DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE I(MINOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED5. Change or addition ofimprints, bossing orother markings (exceptscoring/break lines) ontablets or printing oncapsules, includingreplacement, or additionof inks used for productmarking.A4P1P5.1P5.2D3E8(if applicable)E9A2D3F8(if applicable)B4F9CONDITIONS1. Any new ink must be of oral pharmaceutical/ foodgrade and not a listed banned substance.2. Release and end-of-shelf life specifications of thedrug product remain unchanged except forappearance.3. New markings do not cause confusion with otherregistered products.SUPPORTING DOCUMENTS1. Revised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).2. Release and end-of-shelf life specifications of thedrug product with the new product description.3. Certificate of analysis (CoA) of new ink.4. Details of the proposed new inks (whereapplicable)5. Detailed drawing or written description of thecurrent and proposed imprint/ bossing/ markings.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 456
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE I(MINOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED6. Change in shape ordimensions of thecontainer or closurewithout any otherchanges.P7C (if applicable)C (if applicable)CONDITIONS1. The primary packaging material of container orclosure remains the same.2. Not applicable for sterile products.3. No change is made to the product shelf life and/orstorage conditions.4. No change in the qualitative or quantitativecomposition of the container and/or closure and thechange do not affect the delivery, use, safety orstability of the drug product.SUPPORTING DOCUMENTSRevised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).7. Change in pack size ofthe drug product(Finished product),without change inprimary packagingmaterial.Change in the numberor units (e.g. tablets,ampoules) in a pack.CD1D2D3E8(if applicable)P7CD1D2D3F8(if applicable)CONDITIONS1. The primary packaging material of container orclosure remains the same. Primary packagingmaterial is the material that is in contact with thefinished product and may affect the delivery, use,safety or stability.2. No other changes to the label/ package insertexcept for the pack size.3. The new size is consistent with the dosageregimen and duration of use as approved in theNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 457
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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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