DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)m) Importer and Store AddressPlease key in (where applicable).n) Other Supporting DocumentPlease attach (if any).PART II, III & IV – QUALITY , NONCLINICAL DOCUMENT & CLINICALDOCUMENTIn order to complete these parts, please refer the main DRGD as well as ASEANCommon Technical Requirements Guidance Documents, and the followingdocuments (where applicable):a) Appendix 2: Requirements for Product Registrationb) Appendix 3: Guidelines on Registration of Biologicsc) Appendix 4: Guideline on Registration of Health Supplementsd) Appendix 5: Guideline on Registration of Natural Productse) Appendix 6: Guideline on Regulatory Control of Active PharmaceuticalIngredients (API)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 446
Drug Registration Guidance Document (DRGD)APPENDIX 12CONDITIONS AND SUPPORTING DOCUMENTS REQUIRED FOR AN APPLICATION OFVARIATIONa) VARIATION TYPE I (MINOR VARIATION)NO.VARIATION TYPE I(MINOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED1. Change in name ofmanufacturer and/or othermanufacturers withoutany change in address ofsite.E13(manufacturer)E14 (othermanufacturers)D1D2D3E6E12E2 (manufacturer)E3 (othermanufacturers)D1D2D3F6F12CONDITIONS1. The manufacturing/ other manufacturing site of thedrug product remains unchanged.2. No other changes to the label/ package insertexcept for the change of the name of amanufacturer/ other manufacturers of the drugproduct.3. The manufacturing site remains the same.SUPPORTING DOCUMENTS1. For local manufacturers/ other manufacturers:Certificate of name change i.e. Form 13 CompanyAct 1965.(Please attach the supporting document at E12/F12).2. For foreign manufacturers/ other manufacturers:A valid Good Manufacturing Practice (GMP)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 447
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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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