Legislative Observatory
European Parliament
Please fill in this field to find a procedure

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.

Key players

Key events

Date Event Reference Summary
17/07/2012 Legislative proposal published COM(2012)0369
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 Decision by Parliament, 1st reading T7-0273/2014
02/04/2014 Results of vote in Parliament
02/04/2014 Debate in Parliament
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 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/7/10164

Documentation gateway

  • Document type Committee Reference Date Summary
    Committee draft report PE504.236 31/01/2013
    Amendments tabled in committee PE504.308 01/02/2013
    Amendments tabled in committee PE506.087 27/02/2013
    Amendments tabled in committee PE506.158 01/03/2013
    Amendments tabled in committee PE506.162 01/03/2013
    Amendments tabled in committee PE506.161 01/03/2013
    Amendments tabled in committee PE506.160 06/03/2013
    Amendments tabled in committee PE506.159 06/03/2013
    Amendments tabled in committee PE507.970 20/03/2013
    Committee opinion ITRE PE504.167 21/03/2013
    Committee opinion IMCO PE500.727 26/03/2013
    Committee opinion LIBE PE506.211 09/04/2013
    Committee report tabled for plenary, 1st reading/single reading A7-0208/2013 10/06/2013
    Text adopted by Parliament, 1st reading/single reading T7-0273/2014 02/04/2014
  • Document type Reference Date Summary
    Draft final act 00002/2014/LEX 16/04/2014
  • Document type Reference Date Summary
    Document attached to the procedure SWD(2012)0201 17/07/2012
    Document attached to the procedure SWD(2012)0200 17/07/2012
    Legislative proposal COM(2012)0369 17/07/2012
    Commission response to text adopted in plenary SP(2014)471 09/07/2014
  • Document type Parliament/Chamber Reference Date Summary
    Contribution IT_SENATE COM(2012)0369 04/10/2012
    Contribution PT_PARLIAMENT COM(2012)0369 11/10/2012
    Contribution CZ_SENATE COM(2012)0369 07/11/2012
    Contribution EL_PARLIAMENT COM(2012)0369 26/11/2012
  • Institution/body Document type Reference Date Summary
    ESC Economic and Social Committee: opinion, report CES2059/2012 12/12/2012
    EDPS Document attached to the procedure N7-0092/2013 OJ C 253 03.09.2013, p. 0010 19/12/2012

Additional information

Source Document Date
National parliaments IPEX
European Commission EUR-Lex
European Commission EUR-Lex

Final act

Delegated acts

Reference Subject
2017/2710(DEA) Examination of delegated act
2022/2819(DEA) Examination of delegated act