2020/0321(COD)

European Medicines Agency

Basic information

2020/0321(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Subject

4.20.01 Medicine, diseases
4.20.04 Pharmaceutical products and industry
4.20.05 Health legislation and policy
8.40.08 Agencies and bodies of the EU

Legislative priorities

Joint Declaration 2021

Status

Procedure completed

Key players

Key events

Date Event Reference Summary
11/11/2020 Legislative proposal published COM(2020)0725
14/12/2020 Committee referral announced in Parliament, 1st reading
22/06/2021 Vote in committee, 1st reading
25/06/2021 Committee report tabled for plenary, 1st reading A9-0216/2021
07/07/2021 Debate in Parliament
08/07/2021 Decision by Parliament, 1st reading T9-0351/2021
08/07/2021 Matter referred back to the committee responsible for interinstitutional negotiations
30/11/2021 Approval in committee of the text agreed at 1st reading interinstitutional negotiations PE700.456
20/01/2022 Decision by Parliament, 1st reading T9-0006/2022
20/01/2022 Results of vote in Parliament
25/01/2022 Act adopted by Council after Parliament's 1st reading
25/01/2022 Final act signed
31/01/2022 Final act published in Official Journal

Technical information

Procedure Information
Procedure reference 2020/0321(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Nature of procedure Legislation
Legislative instrument Regulation
Legal basis Treaty on the Functioning of the EU TFEU 168-p4 Treaty on the Functioning of the EU TFEU 114-p1
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/9/04630

Documentation gateway

  • Document type Committee Reference Date Summary
    Amendments tabled in committee PE691.131 25/03/2021
    Committee draft report PE680.818 31/03/2021
    Amendments tabled in committee PE691.443 28/04/2021
    Committee opinion ITRE PE689.565 27/05/2021
    Committee report tabled for plenary, 1st reading/single reading A9-0216/2021 25/06/2021
    Text adopted by Parliament, partial vote at 1st reading/single reading T9-0351/2021 08/07/2021
    Text adopted by Parliament, 1st reading/single reading T9-0006/2022 20/01/2022
  • Document type Reference Date Summary
    Draft final act 00076/2021/LEX 25/01/2022
  • Document type Reference Date Summary
    Legislative proposal COM(2020)0725 11/11/2020
    Commission response to text adopted in plenary SP(2022)66 24/02/2022
  • Document type Parliament/Chamber Reference Date Summary
    Contribution ES_PARLIAMENT COM(2020)0725 22/02/2021
    Contribution PT_PARLIAMENT COM(2020)0725 25/02/2021
    Contribution CZ_SENATE COM(2020)0725 24/03/2021
    Reasoned opinion FR_SENATE PE691.143 30/03/2021
    Contribution IT_SENATE COM(2020)0725 19/05/2021