2008/0257(COD)

Medicinal products for human use: pharmacovigilance of products

Basic information

2008/0257(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Amending Regulation (EC) No 726/2004, Community procedures 2001/0252(COD)
Amending Regulation (EC) No 1394/2007 2005/0227(COD)
See also 2008/0260(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

Date Event Reference Summary
10/12/2008 Legislative proposal published COM(2008)0664
13/01/2009 Committee referral announced in Parliament, 1st reading
19/10/2009 Committee referral announced in Parliament, 1st reading
30/11/2009 Debate in Council
27/04/2010 Vote in committee, 1st reading
10/05/2010 Committee report tabled for plenary, 1st reading A7-0153/2010
21/09/2010 Debate in Parliament
22/09/2010 Decision by Parliament, 1st reading T7-0331/2010
22/09/2010 Results of vote in Parliament
29/11/2010 Act adopted by Council after Parliament's 1st reading
15/12/2010 Final act signed
15/12/2010 End of procedure in Parliament
31/12/2010 Final act published in Official Journal

Technical information

Procedure Information
Procedure reference 2008/0257(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Nature of procedure Legislation
Legislative instrument Regulation
Amending Regulation (EC) No 726/2004, Community procedures 2001/0252(COD)
Amending Regulation (EC) No 1394/2007 2005/0227(COD)
See also 2008/0260(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
Stage reached in procedure Procedure completed
Committee dossier ENVI/7/00162

Documentation gateway

  • Document type Committee Reference Date Summary
    Committee draft report PE430.928 17/12/2009
    Amendments tabled in committee PE438.462 12/02/2010
    Amendments tabled in committee PE438.505 23/02/2010
    Committee opinion IMCO PE431.040 24/02/2010
    Amendments tabled in committee PE438.413 01/03/2010
    Committee opinion ITRE PE430.771 16/04/2010
    Committee report tabled for plenary, 1st reading/single reading A7-0153/2010 10/05/2010
    Text adopted by Parliament, 1st reading/single reading T7-0331/2010 22/09/2010
  • Document type Reference Date Summary
    Draft final act 00046/2010/LEX 15/12/2010
  • Document type Reference Date Summary
    Legislative proposal COM(2008)0664 10/12/2008
    Document attached to the procedure SEC(2008)2670 10/12/2008
    Document attached to the procedure SEC(2008)2671 10/12/2008
    Commission response to text adopted in plenary SP(2010)7193 13/10/2010
  • Institution/body Document type Reference Date Summary
    EDPS Document attached to the procedure JOC_2009/C/229/04 OJ C 229 23.09.2009, p. 0019 22/04/2009
    ESC Economic and Social Committee: opinion, report CES1023/2009 10/06/2009

Additional information

Source Document Date
National parliaments IPEX
European Commission EUR-Lex