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
03/06/2025 Committee decision to open interinstitutional negotiations after 1st reading in Parliament
16/06/2025 Committee decision to enter into interinstitutional negotiations announced in plenary (Rule 72)

Technical information

Procedure reference 2023/0131(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype Legislation
Legislative instrument Regulation
Amendments and repeals 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 PE756.131 21/11/2023
    Amendments tabled in committee PE756.132 21/11/2023
    Amendments tabled in committee PE756.133 21/11/2023
    Amendments tabled in committee PE756.134 21/11/2023
    Amendments tabled in committee PE756.135 21/11/2023
    Amendments tabled in committee PE756.136 21/11/2023
    Amendments tabled in committee PE756.137 21/11/2023
    Amendments tabled in committee PE756.138 21/11/2023
    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
    Legislative proposal COM(2023)0193 26/04/2023
    Document attached to the procedure SWD(2023)0192 26/04/2023
    Document attached to the procedure SWD(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
    EESC Economic and Social Committee: opinion, report CES1968/2023 25/10/2023

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
    SOKOL Tomislav Shadow rapporteur SANT 18/11/2025 Novo Nordisk A/S
    SOKOL Tomislav Shadow rapporteur SANT 12/11/2025 European Society for Phenylketonuria and Allied Disorders Treated as Phenylketonuria
    WÖLKEN Tiemo Rapporteur SANT 10/11/2025 kohlpharma
    WINZIG Angelika Rapporteur for opinion ITRE 05/11/2025 Boehringer Ingelheim
    PHARMIG - Verband der pharmazeutischen Industrie Österreichs
    SOKOL Tomislav Shadow rapporteur SANT 16/10/2025 European Society of Cardiology
    WÖLKEN Tiemo Rapporteur SANT 15/10/2025 European Patients' Forum (EPF)
    WÖLKEN Tiemo Rapporteur SANT 15/10/2025 Permanent Representation of Malta to the European Union
    SOKOL Tomislav Shadow rapporteur SANT 14/10/2025 Merck Sharp & Dohme Europe Belgium SRL
    WÖLKEN Tiemo Rapporteur SANT 13/10/2025 GSK
    WINZIG Angelika Rapporteur for opinion ITRE 11/09/2025 PHARMIG - Verband der pharmazeutischen Industrie Österreichs