BETA


2012/0025(COD) Pharmacovigilance: transparency and efficiency of the system. Directive

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

2012/10/27
   Final act published in Official Journal
Details

PURPOSE: to strengthen the rules on pharmacovigilance in order to address weaknesses identified in the EU pharmacovigilance system, and amending Directive 2001/83/EC.

LEGISLATIVE ACT: Directive 2012/26/EU of the European Parliament and of the Council amending Directive 2001/83/EC as regards pharmacovigilance.

CONTENT: following agreement at first reading, the European Parliament and the Council adopted this Directive aimed at strengthening the post-authorisation monitoring of medicines for human use ("pharmacovigilance"), thereby further improving patient safety.

The new legislation focuses in particular on obligations on marketing authorisation holders in relation to adverse reactions to medicinal products and clarifies the procedures when competent authorities follow up such reporting.

The main points of the Directive are as follows:

Automatic assessment at EU level : recent pharmacovigilance incidents in the Union have shown the need for an automatic procedure at Union level in cases of specific safety issues to ensure that a matter is assessed and addressed in all Member States where the medicinal product is authorised. The Directive clarifies the scope of different Union procedures concerning products authorised at national level, as laid down in Directive 2001/83/EC on the Community code relating to medicinal products for human use.

Clarification of Normal Procedure and Urgent Procedure : these procedures are strengthened in order to ensure coordination, swift assessment in case of urgency and the possibility of taking immediate action, where necessary to protect public health, before a decision is taken at Union level.

· The Normal Procedure should be initiated for matters concerning quality, safety or efficacy of medicinal products where the interests of the Union are involved.

· The Urgent Union Procedure should be initiated when there is a need to swiftly assess concerns resulting from the evaluation of data from pharmacovigilance activities.

Regardless of whether the Urgent Union Procedure or the Normal Procedure is applied, and regardless of the procedure by means of which the medicinal product was authorised, be it centralised or otherwise, the Pharmacovigilance Risk Assessment Committee must always give its recommendation when the reason for taking action is based on pharmacovigilance data.

Member States must bring cases concerning new contraindications, reductions in the recommended dose or restrictions to the indication for medicinal products authorised in accordance with the decentralised procedure and the mutual recognition procedure to the attention of the coordination group when the Urgent Union Procedure is not initiated. In order to ensure harmonisation for those products, the coordination group may discuss whether any action is necessary in the event that no Member State has triggered the Normal Procedure.

Notification to competent authorities where product is withdrawn : voluntary action by the marketing authorisation holder should not lead to a situation where concerns relating to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, the Directive requires marketing authorisation holder to inform the relevant competent authorities and the European Medicines Agency of the reasons for with­drawing or interrupting the placing on the market of a medicinal product, for requesting that a marketing auth­orisation be revoked, or for not renewing a marketing authorisation. This also applies if the marketing authorisation holder withdraws a medicine from a third country market.

Transparency: each year, the European Medicines Agency shall make public a list of the medicinal products for which marketing authorisations have been refused, revoked or suspended in the Union, whose supply has been prohibited or which have been withdrawn from the market, including the reasons for such action.

Wholesale distribution of medicinal products : the Directive further strengthens the rules concerning wholesale distribution of medicinal products to third countries.

ENTRY INTO FORCE: 16 November 2012.

TRANSPOSITION: 28 October 2013.

APPLICATION: from 28 October 2013.

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 659 votes to 9, with 9 abstentions, a legislative resolution on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC 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:

Obligations regarding information: the marketing authorisation holder shall be obliged to inform the relevant competent authorities and the European Medicines Agency of the reasons for withdrawing or interrupting the placing on the market of a medicinal product, for requesting that a marketing authorisation be revoked, or for not renewing a marketing authorisation.

Normal Procedure and Urgent Union Procedure: the amended text clarifies and further strengthens the normal procedure and the urgent Union procedure in order to ensure coordination, swift assessment in case of urgency and the possibility to take immediate action, where necessary to protect public health, before a decision is taken at Union level.

The Normal Procedure should be initiated for matters concerning quality, safety or efficacy of medicinal products where the interests of the Union are involved. The Urgent Union Procedure should be initiated when there is a need to swiftly assess concerns resulting from the evaluation of data from pharmacovigilance activities.

Regardless of whether the Urgent Union Procedure or the Normal Procedure is applied, and regardless of the procedure by means of which the medicinal product was authorised, be it centralised or otherwise, the Pharmacovigilance Risk Assessment Committee should always give its recommendation when the reason for taking action is based on pharmacovigilance data. The coordination group and the Committee for Medicinal Products for Human Use shall rely on that recommendation when carrying out the assessment of the issue.

Drug-Fact-Box: the package leaflet must be written and designed in such a way as to be clear and understandable , enabling users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market

Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet. They may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market.

Wholesale distribution of medicinal products to third countries: in this case, wholesale distributors shall ensure that the medicinal products are obtained only from persons who are authorised or entitled to supply medicinal products in accordance with the applicable legal and administrative provisions of the third country concerned.

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 directive of the European Parliament and of the Council amending Directive 2001/83/EC 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:

Obligations regarding information : Members want to reinsert two obligations which make the referral procedure work more smoothly. Accordingly:

· the Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or marketing authorisation holder accordingly;

· the Member States and the applicant or marketing authorisation holder shall supply the Committee with all available information relating to the matter in question.

Drug-Fact-Box : the notice must include a Drug-Fact-Box - a brief description of essential/necessary facts and details of the medicinal product, which are required by the patient to understand the usefulness as well as possible risks of the medicinal product and to use it in a safe and proper way. The information contained in the Drug-Fact-Box shall be presented in a clear and legible way, and shall be distinguishable from the rest of the text form.

Third countries: the marketing authorisation holder shall also make the notification to Member States and the Agency of action to suspend the marketing of a medicinal product, or the non-renewal of a marketing authorization if the action is taken in a third country.

Notification to the Agency : the marketing authorisation holder shall be obliged to notify the Agency as well as Member States forthwith of any action taken by him 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.

Transparency : the Agency shall not only make public annually a list of the medicinal products for which marketing authorisations have been refused, revoked or suspended, whose supply has been prohibited or which have been withdrawn from the market, but also the reasons for such action.

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 Directive 2001/83/EC as regards pharmacovigilance in order to address weaknesses identified in the EU pharmacovigilance system.

PROPOSED ACT: Directive 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 “Mediator case”, 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 Regulation (EC) No 726/2004.

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:

Automatic assessment at EU level : Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatic assessment being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level.

Recent pharmacovigilance events in the Union have shown the need for an automatic procedure at Union level in the cases of specific safety issues to ensure that a matter is assessed and addressed in all Member States where the medicinal product is authorised. The scope of different Union procedures concerning nationally authorised products is clarified in the text.

Transparency : 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.

Voluntary action by the marketing authorisation holder should not lead to a situation where concerns related to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, provision is made for the marketing authorisation holder to inform competent authorities 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.

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

Votes

A7-0165/2012 - Linda McAvan - Résolution législative #

2012/09/11 Outcome: +: 659, 0: 9, -: 9
DE FR IT GB ES PL RO CZ BE HU EL PT AT SE NL BG FI DK SK LT LV SI IE EE CY LU MT ??
Total
94
68
62
65
46
46
31
22
21
21
20
18
18
17
21
15
12
12
11
9
9
8
7
6
6
5
4
3
icon: PPE PPE
246

Czechia PPE

2

Denmark PPE

For (1)

1

Ireland PPE

For (1)

1

Estonia PPE

For (1)

1
2

Luxembourg PPE

3

Malta PPE

For (1)

1
icon: S&D S&D
171

Netherlands S&D

2

Bulgaria S&D

3

Finland S&D

2

Latvia S&D

1

Slovenia S&D

2

Ireland S&D

2

Estonia S&D

For (1)

1

Luxembourg S&D

For (1)

1
icon: ALDE ALDE
75

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

Ireland ALDE

3

Luxembourg ALDE

For (1)

1
icon: Verts/ALE Verts/ALE
49

United Kingdom Verts/ALE

5

Spain Verts/ALE

2

Greece Verts/ALE

1

Portugal Verts/ALE

For (1)

1

Austria Verts/ALE

2

Sweden Verts/ALE

2

Netherlands Verts/ALE

2

Finland Verts/ALE

For (1)

1

Denmark Verts/ALE

For (1)

1

Latvia Verts/ALE

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
30

France EFD

Against (1)

1

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: 2012-10-11T00:00:00 docs: url: /oeil/spdoc.do?i=21560&j=0&l=en title: SP(2012)665 type: Commission response to text adopted in plenary
  • date: 2012-10-25T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F12&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 00043/2012/LEX type: Draft final act body: CSL
  • date: 2012-04-12T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2012)0052 title: COM(2012)0052 type: Contribution body: IT_SENATE
  • date: 2012-04-12T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2012)0052 title: COM(2012)0052 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/2012/0052/COM_COM(2012)0052_EN.pdf title: COM(2012)0052 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=52 title: EUR-Lex summary: PURPOSE: to amend Directive 2001/83/EC as regards pharmacovigilance in order to address weaknesses identified in the EU pharmacovigilance system. PROPOSED ACT: Directive 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 “Mediator case”, 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 Regulation (EC) No 726/2004. 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: Automatic assessment at EU level : Directive 2001/83/EC provides for an automatic assessment at Union level when specific serious safety issues have been identified with regard to nationally authorised products. In the 2010 pharmacovigilance legislation, changes to the Commission's proposal during co-decision have led to the automatic assessment being lost, as the initiation of the procedure is linked to an appreciation by the Member State or the Commission as to whether an urgent action is considered necessary. Thus, when a Member State considers suspending, revoking or refusing renewal of a marketing authorisation, but does not consider that urgent action is needed, no evaluation of the safety concern will be conducted at Union level. Recent pharmacovigilance events in the Union have shown the need for an automatic procedure at Union level in the cases of specific safety issues to ensure that a matter is assessed and addressed in all Member States where the medicinal product is authorised. The scope of different Union procedures concerning nationally authorised products is clarified in the text. Transparency : 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. Voluntary action by the marketing authorisation holder should not lead to a situation where concerns related to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, provision is made for the marketing authorisation holder to inform competent authorities 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. 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=A7-2012-165&language=EN title: A7-0165/2012 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 directive of the European Parliament and of the Council amending Directive 2001/83/EC 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: Obligations regarding information : Members want to reinsert two obligations which make the referral procedure work more smoothly. Accordingly: · the Member State concerned or the Commission shall clearly identify the question which is referred to the Committee for consideration and shall inform the applicant or marketing authorisation holder accordingly; · the Member States and the applicant or marketing authorisation holder shall supply the Committee with all available information relating to the matter in question. Drug-Fact-Box : the notice must include a Drug-Fact-Box - a brief description of essential/necessary facts and details of the medicinal product, which are required by the patient to understand the usefulness as well as possible risks of the medicinal product and to use it in a safe and proper way. The information contained in the Drug-Fact-Box shall be presented in a clear and legible way, and shall be distinguishable from the rest of the text form. Third countries: the marketing authorisation holder shall also make the notification to Member States and the Agency of action to suspend the marketing of a medicinal product, or the non-renewal of a marketing authorization if the action is taken in a third country. Notification to the Agency : the marketing authorisation holder shall be obliged to notify the Agency as well as Member States forthwith of any action taken by him 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. Transparency : the Agency shall not only make public annually a list of the medicinal products for which marketing authorisations have been refused, revoked or suspended, whose supply has been prohibited or which have been withdrawn from the market, but also the reasons for such action.
  • 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=21560&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-2012-313 title: T7-0313/2012 summary: The European Parliament adopted by 659 votes to 9, with 9 abstentions, a legislative resolution on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC 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: Obligations regarding information: the marketing authorisation holder shall be obliged to inform the relevant competent authorities and the European Medicines Agency of the reasons for withdrawing or interrupting the placing on the market of a medicinal product, for requesting that a marketing authorisation be revoked, or for not renewing a marketing authorisation. Normal Procedure and Urgent Union Procedure: the amended text clarifies and further strengthens the normal procedure and the urgent Union procedure in order to ensure coordination, swift assessment in case of urgency and the possibility to take immediate action, where necessary to protect public health, before a decision is taken at Union level. The Normal Procedure should be initiated for matters concerning quality, safety or efficacy of medicinal products where the interests of the Union are involved. The Urgent Union Procedure should be initiated when there is a need to swiftly assess concerns resulting from the evaluation of data from pharmacovigilance activities. Regardless of whether the Urgent Union Procedure or the Normal Procedure is applied, and regardless of the procedure by means of which the medicinal product was authorised, be it centralised or otherwise, the Pharmacovigilance Risk Assessment Committee should always give its recommendation when the reason for taking action is based on pharmacovigilance data. The coordination group and the Committee for Medicinal Products for Human Use shall rely on that recommendation when carrying out the assessment of the issue. Drug-Fact-Box: the package leaflet must be written and designed in such a way as to be clear and understandable , enabling users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market Where the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet. They may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market. Wholesale distribution of medicinal products to third countries: in this case, wholesale distributors shall ensure that the medicinal products are obtained only from persons who are authorised or entitled to supply medicinal products in accordance with the applicable legal and administrative provisions of the third country concerned.
  • 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: 2012-10-27T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to strengthen the rules on pharmacovigilance in order to address weaknesses identified in the EU pharmacovigilance system, and amending Directive 2001/83/EC. LEGISLATIVE ACT: Directive 2012/26/EU of the European Parliament and of the Council amending Directive 2001/83/EC as regards pharmacovigilance. CONTENT: following agreement at first reading, the European Parliament and the Council adopted this Directive aimed at strengthening the post-authorisation monitoring of medicines for human use ("pharmacovigilance"), thereby further improving patient safety. The new legislation focuses in particular on obligations on marketing authorisation holders in relation to adverse reactions to medicinal products and clarifies the procedures when competent authorities follow up such reporting. The main points of the Directive are as follows: Automatic assessment at EU level : recent pharmacovigilance incidents in the Union have shown the need for an automatic procedure at Union level in cases of specific safety issues to ensure that a matter is assessed and addressed in all Member States where the medicinal product is authorised. The Directive clarifies the scope of different Union procedures concerning products authorised at national level, as laid down in Directive 2001/83/EC on the Community code relating to medicinal products for human use. Clarification of Normal Procedure and Urgent Procedure : these procedures are strengthened in order to ensure coordination, swift assessment in case of urgency and the possibility of taking immediate action, where necessary to protect public health, before a decision is taken at Union level. · The Normal Procedure should be initiated for matters concerning quality, safety or efficacy of medicinal products where the interests of the Union are involved. · The Urgent Union Procedure should be initiated when there is a need to swiftly assess concerns resulting from the evaluation of data from pharmacovigilance activities. Regardless of whether the Urgent Union Procedure or the Normal Procedure is applied, and regardless of the procedure by means of which the medicinal product was authorised, be it centralised or otherwise, the Pharmacovigilance Risk Assessment Committee must always give its recommendation when the reason for taking action is based on pharmacovigilance data. Member States must bring cases concerning new contraindications, reductions in the recommended dose or restrictions to the indication for medicinal products authorised in accordance with the decentralised procedure and the mutual recognition procedure to the attention of the coordination group when the Urgent Union Procedure is not initiated. In order to ensure harmonisation for those products, the coordination group may discuss whether any action is necessary in the event that no Member State has triggered the Normal Procedure. Notification to competent authorities where product is withdrawn : voluntary action by the marketing authorisation holder should not lead to a situation where concerns relating to the risks or benefits of a medicinal product authorised in the Union are not properly addressed in all Member States. Therefore, the Directive requires marketing authorisation holder to inform the relevant competent authorities and the European Medicines Agency of the reasons for with­drawing or interrupting the placing on the market of a medicinal product, for requesting that a marketing auth­orisation be revoked, or for not renewing a marketing authorisation. This also applies if the marketing authorisation holder withdraws a medicine from a third country market. Transparency: each year, the European Medicines Agency shall make public a list of the medicinal products for which marketing authorisations have been refused, revoked or suspended in the Union, whose supply has been prohibited or which have been withdrawn from the market, including the reasons for such action. Wholesale distribution of medicinal products : the Directive further strengthens the rules concerning wholesale distribution of medicinal products to third countries. ENTRY INTO FORCE: 16 November 2012. TRANSPOSITION: 28 October 2013. APPLICATION: from 28 October 2013. docs: title: Directive 2012/26 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012L0026 title: OJ L 299 27.10.2012, p. 0001 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2012:299: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/7/08830
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  • ENVI/7/08830
procedure/final/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012L0026
New
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012L0026
procedure/instrument
Old
Directive
New
  • Directive
  • Amending Directive 2001/83/EC 1999/0134(COD) See also 2012/0023(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 Directive 2001/83/EC
  • See also
activities/0/docs/0/celexid
CELEX:52012PC0052:EN
activities/0/docs/0/celexid
CELEX:52012PC0052: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/2012/0052/COM_COM(2012)0052_EN.pdf title: COM(2012)0052 type: Legislative proposal published celexid: CELEX:52012PC0052: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=A7-2012-165&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A7-0165/2012 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=21560&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-2012-313 type: Decision by Parliament, 1st reading/single reading title: T7-0313/2012 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: 2012-10-27T00:00:00 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=32012L0026 title: Directive 2012/26 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2012:299:TOC title: OJ L 299 27.10.2012, p. 0001
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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Legislation
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Directive
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Pharmacovigilance: transparency and efficiency of the system. Directive
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