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)

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

Status

Procedure completed

 

Key players  
Key events  
17/07/2012
Legislative proposal published
11/09/2012
Committee referral announced in Parliament, 1st reading/single reading
29/05/2013
Vote in committee, 1st reading/single reading
10/06/2013
Committee report tabled for plenary, 1st reading/single reading
02/04/2014
Results of vote in Parliament
02/04/2014
Debate in Parliament
02/04/2014
Decision by Parliament, 1st reading/single reading
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)

Legal basis
Treaty on the Functioning of the EU TFEU 168-p4; Treaty on the Functioning of the EU TFEU 114-p1
Modified legal basis
Rules of Procedure EP 150
Mandatory consultation of other institutions
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
       
    31/01/2013
    EP
     
    Amendments tabled in committee
       
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    06/03/2013
    EP
     
    Amendments tabled in committee
       
    06/03/2013
    EP
     
    Committee opinion
    ITRE  
    21/03/2013
    EP
     
    Committee opinion
    IMCO  
    26/03/2013
    EP
     
    Committee opinion
    LIBE  
    09/04/2013
    EP
     
    Amendments tabled in committee
       
    PE513.021
    27/05/2013
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    10/06/2013
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    02/04/2014
    EP
  • European Commission 
    Legislative proposal
     
    17/07/2012
    EC
    Document attached to the procedure
     
    Eur-Lex link   SWD(2012)0200
    17/07/2012
    EC
     
    Document attached to the procedure
     
    Eur-Lex link   SWD(2012)0201
    17/07/2012
    EC
     
    Commission response to text adopted in plenary
     
    09/07/2014
     
     
  • National parliaments 
    Contribution
    CZ_SENATE
    07/11/2012
    NP
     
    Contribution
    EL_PARLIAMENT
    26/11/2012
    NP
     
    Contribution
    IT_SENATE
    04/10/2012
    NP
     
    Contribution
    PT_PARLIAMENT
    11/10/2012
    NP
     
  • Other institutions 
    Economic and Social Committee: opinion, report
     
    12/12/2012
    ESC
     
    Document attached to the procedure
     
    19/12/2012
    EDPS
  • All 
    Legislative proposal
       
    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
       
    12/12/2012
    ESC
     
    Document attached to the procedure
       
    19/12/2012
    EDPS
    Amendments tabled in committee
       
    PE502.281
    11/01/2013
    EP
     
    Committee draft report
       
    31/01/2013
    EP
     
    Amendments tabled in committee
       
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    01/03/2013
    EP
     
    Amendments tabled in committee
       
    06/03/2013
    EP
     
    Amendments tabled in committee
       
    06/03/2013
    EP
     
    Committee opinion
    ITRE  
    21/03/2013
    EP
     
    Committee opinion
    IMCO  
    26/03/2013
    EP
     
    Committee opinion
    LIBE  
    09/04/2013
    EP
     
    Amendments tabled in committee
       
    PE513.021
    27/05/2013
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    10/06/2013
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    02/04/2014
    EP
    Commission response to text adopted in plenary
       
    09/07/2014
     
     
    Contribution
    CZ_SENATE
    07/11/2012
    NP
     
    Contribution
    EL_PARLIAMENT
    26/11/2012
    NP
     
    Contribution
    IT_SENATE
    04/10/2012
    NP
     
    Contribution
    PT_PARLIAMENT
    11/10/2012
    NP
     
Final act  
Delegated acts  
Examination of delegated act