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 APPLIEDcertificate.3. Official letter from product owner authorizing themanufacturer with new name to manufacture thedrug product.4. Revised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).2. Replacement, addition ordeletion of company logoon the packagingcomponents (without anychanges ongraphic or label content)D1D2D3D1D2D3SUPPORTING DOCUMENTRevised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 448
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE I(MINOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED3. Change in product owner E1.1E1.2E2.1E2.2E12D1D2D3(if applicable)E1F1F2.1F2.2F12D1D2D3(if applicable)CONDITIONS1. The Product Registration Holder remains the same.Submission shall be done by current PRH.2. The manufacturing site remains the same.SUPPORTING DOCUMENTS1. Letter of confirmation for change in productownership countersigned by both old and newproduct owner.2. Official letter from the new product owner declaringthe change, and authorizing the local license holderto be responsible for the product license.3. In the case of a contract manufacturer, newproduct owner to issue Letter Of Appointment tocontract manufacturer and contract manufacturer toissue Letter Of Acceptance.4. Revised labels and package insert (if applicable).4. Change in importer/ storeaddress.E13.1(importer)E15(store address)E2.1(importer)E4(store address)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 449
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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