Transcription of Guidance Applicants Preparation Precise Scope Section ...
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Guidance Applicants Preparation Precise Scope Section ...
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 30 June 2017 EMA/220707/2017 Procedure Management and Committees Support Division Guidance for Applicants for the Preparation of the Precise Scope Section of the variation application form Introduction This Guidance aims at supporting marketing authorisation holders (MAHs) in completing the ' Precise Scope and Background for a change, and Justification for grouping, worksharing and classification for unforeseen changes (if applicable)' (hereinafter called the ' Precise Scope ') Section of the
Content of the section . As detailed in . EudraLex Volume 2B - Presentation and content of the dossier , the ‘Application for Variation to a Marketing Authorisation’ Form includes a free text section to detail the ‘Precise Scope’. This section should include a brief explanation of the change(s) applied for . When the change(s) is/are
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