Legislative Observatory
European Parliament
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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

Please go to Documentation gateway for any follow-up documents.

Key players

Key events

Date Event Reference Summary
26/04/2023 Legislative proposal published COM(2023)0193
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 Decision by Parliament, 1st reading T9-0221/2024
10/04/2024 Results of vote in Parliament
10/04/2024 Debate in Parliament
13/11/2024 Committee referral announced in 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 Rules of Procedure EP 57_o Treaty on the Functioning of the EU TFEU 114 Treaty on the Functioning of the EU TFEU 168-p4
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

  • Document type Committee Reference Date Summary
    Committee draft report PE753.550 20/10/2023
    Amendments tabled in committee PE756.138 21/11/2023
    Amendments tabled in committee PE756.137 21/11/2023
    Amendments tabled in committee PE756.136 21/11/2023
    Amendments tabled in committee PE756.134 21/11/2023
    Amendments tabled in committee PE756.133 21/11/2023
    Amendments tabled in committee PE756.132 21/11/2023
    Amendments tabled in committee PE756.131 21/11/2023
    Amendments tabled in committee PE756.135 21/11/2023
    Amendments tabled in committee PE757.081 30/11/2023
    Amendments tabled in committee PE757.080 30/11/2023
    Specific opinion AGRI PE757.314 17/01/2024
    Committee opinion ITRE PE754.772 22/02/2024
    Specific opinion BUDG PE759.054 23/02/2024
    Committee report tabled for plenary, 1st reading/single reading A9-0141/2024 21/03/2024
    Text adopted by Parliament, 1st reading/single reading T9-0221/2024 10/04/2024
  • Document type Reference Date Summary
    Document attached to the procedure SWD(2023)0193 26/04/2023
    Document attached to the procedure SWD(2023)0192 26/04/2023
    Legislative proposal COM(2023)0193 26/04/2023
    Document attached to the procedure SWD(2023)0194 26/04/2023
    Commission response to text adopted in plenary SP(2024)377 29/07/2024
  • Document type Parliament/Chamber Reference Date Summary
    Contribution CZ_CHAMBER COM(2023)0193 06/09/2023
    Contribution CZ_SENATE COM(2023)0193 10/11/2023
    Contribution RO_SENATE COM(2023)0193 20/11/2023
    Contribution DE_BUNDESRAT COM(2023)0193 04/12/2023
    Contribution IT_SENATE COM(2023)0193 07/12/2023
    Contribution FR_SENATE COM(2023)0193 28/10/2024
  • Institution/body Document type Reference Date Summary
    EDPS Document attached to the procedure N9-0082/2023 OJ C 000 14.11.2023, p. 0000 19/06/2023

Additional information

Source Document Date
EP Research Service Briefing 03/04/2024

Transparency

Meetings with interest representatives published in line with the Rules of Procedure

  • Name Role Committee Date Interest representatives
    WÖLKEN Tiemo Rapporteur ENVI 06/02/2025 The Mission of Japan to the EU
    WÖLKEN Tiemo Rapporteur ENVI 28/01/2025 Deutsches Netzwerk gegen Antimikrobielle Resistenzen (DNAMR)
    WÖLKEN Tiemo Rapporteur ENVI 28/01/2025 Permanent Representation of Denmark to the European Union
    WÖLKEN Tiemo Rapporteur ENVI 27/01/2025 Vertretung des Bundestages in Brüssel
    WÖLKEN Tiemo Rapporteur ENVI 14/01/2025 European Commission - DG SANTE
    WÖLKEN Tiemo Rapporteur ENVI 14/01/2025 Permanent Representation of Slovakia to the EU
    BOSSE Stine Shadow rapporteur ENVI 05/11/2024 European Federation of Pharmaceutical Industries and Associations
    METZ Tilly Shadow rapporteur ENVI 10/04/2024 Asociación de Sarcomas Grupo Asistencial
    WÖLKEN Tiemo Rapporteur ENVI 08/04/2024 MEDEV
    METZ Tilly Shadow rapporteur ENVI 08/04/2024 Standing Committee of European Doctors