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2023/0132(COD)

Medicinal products for human use

Basic information

2023/0132(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Directive

Repealing Directive 2001/83 1999/0134(COD)
Repealing Directive 2009/35 2008/0001(COD)

Subject

4.20.01 Medicine, diseases
4.20.04 Pharmaceutical products and industry

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)0192
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 A9-0140/2024
10/04/2024 Decision by Parliament, 1st reading T9-0220/2024
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 2023/0132(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype Legislation
Legislative instrument Directive
Amendments and repeals Repealing Directive 2001/83 1999/0134(COD)
Repealing Directive 2009/35 2008/0001(COD)
Legal basis Rules of Procedure EP 57_o Treaty on the Functioning of the European Union TFEU 114 Treaty on the Functioning of the European Union 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/9/11861

Documentation gateway

  • Document type Committee Reference Date Summary
    Committee draft report PE753.470 03/10/2023
    Amendments tabled in committee PE754.916 21/11/2023
    Amendments tabled in committee PE754.917 21/11/2023
    Amendments tabled in committee PE756.260 21/11/2023
    Amendments tabled in committee PE756.261 21/11/2023
    Specific opinion JURI PE758.884 13/02/2024
    Committee opinion ITRE PE754.773 22/02/2024
    Committee report tabled for plenary, 1st reading/single reading A9-0140/2024 21/03/2024
    Text adopted by Parliament, 1st reading/single reading T9-0220/2024 10/04/2024
  • Document type Reference Date Summary
    Legislative proposal COM(2023)0192 26/04/2023
    Document attached to the procedure SEC(2023)0390 26/04/2023
    Document attached to the procedure SWD(2023)0191 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
    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)0192 06/09/2023
    Contribution CZ_SENATE COM(2023)0192 10/11/2023
    Contribution RO_SENATE COM(2023)0192 20/11/2023
    Contribution DE_BUNDESRAT COM(2023)0192 04/12/2023
    Contribution IT_SENATE COM(2023)0192 07/12/2023
  • Institution/body Document type Reference Date Summary
    EESC Economic and Social Committee: opinion, report CES1968/2023 25/10/2023

Additional information

Source Document Date
EP Research Service Briefing 03/04/2024
European Commission EUR-Lex

Transparency

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