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 Council's 1st reading position

 

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
19/03/2024
Vote in committee, 1st reading
21/03/2024
Committee report tabled for plenary, 1st reading
A9-0140/2024
10/04/2024
Results of vote in Parliament
10/04/2024
Debate in Parliament
10/04/2024
Decision by Parliament, 1st reading
T9-0220/2024
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
Treaty on the Functioning of the EU TFEU 168-p4; Treaty on the Functioning of the EU TFEU 114; Rules of Procedure EP 57_o
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  
  • 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
     
    Specific opinion
    JURI  
    PE758.884  
    13/02/2024
    EP
     
    Committee opinion
    ITRE  
    PE754.773  
    22/02/2024
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    A9-0140/2024  
    21/03/2024
    EP
     
    Text adopted by Parliament, 1st reading/single reading
       
    T9-0220/2024  
    10/04/2024
    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
     
    Commission response to text adopted in plenary
     
    SP(2024)377  
    29/07/2024
    EC
     
  • National parliaments 
    Contribution
    IT_SENATE
    COM(2023)0192  
    07/12/2023
    NP
     
    Contribution
    CZ_SENATE
    COM(2023)0192  
    10/11/2023
    NP
     
    Contribution
    RO_SENATE
    COM(2023)0192  
    20/11/2023
    NP
     
    Contribution
    DE_BUNDESRAT
    COM(2023)0192  
    04/12/2023
    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
     
    Specific opinion
    JURI  
    PE758.884  
    13/02/2024
    EP
     
    Committee opinion
    ITRE  
    PE754.773  
    22/02/2024
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    A9-0140/2024  
    21/03/2024
    EP
     
    Text adopted by Parliament, 1st reading/single reading
       
    T9-0220/2024  
    10/04/2024
    EP
    Commission response to text adopted in plenary
       
    SP(2024)377  
    29/07/2024
    EC
     
    Contribution
    IT_SENATE
    COM(2023)0192  
    07/12/2023
    NP
     
    Contribution
    CZ_SENATE
    COM(2023)0192  
    10/11/2023
    NP
     
    Contribution
    RO_SENATE
    COM(2023)0192  
    20/11/2023
    NP
     
    Contribution
    DE_BUNDESRAT
    COM(2023)0192  
    04/12/2023
    NP
     
    Contribution
    CZ_CHAMBER
    COM(2023)0192  
    06/09/2023
    NP
     
Transparency  
Meetings with interest representatives published in line with the Rules of Procedure