2013/0222(COD)

Medicinal products for human use: fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities

Basic information

2013/0222(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)

Regulation

Repealed by 2022/0417(COD)

Subject

4.20.04 Pharmaceutical products and industry
8.40.08 Agencies and bodies of the EU

Status

Procedure completed

Key players

Key events

Date Event Reference Summary
26/06/2013 Legislative proposal published COM(2013)0472
01/07/2013 Committee referral announced in Parliament, 1st reading
17/12/2013 Vote in committee, 1st reading
20/12/2013 Committee report tabled for plenary, 1st reading A7-0476/2013
16/04/2014 Decision by Parliament, 1st reading T7-0438/2014
16/04/2014 Results of vote in Parliament
08/05/2014 Act adopted by Council after Parliament's 1st reading
15/05/2014 Final act signed
15/05/2014 End of procedure in Parliament
27/06/2014 Final act published in Official Journal

Technical information

Procedure Information
Procedure reference 2013/0222(COD)
Procedure type COD - Ordinary legislative procedure (ex-codecision procedure)
Nature of procedure Legislation
Legislative instrument Regulation
Repealed by 2022/0417(COD)
Legal basis Treaty on the Functioning of the EU TFEU 168-p4 Treaty on the Functioning of the EU TFEU 114
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/7/13158

Documentation gateway

  • Document type Committee Reference Date Summary
    Committee draft report PE519.514 24/10/2013
    Amendments tabled in committee PE523.004 11/11/2013
    Committee report tabled for plenary, 1st reading/single reading A7-0476/2013 20/12/2013
    Text adopted by Parliament, 1st reading/single reading T7-0438/2014 16/04/2014
  • Document type Reference Date Summary
    Draft final act 00044/2014/LEX 15/05/2014
  • Document type Reference Date Summary
    Document attached to the procedure SWD(2013)0234 26/06/2013
    Legislative proposal COM(2013)0472 26/06/2013
    Document attached to the procedure SWD(2013)0235 26/06/2013
    Commission response to text adopted in plenary SP(2014)471 09/07/2014
    Follow-up document COM(2019)0439 30/09/2019
  • Document type Parliament/Chamber Reference Date Summary
    Contribution IT_SENATE COM(2013)0472 20/08/2013
  • Institution/body Document type Reference Date Summary
    ESC Economic and Social Committee: opinion, report CES5169/2013 16/10/2013

Additional information

Source Document Date
National parliaments IPEX
European Commission EUR-Lex

Delegated acts

Reference Subject
2018/2805(DEA) Examination of delegated act
2017/2923(DEA) Examination of delegated act
2020/2725(DEA) Examination of delegated act
2023/2771(DEA) Examination of delegated act
2022/2730(DEA) Examination of delegated act