Document reference

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
Ireland
Malta
United Kingdom
Cyprus

Status

Procedure completed

 

Key players  
Key events  
17/12/2021
Legislative proposal published
20/01/2022
Committee referral announced in Parliament, 1st reading
28/03/2022
Decision by committee, without report
07/04/2022
Results of vote in Parliament
07/04/2022
Decision by Parliament, 1st reading
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 reference
2021/0432(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Regulation

Amending Regulation 2014/536 2012/0192(COD)

Legal basis
Treaty on the Functioning of the EU TFEU 168-p4; Rules of Procedure EP 163; Treaty on the Functioning of the EU TFEU 114
Mandatory consultation of other institutions
Stage reached in procedure
Procedure completed
Committee dossier
ENVI/9/08019
Documentation gateway  
  • European Parliament 
    Text adopted by Parliament, 1st reading/single reading
       
    07/04/2022
    EP
  • Council of the EU 
    Draft final act
     
    00007/2022/LEX
    12/04/2022
    CSL
     
  • European Commission 
    Legislative proposal
     
    17/12/2021
    EC
    Commission response to text adopted in plenary
     
    01/06/2022
    EC
     
  • Other institutions 
    Economic and Social Committee: opinion, report
     
    23/02/2022
    ESC
     
  • All 
    Legislative proposal
       
    17/12/2021
    EC
    Economic and Social Committee: opinion, report
       
    23/02/2022
    ESC
     
    Text adopted by Parliament, 1st reading/single reading
       
    07/04/2022
    EP
    Draft final act
       
    00007/2022/LEX
    12/04/2022
    CSL
     
    Commission response to text adopted in plenary
       
    01/06/2022
    EC
     
Final act