Guidance Applicants Preparation Precise Scope Section ...
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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Q12 Step 2b Technical and regulatory …
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