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
Status
Awaiting Parliament's position in 1st reading
Key players
-
European Parliament
Committee responsible Rapporteur Appointed SANTSOKOL Tomislav (EPP)
02/05/2025
Committee for opinion Rapporteur for opinion Appointed PICARO Michele (ECR)
18/06/2025
SCHENK Oliver (EPP)
15/04/2025
WALSMANN Marion (EPP)
23/06/2025
Committee for budgetary assessment Rapporteur for budgetary assessment Appointed BUDGThe committee decided not to give an opinion. -
European Commission
Commission DG Commissioner Health and Food Safety VÁRHELYI Olivér
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 |
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 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 -
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
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 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 Antoine Prioux SMITH Anthony Rapporteur for opinion ITRE 09/12/2025 Rozenn le Saint SOKOL Tomislav Rapporteur SANT 02/12/2025 EPP Health Ministers Meeting SOKOL Tomislav Rapporteur SANT 02/12/2025 Minister of Social Affairs of Estonia SOKOL Tomislav Rapporteur SANT 02/12/2025 Minister of Health of Cyprus WÖLKEN Tiemo Rapporteur SANT 02/12/2025 European Federation of Pharmaceutical Industries and Associations KNOTEK Ondřej Shadow rapporteur SANT 25/11/2025 PGEU SOKOL Tomislav Rapporteur SANT 25/11/2025 Deputy Permanent Representative of the Slovak Republic to the EU and Deputy Permanent Representative of the Czech Republic to the EU
-
Name Date Interest representatives GONZÁLEZ CASARES Nicolás 25/11/2025 Organon & Co FRAGKOS Emmanouil 05/11/2025 Giacomo Borgo NEVADO DEL CAMPO Elena 05/11/2025 FEDERACIÓN DE DISTRIBUIDORES FARMACÉUTICOS HADJIPANTELA Michalis 03/11/2025 AbbVie HADJIPANTELA Michalis 27/10/2025 Affordable Medicines Europe GONZÁLEZ CASARES Nicolás 22/10/2025 European Federation of Pharmaceutical Industries and Associations NEVADO DEL CAMPO Elena 21/10/2025 European Federation of Pharmaceutical Industries and Associations FIOCCHI Pietro 16/10/2025 Pharmaceutical Group of the European Union
PGEFIOCCHI Pietro 15/10/2025 BGP Products Operations GmbH – a Viatris Company BALJEU Jeannette 15/10/2025 AbbVie