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Guidance Document For Preparation of Good Manufacturing Practice (GMP) Inspections On Traditional Medicines, Health Supplements and Cosmetics Manufacturers, Fourth Edition, June 2024
- Industry
Industry - National Pharmaceutical Regulatory Agency (NPRA)...
- Consumers
Consumers - National Pharmaceutical Regulatory Agency (NPRA)...
- Health Professionals
Please report ALL suspected Adverse Drug Reactions (ADRs)...
- About NPRA
About NPRA - National Pharmaceutical Regulatory Agency...
- Biologic
Biologic - National Pharmaceutical Regulatory Agency (NPRA)...
- Combination Products
DEFINITION OF MEDICAL DEVICE. The term medical device...
- Cosmetic Products
A cosmetic product shall mean “any substance or preparation...
- Generic Medicines
Generic Medicines - National Pharmaceutical Regulatory...
- Industry
Jun 28, 2024 · For application of CPP, applicant shall fill in form BPFK 412.2: Permohonan Perakuan Keluaran Farmaseutikal. Upon receipt of complete application, the certificate shall be issued within fifteen (15) working days.
Aug 19, 2020 · Borang BPFK-413: Application for Licence for Registered Products (Manufacturer’s Licence, Import Licence, and Wholesaler’s Licence) only applicable for government agencies. Additional List of Licence for Registered Products.
Product Class boleh dibuat carian dengan perkataan: Poison, Non Poison, Health Supplement, Traditional, Posion Veterinary atau Non Poison Veterinary. QUEST3+.
BPFK Malaysia relationship started 30+ years ago, in registering products ranging from product gazetting into the food act to supplement (MAL), traditional (MAL), cosmetics (NOT) and food products registrations.
Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) yang dahulunya dikenali sebagai Makmal Kimia Ubat Kebangsaan ditubuhkan di bawah aktiviti Kawalan Kualiti Program Farmasi dan Bekalan. Institusi ini ditubuhkan untuk menjalankan ujian Kawalan Kualiti produk farmaseutikal. Apabila Peraturan Kawalan Dadah dan Kosmetik (Control of Drugs and Cosmetics Regulations) 1984 digubal dan Pihak Berkuasa ...
The basic requirements of GMP are that: all manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing traditional medicines and health supplements of the required quality and complying with their specifications;