BETA


2012/0023(COD) Pharmacovigilance: transparency and efficiency of the system. Regulation

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI MCAVAN Linda (icon: S&D S&D) AYUSO Pilar (icon: PPE PPE), PARVANOVA Antonyia (icon: ALDE ALDE), RIVASI Michèle (icon: Verts/ALE Verts/ALE), YANNAKOUDAKIS Marina (icon: ECR ECR)
Committee Opinion ITRE
Committee Opinion IMCO
Lead committee dossier:
Legal Basis:
TFEU 114-p1, TFEU 168-p4

Events

2012/11/14
   Final act published in Official Journal
Details

PURPOSE: determination of precise rules on pharmacovigilance and the improvement of medicines for human use in accordance with Regulation (EC) No 726/2004.

LEGISLATIVE ACT: Regulation (EC) No 1027/2012of the European Parliament and of the Council amending Regulation (EC) No 726/2004 relating to pharmacovigilance.

CONTENT: following a first reading agreement with the European Parliament, the Council adopted this Regulation as well as a Directive to improve medicines for human use (pharmacovigilance) so as to further improve general patient safety.

The main changes introduced to the legislation in force are as follows:

Information requirements :

· if the product ceases to be placed on the market of a Member State, either temporarily or permanently . Such notification shall, other than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product;

· the marketing authorisation holder shall notify the Agency forthwith of any action the holder takes to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation , together with the reasons for such action. The marketing authorisation holder shall in particular declare if such action is based on any of the grounds set out in Article 116 or Article 117(1) of Directive 2001/83/EC. They shall also make the notification if the action is taken in a third country.

List of medicinal products : the Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. The list referred to shall include an electronic link to the product information and to the summary of the risk management plan.

At the request of the Commission, medicinal products that are authorised pursuant to this Regulation, subject to certain conditions may also be included in the list.

By 5 June 2018 , the Commission shall present to the European Parliament and the Council a report on the use of the list, based on the experience and data provided by the Member States and the Agency.

Missions of the Agency : the Agency will ensure, inter alia, the following functions:

· coordinating the monitoring of medicinal products which have been authorised within the Union and providing advice on the measures necessary to ensure the safe and effective use of those medicinal products, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation;

· ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products authorised in the Union by means of a database which is permanently accessible to all Member States.

Marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised in the Union, using the format referred to in the Regulation.

ENTRY INTO FORCE: 04/12/2012.

APPLICATION: from 05/06/2013, with the exception of some sections which shall apply from 04/12/2012.

2012/10/25
   CSL - Draft final act
Documents
2012/10/25
   CSL - Final act signed
2012/10/25
   EP - End of procedure in Parliament
2012/10/11
   EC - Commission response to text adopted in plenary
Documents
2012/10/04
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2012/10/04
   CSL - Council Meeting
2012/09/11
   EP - Results of vote in Parliament
2012/09/11
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted by 665 votes to 9, with 10 abstentions, a legislative resolution on the proposal for a Regulation of the European Parliament and of the Council amending Regulation No 726/2004 as regards pharmacovigilance.

Parliament adopted its position on first reading following the ordinary legislative procedure. The agreement was the result of a compromise negotiated between Parliament and Council. The main amendments are as follows:

Information requirements: the marketing authorisation holder shall notify the Agency forthwith of any action the holder takes to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action. He shall in particular declare if such action is based on any of the grounds set out in Directive 2001/83/EC. He shall also make the notification if the action is taken in a third country.

List of medicinal products: the Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring.

The amended text stipulates that, at the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation and subject to certain conditions may also be included in the list.

Tasks of the Agency : the Agency will assume, among other things, the following tasks:

coordinating the monitoring of medicinal products which have been authorised within the Union and providing advice on the measures necessary to ensure the safe and effective use of those medicinal products, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation; ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products authorised in the Union by means of a database which is permanently accessible to all Member States.

Marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised in the Union, using the format referred to in the Regulation.

Documents
2012/09/10
   EP - Debate in Parliament
2012/07/12
   EP - Committee report tabled for plenary, 1st reading
Details

The Committee on the Environment, Public Health and Food Safety adopted the report by Linda McAVAN (S&D, UK) on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards pharmacovigilance.

The committee recommends that the European Parliament’s position in first reading following the ordinary legislative procedure should amend the Commission proposal as follows:

List of products : the list of products subject to additional monitoring should only include products subject to the most serious conditions and safety concerns, as otherwise the list becomes too long and loses meaning. It should automatically include all new products containing new active substances, as well as all new biosimilars, for the first five years.

Fees: in order to ensure full implementation of the new provisions related to pharmacovigilance the European Medicines Agency must be empowered to charge fees to marketing authorisation holders for the fulfilment of the pharmacovigilance tasks.

Consequently, the Commission should be empowered to adopt a delegated act in order to supplement the provisions in Article 67(3) as regards services provided by the Agency or the coordination group with respect to pharmacovigilance.

The power to adopt the delegated acts shall be conferred on the Commission for a period of 5 years from 1 July 2012. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it.

Documents
2012/05/08
   EP - Vote in committee, 1st reading
2012/05/02
   EP - Amendments tabled in committee
Documents
2012/04/12
   IT_SENATE - Contribution
Documents
2012/04/12
   PT_PARLIAMENT - Contribution
Documents
2012/04/03
   EP - Committee draft report
Documents
2012/03/28
   ESC - Economic and Social Committee: opinion, report
Documents
2012/02/16
   EP - Committee referral announced in Parliament, 1st reading
2012/02/10
   EC - Legislative proposal published
Details

PURPOSE: to amend Regulation (EC) No 726/2004 as regards pharmacovigilance in order to address weaknesses identified in the EU pharmacovigilance system.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

BACKGROUND: in December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation will apply from July 2012.

These measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns.

However, recent pharmacovigilance events in the European Union, in particular the “Mediatorcase”, have shown the need for a further improvement of the pharmacovigilance system . Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system that need to be addressed.

It should be noted that this proposal is closely linked to the proposal to amend Directive 2001/83/EC.

IMPACT ASSESSMENT: no impact assessment has been undertaken.

LEGAL BASIS: Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the EU.

CONTENT: the general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are to ensure the proper functioning of the internal market for medicinal products for human use and to protect better the health of EU citizens. Following this line, the proposals aim specifically to address weaknesses identified in the EU pharmacovigilance system and provide for more transparency and efficiency of the system in cases where safety concerns are identified.

The main amendments to the Regulation are as follows:

Reasons for withdrawal : marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns.

Accordingly, provision is made for the marketing authorisation holder to inform the Agency of the reasons for the withdrawal of a medicinal product, for interrupting the placing on the market of a medicinal product, for requests for revoking a marketing authorisation, or for not renewing a marketing authorisation.

Transparency : the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance.

The proposal provides that, in order to ensure transparency on the surveillance of authorised medicinal products, the list of medicinal products subject to additional monitoring established by Regulation (EC) No 726/2004 should systematically include medicinal products that are subject to post-authorisation safety conditions .

BUDGETARY IMPLICATIONS: the proposal has no implication for the budget of the Union. It makes minor changes to the system set forth by the 2010 pharmacovigilance legislation, and does not require additional human or administrative resources.

2011/12/20
   EP - MCAVAN Linda (S&D) appointed as rapporteur in ENVI

Documents

Activities

Votes

A7-0164/2012 - Linda McAvan - Résolution législative #

2012/09/11 Outcome: +: 665, 0: 10, -: 9
DE FR IT GB ES PL RO CZ BE EL HU SE PT AT BG NL FI DK SK LT LV SI IE LU EE CY MT ??
Total
95
67
62
65
46
46
31
22
21
21
21
18
18
18
16
21
12
12
12
9
9
8
9
6
6
6
4
3
icon: PPE PPE
246

Czechia PPE

2

Denmark PPE

For (1)

1

Ireland PPE

For (1)

1

Luxembourg PPE

3

Estonia PPE

For (1)

1
2

Malta PPE

For (1)

1
icon: S&D S&D
174

Bulgaria S&D

3

Netherlands S&D

2

Finland S&D

2

Latvia S&D

1

Slovenia S&D

2

Ireland S&D

Against (1)

3

Luxembourg S&D

For (1)

1

Estonia S&D

For (1)

1
icon: ALDE ALDE
77

Spain ALDE

1

Greece ALDE

1

Sweden ALDE

3
3

Slovakia ALDE

For (1)

1

Lithuania ALDE

1

Latvia ALDE

For (1)

1

Slovenia ALDE

2

Luxembourg ALDE

For (1)

1
icon: Verts/ALE Verts/ALE
52

United Kingdom Verts/ALE

5

Spain Verts/ALE

2

Greece Verts/ALE

1
3

Portugal Verts/ALE

For (1)

1

Austria Verts/ALE

2

Netherlands Verts/ALE

2

Finland Verts/ALE

For (1)

1

Denmark Verts/ALE

For (1)

1

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

1

Estonia Verts/ALE

For (1)

1
icon: ECR ECR
48

Belgium ECR

For (1)

1

Hungary ECR

For (1)

1

Netherlands ECR

For (1)

1

Denmark ECR

For (1)

1

Lithuania ECR

1

Latvia ECR

For (1)

1
icon: GUE/NGL GUE/NGL
33

United Kingdom GUE/NGL

1

Spain GUE/NGL

For (1)

1

Sweden GUE/NGL

1

Netherlands GUE/NGL

1

Denmark GUE/NGL

1

Latvia GUE/NGL

For (1)

1

Ireland GUE/NGL

For (1)

1
icon: EFD EFD
29

Belgium EFD

For (1)

1

Greece EFD

2

Netherlands EFD

For (1)

1

Finland EFD

For (1)

1

Denmark EFD

1

Slovakia EFD

For (1)

1

Lithuania EFD

For (1)

1
icon: NI NI
25

Spain NI

1

Romania NI

2

Belgium NI

For (1)

1

Hungary NI

2

Bulgaria NI

2

History

(these mark the time of scraping, not the official date of the change)

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  • date: 2012-04-12T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2012)0051 title: COM(2012)0051 type: Contribution body: PT_PARLIAMENT
events
  • date: 2012-02-10T00:00:00 type: Legislative proposal published body: EC docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2012/0051/COM_COM(2012)0051_FR.pdf title: COM(2012)0051 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=51 title: EUR-Lex summary: PURPOSE: to amend Regulation (EC) No 726/2004 as regards pharmacovigilance in order to address weaknesses identified in the EU pharmacovigilance system. PROPOSED ACT: Regulation of the European Parliament and of the Council. BACKGROUND: in December 2010, the European Parliament and the Council adopted Directive 2010/84/EU and Regulation (EU) No 1235/2010 ("2010 pharmacovigilance legislation") amending respectively, as regards pharmacovigilance, Directive 2001/83/EC and Regulation (EC) No 726/2004. The new legislation will apply from July 2012. These measures have substantially strengthened the legal framework for the surveillance of medicinal products, with provisions to reinforce the coordinating role of the Agency, the possibilities for signal detection, and the operation of coordinated procedures at European level to respond to safety concerns. However, recent pharmacovigilance events in the European Union, in particular the “Mediatorcase”, have shown the need for a further improvement of the pharmacovigilance system . Following an analysis of the Mediator case in the light of the 2010 pharmacovigilance legislation ("Stress test"), the Commission has detected certain weaknesses in the pharmacovigilance system that need to be addressed. It should be noted that this proposal is closely linked to the proposal to amend Directive 2001/83/EC. IMPACT ASSESSMENT: no impact assessment has been undertaken. LEGAL BASIS: Article 114 and Article 168(4)(c) of the Treaty on the Functioning of the EU. CONTENT: the general policy objectives of the proposals to amend Directive 2001/83/EC and Regulation (EC) No 726/2004 are to ensure the proper functioning of the internal market for medicinal products for human use and to protect better the health of EU citizens. Following this line, the proposals aim specifically to address weaknesses identified in the EU pharmacovigilance system and provide for more transparency and efficiency of the system in cases where safety concerns are identified. The main amendments to the Regulation are as follows: Reasons for withdrawal : marketing authorisation holders are not required to declare the reasons for the withdrawal of a marketing authorisation or product. Therefore, it cannot be ruled out that voluntary withdrawal of a marketing authorisation or product by the marketing authorisation holder could lead to safety issues being missed, in particular if the company is not transparent about possible safety concerns. Accordingly, provision is made for the marketing authorisation holder to inform the Agency of the reasons for the withdrawal of a medicinal product, for interrupting the placing on the market of a medicinal product, for requests for revoking a marketing authorisation, or for not renewing a marketing authorisation. Transparency : the public list of medicinal product subject to additional monitoring provided for in Article 23 of Regulation (EC) No 726/2004 will include certain medicinal products subject to post-authorisation safety conditions. Those products will be included in the list, following consultation with the Pharmacovigilance Risk Assessment Committee, only if the Commission or a Member States' competent authorities make a request. Therefore, competent authorities will have to decide on a case-by-case basis whether to make public the fact that products are subject to strengthened surveillance. The proposal provides that, in order to ensure transparency on the surveillance of authorised medicinal products, the list of medicinal products subject to additional monitoring established by Regulation (EC) No 726/2004 should systematically include medicinal products that are subject to post-authorisation safety conditions . BUDGETARY IMPLICATIONS: the proposal has no implication for the budget of the Union. It makes minor changes to the system set forth by the 2010 pharmacovigilance legislation, and does not require additional human or administrative resources.
  • date: 2012-02-16T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2012-05-08T00:00:00 type: Vote in committee, 1st reading/single reading body: EP
  • date: 2012-07-12T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-164&language=EN title: A7-0164/2012 summary: The Committee on the Environment, Public Health and Food Safety adopted the report by Linda McAVAN (S&D, UK) on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards pharmacovigilance. The committee recommends that the European Parliament’s position in first reading following the ordinary legislative procedure should amend the Commission proposal as follows: List of products : the list of products subject to additional monitoring should only include products subject to the most serious conditions and safety concerns, as otherwise the list becomes too long and loses meaning. It should automatically include all new products containing new active substances, as well as all new biosimilars, for the first five years. Fees: in order to ensure full implementation of the new provisions related to pharmacovigilance the European Medicines Agency must be empowered to charge fees to marketing authorisation holders for the fulfilment of the pharmacovigilance tasks. Consequently, the Commission should be empowered to adopt a delegated act in order to supplement the provisions in Article 67(3) as regards services provided by the Agency or the coordination group with respect to pharmacovigilance. The power to adopt the delegated acts shall be conferred on the Commission for a period of 5 years from 1 July 2012. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it.
  • date: 2012-09-10T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20120910&type=CRE title: Debate in Parliament
  • date: 2012-09-11T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=21559&l=en title: Results of vote in Parliament
  • date: 2012-09-11T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-314 title: T7-0314/2012 summary: The European Parliament adopted by 665 votes to 9, with 10 abstentions, a legislative resolution on the proposal for a Regulation of the European Parliament and of the Council amending Regulation No 726/2004 as regards pharmacovigilance. Parliament adopted its position on first reading following the ordinary legislative procedure. The agreement was the result of a compromise negotiated between Parliament and Council. The main amendments are as follows: Information requirements: the marketing authorisation holder shall notify the Agency forthwith of any action the holder takes to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action. He shall in particular declare if such action is based on any of the grounds set out in Directive 2001/83/EC. He shall also make the notification if the action is taken in a third country. List of medicinal products: the Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. The amended text stipulates that, at the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation and subject to certain conditions may also be included in the list. Tasks of the Agency : the Agency will assume, among other things, the following tasks: coordinating the monitoring of medicinal products which have been authorised within the Union and providing advice on the measures necessary to ensure the safe and effective use of those medicinal products, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation; ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products authorised in the Union by means of a database which is permanently accessible to all Member States. Marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised in the Union, using the format referred to in the Regulation.
  • date: 2012-10-04T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL
  • date: 2012-10-25T00:00:00 type: Final act signed body: CSL
  • date: 2012-10-25T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2012-11-14T00:00:00 type: Final act published in Official Journal summary: PURPOSE: determination of precise rules on pharmacovigilance and the improvement of medicines for human use in accordance with Regulation (EC) No 726/2004. LEGISLATIVE ACT: Regulation (EC) No 1027/2012of the European Parliament and of the Council amending Regulation (EC) No 726/2004 relating to pharmacovigilance. CONTENT: following a first reading agreement with the European Parliament, the Council adopted this Regulation as well as a Directive to improve medicines for human use (pharmacovigilance) so as to further improve general patient safety. The main changes introduced to the legislation in force are as follows: Information requirements : · if the product ceases to be placed on the market of a Member State, either temporarily or permanently . Such notification shall, other than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product; · the marketing authorisation holder shall notify the Agency forthwith of any action the holder takes to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation , together with the reasons for such action. The marketing authorisation holder shall in particular declare if such action is based on any of the grounds set out in Article 116 or Article 117(1) of Directive 2001/83/EC. They shall also make the notification if the action is taken in a third country. List of medicinal products : the Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring. The list referred to shall include an electronic link to the product information and to the summary of the risk management plan. At the request of the Commission, medicinal products that are authorised pursuant to this Regulation, subject to certain conditions may also be included in the list. By 5 June 2018 , the Commission shall present to the European Parliament and the Council a report on the use of the list, based on the experience and data provided by the Member States and the Agency. Missions of the Agency : the Agency will ensure, inter alia, the following functions: · coordinating the monitoring of medicinal products which have been authorised within the Union and providing advice on the measures necessary to ensure the safe and effective use of those medicinal products, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation; · ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products authorised in the Union by means of a database which is permanently accessible to all Member States. Marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised in the Union, using the format referred to in the Regulation. ENTRY INTO FORCE: 04/12/2012. APPLICATION: from 05/06/2013, with the exception of some sections which shall apply from 04/12/2012. docs: title: Regulation 2012/1027 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012R1027 title: OJ L 316 14.11.2012, p. 0038 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2012:316:TOC
other
  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers commissioner: DALLI John
otherinst
  • name: European Economic and Social Committee
  • name: European Committee of the Regions
procedure/Mandatory consultation of other institutions
Economic and Social Committee Committee of the Regions
procedure/Modified legal basis
Old
Rules of Procedure of the European Parliament EP 150
New
Rules of Procedure EP 150
procedure/dossier_of_the_committee
Old
ENVI/7/08833
New
  • ENVI/7/08833
procedure/final/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012R1027
New
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012R1027
procedure/instrument
Old
Regulation
New
  • Regulation
  • Amending Regulation (EC) No 726/2004 2001/0252(COD) See also 2012/0025(COD)
procedure/other_consulted_institutions
European Economic and Social Committee European Committee of the Regions
procedure/subject
Old
  • 4.20.04 Pharmaceutical products and industry
  • 4.20.05 Health legislation and policy
  • 4.60.08 Safety of products and services, product liability
New
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/summary
  • Amending Regulation (EC) No 726/2004
  • See also
activities/0/docs/0/celexid
CELEX:52012PC0051:EN
activities/0/docs/0/celexid
CELEX:52012PC0051:EN
links/European Commission/title
Old
PreLex
New
EUR-Lex
activities
  • date: 2012-02-10T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2012/0051/COM_COM(2012)0051_FR.pdf title: COM(2012)0051 type: Legislative proposal published celexid: CELEX:52012PC0051:EN body: EC type: Legislative proposal published commission: DG: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers Commissioner: DALLI John
  • date: 2012-02-16T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP shadows: group: PPE name: AYUSO Pilar group: ALDE name: PARVANOVA Antonyia group: Verts/ALE name: RIVASI Michèle group: ECR name: YANNAKOUDAKIS Marina group: GUE/NGL name: MAŠTÁLKA Jiří responsible: True committee: ENVI date: 2011-12-20T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: MCAVAN Linda body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
  • date: 2012-05-08T00:00:00 body: EP type: Vote in committee, 1st reading/single reading committees: body: EP shadows: group: PPE name: AYUSO Pilar group: ALDE name: PARVANOVA Antonyia group: Verts/ALE name: RIVASI Michèle group: ECR name: YANNAKOUDAKIS Marina group: GUE/NGL name: MAŠTÁLKA Jiří responsible: True committee: ENVI date: 2011-12-20T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: MCAVAN Linda body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
  • body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-164&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A7-0164/2012 type: Committee report tabled for plenary, 1st reading/single reading committees: body: EP shadows: group: PPE name: AYUSO Pilar group: ALDE name: PARVANOVA Antonyia group: Verts/ALE name: RIVASI Michèle group: ECR name: YANNAKOUDAKIS Marina group: GUE/NGL name: MAŠTÁLKA Jiří responsible: True committee: ENVI date: 2011-12-20T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: MCAVAN Linda body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE date: 2012-07-12T00:00:00
  • date: 2012-09-10T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20120910&type=CRE type: Debate in Parliament title: Debate in Parliament body: EP type: Debate in Parliament
  • date: 2012-09-11T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=21559&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-314 type: Decision by Parliament, 1st reading/single reading title: T7-0314/2012 body: EP type: Results of vote in Parliament
  • date: 2012-10-04T00:00:00 body: CSL type: Council Meeting council: Employment, Social Policy, Health and Consumer Affairs meeting_id: 3188
  • date: 2012-10-04T00:00:00 body: EP/CSL type: Act adopted by Council after Parliament's 1st reading
  • date: 2012-10-25T00:00:00 body: CSL type: Final act signed
  • date: 2012-10-25T00:00:00 body: EP type: End of procedure in Parliament
  • date: 2012-11-14T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012R1027 title: Regulation 2012/1027 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2012:316:TOC title: OJ L 316 14.11.2012, p. 0038
committees
  • body: EP shadows: group: PPE name: AYUSO Pilar group: ALDE name: PARVANOVA Antonyia group: Verts/ALE name: RIVASI Michèle group: ECR name: YANNAKOUDAKIS Marina group: GUE/NGL name: MAŠTÁLKA Jiří responsible: True committee: ENVI date: 2011-12-20T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: MCAVAN Linda
  • body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO
  • body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
links
National parliaments
European Commission
other
  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers commissioner: DALLI John
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ENVI/7/08833
Mandatory consultation of other institutions
Economic and Social Committee Committee of the Regions
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2012/0023(COD)
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Legislation
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instrument
Regulation
Modified legal basis
Rules of Procedure of the European Parliament EP 150
title
Pharmacovigilance: transparency and efficiency of the system. Regulation
type
COD - Ordinary legislative procedure (ex-codecision procedure)
final
subject