Published by:
Malaysian Investment Development Authority
MIDA Sentral, No.5, Jalan Stesen Sentral 5
50470 Kuala Lumpur, Malaysia
Tel:
(603) 2267 3633
Fax:
(603) 2274 7970
Website: www.mida.gov.my
E-mail:
investmalaysia@mida.gov.my
Kuala Lumpur
Malaysia
Your Profit Centre in Asia
www.mida.gov.my
Preface
This guidebook for the pharmaceutical
industry in Mal aysia ser ves as an
important so urce of inf ormat ion f or
investors i ntending to invest in t his
i n d u s t r y. I t a l s o s p e l l s o u t t h e
procedures and requirements f or the
va rious appli cati ons for li cences and
permits for the setting up of a business
in the pharmaceutical industry.
The Malaysian Investment Development
Authority (MIDA) is the Gover nment's
principal agency under the Ministry of
International Trade and Industry (MITI)
responsi ble for the promot i on and
coordination of industrial development
in Malaysia. MIDA assists companies
which intend to invest in the
manufacturing and services sectors in
the country. MIDA has a global network
of 24 overseas offices covering North
America, Europe, Asia Pacific and Africa
to assist i nvesto rs. W it hin Malaysia,
MIDA has 12 branch offi ces in the
various states to facilitate investors in
the i mpl ementat ion and oper ation of
their projects.
For more inform ati on on i nvest ment
opportunities in Malaysia and contact
details of MIDA, visit www.mida.gov.my.
Published by
Contents
Fact Sheet of Malaysia
- Background of Malaysia
- Key Economic Indicators
2
Healthcare in Malaysia
- The Pharmaceutical Industry in Malaysia
- Investment Opportunities
- Infrastructure Support
- Intellectual Property (IP) Protection
3
Why Malaysia
12
Getting Started in Malaysia
- Starting a Business
- Taxation
- Approval of Manufacturing Projects
- Approval of Expatriate Posts
13
Incentives for Investment
- 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
18
Regulatory Control in the Pharmaceutical Industry
- 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
21
Useful Contacts
- MIDA Overseas Offices
- MIDA State Offices
- MITI Overseas Offices
- MATRADE Overseas Offices
- MATRADE State Offices
- Ministry of Health and Relevant Division/Agencies
45
2
Fact Sheet of Malaysia
Background of Malaysia
Malaysia covers an area of about 330,252 square kilometres, consisting of
13 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 Kuala
Lumpur, Putrajaya and Labuan. Kuala Lumpur is the capital of Malaysia.
Malaysia lies entirely in the equatorial zone and the average daily
temperature throughout Malaysia varies from 21°C to 32°C.
Malaysia is a multi-ethnic country. The principal ethnic groups are Malays,
followed by Chinese and Indians. Other significant groups are the
indigenous people of Sarawak and Sabah, including the Dayaks, Kadazans,
Bajaus, Melanaus and Muruts.
Major exports of Malaysia are manufactured goods such as electrical and
electronics products, machinery and appliances, chemicals, plastic
products, iron, steel and metal products, and petroleum-based products.
In the year 2010, the share of exports of manufactured goods to total
exports is 72%. Imports comprise mainly intermediate goods such as
primary and processed industrial supplies, thermionic valves and tubes,
parts and accessories of capital goods, primary and processed fuel
lubricants, and parts and accessories for transport equipment.
PERLIS
PE
E L
ERL
LI
KED
AH
KEDAH
PULAU
PULA
U PINANG
PIN
IN
NAN
NG
N
G
KELANTAN
KE
KELANT
K
AN
N
SABAH
SAB
AH
PERAK
TERENGGANU
RENGGANU
E
SELANGOR
SELANG
GOR
G
KUALA LUMPUR
PU
P
AHANG
N
PAHANG
NEGERI
N
RI
SEMBILAN
S
N
MELAKA
MEL
EL A
ELAKA
SARAWAK
SARA
WAK
JOHOR
Key Economic Indicators
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
f: forecast
Sources: Economic Report 2012/13
Exchange rate: USD1 = RM3.09 (as at January 2013)
Healthcare in Malaysia
Healthcare in Malaysia
Malaysia’s primary care model has been acknowledged by the World Health
Organisation as a viable system to achieve “Health for All”. The demand for
quality healthcare continues to rise in Malaysia with increasing affluence and
rising consumer awareness. Currently, about 7.25% of the country’s GDP is
expected to be spent on healthcare. This is expected to increase with the
growing population and a longer life expectancy, as well as the Government’s
increasing expenditures on provision of better healthcare facilities and services.
Healthcare remains a priority of the Malaysian Government. For 2012, the
Government had increased the budget allocation for healthcare to RM16.87
billion. A total RM1.87 billion for the budget will be spent on healthcare
development to enhance health facilities and provide medical equipment,
increase supply of medicines, develop human resources, intensify research and
enforcement activities, as well as to build more hospitals, clinics and quarters.
Demographics - 2011
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*
* Provisional/Preliminary data (as of 2010)
Health Facts
Number of registered doctors (Government & Private)
Population per doctor
Number of hospitals
Number of clinics
Number of beds
Number of dental chairs
36,607
791
366*
11,212**
55,923
486***
* Includes Government hospitals, special medical institutions, non-MOH Government hospitals
& private hospitals.
** Includes MOH dental clinics, MOH mobile dental clinics (including mobile and pre-school
team); 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)
3
4
Healthcare in Malaysia
The Pharmaceutical Industry in Malaysia
The pharmaceutical industry is one of the new growth areas targeted for
promotion and development by the Government. The products manufactured
by the Malaysian pharmaceutical industry are broadly categorised into four
categories, i.e prescription medicines, over-the-counter (OTC) products,
traditional medicines and health/food supplements. The pharmaceutical
companies are mainly small and medium-sized companies engaged in the
production of generic drugs, traditional medicines and herbal supplements as
well as contract manufacturing for foreign multinational corporations (MNCs).
According to the Drug Control Authority (DCA) of
the Ministry of Health, as of October 2012, there
are 259 manufacturing companies licenced by
DCA comprising 182 traditional medicine
companies, 75 pharmaceutical companies and
3 veterinary product companies.
Among the major local companies are
Pharmaniaga Manufacturing Berhad, Hovid
Berhad, CCM Duopharma Biotech Sdn Bhd, and
Kotra Pharma (M) Sdn Bhd. These companies
focus mainly on generic drugs, particularly
a n t i b i o t i c s , p a i n k i l l e r s , h e a l t h supplements
and injectables. Some of the foreign-owned
companies with manufacturing presence in the
country include Y.S.P. Industries (M) Sdn Bhd
(Taiwan), Sterling Drug (M) Sdn Bhd (the
manufacturing arm of GlaxoSmithKline from UK),
Ranbaxy (M) Sdn Bhd (India), Xepa-Soul
Pattinson (M) Sdn Bhd (Singapore) and SM
Pharmaceutical Sdn Bhd (India).
The large MNCs such as Pfizer, Schering Plough, Novartis, Eli Lilly, Astra
Zeneca are mainly licenced importers. Their products, which are mostly
branded drugs, are distributed by locally incorporated companies.
The Malaysian pharmaceutical industry has the capability to produce almost all
dosage forms, including sterile preparations such as eye preparations,
injections, soft gelatine capsules and time release medications. In January
2002, Malaysia was admitted as the 26 t h member of the Pharmaceutical
Inspection Cooperation/Scheme (PIC/S)*. This would facilitate exports of
Malaysian pharmaceutical products to the member countries which include EU,
Australia and Canada.
* The PIC/S provides an active and constructive co-operation in the field of Good
Manufacturing Practice(GMP) between countries and pharmaceutical inspection authorities.
It leads the international development, implementation and maintenance of harmonised GMP
Standards and Quality System of Inspectorates in the field of medical products.
Healthcare in Malaysia
Investment Opportunities
Biopharmaceuticals / Biogenerics (Biosimilars)
The potential expansion of biosimilars is expected to have a major implication
on the biopharmaceutical industry. The impact of biosimilars on the
biopharmaceutical industry is expected to be similar if not greater than the impact
of generics on the pharmaceutical industry. Currently biopharmaceuticals are
considerably more expensive than conventional medications. However, Malaysia
offers a more competitive cost option to investors due to the available ecosystem.
A large number of first generation biopharmaceutical products are nearing maturity
and major biopharmaceutical companies are likely to move these out to countries
like Malaysia that offer a good value preposition.
Currently, in Malaysia, local and foreign players are
already engaged in activities like biopharmaceutical APIs,
FDA / EMEA cGMP compliant services, specialising in
monoclonal antibodies and recombinant proteins. In
addition, specialised research, development and
commercialisation of biopharmaceutical products is ongoing. The government is further encouraging potential
investors to move up the value-chain.
Contract Manufacturing
The current trend among the major global drug companies is to outsource their
manufacturing operations to enable them to concentrate on time consuming and
costly `gene hunting’ methods of R&D for new drug discovery. The pharmaceutical
industry in Malaysia could capitalise on this development by manufacturing generic
and patented products of these companies on contract basis. A number of local
companies are keen to provide contract manufacturing services to interested parties.
Generic Drugs
Foreign pharmaceutical companies are encouraged to set up facilities in
Malaysia to manufacture off-patented drugs.
Herbal Medicines
Foreign pharmaceutical companies could enter into collaborations with local
companies 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 manufacturing of local
pharmaceuticals as well as for export.
Other higher value-added products and services
The products include innovator drugs, vaccines, biopharmaceuticals, inhalation
products drug discovery activities or new chemical entity (NCE) and novel
delivery systems.
5
6
Healthcare in Malaysia
Infrastructure Support
Efficient Logistics
and Well-Developed
Infrastructure
The
prime
advantage
to
manufacturers in Malaysia has
been and continues to be the
nation's persistent drive to
develop
and
infrastructure.
upgrade
its
Integrated
logistics 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 Industrial
Estates and Specialised
Parks
Industries in Malaysia are mainly
located in over 200 industrial
estates or parks and 13 Free
Industrial Zones (FIZs) developed throughout the country. FIZs are export
processing zones which have been developed to cater to the needs of exportoriented 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 available, companies can set up Licenced Manufacturing
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 Jalil, Kuala Lumpur
and the Kulim Hi-Tech Park in the norther n state of Kedah. These parks
comprise state-of-the-art buildings with specific functions and fully-integrated
high technology park.
Healthcare in Malaysia
Perlis
Kulim Hi-Tech
Park
Penang
Kedah
Perak
Technology
Park Malaysia
Kelantan
Sabah
Terengganu
Pahang
M A L AY S I A
Selangor
Kuala Lumpur
N. Sembilan
Melaka
Enstek
Johor
Sarawak
Nusajaya
Other specialised parks developed by the Malaysian Government agencies are
as follows:
Bio-XCell Malaysia
Bio-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 amenities such auditorium,
business centre, training facilities, Food & Beverage and retail outlets.
Central Utilities Facility: Providing utilities for biomanufacturing such as
industrial steam, chilled water and waste water treatment service to clients
on a user pays basis.
For further information on Bio-XCell,
visit www.bio-xcell.my
7
8
Healthcare in Malaysia
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 Park
Penang 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.
For further information on
Penang 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
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).
Healthcare in Malaysia
The KHTP is conceived and developed as one of the national strategies of
Vision 2020 for Malaysia to become a fully-industrialised 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
fields
of
advanced
electronics,
mechanical
electronics,
telecommunications, 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
critical
advisory
and
promotion
For further information on
Kulim Hi – Tech Park, visit
www.khtp.com.my
support.
Enstek
PAHANG
techpark@enstek
SELANGOR
is
currently
the
technology park with the highest number
NEGERI
SEMBILAN
of Biotechnology and Medical Industrial
MELAKA
Companies in Malaysia.
JOHOR
ENSTEK Technology Park
Located within the township of Bandar
Enstek, techpark@enstek is just 10 minute
away from Kuala Lumpur Inter national
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.
9
10
Healthcare in Malaysia
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
industries. It is also endowed with
For further information on
Enstek, visit
ready infrastructure and amenities
www.techpark.enstek.com
and information technology (ICT)
to support such sectors.
Availability of Clinical Trials and Bioequivalence Centres
The Clinical Research Centre (CRC), comprising a network of 17 centres around
the country, acts as a one-stop-centre by providing a single point of contact to
access all Ministry of Health hospitals and clinics to conduct clinical trials in
Malaysia. These clinical trial centres have linkages to more than 50 general and
district hospitals, and more than 100 health clinics as potential sites for clinical
trials with access to 550 clinical investigators and 17 million patients from
diverse 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
Healthcare in Malaysia
Intellectual Property (IP) Protection
Malaysia has strong IP protection in place and is committed to safeguarding IP
on inventions. To ensure IP protection in Malaysia is in line with international
standards and provides protection for both local and foreign investors, Malaysia
is 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
IP in Malaysia comprises:
• Patents
• Trade Marks
• Industrial Designs
• Copyrights
• Geographical Indications
• IC Layout Designs
For further information
on IP protection in
Malaysia, visit
www.myipo.gov.my
11
12
Why Malaysia
“Why Malaysia”
Supportive Government Policies
• Pro-business policies
• Responsive government
Vibrant Business Environment
• Market-oriented economy
• Well-developed financial and banking
• Liberal investment policies
s e c t o r, i n c l u d i n g t h e L a b u a n
• Attractive tax and other incentives
International Financial Exchange
• Liberal exchange control regime
• Intellectual property protection
• Wide use of English, especially in
business Legal and accounting
practice based on the British system
• Large local business community with
a long history in international
An Educated Workforce
• Talented, young, educated and
productive workforce
• Multilingual workforce speaking two
or three languages, including English
• Comprehensive system of vocational
and industrial training, including
advanced skills training.
business links
• Large foreign business community in
all business sectors
• Extensive trade links - country's total
trade was valued at RM1.31 trillion
(2012)
• Harmonious industrial relations with
minimal trade disputes
Quality of Life
• Friendly and hospitable Malaysians
• Safe and comfortable living
Developed Infrastructure
• Network of well-maintained highways
and railways
• Well-equipped seaports and airports
• High quality telecommunications
network and services
• Fully developed industrial parks,
environment
• Excellent housing, modern amenities,
good healthcare and medical
facilities
• Excellent educational institutions
including international schools for
expatriate children
including free industrial zones,
technology parks and Multimedia
Super Corridor (MSC)
• Advanced MSC Malaysia Cybercities
and Cybercentres
• World-class recreational and sports
facilities
• Excellent shopping with goods from
all over the world
Getting Started in Malaysia
Getting Started in Malaysia
Starting a Business
In general, the overall cost of doing business in Malaysia is competitive. In
Malaysia, the process is facilitated by experienced and reputable agencies that
exist both within and outside the Federal and local governments. For starting
a business in Malaysia, the main fees which need to be paid are fees to the
Companies Commission of Malaysia (SSM) and fees for company secretarial
services.
Main fees to be paid to the Companies Commission of Malaysia
Reservation of a name
RM
USD
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
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 rental
rates for prime office space, cost of industrial land, cost of ready-built factory
and average construction costs of factory building. The costs will depend on
the business location selected by the investors. For example, if it is in Kuala
L u m p u r, t h e r e n t a l r a t e f o r
p r i m e office space is in the
For more details on these costs,
range of RM64.60 - RM102.25
visit www.mida.gov.my
(USD20.77 – USD32.88)/square
metre/month.
13
14
Getting Started in Malaysia
Registration of Business/
Incorporation of Company
Companies Commission of
Malaysia (SSM)
www.ssm.com.my
• Sole proprietorships
• Partnerships
• Company
Application for Manufacturing
Licences and/or Tax Incentives
Malaysian Investment
Development Authority (MIDA)
www.mida.gov.my
Application for Other Approvals and Permits
Approvals at the Level of State
Governments and Local
Authorities
Approvals at the Level of
Federal Ministries /
Departments / Agencies
• Acquire land and premise
(Industrial land /Premise /
Factory Approval)
• No Objection Letter (NOL) for
location of projects
• Planning Permits
• Building Plans
• Certificate of Fitness (CF)
• Business Licence
• Good Manufacturing Practice
(GMP) & Registration of
Products from National
Pharmaceutical Control
Bureau (NPCB),
Ministry of Health
(www.bpfk.gov.my)
• Department of Occupational
Safety and Health
(www.dosh.gov.my)
• Fire and Rescue Department
(www.bomba.gov.my)
• Department of Environment
(www.doe.gov.my)
Utilities
Immigration
• 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)
• Expatriates - MIDA (www.mida.gov.my) or
Immigration Department (www.imi.gov.my)
• Foreign Workers - Immigration Department
(www.imi.gov.my)
Getting Started in Malaysia
Taxation
Generally, all income of companies and individuals accrued in or derived from
sources outside Malaysia and received in Malaysia is liable to tax. However,
effective from the year of assessment 2004 income remitted to Malaysia by
resident companies (other than companies carrying on the business of banking,
insurance, air and sea transportation), resident individuals, non-resident
companies and non-resident individuals are exempted from tax.
Income tax in Malaysia is assessed on income earned in the current year. The
self-assessment system was implemented for companies, sole proprietors,
partnerships, cooperatives and salaried groups to streamline the tax
administration system.
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 period
for a year of assessment
• on the first RM500,000 (USD162,337.67) chargeable income
• on subsequent chargeable income
20%
25%
Personal Income Tax
Resident individuals with chargeable income of RM16,667
(USD5,411.36) and above per annum (after deduction of personal reliefs)
Non-resident individuals (not entitled to any personal reliefs)
1%-26%
26%
Withholding Tax (Non-resident persons)
Special classes of income (use of moveable property, technical
services, installation services on the supply of plant and machinery, etc.)
Interest
Royalty
Contract payment on:
- account of contractor
- account of employee
Other income such as commission, guarantee fees,
agency fees, brokerage fees, introducers fees etc.
Source: Inland Revenue Board – www.hasil.org.my
USD1 = RM3.08 (As at January 2013)
10%
15%
10%
10%
3%
10%
15
16
Getting Started in Malaysia
Sales Tax
5%-10%
Sales tax is imposed on certain imported and locally manufactured
goods under the Sales Tax Act, 1972. The tax rate ranges from 5 - 10%
for majority of the goods except for food preparations other than
alcoholic and non-alcoholic compound preparations (other than those
of heading No. 33.02) used for making beverages which falls under the
tariff code 2106.90.490 with a tax rate of 20%. Sales tax is also imposed
on petroleum and petroleum products according to specific rates.
Service Tax
Service tax is imposed on taxable services provided by taxable persons
under the Service Tax Act, 1975. Services include services provided by
professionals (such as lawyers, engineers, architects, surveyors,
consultants), advertising firms, private hospitals, insurance companies,
communication companies, hotels and restaurants.
6%
Source: Royal Malaysian Customs - www.customs.gov.my
Rates of Capital Allowances
Capital allowances are given on qualifying capital expenditure. Initial
allowances are given only once while annual allowances are given every year
by the straightline method. Some of the items accorded allowances are shown
below. For plant and machinery, companies are advised to verify with the
Inland 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: Inland Revenue Board - www.hasil.org.my
Getting Started in Malaysia
Approval of Manufacturing Projects
The Industrial Co-ordination Act 1975 (ICA) requires companies manufacturing
pharmaceutical products with shareholders' funds of RM2.5 million and above
or engaging 75 or more full-time paid employees to apply for a manufacturing
licence 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 creating a safe investment environment has
convinced more than 4,000 international companies from over 50 countries
to make Malaysia their offshore base.
A company whose equity participation has been approved will not be required to
restructure its equity at any time as long as the company continues to comply
with 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 a
shortage 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 by
foreigners. The current guidelines on the employment of expatriate personnel for
manufacturing 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.
17
18
Incentives for Investment
Incentives for Investment
The manufacturer of pharmaceuticals and related product is categorised as “promoted
activities” or “promoted products”. The list of promoted activities and products is
available 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 for
a period of 5 years, or
• Investment Tax Allowance (ITA) of 60% or 100% on qualifying capital expenditure
incurred for a period of 5 years, or
• Reinvestment Allowance (RA) of 60% on qualifying capital expenditure (to be offset
against 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% of
statutory 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
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% of
statutory income
In-house Research
Investment Tax Allowance of 50% on qualifying capital expenditure for 10 years to be
offset 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 its
related companies in Malaysia will not be taxed during its tax-exempt period, provided
such income does not exceed 20% of its overall income derived by providing qualifying
services
• Expatriates working in OHQ companies are taxed only on the portion of their
chargeable 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 of
shareholders
• Expatriates working in IPC/RDC companies are taxed only on the portion of their
chargeable income attributable to the number of days that they are in Malaysia
19
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 incentives
for investment, visit
www.mida.gov.my
21
REGULATORY CONTROL IN
THE PHARMACEUTICAL INDUSTRY
22
Regulatory Control in Pharmaceutical Industry
Regulatory Agency
National Pharmaceutical Control Bureau (NPCB)
The regulatory control of pharmaceutical products and traditional medicines in
Malaysia is carried out by the National Pharmaceutical Control Bureau (NPCB),
an institution under the Pharmaceutical Services Division (PSD) Ministry of
Health, which ensures the quality, efficacy and safety of pharmaceutical
products as well as the quality and safety of traditional medicines and
cosmetics 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 pharmaceutical
products. The infrastructure and facilities were designed to meet the
requirements 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 traditional
medicines as well as the notification of cosmetic products under the Control of
Drug and Cosmetics Regulations 1984.
The introduction of these regulations in June 1984 was an important milestone
in the history of drug regulatory activities in Malaysia as it provides for the
establishment of the Drug Control Authority (DCA) to regulate the
pharmaceutical industry. The DCA, an executive committee which is responsible
for product registration and licensing of manufacturers, importers and
wholesalers was established in 1985, whereby the NPCB functions as the
operational arm and the secretariat to the DCA.
Regulatory Control in Pharmaceutical Industry
Since 1985, the NPCB has been given the task of ensuring the quality, efficacy
and safety of pharmaceuticals through the registration and licensing scheme.
This is achieved through evaluation of scientific data and laboratory tests on all
products before they are marketed. A system to monitor products in the market
was also setup. In addition, the Adverse Drug Reactions (ADR) monitoring
program was launched in Malaysia in 1987 to carry out pharmacovigilance
activities. Under the surveillance program, registered products are routinely
sampled to ensure compliance with regulatory requirements.
Under the ASEAN Technical Co-operation among Developing Countries (ASEAN
TCDC) Program, the NPCB has been chosen and recognised by the ASEAN
countries as the regional training centre for quality control of pharmaceuticals. NPCB
has been the host for various training programs in quality control and has
successfully conducted such trainings since 1986. In addition, the NPCB has also
been receiving trainees from ASEAN countries as well as various other countries.
In view of the technical expertise and training capabilities of NPCB, it received
the recognition as a "WHO Collaborating Centre in the Regulatory Control of
Pharmaceuticals" on 10th May 1996. As a WHO Collaborating Centre for
Regulatory Control of Pharmaceuticals, the NPCB will continue to provide
training in pharmaceutical quality assurance and regulatory affairs to fellows
from other countries. Due to its commitment and technical expertise, this
institution is redesigned as WHO collaborating centre effective 1st August 2011
for a period of 4 years.
In Addition, the NPCB successfully gained accession as the 26th member of
the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January
2002. Since then, NPCB has been activety involved in Inter national Good
Manufacturing Practice (GMP) and Quality Assurance programmes.
Drug Control Authority (DCA)
The Drug Control Authority (DCA) is the executive body established under the
Control of Drugs and Cosmetics Regulations 1984. The main task of this
Authority is to ensure the safety, quality and efficacy of pharmaceuticals,
traditional medicines, health supplements, veterinary products and personal
care products that are marketed in Malaysia.
This objective is being achieved through the following:
• Registration of pharmaceutical products, natural products (traditional
medicines) and veterinary products
• Licensing of premises for importers, manufacturers and wholesalers
• Monitoring the quality of registered products in the market
• Adverse Drug Reaction Monitoring
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24
Regulatory Control in Pharmaceutical Industry
NA
NATIONAL
ATIONAL PHARMACEUTICAL
PHA
CONTROL BUREAU
MINISTR
Y OF HEALTH
TH MALAYSIA
Y
YSIA
MINISTRY
HEAL
LTH
MALA
AYSIA
DIRECTOR OF REGULA
REGULATORY
ATOR
TORY PHARMACY
CENTRE FOR PRODUCT
REGISTRATION
REGISTRA
STRA
ATION
CENTRE FOR
REGISTRATION
POST REGISTRA
ATION
TION
CENTRE FOR
COMPLIANCE &
LICENSING
Therapeutic
Medical Section
Pharmacovigilance
Section
GMP Section
(Pharmaceutical)
eterinary
Veterinary
V
ete
e
Medicine Section
Surveilance and
Pr
oduct Complaints
Product
Section
GMP Section
(Complementary)
Active Pharmaceutical
Ingredient
Ingredient (API)
Section
Cosmetics
Section
Licensing and
Certification Section
Regulatory
Coordination
Coor
dination Section
Variations
V
ariations
Section
GDP Section
CENTRE FOR
ORGANISA
ATIONAL
ORGANISATIONAL
DEVELOPMENT
Quality and Industrial
Development Section
Biologics and
Complementary
Section
CENTRE FOR
QUALITY CONTROL
Information
Communication
Technology
T
echnology Section
CENTRE FOR
ADMINISTRA
ATION
T
ADMINISTRATION
Interr
elations and
Interrelations
Policy Section
Finance Unit
Natural Pr
oducts
Products
esting Section
T
Testing
Human Resour
ce and
Resource
Coordination
Quality Coor
dination
Section
Development Unit
Pharmaceutical
Chemistry
stry Testing
Testing
Section
CENTRE FOR
INVESTIGA
INVESTIGATIONAL
ATIONAL
NEW PRODUCT
Administration Unit
Research and
Research
Development
Section
Investigational
Pr
Product
oduct Evaluation
Section
Asset Management/
Store Unit
Store
Laboratory
Services Section
Investigational
Product
Pr
oduct Safety
Monitoring Section
Standar
Standards
ds and
Quality Section
GCP Compiance
Section
Bio-Pharmaceutical
Testing
Testing Section
GLP Compliance
Section
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 of
Drugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984.
Although the legal requirements of other related legislations have been
included, applicants are reminded that it is their responsibility to ensure that
their 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’ as
defined in the Regulations, means a ‘drug’ in a dosage unit or otherwise, for
use wholly or mainly by being administered to one or more human beings or
animals for a medicinal purpose. Under the Sale of Drugs Act 1952, ‘drug’
includes any substance, product or article intended to be used or capable, or
purported or claimed to be capable of being used on humans or any animal,
whether internally or externally for a medicinal purpose used in humans (and
animals).
Drug Registration
• R e g u l a t i o n 7 ( 1 ) ( a ) o f t h e C o n t ro l o f D r u g s a n d C o s m e t i c s 1 9 8 4
(Amendment 2006) requires all products to be registered with the DCA
prior to being manufactured, sold, supplied, imported or prossessed or
administered, unless the product is exempted under specific provision of
the Regulations.
• Any drug in a pharmaceutical dosage form intended to be used, or
capable or purported or claimed to be capable of being used on humans
or any animals, whether internally or externally for a medical purposes is
required to be registered with the DCA.
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26
Regulatory Control in Pharmaceutical Industry
• Medicinal purpose means any of the following purposes:
- Alleviating, treating, curing or preventing 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 defined under Food Act 1983 and Food Regulations 1985,
includes every article manufactured, sold or represented for use as food or
drink 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 specific disease, disorder or medical condition,
and food which contain quantities of added nutrients allowable under the
Food Act and Regulations).
- Cosmetics, (in conformance with the harmonisation of cosmetic regulations
in the ASEAN region and in compliance to the ASEAN Cosmetic Directive,
cosmetics are regulated via the notification process starting 1 January
2008).
• Products which are not registered with the DCA and are intended to be
imported for the purpose of clinical trial shall have a Clinical Trial Import
Licence (CTIL).
• Products which are not registered with the DCA and are intended to be
manufactured locally for the purpose of clinical trial should apply for
exemption by the DCA (Clinical Trial Exemption) from Director of
Pharmaceutical Services.
• Any person who wishes to manufacture any product solely for the purpose of
producing a sample for the sole purpose of registration should apply for an
exemption for manufacture of sample (Applies to locally manufactured
products only).
Regulatory Control in Pharmaceutical Industry
New Application Processing Procedures
A
Application Type
Application 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)
B
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.
C
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 only
iii. 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.
27
28
Regulatory Control in Pharmaceutical Industry
Application Formalities
The DCA only accepts applications which are being submitted through webbased online system at http://www.bpfk.gov.my. The applicant for product
registration must be registered with Malaysian Registrar of Business (ROB) or
Companies Commission of Malaysia (SSM). The applicant, (if the said company
is not the product owner) should be authorised in writing by the product owner
to be the holder of the product registration certificate and be responsible for
all 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.
Regulatory Control in Pharmaceutical Industry
b. Application Fee
Every application for registration shall incur a processing fee:
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)
* The DCA will charge the applicant such costs as it may incur for the purpose of carrying out
laboratory investigation relating to the registration of any product. (Any payment made is not
refundable once an application has been submitted and payment confirmed)
29
30
Regulatory Control in Pharmaceutical Industry
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 well
as 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 be
on the product owner’s original letterhead and be dated and signed by the
Managing Director, President, CEO or an equivalent person who has overall
responsibility for the company or organisation
iii) The letters should state the name of the product concerned, name and
actual plant address of the manufacturer(s) involved in the manufacture of
the product.
iv) Imported products will also need to be accompanied with either:
• Certificate of Pharmaceutical Product (CPP) from the competent authority
in the country of origin; OR
• Certification for Free Sales (CFS) and Good Manufacturing Practice (GMP)
from the relevant authorities for traditional medicines and dietary
supplements
For more information, please refer
to the ‘Drug Registration Guidance
Document’ in the NPCB’s website
at www.bpfk.gov.my
Regulatory Control in Pharmaceutical Industry
Application Process
a. Initiation of Review
Review of applications will follow a queue system. There will be separate
queues 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:
Full Evaluation
Timeline
Prescription Drugs (Poison)
210 working days
Non-prescription (Non-poison) Drugs
210 working days
NCE
245 working days
Abridged Evaluation
Health Supplement Products
Natural Products (Traditional)
Cosmetic Products (Notification Note)
Timeline
- Single active ingredient:
60 working days
- 2 or more active ingredients:
80 working days
• The time frame for each product is calculated from the date of final and
complete submission.
• Priority review may be granted where the product is intended for treatment
of a serious or life-threatening disease (where the likelihood of death is
high unless the course of the disease is interrupted).
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Regulatory Control in Pharmaceutical Industry
Regulatory Outcome
a. Decisions of the DCA
An application may be approved or rejected and the DCA decision will be sent
via e-mail to the marketing authorisation holder.
b. Product Registration Number
• A Registration Number, which is specific for the product registered, will be
given via e-mail when an application is approved by the DCA. Registration
is valid for a period of 5 years.
• Product Notification Number will be given to a cosmetic product after the
notification process.
c. Rejection, Cancellation, Suspension of Registration
The DCA may reject, cancel or suspend the registration of any product if
there are deficiencies in safety, quality or efficacy of the product or failure to
comply with conditions of registration.
d. Appeal against DCA decisions
Any applicant aggrieved by the decisions of the DCA may make a written appeal
to the Minister of Health. Appeals MUST be made within fourteen days from the
date of the DCA notification. A period of 180 days from the date of appeal is
given for submission of any supporting data or documents for NCE and
biotechnology products and 90 days for other products. The appeal is closed
if 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.
Regulatory Control in Pharmaceutical Industry
Registration Maintenance
a. Conditions for Registration
The affixing of the security device, one of the conditions for product registration,
to product labelling has been identified as a means to verify and authenticate
that the product has been duly registered with the DCA.
The DCA may specify certain conditions for registration for a particular group,
amend any conditions for registration and may lay down specific product
labelling requirements.
The DCA may cancel the
registration of any product if
the conditions for registration
are not complied with.
For information on product conditions
f o r re g i s t r a t i o n , p l e a s e re f e r t o
Appendices 1, 1.1, 2 & 3 of the Drug
Registration Guidance Document from
www.bpfk.gov.my.
b. Validity Period
The registration of a product is valid for 5 years or such period as specified in
the registration certificate.
For cosmetic products, the Notification Note is valid for 2 years or such period
as specified in the Notification Note.
Renewal of product registration should be done six months prior to the expiry
of the validity period of product registration. Upon expiry of the validity period
of registration, the module for renewal of product registration will no longer
be accessible and application for re-registration of the product can no longer
be submitted.
c. Change In Particulars of Registered Products
Changes in particulars of a Registered product require DCA approval. Changes
refer to any changes in product name, product specifications, 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, solvent
in film coating, etc to improve product formulation requires prior approval of
the DCA.
• Explanation/reason for the changes should be given. All relevant supporting
data related to the above changes should be updated accordingly.
• The registration of a product may be cancelled if changes are made without
prior approval of the DCA.
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Regulatory Control in Pharmaceutical Industry
• The marketing authorisation holder must
ensure that all the necessary validation has
been conducted to demonstrate that the
change does not reduce the quality, safety or
efficacy of the product and submit all
necessary documents.
For more information,
please refer to Appendix 4
of Drug Registration
Guidance Document from
www.bpfk.gov.my
d. Reporting Problems with Registered Products
i. Adverse Drug Reactions (ADR)
• All market authorisation holders (MAH) must ensure that an appropriate
system of pharmacovigilance is in place in the company order to accent
responsibility and liability for its products on the market and ensure that
appropriate action can be taken, when neccessary.
• MAH sould inform the pharmacovigilance section of National
Pharmaceutical Control Bureau, in writing of all matters pertaining to
the safety of the products.
• All report of adverse reaction associated in the use of registered product
occuring in Malaysia must be reported to the NPCB within the stimulated
timeline.
• MAH who have registered a product containing new chemical entity must
routinely submit periodic safety updates reports (PSUR) on that product
6 monthly for the first 2 years after approved in Malaysia and annually
for 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 compliance with
standards or specifications and if they fail to meet adequate
specifications, the marketing authorisation holder will be issued a warning
and has up to 30 days to identify the source of quality defect(s) and
actions taken to improve quality unless the failure is serious enough to
justify recall of the product.
iii. Product Complaints
• The market authorisation holder should notify the DCA of any product
quality 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 of
these investigations, appropriate action will be taken which may include
product/batch recalls, cancellation/suspension of product registrations
or other regulatory action as deemed necessary.
Regulatory Control in Pharmaceutical Industry
iv. Product Recalls
• The decision for recall shall be made when there is or may cause potential
risk to the user of the products. Recall may be done voluntanly by the
product registration holder or directed by the Senior Director of
Pharmaceutical Services, Ministry of Health Malaysia.
• The product registration holder is responsible for conducting recalls of
defect or unsafe product. No recall should take place without first
consulting 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 terminate
the registration of a product before the end of the validity of such registration
and 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 manufacturing
process of the product but does not cover changes related to a new site
where only batch release takes place or to a new packager as these changes
are covered under applications for amendments to the particulars of a
registered product (variation).
• The new manufacturing site should comply with the current Good
Manufacturing Practice (GMP). Local manufacturing sites are subjected to
pre-licensing inspections and for sites outside Malaysia, certification by a
competent authority is sufficient. However, the DCA reserves the right to
conduct an inspection on any manufacturing site.
• This procedure is applicable for:
- Change in the manufacturing 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 manufacturing 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 of
accompanying documents.
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Regulatory Control in Pharmaceutical Industry
Type I :
Change of Manufacturing Site Within Malaysia
Type II :
Change of Manufacturing Site from Foreign
Country to Malaysia
Type III :
Change to Manufacturing Site Located Outside
Malaysia
Ty p e I V : C h a n g e o f M a n u f a c t u r i n g S i t e f o r S p e c i a l
Category Products
Type V :
Crisis Situation
For the description of each category, please refer to Drug
Registration Guidance Document in the NPCB website at
www.bpfk.gov.my
g. Other Information
i) Products for Export Only
• The DCA may register the following locally manufactured products for
export only:
- Product(s) registered by the DCA but sold in a different 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
question. Evidence of registration of solid formulation with the
competent authority in importing 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 Free
Sale Certification (CFS) of the product whereby the applicant need to
declare to the DCA the differences in the product for export compared
to the registered product marketed in Malaysia.
• A Certificate of Pharmaceutical Product will be issued to the applicant for
the registered product.
Regulatory Control in Pharmaceutical Industry
ii) Combination Packs
• Products which are packed together in combination for a therapeutic
regimen can be registered as a single product.
• Where the combination pack product consists of registered and
unregistered products, the unregistered product needs to be registered
before submitting the registration application for the combination pack.
• Where the combination pack consists of registered products which are
sourced from different product owners, letters of authorisation from the
product owners shall be submitted, together with the following product
details :- Product Name;
- Product Registration Number.
iii) Use of HALAL logo
The use of HALAL logo on the labels of pharmaceutical products will not
b e allowed except for traditional products, dietary supplements and
a l s o cosmetics provided
that such products have
For details, please visit the Halal
been
certified
and
Industry
Development Corporation
approved as HALAL by
website at www.halal.gov.my
Department of Islamic
Development Malaysia
(JAKIM)
iv) Product Labelling, Bioequivalence, New/Additional Indication
Please refer to the Drug Registration Guidance Document in NPCB website
for details.
37
38
Regulatory Control in Pharmaceutical Industry
Online Registration System
Quest is an online submission system for the product licence holder to conduct
secured online transactions on registration, change request, market sampling,
renewal and other transactions
Quest 3 Customer Support Number
603-7883 5400
extension: 5560/ 5561/ 5562
USB Token System
Customer Service Department
Tel:
603-8992 8888
URL: http://www.digicert.com.my
E-mail:customercare@digicert.com.my
Note:
The public can access the product search on both QUEST 2 and QUEST 3 to
search for registered products, product registration holders as well as product
manufacturers.
Regulatory Control in Pharmaceutical Industry
Quest 3
USB TOKEN/MEMBERSHIP APPLICATION FOR FIRST TIME USER
www.bpfk.gov.my
Applicant must
remember the
chosen
Username
First time user registration
Membership registration form
Resubmit application
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
Evaluation of application
by BPFK Officer
Print membership slip
Send payment+ slip as
adviced in the slip (to
Digicert Sdn. Bhd.)
Not satisfactory
Correspondence through email
Payment received by Digicert
No response
Application rejected
Satisfactory
Print membership slip
Password will be
emailed to the email
address specified in
the application
USB Token will be sent
within 7 working days
by Digicert Sdn. Bhd.
via POSLAJU
Pin number
will be send
separately via
POSLAJU
Login to QUEST3 and proceed with Product Registration/Cosmetic Notification
39
40
Regulatory Control in Pharmaceutical Industry
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 Fees
The licensing fees for the application for the various licences are as follows:
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
Licence Application
The Application for the above licences can be submitted manually or online
through the NPCB QUEST 3 Online Submission System. Application forms must
be 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*
Regulatory Control in Pharmaceutical Industry
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’s
Licence, Importer’s Licence and
Wholesaler’s
Licence
can
be
downloaded from NPCB’s website at
www.bpfk.gov.my
41
42
Regulatory Control in Pharmaceutical Industry
Manufacturer’s Licence Application Procedures
The layout plan must be submitted to the Centre for Compliance and Licensing
of National Pharmaceutical Control Bureau for evaluation. At the same time, an
applicant 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 and
other materials for operational purposes.
• Able to avoid cross over between material flow personnel flow, and storage
of materials.
• Once the plan has been approved, applicant shall seek additional advice/
approval from the Fire Department and Department of Environmental prior to
construction.
• Applicant shall prepare a complete documentation system that comprises
of directions, explanations, specifications and records pertaining to the
operation.
• Once the construction of manufacturing facilities is completed, the applicant
shall seek an appointment with the GMP auditor to inspect the premise for
pre-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 of
inspection and Letter of Confirmation (LOC) will be issued by the Centre for
Compliance and Licensing once approved.
• During product registration, if the Centre for Product Registration requires
samples for testing purposes, applicant may write an official letter to permit
the manufacturing of that particular product.
• Once product has been registered, applicant may apply for manufacturer’s
licence.
• Application will only be processed once payment has been made to the
Centre for Administration.
• Once approved, the manufacturer’s licence can be collected from Centre
for Compliance And Licensing or it will be posted to the manufacturing
address.
Regulatory Control in Pharmaceutical Industry
Application Process to Obtain
Manufacturing Licence
Corrective Action
Send Floor Plan to CGMP for Evaluation
Floor plan does not
comply with
GMP requirement
Floor Plan Approved
Corrective Action
Invite GMP Auditor to Perform
Pre-licensing Inspection
Premise does not
comply with
GMP requirement
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
43
44
Regulatory Control in Pharmaceutical Industry
Bioavailability and Bioequivalence Study for
Pharmaceutical Products
Introduction
Bioavailability (BA) testing of drug products in humans provides the most
appropriate method available for determining bioequivalence. Demonstration
of bioequivalence (BE) is generally the most appropriate method of
substantiating therapeutic equivalence between medicinal products.
Bioavailability:
Bioavailability means the rate and extent to which the active substance or
therapeutic moiety is absorbed from a pharmaceutical form and becomes
available at the site of action.
Bioequivalence:
Two medicinal products are bioequivalent if they are pharmaceutical equivalents
or alternatives and if their bioavailabilities (rate and extent) after administration
in the same molar dose are similar to such degree that their effects, with respect
to 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 generic
products containing scheduled poison as Active Ingredients as well as
accreditation of BE research centres.
Generic Product List and Guidelines for Bioequivalance
Studies
A list of drug substances which, when formulated in oral solid dosage forms,
require BE data as a prerequisite for registration, has been established by the
DCA. The list and guidelines can be found in the NPCB website at
www.bpfk.gov.my .
45
USEFUL CONTACTS
46
Useful Contacts
MALAYSIAN INVESTMENT DEVELOPMENT AUTHORITY (MIDA)
MIDA Sentral
No. 5, Jalan Stesen Sentral 5
Kuala Lumpur Sentral
50470 Kuala Lumpur, Malaysia
Tel:
(603) 2267 3633
Fax:
(603) 2274 7970
E-mail: investmalaysia@mida.gov.my
Website: www.mida.gov.my
MIDA’S OVERSEAS OFFICES
ASIA-PACIFIC
AUSTRALIA
Consul-Investment/Director
Consulate of Malaysia
Malaysian Investment
Development Authority
Level 6, MAS Building
16 Spring Street
Sydney, NSW 2000, Australia
Tel:
(612) 9251 1933
Fax:
(612) 9251 4333
E-mail: midasyd@bigpond.net.au
JAPAN
Tokyo
Director
Malaysian Investment
Development Authority
32F, Shiroyama Trust Tower
4-3-1, Toranomon, Minato-ku
Tokyo 105-6032, Japan
Tel:
(813) 5777 8808
Fax:
(813) 5777 8809
E-mail:
midatokyo@midajapan.or.jp
Website: www.midajapan.or.jp
Osaka
Director
Malaysian Investment
Development Authority
Mainichi Intecio 18F
3-4-5 Umeda, Kita-ku
Osaka 530-0001, Japan
Tel:
(816) 6451 6661
Fax:
(816) 6451 6626
E-mail: midaosaka@mida.or.jp
PEOPLE’S REPUBLIC OF
CHINA
Shanghai
Consul (Investment)
Consulate General of Malaysia
(Investment Section)
Malaysian Investment
Development Authority
Units 807-809, Level 8
Shanghai Kerry Centre
No. 1515, Nanjing Road (West)
Shanghai, 200040
People’s Republic of China
Tel:
(8621) 6289 4547/5298
6335
Fax:
(8621) 6279 4009
E-mail: midash@mida.org.cn
Guangzhou
Director
Malaysian Investment
Development Authority
Unit 1804B-05
CITIC Plaza Office Tower
233 Tianhe Be Road
Guangzhou, 510610
People’s Republic of China
Tel:
(8620) 8752 0739
Fax:
(8620) 8752 0753
E-mail: midagz@mida.org.cn
TAIWAN
Director (Investment Section)
Malaysian Friendship & Trade
Centre
Malaysian Investment
Development Authority
12F Suite A, Hung Kuo Building
No. 167, Tun Hua North Road
Taipei 105, Taiwan
Tel:
(8862) 2713 5020/
2718 6094
Fax:
(8862) 2514 7581
E-mail: midatpe@ms18.hinet.net
KOREA, REPUBLIC OF
Counsellor (Investment)
Embassy of Malaysia
(Investment Section)
Malaysian Investment
Development Authority
17th Floor, SC First Bank Building
100, Gongpyung-dong,
Jongro-gu
Seoul 110-702,
Republic of Korea
Tel:
(822) 733 6130/6131
Fax:
(822) 733 6132
E-mail: midasel@chollian.net
UNITED ARAB EMIRATES
Director/Consul Investment
Malaysian Investment
Development Authority
Consulate General of Malaysia
(Investment Section)
Unit 2205, 22nd Floor, Tower A
Business Central Tower, Dubai
Media City
(P.O. Box: 502876) Dubai
United Arab Emirates
Tel:
(9714) 4343 696/697
Fax:
(9714) 4343 698
E-mail: mida@midadubai.ae
INDIA
Director/Consul Investment
Malaysian Investment
Development Authority
Consulate General of Malaysia
(Investment Section)
81 & 87, 8th Floor, 3rd North
Avenue
Marker Maxity
Bandra Kurla Complex,
Bandra (E)
Mumbai 400051, India
Tel:
(9122) 2659 1155/1156
Fax:
(9122) 2659 1154
E-mail: midamumbai@mida.ind.in
SINGAPORE
Director/Consul Investment
Malaysian Investment
Development Authority
No. 7, Temasek Boulevard
26-01, Suntec Tower One
Singapore 038987
Tel:
(65) 6835 9326/
9580/7069
Fax:
(65) 6835 7926
E-mail: mida@midasing.sg
THAILAND
Director/Investment Counsellor
Malaysian Investment
Development Authority
3601, 36th Floor, Q. House
Lumpini Building
South Sathorn Road
Tungmahamek, Sathorn
Bangkok 10120, Thailand
Tel:
(66) 2677 7487
Fax:
(66) 2677 7488
E-mail:
midabangkok@mida.truemail.co.th
Useful Contacts
EUROPE
SWEDEN
Economic Counsellor
Embassy of Malaysia
Karlavägen 37, P.O. Box 26053
S-10041 Stockholm, Sweden
Tel:
(468) 791 7942/
440 8400
Fax:
(468) 791 8761
E-mail: mida@malemb.se
UNITED KINGDOM
Director
Malaysian Investment
Development Authority
17 Curzon Street
London W1J 5HR,
United Kingdom
Tel:
(4420) 7493 0616
Fax:
(4420) 7493 8804
E-mail:
midalon@btconnect.com
NORTH AMERICA
LOS ANGELES
Consul (Investment)
Consulate General of Malaysia
(Investment Section)
550, South Hope Street,
Suite 400
Los Angeles, California 90071
United States of America
Tel:
(1213) 955 9183/
9877
Fax:
(1213) 955 9878
E-mail: mida@midala.org
SAN JOSE
Malaysian Investment
Development Authority
226, Airport Parkway, Suite 480
San Jose, California 95110
United States of America
Tel:
(1408) 392 0617/8
Fax:
(1408) 392 0619
E-mail: midasanjose@aol.com
AFRICA
JOHANNESBURG
REPUBLIC OF SOUTH AFRICA
Economic Counsellor
High Commission of Malaysia
Ground Floor, Building 5
Commerce Square Office Park
39 Rivonia Road, Sandhurst
Sandton, Johannesburg
Republic of South Africa
Tel:
(2711) 268 2307/
268 2314
Fax:
(2711) 268 2204
E-mail: midajhb@telkomsa.net
GERMANY, FEDERAL
REPUBLIC OF
Frankfurt
Director/Consul Investment
Malaysian Investment
Development Authority
Consulate General of Malaysia
(Investment Section)
17th Floor, Frankfurt Kastor
Platz der Einheit 1
60327 Frankfurt am Main,
Germany
Tel:
(4969) 7680 7080
Fax:
(4969) 7680 708-20
E-mail:
mida.frankfurt@t-online.de
Munich
Director
Malaysian Investment
Development Authority
6th Floor, Burkleinhaus
Burkleinstrasse 10
80538 Munich, Germany
Tel:
(4989) 2030 0430
Fax:
(4989) 2030 4315
E-mail: midamunich@aol.de
NEW YORK
Consul (Investment)
Consulate General of Malaysia
(Investment Section)
313 East, 43rd Street, New
York
New York 10017
United States of America
Tel:
(1212) 687 2491
Fax:
(1212) 490 8450
E-mail: mida@midany.org
BOSTON
Director
Malaysian Investment
Development Authority
One International Place, Floor 8
Boston, MA 02110
United States of America
Tel:
(1617) 338 1128/
338 1129
Fax:
(1617) 338 6667
E-mail: midaboston@aol.com
FRANCE
Director
Malaysian Investment
Development Authority
42, Avenue Kleber
75116 Paris, France
Tel:
(331) 4727 3689/6696
Fax:
(331) 4755 6375
E-mail: mida.paris@wanadoo.fr
ITALY
Consul-Investment
Consulate of Malaysia
(Investment Section)
Malaysian Investment
Development Authority
5th Floor, Piazza Missori 3
20123 Milan (MI), Italy
Tel:
(3902) 3046 521
Fax:
(3902) 3046 5242
E-mail: midamln@tin.it
CHICAGO
Director
Malaysian Investment
Development Authority
John Hancock Center,
Suite 1515
875, North Michigan Avenue
Chicago, Illinois 60611
United States of America
Tel:
(1312) 787 4532
Fax:
(1312) 787 4769
E-mail: mida@midachicago.org
HOUSTON
Director
Malaysian Investment
Development Authority
6th Floor, Suite 630
Lakes on Post Oak
3050 Post Oak Boulevard
Houston, TX 77056
United States of America
Tel:
(1713) 979 5170
Fax:
(1713) 979 5177/78
E-mail: mida@midahouston.org
47
48
Useful Contacts
MIDA STATE OFFICES
KEDAH & PERLIS
NEGERI SEMBILAN
SELANGOR
Director
Malaysian Investment Development
Authority
Level 4, East Wing, No. 88
Menara Bina Darulaman Berhad
Lebuhraya Darulaman
05100 Alor Setar
Kedah Darul Aman
Malaysia
Tel:
(604) 731 3978
Fax:
(604) 731 2439
Email: kedah@mida.gov.my
Director
Malaysian Investment Development
Authority
Suite 13.01 & 13.02
13th Floor, Menara MAA
70200 Seremban
Negeri Sembilan
Malaysia
Tel:
(606) 762 7921/7884
Fax:
(606) 762 7879
E-mail: nsembilan@mida.gov.my
Director
Malaysian Investment Development
Authority
22nd Floor, Wisma MBSA
Persiaran Perbandaran
40000 Shah Alam
Selangor Darul Ehsan
Malaysia
Tel:
(603) 5518 4260
Fax:
(603) 5513 5392
E-mail: selangor@mida.gov.my
JOHOR
TERENGGANU
Director
Malaysian Investment Development
Authority
No.5, Level 13
Menara Tabung Haji
Jalan Ayer Molek
80000 Johor Bahru, Johor
Malaysia
Tel:
(607) 224 2550/ 5500
Fax:
(607) 224 2360
E-mail: johor@mida.gov.my
Director
Malaysian Investment Development
Authority
5th Floor, Menara Yayasan Islam
Terengganu
Jalan Sultan Omar
20300 Kuala Terengganu, Terengganu
Malaysia
Tel:
(609) 622 7200
Fax:
(609) 623 2260
E-mail: terengganu@mida.gov.my
PAHANG
SABAH
Director
Malaysian Investment Development
Authority
Suite 3, 11th Floor
Kompleks Teruntum
P.O.Box 178,
25720 Kuantan, Pahang
Malaysia
Tel:
(609) 513 7334
Fax:
(609) 513 7333
E-mail: pahang@mida.gov.my
Director
Malaysian Investment Development
Authority
Lot D9.4 & D9.5, Tingkat 9
Block D, Bangunan KWSP
Karamunsing
88100 Kota Kinabalu
Sabah
Tel:
(6088) 211 411
Fax:
(6088) 211 412
Email: sabah@mida.gov.my
KELANTAN
SARAWAK
Director
Malaysian Investment Development
Authority
Aras 5-C
Menara Pejabat Kelantan
Trade Centre
Jalan Bayam
15200 Kota Bharu, Kelantan
Malaysia
Tel:
(609) 748 3151
Fax:
(609) 744 7294
E-mail: kelantan@mida.gov.my
Director
Malaysian Investment Development
Authority
Room 404, 4th Floor
Bangunan Bank Negara
No.147, Jalan Satok, P.O.Box 716
93714 Kuching
Sarawak
Malaysia
Tel:
(6082) 254 251/237 484
Fax:
(6082) 252 375
E-mail: sarawak@mida.gov.my
PENANG
Director
Malaysian Investment Development
Authority
4.03, 4th Floor
Menara Boustead Penang
39, Jalan Sultan Ahmad Shah
10050 Pulau Pinang
Malaysia
Tel:
(604) 228 0575
Fax:
(604) 228 0327
E-mail: penang@mida.gov.my
PERAK
Director
Malaysian Investment Development
Authority
4th Floor
Perak Techno Trade Centre (PTTC)
Bandar Meru Raya
Off Jalan Jelapang
P.O. Box 210, 30720 Ipoh
Perak Darul Ridzuan
Malaysia
Tel:
(605) 5269 962 / 961
Fax:
(605) 5279 960
E-mail: perak@mida.gov.my
MELAKA
Director
Malaysian Investment Development
Authority
3rd Floor, Menara MITC
Kompleks MITC
Jalan Konvensyen
75450 Ayer Keroh
Melaka
Malaysia
Tel:
(606) 232 2876/78
Fax:
(606) 232 2875
E-mail: melaka@mida.gov.my
Useful Contacts
MINISTRY OF INTERNATIONAL TRADE & INDUSTRY (MITI)
Block 10, Government Offices Complex, Jalan Duta 50622 Kuala Lumpur, Malaysia
Tel: (603) 6203 3022 Fax: (603) 6203 2337/ 6203 1303
Website: www.miti.gov.my E-mail: webmiti@miti.gov.my
MITI OVERSEAS OFFICES
BELGIUM
JAPAN
THAILAND
Minister Counsellor (Economy)
Mission of Malaysia to the EU
Embassy of Malaysia in Belgium
Avenue de Tervuren 414A
1150 Brussels
Belgium
(322) 776 0340/762 5939
Tel:
Fax:
(322) 771 2380
Email:
arividya@miti.gov.my/
miti.brussels@skynet.be
Minister Counsellor (Economy)
Department of Trade Affairs
Embassy of Malaysia
20-16 Nanpeidai-Cho
Shibuya-ku, Tokyo 150-0036
Japan
(813) 3476 3844
Tel:
Fax:
(813) 3476 4972
E-mail:
sanusi@miti.gov.my
Counsellor (Economics)
Embassy of Malaysia (Trade Office)
35, South Sathorn Road
Tungmahamek, Sathorn
Bangkok 10120
Thailand
(662) 679 2190-9
Tel:
Ext. 2303/ 2304/ 2305
Fax:
(662) 679 2200
fary@miti.gov.my
E-mail:
CHINA, PEOPLE’S OF REPUBLIC OF
Counsellor (Economics)
Malaysian Trade Commission
80 Robinson Road #01-02
Singapore 068896
Tel:
(0265) 6222 0126/1356/1357
Fax:
(0265) 6221 5121
Email:
wansu@miti.gov.my
SINGAPORE
Minister Counsellor (Economy)
Embassy of Malaysia (Economic Section)
No.2 Liang Ma Qiau Bei Jie
Chaoyang District, 100600 Beijing
People’s Republic of China
Tel:
(8610) 6532 2533/7990
Fax:
(8610) 6523 3617
Email:
ongcy@miti.gov.my
INDIA, REPUBLIC OF
Minister Counsellor (Economy)
High Commission of Malaysia in New Delhi
50-M, Satya Marg
Chanakyapuri
New Delhi 110021
Republic of India
Tel:
(91-11) 2611 1291/1292/
1293/1297
Fax:
(91-11) 2688 1538
Email:
muthafa@miti.gov.my
INDONESIA
Counsellor (Economics)
Embassy of Malaysia
(Commercial Section)
Jalan H.R. Rasuna Said, Kav X6
No.1-3, Kuningan
Jakarta 12950
Indonesia
Tel:
(6221) 522 4947/522 4962
Fax:
(6221) 522 4963
Email:
syahril@miti.gov.my
SWITZERLAND
Permanent Mission of Malaysia to the WTO
International Centre Cointrin (ICC)
3rd Floor, Block C
20, Route de Pre-Bois
Case Postale 1909
CH 1215, Geneva 15
Switzerland
Tel:
(4122) 799 4040
Fax:
(4122) 799 4041
E-mail:
hiswani@miti.gov.my
UNITED STATES OF AMERICA
Minister Counsellor (Economy)
Embassy of Malaysia
3516 International Court NW
Washington DC 20008
United States of America
Tel:
(1202) 572 9700/10/34
Fax:
(1202) 572 9782/882
E-mail:
hairil@miti.gov.my
49
50
Useful Contacts
MALAYSIA EXTERNAL TRADE DEVELOPMENT CORPORATION (MATRADE)
Menara MATRADE, Jalan Khidmat Usaha, Off Jalan Duta, 50480 Kuala Lumpur, Malaysia
Tel: (603) 6207 7077 Fax: (603) 6203 7037 Toll Free: 1800-88-7280
Website: www.matrade.gov.my E-mail: info@matrade.gov.my
MATRADE’S OVERSEAS OFFICES
AUSTRALIA
Trade Commissioner
Consulate of Malaysia (Commercial Section)
Level 4, Malaysia Airlines Building
16, Spring Street, Sydney
NSW 2000, Australia
Tel:
(612) 9252 2270
Fax:
(612) 9252 2285
E-mail: sydney@matrade.gov.my
CENTRAL ASIA
UZBEKISTAN
Marketing Officer
Trade Office (MATRADE)
Embassy of Malaysia
28, Maryam Yakubova Street, Yakkasaray District
100 031 Tashkent, Republic of Uzbekistan
Tel:
(99871) 256 67 07
Fax:
(99871) 256 69 09
Email: tashkent@matrade.gov.my
EAST - ASIA
CHINA, PEOPLE’S REPUBLIC OF
Beijing
Trade Commissioner
Embassy of Malaysia (Trade Section)
Unit E, 11th Floor, Tower B
Gateway Plaza
18, Xiaguangli, North Road
Dongsanhuan
Chaoyang District, Beijing 100027
People’s Republic of China
Tel:
(8610) 8451 5109/5110/1113
Fax:
(8610) 8451 5112
E-mail: beijing@matrade.gov.my
Guangzhou
Trade Commissioner
Consulate General of Malaysia
(Trade Section)
Unit 5305, Citic Plaza Office Tower
233, Tianhe Bei Road
Guangzhou, 510610 Guangdong
People's Republic of China
Tel:
(8620) 3877 3865/ 3975
Fax:
(8620) 3877 3985
E-mail: guangzhou@matrade.gov.my
Shanghai
Trade Consul
Consulate General of Malaysia (Trade
Section)
Unit 807-809, 8th Floor
Shanghai Kerry Centre
1515, Nanjing Road West
Shanghai, 200040
People’s Republic of China
Tel:
(8621) 6289 4420/4467
Fax:
(8621) 6289 4381
E-mail: shanghai@matrade.gov.my
Chengdu
Director
Malaysia External Trade Development
Corporation
(Chengdu Representative Office)
Level 14, Unit 1402-1404
The Office Tower
Shangri-La Centre
9 Binjiang Road East
Chengdu 610021, Sichuan Province
People’s Republic of China
Tel:
(8628) 6687 7517
Fax:
(8628) 6687 7524
E-mail: chengdu@matrade.gov.my
Hong Kong
Trade Commissioner/Consul
Consulate General of Malaysia
(Trade Section)
19th Floor, Malaysia Building
50 Gloucester Road, Wanchai
Hong Kong Special Administrative
Region
Region of the People’s Republic of
China
Tel:
(852) 2527 8109
Fax:
(852) 2804 2866
E-mail: hongkong@matrade.gov.my
TAIWAN
Director
Malaysian Friendship & Trade Centre
(Trade Section)
10F-D, Hung Kuo Building
167 Dun Hwa North Road
Taipei 105, Taiwan
Tel:
(8862) 2545 2260
Fax:
(8862) 2718 1877
E-mail: taipei@matrade.gov.my
Useful Contacts
JAPAN
Tokyo
Director
Malaysia External Trade Development
Corporation
6th FIoor, Ginza Showadori Building
8-14-14, Ginza Chuo-ku
Tokyo 104-0061, Japan
Tel:
(813) 3544 0712/ 0713
Fax:
(813) 3544 0714
Email: tokyo@matrade.gov.my
KOREA, REPUBLIC OF
Osaka
Marketing Officer
Malaysia External Trade Development
Corporation
Mainichi Intecio 18F
3-4-5, Umeda, Kita-ku
Osaka 530-0001
Japan
Tel :
(816) 6451 6520
Fax : (816) 6451 6521
E-mail: osaka@matrade.gov.my
Trade Commissioner
Embassy of Malaysia
(Trade & Investment Section)
17th Floor, SC SC Bank Korea Limited
47, Chongro, Chongro ru
Seoul 110-702
Republic of Korea
Tel:
(822) 739 6813/ 6814/ 6812
Fax:
(822) 739 6815
E-mail: seoul@matrade.gov.my
SOUTH ASIA
INDIA
Chennai
Mumbai
Trade Commissioner
Consulate General of Malaysia
(Trade Section)
Capitale 2A, 2nd Floor
554 & 555, Anna Salai
Teynampet, Chennai-600018
India
Tel:
(9144) 2431 3722 / 3723
Fax:
(9144) 2431 3725
E-mail: chennai@matrade.gov.my
Consul
Consulate General of Malaysia
Trade Section (MATRADE)
Suite 301, 3rd Floor, Noman Centre
Block G
Bandra Kurla Complex, Bandra (E)
Mumbai 400051
India
Tel:
(9122) 2659 7272 / 3
Fax:
(9122)2695 7274
E-mail: mumbai@matrade.gov.my
SOUTH EAST ASIA
CAMBODIA
PHILIPPINES
VIETNAM
Marketing Officer
Malaysia External Trade Development
Corporation (MATRADE)
No. 222, Preah Nurodorn Boulevard
Sangkat Tonle Bassac Khan
Chamkarmorn
Phnom Penh
Cambodia
Tel:
(855) 2372 1224
Fax:
(855) 2372 1225
E-mail: phnompenh@matrade.gov.my
Marketing Officer
Embassy of Malaysia
Trade Office (MATRADE)
10/F, The World Trade Centre
330 Sen, Gil Puyat Avenue
Makati City, Philippines
Tel:
(632) 864 0761
Fax:
(632) 891 1695
E-mail: manila@matrade.gov.my
Ho Chi Minh City
Trade Commissioner
Consulate General of Malaysia
(Trade Section)
1208, 12th FIoor, Me Linh Point Tower
2, Ngo Duc Ke Street, District 1
Ho Chi Minh City
Vietnam
Tel:
(848) 829 9023/ 8256
Fax:
(848) 823 1882
E-mail: hcmc@matrade.gov.my
INDONESIA
Trade Commissioner
Embassy of Malaysia (Trade Section)
12th Floor, Plaza Mutiara
Jln. Lingkar Kuningan
Kav E.1.2. No1 & 2
Kawasan Mega Kuningan
Jakarta 12950
Indonesia
Tel:
(6221) 576 4297/ 4322
Fax:
(6221) 576 4321
E-mail: jakarta@matrade.gov.my
SINGAPORE
Director
Malaysia External Trade Development
Corporation
#33-01/03, Shaw Towers 100
Beach Road, Singapore 189702
Tel:
(0265) 6392 2238
Fax:
(0265) 6392 2239
E-mail: singapore@matrade.gov.my
THAILAND
Marketing Officer
Embassy of Malaysia (Trade Section)
35, South Sathorn Road
Tungmahamed, Sathorn
Bangkok, 10120, Thailand
Tel:
(662) 679 2190-9 ext 2209
(662) 679 2200/ 2131
Fax:
(662) 679 2200
E-mail: bangkok@matrade.gov.my
Hanoi
Marketing Officer
Embassy of Malaysia
Trade Office (MATRADE)
45-46 Dien Bien Phu Street
Ba Dinh District, Hanoi
Vietnam
Tel:
(844) 734 7521
Fax:
(844) 734 7520
Email: hanoi@matrade.gov.my
51
52
Useful Contacts
WEST ASIA
SAUDI ARABIA
UNITED ARAB EMIRATES
Trade Commissioner
Consulate General of Malaysia
(Commercial Section)
14th Floor, Saudi Business Centre
Madina Road
P.O.Box 20802
Jeddah 21465
Saudi Arabia
Tel:
(9662) 653 2143/ 98
Fax:
(9662) 653 0274
E-mail:
jeddah@matrade.gov.my
Consul General / Trade Commissioner
Consulate General of Malaysia
Malaysia Trade Centre
Lot 1-3 Ground Floor &
6-10 Mezzanine Floors
Al-Safeena Building Near Lamcy Plaza
Zaabeel Road
P.O.Box 4598, Dubai
United Arab Emirates
Tel:
(9714) 335 5528/38
Fax:
(9714) 335 2220
E-mail:
dubai@matrade.gov.my
EUROPE
FRANCE
ITALY
UKRAINE
Trade Commissioner
Service Commercial De Malaisie
De L’ Ambassade De Malaisie
90, Avenue Des Champs Elysees
75008 Paris, France
Tel:
(331) 4076 0000/0034
Fax:
(331) 4076 0001
E-mail: paris@matrade.gov.my
Consul and Trade Commissioner
Consulate of Malaysia (Commercial
Service)
5th FIoor, Via Vittor Pisani 31
20124 Milano
Italy
Tel:
(3902) 669 0501
Fax:
(3902) 670 2872
E-mail: milan@matrade.gov.my
Marketing Officer
Trade Office (MATRADE)
Embassy of Malaysia
No. 25 Bulivska Street
Perchersk, Kiev 01014
Ukraine
Tel:
(38044) 286 7128
Fax:
(38044) 286 8942
Email: kiev@matrade.gov.my
GERMANY
Trade Commissioner / Consul
Consulate of Malaysia (Trade Section)
MATRADE
Kastor-Hochhaus (Commerzbank)
17th Floor, Platz der Einheit 1
60327 Frankfurt am Main
Germany
Tel:
(4969) 247 5015-10
Fax:
(4969) 247 5015-20
Email: frankfurt@matrade.gov.my
HUNGARY
Trade Commissioner
Embassy of Malaysia (Trade Section)
Ground Floor, Museum Atrium
Dozsa Gyorgy ut 84/b
1068 Budapest
Hungary
Tel:
(361) 461 0290
Fax:
(361) 461 0291
E-mail: budapest@matrade.gov.my
THE NETHERLANDS
Trade Commissioner
Embassy of Malaysia (Commercial
Section)
Rustenburgweg 2
2517 KE The Hague
The Netherlands
Tel:
(31010) 462 7759
Fax:
(31010) 462 7349
E-mail: rotterdam@matrade.gov.my
RUSSIA
Trade Commissioner
Embassy of Malaysia (Trade Section)
Mosfilmovskaya Ulitsa 50
Moscow 117192
Russian Federation
Tel:
(7495) 147 1514/ 1523
Fax:
(7495) 143 6043
E-mail: moscow@matrade.gov.my
UNITED KINGDOM
Trade Commissioner
Malaysian Trade Commission
(Commercial Section)
3rd & 4th Floor, 17 Curzon Street
London W1J 5HR
United Kingdom
Tel:
(4420) 7499 5255/4644
Fax:
(4420) 7499 4597
E-mail: london@matrade.gov.my
UZBEKISTAN
Embassy of Malaysia
28, Maryam Yakubova Street
Yakkasaray District
100 031 Tashkent
Republic of Uzbekistan
Tel:
(99871) 256 6707
Fax:
(99871) 256 6909
Email: tashkent@matrade.gov.my
Useful Contacts
NORTH AMERICA
CANADA
Trade Commissioner
Consulate of Malaysia (Trade Office)
First Canadian Place
Suite 3700
100 King Street West
Toronto, Ontario M5X 1E2
Canada
Tel:
(1416) 504 6111
Fax:
(1416) 504 8315
E-mail: toronto@matrade.gov.my
MIAMI, THE USA
NEW YORK, THE USA
Director
Malaysia Trade Centre
703 Waterford Way, Suite 150
Miami, Florida 33126
United States of America
E-mail: miami@matrade.gov.my
Tel:
(1305) 267 8779
Fax:
(1305) 267 8784
E-mail: losangeles@matrade.gov.my
Trade Commissioner
Consulate General of Malaysia
(Commercial Section)
3rd Floor, 313 East, 43rd Street
New York, NY 10017
United States of America
Tel:
(1212) 682 0232
Fax:
(1212) 983 1987
E-mail: newyork@matrade.gov.my
LOS ANGELES, THE USA
Trade Commissioner
Consulate General of Malaysia
(Commercial Section)
550 South Hope Street
Suite 400, Los Angeles, CA 90071
United States of America
Tel:
(1213) 892 9034
Fax:
(1213) 955 9142
E-mail: losangeles@matrade.gov.my
SOUTH AMERICA
BRAZIL
MEXICO
Trade Commissioner
Embassy of Malaysia (Commercial
Section)
771, Alameda Santos, Suite 72
7th Floor, 01419-00141, Sao Paulo
Brazil
Tel:
(5511) 3285 2966
Fax:
(5511) 3289 1595
E-mail: saopaulo@matrade.gov.my
Trade Commissioner
Embassy of Malaysia, Mexico City
Paseo de Las Palmas # 425
Torre Optima 3, Office 1101 & 1102
Col. Lomas de Chapultepec
Del. Miguel Hidalgo, C.P.11000
Mexico D.F.
Tel:
+5255 5201 4540
Fax:
+5255 5202 7338
E-mail: mexicocity@matrade.gov.my
CHILE
Trade Commissioner
Oficina Commercial de Malasia
Embajada De Malasia Avda
Tajamar 183
Oficina 302, Las Condes
Santiago
Chile
Tel:
(562) 234 2647
Fax:
(562) 234 2652
E-mail: santiago@matrade.gov.my
ARGENTINA
Embassy of Malaysia Trade Office
(MATRADE)
Villanveva 1040
C1426B MD Buenos Aires
Republic of Argentina
Tel:
(54) 11 4776 0504 / 2553 /
(54) 11 4777 8420
Fax:
(54) 11 4776 0604
E-mail: buerosaires@matrade.gov.my
AFRICA
SOUTH AFRICA
CAIRO, EGYPT
KENYA
Trade Commissioner
Embassy of Malaysia (Trade Section)
17th Floor, North Tower
Nile City Building
Cornish El-Nil Street
Cairo
Egypt
Tel:
(202) 461 9063/ 9064
Fax:
(202) 461 9065
E-mail: cairo@matrade.gov.my
Trade Commissioner
Malaysian Trade Commission
Block 91/404, Gigiri,Groove, Gigiri
P.O. Box 42286
00200 Nairobi
Kenya
Tel:
(25420) 712 0915
Fax:
(25420) 712 0916
E-mail: nairobi@matrade.gov.my
Trade Commissioner
Malaysia Trade Commission
Ground Floor, Building 5
Commerce Square Office Park
39, Rivonia Road, Sandhurst
Sandton, Johannesburg
South Africa
Tel:
(2711) 268 2380/ 2381
Fax:
(2711) 268 2382
Email: johannesburg@matrade.gov.my
53
54
Useful Contacts
MATRADE STATE OFFICES
JOHOR
SARAWAK
DIRECTOR
MATRADE Southern Regional Office
Malaysia External Trade Development
Corporation (MATRADE)
Suite 6B, Tingkat 6, Menara Ansar
65, Jalan Trus, 80000 Johor Bahru,
Johor
Tel:
(607) 222 9400
Fax:
(607) 222 9500
Email: johor@matrade.gov.my
Malaysia External Trade Development
Corporation (MATRADE)
Tingkat 10, Menara Grand, Lot 42,
Section 46
Ban Hock Road, 93100 Kuching,
Sarawak
Tel:
(6082) 246 780 / 248 780
Fax:
(6082) 256 780
Email: sarawak@matrade.gov.my
SABAH
PENANG
Malaysia External Trade Development
Corporation (MATRADE)
1st Floor, FMM Building 2767, Mukim 1
Lebuh Tenggiri 2, Bandar Seberang
Jaya
13700 Seberang Perai Tengah, Pulau
Pinang
Tel:
(604) 398 2020
Fax:
(604) 298 2288
Email: penang@matrade.gov.my
TERENGGANU
DIRECTOR
MATRADE Eastern Regional Office
Malaysia External Trade Development
Corporation (MATRADE)
Tingkat 5, Menara Yayasan Islam
Terengganu
Jalan Sultan Omar, 20300 Kuala
Terengganu, Terengganu
Tel:
(609) 624 4778
Fax:
(609) 624 0778
Email: terengganu@matrade.gov.my
Malaysia External Trade Development
Corporation (MATRADE)
Lot C5.2A, Tingkat 5, Block C,
Bangunan KWSP
Jalan Karamunsing, 88100 Kota
Kinabalu, Sabah
Tel:
(6088) 240 881 / 242 881
Fax:
(6088) 243 881
Email: sabah@matrade.gov.my
Useful Contacts
MINISTRIES OF HEALTH MALAYSIA
Block E1, E6, E7 & E10, Complex E
Federal Government Administrative Centre
62590 Putrajaya, Malaysia
Tel:
(603) 8883 3888
Fax:
(603) 2274 7970
Website: www.moh.gov.my
E-mail:
kkm@moh.gov.my
RELEVANT DIVISIONS/AGENCIES
CLINICAL RESEARCH CENTRE
Level 3, Dermatology Block,
Kuala Lumpur Hospital,
Jalan Pahang,
50586, Kuala Lumpur
Malaysia
Tel:
(603) 26924249/(603) 26911486
Fax:
(603) 26911682
Website:http://www.crc.gov.my
NATIONAL PHARMACEUTICAL
CONTROL BUREAU (NPCB)
Ministry of Health Malaysia
Lot 36, Jalan Universiti
46200 Petaling Jaya
Selangor
Malaysia
Tel:
(603) 78835400
Fax:
(603) 79562924
Website:http://www.bpfk.gov.my
PHARMACEUTICAL SERVICES
DIVISION
Pharmacy Board of Malaysia
Ministry of Health Malaysia
Lot 36, Jalan Universiti
46350 Petaling Jaya
Selangor
Malaysia
Tel:
(603) 78413200
Fax:
(603) 79682222
Website: http://www.pharmacy.gov.my
POLICY AND INTERNATIONAL
RELATIONS DIVISION
Ministry of Health Malaysia
Level 6, 8 & 11, Complex E, Precinct 1
Federal Government Administrative
Centre, 62590 Putrajaya
Malaysia
Tel:
(603) 8883 2865
Fax:
(603) 8888 8692
Website:http://korporat.moh.gov.my
55
56
Useful Contacts
OTHER RELEVANT ORGANISATIONS
BANK NEGARA MALAYSIA
Jalan Dato’ Onn, P.O. Box 10922
50929 Kuala Lumpur
Malaysia
Tel:
(603) 2698 8044
Fax:
(603) 2691 2990
Website:www.bnm.gov.my
E-mail: bnmtelelink@bnm.gov.my
COMPANIES COMMISSION OF
MALAYSIA (SSM)
Menara SSM@Sentral
No.7, Jalan Stesen Sentral 5
Kuala Lumpur Sentral
50200 Kuala Lumpur
Malaysia
Tel:
(603) 2299 4400
Fax:
(603) 2299 4411
Website:www.ssm.gov.my
Email: enquiry@ssm.com.my
DEPARTMENT OF
ENVIRONMENT
Ministry of Natural Resources
and Environment
Level 1-4, Podium 2&3,
Wisma Sumber Asli,
No.25, Persiaran Perdana, Precinct 4
Federal Government
Administrative Centre
62574 Putrajaya
Malaysia
Tel:
(603) 8871 2000/ 8871 2200
Fax:
(603) 8889 1973/75
Website:www.doe.gov.my
E-mail: aduan_k@doe.gov.my
DEPARTMENT OF INDUSTRIAL
RELATIONS
Level 9, Block D4, Complex D
Federal Government
Administrative Centre
62530 Putrajaya
Malaysia
Tel:
(603) 8871 1205
Fax:
(603) 8889 2355
Website:www.mohr.gov.my/depart/jpp/
E-mail: jppm@mohr.gov.my
DEPARTMENT OF LABOUR
Level 5, Block D3, Complex D
Federal Government
Administrative Centre
62502 Putrajaya
Malaysia
Tel:
(603) 8886 5192
Fax:
(603) 8889 2368
Website:www.jtksm.mohr.gov.my
E-mail: jtksm@mohr.gov.my
DEPARTMENT OF
OCCUPATIONAL
SAFETY AND HEALTH
Level 2, 3 and 4, Block D3, Complex D
Federal Government
Administrative Centre
62530 Putrajaya
Malaysia
Tel:
(603) 8886 5000
Fax:
(603) 8889 2443
Website:www.dosh.gov.my
E-mail: jkkp@mohr.gov.my.
EMPLOYEES PROVIDENT FUND
KWSP Building
Jalan Raja Laut
50350 Kuala Lumpur
Malaysia
Tel:
(603) 8922 6000
Fax:
(603) 8922 6222
Website:www.kwsp.gov.my
E-mail: enquiry@kwsp.gov.my
HALAL INDUSTRY
DEVELOPMENT
CORPORATION (HDC)
5.02, Level 5
KPMG Tower, First Avenue
Persiaran Bandar Utama
47800 Petaling Jaya
Selangor Darul Ehsan
Malaysia
Tel:
(603) 7965-5555
Fax:
(603) 7965-5500
Hotline: 1800-880-555
Website:www.hdcglobal.com
E-mail: refcenter@hdcglobal.com
IMMIGRATION DEPARTMENT
Level 1 – 7(Podium)
No.15, Persiaran Perdana, Precinct 2
Federal Government
Administrative Centre
62550 Putrajaya
Malaysia
Tolfree: 1800 22 6969
Tel:
(603) 8000 8000
Fax:
(603) 8880 1200
Website:www.imi.gov.my
E-mail: pro@imi.gov.my
INLAND REVENUE BOARD
Menara Hasil
Persiaran Rimba Permai
Cyber 8, 63000 Cyberjaya
Selangor
Malaysia
Tel:
(603) 8313 8888
Fax:
(603) 8313 7801
Website:www.hasil.gov.my
Email: callcentre@hasil.gov.my
INTELLECTUAL PROPERTY
CORPORATION OF MALAYSIA
Unit 1-7, Ground Floor
Menara UOA Bangsar
No.5, Jalan Bangsar Utama 1
59000 Kuala Lumpur
Malaysia
Tel:
(603) 2299 8400
Fax:
(603) 2299 8989
Website:www.myipo.gov.my
E-mail: ipmalaysia@myipo.gov.my
MALAYSIA DEPARTMENT OF
ISLAMIC DEVELOPMENT
Level 4-9, Block D7, Complex D
Federal Government Administrative
Centre
62519 Putrajaya
Malaysia
Tolfree: 1800 22 224
Tel:
(603) 8886 4000
(Halal Hub Division)
Fax:
(603) 8889 2031
Website:www.islam.gov.my
MALAYSIAN BIOTECHNOLOGY
CORPORATION SDN BHD
Level 23, Menara Atlan
161B Jalan Ampang
50450 Kuala Lumpur
Malaysia
Tel:
(603) 2116 5588
Fax:
(603) 2116 5411
Website:www.biotechcorp.com.my
Email: shamini.poovendran@
biotechcorp.com.my
MALAYSIAN INDUSTRIAL
DEVELOPMENT
FINANCE BHD (MIDF)
21st Floor, Menara MIDF
82, Jalan Raja Chulan
50200 Kuala Lumpur
Malaysia
Tel:
(603) 2173 8888
Fax:
(603) 2173 8877
Website:www.midf.com.my
E-mail: inquiry-feedback@
midf.com.my
Useful Contacts
MALAYSIAN ORGANISATION OF
PHARMACEUTICAL
INDUSTRIES (MOPI)
Global Business & Convention Centre
Mezzanine Floor, Block A
No 8, Jalan 19/1, Section 19
46300 Petaling Jaya, Selangor
Malaysia
Tel:
(603) 7931 9003
Fax:
(603) 7932 2736
Website:www. mopi.org.my
E-mail: admin@mopi.gov.my
SME CORP MALAYSIA
Level 6, SME 1, Block B
Lot E, Jalan Stesen Sentral 2
Kuala Lumpur Sentral
50470 Kuala Lumpur
Malaysia
Tel:
(603) 2775 6000
Fax:
(603) 2775 6001
Infoline: 1-300-88-1801
Website:www.smecorp.gov.my
E-mail: info@smecorp.gov.my
SME BANK
MALAYSIAN TECHNOLOGY
DEVELOPMENT
CORPORATION SDN BHD
(MTDC)
Menara Yayasan Tun Razak
Level 8-9, Jalan Bukit Bintang
55100 Kuala Lumpur
Malaysia
Tel:
(603) 2172 6000
Fax:
(603) 2163 7549
Website:www.mtdc.com.my
E-mail: comms@mtdc.com.my
MALAYSIAN INDUSTRYGOVERNMENT
GROUP FOR HIGH
TECHNOLOGY (MIGHT)
Block 3517, Jalan Teknokrat 5
63000 Cyberjaya
Selangor
Malaysia
Tel:
(603) 8315 7888
Fax:
(603) 8312 0300
Website:www.might.org.my
E-mail: info@might.org.my
ROYAL CUSTOMS MALAYSIA
Level 7 North,
Ministry of Finance Complex
Precinct 2
No.3 Persiaran Perdana
Federal Government
Administrative Centre
62592 Putrajaya
Malaysia
Tel:
(603) 8882 2300/2500/2100
Fax:
(603) 8889 5901
Website:www.customs.gov.my
E-mail: cpa@customs.gov.my
Menara SME Bank
Jalan Sultan Ismail
P.O.Box 12352
50774 Kuala Lumpur
Malaysia
Tel:
(603) 2615 2020/ 2828
Fax:
(603) 2692 8520/ 2698 1748
Website:www.smebank.com.my
E-mail: customercare@
smebank.com.my
TELEKOM MALAYSIA BERHAD
Level 51, North Wing, Menara TM
Off Jalan Pantai Baru
50672 Kuala Lumpur
Malaysia
Tel:
(603) 2240 1221
Fax:
(603) 2283 2415
Website:www.tm.com.my
E-mail: feedback@telekom.com.my
TENAGA NASIONAL BERHAD
129, Jalan Bangsar
59200 Kuala Lumpur
Malaysia
Tel:
(603) 2296 5566
Fax:
(603) 2283 3686
Website:www.tnb.com.my
E-mail: ird@tnb.com.my
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