DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No.FieldGeneral orNutritionalClaimsFunctionalClaimsA8 Drug Interaction, if applicable √ √A9 Side Effects/ Adverse Reactions, if applicable √ √A10Signs and Symptoms of overdose andtreatment, if applicable√√A11Storage Condition- According to stability data√√Shelf lifeA12- Must be supported by stability study- Please refer to B5√√A13Therapeutic Code- As a health supplement√√B1.1 Batch Manufacturing Formula √ √B1.2List of Active ingredient(s)- BSE/ TSE free certificate if active ingredientfrom animal sourceB1.3 List of excipient(s) √ √B1.4Attachment of Batch Manufacturing Formula- Shall be on the product owner‟s/manufacturer‟s original letterhead, productdetails, date and signature & designation ofauthorized personnelB2.1 Manufacturing Process √ √√√√√B2.2Attachment of Manufacturing ProcessDocument or Manufacturing Flow Diagram√√B3In-Process Quality Control (IPQC)√*LOC to submitdata during postregistration√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 224
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 | 225
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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