2008/0045(COD)

Medicinal products for human and veterinary use: marketing authorisations

Basic information

2008/0045(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Directive

Amending Directive 2001/83/EC 1999/0134(COD)
Amending Directive 2001/82/EC 1999/0180(COD)

Subject

3.10.08 Animal health requirements, veterinary legislation and pharmacy
4.20.04 Pharmaceutical products and industry
4.20.05 Health legislation and policy

Status

Procedure completed

Key players

Key events

Date Event Reference Summary
04/03/2008 Legislative proposal published COM(2008)0123
13/03/2008 Committee referral announced in Parliament, 1st reading
09/06/2008 Debate in Council
09/09/2008 Vote in committee, 1st reading
15/09/2008 Committee report tabled for plenary, 1st reading A6-0346/2008
22/10/2008 Decision by Parliament, 1st reading T6-0510/2008
22/10/2008 Results of vote in Parliament
22/10/2008 Debate in Parliament
28/05/2009 Act adopted by Council after Parliament's 1st reading
18/06/2009 Final act signed
18/06/2009 End of procedure in Parliament
30/06/2009 Final act published in Official Journal

Technical information

Procedure reference 2008/0045(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype Legislation
Legislative instrument Directive
Amending Directive 2001/83/EC 1999/0134(COD)
Amending Directive 2001/82/EC 1999/0180(COD)
Legal basis EC Treaty (after Amsterdam) EC 095
Stage reached in procedure Procedure completed
Committee dossier ENVI/6/60575

Documentation gateway

  • Document type Committee Reference Date Summary
    Committee draft report PE409.420 26/06/2008
    Amendments tabled in committee PE409.694 18/07/2008
    Amendments tabled in committee PE409.740 26/08/2008
    Committee opinion AGRI PE407.833 09/09/2008
    Committee report tabled for plenary, 1st reading/single reading A6-0346/2008 15/09/2008
    Text adopted by Parliament, 1st reading/single reading T6-0510/2008 22/10/2008
  • Document type Reference Date Summary
    Draft final act 03713/2008/LEX 18/06/2009
  • Document type Reference Date Summary
    Legislative proposal COM(2008)0123 04/03/2008
    Document attached to the procedure SEC(2008)0274 04/03/2008
    Document attached to the procedure SEC(2008)0273 04/03/2008
    Commission response to text adopted in plenary SP(2008)6664 12/11/2008
  • Institution/body Document type Reference Date Summary
    ESC Economic and Social Committee: opinion, report CES1194/2008 09/07/2008

Additional information

Source Document Date
National parliaments IPEX
European Commission EUR-Lex