Procedure File: 2008/0261(COD) | Legislative Observatory

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European Parliament / Legislative Observatory

Procedure file

2008/0261(COD)

Medicinal products for human use: prevention of the entry into the legal supply chain of falsified medicinal products

Basic information
Key players
Key events
Technical information
Documentation gateway
Additional information
Final act

Basic information

2008/0261(COD)

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

Medicinal products for human use: prevention of the entry into the legal supply chain of falsified medicinal products

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

Subject
4.20.04 Pharmaceutical products and industry
4.60.02 Consumer information, advertising, labelling
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

GUE/NGL MATIAS Marisa

31/08/2009

Former committee responsible	Former rapporteur	Appointed
ENVI Environment, Public Health and Food Safety

Committee for opinion

Rapporteur for opinion

Appointed

ITRE Industry, Research and Energy

PPE SARTORI Amalia

16/09/2009

IMCO Internal Market and Consumer Protection

PPE BASTOS Regina

14/09/2009

Former committee for opinion	Former rapporteur for opinion	Appointed
ITRE Industry, Research and Energy
IMCO Internal Market and Consumer Protection

Council of the European Union

Council configuration

Meeting

Date

Employment, Social Policy, Health and Consumer Affairs

3019

07/06/2010

Former Council configuration
Employment, Social Policy, Health and Consumer Affairs	2980	30/11/2009

European Commission

Commission DG

Health and Food Safety

Commissioner

DALLI John

Key events

10/12/2008	Legislative proposal published	COM(2008)0668	Summary
15/01/2009	Committee referral announced in Parliament, 1st reading/single reading
19/10/2009	Committee referral announced in Parliament, 1st reading/single reading
30/11/2009	Debate in Council	2980	Summary
27/04/2010	Vote in committee, 1st reading/single reading		Summary
07/05/2010	Committee report tabled for plenary, 1st reading/single reading	A7-0148/2010
07/06/2010	Debate in Council	3019	Summary
15/02/2011	Debate in Parliament
16/02/2011	Results of vote in Parliament
16/02/2011	Decision by Parliament, 1st reading/single reading	T7-0056/2011	Summary
27/05/2011	Act adopted by Council after Parliament's 1st reading
08/06/2011	Final act signed
08/06/2011	End of procedure in Parliament
01/07/2011	Final act published in Official Journal

Technical information

Procedure reference	2008/0261(COD)
Procedure type	COD - Ordinary legislative procedure (ex-codecision procedure)
Procedure subtype	Legislation
Legislative instrument	Directive
	Amending Directive 2001/83/EC 1999/0134(COD)
Legal basis	Treaty on the Functioning of the EU TFEU 168-p4; Treaty on the Functioning of the EU TFEU 114-p1
Modified legal basis	Rules of Procedure EP 150
Stage reached in procedure	Procedure completed
Committee dossier	ENVI/7/00148

Documentation gateway

European Parliament

Committee draft report		PE430.883	07/01/2010	EP
Amendments tabled in committee		PE439.406	12/03/2010	EP
Amendments tabled in committee		PE439.407	12/03/2010	EP
Amendments tabled in committee		PE439.409	12/03/2010	EP
Amendments tabled in committee		PE439.860	12/03/2010	EP
Committee opinion	ITRE	PE430.741	24/03/2010	EP
Committee opinion	IMCO	PE438.139	06/04/2010	EP
Amendments tabled in committee		PE441.047	21/04/2010	EP
Committee report tabled for plenary, 1st reading/single reading		A7-0148/2010	07/05/2010	EP
Text adopted by Parliament, 1st reading/single reading		T7-0056/2011	16/02/2011	EP	Summary

European Commission

Legislative proposal	COM(2008)0668	10/12/2008	EC	Summary
Document attached to the procedure	SEC(2008)2674	10/12/2008	EC
Document attached to the procedure	SEC(2008)2675	10/12/2008	EC
Commission response to text adopted in plenary	SP(2011)2217	16/03/2011
Follow-up document	COM(2018)0049	26/01/2018	EC	Summary

Other institutions

Economic and Social Committee: opinion, report

CES1191/2009

15/07/2009

ESC

All

Legislative proposal		COM(2008)0668	10/12/2008	EC	Summary
Document attached to the procedure		SEC(2008)2674	10/12/2008	EC
Document attached to the procedure		SEC(2008)2675	10/12/2008	EC
Economic and Social Committee: opinion, report		CES1191/2009	15/07/2009	ESC
Committee draft report		PE430.883	07/01/2010	EP
Amendments tabled in committee		PE439.406	12/03/2010	EP
Amendments tabled in committee		PE439.407	12/03/2010	EP
Amendments tabled in committee		PE439.409	12/03/2010	EP
Amendments tabled in committee		PE439.860	12/03/2010	EP
Committee opinion	ITRE	PE430.741	24/03/2010	EP
Committee opinion	IMCO	PE438.139	06/04/2010	EP
Amendments tabled in committee		PE441.047	21/04/2010	EP
Committee report tabled for plenary, 1st reading/single reading		A7-0148/2010	07/05/2010	EP
Text adopted by Parliament, 1st reading/single reading		T7-0056/2011	16/02/2011	EP	Summary
Commission response to text adopted in plenary		SP(2011)2217	16/03/2011
Follow-up document		COM(2018)0049	26/01/2018	EC	Summary

Additional information

National parliaments	IPEX
European Commission	EUR-Lex

Final act

Directive 2011/62
OJ L 174 01.07.2011, p. 0074 Summary

Final legislative act with provisions for delegated acts

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