guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
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Guidelines <strong>on</strong> Variati<strong>on</strong>s <strong>to</strong> a Registered Pharmaceutical Product5.4 Safety and Efficacy changes5.4.1 Human and Veterinary Pharmaceutical ProductsDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype54 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 <strong>product</strong> is covered by thedefined scope of the referralThe medicinal <strong>product</strong> is not covered by thedefined scope of the referral but the changeimplements the outcome of the referral andno new additi<strong>on</strong>al data are submitted by theMAHDocumentati<strong>on</strong> required1-3 IN1-3 Vmin1. A reference of the EU Commissi<strong>on</strong> Decisi<strong>on</strong> c<strong>on</strong>cerned with the annexed Summary of ProductCharacteristics, Labelling or Package Leaflet2. A declarati<strong>on</strong> that the proposed Summary of Product Characteristics, Labelling and Package Leafletis identical, for the c<strong>on</strong>cerned secti<strong>on</strong>s <strong>to</strong> that annexed <strong>to</strong> the Commissi<strong>on</strong> Decisi<strong>on</strong> <strong>on</strong> the referralprocedure for the reference <strong>pharmaceutical</strong> <strong>product</strong>3. Revised <strong>product</strong> informati<strong>on</strong>Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype55 Change in the Summary of <strong>product</strong> Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar <strong>pharmaceutical</strong> <strong>product</strong> following assessment of the same change for thereference (innova<strong>to</strong>r) <strong>product</strong>55a55bImplementati<strong>on</strong> of change(s) for which n<strong>on</strong>ew additi<strong>on</strong>al data are submitted by theMAHImplementati<strong>on</strong> of change(s) whichrequire <strong>to</strong> be further substantiated by newadditi<strong>on</strong>al data <strong>to</strong> be submitted by the MAH(e.g. comparability)1 Vmin1,2 VmajDoc. No.: DAR/GDL/005 Revisi<strong>on</strong> Date: 8 th July 2013 Review Due Date: 16 th July 2016Revisi<strong>on</strong> No.: 1 Effective Date : 16 th July 2013 Page 58 of 70