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)

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]

Council adopted its 1st-reading position 28 September 2026

Record as of 28 September 2026 — the most recent action in the official record. Status can lag; each step below carries its own date.

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.
18 March 2026 Lead committee approved the trilogue deal
13 more actions
1. 6 March 2026 Endorsement of the provisional agreement by Coreper
2. 19 December 2025 Deliberations in Coreper
3. 3 December 2025 Deliberations in Coreper
4. 14 November 2025 Deliberations in Coreper
5. 7 November 2025 Deliberations in Coreper
6. 15 October 2025 Deliberations in Coreper
7. 1 October 2025 Deliberations in Coreper
8. 25 September 2025 Deliberations in Council working party
9. 22 September 2025 Deliberations in Council working party
10. 3 September 2025 Deliberations in Council working party
11. 9 July 2025 Deliberations in Council working party
12. 25 June 2025 Deliberations in Coreper
13. 24 June 2025 Deliberations in Council working party
16 June 2025 Committee decision to enter into interinstitutional negotiations announced in plenary (Rule 73)
1 more action
1. 4 June 2025 Adoption of negotiating mandate by Coreper
3 June 2025 Committee decision to open interinstitutional negotiations after 1st reading in Parliament
12 more actions
1. 21 May 2025 Adoption of negotiating mandate by Coreper
2. 14 May 2025 Adoption of negotiating mandate by Coreper
3. 12 May 2025 Deliberations in Council working party
4. 6 May 2025 Deliberations in Council working party
5. 5 May 2025 Deliberations in Council working party
6. 28 April 2025 Deliberations in Council working party
7. 15 April 2025 Deliberations in Council working party
8. 8 April 2025 Deliberations in Council working party
9. 3 April 2025 Deliberations in Council working party
10. 18 December 2024 Deliberations in Coreper
11. 22 November 2024 Deliberations in Coreper
12. 20 November 2024 Deliberations in Coreper
13 November 2024 Resumption of business from the previous parliamentary term
10 April 2024 Parliament adopted its 1st-reading positionVerified by one of two sources
3 more actions
1. 10 April 2024 Debate in Parliament
2. 10 April 2024 Results of vote in Parliament
3. 21 March 2024 Committee report tabled for plenary, 1st reading
19 March 2024 Lead committee adopted its report
4 more actions
1. 25 October 2023 European Economic and Social Committee opinion
2. 14 September 2023 Referral to associated committees announced in Parliament
3. 14 September 2023 Committee referral announced in Parliament, 1st reading
4. 19 June 2023 European Data Protection Supervisor opinion
26 April 2023 New legislative proposal

This path starts where the file does — the legislative proposal in the official record. Routine procedural steps sit in the “more actions” rows above rather than on the main line.

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