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
COM(2023)0193 Eur-Lex link
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
A9-0141/2024
10/04/2024
Debate in Parliament
10/04/2024
Decision by Parliament, 1st reading
T9-0221/2024
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 168-p4; Treaty on the Functioning of the EU TFEU 114; Rules of Procedure EP 57
Other legal basis
Rules of Procedure EP 159
Mandatory consultation of other institutions
European Economic and Social Committee European Committee of the Regions
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