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Berita Ubat-ubatan
November 1998

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Seminar on Pharmacovigilance
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Mandatory ADR Reporting of New Chemical Entities
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Nifedipine – Induced Hypotensive Shock
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Licensing – Ten Years of Implementation
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Stage I Application Form Amended (434.1)
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Comparative Dissolution Performance of Locally Available Piroxicam Products
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Clinical Trials
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New Chemical Entity Approved For Marketing In Malaysia
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New Indications Approved For Registration
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International Visitors and Delegation
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NPCB – Contact Person

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NATIONAL PHARMACEUTICAL CONTROL BUREAU
Ministry of Health Malaysia
Jalan Universiti, P. O. Box 319, 46730 Petaling Jaya.

(Telephone: 603-7573611, Fax: 603-7562924)

OFFICERS TO CONTACT

ISSUES / AREAS Officer/division/ UNIT involved Name of officer tel- ext
National Pharmaceutical Control Bureau Director Leslie Teo Ai Hui 201
Drug Evaluation and Safety Division Deputy Director Che Mohd. Zin Che Awang 244
– 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
– Cosmetic / Nutritional Supplements
– Poisons Unit
– Non Poisons Unit
– Traditional Medicines Unit
– New Chemical Entity Unit
– Cosmetic / Nutritional Supplements Unit
Fudziah Ariffin (Head)
Tan Lie Sie (Head)
Napsah Mahmud (Head)
Dr. Ramli Ghani (Head)
Ramli b. Zainal (Head)
233
240
238
239
241
– Manufacturer’s Licence
– Import Licence
– Wholesaler’s Licence
– Clinical Trial Import Licence
– Report of Adverse Drug Reaction
– Marketing Surveillance Programme
– Product Complaints / Product Recalls
GMP and Licensing Division
New Chemical Entity Unit
Pharmacovigilance Division
Eishah Abd. Rahman (Head)
Dr. Ramli Ghani (Head)
Abida Haq (Head)
205
239
258
– Good Manufacturing Practice
– Good Storage Practice
GMP and Licensing Division Eishah Abd. Rahman (Head 205
– Drug Information
– Library
– Classification of Products
Organisational Development & Information Technology 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) 259
– Payment for Laboratory Tests Laboratory Service Unit Choy Khye Moon 212
– Submission of Samples for Stage 2 of Registration Application Laboratory Officers on Duty (according to schedule)  
– Submission of Letters for Drug Evaluation and Safety Division Receiving Counter Administrative Assistant  
– Collection of Application Forms
– Purchase of NPCB Publications/Guidelines
Administrative Division Rosnani Yusoff (Head) 203
– General Inquiries and Technical Information
– Classification of Products
Public Affairs Unit Rosnaini Kamaruddin (Head) 223