DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)1.1 CHARGES FOR USB TOKEN OF QUEST MEMBERSHIPApplicationcategoryFirst-time UserSupplementaryUserRenewal of USBtokenChargesPackage A(USB Token of 2-years validity + Guide Manual) : COST RM335Package B(USB Token of 1-year validity + Guide Manual) : COST RM320Package A(USB Token of 2-years validity + Guide Manual) : COST RM335Package B(USB Token of 1-year validity + Guide Manual) : COST RM320Package C1(New USB Token of 2-years validity) : COST RM280Package C2(Utilized old USB Token of 2-years validity) : COST RM100National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 128
Drug Registration Guidance Document (DRGD)1.2 PROCESSING AND ANALYSIS FEE FOR PRODUCT REGISTRATIONEvery application for registration shall be accompanied with a processing andanalysis fee, as specified below (effective 1 st January 2007):No.Category ofProduct* ProcessingFeesAnalysis FeesTotal FeesPharmaceuticalSingle active ingredient :RM 3,000.00RM 4,000.001.a) New DrugProductsRM 1,000.00b) BiologicsTwo or more active ingredients :RM 4,000.00RM 5,000.00Pharmaceuticala) Generic(ScheduledPoison)Single active ingredient :RM 1,200.00RM 2,200.002.b) Generic(Non-ScheduledPoison)c) HealthsupplementRM 1,000.00Two or more active ingredients:RM 2,000.00RM 3,000.003. Natural Product RM 500.00 RM 700.00 RM 1,200.00* As stipulated in the CDCR 1984, Regulation 8.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 129
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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