Document reference

2022/0417(COD)  
Fees and charges payable to the European Medicines Agency  
Basic information  

2022/0417(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)
Regulation

Repealing Regulation 1995/297 1994/0220(CNS)
Amending Regulation 2017/745 2012/0266(COD)
Repealing Regulation 2014/658 2013/0222(COD)

Subject
4.20.04 Pharmaceutical products and industry
8.40.08 Agencies and bodies of the EU

Status

Procedure completed

 

Please go to Documentation gateway for any follow-up documents.: Please go to Documentation gateway for any follow-up documents. 
Key players  
Key events  
13/12/2022
Legislative proposal published
COM(2022)0721 Eur-Lex link
15/12/2022
Committee referral announced in Parliament, 1st reading
27/06/2023
Vote in committee, 1st reading
30/06/2023
Committee report tabled for plenary, 1st reading
A9-0224/2023
12/07/2023
Decision by Parliament, 1st reading
T9-0273/2023
12/07/2023
Matter referred back to the committee responsible
24/10/2023
Approval in committee of the text agreed at 1st reading interinstitutional negotiations
PE754.973
12/12/2023
Results of vote in Parliament
12/12/2023
Decision by Parliament, 1st reading
T9-0446/2023
23/01/2024
Act adopted by Council after Parliament's 1st reading
07/02/2024
Final act signed
14/02/2024
Final act published in Official Journal
Technical information  
Procedure reference
2022/0417(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Regulation

Repealing Regulation 1995/297 1994/0220(CNS)

Amending Regulation 2017/745 2012/0266(COD)

Repealing Regulation 2014/658 2013/0222(COD)

Legal basis
Treaty on the Functioning of the EU TFEU 168-p4; Treaty on the Functioning of the EU TFEU 114
Other legal basis
Rules of Procedure EP 159
Mandatory consultation of other institutions
European Economic and Social Committee European Committee of the Regions
Stage reached in procedure
Procedure completed
Committee dossier
ENVI/9/10980
Documentation gateway  
  • European Parliament 
    Committee draft report
       
    PE742.478  
    27/03/2023
    EP
     
    Amendments tabled in committee
       
    PE747.008  
    04/05/2023
    EP
     
    Specific opinion
    BUDG  
    PE746.962  
    23/05/2023
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    A9-0224/2023  
    30/06/2023
    EP
    Text adopted by Parliament, partial vote at 1st reading/single reading
       
    T9-0273/2023  
    12/07/2023
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    T9-0446/2023  
    12/12/2023
    EP
  • Council of the EU 
    Draft final act
     
    00059/2023/LEX
    07/02/2024
    CSL
     
  • European Commission 
    Legislative proposal
     
    COM(2022)0721 Eur-Lex link  
    13/12/2022
    EC
    Document attached to the procedure
     
    SEC(2022)0440 Eur-Lex link  
    13/12/2022
    EC
     
    Document attached to the procedure
     
    SWD(2022)0413 Eur-Lex link  
    13/12/2022
    EC
     
    Document attached to the procedure
     
    SWD(2022)0414 Eur-Lex link  
    13/12/2022
    EC
     
    Document attached to the procedure
     
    SWD(2022)0415 Eur-Lex link  
    13/12/2022
    EC
     
    Commission response to text adopted in plenary
     
    SP(2024)56  
    22/03/2024
    EC
     
  • National parliaments 
    Contribution
    IT_CHAMBER
    COM(2022)0721  
    21/03/2023
    NP
     
    Contribution
    FR_SENATE
    COM(2022)0721  
    11/05/2023
    NP
     
    Contribution
    SE_PARLIAMENT
    COM(2022)0721  
    22/03/2023
    NP
     
    Contribution
    PT_PARLIAMENT
    COM(2022)0721  
    15/09/2023
    NP
     
  • Other institutions 
    Economic and Social Committee: opinion, report
     
    CES0215/2023  
    24/01/2023
    ESC
     
  • All 
    Legislative proposal
       
    COM(2022)0721 Eur-Lex link  
    13/12/2022
    EC
    Document attached to the procedure
       
    SEC(2022)0440 Eur-Lex link  
    13/12/2022
    EC
     
    Document attached to the procedure
       
    SWD(2022)0413 Eur-Lex link  
    13/12/2022
    EC
     
    Document attached to the procedure
       
    SWD(2022)0414 Eur-Lex link  
    13/12/2022
    EC
     
    Document attached to the procedure
       
    SWD(2022)0415 Eur-Lex link  
    13/12/2022
    EC
     
    Economic and Social Committee: opinion, report
       
    CES0215/2023  
    24/01/2023
    ESC
     
    Committee draft report
       
    PE742.478  
    27/03/2023
    EP
     
    Amendments tabled in committee
       
    PE747.008  
    04/05/2023
    EP
     
    Specific opinion
    BUDG  
    PE746.962  
    23/05/2023
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    A9-0224/2023  
    30/06/2023
    EP
    Text adopted by Parliament, partial vote at 1st reading/single reading
       
    T9-0273/2023  
    12/07/2023
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    T9-0446/2023  
    12/12/2023
    EP
    Draft final act
       
    00059/2023/LEX
    07/02/2024
    CSL
     
    Commission response to text adopted in plenary
       
    SP(2024)56  
    22/03/2024
    EC
     
    Contribution
    IT_CHAMBER
    COM(2022)0721  
    21/03/2023
    NP
     
    Contribution
    FR_SENATE
    COM(2022)0721  
    11/05/2023
    NP
     
    Contribution
    SE_PARLIAMENT
    COM(2022)0721  
    22/03/2023
    NP
     
    Contribution
    PT_PARLIAMENT
    COM(2022)0721  
    15/09/2023
    NP
     
Final act  
Transparency  
Meetings with interest representatives published in line with the Rules of Procedure
  • Rapporteurs, Shadow Rapporteurs and Committee Chairs 
    SOLÍS PÉREZ Susana
    Shadow rapporteur
    ENVI  
    27/03/2023
    European Medicines Agency
    BUŞOI Cristian-Silviu
    Rapporteur
    ENVI  
    08/03/2023
    MEDICINES FOR EUROPE
    BUŞOI Cristian-Silviu
    Rapporteur
    ENVI  
    08/03/2023
    EFPIA - European Federation of Pharmaceutical Industries and Associations