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Detailed GuideMHRA

Medicines: apply for a variation to your marketing authorisation

Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.

First published: Dec 18, 2014Last updated: Jul 2, 2026Changes: 20

Latest change: Added section 'Deadlines for new therapeutic indication variations' to the section 'Variations to add a new therapeutic indication'.

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