2021/0432(COD)

Derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom with respect to Northern Ireland as well as in Cyprus, Ireland and Malta

Basic information

2021/0432(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Amending Regulation 2014/536 2012/0192(COD)

Subject

4.20.02 Medical research
4.20.02.06 Clinical practice and experiments
4.20.04 Pharmaceutical products and industry

Geographical area

Cyprus
Ireland
Malta
United Kingdom

Status

Procedure completed

Key players

Key events

Date Event Reference Summary
17/12/2021 Legislative proposal published COM(2021)0998
20/01/2022 Committee referral announced in Parliament, 1st reading
07/04/2022 Decision by Parliament, 1st reading T9-0117/2022
07/04/2022 Results of vote in Parliament
12/04/2022 Act adopted by Council after Parliament's 1st reading
12/04/2022 Final act signed
20/04/2022 Final act published in Official Journal

Technical information

Procedure Information
Procedure reference 2021/0432(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Nature of procedure Legislation
Legislative instrument Regulation
Amending Regulation 2014/536 2012/0192(COD)
Legal basis Rules of Procedure EP 170 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 Procedure completed
Committee dossier ENVI/9/08019

Documentation gateway

  • Document type Committee Reference Date Summary
    Text adopted by Parliament, 1st reading/single reading T9-0117/2022 07/04/2022
  • Document type Reference Date Summary
    Draft final act 00007/2022/LEX 12/04/2022
  • Document type Reference Date Summary
    Legislative proposal COM(2021)0998 17/12/2021
    Commission response to text adopted in plenary SP(2022)281 01/06/2022
  • Institution/body Document type Reference Date Summary
    ESC Economic and Social Committee: opinion, report CES0378/2022 23/02/2022