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
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European Parliament
Committee responsible Rapporteur Appointed ENVIEnvironment, Public Health and Food Safety
MCAVAN Linda (S&D)
20/12/2011
Committee for opinion Rapporteur for opinion Appointed ITREIndustry, Research and Energy
The committee decided not to give an opinion. IMCOInternal Market and Consumer Protection
The committee decided not to give an opinion. -
Council of the European Union
Council configuration Meetings Date Employment, Social Policy, Health and Consumer Affairs 3188 04/10/2012 -
European Commission
Commission DG Commissioner Health and Food Safety DALLI John
Technical information
| Procedure | Information |
|---|---|
| Procedure reference | 2012/0025(COD) |
| Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
| Nature of procedure | 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 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/7/08830
|
Documentation gateway
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Document type Committee Reference Date Summary Committee draft report PE486.167 03/04/2012 Committee report tabled for plenary, 1st reading/single reading A7-0165/2012 12/07/2012 Text adopted by Parliament, 1st reading/single reading T7-0313/2012 11/09/2012 -
Document type Reference Date Summary Draft final act 00043/2012/LEX 25/10/2012 -
Document type Reference Date Summary Legislative proposal COM(2012)0052 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)0052 12/04/2012 Contribution PT_PARLIAMENT COM(2012)0052 12/04/2012 -
Institution/body Document type Reference Date Summary ESC Economic and Social Committee: opinion, report CES0811/2012 28/03/2012