guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical Product5.4 Safety and Efficacy changes5.4.1 Human and Veterinary Pharmaceutical ProductsDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype54 Change in the Summary of Product Characteristics, Labelling or Package Leaflet following aprocedure in accordance with Article 30 or 31 of Directive 2001/83/EC or Articles 34 or 35 ofDirective 2001/82/EC (referral procedure)54a54bThe medicinal product is covered by thedefined scope of the referralThe medicinal product is not covered by thedefined scope of the referral but the changeimplements the outcome of the referral andno new additional data are submitted by theMAHDocumentation required1-3 IN1-3 Vmin1. A reference of the EU Commission Decision concerned with the annexed Summary of ProductCharacteristics, Labelling or Package Leaflet2. A declaration that the proposed Summary of Product Characteristics, Labelling and Package Leafletis identical, for the concerned sections to that annexed to the Commission Decision on the referralprocedure for the reference pharmaceutical product3. Revised product informationDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype55 Change in the Summary of product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar pharmaceutical product following assessment of the same change for thereference (innovator) product55a55bImplementation of change(s) for which nonew additional data are submitted by theMAHImplementation of change(s) whichrequire to be further substantiated by newadditional data to be submitted by the MAH(e.g. comparability)1 Vmin1,2 VmajDoc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 58 of 70
Guidelines on Variations to a Registered Pharmaceutical ProductDocumentation required1. Revised product information2. Applicable additional dataDescription of changeConditions to befulfilledDocumentationrequiredReportingtype56 Implementation of change(s) requested by NDA (National Drug Authority) following assessment ofan Urgent safety restriction, class labelling or periodic safety update report56a56bImplementation of agreed wordingchange(s) for which no new additionaldata are submitted by the MAHImplementation of change(s) whichrequire to be further substantiated bynew additional data to be submitted bythe MAHDocumentation required1. NDA request with attached relevant assessment report, if available2. Revised product information1,2 VminVmajDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype57 Variations related to significant modifications of the Summary of Product Characteristics due inparticular to new quality, pre-clinical, clinical or pharmacovigilance dataVmajDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype58 Change(s) to therapeutic indication(s)58aAddition of a new therapeutic indication ormodification of an approved oneVmaj58b Deletion of a therapeutic indication VminNote: Where the addition or modification of a therapeutic indication takes place in the context of theimplementation of the outcome of a referral procedure or of changes to the product information of ageneric/hybrid/biosimilar product following assessment of the same change for the reference (innovator)product, variations 54 and 55 apply, respectively.Doc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 59 of 70
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