### importers shall ensure that the radio equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other users , as determined by the member state concerned . ### importers shall ensure that the radio equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned . such instructions and safety information , as well as any labelling , shall be clear , understandable and intelligible .


### before making radio equipment available on the market distributors shall verify that the radio equipment bears the required ce marking , that it is accompanied by the required documents and by instructions and safety information in a language which can be easily understood by consumers and other users in the member state in which the radio equipment is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 10 to , and article 12 . ### before making radio equipment available on the market distributors shall verify that the radio equipment bears the ce marking , that it is accompanied by the required documents and by instructions and safety information in a language which can be easily understood by consumers and other end - users in the member state in which the radio equipment is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 10 to , and article 12 and .


### manufacturers may demonstrate compliance of radio equipment with the essential requirements identified in articles 3 and using any of the following conformity assessment procedures : ### manufacturers shall demonstrate compliance of radio equipment with the essential requirements set out in article 3 using any of the following conformity assessment procedures :


### eu - type examination followed by the conformity to type procedure set out in annex iv ; ### eu - type examination followed by the conformity to type based on the internal production control procedure set out in annex iv ;


### where in assessing the compliance of radio equipment with the essential requirements identified in articles 3 and , the manufacturer has applied harmonised standards , the reference number of which has been published in the official journal of the european union , he may use any of the following procedures : ### where in assessing the compliance of radio equipment with the essential requirements set out in articles 3 and , the manufacturer has applied harmonised standards , the reference number of which has been published in the official journal of the european union , he shall use any of the following procedures :


### the eu declaration of conformity shall have the model structure and shall contain the elements set out in annex vii and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the radio equipment is placed or made available . ### the eu declaration of conformity shall have the model structure , set out in annex vii , shall contain the elements set out in annex vii and shall be continuously updated . upon the request of the market surveillance authorities , the economic operator shall provide a copy of the eu declaration of conformity in paper or electronic form , and shall ensure that it is translated into the language or languages required by the member state in which the radio equipment is placed or made available on the market .


### by drawing up the eu declaration of conformity , the manufacturer shall assume responsibility for the compliance of radio equipment . ### by drawing up the eu declaration of conformity , the manufacturer shall assume responsibility for the compliance of radio equipment with the requirements laid down in this directive .


### rules and conditions for affixing the ce marking ### rules and conditions for affixing the ce marking and identification number of the notified body


### the technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that radio equipment complies with the requirements set out in article 3 . it shall , at least , contain the documents listed in annex vi . ### the technical documentation shall contain all relevant data or details of the means used by the manufacturer to ensure that radio equipment complies with the requirements set out in article 3 . it shall , at least , contain the elements listed in annex vi .


### the personnel responsible for carrying out conformity assessment activities shall have the following : ### the personnel responsible for carrying out conformity assessment tasks shall have the following :


### the impartiality of the conformity assessment bodies , their top level management and of the assessment personnel shall be guaranteed . ### the impartiality of the conformity assessment bodies , their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed .


### the remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments . ### the remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments .


### conformity assessment bodies shall participate in , or ensure that their assessment personnel are informed of , the relevant standardisation activities , the regulatory activities in the area of radio equipment and frequency planning , and the activities of the notified body coordination group established under the relevant union harmonisation legislation and apply as general guidance the administrative decisions and documents produced as a result of the work of that group . ### conformity assessment bodies shall participate in , or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of , the relevant standardisation activities , the regulatory activities in the area of radio equipment and frequency planning , and the activities of the notified body coordination group established under the relevant union harmonisation legislation and apply as general guidance the administrative decisions and documents produced as a result of the work of that group .


### that application shall be accompanied by a description of the conformity assessment activities , the conformity assessment module or modules and categories of radio equipment for which that body claims to be competent , as well as by an accreditation certificate , where one exists , issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in article 26 . ### the application for notification shall be accompanied by a description of the conformity assessment activities , the conformity assessment module or modules and categories of radio equipment for which that body claims to be competent , as well as by an accreditation certificate , where one exists , issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in article 26 .


### the commission shall make publicly available the list of the bodies notified under this directive , including the identification numbers that have been allocated to them and the activities for which they have been notified . ### the commission shall make publicly available the list of the bodies notified under this directive , including the identification numbers that have been assigned to them and the activities for which they have been notified .


### the commission shall ensure that that list is kept up to date . ### the commission shall ensure that the list is kept up to date .


### the notifying member state shall provide the commission , on request , with all information relating to the basis for the notification or the maintenance of the competence of the body concerned . ### the notifying member state shall provide the commission , on request , with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned .


### union market surveillance and control of products entering the union market ### union market surveillance and control of radio equipment entering the union market


### where the market surveillance authorities of one member state have taken action pursuant to article 20 of regulation no 765 / 2008 , or where they have sufficient reason to believe that radio equipment covered by this directive presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this directive , they shall carry out an evaluation in relation to the radio equipment concerned covering all the requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities . ### where the market surveillance authorities of one member state have sufficient reasons to believe that radio equipment covered by this directive presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this directive , they shall carry out an evaluation in relation to the radio equipment concerned covering all the relevant requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose .


### where , in the course of that evaluation , the market surveillance authorities find that the radio equipment does not comply with the requirements laid down in this directive , they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the radio equipment into compliance with those requirements , to withdraw the radio equipment from the market , or to recall it within a reasonable period , commensurate with the nature of the risk , as they may prescribe . ### where , in the course of the evaluation referred to in the first subparagraph , the market surveillance authorities find that the radio equipment does not comply with the requirements laid down in this directive , they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the radio equipment into compliance with those requirements , to withdraw the radio equipment from the market , or to recall it within a reasonable period , commensurate with the nature of the risk , as they may prescribe .


### article 21 of regulation no 765 / 2008 shall apply to the measures referred to in the second subparagraph . ### article 21 of regulation no 765 / 2008 shall apply to the measures referred to in the second subparagraph of this paragraph .


### the information referred to in paragraph 4 shall include all available details , in particular the data necessary for the identification of the non - compliant radio equipment , the origin of radio equipment , the nature of the non - compliance alleged and the risk involved , the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator . in particular , the market surveillance authorities shall indicate whether the non - compliance is due to any of the following : ### the information referred to in the second subparagraph of paragraph 4 shall include all available details , in particular the data necessary for the identification of the non - compliant radio equipment , the origin of radio equipment , the nature of the non - compliance alleged and the risk involved , the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator . in particular , the market surveillance authorities shall indicate whether the non - compliance is due to any of the following :


### member states other than the member state initiating the procedure shall without delay inform the commission and the other member states of any measures adopted and of any additional information at their disposal relating to the non - compliance of radio equipment concerned , and , in the event of disagreement with the notified national measure , of their objections . ### member states other than the member state initiating the procedure under this article shall without delay inform the commission and the other member states of any measures adopted and of any additional information at their disposal relating to the non - compliance of radio equipment concerned , and , in the event of disagreement with the adopted national measure , of their objections .


### where , within 8 weeks of receipt of the information referred to in paragraph 4 , no objection has been raised by either a member state or the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified . ### where , within eight weeks of receipt of the information referred to in second subparagraph of paragraph 4 , no objection has been raised by either a member state or the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified .


### member states shall ensure that appropriate restrictive measures are taken in respect of the apparatus concerned without delay . ### member states shall ensure that appropriate restrictive measures , such as withdrawal of the radio equipment from the market , are taken in respect of the radio equipment concerned without delay .


### if the national measure is considered justified , all member states shall take the measures necessary to ensure that the non - compliant radio equipment is withdrawn or recalled from their market , and shall inform the commission accordingly . if the national measure is considered unjustified , the member state concerned shall withdraw the measure . ### if the national measure is considered justified , all member states shall take the measures necessary to ensure that the non - compliant radio equipment is withdrawn or recalled from their market , and shall inform the commission accordingly . if the national measure is considered unjustified , the member state concerned shall withdraw that measure .


### where the national measure is considered justified and the non - compliance of the radio equipment is attributed to shortcomings in the harmonised standards referred to in article 16 of this directive , the commission shall apply the procedure provided for in article [ 8 ] of regulation no [ . . / . . ] [ on european standardisation ] . ### where the national measure is considered justified and the non - compliance of the radio equipment is attributed to shortcomings in the harmonised standards referred to in point of article 40 of this directive , the commission shall apply the procedure provided for in article 11 of regulation no 1025 / 2012 .


### where , having performed an evaluation under article 40 , a member state finds that although radio equipment is in compliance with this directive , it presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this directive it shall require the relevant economic operator to take all appropriate measures to ensure that the radio equipment concerned , when placed on the market , no longer presents that risk , to withdraw the radio equipment from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe . ### where , having carried out an evaluation under article 40 , a member state finds that although radio equipment is in compliance with this directive , it presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this directive it shall require the relevant economic operator to take all appropriate measures to ensure that the radio equipment concerned , when placed on the market , no longer presents that risk , to withdraw the radio equipment from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe .


### product does not comply with the requirements set out in articles 10 , and 12 ; ### the information referred to in articles 10 , and 12 is absent , false or incomplete ;


### information on intended use of radio equipment , eu declaration of conformity and usage restrictions as set out in article 10 , and does not accompany radio equipment ; ### information on intended use of radio equipment , eu declaration of conformity or usage restrictions as set out in article 10 , and does not accompany radio equipment ;


### the delegation of power referred to in articles 2 , 3 , 4 and 5 shall be conferred for an indeterminate period of time from the [ date of entry into force ] ### the delegation of power referred to in articles 3 and 4 shall be conferred for an indeterminate period of time from the [ date of entry into force ]


### the delegation of power referred to in articles 2 , 3 , 4 and 5 may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of power referred to in articles 3 and 4 may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### a delegated act adopted pursuant to articles 2 , 3 , 4 and 5 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to articles 3 and 4 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or the council .


### member states shall lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . ### member states shall lay down rules on penalties applicable to infringements by economic operators of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . such rules may include criminal penalties for serious infringements .


### radio equipment used by radio amateurs within article 1 , definition 56 , of the international telecommunications union radio regulations unless the equipment is available commercially . kits of components to be assembled by radio amateurs and commercial equipment modified by and for the use of radio amateurs are not regarded as commercially available equipment . ### non - commercially available radio equipment used by radio amateurs within article 1 , definition 56 , of the international telecommunications union radio regulations : radio assembly kits modified by and for the use of radio amateurs . commercially available radio equipment modified by and for the use of radio amateurs . equipment for self - assembly by radio amateurs for experimental and scientific purposes related to amateur radio .


### draft legislative resolution ### requests that the commission present a financial statement which fully takes into account the result of the legislative agreement between the european parliament and the council on all pieces of legislation within the fourth railway package to meet the budgetary and staff requirements of era and possibly of the commission services ;


### draft legislative resolution ### emphasises that any decision of the legislative authority on the draft regulation shall be without prejudice to the decisions of the budgetary authority in the context of the annual budgetary procedure ;


### competent national authorities have been normally charging for issuing vehicle authorisations and safety certificates . with the transfer competence to the union level , the agency should be entitled to charge the applicants for issuing the certificates and authorisations mentioned in the preceding recitals . the level of those charges should be equal to or lower than the current average in the union and should be determined in a delegated act to be adopted by the commission . ### competent national authorities have been normally charging for issuing vehicle authorisations and safety certificates . with the transfer competence to the union level , the agency should be entitled to charge the applicants for issuing the certificates and authorisations mentioned in the preceding recitals . the level of those charges should be equal to or lower than the current average in the union and should be determined in a delegated act to be adopted by the commission . establishment plan posts financed by those charges should not be subject to the staff reductions foreseen for all union institutions and bodies .


### over the past years , as more decentralised agencies have been created , the budgetary authority has looked to improve transparency and control over the management of the union funding allocated to them , in particular concerning the budgetisation of fees , financial control , power of discharge , pension scheme contributions and the internal budgetary procedure . in a similar way , regulation no 1073 / 1999 of the european parliament and of the council of 25 may 1999 concerning investigations conducted by the european anti - fraud office 5 should apply without restriction to the agency , which should accede to the interinstitutional agreement of 25 may 1999 between the european parliament , the council of the european union and the commission of the european communities concerning internal investigations by the european anti - fraud office . ### regulation no 1073 / 1999 of the european parliament and of the council of 25 may 1999 concerning investigations conducted by the european anti - fraud office 5 should apply without restriction to the agency , which should accede to the interinstitutional agreement of 25 may 1999 between the european parliament , the council of the european union and the commission of the european communities concerning internal investigations by the european anti - fraud office .


### the management board shall be composed of one representative from each member state and four representatives of the commission , all with a right to vote . ### the management board shall be composed of one representative from each member state and two representatives of the commission , all with a right to vote .


### the unprecedented global crisis that has hit the world over the last three years has seriously damaged economic growth and financial stability and provoked a strong deterioration in the government deficit and debt position of the member states , leading a number of them to seek financial assistance outside the framework of the union . ### the unprecedented global crisis and the downturn in economic activity that hit the world over the last three years have seriously damaged economic growth and financial stability and provoked a strong deterioration in financial , economic and social conditions and increased the government deficit and debt position of the member states , leading a number of them to seek financial assistance outside the framework of the union .


### the unprecedented global crisis that has hit the world over the last three years has seriously damaged economic growth and financial stability and provoked a strong deterioration in the government deficit and debt position of the member states , leading a number of them to seek financial assistance outside the framework of the union . ### the unprecedented global crisis and the downturn in economic activity that have hit the world over the last three years have seriously damaged economic growth and financial stability and provoked a strong deterioration in financial , economic and social conditions and in the government deficit and debt position of the member states , leading a number of them to seek financial assistance outside the framework of the union .


### the full consistency between the union multilateral surveillance framework established by the treaty and the possible policy conditions attached to this financial assistance should be enshrined in union law . the economic and financial integration of the member states whose currency is the euro calls for a reinforced surveillance to prevent a contagion from a member state experiencing difficulties with respect to its financial stability to the rest of the euro area . ### the full consistency between the union multilateral surveillance framework established by the treaty and the possible policy conditions attached to this financial assistance , coupled with incentives to promote sustainable growth , employment and social progress , should be enshrined in union law . the economic and financial integration of the member states whose currency is the euro calls for a reinforced surveillance to prevent a contagion from a member state experiencing difficulties with respect to its financial stability to the rest of the euro area .


### the full consistency between the union multilateral surveillance framework established by the treaty and the possible policy conditions attached to this financial assistance should be enshrined in union law . the economic and financial integration of the member states whose currency is the euro calls for a reinforced surveillance to prevent a contagion from a member state experiencing difficulties with respect to its financial stability to the rest of the euro area . ### the full consistency between the union multilateral surveillance framework established by the treaty and the possible policy conditions attached to this financial assistance , coupled with incentives to promote growth , employment and social progress , should be enshrined in union law . the economic and financial integration of the member states whose currency is the euro calls for a reinforced surveillance to prevent a contagion from a member state experiencing difficulties with respect to its financial stability to the rest of the euro area .


### a member state whose currency is the euro should be subject to enhanced surveillance when it is experiencing - or at risk of experiencing - severe financial disturbance , with a view to ensuring its swift return to a normal situation and to protecting the other euro area member states against possible negative spill over effects . this enhanced surveillance should include a wider access to the information needed for a close monitoring of the economic , fiscal and financial situation and a regular reporting to the economic and financial committee or to any sub - committee the latter may designate for that purpose . the same modalities of surveillance should apply to member states requesting precautionary assistance from the european financial stability facility , the european stability mechanism the international monetary fund or another international financial institution . ### a member state whose currency is the euro should be subject to enhanced surveillance when it is experiencing - or at risk of experiencing - severe financial disturbance , with a view : a ) to ensuring its swift return to a normal situation and to protecting the other euro area member states against possible negative spill over effects ; b ) to preventing the consequences of financial turbulence in causing cuts in the social provisions and the unsustainability of pension systems ; c ) to combating social exclusion , poverty and lack of access to educational opportunities , especially for the most vulnerable groups . this enhanced surveillance should include a wider access to the information needed for a close monitoring of the economic , fiscal and financial situation and a regular reporting to the economic and financial committee or to any sub - committee the latter may designate for that purpose . the same modalities of surveillance should apply to member states requesting precautionary assistance from the european financial stability facility , the european stability mechanism the international monetary fund or another international financial institution .


### a member state whose currency is the euro should be subject to enhanced surveillance when it is experiencing - or at risk of experiencing - severe financial disturbance , with a view to ensuring its swift return to a normal situation and to protecting the other euro area member states against possible negative spill over effects . this enhanced surveillance should include a wider access to the information needed for a close monitoring of the economic , fiscal and financial situation and a regular reporting to the economic and financial committee or to any sub - committee the latter may designate for that purpose . the same modalities of surveillance should apply to member states requesting precautionary assistance from the european financial stability facility , the european stability mechanism the international monetary fund or another international financial institution . ### a member state whose currency is the euro should be subject to enhanced surveillance when it is experiencing - or at risk of experiencing - severe financial disturbance , with a view to ensuring its swift return to a normal situation and to protecting the other euro area member states against possible negative spill over effects . this enhanced surveillance should include a wider access to the information needed for a close monitoring of the social , employment , fiscal and financial situation and the establishment of a regular report to the european parliament , the economic and financial committee , the employment committee and the social protection committee or to any sub - committee the said committees may designate for that purpose . the same modalities of surveillance should apply to member states requesting precautionary assistance from the european financial stability facility , the european stability mechanism the international monetary fund or another international financial institution .


### a member state whose currency is the euro should be subject to enhanced surveillance when it is experiencing - or at risk of experiencing - severe financial disturbance , with a view to ensuring its swift return to a normal situation and to protecting the other euro area member states against possible negative spill over effects . this enhanced surveillance should include a wider access to the information needed for a close monitoring of the economic , fiscal and financial situation and a regular reporting to the economic and financial committee or to any sub - committee the latter may designate for that purpose . the same modalities of surveillance should apply to member states requesting precautionary assistance from the european financial stability facility , the european stability mechanism the international monetary fund or another international financial institution . ### a member state whose currency is the euro should be subject to enhanced surveillance when it is experiencing - or at risk of experiencing - severe financial disturbance , with a view to ensuring its swift return to a normal situation and to protecting the other euro area member states against possible negative spill over effects . this enhanced surveillance should include a wider access to the information needed for a close monitoring of the economic , social , employment , fiscal and financial situation and the establishment of a regular report to the economic and financial committee , the employment committee and the social protection committee or to any sub - committee the said committees may designate for that purpose . the same modalities of surveillance should apply to member states requesting precautionary assistance from the european financial stability facility , the european stability mechanism the international monetary fund or another international financial institution .


### the surveillance of the economic and fiscal situation should be strongly reinforced for member states under macro - economic adjustment programme . because of the comprehensive nature of the latter , the other processes of economic and fiscal surveillance should be suspended for the duration of the macro - economic adjustment programme , with a view to avoiding a duplication of reporting obligations . ### the surveillance of the economic , fiscal , employment and social situation should be strongly reinforced for member states under macro - economic adjustment programme . the latter shall contain measures that have the integrated aim to restore financial stability and achieve the objectives of the ' jobs and growth strategy ' . member states shall report progress on both aspects . because of the comprehensive nature of the macro - economic adjustment programme , the other processes of economic and fiscal surveillance should be suspended for the duration of the macro - economic adjustment programme , with a view to avoiding a duplication of reporting obligations .


### the surveillance of the economic and fiscal situation should be strongly reinforced for member states under macro - economic adjustment programme . because of the comprehensive nature of the latter , the other processes of economic and fiscal surveillance should be suspended for the duration of the macro - economic adjustment programme , with a view to avoiding a duplication of reporting obligations . ### the surveillance of the economic , social , fiscal and employment situation should be strongly reinforced for member states under a macro - economic adjustment programme . because of the comprehensive nature of the latter , the other processes of economic and fiscal surveillance should be suspended for the duration of the macro - economic adjustment programme , with a view to avoiding a duplication of reporting obligations .


### rules should be provided in order to enhance the dialogue between the union institutions , in particular the european parliament , the council and the commission , and to ensure greater transparency and accountability . ### rules should be provided in order to enhance the dialogue between the union institutions , in particular the european parliament , the council and the commission , as well as the dialogue between the union’s institutions and management and labour , and to ensure greater transparency and accountability .


### the commission may decide to make a member state experiencing severe difficulties with regard to its financial stability subject to enhanced surveillance . the member state concerned shall be given the possibility to express its views beforehand . the commission shall decide every six months whether to prolong the enhanced surveillance . ### the commission may decide to make a member state experiencing severe difficulties with regard to its financial stability subject to enhanced surveillance . the member state as well as the social partners concerned shall be given the possibility to express its views beforehand . the commission shall decide every six months whether to prolong the enhanced surveillance .


### communicate to the commission , the ecb and the european banking authority at the requested frequency disaggregated information on the financial situation of the financial institutions which are under the surveillance of its national supervisors ; ### communicate to the european parliament , the commission , the ecb and the european banking authority at the requested frequency disaggregated information on the financial situation of the financial institutions which are under the surveillance of its national supervisors ;


### the commission shall conduct , in liaison with the ecb , regular review missions in the member state under surveillance to verify the progresses made in the implementation of the measures mentioned in paragraph 1 , 2 and 3 . it shall communicate every quarter its findings to the economic and financial committee - or to any subcommittee the latter may designate for that purpose - and assess notably whether further measures are needed . these review missions shall replace the onsite monitoring foreseen in article 10a of regulation no 1467 / 97 . ### the commission shall conduct , in liaison with the ecb and the international labour organisation , regular review missions in the member state under surveillance to verify the progresses made in the implementation of the measures mentioned in paragraph 1 , 2 and 3 . it shall communicate every quarter its findings to the economic and financial committee , the employment committee and the social protection committee - or to any subcommittee the said committees may designate for that purpose - and assess notably whether further measures are needed . these review missions shall replace the onsite monitoring foreseen in article 10a of regulation no 1467 / 97 .


### a member state wishing to obtain financial assistance from one or several other states , the efsf , the esm , the international monetary fund or another institution outside of the union framework shall immediately inform the council , the commission and the ecb of its intention . the efc , or any subcommittee the latter may designate for that purpose , shall hold a discussion on this envisaged request , after having received an assessment from the commission . ### a member state wishing to obtain financial assistance from one or several other states , the efsf , the esm , the international monetary fund or another institution outside of the union framework shall immediately inform the european parliament , the council , the commission and the ecb of its intention . the efc , or any subcommittee the latter may designate for that purpose , shall hold a discussion on this envisaged request , after having received an assessment from the commission .


### a member state wishing to obtain financial assistance from one or several other states , the efsf , the esm , the international monetary fund or another institution outside of the union framework shall immediately inform the council , the commission and the ecb of its intention . the efc , or any subcommittee the latter may designate for that purpose , shall hold a discussion on this envisaged request , after having received an assessment from the commission . ### a member state wishing to obtain financial assistance from one or several other states , the efsf , the esm , the international monetary fund or another institution outside of the union framework shall immediately inform the council , the commission and the ecb of its intention . the efc , the emco and the spc , or any subcommittee the said committees may designate for that purpose , shall hold a discussion on this envisaged request , after having received an assessment from the commission .


### where financial assistance is sought from the efsf or the esm , the commission shall prepare – in liaison with the ecb and wherever possible , the imf - an analysis of the sustainability of the government debt of the member state concerned , including the member state ' s ability to repay the envisaged financial assistance , and forward it to the efc or to any subcommittee the latter may designate for that purpose . ### where financial assistance is sought from the efsf or the esm , the commission shall prepare – in liaison with the ecb and wherever possible , the imf - an analysis of medium and long term sustainability of the government debt of the member state concerned , including the member state ' s ability to repay the envisaged financial assistance , and forward it to the efc or to any subcommittee the latter may designate for that purpose .


### a member state receiving financial assistance from one or several other states , the imf , the efsf or the esm shall prepare in agreement with the commission - acting in liaison with the ecb - a draft adjustment programme aimed at re - establishing a sound and sustainable economic and financial situation and restoring its capacity to finance itself fully on the financial markets . the draft adjustment programme shall take due account of the current recommendations addressed to the member state concerned under articles 121 , 126 and / or 148 of the treaty - and its actions to comply with them - while aiming at broadening , strengthening and deepening the required policy measures . ### a member state receiving financial assistance from one or several other states , the imf , the efsf or the esm shall prepare in agreement with the commission - acting in liaison with the ecb and the international labour organisation - a draft adjustment programme aimed at re - establishing a sound and sustainable economic , financial and social situation and restoring its capacity to finance itself fully on the financial markets . the draft adjustment programme shall be fully compatible with article 9 of the treaty on the functioning of the european union and with&#160 ; the current recommendations addressed to the member state concerned under articles 121 , 126 and / or 148 of the treaty - and its actions to comply with them - while aiming at broadening , strengthening and deepening the required policy measures . member states shall include in their macro - economic adjustment programmes an updated and detailed description of projected multiannual expenditure targets directly related to the achievement of the objectives embedded in the eu jobs and growth strategy , including public investments . the detailed description referred to above shall duly explain differences of projected expenditure from the most recent stability programmes .


### a member state receiving financial assistance from one or several other states , the imf , the efsf or the esm shall prepare in agreement with the commission - acting in liaison with the ecb - a draft adjustment programme aimed at re - establishing a sound and sustainable economic and financial situation and restoring its capacity to finance itself fully on the financial markets . the draft adjustment programme shall take due account of the current recommendations addressed to the member state concerned under articles 121 , 126 and / or 148 of the treaty - and its actions to comply with them - while aiming at broadening , strengthening and deepening the required policy measures . ### a member state receiving financial assistance from one or several other states , the imf , the efsf or the esm shall prepare in agreement with the commission - acting in liaison with the ecb - a draft adjustment programme aimed at re - establishing a sound and sustainable economic , social and financial situation and restoring its capacity to finance itself fully on the financial markets . all adjustment programme must be set for a realistic time line , taking into account that&#160 ; adjustment programmes must neither be too abrupt nor too fast otherwise they will undermine economic and job recovery , aggravating even more the economic and social impact of the crisis . the draft adjustment programme shall take due account of the current recommendations addressed to the member state concerned under articles 121 , 126 and / or 148 of the treaty - and its actions to comply with them - while aiming at broadening , strengthening and deepening the required policy measures .


### the commission , in liaison with the ecb , shall monitor the progress made in the implementation of the adjustment programme and inform every three months the efc or any subcommittee the latter may designate for that purpose . the member state concerned shall give the commission its full cooperation . it shall in particular provide to the commission all the information that the latter deems necessary for the monitoring of the programme . article 3 shall apply . ### the commission , in liaison with the ecb and the ilo , shall monitor the progress made in the implementation of the adjustment programme and inform every three months the efc or any subcommittee the latter may designate for that purpose as well as the european parliament and the parliament of the member state concerned . the member state concerned shall give the commission its full cooperation . it shall in particular provide to the commission all the information that the latter deems necessary for the monitoring of the programme . article 3 shall apply .


### the commission , in liaison with the ecb , shall monitor the progress made in the implementation of the adjustment programme and inform every three months the efc or any subcommittee the latter may designate for that purpose . the member state concerned shall give the commission its full cooperation . it shall in particular provide to the commission all the information that the latter deems necessary for the monitoring of the programme . article 3 shall apply . ### the commission , in liaison with the ecb , shall monitor the progress made in the implementation of the adjustment programme and inform every three months the efc , the emco and the spc , or any subcommittee the said committees may designate for that purpose . the member state concerned shall give the commission its full cooperation . it shall in particular provide to the commission all the information that the latter deems necessary for the monitoring of the programme . article 3 shall apply .


### the commission - in liaison with the ecb - shall examine with the member state concerned the changes that may be needed to its adjustment programme . the council , acting by a qualified majority on a proposal from the commission , shall decide on any change to be made to the adjustment programme . ### the commission - in liaison with the ecb and the ilo - shall examine with the member state concerned the changes that may be needed to its adjustment programme . the council , acting by a qualified majority on a proposal from the commission , shall decide on any change to be made to the adjustment programme .


### the commission shall conduct , in liaison with the ecb , regular review missions in the member state under post programme surveillance to assess its economic , fiscal and financial situation . it shall communicate every semester its findings to the efc or to any subcommittee the latter may designate for that purpose and assess notably whether corrective measures are needed . ### the commission shall conduct , in liaison with the ecb and the ilo , regular review missions in the member state under post programme surveillance to assess its economic , fiscal and financial situation . it shall communicate every semester its findings to the efc or to any subcommittee the latter may designate for that purpose and assess notably whether corrective measures are needed .


### the commission shall conduct , in liaison with the ecb , regular review missions in the member state under post programme surveillance to assess its economic , fiscal and financial situation . it shall communicate every semester its findings to the efc or to any subcommittee the latter may designate for that purpose and assess notably whether corrective measures are needed . ### the commission shall conduct , in liaison with the ecb , regular review missions in the member state under post programme surveillance to assess its economic , fiscal and financial situation . it shall communicate every semester its findings to the efc , the emco and the spc or to any subcommittee the said committees may designate for that purpose and assess notably whether corrective measures are needed .


### the composition of the eit bodies should be simplified . the functioning of the eit governing board should be streamlined and the respective roles and tasks of the governing board and the director should be further clarified . ### the composition of the eit bodies should be simplified . the functioning of the eit governing board should be streamlined and the respective roles and tasks of the governing board , the director and the executive committee should be further clarified .


### ' higher education institution ' means an institution within the meaning of article 2 of decision no xxx / 20xx of the european parliament and of the council establishing ' erasmus for all ' . ### ' higher education institution ' means an institution within the meaning of article 2 of regulation no xxx / 20xx of the european parliament and of the council establishing ' erasmus for all ' .


### the eit’s mission is to contribute to sustainable european economic growth and competitiveness by reinforcing the innovation capacity of the member states and the union . it shall do this by promoting and integrating higher education , research and innovation of the highest standards . ### the eit’s mission is to contribute to sustainable european economic growth and competitiveness by reinforcing the innovation capacity of the member states and the union . this shall be achieved through synergies , cooperation and integration of higher education , research activities and innovation at the highest standards .


### venture capital provides finance to undertakings that are generally very small , in the initial stages of their corporate existence and display a strong potential for growth and expansion . in addition , venture capital funds provide these undertakings with valuable expertise and knowledge , business contacts , brand - equity and strategic advice . by providing finance and advice to these undertakings , venture capital funds stimulates economic growth , contribute to the creation of jobs , boost innovative undertakings , increase their investment in research and development and foster entrepreneurship , innovation and competitiveness in the union . ### venture capital provides finance to undertakings that are generally very small , in the initial stages of their corporate existence and display a strong potential for growth and expansion . in addition , venture capital funds provide these undertakings with valuable expertise and knowledge , business contacts , brand - equity and strategic advice . by providing finance and advice to these undertakings , venture capital funds stimulate economic growth , contribute to the creation of jobs , boost innovative undertakings , increase their investment in research and development and foster entrepreneurship , innovation and competitiveness in the union . in order to boost investment into small and medium - sized enterprises , this regulation on european venture capital funds should be integrated in the investments to be made by the commission in the context of the horizon 2020 framework programme for research and innovation . the commission should put forward an integrated strategy on financial instruments for smes and evaluate the impact of directive 2009 / 138 / ec of the european parliament and of the council of 25 november 2009 on the taking - up and pursuit of the business of insurance and reinsurance 1 , directive 2006 / 48 / ec of the european parliament and of the council of 14 june 2006 relating to the taking up and pursuit of the business credit institutions2 and directive 2006 / 49 / ec of the european parliament and of the council of 14 june 2006 on the capital adequacy of investment firms and credit institutions3 , on the availability of risk capital . ________ 1 oj l 335 , 17 . 12 . 2009 , p . 1 . 2 oj l 177 , 30 . 6 . 2006 , p . 1 . 3 oj l 177 , 30 . 6 . 2006 , p . 201 .


### whether the financial resources that the member state has provided to developing countries are new and additional in the context of the unfccc and how this was calculated ; ### whether the financial resources that the member state has provided to developing countries are new and additional to the target of raising official development assistance to 0 , 7 % of gross national income in the context of the unfccc and how this was calculated ;


### information on any financial resources allocated by the member state related to the implementation of the unfccc by type of channel such as bilateral , regional or other multilateral channels ; ### information on any financial resources allocated by the member state related to the implementation of the unfccc by type of financial instrument and channel such as bilateral , regional or other multilateral channels ;


### quantitative information on financial flows based on the so - called ' rio markers for climate change mitigation - related aid and climate change adaptation - related aid ' introduced by the oecd development assistance group and methodological information concerning the implementation of the climate change rio markers methodology ; ### quantitative information on financial flows , either through project or budget support , based on the so - called ' rio markers for climate change mitigation - related aid and climate change adaptation - related aid ' introduced by the oecd development assistance group and methodological information concerning the implementation of the climate change rio markers methodology ;


### information on activities by the member state related to technology transfer to developing countries under the unfccc and on technologies transferred for the year x - 1 , information on planned activities related to technology transfer to developing countries under the unfccc and on technologies to be transferred for the year x and subsequent years . it should include information on whether the technology transferred was used for mitigating or adapting to the effects of climate change , recipient country , amount of support provided , and type of technology transferred . ### information on activities by the member state related to technology transfer to developing countries under the unfccc and on technologies transferred for the year x - 1 , information on planned activities related to technology transfer to developing countries under the unfccc and on technologies to be transferred for the year x and subsequent years . it should include information on whether the technology transferred was used for mitigating or adapting to the effects of climate change , recipient country , amount of support provided , source of funding , and type of technology transferred .


### experience with egtcs set up so far shows that the new legal instrument is also being used for cooperation in the implementation of other european policies . the efficiency and effectiveness of egtcs should be enhanced by broadening the nature of egtcs . ### experience with egtcs set up so far shows that the new legal instrument is also being used for cooperation in the implementation of other european policies . egtcs should therefore not be discriminated against when they are deemed to be a single partner for the purposes of calls for projects related to eu sectoral policies , and recognition should be accorded to their role in the establishment of integrated european union policies .


### specifically , the tasks of an egtc may concern the implementation of cooperation programmes or parts thereof or of operations supported by the union through the european regional development fund , the european social fund and / or the cohesion fund . ### specifically , the tasks of an egtc may concern the implementation of cooperation programmes or parts thereof , the framing and implementation of integrated territorial strategies , or the implementation of operations supported by the union through the european regional development fund , the european social fund , the cohesion fund , and / or calls for projects related to union sectoral policies .


### in connection with the modernisation and restructuring of the fleets , social measures should be envisaged to help workers who wish to leave the inland waterway industry or to retrain for jobs in another sector , together with measures to encourage the establishment of groupings of undertakings , improve operators ' skills and promote the adaptation of vessels to technical progress . ### in connection with the modernisation and restructuring of the fleets , social measures , including early and preventive measures , should be envisaged to help workers who wish to leave the inland waterway industry or to retrain for jobs in another sector , together with measures to encourage the establishment of groupings of undertakings , improve operators ' skills and promote the adaptation of vessels to technical progress .


### in connection with the modernisation and restructuring of the fleets , social measures should be envisaged to help workers who wish to leave the inland waterway industry or to retrain for jobs in another sector , together with measures to encourage the establishment of groupings of undertakings , improve operators ' skills and promote the adaptation of vessels to technical progress . ### in connection with the modernisation and restructuring of the fleets , social and financial measures should be envisaged to help workers who wish to leave the inland waterway industry or to retrain for jobs in another sector , together with measures to encourage the establishment of groupings of undertakings , improve operators ' skills and promote the adaptation of vessels to technical progress .


### – make it easier for inland waterway carriers leaving the industry to obtain an early retirement pension or to transfer to another economic activity , ### – make it easier for inland waterway carriers leaving the industry to obtain an early retirement pension or to transfer to another economic activity by providing comprehensive information , among other measures ,


### – organise vocational training or retraining schemes for crew members leaving the industry , ### – organise vocational training or retraining schemes for crew members leaving the industry and provide appropriate information about those schemes ,


### – organise vocational training or retraining schemes for crew members leaving the industry , ### – organise vocational training or retraining schemes for crew members leaving the industry , as well as making provision for early retirement and providing relevant information ;


### – improve skills in inland navigation in order to safeguard the development and future of the profession , ### – improve skills among actors especially employees and operators in inland navigation in order to safeguard the development and future of the profession where modernisation is foreseeable and required by legislation ,


### – encourage adaptation of vessels to technical progress in order to improve working conditions and promote safety , ### – encourage adaptation of vessels to technical progress in order to improve working conditions and health protection and promote safety ,


### – encourage adaptation of vessels to technical progress in order to improve working conditions and promote safety , ### – encourage adaptation of vessels to technical progress in order to improve working conditions and promote health and safety at work ,


### member states shall ensure that the collection and transport of separately collected weee is carried out in a way which optimises re - use and recycling and the confinement of hazardous substances . ### member states shall ensure that the collection and transport of separately collected weee is carried out in a way which optimises reuse and recycling and the confinement of hazardous substances . in order to maximise reuse of whole appliances , member states shall also ensure that collection schemes allow for the segregation of reusable appliances from separately collected weee at the collection points , prior to any transportation .


### member states shall ensure that all separately collected weee undergoes treatment . ### member states shall ensure that all separated collected weee undergoes treatment in accordance with the waste hierarchy priority order established by directive 2008 / 98 / ec . to give priority to preparation for reuse , a check should be implemented prior to any treatment , to ascertain whether the waste equipment or individual components thereof are reusable . this check should be carried out by accredited repair and reuse centres , established according to article 11 . 1 and annex iv of directive 2008 / 98 / ec , or similarly qualified personnel


### for weee falling under categories 1 and 10 of annex i to directive 20xx / xx / ec , - 85% shall be recovered and - 80% shall be prepared for reuse and recycled ; ### for weee falling under categories 1 and 4 of annex ia - 85% shall be recovered , - 75% shall be recycled and - 5% shall be prepared for reuse ;


### for weee falling under categories 3 and 4 of annex i to directive 20xx / xx / ec , - 80% shall be recovered , and - 70% shall be prepared for reuse and recycled ; ### for weee falling under category 2 of annex ia - 80% shall be recovered , - 65% shall be recycled and - 5% shall be prepared for reuse ;


### for weee falling under categories 2 , 5 , 6 , 7 , 8 and 9 of annex i to directive 20xx / xx / ec , - 75% shall be recovered , and - 55% shall be prepared for reuse and recycled ; ### for weee falling under category 5 of annex ia , - 75% shall be recovered , - 50% shall be recycled and - 5% shall be prepared for reuse ;


### member states shall ensure that producers provide at least for the financing of the collection , treatment , recovery and environmentally sound disposal of weee from private households deposited at collection facilities set up under article 5 . member states , where appropriate , shall encourage producers to finance all the cost occurring for collection facilities for weee from private households . ### member states shall ensure that producers provide at least for the financing of the collection , treatment , recovery and environmentally sound disposal of weee from private households deposited at collection facilities set up under article 5 . in addition , where appropriate , member states shall ensure that , to improve the collection of weee , sufficient financial resources are raised according to the polluter pays principle at the moment of selling new eee to cover the cost of collection of weee from households , including the cost of running the collection facilities and associated awareness - raising campaigns on the management of weee . these financial resources shall be available only to operators legally obliged to collect weee . where receiving full coverage for their costs , municipalities and private collection points shall hand over all the weee collected to producer responsibility schemes . the financing of the collection of weee from households for removal to collection facilities should not fall under the individual producer responsibility for financing provided for in article&#160 ; 12 . 2 .


### member states shall ensure that producers provide at least for the financing of the collection , treatment , recovery and environmentally sound disposal of weee from private households deposited at collection facilities set up under article 5 . member states , where appropriate , shall encourage producers to finance all the cost occurring for collection facilities for weee from private households . ### member states shall ensure producers provide at least for the financing of the collection , treatment , recovery and environmentally sound disposal of weee from private households deposited at collection facilities set up under article 5 . in addition , member states , where appropriate , shall ensure that , to improve the collection of weee , sufficient financial resources are raised according to the polluter pays principle at the moment of selling new eee to cover the cost of collection of weee from households , including the cost of running the collection facilities and associated awareness - raising campaigns on the management of weee . these financial resources shall be available only to operators legally obliged to collect weee . where receiving full coverage for their costs , municipalities and private collection points shall hand over all the weee collected to producer responsibility schemes . the financing of the collection of weee from households for removal to collection facilities should not fall under the individual producer responsibility for financing provided for in article 12 . 2 . additional rules on the calculation methods regarding the costs of collection and collection facilities may be laid down by member states .


### member states may require that some or all of the information referred to in paragraphs 2 shall be provided by producers and / or distributors , e . g . in the instructions for use or at the point of sale . ### member states may require that some or all of the information referred to in paragraph 2 shall be provided by producers and / or distributors , e . g . in the instructions for use or at the point of sale , or through public awareness campaigns .


### in order to facilitate the preparation for reuse and the correct and environmentally sound treatment of weee , including maintenance , upgrade , refurbishment and recycling , member states shall take the necessary measures to ensure that producers provide reuse and treatment information for each type of new eee placed on the market within one year after the equipment is placed on the market . this information shall identify , as far as it is needed by reuse centres , treatment and recycling facilities in order to comply with the provisions of this directive , the different eee components and materials , as well as the location of dangerous substances and preparations in eee . it shall be made available to reuse centres , treatment and recycling facilities by producers of eee in the form of manuals or by means of electronic media . ### in order to facilitate the use and the correct and environmentally sound treatment of weee , including maintenance , upgrade , reuse , preparation for reuse , refurbishment and recycling , member states shall take the necessary measures to ensure that producers provide free of charge reuse and treatment information for each type of new eee placed on the market within one year after the equipment is placed on the market . this information shall identify , as far as it is needed by reuse centres , treatment and recycling facilities in order to comply with the provisions of this directive , the different eee components and materials , as well as the location of dangerous substances and preparations in eee . it shall be made available to reuse centres , treatment and recycling facilities by producers of eee in the form of manuals or by means of electronic media .


### this directive shall apply to electronic invoices issued as a result of the performance of contracts awarded in accordance with directive [ replacing directive 2004 / 18 / ec ] , directive [ replacing directive 2004 / 17 / ec ] , or directive 2009 / 81 / ec . ### this directive shall apply to electronic invoices issued as a result of the performance of contracts awarded in accordance with directive [ replacing directive 2004 / 18 / ec ] , directive [ replacing directive 2004 / 17 / ec ] , directive 2009 / 81 / ec and directive on concession contracts [ directive . . ] .


### with a view to ensuring that the same level of scientific expertise in the area of pharmacovigilance decision - making at both community and national level , when fulfilling pharmacovigilance tasks the coordination group should be able to rely on the advice of the pharmacovigilance risk assessment advisory committee of the agency . ### with a view to ensuring that the same level of scientific expertise in the area of pharmacovigilance decision - making at both community and national level , when fulfilling pharmacovigilance tasks the coordination group should rely on the recommendation of the pharmacovigilance risk assessment committee of the agency .


### in order to enforce the provisions related to the pharmacovigilance , the member states should ensure that effective , proportionate and dissuasive penalties are applied to marketing authorisation holders for non - compliance with pharmacovigilance obligations . ### in order to enforce the provisions related to pharmacovigilance , the member states should ensure that effective , proportionate and dissuasive penalties are applied to marketing authorisation holders for non - compliance with pharmacovigilance obligations . if the conditions included in the marketing authorisation are not fulfilled within the given deadline , the national competent authorities should have the power to review the marketing authorisation granted .


### for the purposes of point of the first paragraph the member states may impose specific requirements on doctors , pharmacists and other health - care professionals in respect of the reporting of suspected serious or unexpected adverse reactions . ### for the purposes of point of the first paragraph the member states may impose specific requirements on doctors , pharmacists and other health - care professionals in respect of the reporting of suspected serious or unexpected adverse reactions . reporting of suspected adverse reactions due to medication errors should be on an anonymous ' no blame ' basis , and should be subject to legal professional privilege .


### marketing authorisation holders shall be required to submit electronically to the database and data - processing network referred to in article 24 of regulation no 726 / 2004 information on all serious suspected adverse reactions that occur in the community and in third countries within 15 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . ### marketing authorisation holders shall be required to submit electronically to the database and data - processing network referred to in article 24 of regulation no 726 / 2004 information on all serious suspected adverse reactions that occur in the community and in third countries within 15 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . a system shall be established to simultaneously notify the relevant member states of these submitted reports .


### at its next meeting following the end of the period for comments by the marketing authorisation holder referred to in paragraph 2 , the pharmacovigilance risk assessment advisory committee shall adopt the assessment report with or without changes , taking into account any comments submitted in accordance with that paragraph . ### at its next meeting following the end of the period for comments by the marketing authorisation holder referred to in paragraph 2 , the pharmacovigilance risk assessment committee shall adopt the assessment report with or without changes , taking into account any comments submitted in accordance with that paragraph . it shall formulate a recommendation for the coordination group on the basis of the assessment report . the word « advisory » should be deleted from the title of the pharmacovigilance risk assessment committee so that the title better reflects the powers of the committee . if adopted the name will be changed throughout the text .


### in the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with article 107e which does not include any marketing authorisation granted in accordance with regulation no 726 / 2004 , the coordination group shall , within 30 days of receipt of the report of the pharmacovigilance risk assessment advisory committee , consider the report and adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisations concerned , including a timetable for the implementation of the opinion . ### in the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with article 107e which does not include any marketing authorisation granted in accordance with regulation no 726 / 2004 , the coordination group shall , within 30 days of receipt of the recommendation of the pharmacovigilance risk assessment committee , adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisations concerned , including a timetable for the implementation of the opinion .


### in the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with article 107e which includes at least one marketing authorisation granted in accordance with the procedure of regulation no 726 / 2004 , the committee for medicinal products for human use shall , within 30 days of receipt of the report of the pharmacovigilance risk assessment advisory committee , consider the report and adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisations concerned . ### in the case of a single assessment of periodic safety update reports concerning more than one marketing authorisation in accordance with article 107e which includes at least one marketing authorisation granted in accordance with the procedure of regulation no 726 / 2004 , the committee for medicinal products for human use shall , within 30 days of receipt of the recommendation of the pharmacovigilance risk assessment committee , adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisations concerned . the chmp shall only adopt an opinion which differs from the recommendation of the pharmacovigilance risk assessment committee , if there exist strong scientific and public health grounds for doing so . the chmp shall explain these grounds in a justification which it shall annex to its opinion .


### community procedure ### urgent union procedure


### where the scope of the procedure , as determined in accordance with article 107i , does not include any marketing authorisation granted in accordance with the procedure of regulation no 726 / 2004 , the coordination group shall , within 30 days of the recommendation of the pharmacovigilance risk assessment advisory committee , consider the recommendation and adopt an opinion on the maintenance , variation , suspension , revocation or refusal of the renewal of the marketing authorisations concerned , including a timetable for the implementation of the opinion . ### where the scope of the procedure , as determined in accordance with article 107i , does not include any marketing authorisation granted in accordance with the procedure of regulation no 726 / 2004 , the coordination group shall act in accordance with article 107g .


### where the scope of the procedure , as determined in accordance with article 107i , includes at least one marketing authorisation granted in accordance with the procedure of regulation no 726 / 2004 , the committee for medicinal products for human use shall , within 30 days of the recommendation of the pharmacovigilance risk assessment advisory committee , consider the recommendation and adopt an opinion on the maintenance , variation , suspension , revocation or refusal of the renewal of the marketing authorisations concerned . ### where the scope of the procedure , as determined in accordance with article 107i , includes at least one marketing authorisation granted in accordance with the procedure of regulation no 726 / 2004 , the committee for medicinal products for human use shall act in accordance with article 107g .


### this chapter shall apply to non - interventional post - authorisation safety studies which are initiated , managed or financed by the marketing authorisation holder , voluntarily or following a requirement in accordance with articles 21a or 22a , and which involve the collection of data from patients or health - care professionals . ### the procedures laid down in articles 107o to 107r shall apply to non - interventional post - authorisation safety studies which are initiated , managed or financed by the marketing authorisation holder , voluntarily or following a requirement in accordance with articles 21a or 22a , and which involve the collection of data from patients or health - care professionals .


### the esf should improve employment opportunities , promote education and life - long learning and develop active inclusion policies in accordance with the tasks entrusted to the esf by article 162 of the treaty , and thereby contribute to economic , social and territorial cohesion in accordance with article 174 of the treaty . in accordance with article 9 of the treaty , the esf should take into account requirements linked to the promotion of a high level of employment , the guarantee of adequate social protection , the fight against social exclusion , and a high level of education , training and protection of human health . ### the esf should improve employment opportunities , support the creation of sustainable jobs , promote education and life - long learning , develop active inclusion policies and fight poverty and social exclusion in accordance with article 9 of the treaty and with the tasks entrusted to the esf by article 162 of the treaty , and thereby contribute to economic , social and territorial cohesion in accordance with article 174 of the treaty . in accordance with article 9 of the treaty , the esf should take into account requirements linked to the promotion of a high level of employment , the guarantee of adequate social protection , the fight against poverty and social exclusion , and a high level of education , training and protection of human health .


### the esf should improve employment opportunities , promote education and life - long learning and develop active inclusion policies in accordance with the tasks entrusted to the esf by article 162 of the treaty , and thereby contribute to economic , social and territorial cohesion in accordance with article 174 of the treaty . in accordance with article 9 of the treaty , the esf should take into account requirements linked to the promotion of a high level of employment , the guarantee of adequate social protection , the fight against social exclusion , and a high level of education , training and protection of human health . ### the esf must improve employment opportunities , promote education and life - long learning and develop and support active inclusion policies and policies to combat poverty in accordance with the tasks entrusted to the esf by article 162 of the treaty , and thereby contribute to economic , social and territorial cohesion in accordance with article 174 of the treaty . in accordance with article 9 of the treaty , the esf must take into account requirements linked to the promotion of a high level of employment , the guarantee of adequate social protection , the fight against social exclusion , and a high level of education , training and protection of human health . all measures should take care to ensure that they help to promote quality employment and do not support precarious employment .


### the european council of 17 june 2010 called for all common policies , including cohesion policy , to support the europe 2020 strategy for smart , sustainable and inclusive growth ' . in order to ensure the full alignment of the esf with the objectives of this strategy , particularly as regards employment , education , and the fight against social exclusion , the esf should support member states in implementing the council recommendations on broad guidelines for economic policies of the member states and the union and the council decisions on guidelines for the employment policies of the member states adopted in accordance with articles 121 and 148 of the treaty . it should also contribute to the implementation of the flagship initiatives , with special regard to the ' agenda for new skills and jobs ' , ' youth on the move ' , and the ' european platform against poverty and social exclusion ' . it will also support the activities in the ' digital agenda ' and the ' innovation union ' initiatives . ### the european council of 17 june 2010 called for all common policies , including cohesion policy , to support the europe 2020 strategy for smart , sustainable and inclusive growth ' . in order to ensure the full alignment of the esf with the objectives of this strategy , particularly as regards employment , education , training and the fight against social exclusion , the esf must support member states in implementing the council recommendations on broad guidelines for economic policies of the member states and the union and the council decisions on guidelines for the employment policies of the member states adopted in accordance with articles 121 and 148 of the treaty . it should also contribute to the implementation of the flagship initiatives , with special regard to the ‘ agenda for new skills and jobs’ , ‘ youth on the move’ , and the ‘ european platform against poverty and social exclusion’ . it should also support the activities in the ‘ digital agenda’ and the ‘ innovation union’ initiatives .


### the european council of 17 june 2010 called for all common policies , including cohesion policy , to support the europe 2020 strategy for smart , sustainable and inclusive growth ‘ . in order to ensure the full alignment of the esf with the objectives of this strategy , particularly as regards employment , education , and the fight against social exclusion , the esf should support member states in implementing the council recommendations on broad guidelines for economic policies of the member states and the union and the council decisions on guidelines for the employment policies of the member states adopted in accordance with articles 121 and 148 of the treaty . it should also contribute to the implementation of the flagship initiatives , with special regard to the ’agenda for new skills and jobs ‘ , ’youth on the move ‘ , and the ’european platform against poverty and social exclusion ‘ . it will also support the activities in the ’digital agenda ‘ and the ’innovation union ‘ 17 initiatives . ### the european council of 17 june 2010 called for all common policies , including cohesion policy , to support the europe 2020 strategy for smart , sustainable and inclusive growth ‘ . in order to ensure the full alignment of the esf with the objectives of this strategy , particularly as regards employment , education , and the fight against poverty and social exclusion , the esf should support member states in implementing the council recommendations on broad guidelines for economic policies of the member states and the union and the council decisions on guidelines for the employment policies of the member states adopted in accordance with articles 121 and 148 of the treaty . it should also contribute to the implementation of the flagship initiatives , with special regard to the ’agenda for new skills and jobs ‘ , ’youth on the move ‘ , and the ’european platform against poverty and social exclusion ‘ . it will also support the activities in the ’digital agenda ‘ and the ’innovation union ‘ initiatives .


### in addition to these priorities , in the less developed regions and member states , and with a view to increasing economic growth and employment opportunities , the efficiency of public administration should be improved and the institutional capacity of stakeholders delivering employment , education and social policies should be strengthened . ### in addition to these priorities , in the less developed regions and member states , and with a view to increasing economic growth and employment opportunities , the efficiency of public administration should be improved and the institutional capacity of stakeholders delivering employment , education and social policies as well as working in the field of anti - discrimination should be strengthened , with special emphasis on ngos .


### the esf should contribute to the europe 2020 strategy , ensuring greater concentration of support on the priorities of the european union . the esf should in particular increase its support for the fight against social exclusion and poverty , through a minimum ring - fenced allocation . according to the level of development of the supported regions , the choice and number of investment priorities for esf support should also be limited . ### the esf should contribute to the europe 2020 strategy , ensuring greater concentration of support on the priorities of the european union and support member states in their implementation of their national reform programmes . the esf should in particular increase its active support for the fight against social exclusion and poverty , through a minimum ring - fenced allocation . according to the level of development of the supported regions , the choice and number of investment priorities for esf support should also be limited .


### the mobilisation of regional and local stakeholders is necessary to deliver the europe 2020 strategy and its headline targets . territorial pacts , local initiatives for employment and social inclusion , community - led local development strategies and sustainable urban development strategies may be used and supported to involve more actively regional and local authorities , cities , social partners and non - governmental organisations in the implementation of programmes . ### the mobilisation of regional and local stakeholders is necessary to deliver the europe 2020 strategy and its headline targets . territorial pacts , local initiatives for employment and social inclusion , sustainable community - led local development strategies and sustainable urban as well as rural development strategies may be used and supported to involve more actively regional and local authorities , cities , social partners and non - governmental organisations in the programming , implementation , monitoring and evaluation of programmes .


### with a view to simplifying the use of the esf and reducing the risk of errors , and with regard to the specificities of the operations supported by the esf , it is appropriate to lay down provisions which complement articles 57 and 58 of regulation no [ … ] . ### with a view to simplifying the use of the esf and reducing the risk of errors , and with regard to the specificities of the operations supported by the esf , it is appropriate to lay down provisions which complement articles 57 and 58 of regulation no [ … ] . improving implementation and quality of spending should constitute guiding principles for achieving the objectives of the programme , ensuring optimal use of the financial resources ;


### the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission for establishing the definition of standard scales of unit costs and lump sums and their maximum amounts according to different types of operations and for defining the specific rules and conditions of policy - based guarantees . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure the simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council . ### the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission for establishing the definition in accordance with the relevant provisions of the financial regulation of standard scales of unit costs and lump sums and their maximum amounts according to different types of operations and for defining the specific rules and conditions of policy - based guarantees . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure the simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council .


### the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission for establishing the definition of standard scales of unit costs and lump sums and their maximum amounts according to different types of operations and for defining the specific rules and conditions of policy - based guarantees . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure the simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council . ### the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission for establishing the definition of standard scales of unit costs and lump sums and their maximum amounts according to different types of operations and for defining the specific rules and conditions of policy - based guarantees . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , must ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### the esf shall promote high levels of employment and job quality , support the geographical and occupational mobility of workers , facilitate their adaptation to change , encourage a high level of education and training , promote gender equality , equal opportunities and non - discrimination , enhance social inclusion and combat poverty , thereby contributing to the priorities of the european union as regards strengthening economic , social and territorial cohesion . ### the esf shall promote high levels of employment and the creation and preservation of quality jobs , support the voluntary geographical and occupational mobility of workers , facilitate their adaptation to change , encourage a high level of education and training , promote gender equality , equal opportunities and non - discrimination , enhance social inclusion and combat poverty , thereby contributing to the priorities of the european union as regards strengthening economic , social and territorial cohesion .


### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , ethnic minorities , marginalised communities and people facing social exclusion . the esf shall also provide support to enterprises , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance and the implementation of reforms , in particular in the fields of employment , education and social policies . ### the esf shall benefit people , including disadvantaged groups such as the long - term unemployed , people with disabilities , migrants , ethnic minorities , marginalised persons and communities and other groups of people facing or at risk of poverty and social exclusion , including children , in order to prevent the reproduction of poverty through generations , and young people , in order to tackle youth unemployment . the esf shall also provide support to enterprises , systems and structures with a view to facilitating their adaptation to new challenges and promoting good governance and the implementation of reforms , in particular in the fields of employment , education and social policies .


### self - employment , entrepreneurship and business creation ; ### self - employment , entrepreneurship , including in particular social entrepreneurship , and business creation ;


### equality between men and women and reconciliation between work and private life ; ### equality between men and women and reconciliation between work and family and private life , including through part - time skills training for single parents ;


### reducing early school - leaving and promoting equal access to good - quality early - childhood , primary and secondary education ; ### reducing and preventing early school drop - out and promoting equal access to high - quality early - childhood development programs , primary and secondary education as well as informal and non - formal learning opportunities ;


### improving the quality , efficiency and openness of tertiary and equivalent education with a view to increasing participation and attainment levels ; ### improving the quality , efficiency and openness of tertiary and equivalent education with a view to increasing participation and attainment levels and promoting equal access for disadvantaged social groups ;


### promoting social inclusion and combating poverty through : ### promoting active social inclusion and combating poverty through :


### enhancing access to affordable , sustainable and high - quality services , including health care and social services of general interest ; ### measures aimed at breaking the poverty cycle and promoting children ' s and youth active participation in society , such as by enhancing equal access to affordable , sustainable and high - quality public services , including health care , early childhood education and childcare services , family support , socially inclusive public education ;


### promoting the social economy and social enterprises ; ### promoting the social and inclusive economy and social enterprises ;


### supporting the shift towards a low - carbon , climate - resilient , resource - efficient and environmentally sustainable economy , through reform of education and training systems , adaptation of skills and qualifications , up - skilling of the labour force , and the creation of new jobs in sectors related to the environment and energy ; ### supporting the shift towards a low - carbon , climate - resilient , resource - efficient and environmentally sustainable economy , through the improvement of education and training systems , adaptation of skills and qualifications , up - skilling of the labour force , and the creation of new jobs in sectors related to the environment and energy ;


### common indicators as set out in the annex to this regulation and programme specific indicators shall be used in accordance with article 24 and 87 of regulation no [ … ] . all indicators shall be expressed in absolute numbers . ### common quantitative and qualitative indicators as set out in the annex to this regulation and programme specific indicators shall be used in accordance with article 24 and 87 of regulation no [ . . . ] . all indicators shall be expressed in absolute numbers .


### the member states and the commission shall promote equality between men and women through mainstreaming as referred to in article 7 of regulation no [ … ] and specific targeted actions as referred to in article 3 , in particular with the aim of increasing the sustainable participation and progress of women in employment , reducing gender - based segregation in the labour market , combating gender stereotypes in education and training and promoting reconciliation of work and personal life for men and women . ### the member states and the commission shall promote equality between men and women through mainstreaming as referred to in article 7 of regulation no [ . . . ] , integrating gender perspective to actions under all thematic priorities . member states shall allocate funding for specific targeted actions as referred to in article 3 , in particular but not exclusively with the aim of increasing the sustainable participation and progress of women in employment , reducing gender - based segregation in the labour market , combating gender stereotypes in education and training , addressing the feminisation of poverty , promoting equal sharing of care responsibilities between women and men , and promoting reconciliation of work , family and personal life for men and women .