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Regulatory Affairs for Food, Pharmaceutical & Cosmetics Products [Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) / National Pharmaceutical Control Bureau (NPCB)]

Under Malaysia's Control of Drugs and Cosmetics Regulations 1984, registration is mandatory for all pharmaceutical products (unless specifically exempted by the Regulations) before they can be manufactured, distributed or imported into Malaysia. A foreign company shall have to appoint a Product Holder, who will then be responsible for all matters relating to product quality, safety and efficacy, to obtain product registration.

 

We have the expertise and in depth knowledge in dealing with all these registrations.

 
  • Pharmaceutical Product Registration (MAL Application)

  • Traditional Product Registration (MAL Application)

  • Cosmetic Product Notification

  • Product Information File (PIF) Compilation

  • Manufacturing License Application

  • Distribution License Application

  • Import License Application

  • Change of Product Holder

  • Change of Manufacturing Site

  • Certificate of Pharmaceutical Product (CPP) Application

  • Certificate of Free Sale (CFS) Application

  • GMP Letter Application

  • Application for Import Permit for Unregistered Live Saving Product

  • KLIU Application
Kindly contact our associate partner. Jascal Management & Consultancy.
 
 
 
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