Document reference

2012/0192(COD)  
Clinical trials on medicinal products for human use  
Basic information  

2012/0192(COD)

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

Repealing Directive 2001/20/EC 1997/0197(COD)
Amended by 2021/0432(COD)

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

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  
17/07/2012
Legislative proposal published
COM(2012)0369 Eur-Lex link
11/09/2012
Committee referral announced in Parliament, 1st reading
29/05/2013
Vote in committee, 1st reading
10/06/2013
Committee report tabled for plenary, 1st reading
A7-0208/2013
02/04/2014
Results of vote in Parliament
02/04/2014
Debate in Parliament
02/04/2014
Decision by Parliament, 1st reading
T7-0273/2014
14/04/2014
Act adopted by Council after Parliament's 1st reading
16/04/2014
Final act signed
16/04/2014
End of procedure in Parliament
27/05/2014
Final act published in Official Journal
Technical information  
Procedure reference
2012/0192(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Regulation

Repealing Directive 2001/20/EC 1997/0197(COD)

Amended by 2021/0432(COD)

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 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/7/10164
Documentation gateway  
Final act  
Delegated acts  
2017/2710(DEA)  
Examination of delegated act  
2022/2819(DEA)  
Examination of delegated act