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2023/0131(COD)

Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency

SANT · Tiemo Wölken (S&D)

28 September 2026  |  Council adopted its 1st-reading position

What's next: Parliament's 2nd reading: 3 months (+1 on request) to approve the text (the act is then adopted), amend it, or reject it — amendment or rejection needs an absolute majority of all MEPs (361 of 720). Approval is likely here: the position reflects a negotiated deal.

Posted 28 September 2026

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