DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCESupplements,4.5 ProductName;Appendix 5:Guideline onRegistration ofNaturalProducts, 2.4Product Name.“If a product name is found similar to another registeredproduct or any other name which deemed inappropriate bythe Authority, NPCB reserves the rights to request for thechange of the product name.”b) Addition of the following paragraph at these twolocations:“Any product name which is the same or similar either inwriting/ pronunciation, with the product name of anadulterated product is prohibited.”11. May 2013Section E:Post-RegistrationProcessAddition of link to the directive and amendment ofprocedure at 16.3 Change of Product Registration HolderDirective No. 4 Year 2013(2)dlm.<strong>BPFK</strong>/PPP/07/25, 3Jun 2013: Direktif UntukMeminda ProsedurPertukaran PemegangPendaftaranNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 500
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Appearance/organoleptic(odor, color
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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