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2023/0131(COD)

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.

Summary: This proposal aims to establish rules for how medicines for people would be authorised and monitored to ensure they are safe and effective. It would set out the procedures and requirements that pharmaceutical companies must follow to get approval for their medicines. The proposal would also define how the European Medicines Agency would oversee and supervise these products throughout their use.

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Posted 28 September 2026

As published — the exact text this tracker posted, kept verbatim for the record
2023/0131(COD) | European Medicines Agency Reform Council of the EU 📅 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. Summary: This proposal aims to establish rules for how medicines for people would be authorised and monitored to ensure they are safe and effective. It would set out the procedures and requirements that pharmaceutical companies must follow to get approval for their medicines. The proposal would also define how the European Medicines Agency would oversee and supervise these products throughout their use. [AI-Generated] Source: OEIL procedure file 2023/0131(COD)

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