Legislative Observatory
European Parliament
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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)
Repealing Regulation 2014/658 2013/0222(COD)
Amending Regulation 2017/745 2012/0266(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.

Key players

Key events

Date Event Reference Summary
13/12/2022 Legislative proposal published COM(2022)0721
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 for interinstitutional negotiations
24/10/2023 Approval in committee of the text agreed at 1st reading interinstitutional negotiations PE754.973
12/12/2023 Decision by Parliament, 1st reading T9-0446/2023
12/12/2023 Results of vote in Parliament
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 Information
Procedure reference 2022/0417(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Nature of procedure Legislation
Legislative instrument Regulation
Repealing Regulation 1995/297 1994/0220(CNS)
Repealing Regulation 2014/658 2013/0222(COD)
Amending Regulation 2017/745 2012/0266(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 165
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

  • Document type Committee Reference Date Summary
    Committee draft report PE742.478 27/03/2023
    Amendments tabled in committee PE747.008 04/05/2023
    Specific opinion BUDG PE746.962 23/05/2023
    Committee report tabled for plenary, 1st reading/single reading A9-0224/2023 30/06/2023
    Text adopted by Parliament, partial vote at 1st reading/single reading T9-0273/2023 12/07/2023
    Text adopted by Parliament, 1st reading/single reading T9-0446/2023 12/12/2023
  • Document type Reference Date Summary
    Draft final act 00059/2023/LEX 07/02/2024
  • Document type Reference Date Summary
    Document attached to the procedure SWD(2022)0413 13/12/2022
    Document attached to the procedure SEC(2022)0440 13/12/2022
    Document attached to the procedure SWD(2022)0415 13/12/2022
    Document attached to the procedure SWD(2022)0414 13/12/2022
    Legislative proposal COM(2022)0721 13/12/2022
    Commission response to text adopted in plenary SP(2024)56 22/03/2024
  • Document type Parliament/Chamber Reference Date Summary
    Contribution IT_CHAMBER COM(2022)0721 21/03/2023
    Contribution SE_PARLIAMENT COM(2022)0721 22/03/2023
    Contribution FR_SENATE COM(2022)0721 11/05/2023
    Contribution PT_PARLIAMENT COM(2022)0721 15/09/2023
  • Institution/body Document type Reference Date Summary
    ESC Economic and Social Committee: opinion, report CES0215/2023 24/01/2023

Transparency

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

  • Name Role Committee Date Interest representatives
    SOLÍS PÉREZ Susana Shadow rapporteur ENVI 27/03/2023 European Medicines Agency
    BUŞOI Cristian-Silviu Rapporteur ENVI 08/03/2023 EFPIA - European Federation of Pharmaceutical Industries and Associations
    BUŞOI Cristian-Silviu Rapporteur ENVI 08/03/2023 MEDICINES FOR EUROPE

Final act