DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No.FieldGeneral orNutritionalClaimsFunctionalClaimsB4Finished Product Specification (FPQC)√* LOC to submitdata during postregistration√B5 Stability Data (Please refer page 24) √ √D1 Label for immediate container √ √D2 Label for outer carton (if applicable) √ √D3Proposed package insert / Product informationleaflet (if applicable)√√E1 Company name and address of product owner √ √E2Company name and address ofmanufacturer(s)√√E3Company name and address of repacker(if applicable)√√E4Company name and address of othermanufacturer (if applicable)√√E5 Store address(s) √ √E6 Importer(s) √ √F1Letter of authorization from product owner tomarketing authorization holder (if applicable)√√F2Letter of Appointment of ContractManufacturer/ Repacker from Product Owner(if applicable)√√F3Letter of Acceptance from ContractManufacturer/ Repacker (if applicable)√√F4Certificate of Pharmaceutical Product (CPP)- Applicable to imported products, must beissued by the competent authority in thecountry of origin. CPP issued by referencecountry may be considered.√√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 222
Drug Registration Guidance Document (<strong>DRGD</strong>)No.FieldGeneral orNutritionalClaimsFunctionalClaimsF5Certificate of Free Sale (CFS)- Applicable if CPP is not available, must beissued by the competent authority in thecountry of origin/ products owner country.√√F6Certificate of Good Manufacturing Practice(GMP)- Applicable if CPP is not available, must beissued by the competent authority in themanufacturing country.√√F9Attachment of protocol analysis√- dosage formextendedrelease* LOC to submitduring post forother types ofdosage form√- dosage formextendedrelease- validation ofanalyticalmethod fornew actives ornewcombinationdosageF10Attachment of Certificate of finished product(COA of finished product)√* LOC to submitduring postregistration√F11Attachment of Specifications and Certificate ofAnalysis (COA) of Active Ingredient√√Examples of supporting documentsDioxin level test results (for product containingingredients derived from seafood)F12Certificate of Good Manufacturing Practice(GMP) for premixed active ingredientsHormone free test results(for placenta products)√√Declaration letter from product manufacturer onthe hormone - free status for product containingplacentaNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 223
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Page 172 and 173: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 238 and 239: 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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