DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)1.3 CHARGES FOR APPLICATION OF LICENSES1.3.1 Before a product is registered, the applicant shall apply for a manufacturerlicense. The processing fee is as specified below:License Processing fee Timeline Validity1. Manufacturer RM 1,000.00 Not more than 1 month 1 year1.3.2 After a product is registered, the applicant shall apply for an import/ wholesalelicense. The processing fees are as specified below:License Processing fee Timeline Validity1. Import RM 500.00 Not more than 1 month 1 year2. Wholesale RM 500.00 Not more than 1 month 1 year1.4 CHARGES FOR AMENDMENTS TO PARTICULARS OF AREGISTERED PRODUCTTypes of AmendmentPharmaceuticalProcessing feeNatural Product1. Change of Manufacturing Site(Type II, III, IV, V)RM 1,000.00 RM 500.002. Change of Product Registration Holder RM 1,000.00 RM 500.00National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 124
Drug Registration Guidance Document (<strong>DRGD</strong>)1.5 FEE FOR CERTIFICATESUnder the CDCR 1984, Regulation 16: “The Director of Pharmaceutical Services may issuesuch certification on any matter relating to any product where such certification is requiredby any country importing such a product.”Certificates Fee ValidityIssuance of one (1) Certificate ofPharmaceutical ProductRM 50.002 yearsIssuance of one (1) Certificate of GoodManufacturing Practice (GMP)RM 50.002 yearsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 125
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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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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