2012/0023(COD)

Pharmacovigilance: transparency and efficiency of the system. Regulation

Basic information

2012/0023(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Amending Regulation (EC) No 726/2004 2001/0252(COD)
See also 2012/0025(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

Technical information

Procedure Information
Procedure reference 2012/0023(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Nature of procedure Legislation
Legislative instrument Regulation
Amending Regulation (EC) No 726/2004 2001/0252(COD)
See also 2012/0025(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/7/08833

Documentation gateway

  • Document type Committee Reference Date Summary
    Committee draft report PE486.166 03/04/2012
    Committee report tabled for plenary, 1st reading/single reading A7-0164/2012 12/07/2012
    Text adopted by Parliament, 1st reading/single reading T7-0314/2012 11/09/2012
  • Document type Reference Date Summary
    Draft final act 00042/2012/LEX 25/10/2012
  • Document type Reference Date Summary
    Legislative proposal COM(2012)0051 10/02/2012
    Commission response to text adopted in plenary SP(2012)665 11/10/2012
  • Document type Parliament/Chamber Reference Date Summary
    Contribution IT_SENATE COM(2012)0051 12/04/2012
    Contribution PT_PARLIAMENT COM(2012)0051 12/04/2012
  • Institution/body Document type Reference Date Summary
    ESC Economic and Social Committee: opinion, report CES0812/2012 28/03/2012