{"change_dates":[],"dossier":{"amendments":[],"changes":{"2014-11-09T22:26:35":[{"data":[{"body":"EC","commission":[{"Commissioner":"DALLI John","DG":{"title":"Health and Consumers","url":"http://ec.europa.eu/dgs/health_consumer/index_en.htm"}}],"date":"2012-02-10T00:00:00","docs":[{"celexid":"CELEX:52012PC0051:EN","text":["
PURPOSE: to amend Regulation (EC) No 726/2004 as\nregards pharmacovigilance in order to address weaknesses identified\nin the EU pharmacovigilance system.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: in December 2010, the European Parliament\nand the Council adopted Directive\n2010/84/EU and Regulation\n(EU) No 1235/2010 (\"2010 pharmacovigilance legislation\")\namending respectively, as regards pharmacovigilance, Directive\n2001/83/EC and Regulation (EC) No 726/2004. The new legislation\nwill apply from July 2012.
\nThese measures have substantially strengthened the\nlegal framework for the surveillance of medicinal products, with\nprovisions to reinforce the coordinating role of the Agency, the\npossibilities for signal detection, and the operation of\ncoordinated procedures at European level to respond to safety\nconcerns.
\nHowever, recent pharmacovigilance events in the\nEuropean Union, in particular the Mediatorcase, have\nshown the need for a further improvement of the\npharmacovigilance system. Following an analysis of the Mediator\ncase in the light of the 2010 pharmacovigilance legislation\n(\"Stress test\"), the Commission has detected certain weaknesses in\nthe pharmacovigilance system that need to be addressed.
\nIt should be noted that this proposal is closely\nlinked to the proposal\nto amend Directive 2001/83/EC.
\nIMPACT ASSESSMENT: no impact assessment has been\nundertaken.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the EU.
\nCONTENT: the general policy objectives of the\nproposals to amend Directive 2001/83/EC and Regulation (EC) No\n726/2004 are to ensure the proper functioning of the internal\nmarket for medicinal products for human use and to protect better\nthe health of EU citizens. Following this line, the proposals aim\nspecifically to address weaknesses identified in the EU\npharmacovigilance system and provide for more transparency and\nefficiency of the system in cases where safety concerns are\nidentified.
\nThe main amendments to the Regulation are as\nfollows:
\nReasons for withdrawal:\nmarketing authorisation holders are not required to declare the\nreasons for the withdrawal of a marketing authorisation or product.\nTherefore, it cannot be ruled out that voluntary withdrawal of a\nmarketing authorisation or product by the marketing authorisation\nholder could lead to safety issues being missed, in particular if\nthe company is not transparent about possible safety\nconcerns.
\nAccordingly, provision is made for the marketing\nauthorisation holder to inform the Agency of the reasons for the\nwithdrawal of a medicinal product, for interrupting the placing on\nthe market of a medicinal product, for requests for revoking a\nmarketing authorisation, or for not renewing a marketing\nauthorisation.
\nTransparency: the public\nlist of medicinal product subject to additional monitoring provided\nfor in Article 23 of Regulation (EC) No 726/2004 will include\ncertain medicinal products subject to post-authorisation safety\nconditions. Those products will be included in the list,\nfollowing consultation with the Pharmacovigilance Risk Assessment\nCommittee, only if the Commission or a Member States' competent\nauthorities make a request. Therefore, competent authorities will\nhave to decide on a case-by-case basis whether to make public the\nfact that products are subject to strengthened\nsurveillance.
\nThe proposal provides that, in order to ensure\ntransparency on the surveillance of authorised medicinal products,\nthe list of medicinal products subject to additional monitoring\nestablished by Regulation (EC) No 726/2004 should systematically\ninclude medicinal products that are subject to post-authorisation\nsafety conditions.
\nBUDGETARY IMPLICATIONS: the proposal has no\nimplication for the budget of the Union. It makes minor changes to\nthe system set forth by the 2010 pharmacovigilance legislation, and\ndoes not require additional human or administrative\nresources.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Linda McAVAN (S&D, UK) on the\nproposal for a regulation of the European Parliament and of the\nCouncil amending Regulation (EC) No 726/2004 as regards\npharmacovigilance.
\nThe committee recommends that the European\nParliaments position in first reading following the ordinary\nlegislative procedure should amend the Commission proposal as\nfollows:
\nList of products: the\nlist of products subject to additional monitoring should only\ninclude products subject to the most serious conditions and safety\nconcerns, as otherwise the list becomes too long and loses meaning.\nIt should automatically include all new products containing new\nactive substances, as well as all new biosimilars, for the first\nfive years.
\nFees: in order to ensure\nfull implementation of the new provisions related to\npharmacovigilance the European Medicines Agency must be empowered\nto charge fees to marketing authorisation holders for the\nfulfilment of the pharmacovigilance tasks.
\nConsequently, the Commission should be empowered to\nadopt a delegated act in order to supplement the provisions in\nArticle 67(3) as regards services provided by the Agency or the\ncoordination group with respect to pharmacovigilance.
\nThe power to adopt the delegated acts shall be\nconferred on the Commission for a period of 5 years from 1 July\n2012. The delegation of powers shall be automatically extended for\nperiods of an identical duration, unless the European Parliament or\nthe Council revokes it.
\nThe European Parliament adopted by 665 votes to 9,\nwith 10 abstentions, a legislative resolution on the proposal for a\nRegulation of the European Parliament and of the Council amending\nRegulation No 726/2004 as regards pharmacovigilance.
\nParliament adopted its position on first reading\nfollowing the ordinary legislative procedure. The agreement was the\nresult of a compromise negotiated between Parliament and Council.\nThe main amendments are as follows:
\nInformation requirements: the marketing authorisation holder shall notify the\nAgency forthwith of any action the holder takes to suspend the\nmarketing of a medicinal product, to withdraw a medicinal product\nfrom the market, to request the withdrawal of a marketing\nauthorisation or not to apply for the renewal of a marketing\nauthorisation, together with the reasons for such action. He shall\nin particular declare if such action is based on any of the grounds\nset out in Directive 2001/83/EC. He shall also make the\nnotification if the action is taken in a third country.
\nList of medicinal products: the Agency shall, in collaboration with the Member\nStates, set up, maintain and make public a list of medicinal\nproducts that are subject to additional monitoring.
\nThe amended text stipulates that, at the request of\nthe Commission, following consultation with the Pharmacovigilance\nRisk Assessment Committee, medicinal products that are authorised\npursuant to this Regulation and subject to certain conditions may\nalso be included in the list.
\nTasks of the Agency: the\nAgency will assume, among other things, the following\ntasks:
\nMarketing authorisation holders shall, by 2 July 2012\nat the latest, electronically submit to the Agency information on\nall medicinal products for human use authorised in the Union, using\nthe format referred to in the Regulation.
\n\nPURPOSE: determination of precise rules on\npharmacovigilance and the improvement of medicines for human use in\naccordance with Regulation (EC) No 726/2004.
\n\nLEGISLATIVE ACT: Regulation (EC) No 1027/2012of\nthe European Parliament and of the Council amending Regulation (EC)\nNo 726/2004 relating to pharmacovigilance.
\nCONTENT: following a first reading agreement with the\nEuropean Parliament, the Council adopted this Regulation as well as\na Directive to improve\nmedicines for human use (pharmacovigilance) so as to further improve general patient\nsafety.
\nThe main changes introduced to the legislation in\nforce are as follows:
\nInformation\nrequirements:
\n\n· \nif the product ceases to be placed on the\nmarket of a Member State, either temporarily or permanently.\nSuch notification shall, other than in exceptional circumstances,\nbe made no less than two months before the interruption in the\nplacing on the market of the product;
\n\n· \nthe marketing authorisation holder shall notify\nthe Agency forthwith of any action the holder takes to suspend\nthe marketing of a medicinal product, to withdraw a medicinal\nproduct from the market, to request the withdrawal of a marketing\nauthorisation or not to apply for the renewal of a marketing\nauthorisation, together with the reasons for such action. The\nmarketing authorisation holder shall in particular declare if such\naction is based on any of the grounds set out in Article 116 or\nArticle 117(1) of Directive 2001/83/EC. They shall also make the\nnotification if the action is taken in a third country.
\nList of medicinal products: the Agency shall, in collaboration with the Member\nStates, set up, maintain and make public a list of medicinal\nproducts that are subject to additional monitoring. The list\nreferred to shall include an electronic link to the product\ninformation and to the summary of the risk management\nplan.
\nAt the request of the Commission, medicinal products\nthat are authorised pursuant to this Regulation, subject to certain\nconditions may also be included in the list.
\nBy 5 June 2018, the\nCommission shall present to the European Parliament and the Council\na report on the use of the list, based on the experience and data\nprovided by the Member States and the Agency.
\nMissions of the Agency:\nthe Agency will ensure, inter alia, the following\nfunctions:
\n· \ncoordinating the monitoring of medicinal\nproducts which have been authorised within the Union and providing\nadvice on the measures necessary to ensure the safe and effective\nuse of those medicinal products, in particular by coordinating the\nevaluation and implementation of pharmacovigilance obligations and\nsystems and the monitoring of such implementation;
\n· \nensuring the collation and dissemination of\ninformation on suspected adverse reactions to medicinal products\nauthorised in the Union by means of a database which is permanently\naccessible to all Member States.
\nMarketing authorisation holders shall, by 2 July 2012\nat the latest, electronically submit to the Agency information on\nall medicinal products for human use authorised in the Union, using\nthe format referred to in the Regulation.
\nENTRY INTO FORCE: 04/12/2012.
\nAPPLICATION: from 05/062013, with the exception of\nsome sections which shall apply from 04/12/2012.
\nPURPOSE: to amend Regulation (EC) No 726/2004 as\nregards pharmacovigilance in order to address weaknesses identified\nin the EU pharmacovigilance system.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: in December 2010, the European Parliament\nand the Council adopted Directive\n2010/84/EU and Regulation\n(EU) No 1235/2010 (\"2010 pharmacovigilance legislation\")\namending respectively, as regards pharmacovigilance, Directive\n2001/83/EC and Regulation (EC) No 726/2004. The new legislation\nwill apply from July 2012.
\nThese measures have substantially strengthened the\nlegal framework for the surveillance of medicinal products, with\nprovisions to reinforce the coordinating role of the Agency, the\npossibilities for signal detection, and the operation of\ncoordinated procedures at European level to respond to safety\nconcerns.
\nHowever, recent pharmacovigilance events in the\nEuropean Union, in particular the Mediatorcase, have\nshown the need for a further improvement of the\npharmacovigilance system. Following an analysis of the Mediator\ncase in the light of the 2010 pharmacovigilance legislation\n(\"Stress test\"), the Commission has detected certain weaknesses in\nthe pharmacovigilance system that need to be addressed.
\nIt should be noted that this proposal is closely\nlinked to the proposal\nto amend Directive 2001/83/EC.
\nIMPACT ASSESSMENT: no impact assessment has been\nundertaken.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the EU.
\nCONTENT: the general policy objectives of the\nproposals to amend Directive 2001/83/EC and Regulation (EC) No\n726/2004 are to ensure the proper functioning of the internal\nmarket for medicinal products for human use and to protect better\nthe health of EU citizens. Following this line, the proposals aim\nspecifically to address weaknesses identified in the EU\npharmacovigilance system and provide for more transparency and\nefficiency of the system in cases where safety concerns are\nidentified.
\nThe main amendments to the Regulation are as\nfollows:
\nReasons for withdrawal:\nmarketing authorisation holders are not required to declare the\nreasons for the withdrawal of a marketing authorisation or product.\nTherefore, it cannot be ruled out that voluntary withdrawal of a\nmarketing authorisation or product by the marketing authorisation\nholder could lead to safety issues being missed, in particular if\nthe company is not transparent about possible safety\nconcerns.
\nAccordingly, provision is made for the marketing\nauthorisation holder to inform the Agency of the reasons for the\nwithdrawal of a medicinal product, for interrupting the placing on\nthe market of a medicinal product, for requests for revoking a\nmarketing authorisation, or for not renewing a marketing\nauthorisation.
\nTransparency: the public\nlist of medicinal product subject to additional monitoring provided\nfor in Article 23 of Regulation (EC) No 726/2004 will include\ncertain medicinal products subject to post-authorisation safety\nconditions. Those products will be included in the list,\nfollowing consultation with the Pharmacovigilance Risk Assessment\nCommittee, only if the Commission or a Member States' competent\nauthorities make a request. Therefore, competent authorities will\nhave to decide on a case-by-case basis whether to make public the\nfact that products are subject to strengthened\nsurveillance.
\nThe proposal provides that, in order to ensure\ntransparency on the surveillance of authorised medicinal products,\nthe list of medicinal products subject to additional monitoring\nestablished by Regulation (EC) No 726/2004 should systematically\ninclude medicinal products that are subject to post-authorisation\nsafety conditions.
\nBUDGETARY IMPLICATIONS: the proposal has no\nimplication for the budget of the Union. It makes minor changes to\nthe system set forth by the 2010 pharmacovigilance legislation, and\ndoes not require additional human or administrative\nresources.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Linda McAVAN (S&D, UK) on the\nproposal for a regulation of the European Parliament and of the\nCouncil amending Regulation (EC) No 726/2004 as regards\npharmacovigilance.
\nThe committee recommends that the European\nParliaments position in first reading following the ordinary\nlegislative procedure should amend the Commission proposal as\nfollows:
\nList of products: the\nlist of products subject to additional monitoring should only\ninclude products subject to the most serious conditions and safety\nconcerns, as otherwise the list becomes too long and loses meaning.\nIt should automatically include all new products containing new\nactive substances, as well as all new biosimilars, for the first\nfive years.
\nFees: in order to ensure\nfull implementation of the new provisions related to\npharmacovigilance the European Medicines Agency must be empowered\nto charge fees to marketing authorisation holders for the\nfulfilment of the pharmacovigilance tasks.
\nConsequently, the Commission should be empowered to\nadopt a delegated act in order to supplement the provisions in\nArticle 67(3) as regards services provided by the Agency or the\ncoordination group with respect to pharmacovigilance.
\nThe power to adopt the delegated acts shall be\nconferred on the Commission for a period of 5 years from 1 July\n2012. The delegation of powers shall be automatically extended for\nperiods of an identical duration, unless the European Parliament or\nthe Council revokes it.
\nThe European Parliament adopted by 665 votes to 9,\nwith 10 abstentions, a legislative resolution on the proposal for a\nRegulation of the European Parliament and of the Council amending\nRegulation No 726/2004 as regards pharmacovigilance.
\nParliament adopted its position on first reading\nfollowing the ordinary legislative procedure. The agreement was the\nresult of a compromise negotiated between Parliament and Council.\nThe main amendments are as follows:
\nInformation requirements: the marketing authorisation holder shall notify the\nAgency forthwith of any action the holder takes to suspend the\nmarketing of a medicinal product, to withdraw a medicinal product\nfrom the market, to request the withdrawal of a marketing\nauthorisation or not to apply for the renewal of a marketing\nauthorisation, together with the reasons for such action. He shall\nin particular declare if such action is based on any of the grounds\nset out in Directive 2001/83/EC. He shall also make the\nnotification if the action is taken in a third country.
\nList of medicinal products: the Agency shall, in collaboration with the Member\nStates, set up, maintain and make public a list of medicinal\nproducts that are subject to additional monitoring.
\nThe amended text stipulates that, at the request of\nthe Commission, following consultation with the Pharmacovigilance\nRisk Assessment Committee, medicinal products that are authorised\npursuant to this Regulation and subject to certain conditions may\nalso be included in the list.
\nTasks of the Agency: the\nAgency will assume, among other things, the following\ntasks:
\nMarketing authorisation holders shall, by 2 July 2012\nat the latest, electronically submit to the Agency information on\nall medicinal products for human use authorised in the Union, using\nthe format referred to in the Regulation.
\n\nPURPOSE: determination of precise rules on\npharmacovigilance and the improvement of medicines for human use in\naccordance with Regulation (EC) No 726/2004.
\n\nLEGISLATIVE ACT: Regulation (EC) No 1027/2012of\nthe European Parliament and of the Council amending Regulation (EC)\nNo 726/2004 relating to pharmacovigilance.
\nCONTENT: following a first reading agreement with the\nEuropean Parliament, the Council adopted this Regulation as well as\na Directive to improve\nmedicines for human use (pharmacovigilance) so as to further improve general patient\nsafety.
\nThe main changes introduced to the legislation in\nforce are as follows:
\nInformation\nrequirements:
\n\n· \nif the product ceases to be placed on the\nmarket of a Member State, either temporarily or permanently.\nSuch notification shall, other than in exceptional circumstances,\nbe made no less than two months before the interruption in the\nplacing on the market of the product;
\n\n· \nthe marketing authorisation holder shall notify\nthe Agency forthwith of any action the holder takes to suspend\nthe marketing of a medicinal product, to withdraw a medicinal\nproduct from the market, to request the withdrawal of a marketing\nauthorisation or not to apply for the renewal of a marketing\nauthorisation, together with the reasons for such action. The\nmarketing authorisation holder shall in particular declare if such\naction is based on any of the grounds set out in Article 116 or\nArticle 117(1) of Directive 2001/83/EC. They shall also make the\nnotification if the action is taken in a third country.
\nList of medicinal products: the Agency shall, in collaboration with the Member\nStates, set up, maintain and make public a list of medicinal\nproducts that are subject to additional monitoring. The list\nreferred to shall include an electronic link to the product\ninformation and to the summary of the risk management\nplan.
\nAt the request of the Commission, medicinal products\nthat are authorised pursuant to this Regulation, subject to certain\nconditions may also be included in the list.
\nBy 5 June 2018, the\nCommission shall present to the European Parliament and the Council\na report on the use of the list, based on the experience and data\nprovided by the Member States and the Agency.
\nMissions of the Agency:\nthe Agency will ensure, inter alia, the following\nfunctions:
\n· \ncoordinating the monitoring of medicinal\nproducts which have been authorised within the Union and providing\nadvice on the measures necessary to ensure the safe and effective\nuse of those medicinal products, in particular by coordinating the\nevaluation and implementation of pharmacovigilance obligations and\nsystems and the monitoring of such implementation;
\n· \nensuring the collation and dissemination of\ninformation on suspected adverse reactions to medicinal products\nauthorised in the Union by means of a database which is permanently\naccessible to all Member States.
\nMarketing authorisation holders shall, by 2 July 2012\nat the latest, electronically submit to the Agency information on\nall medicinal products for human use authorised in the Union, using\nthe format referred to in the Regulation.
\nENTRY INTO FORCE: 04/12/2012.
\nAPPLICATION: from 05/062013, with the exception of\nsome sections which shall apply from 04/12/2012.
\n