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
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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
Key events
| Date | Event | Reference | Summary |
|---|---|---|---|
| 10/02/2012 | Legislative proposal published | COM(2012)0051 | |
| 16/02/2012 | Committee referral announced in Parliament, 1st reading | ||
| 08/05/2012 | Vote in committee, 1st reading | ||
| 12/07/2012 | Committee report tabled for plenary, 1st reading | A7-0164/2012 | |
| 10/09/2012 | Debate in Parliament | ||
| 11/09/2012 | Decision by Parliament, 1st reading | T7-0314/2012 | |
| 11/09/2012 | Results of vote in Parliament | ||
| 04/10/2012 | Act adopted by Council after Parliament's 1st reading | ||
| 25/10/2012 | Final act signed | ||
| 25/10/2012 | End of procedure in Parliament | ||
| 14/11/2012 | Final act published in Official Journal |
Technical information
| Procedure reference | 2012/0023(COD) |
|---|---|
| Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
| Procedure subtype | Legislation |
| Legislative instrument | Regulation |
| Amendments and repeals |
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
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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 EESC Economic and Social Committee: opinion, report CES0812/2012 28/03/2012