Document reference

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 committee decision

 

Key players  
Key events  
26/04/2023
Legislative proposal published
COM(2023)0192 Eur-Lex link
14/09/2023
Committee referral announced in Parliament, 1st reading
14/09/2023
Referral to associated committees announced in Parliament
Technical information  
Procedure reference
2023/0132(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
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; Treaty on the Functioning of the EU TFEU 168-p4; Treaty on the Functioning of the EU TFEU 114
Mandatory consultation of other institutions
European Economic and Social Committee European Committee of the Regions
Stage reached in procedure
Awaiting committee decision
Committee dossier
ENVI/9/11861
Documentation gateway  
  • European Parliament 
    Committee draft report
       
    PE753.470  
    03/10/2023
    EP
     
    Amendments tabled in committee
       
    PE754.916  
    21/11/2023
    EP
     
    Amendments tabled in committee
       
    PE754.917  
    21/11/2023
    EP
     
    Amendments tabled in committee
       
    PE756.260  
    21/11/2023
    EP
     
    Amendments tabled in committee
       
    PE756.261  
    21/11/2023
    EP
     
  • European Commission 
    Legislative proposal
     
    COM(2023)0192   Eur-Lex link  
    26/04/2023
    EC
    Document attached to the procedure
     
    SEC(2023)0390
    26/04/2023
    EC
     
    Document attached to the procedure
     
    SWD(2023)0191 Eur-Lex link  
    26/04/2023
    EC
     
    Document attached to the procedure
     
    SWD(2023)0192
    26/04/2023
    EC
     
    Document attached to the procedure
     
    SWD(2023)0193
    26/04/2023
    EC
     
  • National parliaments 
    Contribution
    CZ_SENATE
    COM(2023)0192  
    10/11/2023
    NP
     
    Contribution
    RO_SENATE
    COM(2023)0192  
    20/11/2023
    NP
     
    Contribution
    CZ_CHAMBER
    COM(2023)0192  
    06/09/2023
    NP
     
  • All 
    Legislative proposal
       
    COM(2023)0192   Eur-Lex link  
    26/04/2023
    EC
    Document attached to the procedure
       
    SEC(2023)0390
    26/04/2023
    EC
     
    Document attached to the procedure
       
    SWD(2023)0191 Eur-Lex link  
    26/04/2023
    EC
     
    Document attached to the procedure
       
    SWD(2023)0192
    26/04/2023
    EC
     
    Document attached to the procedure
       
    SWD(2023)0193
    26/04/2023
    EC
     
    Committee draft report
       
    PE753.470  
    03/10/2023
    EP
     
    Amendments tabled in committee
       
    PE754.916  
    21/11/2023
    EP
     
    Amendments tabled in committee
       
    PE754.917  
    21/11/2023
    EP
     
    Amendments tabled in committee
       
    PE756.260  
    21/11/2023
    EP
     
    Amendments tabled in committee
       
    PE756.261  
    21/11/2023
    EP
     
    Contribution
    CZ_SENATE
    COM(2023)0192  
    10/11/2023
    NP
     
    Contribution
    RO_SENATE
    COM(2023)0192  
    20/11/2023
    NP
     
    Contribution
    CZ_CHAMBER
    COM(2023)0192  
    06/09/2023
    NP
     
Transparency  
Meetings with interest representatives published in line with the Rules of Procedure
  • Rapporteurs, Shadow Rapporteurs and Committee Chairs 
    WEISS Pernille
    Rapporteur
    ENVI  
    01/12/2023
    Boiron
    WEISS Pernille
    Rapporteur
    ENVI  
    30/11/2023
    EUROPEAN ORGANISATION FOR RARE DISEASES
    WEISS Pernille
    Rapporteur
    ENVI  
    30/11/2023
    Novo Nordisk A/S
    NIINISTÖ Ville
    Shadow rapporteur for opinion
    ITRE  
    22/11/2023
    EUROPEAN ORGANISATION FOR RARE DISEASES
    WEISS Pernille
    Rapporteur
    ENVI  
    22/11/2023
    Acumen Public Affairs
    British American Tobacco
    British Chamber of Commerce | EU & Belgium
    City of London Corporation
    Instinctif Partners/Policy Action
    Liberty Global Corporate B.V.
    Make UK (formerly EEF)
    RELX International
    Rud Pedersen Public Affairs Brussels
    SEC NEWGATE EU
    BMW group
    MSD
    National Grid
    WEISS Pernille
    Rapporteur
    ENVI  
    22/11/2023
    European Confederation of Pharmaceutical Entrepreneurs
    NIINISTÖ Ville
    Shadow rapporteur for opinion
    ITRE  
    21/11/2023
    MEDICINES FOR EUROPE
    NIINISTÖ Ville
    Shadow rapporteur for opinion
    ITRE  
    16/11/2023
    European Public Health Alliance
    NIINISTÖ Ville
    Shadow rapporteur for opinion
    ITRE  
    16/11/2023
    Pharmaceutical Group of the European Union
    NIINISTÖ Ville
    Shadow rapporteur for opinion
    ITRE  
    15/11/2023
    Oriola Corporation
    GIRP, European Healthcare Distribution Association
  • Other Members 
    JARUBAS Adam
    04/12/2023
    Medicines for Poland
    MONTSERRAT Dolors
    04/12/2023
    Instituto de Salud Carlos III (ISCIII) - RICORS/TERAV
    MONTSERRAT Dolors
    30/11/2023
    AstraZeneca PLC
    MONTSERRAT Dolors
    28/11/2023
    Haleon
    MONTSERRAT Dolors
    28/11/2023
    European Confederation of Pharmaceutical Entrepreneurs
    PATRICIELLO Aldo
    28/11/2023
    Associazione delle Imprese del farmaco
    MONTSERRAT Dolors
    21/11/2023
    Bayer AG
    GYÜRK András
    08/11/2023
    Novartis International AG
    CLUNE Deirdre
    07/11/2023
    Novartis International AG
    CLUNE Deirdre
    07/11/2023
    MEDICINES FOR EUROPE