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2025/0102(COD)

Critical Medicines Act

Basic information

2025/0102(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Amending Regulation 2024/795 2023/0199(COD)

Subject

4.20 Public health
4.20.01 Medicine, diseases
4.20.04 Pharmaceutical products and industry
4.20.05 Health legislation and policy

Legislative priorities

Joint Declaration 2026

Status

Awaiting Parliament's position in 1st reading

Please go to Documentation gateway for any follow-up documents.

Key players

Key events

Date Event Reference Summary
11/03/2025 Legislative proposal published COM(2025)0102
21/05/2025 Committee referral announced in Parliament, 1st reading
15/12/2025 Vote in committee, 1st reading
19/12/2025 Committee report tabled for plenary, 1st reading A10-0272/2025
19/01/2026 Debate in Parliament
20/01/2026 Decision by Parliament, 1st reading T10-0001/2026
20/01/2026 Results of vote in Parliament
20/01/2026 Matter referred back to the committee responsible for interinstitutional negotiations

Technical information

Procedure reference 2025/0102(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype Legislation
Legislative instrument Regulation
Amendments and repeals Amending Regulation 2024/795 2023/0199(COD)
Legal basis Rules of Procedure EP 58 Treaty on the Functioning of the EU TFEU 114
Other legal basis Rules of Procedure EP 165
Mandatory consultation of other institutions European Economic and Social Committee
Stage reached in procedure Awaiting Parliament's position in 1st reading
Committee dossier SANT/10/02427

Documentation gateway

  • Document type Committee Reference Date Summary
    Committee draft report PE775.742 18/07/2025
    Amendments tabled in committee PE778.033 24/09/2025
    Amendments tabled in committee PE778.034 24/09/2025
    Amendments tabled in committee PE778.035 24/09/2025
    Amendments tabled in committee PE778.025 26/09/2025
    Amendments tabled in committee PE778.031 13/10/2025
    Amendments tabled in committee PE778.032 13/10/2025
    Committee opinion ENVI PE775.606 06/11/2025
    Committee opinion ITRE PE774.586 11/11/2025
    Committee opinion IMCO PE776.854 11/11/2025
    Amendments tabled in committee PE781.465 16/12/2025
    Committee report tabled for plenary, 1st reading/single reading A10-0272/2025 19/12/2025
    Text adopted by Parliament, partial vote at 1st reading/single reading T10-0001/2026 20/01/2026
  • Document type Reference Date Summary
    Legislative proposal COM(2025)0102 11/03/2025
    Document attached to the procedure SWD(2025)0263 02/09/2025
  • Document type Parliament/Chamber Reference Date Summary
    Contribution ES_PARLIAMENT COM(2025)0102 17/06/2025
    Contribution IT_CHAMBER COM(2025)0102 24/06/2025
    Contribution CZ_SENATE COM(2025)0102 24/06/2025
    Contribution RO_SENATE COM(2025)0102 25/06/2025
    Reasoned opinion SE_PARLIAMENT PE774.572 10/07/2025
    Contribution IT_SENATE COM(2025)0102 15/07/2025
    Reasoned opinion FR_SENATE PE775.747 24/07/2025
    Contribution IT_SENATE COM(2025)0102 28/07/2025
    Reasoned opinion IT_SENATE PE776.742 29/07/2025
    Contribution DE_BUNDESRAT COM(2025)0102 11/08/2025
    Contribution FR_SENATE COM(2025)0102 10/11/2025
    Contribution RO_CHAMBER COM(2025)0102 27/12/2025
  • Institution/body Document type Reference Date Summary
    EESC Economic and Social Committee: opinion, report CES1074/2025 18/06/2025
    CofR Committee of the Regions: opinion CDR1935/2025 10/12/2025

Additional information

Source Document Date
European Commission EUR-Lex

Transparency

Meetings with interest representatives published in line with the Rules of Procedure

  • Name Role Committee Date Interest representatives
    SOKOL Tomislav Rapporteur SANT 29/01/2026 MEDICINES FOR EUROPE
    VIVALDINI Mariateresa Shadow rapporteur for opinion IMCO 21/01/2026 A. Menarini Industrie Farmaceutiche Riunite s.r.l.
    SOKOL Tomislav Rapporteur SANT 21/01/2026 Deputy Permanent Representative of Poland to the EU
    KNOTEK Ondřej Shadow rapporteur SANT 21/01/2026 A. Menarini Industrie Farmaceutiche Riunite s.r.l.
    SOKOL Tomislav Rapporteur SANT 20/01/2026 Deputy Permanent Representative of Austria to the EU
    SOKOL Tomislav Rapporteur SANT 20/01/2026 Minister of Health of the Republic of Cyprus
    SCHENK Oliver Rapporteur for opinion ITRE 13/01/2026 Bundesverband der Pharmazeutischen Industrie e.V.
    SOKOL Tomislav Rapporteur SANT 10/12/2025 Senior Vice President, Head of Government Relations, HIMSS - Healthcare Information and Management Systems Society
    SMITH Anthony Rapporteur for opinion ITRE 09/12/2025 Association action croisée
    SMITH Anthony Rapporteur for opinion ITRE 09/12/2025 Rozenn le Saint