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2025/0406/COD
Procedure 2025/0406/COD
COM (2025) 1022: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)
Ongoing
Type: Ordinary legislative procedure (COD)
- Legal basis:
- Commission: 12010E168-A168P4 ; 12010E114-A114 ; 12010E173-A173P3 ; 12010E294-A294
- EuroVoc thesaurus:
- pharmaceutical industry; innovation; foodstuffs legislation
- Directory code:
- 13.30.15.00 Industrial policy and internal market / Internal market: approximation of laws / Proprietary medicinal products
- Type of the competence conferred on the EU:
- Shared competence
-
European Commission
-
European Parliament
-
Economic and Social Committee
For a detailed overview of the procedure, please visit the EU Law Tracker.
EU Law Tracker
EU Law Tracker
Steps of procedure 2025/0406/COD
/
Opinions
18/03/2026
- Responsible body:
- Consultative Commission on Industrial Change
- Rapporteur:
- Joan ROGET ALEMANY
- Co-rapporteur:
- Thomas STUDENT
- Procedure:
- Ordinary legislative procedure (COD)
- Plenary session:
- 604
- Plenary date:
- 18/03/2026 - 19/03/2026
- Documents:
- EESC 2026-00031
- CELEX number of the main document:
- 52026AE0031
Proposal
17/12/2025
- Leading person:
- Olivér VÁRHELYI
- Leading service:
- Directorate-General for Health and Food Safety
- Decision mode:
- Oral procedure
- Addressee for formal act:
- European Parliament ; Council of the European Union ; National parliaments
- Addressee for mandatory consultation:
- European Economic and Social Committee ; European Committee of the Regions ; European Data Protection Supervisor ; European Data Protection Board
- Legal basis:
- 12010E168-A168P4 ; 12010E114-A114 ; 12010E173-A173P3 ; 12010E294-A294
- Procedure:
- Ordinary legislative procedure (COD)
- Documents:
- COM/2025/1022/FINAL
SWD/2025/1055/FINAL
SWD/2026/450/FINAL - CELEX number of the main document:
- 52025PC1022 ; 52025PC1022(01) ; 52026AE0031 ; 52026SC0450 ; 52025SC1055