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 APPLIED10. Change in secondarypackaging material (orchange in any part of theprimary packagingmaterial that is not incontact with the finishedproduct (e.g. colour of flipoff caps, colour code ringson ampoules, change ofneedle shields i.e.different plastic used).CD2D3P7CD2D3CONDITIONS1. The primary packaging material of container orclosure remains the same.2. The change does not affect the delivery, use,safety or stability of the finished productSUPPORTING DOCUMENTRevised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).11. Change in testingprocedure of an excipientP4.2P4.3Not applicableCONDITIONSpecifications of the excipient and drug product(finished product) remain the same.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 460
Drug Registration Guidance Document (DRGD)b) VARIATION TYPE II (MAJOR VARIATION)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED1. Change of product name. A1D1D2D3E4(if applicable)E8 (if applicable)A1D1D2D3(if applicable)F4(if applicable)F8 (if applicable)CONDITIONS1. No change to product (formulation, specificationetc) except for the product name2. No confusion with other already registeredproduct‟s name.3. The new name does not (1) suggest greater safetyor efficacy than supported by clinical data (2)imply a therapeutic use (3) imply superiority overanother similar product (4) imply the presence ofsubstance(s) not present in the product.4. Health Supplements & Natural Products - Pleaserefer Appendix 4 and Appendix 5, respectively.SUPPORTING DOCUMENTS1. Revised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).2. Letter confirming change in name only issued bythe product owner or PRH.3. A declaration from the applicant that there is nochange to the product/ label except name.4. Updated CPP if applicable.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 461
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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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