{"change_dates":[],"dossier":{"amendments":[],"changes":{"2014-11-09T22:26:32":[{"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:52012PC0052:EN","text":["
PURPOSE: to amend Directive 2001/83/EC as regards\npharmacovigilance in order to address weaknesses identified in the\nEU pharmacovigilance system.
\nPROPOSED ACT: Directive of the European Parliament and\nof 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 Mediator case, 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 Regulation (EC) No 726/2004.
\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:
\nAutomatic assessment at EU level: Directive 2001/83/EC provides for an automatic\nassessment at Union level when specific serious safety issues have\nbeen identified with regard to nationally authorised products. In\nthe 2010 pharmacovigilance legislation, changes to the Commission's\nproposal during co-decision have led to the automatic assessment\nbeing lost, as the initiation of the procedure is linked to an\nappreciation by the Member State or the Commission as to whether an\nurgent action is considered necessary. Thus, when a Member State\nconsiders suspending, revoking or refusing renewal of a marketing\nauthorisation, but does not consider that urgent action is needed,\nno evaluation of the safety concern will be conducted at Union\nlevel.
\nRecent pharmacovigilance events in the Union have\nshown the need for an automatic procedure at Union level in the\ncases of specific safety issues to ensure that a matter is assessed\nand addressed in all Member States where the medicinal product is\nauthorised. The scope of different Union procedures concerning\nnationally authorised products is clarified in the text.
\nTransparency: marketing\nauthorisation holders are not required to declare the reasons for\nthe withdrawal of a marketing authorisation or product. Therefore,\nit cannot be ruled out that voluntary withdrawal of a marketing\nauthorisation or product by the marketing authorisation holder\ncould lead to safety issues being missed, in particular if the\ncompany is not transparent about possible safety\nconcerns.
\nVoluntary action by the marketing authorisation holder\nshould not lead to a situation where concerns related to the risks\nor benefits of a medicinal product authorised in the Union are not\nproperly addressed in all Member States. Therefore, provision is\nmade for the marketing authorisation holder to inform competent\nauthorities of the reasons for the withdrawal of a medicinal\nproduct, for interrupting the placing on the market of a\nmedicinal product, for requests for revoking a marketing\nauthorisation, or for not renewing a marketing\nauthorisation.
\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 directive of the European Parliament and of the\nCouncil amending Directive 2001/83/EC 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:
\nObligations regarding information: Members want to reinsert two obligations which make\nthe referral procedure work more smoothly.\nAccordingly:
\n\n· \nthe Member State concerned or the\nCommission shall clearly identify the question which is referred to\nthe Committee for consideration and shall inform the applicant or\nmarketing authorisation holder accordingly;
\n\n· \nthe Member States and the\napplicant or marketing authorisation holder shall supply the\nCommittee with all available information relating to the matter in\nquestion.
\nDrug-Fact-Box: the\nnotice must include a Drug-Fact-Box - a brief description of\nessential/necessary facts and details of the medicinal\nproduct, which are required by the patient to understand the\nusefulness as well as possible risks of the medicinal\nproduct and to use it in a safe and proper way. The\ninformation contained in the Drug-Fact-Box shall\nbe presented in a\nclear and legible way, and shall be\ndistinguishable from the rest of the text form.
\nThird countries: the\nmarketing authorisation holder shall also make the notification to\nMember States and the Agency of action to suspend the\nmarketing of a medicinal product, or the non-renewal of a\nmarketing authorization if the action is taken in a third\ncountry.
\nNotification to the Agency: the marketing authorisation holder shall be obliged\nto notify the Agency as well as Member States forthwith of any\naction taken by him to suspend the marketing of a medicinal\nproduct, to withdraw a medicinal product from the market, to\nrequest the withdrawal of a marketing authorisation or not to apply\nfor the renewal of a marketing authorisation, together with the\nreasons for such action.
\nTransparency: the Agency\nshall not only make public annually a list of the medicinal\nproducts for which marketing authorisations have been refused,\nrevoked or suspended, whose supply has been prohibited or which\nhave been withdrawn from the market, but also the reasons for such\naction.
\nThe European Parliament adopted by 659 votes to 9,\nwith 9 abstentions, a legislative resolution on the proposal for a\ndirective of the European Parliament and of the Council amending\nDirective 2001/83/EC 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:
\nObligations regarding information: the marketing authorisation holder shall be obliged to\ninform the relevant competent authorities and the European\nMedicines Agency of the reasons for withdrawing or interrupting the\nplacing on the market of a medicinal product, for requesting that a\nmarketing authorisation be revoked, or for not renewing a marketing\nauthorisation.
\nNormal Procedure and Urgent Union\nProcedure: the amended text clarifies\nand further strengthens the normal procedure and the urgent Union\nprocedure in order to ensure coordination, swift assessment in case\nof urgency and the possibility to take immediate action, where\nnecessary to protect public health, before a decision is taken at\nUnion level.
\nRegardless of whether the Urgent Union Procedure or\nthe Normal Procedure is applied, and regardless of the procedure by\nmeans of which the medicinal product was authorised, be it\ncentralised or otherwise, the Pharmacovigilance Risk Assessment\nCommittee should always give its recommendation when the reason\nfor taking action is based on pharmacovigilance data. The\ncoordination group and the Committee for Medicinal Products for\nHuman Use shall rely on that recommendation when carrying out the\nassessment of the issue.
\nDrug-Fact-Box: the\npackage leaflet must be written and designed in such a way as to be\nclear and understandable, enabling users to act\nappropriately, when necessary with the help of health\nprofessionals. The package leaflet must be clearly legible in an\nofficial language or official languages of the Member State where\nthe medicinal product is placed on the market
\nWhere the medicinal product is not intended to be\ndelivered directly to the patient, or where there are severe\nproblems in respect of the availability of the medicinal product,\nthe competent authorities may, subject to measures they consider\nnecessary to safeguard human health, grant an exemption to the\nobligation that certain particulars should appear on the\nlabelling and in the package leaflet. They may also grant a full or\npartial exemption to the obligation that the labelling and the\npackage leaflet must be in an official language or official\nlanguages of the Member State where the medicinal product is placed\non the market.
\nWholesale distribution of medicinal products to third\ncountries: in this case, wholesale\ndistributors shall ensure that the medicinal products are obtained\nonly from persons who are authorised or entitled to supply\nmedicinal products in accordance with the applicable legal and\nadministrative provisions of the third country\nconcerned.
\nPURPOSE: to strengthen the rules on pharmacovigilance\nin order to address weaknesses identified in the EU\npharmacovigilance system, and amending Directive\n2001/83/EC.
\nLEGISLATIVE ACT: Directive 2012/26/EU of the European\nParliament and of the Council amending Directive 2001/83/EC as\nregards pharmacovigilance.
\nCONTENT: following agreement at first reading, the\nEuropean Parliament and the Council adopted this Directive aimed at\nstrengthening the post-authorisation monitoring of medicines for\nhuman use (\"pharmacovigilance\"), thereby further improving patient\nsafety.
\nThe new legislation focuses in particular on\nobligations on marketing authorisation holders in relation to\nadverse reactions to medicinal products and clarifies the\nprocedures when competent authorities follow up such\nreporting.
\nThe main points of the Directive are as\nfollows:
\nAutomatic assessment at EU level: recent pharmacovigilance incidents in the Union have\nshown the need for an automatic procedure at Union level in cases\nof specific safety issues to ensure that a matter is assessed and\naddressed in all Member States where the medicinal product is\nauthorised. The Directive clarifies the scope of different Union\nprocedures concerning products authorised at national level, as\nlaid down in Directive 2001/83/EC on the Community code relating to\nmedicinal products for human use.
\nClarification of Normal Procedure and Urgent\nProcedure: these procedures are\nstrengthened in order to ensure coordination, swift assessment in\ncase of urgency and the possibility of taking immediate action,\nwhere necessary to protect public health, before a decision is\ntaken at Union level.
\n\n· \nThe Normal Procedure should be initiated for\nmatters concerning quality, safety or efficacy of medicinal\nproducts where the interests of the Union are involved.
\n\n· \nThe Urgent Union Procedure should be initiated\nwhen there is a need to swiftly assess concerns resulting from the\nevaluation of data from pharmacovigilance activities.
\nRegardless of whether the Urgent Union Procedure or\nthe Normal Procedure is applied, and regardless of the procedure by\nmeans of which the medicinal product was authorised, be it\ncentralised or otherwise, the Pharmacovigilance Risk Assessment\nCommittee must always give its recommendation when the reason for\ntaking action is based on pharmacovigilance data.
\nMember States must bring cases concerning new\ncontraindications, reductions in the recommended dose or\nrestrictions to the indication for medicinal products authorised in\naccordance with the decentralised procedure and the mutual\nrecognition procedure to the attention of the coordination group\nwhen the Urgent Union Procedure is not initiated. In order to\nensure harmonisation for those products, the coordination group may\ndiscuss whether any action is necessary in the event that no Member\nState has triggered the Normal Procedure.
\nNotification to competent authorities where product is\nwithdrawn: voluntary action by the\nmarketing authorisation holder should not lead to a situation where\nconcerns relating to the risks or benefits of a medicinal product\nauthorised in the Union are not properly addressed in all Member\nStates. Therefore, the Directive requires marketing\nauthorisation holder to inform the relevant competent authorities\nand the European Medicines Agency of the reasons for\nwithdrawing or interrupting the placing on the market of a\nmedicinal product, for requesting that a marketing\nauthorisation be revoked, or for not renewing a marketing\nauthorisation. This also applies if the marketing authorisation\nholder withdraws a medicine from a third country market.
\nTransparency: each year,\nthe European Medicines Agency shall make public a list of the\nmedicinal products for which marketing authorisations have been\nrefused, revoked or suspended in the Union, whose supply has been\nprohibited or which have been withdrawn from the market, including\nthe reasons for such action.
\nWholesale distribution of medicinal\nproducts: the Directive further\nstrengthens the rules concerning wholesale distribution of\nmedicinal products to third countries.
\nENTRY INTO FORCE: 16 November 2012.
\nTRANSPOSITION: 28 October 2013.
\nAPPLICATION: from 28 October 2013.
\nPURPOSE: to amend Directive 2001/83/EC as regards\npharmacovigilance in order to address weaknesses identified in the\nEU pharmacovigilance system.
\nPROPOSED ACT: Directive of the European Parliament and\nof 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 Mediator case, 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 Regulation (EC) No 726/2004.
\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:
\nAutomatic assessment at EU level: Directive 2001/83/EC provides for an automatic\nassessment at Union level when specific serious safety issues have\nbeen identified with regard to nationally authorised products. In\nthe 2010 pharmacovigilance legislation, changes to the Commission's\nproposal during co-decision have led to the automatic assessment\nbeing lost, as the initiation of the procedure is linked to an\nappreciation by the Member State or the Commission as to whether an\nurgent action is considered necessary. Thus, when a Member State\nconsiders suspending, revoking or refusing renewal of a marketing\nauthorisation, but does not consider that urgent action is needed,\nno evaluation of the safety concern will be conducted at Union\nlevel.
\nRecent pharmacovigilance events in the Union have\nshown the need for an automatic procedure at Union level in the\ncases of specific safety issues to ensure that a matter is assessed\nand addressed in all Member States where the medicinal product is\nauthorised. The scope of different Union procedures concerning\nnationally authorised products is clarified in the text.
\nTransparency: marketing\nauthorisation holders are not required to declare the reasons for\nthe withdrawal of a marketing authorisation or product. Therefore,\nit cannot be ruled out that voluntary withdrawal of a marketing\nauthorisation or product by the marketing authorisation holder\ncould lead to safety issues being missed, in particular if the\ncompany is not transparent about possible safety\nconcerns.
\nVoluntary action by the marketing authorisation holder\nshould not lead to a situation where concerns related to the risks\nor benefits of a medicinal product authorised in the Union are not\nproperly addressed in all Member States. Therefore, provision is\nmade for the marketing authorisation holder to inform competent\nauthorities of the reasons for the withdrawal of a medicinal\nproduct, for interrupting the placing on the market of a\nmedicinal product, for requests for revoking a marketing\nauthorisation, or for not renewing a marketing\nauthorisation.
\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 directive of the European Parliament and of the\nCouncil amending Directive 2001/83/EC 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:
\nObligations regarding information: Members want to reinsert two obligations which make\nthe referral procedure work more smoothly.\nAccordingly:
\n\n· \nthe Member State concerned or the\nCommission shall clearly identify the question which is referred to\nthe Committee for consideration and shall inform the applicant or\nmarketing authorisation holder accordingly;
\n\n· \nthe Member States and the\napplicant or marketing authorisation holder shall supply the\nCommittee with all available information relating to the matter in\nquestion.
\nDrug-Fact-Box: the\nnotice must include a Drug-Fact-Box - a brief description of\nessential/necessary facts and details of the medicinal\nproduct, which are required by the patient to understand the\nusefulness as well as possible risks of the medicinal\nproduct and to use it in a safe and proper way. The\ninformation contained in the Drug-Fact-Box shall\nbe presented in a\nclear and legible way, and shall be\ndistinguishable from the rest of the text form.
\nThird countries: the\nmarketing authorisation holder shall also make the notification to\nMember States and the Agency of action to suspend the\nmarketing of a medicinal product, or the non-renewal of a\nmarketing authorization if the action is taken in a third\ncountry.
\nNotification to the Agency: the marketing authorisation holder shall be obliged\nto notify the Agency as well as Member States forthwith of any\naction taken by him to suspend the marketing of a medicinal\nproduct, to withdraw a medicinal product from the market, to\nrequest the withdrawal of a marketing authorisation or not to apply\nfor the renewal of a marketing authorisation, together with the\nreasons for such action.
\nTransparency: the Agency\nshall not only make public annually a list of the medicinal\nproducts for which marketing authorisations have been refused,\nrevoked or suspended, whose supply has been prohibited or which\nhave been withdrawn from the market, but also the reasons for such\naction.
\nThe European Parliament adopted by 659 votes to 9,\nwith 9 abstentions, a legislative resolution on the proposal for a\ndirective of the European Parliament and of the Council amending\nDirective 2001/83/EC 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:
\nObligations regarding information: the marketing authorisation holder shall be obliged to\ninform the relevant competent authorities and the European\nMedicines Agency of the reasons for withdrawing or interrupting the\nplacing on the market of a medicinal product, for requesting that a\nmarketing authorisation be revoked, or for not renewing a marketing\nauthorisation.
\nNormal Procedure and Urgent Union\nProcedure: the amended text clarifies\nand further strengthens the normal procedure and the urgent Union\nprocedure in order to ensure coordination, swift assessment in case\nof urgency and the possibility to take immediate action, where\nnecessary to protect public health, before a decision is taken at\nUnion level.
\nRegardless of whether the Urgent Union Procedure or\nthe Normal Procedure is applied, and regardless of the procedure by\nmeans of which the medicinal product was authorised, be it\ncentralised or otherwise, the Pharmacovigilance Risk Assessment\nCommittee should always give its recommendation when the reason\nfor taking action is based on pharmacovigilance data. The\ncoordination group and the Committee for Medicinal Products for\nHuman Use shall rely on that recommendation when carrying out the\nassessment of the issue.
\nDrug-Fact-Box: the\npackage leaflet must be written and designed in such a way as to be\nclear and understandable, enabling users to act\nappropriately, when necessary with the help of health\nprofessionals. The package leaflet must be clearly legible in an\nofficial language or official languages of the Member State where\nthe medicinal product is placed on the market
\nWhere the medicinal product is not intended to be\ndelivered directly to the patient, or where there are severe\nproblems in respect of the availability of the medicinal product,\nthe competent authorities may, subject to measures they consider\nnecessary to safeguard human health, grant an exemption to the\nobligation that certain particulars should appear on the\nlabelling and in the package leaflet. They may also grant a full or\npartial exemption to the obligation that the labelling and the\npackage leaflet must be in an official language or official\nlanguages of the Member State where the medicinal product is placed\non the market.
\nWholesale distribution of medicinal products to third\ncountries: in this case, wholesale\ndistributors shall ensure that the medicinal products are obtained\nonly from persons who are authorised or entitled to supply\nmedicinal products in accordance with the applicable legal and\nadministrative provisions of the third country\nconcerned.
\nPURPOSE: to strengthen the rules on pharmacovigilance\nin order to address weaknesses identified in the EU\npharmacovigilance system, and amending Directive\n2001/83/EC.
\nLEGISLATIVE ACT: Directive 2012/26/EU of the European\nParliament and of the Council amending Directive 2001/83/EC as\nregards pharmacovigilance.
\nCONTENT: following agreement at first reading, the\nEuropean Parliament and the Council adopted this Directive aimed at\nstrengthening the post-authorisation monitoring of medicines for\nhuman use (\"pharmacovigilance\"), thereby further improving patient\nsafety.
\nThe new legislation focuses in particular on\nobligations on marketing authorisation holders in relation to\nadverse reactions to medicinal products and clarifies the\nprocedures when competent authorities follow up such\nreporting.
\nThe main points of the Directive are as\nfollows:
\nAutomatic assessment at EU level: recent pharmacovigilance incidents in the Union have\nshown the need for an automatic procedure at Union level in cases\nof specific safety issues to ensure that a matter is assessed and\naddressed in all Member States where the medicinal product is\nauthorised. The Directive clarifies the scope of different Union\nprocedures concerning products authorised at national level, as\nlaid down in Directive 2001/83/EC on the Community code relating to\nmedicinal products for human use.
\nClarification of Normal Procedure and Urgent\nProcedure: these procedures are\nstrengthened in order to ensure coordination, swift assessment in\ncase of urgency and the possibility of taking immediate action,\nwhere necessary to protect public health, before a decision is\ntaken at Union level.
\n\n· \nThe Normal Procedure should be initiated for\nmatters concerning quality, safety or efficacy of medicinal\nproducts where the interests of the Union are involved.
\n\n· \nThe Urgent Union Procedure should be initiated\nwhen there is a need to swiftly assess concerns resulting from the\nevaluation of data from pharmacovigilance activities.
\nRegardless of whether the Urgent Union Procedure or\nthe Normal Procedure is applied, and regardless of the procedure by\nmeans of which the medicinal product was authorised, be it\ncentralised or otherwise, the Pharmacovigilance Risk Assessment\nCommittee must always give its recommendation when the reason for\ntaking action is based on pharmacovigilance data.
\nMember States must bring cases concerning new\ncontraindications, reductions in the recommended dose or\nrestrictions to the indication for medicinal products authorised in\naccordance with the decentralised procedure and the mutual\nrecognition procedure to the attention of the coordination group\nwhen the Urgent Union Procedure is not initiated. In order to\nensure harmonisation for those products, the coordination group may\ndiscuss whether any action is necessary in the event that no Member\nState has triggered the Normal Procedure.
\nNotification to competent authorities where product is\nwithdrawn: voluntary action by the\nmarketing authorisation holder should not lead to a situation where\nconcerns relating to the risks or benefits of a medicinal product\nauthorised in the Union are not properly addressed in all Member\nStates. Therefore, the Directive requires marketing\nauthorisation holder to inform the relevant competent authorities\nand the European Medicines Agency of the reasons for\nwithdrawing or interrupting the placing on the market of a\nmedicinal product, for requesting that a marketing\nauthorisation be revoked, or for not renewing a marketing\nauthorisation. This also applies if the marketing authorisation\nholder withdraws a medicine from a third country market.
\nTransparency: each year,\nthe European Medicines Agency shall make public a list of the\nmedicinal products for which marketing authorisations have been\nrefused, revoked or suspended in the Union, whose supply has been\nprohibited or which have been withdrawn from the market, including\nthe reasons for such action.
\nWholesale distribution of medicinal\nproducts: the Directive further\nstrengthens the rules concerning wholesale distribution of\nmedicinal products to third countries.
\nENTRY INTO FORCE: 16 November 2012.
\nTRANSPOSITION: 28 October 2013.
\nAPPLICATION: from 28 October 2013.
\n