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  • December 9, 2018 at 4:10 pm #285505

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    What specific requirements apply to my Type II variation for a new orphan Examples of changes in presentations for replacement, triggering a new EU
    21 Nov 2016 In both the Q&A guidance documents on the type II variations and the extension of marketing authorizations, EMA has revised the sections on
    This section provides guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations.
    2 Aug 2013 defined in Article 2 of the Variations Regulation: minor vari ations of Type Reference in these guidelines to the Agency means the European.
    New variations regulation: Regulatory and procedural guidance Transitional provisions for implementation of Commission Regulation (EU) No 712/2012
    following categories as defined in Article 2 of the variations regulation: minor Definitions relevant to this guideline are provided in Directive 2001/82/EC,
    12 Jul 2015 REGULATORY AFFAIRS – EUROPE EU: Variations to Marketing in European Union (EU) are regulated by following regulations and Guidelines: EXAMPLES OF TYPE IA VARIATIONS Type IA Changes – Only a minimal
    26 Oct 2009 to ICH concepts. – Further harmonise handling of variations in EU Classification Guideline complements Regulation by. – clarifying ‘scope’ of Other variations: Groups pre-defined in Annex III of Reg. Different Variations25 Jul 2017 When the European Commission’s guideline on classification states Extensions of a marketing authorisation are by definition considered
    defines variation types, a guideline lays out a harmonised list of anticipated variations with classification codes.1. A defined list of variations for European.

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