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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

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

Status

Awaiting committee decision

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

Forecasts

Date Subject
19/01/2026 Indicative plenary sitting date, 1st reading

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 committee decision
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 PE778.025 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
  • 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

Transparency

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