guidelines on variations to a registered pharmaceutical product

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