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EU post-authorisation variations: procedures, classifications and practical guidance for amending marketing authorisations of human medicines, including grouping, worksharing, Brexit impact, proposed reforms, and centralised, mutual recognition and national routes

Practice notes
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In the EU, a medicinal product may only be supplied and used in line with the terms and conditions of its approval, known as a marketing authorisation (MA). The MA decision and its contents are set according to the requisite information and data the marketing authorisation holder (MAH) provides during the marketing authorisation application (MAA) process...

Extensive guidance on EU MAA procedures and on what MAs contain is given in Practice Notes: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products, and Marketing authorisations in the EU—content and form of the application and other practical considerations...

For discussion of the impact of Brexit on authorisations of medicines for the EU and UK, including Northern Ireland, see Practice Notes: UK marketing authorisations for medicinal products, particularly the MA variations section...

However, regulatory submissions do not stop once a medicine is approved. Throughout a product’s development and supply lifecycle, changes arise that affect the particulars in an MA decision and/or its technical dossier. Medicine developers must continually update their MA terms to mirror the current understanding of quality, safety...

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Web page updated on 21/05/2026

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