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Berita Ubat-ubatan
August 2000

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Regulatory Control Beyond 2000
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Separate Manufacturing Facilities For Cephalosporins
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Warning Label for products - NSAID
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Registration of Products Containing Insect Repellants
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Warning for Products containing Hydroquinone
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Actions To Be Taken Against Products Containing CISAPRIDE (PREPULSID)line.gif (87 bytes)
Licensing Update - June 2000
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The Changing Pharmaceutical and Traditional Medicine Premises Landscape: 1987 - 2000
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Additional Indications Approved for Registered Products
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GMP News
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Quality Control Training Course
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Sources of products registered with DCA As At 30.6.2000
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New Products Approved for Marketing in Malaysia
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NPCB officers to contact
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Clinical Trials

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NATIONAL PHARMACEUTICAL CONTROL BUREAU
Ministry of Health Malaysia
Jalan Universiti, P. O. Box 319, 46730 Petaling Jaya.
(Telephone: 603-79573611, Fax: 603-79562924)

Homepage http://www.bpfk.gov.my

 OFFICERS TO CONTACT

ISSUE / AREAS
Officer/Division/ Unit involved
Name of officer
tel- ext

National Pharmaceutical Control Bureau
Director
Che Mohd. Zin Che Awang
301

Product Evaluation and Safety Division
Deputy Director
Normal Sharif
270

– Certificate of free sale
– General information regarding registration
Secretariat Unit
Hasnah Ismail (Head)
242

Application for Registration of
- Poisons
- Non Poisons
- Traditional Medicines
- New Chemical Entity
- Cosmetics / Nutritional Supplements
– Poisons Unit
– Non Poisons Unit
– Traditional Medicines Unit
– New Chemical Entity Unit
– Cosmetic Unit
Fudziah Ariffin (Head)
Tan Lie Sie (Head)
Napsah Mahmud (Head)
Dr. Ramli Abd. Ghani (Head)
Ramli b. Zainal (Head)
233
245
238
239
241

- Manufacturer’s Licence
- Import Licence
- Wholesaler’s Licence
- Clinical Trial Import Licence
- Report of Adverse Drug Reaction
- Market Surveillance Programme
- Product Complaints / Product Recalls

GMP and Licensing Division
New Chemical Entity Unit
Surveillance & Pharmacovigilance Division

Eishah Abd. Rahman (Head)
Dr. Ramli Abd. Ghani (Head)
Abida Haq (Head)
201
239
258

- Good Manufacturing Practice
- Good Storage Practice
GMP and Licensing Division
Eishah Abd. Rahman (Head)
201

- Drug Information
- Library
- Classification of Products
Organizational Development & Information Technology Division
Chuah Siew Khim (Head)
217

Drug Analysis Division
Deputy Director
Lai Lim Swee
204

- Request/Purchase of Reference Standard
Reference Standard Unit
Nasir Hashim (Head)
510

- Payment for Laboratory Tests
Laboratory Service Unit
Choy Khye Moon
512

- Submission of Samples for Stage 2 of Registration Application
Laboratory Officers on Duty
(according to schedule)
512

- Submission of Letters for Product Evaluation and Safety Division
Receiving Counter
Administrative Assistant

- Collection of Application Forms
- Purchase of NPCB Publications/Guidelines
Administrative Division
Rosnani Yusoff (Head)
502

- General Inquiries and Technical Information
- Classification of Products
Public Affairs Unit
Rosnaini Kamaruddin (Head)
223