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EU Parl Watch

Where the law stands, Dossier 2025/0102(COD)

Framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest

Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

· First reading

A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.

Where it stands

Negotiations with the Council

Parliament’s committee approved the deal reached with the Council on 14 July 2026; the plenary vote on it is still to come.

  1. Referred to committee(done) 21 May 2025
  2. Committee work(done) Report adopted 15 December 2025
  3. Tabled for plenary(done) 19 December 2025
  4. Plenary vote(done) Adopted 20 January 2026
  5. Negotiations with the Council Deal approved in committee 14 July 2026
  6. Published as law(to come)

Decided in plenary

20 January 2026 · decision 1

Economy & single market, New EU law

Framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest

Passed 503 for · 57 against · 108 abstained by a large majority

AI summary:The position also calls for better use of existing data tools and involvement of stakeholders across the supply chain.

What changed

  • Latest Tabled for plenary → Adopted by Parliament

    AI summary:Adds provisions on contraceptives and abortifacients, defining them as medicinal products of common interest and requiring Member States to ensure their supply. Extends strategic project criteria to include reserving manufacturing capacity and adds requirements for financial support to ensure availability and affordability. Defines 'systemic wholesaler' and adds conditions for determining significant Union manufacture, including thresholds for active substance production. Lowers the threshold for joint procurement requests from five Member States and adds health security aspects to strategic partnerships. The other changes are formal or wording: typo fixes, terminology alignment, and removal of the report's justification section.

    See the changes →

Who works on it

Lead committee
Public Health
Tomislav Sokol (EPP)
Tiemo Wölken (S&D), Ondřej Knotek (Patriots), Aurelijus Veryga (ECR), Vlad Vasile-Voiculescu (Renew), Tilly Metz (Greens), Catarina Martins (The Left), Christine Anderson (ESN)
Committees giving an opinion

The text, version by version

Newest first.

  1. Adopted by Parliament· 20 Jan 2026

    Adopted text TA10-0001/2026

    AI summary:Parliament's amended version of the proposed regulation lays down a framework to strengthen the security of supply and availability of critical medicinal products and improve access to medicinal products of common interest.

    What changed since Report A10-0272/2025 →

  2. Tabled for plenary· 19 Dec 2025

    Report A10-0272/2025

    AI summary:Parliament's amended version of the proposed regulation aims to strengthen the security of supply and availability of critical medicinal products and improve access to medicinal products of common interest in the EU.

    What changed since Draft report (SANT) →

  3. Committee draft· 18 Jul 2025

    Draft report (SANT)

    AI summary:The draft report proposes amendments to the Commission's regulation on critical medicinal products, aiming to strengthen supply security and availability, and to improve access to medicinal products of common interest.

Committee opinions: Draft opinion (ITRE), Draft opinion (ENVI), Opinion (ITRE), Draft opinion (IMCO), Opinion (IMCO), Opinion (ENVI)

Timeline

Newest first.

Negotiations with the Council 5 steps

  1. 14 July 2026

    Committee approved the deal reached with the Council

    The provisional agreement from the trilogues goes to the whole Parliament for a vote.

  2. 11 May 2026

    Trilogue meeting

    Negotiation between Parliament, Council and Commission on a common text.

  3. 16 March 2026

    Trilogue meeting

    Negotiation between Parliament, Council and Commission on a common text.

  4. 2 February 2026

    Trilogue meeting

    Negotiation between Parliament, Council and Commission on a common text.

  5. 20 January 2026

    Parliament opened negotiations with the Council

    After its vote Parliament sent the file back to committee, so that its negotiators can seek a compromise text with the Council (in “trilogues”).

Plenary stage 4 steps

  1. 20 January 2026

    Plenary vote

    Sitting of 20 Jan 2026 Adopted text TA10-0001/2026Report A10-0272/2025

  2. 19 January 2026

    Debated in plenary

    MEPs debated the text in the chamber ahead of the vote.

    Sitting of 19 Jan 2026 Council / Commission text C10-0048/2025Report A10-0272/2025

  3. 13 January – 19 January 2026

    260 amendments tabled for the plenary vote

    Groups propose changes to the tabled text; each is voted on before the final vote.

    Amendments 1–242Amendments 243–252Amendments 253–255Amendments 256–257Amendment 258Amendments 259–260

  4. 19 December 2025

    Report tabled for plenary

    This is the text all MEPs vote on. Political groups can still table amendments to it.

    Report A10-0272/2025

Committee stage 7 steps

  1. 15 December 2025

    Committee vote: report adopted

    SANT (Public Health) voted on the amendments and adopted the report that goes to plenary.

  2. 11 November 2025

    ITRE (Industry, Research and Energy) adopted its opinion

    The opinion is attached to the report for the lead committee to consider.

    Opinion (ITRE)

  3. 11 November 2025

    IMCO (Internal Market and Consumer Protection) adopted its opinion

    The opinion is attached to the report for the lead committee to consider.

    Opinion (IMCO)

  4. 4 November 2025

    ENVI (Environment, Climate and Food Safety) adopted its opinion

    The opinion is attached to the report for the lead committee to consider.

    Opinion (ENVI)

  5. 26 September – 13 October 2025

    Amendments tabled in committee (3 batches)

    Members of SANT (Public Health) proposed changes to the draft.

    Amendments in committee (SANT)Amendments in committee (SANT)Amendments in committee (SANT)

  6. 18 July 2025

    Draft report published

    The rapporteur’s first text in SANT (Public Health). Members can table amendments before the committee votes.

    Draft report (SANT)

  7. 21 May 2025

    Referred to the SANT (Public Health) committee

    The lead committee prepares the report; ENVI (Environment, Climate and Food Safety), IMCO (Internal Market and Consumer Protection), ITRE (Industry, Research and Energy) give an opinion.

Official record: Legislative Observatory, 2025/0102(COD)