DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED2. Change in content ofleaflet or prescribinginformation/ PIL/ SPC.A1 – A17D1D2D3E7E8(if applicable)A1 – A13D1D2D3F7F8F12CONDITIONAs a subsequent change due to revision of datasheetapproved by regulatory authority e.g. Summary ofProduct Characteristics (SPC), or US Package Insert(USPI) or equivalent document.For natural products:Proposed indication shall be within those listed underAppendix 5.SUPPORTING DOCUMENTS1. For all types of product please provide reviseddrafts of the package insert and labelingincorporating the proposed variation with:a. Copy with amendments clearly marked.b. Clean copy of the proposed new packageinsert.2. For innovator product please provide:a. Datasheet approved by regulatory authoritye.g. Summary of Product Characteristics(SPC), or US Package Insert (USPI) orequivalent document.b. Conclusion or abstract of recent PeriodicSafety Update Report where applicable.c. Expert Clinical Report (if applicable)d. Company Core Datasheet where applicable.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 462
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED3. For generic product please provide supportingdocuments e.g. Martindale or equivalentdocument to support the change.4. For natural products, please provide:a) Justification for the proposed change.b) Supporting documents from the clinicalpapers, Chinese Pharmacopoeia and/orherbal monograph/ compendium on thetherapeutic uses and safety aspect of therelevant active ingredient/s.3. Change in content of labelinclusive of change ingraphics/ artwork.D1D2D3D1D2D3CONDITIONSFor Natural Products Please refer to (List ofProhibited Visuals/ Graphics On Label of NaturalProducts in Appendix 5)SUPPORTING DOCUMENTRevised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 463
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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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