaE-mail: [email protected]: (1305) 267 8779Fax: (1305) 267 8784E-mail: [email protected]

NEW YORK, THE USATrade CommissionerConsulate General of Malaysia(Commercial Section)3rd Floor, 313 East, 43rd Street New York, NY 10017United States of AmericaTel: (1212) 682 0232Fax: (1212) 983 1987E-mail: [email protected]

SOUTH AMERICA

BRAZILTrade CommissionerEmbassy of Malaysia (CommercialSection)771, Alameda Santos, Suite 727th Floor, 01419-00141, Sao PauloBrazilTel: (5511) 3285 2966Fax: (5511) 3289 1595E-mail: [email protected]

CHILETrade CommissionerOficina Commercial de MalasiaEmbajada De Malasia AvdaTajamar 183Oficina 302, Las CondesSantiagoChileTel: (562) 234 2647Fax: (562) 234 2652E-mail: [email protected]

MEXICOTrade CommissionerEmbassy of Malaysia, Mexico CityPaseo de Las Palmas # 425Torre Optima 3, Office 1101 & 1102Col. Lomas de ChapultepecDel. Miguel Hidalgo, C.P.11000Mexico D.F.Tel: +5255 5201 4540Fax: +5255 5202 7338E-mail: [email protected]

ARGENTINAEmbassy of Malaysia Trade Office(MATRADE)Villanveva 1040C1426B MD Buenos AiresRepublic of ArgentinaTel: (54) 11 4776 0504 / 2553 /

(54) 11 4777 8420Fax: (54) 11 4776 0604E-mail: [email protected]

AFRICA

CAIRO, EGYPTTrade CommissionerEmbassy of Malaysia (Trade Section)17th Floor, North TowerNile City BuildingCornish El-Nil StreetCairoEgyptTel: (202) 461 9063/ 9064Fax: (202) 461 9065E-mail: [email protected]

KENYATrade CommissionerMalaysian Trade CommissionBlock 91/404, Gigiri,Groove, GigiriP.O. Box 4228600200 Nairobi KenyaTel: (25420) 712 0915Fax: (25420) 712 0916E-mail: [email protected]

SOUTH AFRICATrade CommissionerMalaysia Trade CommissionGround Floor, Building 5Commerce Square Office Park39, Rivonia Road, SandhurstSandton, JohannesburgSouth AfricaTel: (2711) 268 2380/ 2381Fax: (2711) 268 2382Email: [email protected]

54 Useful Contacts

JOHORDIRECTORMATRADE Southern Regional OfficeMalaysia External Trade DevelopmentCorporation (MATRADE)Suite 6B, Tingkat 6, Menara Ansar65, Jalan Trus, 80000 Johor Bahru,JohorTel: (607) 222 9400Fax: (607) 222 9500Email: [email protected]

PENANGMalaysia External Trade DevelopmentCorporation (MATRADE)1st Floor, FMM Building 2767, Mukim 1Lebuh Tenggiri 2, Bandar SeberangJaya13700 Seberang Perai Tengah, PulauPinangTel: (604) 398 2020Fax: (604) 298 2288Email: [email protected]

TERENGGANUDIRECTORMATRADE Eastern Regional OfficeMalaysia External Trade DevelopmentCorporation (MATRADE)Tingkat 5, Menara Yayasan IslamTerengganuJalan Sultan Omar, 20300 KualaTerengganu, TerengganuTel: (609) 624 4778Fax: (609) 624 0778Email: [email protected]

SARAWAKMalaysia External Trade DevelopmentCorporation (MATRADE)Tingkat 10, Menara Grand, Lot 42,Section 46Ban Hock Road, 93100 Kuching,SarawakTel: (6082) 246 780 / 248 780Fax: (6082) 256 780Email: [email protected]

SABAHMalaysia External Trade DevelopmentCorporation (MATRADE)Lot C5.2A, Tingkat 5, Block C,Bangunan KWSPJalan Karamunsing, 88100 KotaKinabalu, SabahTel: (6088) 240 881 / 242 881Fax: (6088) 243 881Email: [email protected]

MATRADE STATE OFFICES

Useful Contacts 55

MINISTRIES OF HEALTH MALAYSIABlock E1, E6, E7 & E10, Complex EFederal Government Administrative Centre62590 Putrajaya, MalaysiaTel: (603) 8883 3888 Fax: (603) 2274 7970Website: www.moh.gov.myE-mail: [email protected]

CLINICAL RESEARCH CENTRELevel 3, Dermatology Block,Kuala Lumpur Hospital,Jalan Pahang,50586, Kuala LumpurMalaysiaTel: (603) 26924249/(603) 26911486Fax: (603) 26911682Website:http://www.crc.gov.my

NATIONAL PHARMACEUTICALCONTROL BUREAU (NPCB)Ministry of Health MalaysiaLot 36, Jalan Universiti46200 Petaling JayaSelangorMalaysiaTel: (603) 78835400Fax: (603) 79562924Website:http://www.bpfk.gov.my

PHARMACEUTICAL SERVICESDIVISIONPharmacy Board of MalaysiaMinistry of Health MalaysiaLot 36, Jalan Universiti46350 Petaling JayaSelangorMalaysiaTel: (603) 78413200Fax: (603) 79682222Website: http://www.pharmacy.gov.my

POLICY AND INTERNATIONALRELATIONS DIVISIONMinistry of Health MalaysiaLevel 6, 8 & 11, Complex E, Precinct 1Federal Government AdministrativeCentre, 62590 PutrajayaMalaysiaTel: (603) 8883 2865Fax: (603) 8888 8692Website:http://korporat.moh.gov.my

RELEVANT DIVISIONS/AGENCIES

56 Useful Contacts

BANK NEGARA MALAYSIAJalan Dato’ Onn, P.O. Box 1092250929 Kuala LumpurMalaysiaTel: (603) 2698 8044Fax: (603) 2691 2990Website:www.bnm.gov.myE-mail: [email protected]

COMPANIES COMMISSION OFMALAYSIA (SSM)Menara [email protected], Jalan Stesen Sentral 5Kuala Lumpur Sentral50200 Kuala LumpurMalaysiaTel: (603) 2299 4400Fax: (603) 2299 4411Website:www.ssm.gov.myEmail: [email protected]

DEPARTMENT OFENVIRONMENTMinistry of Natural Resources and EnvironmentLevel 1-4, Podium 2&3, Wisma Sumber Asli, No.25, Persiaran Perdana, Precinct 4Federal Government Administrative Centre62574 PutrajayaMalaysiaTel: (603) 8871 2000/ 8871 2200Fax: (603) 8889 1973/75Website:www.doe.gov.myE-mail: [email protected]

DEPARTMENT OF INDUSTRIALRELATIONSLevel 9, Block D4, Complex DFederal Government Administrative Centre62530 PutrajayaMalaysiaTel: (603) 8871 1205Fax: (603) 8889 2355Website:www.mohr.gov.my/depart/jpp/E-mail: [email protected]

DEPARTMENT OF LABOUR Level 5, Block D3, Complex DFederal Government Administrative Centre62502 PutrajayaMalaysiaTel: (603) 8886 5192Fax: (603) 8889 2368Website:www.jtksm.mohr.gov.myE-mail: [email protected]

DEPARTMENT OFOCCUPATIONAL SAFETY AND HEALTHLevel 2, 3 and 4, Block D3, Complex DFederal Government Administrative Centre62530 PutrajayaMalaysiaTel: (603) 8886 5000Fax: (603) 8889 2443Website:www.dosh.gov.myE-mail: [email protected].

EMPLOYEES PROVIDENT FUNDKWSP BuildingJalan Raja Laut50350 Kuala LumpurMalaysiaTel: (603) 8922 6000Fax: (603) 8922 6222Website:www.kwsp.gov.myE-mail: [email protected]

HALAL INDUSTRYDEVELOPMENT CORPORATION (HDC)5.02, Level 5KPMG Tower, First AvenuePersiaran Bandar Utama 47800 Petaling JayaSelangor Darul Ehsan MalaysiaTel: (603) 7965-5555 Fax: (603) 7965-5500 Hotline: 1800-880-555 Website:www.hdcglobal.comE-mail: [email protected]

IMMIGRATION DEPARTMENTLevel 1 – 7(Podium)No.15, Persiaran Perdana, Precinct 2 Federal Government Administrative Centre62550 PutrajayaMalaysiaTolfree: 1800 22 6969Tel: (603) 8000 8000Fax: (603) 8880 1200Website:www.imi.gov.myE-mail: [email protected]

INLAND REVENUE BOARDMenara Hasil Persiaran Rimba PermaiCyber 8, 63000 CyberjayaSelangorMalaysiaTel: (603) 8313 8888Fax: (603) 8313 7801Website:www.hasil.gov.myEmail: [email protected]

INTELLECTUAL PROPERTY CORPORATION OF MALAYSIAUnit 1-7, Ground FloorMenara UOA BangsarNo.5, Jalan Bangsar Utama 159000 Kuala LumpurMalaysiaTel: (603) 2299 8400Fax: (603) 2299 8989Website:www.myipo.gov.myE-mail: [email protected]

MALAYSIA DEPARTMENT OFISLAMIC DEVELOPMENTLevel 4-9, Block D7, Complex D Federal Government AdministrativeCentre62519 PutrajayaMalaysiaTolfree: 1800 22 224Tel: (603) 8886 4000

(Halal Hub Division)Fax: (603) 8889 2031 Website:www.islam.gov.my

MALAYSIAN BIOTECHNOLOGY CORPORATION SDN BHDLevel 23, Menara Atlan161B Jalan Ampang50450 Kuala LumpurMalaysiaTel: (603) 2116 5588Fax: (603) 2116 5411Website:www.biotechcorp.com.myEmail: shamini.poovendran@

biotechcorp.com.my

MALAYSIAN INDUSTRIALDEVELOPMENT FINANCE BHD (MIDF)21st Floor, Menara MIDF82, Jalan Raja Chulan50200 Kuala LumpurMalaysiaTel: (603) 2173 8888Fax: (603) 2173 8877Website:www.midf.com.myE-mail: inquiry-feedback@

midf.com.my

OTHER RELEVANT ORGANISATIONS

Useful Contacts 57

MALAYSIAN ORGANISATION OFPHARMACEUTICALINDUSTRIES (MOPI)Global Business & Convention CentreMezzanine Floor, Block A No 8, Jalan 19/1, Section 1946300 Petaling Jaya, SelangorMalaysiaTel: (603) 7931 9003 Fax: (603) 7932 2736 Website:www. mopi.org.myE-mail: [email protected]

MALAYSIAN TECHNOLOGYDEVELOPMENT CORPORATION SDN BHD(MTDC)Menara Yayasan Tun RazakLevel 8-9, Jalan Bukit Bintang55100 Kuala LumpurMalaysiaTel: (603) 2172 6000Fax: (603) 2163 7549Website:www.mtdc.com.myE-mail: [email protected]

MALAYSIAN INDUSTRY-GOVERNMENTGROUP FOR HIGHTECHNOLOGY (MIGHT)Block 3517, Jalan Teknokrat 563000 CyberjayaSelangorMalaysiaTel: (603) 8315 7888Fax: (603) 8312 0300Website:www.might.org.myE-mail: [email protected]

ROYAL CUSTOMS MALAYSIALevel 7 North, Ministry of Finance ComplexPrecinct 2No.3 Persiaran PerdanaFederal GovernmentAdministrative Centre62592 PutrajayaMalaysiaTel: (603) 8882 2300/2500/2100Fax: (603) 8889 5901Website:www.customs.gov.myE-mail: [email protected]

SME CORP MALAYSIALevel 6, SME 1, Block BLot E, Jalan Stesen Sentral 2Kuala Lumpur Sentral50470 Kuala LumpurMalaysiaTel: (603) 2775 6000Fax: (603) 2775 6001Infoline: 1-300-88-1801Website:www.smecorp.gov.myE-mail: [email protected]

SME BANKMenara SME BankJalan Sultan Ismail P.O.Box 1235250774 Kuala LumpurMalaysia Tel: (603) 2615 2020/ 2828Fax: (603) 2692 8520/ 2698 1748Website:www.smebank.com.myE-mail: customercare@

smebank.com.my

TELEKOM MALAYSIA BERHADLevel 51, North Wing, Menara TMOff Jalan Pantai Baru50672 Kuala LumpurMalaysiaTel: (603) 2240 1221Fax: (603) 2283 2415Website:www.tm.com.myE-mail: [email protected]

TENAGA NASIONAL BERHAD129, Jalan Bangsar59200 Kuala LumpurMalaysiaTel: (603) 2296 5566Fax: (603) 2283 3686Website:www.tnb.com.myE-mail: [email protected]

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