DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)12.1 FOREIGN GMP INSPECTIONPRH must provide acceptable evidence to show that the manufacturer of the productfollows an internationally accepted standard of Good Manufacturing Practice (GMP) andrecognized by the Authority in Malaysia.The Control of Drugs and Cosmetics Regulations 1984 (CDCR) requires that the standardof manufacture and quality control of medicinal products manufactured outside Malaysia istaken into consideration before the products are registered with the Authority. NPCB as thesecretariat to the DCA is responsible to ensure all manufacturers of registered products inMalaysia are able to provide acceptable evidence that the manufacturing premises conformto current GMP requirements. Hence, foreign manufacturers are also subjected to GMPconformity assessments through acceptable GMP evidence or GMP inspection.For details and forms, please refer Guidance Document on Foreign GMP Inspection.13. LICENSINGAccording to the Controls of Drugs and Cosmetics Regulations 1984, any company thatwant to manufacture, import or wholesale any registered products need to have a validManufacturer‟s License, Import License or Wholesale License.13.1 TYPES OF LICENSESTable XIII:Type of LicensesManufacturer‟s LicenseImport LicenseWholesaler‟s LicenseActivityLicensed Premises is allowed to:Manufacture registered products and to sell by wholesaleor supply their productsLicensed Premises is allowed to:Import and sell by wholesale or supply registered productsLicensed Premises is allowed to:Sell by wholesale or supply registered productsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 101