DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)SECTION D: INSPECTION & LICENSINGInspection and licensing of manufacturing premises or facilities, importers and wholesalersof registered products or notified cosmetics on the basis of compliance with GoodManufacturing Practice (GMP) as well as Good Distribution Practice (GDP) are vitalelement of drug control. Compliance to GMP is a prerequisite for the application of amanufacturing license as well as product registration or cosmetic notification whereascompliance to GDP is a prerequisite for the application of a wholesale license or importlicense.12. INSPECTIONInspection of GMP and GDP are conducted to ensure manufacturers‟, importers‟ andwholesalers‟ compliance towards the current GMP and GDP requirements besidesensuring the registered products and notified cosmetics that are put in the market are safe,efficacious and of quality.The related GMP and GDP guidelines referred are as below in Table XII:GuidelinesPIC/S Guide to Good ManufacturingPractice for Medicinal Products *GMP Guideline for Traditional Medicinesand Health Supplements, 1 st Edition, 2008Guidelines on Good Manufacturing Practice(GMP) for Cosmetic (Annex 1, Part 9)Supplementary Guidelines on GMP forVeterinary Premixes, Supplements andHerbal/ Natural Preparations, 1 st Edition, 1January 2012Guidelines on Good Distribution Practice(GDP); 1st Edition 2011Product Type/ CategoryPharmaceuticals(Poison and Non-Poison)Veterinary ProductsTraditional ProductsHealth SupplementsCosmeticsVeterinary ProductsFor activities related to the storage anddistribution by manufacturers, importersand wholesalers (where applicable)* Refer to Pharmaceutical Inspection Co-operation Scheme (PIC/S) website at www.picscheme.orgNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 100
Drug Registration Guidance Document (<strong>DRGD</strong>)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
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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