Procedure File: 2012/0025(COD)

European Parliament / Legislative Observatory

Procedure file

2012/0025(COD)

Pharmacovigilance: transparency and efficiency of the system. Directive

Basic information
Key players
Key events
Technical information
Documentation gateway
Links to other sites
Final act

Basic information

2012/0025(COD)

COD - Ordinary legislative procedure (ex-codecision procedure)
Directive

Pharmacovigilance: transparency and efficiency of the system. 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

Procedure completed

Please go to Documentation gateway for any follow-up documents.

Key players

European Parliament

Committee responsible

Rapporteur

Appointed

ENVI Environment, Public Health and Food Safety

MCAVAN Linda

Shadow rapporteur

20/12/2011

Committee for opinion	Rapporteur for opinion	Appointed
IMCO Internal Market and Consumer Protection	The committee decided not to give an opinion.
ITRE Industry, Research and Energy	The committee decided not to give an opinion.

Council of the European Union

Council configuration	Meeting	Date
Employment, Social Policy, Health and Consumer Affairs	3188	04/10/2012

European Commission

Commission DG

Health and Consumers

Commissioner

DALLI John

Economic and Social Committee

Committee of the Regions

Key events

10/02/2012	Legislative proposal published	COM(2012)0052	Summary
16/02/2012	Committee referral announced in Parliament, 1st reading/single reading
08/05/2012	Vote in committee, 1st reading/single reading
12/07/2012	Committee report tabled for plenary, 1st reading/single reading	A7-0165/2012	Summary
10/09/2012	Debate in Parliament
11/09/2012	Decision by Parliament, 1st reading/single reading	T7-0313/2012	Summary
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
27/10/2012	Final act published in Official Journal

Technical information

Procedure reference

2012/0025(COD)

Procedure type

COD - Ordinary legislative procedure (ex-codecision procedure)

Procedure subtype

Legislation

Legislative instrument

Directive

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

European Parliament

Committee draft report	PE486.167	03/04/2012
Amendments tabled in committee	PE488.004	02/05/2012
Committee report tabled for plenary, 1st reading/single reading	A7-0165/2012	12/07/2012	Summary
Text adopted by Parliament, 1st reading/single reading	T7-0313/2012	11/09/2012	Summary

European Commission

Legislative proposal	COM(2012)0052	10/02/2012	Summary
Commission response to text adopted in plenary	SP(2012)665	11/10/2012

Other institutions

Economic and Social Committee: opinion, report

CES0811/2012

28/03/2012

All

Legislative proposal	COM(2012)0052	10/02/2012	Summary
Economic and Social Committee: opinion, report	CES0811/2012	28/03/2012
Committee draft report	PE486.167	03/04/2012
Amendments tabled in committee	PE488.004	02/05/2012
Committee report tabled for plenary, 1st reading/single reading	A7-0165/2012	12/07/2012	Summary
Text adopted by Parliament, 1st reading/single reading	T7-0313/2012	11/09/2012	Summary
Commission response to text adopted in plenary	SP(2012)665	11/10/2012

Links to other sites

National parliaments	IPEX
European Commission	PreLex

Final act

Directive 2012/26
OJ L 299 27.10.2012, p. 0001 Summary

Choose your language:

Document reference

Main navigation

European Parliament

European Commission

Other institutions

All