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 114-p1; Treaty on the Functioning of the EU TFEU 168-p4
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  
  • European Parliament 
    Amendments tabled in committee
       
    PE502.281
    11/01/2013
    EP
     
    Committee draft report
       
    PE504.236  
    31/01/2013
    EP
     
    Amendments tabled in committee
       
    PE506.158  
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    PE506.161  
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    PE506.162  
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    PE506.159  
    06/03/2013
    EP
     
    Amendments tabled in committee
       
    PE506.160  
    06/03/2013
    EP
     
    Committee opinion
    ITRE  
    PE504.167  
    21/03/2013
    EP
     
    Committee opinion
    IMCO  
    PE500.727  
    26/03/2013
    EP
     
    Committee opinion
    LIBE  
    PE506.211  
    09/04/2013
    EP
     
    Amendments tabled in committee
       
    PE513.021
    27/05/2013
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    A7-0208/2013  
    10/06/2013
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    T7-0273/2014  
    02/04/2014
    EP
  • Council of the EU 
    Draft final act
     
    00002/2014/LEX  
    16/04/2014
    CSL
     
  • European Commission 
    Legislative proposal
     
    COM(2012)0369   Eur-Lex link  
    17/07/2012
    EC
    Document attached to the procedure
     
    SWD(2012)0200 Eur-Lex link  
    17/07/2012
    EC
     
    Document attached to the procedure
     
    SWD(2012)0201 Eur-Lex link  
    17/07/2012
    EC
     
    Commission response to text adopted in plenary
     
    SP(2014)471  
    09/07/2014
    EC
     
  • National parliaments 
    Contribution
    CZ_SENATE
    COM(2012)0369  
    06/11/2012
    NP
     
    Contribution
    EL_PARLIAMENT
    COM(2012)0369  
    25/11/2012
    NP
     
    Contribution
    IT_SENATE
    COM(2012)0369  
    03/10/2012
    NP
     
    Contribution
    PT_PARLIAMENT
    COM(2012)0369  
    10/10/2012
    NP
     
  • Other institutions 
    Economic and Social Committee: opinion, report
     
    CES2059/2012  
    12/12/2012
    ESC
     
    Document attached to the procedure
     
    N7-0092/2013
    OJ C 253 03.09.2013, p. 0010  
    19/12/2012
    EDPS
  • All 
    Legislative proposal
       
    COM(2012)0369   Eur-Lex link  
    17/07/2012
    EC
    Document attached to the procedure
       
    SWD(2012)0200 Eur-Lex link  
    17/07/2012
    EC
     
    Document attached to the procedure
       
    SWD(2012)0201 Eur-Lex link  
    17/07/2012
    EC
     
    Economic and Social Committee: opinion, report
       
    CES2059/2012  
    12/12/2012
    ESC
     
    Document attached to the procedure
       
    N7-0092/2013
    OJ C 253 03.09.2013, p. 0010  
    19/12/2012
    EDPS
    Amendments tabled in committee
       
    PE502.281
    11/01/2013
    EP
     
    Committee draft report
       
    PE504.236  
    31/01/2013
    EP
     
    Amendments tabled in committee
       
    PE506.158  
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    PE506.161  
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    PE506.162  
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    PE506.159  
    06/03/2013
    EP
     
    Amendments tabled in committee
       
    PE506.160  
    06/03/2013
    EP
     
    Committee opinion
    ITRE  
    PE504.167  
    21/03/2013
    EP
     
    Committee opinion
    IMCO  
    PE500.727  
    26/03/2013
    EP
     
    Committee opinion
    LIBE  
    PE506.211  
    09/04/2013
    EP
     
    Amendments tabled in committee
       
    PE513.021
    27/05/2013
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    A7-0208/2013  
    10/06/2013
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    T7-0273/2014  
    02/04/2014
    EP
    Draft final act
       
    00002/2014/LEX  
    16/04/2014
    CSL
     
    Commission response to text adopted in plenary
       
    SP(2014)471  
    09/07/2014
    EC
     
    Contribution
    CZ_SENATE
    COM(2012)0369  
    06/11/2012
    NP
     
    Contribution
    EL_PARLIAMENT
    COM(2012)0369  
    25/11/2012
    NP
     
    Contribution
    IT_SENATE
    COM(2012)0369  
    03/10/2012
    NP
     
    Contribution
    PT_PARLIAMENT
    COM(2012)0369  
    10/10/2012
    NP
     
Final act  
Delegated acts  
2017/2710(DEA)  
Examination of delegated act  
2022/2819(DEA)  
Examination of delegated act