Document reference

2012/0025(COD)  
Pharmacovigilance: transparency and efficiency of the system. Directive  
Basic information  

2012/0025(COD)

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

Amending Directive 2001/83/EC 1999/0134(COD)
See also 2012/0023(COD)

Subject
4.20.04 Pharmaceutical products and industry
4.20.05 Health legislation and policy
4.60.08 Safety of products and services, product liability

Status

Procedure completed

 

Key players  
Key events  
10/02/2012
Legislative proposal published
16/02/2012
Committee referral announced in Parliament, 1st reading/single reading
08/05/2012
Vote in committee, 1st reading/single reading
12/07/2012
Committee report tabled for plenary, 1st reading/single reading
10/09/2012
Debate in Parliament
11/09/2012
Results of vote in Parliament
11/09/2012
Decision by Parliament, 1st reading/single reading
04/10/2012
Act adopted by Council after Parliament's 1st reading
25/10/2012
Final act signed
25/10/2012
End of procedure in Parliament
27/10/2012
Final act published in Official Journal
Technical information  
Procedure reference
2012/0025(COD)
Procedure type
COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype
Legislation
Legislative instrument
Directive

Amending Directive 2001/83/EC 1999/0134(COD)

See also 2012/0023(COD)

Legal basis
Treaty on the Functioning of the EU TFEU 114-p1; Treaty on the Functioning of the EU TFEU 168-p4
Modified legal basis
Rules of Procedure EP 150
Mandatory consultation of other institutions
Stage reached in procedure
Procedure completed
Committee dossier
ENVI/7/08830
Documentation gateway  
  • European Parliament 
    Committee draft report
       
    03/04/2012
    EP
     
    Amendments tabled in committee
       
    PE488.004
    02/05/2012
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    12/07/2012
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    11/09/2012
    EP
  • Council of the EU 
    Draft final act
     
    25/10/2012
    CSL
     
  • European Commission 
    Legislative proposal
     
    10/02/2012
    EC
    Commission response to text adopted in plenary
     
    11/10/2012
     
     
  • National parliaments 
    Contribution
    IT_SENATE
    12/04/2012
    NP
     
    Contribution
    PT_PARLIAMENT
    12/04/2012
    NP
     
  • Other institutions 
    Economic and Social Committee: opinion, report
     
    28/03/2012
    ESC
     
  • All 
    Legislative proposal
       
    10/02/2012
    EC
    Economic and Social Committee: opinion, report
       
    28/03/2012
    ESC
     
    Committee draft report
       
    03/04/2012
    EP
     
    Amendments tabled in committee
       
    PE488.004
    02/05/2012
    EP
     
    Committee report tabled for plenary, 1st reading/single reading
       
    12/07/2012
    EP
    Text adopted by Parliament, 1st reading/single reading
       
    11/09/2012
    EP
    Commission response to text adopted in plenary
       
    11/10/2012
     
     
    Draft final act
       
    25/10/2012
    CSL
     
    Contribution
    IT_SENATE
    12/04/2012
    NP
     
    Contribution
    PT_PARLIAMENT
    12/04/2012
    NP
     
Final act