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 committee decision

 

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
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
Mandatory consultation of other institutions
European Economic and Social Committee European Committee of the Regions
Stage reached in procedure
Awaiting committee decision
Committee dossier
ENVI/9/11874
Documentation gateway  
  • European Parliament 
    Committee draft report
       
    PE753.550  
    20/10/2023
    EP
     
  • European Commission 
    Legislative proposal
     
    COM(2023)0193   Eur-Lex link  
    26/04/2023
    EC
    Document attached to the procedure
     
    SWD(2023)0192
    26/04/2023
    EC
     
    Document attached to the procedure
     
    SWD(2023)0193
    26/04/2023
    EC
     
    Document attached to the procedure
     
    SWD(2023)0194 Eur-Lex link  
    26/04/2023
    EC
     
  • National parliaments 
    Contribution
    CZ_CHAMBER
    COM(2023)0193  
    06/09/2023
    NP
     
    Contribution
    CZ_SENATE
    COM(2023)0193  
    10/11/2023
    NP
     
  • Other institutions 
    Document attached to the procedure
     
    N9-0082/2023
    OJ C 000 14.11.2023, p. 0000  
    19/06/2023
    EDPS
     
  • All 
    Legislative proposal
       
    COM(2023)0193   Eur-Lex link  
    26/04/2023
    EC
    Document attached to the procedure
       
    SWD(2023)0192
    26/04/2023
    EC
     
    Document attached to the procedure
       
    SWD(2023)0193
    26/04/2023
    EC
     
    Document attached to the procedure
       
    SWD(2023)0194 Eur-Lex link  
    26/04/2023
    EC
     
    Document attached to the procedure
       
    N9-0082/2023
    OJ C 000 14.11.2023, p. 0000  
    19/06/2023
    EDPS
     
    Committee draft report
       
    PE753.550  
    20/10/2023
    EP
     
    Contribution
    CZ_CHAMBER
    COM(2023)0193  
    06/09/2023
    NP
     
    Contribution
    CZ_SENATE
    COM(2023)0193  
    10/11/2023
    NP
     
Transparency  
Meetings with interest representatives published in line with the Rules of Procedure