DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 226
Drug Registration Guidance Document (<strong>DRGD</strong>)No.FieldGeneral orNutritionalClaimsFunctionalClaimsManufacturing process validation report ifapplicableLetter of commitment if applicableEtc.* Complete stability study conducted at 30 ± 2 ºC / RH 75 ± 5%, IPQC, FPQC, protocol analysisand COA of finished product are required to be submitted 2 years after product registration withSAMPLE of the products. Failure on submission will cause the product be suspended until thecomplete documents are submitted, the registration of the product will be terminated if thecomplete documents still cannot be produced upon renewal of product registration.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 227
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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