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Detailed GuideMHRA

Handling of Active Substance Master Files and Certificates of Suitability

The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.

First published: Dec 31, 2020Last updated: Oct 18, 2024Changes: 2

Latest change: • Added section numbers and document overview • Updated all sections for clarity and territorial changes GB revised to UK • Added details of changes with respect to the Windsor framework following implementation and external references • Updated section 4 contact information

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