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
Status
Awaiting Council's 1st reading position
Key players
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European Parliament
Committee responsible Rapporteur Appointed MONTSERRAT Dolors (EPP)
29/07/2024
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Former committee responsible Former rapporteur Appointed WEISS Pernille (EPP)
15/05/2023
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Former committee for opinion Former rapporteur for opinion Appointed BUDGThe committee decided not to give an opinion. VIRKKUNEN Henna (EPP)
05/10/2023
The committee decided not to give an opinion. JURI
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European Commission
Commission DG Commissioner Health and Food Safety KYRIAKIDES Stella
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 |
Technical information
Procedure | Information |
---|---|
Procedure reference | 2023/0132(COD) |
Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
Nature of procedure | Legislation |
Legislative instrument | Directive |
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 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/9/11861
|
Documentation gateway
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Document type Committee Reference Date Summary Committee draft report PE753.470 03/10/2023 Amendments tabled in committee PE754.917 21/11/2023 Amendments tabled in committee PE756.261 21/11/2023 Amendments tabled in committee PE754.916 21/11/2023 Amendments tabled in committee PE756.260 21/11/2023 Amendments tabled in committee PE757.084 01/12/2023 Amendments tabled in committee PE757.083 01/12/2023 Amendments tabled in committee PE757.082 01/12/2023 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 SWD(2023)0191 26/04/2023 Document attached to the procedure SEC(2023)0390 26/04/2023 Document attached to the procedure SWD(2023)0193 26/04/2023 Document attached to the procedure SWD(2023)0192 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
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
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Name Role Committee Date Interest representatives MONTSERRAT Dolors Rapporteur ENVI 24/10/2024 MEDICINES FOR EUROPE MONTSERRAT Dolors Rapporteur ENVI 08/10/2024 BioMarin UK Limited MONTSERRAT Dolors Rapporteur ENVI 26/09/2024 Teva Pharmaceuticals Europe BV MONTSERRAT Dolors Rapporteur ENVI 12/09/2024 GSK WEISS Pernille Rapporteur ENVI 18/06/2024 Novo Nordisk A/S WEISS Pernille Rapporteur ENVI 08/05/2024 Johnson & Johnson AMALRIC Catherine Shadow rapporteur ENVI 02/05/2024 Laboratoires Delbert GONZÁLEZ CASARES Nicolás Shadow rapporteur ENVI 23/04/2024 AFEPADI GONZÁLEZ CASARES Nicolás Shadow rapporteur ENVI 18/04/2024 Farmaindustria WEISS Pernille Rapporteur ENVI 05/04/2024 Novo Nordisk A/S
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Name Date Interest representatives BOSSE Stine 16/07/2024 Novo Nordisk A/S COLIN-OESTERLÉ Nathalie 30/05/2024 Les entreprises du médicament ŠTEFANEC Ivan 04/04/2024 Národný inštitút pre hodnotu a technológie v zdravotníctve BERNHUBER Alexander 15/03/2024 Wirtschaftskammer Österreich JARUBAS Adam 15/03/2024 Medicines for Poland
The Employers' Union of Innovative Pharmaceutical Companies
polityka insightKNOTEK Ondřej 08/03/2024 GSK BERNHUBER Alexander 07/03/2024 Takeda Pharmaceuticals International AG RASMUSSEN Bergur Løkke 06/03/2024 The Danish Association of the Pharmaceutical Industry MONTSERRAT Dolors 06/03/2024 Bayer AG POULSEN Erik 05/03/2024 The Danish Association of the Pharmaceutical Industry