2008/0260(COD)
Medicinal products for human use: pharmacovigilance of products
Basic information
2008/0260(COD)
COD - Ordinary legislative procedure (ex-codecision procedure)
Directive
Amending Directive 2001/83/EC, Community code
1999/0134(COD)
See also
2008/0257(COD)
Subject
4.20.04 Pharmaceutical products and industry
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)
10/09/2009
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Former committee responsible Former rapporteur Appointed ENVIEnvironment, Public Health and Food Safety
Committee for opinion Rapporteur for opinion Appointed ITREIndustry, Research and Energy
RIVASI Michèle (Verts/ALE)
16/09/2009
IMCOInternal Market and Consumer Protection
TURMES Claude (Verts/ALE)
28/09/2009
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Former committee for opinion Former rapporteur for opinion Appointed ITREIndustry, Research and Energy
IMCOInternal Market and Consumer Protection
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Council of the European Union
Council configuration Meetings Date Employment, Social Policy, Health and Consumer Affairs 2980 30/11/2009 Agriculture and Fisheries 3050 29/11/2010 -
European Commission
Commission DG Commissioner Health and Food Safety DALLI John
Key events
| Date | Event | Reference | Summary |
|---|---|---|---|
| 10/12/2008 | Legislative proposal published | COM(2008)0665 | |
| 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 | ||
| 02/06/2010 | Committee report tabled for plenary, 1st reading | A7-0159/2010 | |
| 21/09/2010 | Debate in Parliament | ||
| 22/09/2010 | Decision by Parliament, 1st reading | T7-0332/2010 | |
| 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 | ||
| 25/01/2011 | Final act published in Official Journal |
Technical information
| Procedure | Information |
|---|---|
| Procedure reference | 2008/0260(COD) |
| Procedure type | COD - Ordinary legislative procedure (ex-codecision procedure) |
| Nature of procedure | Legislation |
| Legislative instrument | Directive |
|
Amending Directive 2001/83/EC, Community code
1999/0134(COD)
See also 2008/0257(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/7/00153
|
Documentation gateway
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Document type Committee Reference Date Summary Committee draft report PE430.927 17/12/2009 Amendments tabled in committee PE438.448 02/02/2010 Amendments tabled in committee PE438.514 08/02/2010 Committee opinion IMCO PE431.039 05/03/2010 Amendments tabled in committee PE438.412 15/03/2010 Committee opinion ITRE PE430.773 15/04/2010 Committee report tabled for plenary, 1st reading/single reading A7-0159/2010 02/06/2010 Text adopted by Parliament, 1st reading/single reading T7-0332/2010 22/09/2010 -
Document type Reference Date Summary Draft final act 00047/2010/LEX 15/12/2010 -
Document type Reference Date Summary Document attached to the procedure SEC(2008)2670 10/12/2008 Document attached to the procedure SEC(2008)2671 10/12/2008 Legislative proposal COM(2008)0665 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 CES1024/2009 10/06/2009