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
Results of vote in Parliament
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; Rules of Procedure EP 57_o; 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 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
  • Rapporteurs, Shadow Rapporteurs and Committee Chairs 
    METZ Tilly
    Shadow rapporteur
    ENVI  
    10/04/2024
    Asociación de Sarcomas Grupo Asistencial
    METZ Tilly
    Shadow rapporteur
    ENVI  
    08/04/2024
    Standing Committee of European Doctors
    WÖLKEN Tiemo
    Rapporteur
    ENVI  
    08/04/2024
    MEDEV
    METZ Tilly
    Shadow rapporteur
    ENVI  
    11/03/2024
    BEAM Alliance
    RIES Frédérique
    Shadow rapporteur
    ENVI  
    07/03/2024
    Acumen Public Affairs
    RIES Frédérique
    Shadow rapporteur
    ENVI  
    07/03/2024
    EUROPEAN ORGANISATION FOR RARE DISEASES
    WÖLKEN Tiemo
    Rapporteur
    ENVI  
    06/03/2024
    Beglian PermRep
    WÖLKEN Tiemo
    Rapporteur
    ENVI  
    05/03/2024
    European Confederation of Pharmaceutical Entrepreneurs
    WÖLKEN Tiemo
    Rapporteur
    ENVI  
    05/03/2024
    Eurordis - Rare Disease Europe
    WÖLKEN Tiemo
    Rapporteur
    ENVI  
    05/03/2024
    European Patients' Forum (EPF)
  • Other Members 
    23/07/2024
    Novo Nordisk A/S
    JARUBAS Adam
    09/07/2024
    Chambre de Commerce et d’Industrie France Pologne
    ECKE Matthias
    28/03/2024
    European Federation of Pharmaceutical Industries and Associations
    GSK
    KNOTEK Ondřej
    20/03/2024
    BioMarin UK Limited
    GUALMINI Elisabetta
    19/03/2024
    European Confederation of Pharmaceutical Entrepreneurs
    ZAMBELLI Stefania
    13/03/2024
    Assosalute
    GLAVAK Sunčana
    29/02/2024
    Bayer AG
    27/02/2024
    European Society of Cardiology
    LIESE Peter
    23/02/2024
    European Federation of Pharmaceutical Industries and Associations
    LUENA César
    21/02/2024
    Roche Farma