Document reference

2023/0131(COD)  
Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency  
Basic information  

2023/0131(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation

Repealing Regulation 2000/141 1998/0240(COD)
Repealing Regulation 2004/726 2001/0252(COD)
Repealing Regulation 2006/1901 2004/0217(COD)
Amending Regulation 2007/1394 2005/0227(COD)
Amending Regulation 2014/536 2012/0192(COD)

Subject
4.20.01 Medicine, diseases
4.20.04 Pharmaceutical products and industry
4.60.08 Safety of products and services, product liability
8.40.08 Agencies and bodies of the EU

Legislative priorities
Joint Declaration 2023-24

Status

Awaiting Council's 1st reading position

 

Key players  
Key events  
26/04/2023
Legislative proposal published
14/09/2023
Committee referral announced in Parliament, 1st reading
14/09/2023
Referral to associated committees announced in Parliament
19/03/2024
Vote in committee, 1st reading
21/03/2024
Committee report tabled for plenary, 1st reading
10/04/2024
Debate in Parliament
10/04/2024
Decision by Parliament, 1st reading
Technical information  
Procedure reference
2023/0131(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Regulation

Repealing Regulation 2000/141 1998/0240(COD)

Repealing Regulation 2004/726 2001/0252(COD)

Repealing Regulation 2006/1901 2004/0217(COD)

Amending Regulation 2007/1394 2005/0227(COD)

Amending Regulation 2014/536 2012/0192(COD)

Legal basis
Treaty on the Functioning of the EU TFEU 114; Treaty on the Functioning of the EU TFEU 168-p4; Rules of Procedure EP 57
Other legal basis
Rules of Procedure EP 159
Mandatory consultation of other institutions
Stage reached in procedure
Awaiting Council's 1st reading position
Committee dossier
ENVI/9/11874
Documentation gateway  
Transparency  
Meetings with interest representatives published in line with the Rules of Procedure