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Detailed GuideMHRA

Comparator products in bioequivalence/therapeutic equivalence studies

Information on comparator products used in studies supporting abridged marketing authorisation application.

First published: Dec 31, 2020Last updated: Dec 20, 2024Changes: 2

Latest change: Added section numbers and document overview. Updated all sections for clarity and territorial changes – GB revised to UK. Updated references to applicable regulations. Updated section 3.2 list of acceptable regulator countries. Updated section 4 contact details

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