### a new deadline for the next report should be fixed . in accordance with the commission ' s move towards more evidence - based policy - making , this report should address the main evaluation questions including effectiveness , efficiency , european added value , relevance and sustainability . it should also be specified that taking account of the first subparagraph of article 307 of the treaty this report should also be forwarded to the committee of the regions . ### a new deadline for the next report should be fixed . in accordance with the commission ' s move towards more evidence - based policy - making , this report should address the main evaluation questions including effectiveness , efficiency , european added value , relevance and sustainability . effectiveness is understood as also covering the attempts inside the different commission services and between the commission and other bodies such as the european external action service to disseminate the knowledge about the egtc instrument . it should also be specified that taking account of the first subparagraph of article 307 of the treaty this report should also be forwarded to the committee of the regions .


### it should be clarified that existing egtcs are not obliged to adapt their convention and statutes to amendments to the egtc regulation . ### it should be clarified that existing egtcs may not adapt their convention and statutes to amendments to the egtc regulation .


### in order to adapt existing national rules to implement this regulation before programmes under the european territorial cooperation goal have to be submitted to the commission , the starting date of its application should be 6 months after the date of its entry into force . ### in order to adapt existing national rules to implement this regulation before programmes under the european territorial cooperation goal have to be submitted to the commission , the starting date of this regulation ' s application should be six months after the date of its entry into force . when adapting their existing national rules member states should ensure that competent authorities responsible for approval of egtcs are determined and that , in accordance with their legal and administrative arrangements , these should be the same bodies responsible for receipt of notifications in accordance with article 4 of this regulation .


### the objective of an egtc shall be to facilitate and promote territorial cooperation , including one or more of cross - border , transnational and interregional cooperation , between its members as set out in article 3 , with the aim of strengthening economic , social and territorial cohesion . ” ### the objective of an egtc shall be to facilitate and promote in particular territorial cooperation , including one or more of cross - border , transnational and interregional cooperation , between its members as set out in article 3 , with the aim of strengthening union economic , social and territorial cohesion . '


### ' 1 . an egtc and its acts and activities shall be governed by the following : this regulation and , where applicable , other union law concerning activities of the egtc ; where expressly authorised by this regulation , the provisions of the convention referred to in article 8 ; in the case of matters not , or only partly , regulated by this regulation , the law of the member state where the egtc has its registered office or , where allowed under this regulation , the law of the member state where statutory organs exercise their powers or where the egtc carries out its activities . an egtc shall be considered to be an entity of the member state where it has its registered office for the purposes of determining the applicable law . ” ### ' 1 . the acts of the statutory organs of an egtc shall be governed by the following : this regulation ; the convention referred to in article 8 , when it is expressly authorised by this regulation ; and , in the case of matters not , or only partly , regulated by this regulation , the national law of the member state where the registered office of the egtc is located . ' an egtc shall be considered to be an entity of the member state where it has its registered office where it is necessary to determine the applicable law under union or private international law .


### national , regional or local authorities or bodies or public enterprises equivalent to those referred to under point from third countries or overseas territories , subject to the conditions laid down in article 3a . ” ### national , regional or local authorities or bodies or public undertakings equivalent to those referred to under point from third countries , subject to the conditions laid down in article 3a . '


### an egtc shall be made up of members drawn from the territory of at least two member states , except as provided for in article 3a . ” ### an egtc shall be made up of members drawn from the territory of at least two member states , except as provided for in article 3a , and shall be competent to act on behalf of its members for the purpose of implementing cooperation projects and programmes . ”


### “2 . an egtc shall be made up of members drawn from the territory of at least two member states , except as provided for in article 3a . ” ### ' 2 . an egtc shall be made up of members drawn from the territory of at least two member states , except as provided for in article 3a , paragraphs and . '


### “article 3a accession of members from third countries or overseas territories in accordance with article 4 , an egtc may be made up of members drawn from the territory of at least two member states and of one or more third country or overseas territory , where those member states and third countries or overseas territories jointly carry out territorial cooperation actions or implement programmes supported by the union . 2 . an egtc may be made up of members drawn from the territory of only one member state and of one third country or overseas territory , where that member state considers such an egtc consistent with the scope of its territorial cooperation or bilateral relations with the third country or overseas territory . ” ### ' article 3a accession of members from third countries or overseas countries or territories in accordance with article 4 , an egtc may be made up of members drawn from the territory of at least two member states and of one or more third countries neighbouring at least one of the member states including its outermost regions where those member states and third countries jointly carry out territorial cooperation actions or implement programmes supported by the union . 1a . for the purposes of this regulation , a third country or an oct is considered as neighbouring a member state including its outermost regions where the third country or an oct and the member states share a common land border or where both the third country or and oct and a member state are eligible under a joint maritime cross - border or transnational programme under etc or under another cross - border , sea - crossing or sea - basin cooperation programme , including where separated by international waters . 2 . an egtc may be made up of members drawn from the territory of only one member state and of one or more third countries neighbouring the member state including its outermost regions , where that member state considers such an egtc consistent with the scope of its territorial cooperation in the context of cross - border or transnational cooperation or bilateral relations with the third countries concerned . ” 2a . for the application of paragraphs and of this article , third countries neighbouring a member state including its outermost regions include maritime borders between the countries concerned . 2b . in accordance with article 4a and subject to the conditions set out in paragraph , an egtc may also be made up of members drawn from one or more member states including its outermost regions and one or more oct , with or without members from one or more third countries . 2c . in accordance with article 4a and subject to the conditions set out in paragraph , an egtc may also be made up of members drawn from only one member state including its outermost regions and of one or more oct , with or without members from one or more third countries . 2d . an egtc may not be set up only between members from a member state and one or more oct linked to that same member state . '


### “3 . following notification under paragraph 2 by a prospective member , the member state concerned shall approve the convention , taking into account its constitutional structure , and the prospective member ' s participation in the egtc , unless it considers that such participation is not in conformity with this regulation , other union law concerning the activities of the egtc or national law concerning the competences of the prospective member or that such participation is not justified for reasons of public interest or of public policy of that member state . in such a case , the member state shall give a statement of its reasons for withholding agreement or shall suggest the necessary amendments to the convention to enable the prospective member’s participation . the member state shall reach its decision within a deadline of six months from the date of receipt of an application in accordance with paragraph 2 . if the member state concerned does not respond within the time limit laid down , the convention shall be deemed to be approved . in deciding on the prospective member ' s participation in the egtc , member states may apply their national rules . ' ### ' 3 . following notification under paragraph 2 by a prospective member , the member state which has received the notification shall , taking into account its constitutional structure , approve the prospective member ' s participation in the egtc and the convention , unless : it considers that such participation or the convention is not in conformity with : this regulation ; other union law concerning the acts and activities of the egtc ; or national law relating to the powers and competences of the prospective member ; it considers that such participation is not justified for reasons of public interest or of public policy of that member state ; or it considers that the statutes are not consistent with the convention . in case of non - approval , the member state shall give a statement of its reasons for withholding approval and shall , where appropriate , suggest the necessary amendments to the convention . the member state shall reach its decision within a deadline of six months from the date of receipt of a notification in accordance with paragraph 2 . if the member state which has received the notification , does not raise any objection within the time limit laid down , the convention shall be deemed to be approved . however , the member state where the proposed registered office of the egtc will be located shall formally approve the convention before the egtc can be established . any request for additional information from the member state shall interrupt the time limit . the period of interruption shall start on the day following the date on which the member state has sent its observations to the prospective member and shall last until the prospective member has responded to the observations . however , an interruption of the time limit shall not occur as long as the prospective member has submitted a reply to the observations by the member state within ten working days following the start of the period of interruption . in deciding on the prospective member ' s participation in the egtc , member states may apply their national rules . '


### the following paragraph 3a is inserted : “3a . in the case of an egtc with prospective members from third countries or overseas territories , the member state where the proposed registered office of the egtc will be located shall ensure that the conditions laid down in article 3a are fulfilled and that the third country or the member state under whose laws the prospective member from an overseas territory is established have approved the prospective member’s participation according to equivalent conditions and procedures to those laid down in this regulation , or in accordance with an agreement concluded between at least one member state under whose law a prospective member is established and such third country or overseas territory . paragraph 3 of this article shall apply . ” ### the following paragraph 3a shall be inserted : ' 3a . in the case of an egtc with prospective members from third countries the member state where the proposed registered office of the egtc will be located shall , in consultation with the other member states concerned , satisfy itself that the conditions laid down in article 3a are fulfilled and that the third country has approved the prospective member’s participation in accordance with : equivalent conditions and procedures to those laid down in this regulation ; or an agreement concluded between at least one member state under whose law a prospective member is established and such third country . '


### “5 . the members shall agree on the convention referred to in article 8 ensuring consistency with the approval or the amendments suggested by the member states in accordance with paragraph 3 of this article . ### ' 5 . the members shall agree on the convention referred to in article 8 ensuring consistency with the approval in accordance with paragraph 3 of this article .


### any amendment to the convention or to the statutes shall be notified by the egtc to the member states under whose law its members are established . any amendment to the convention shall be approved by the member states according to the procedure set out in this article . however , in case of accession to an existing egtc of a new member from a member state that has already approved the convention , such accession shall only be approved by the member state under whose laws the new member is established . paragraph 3 of this article shall apply . in case of the accession of a new member from a third country or overseas territory to an existing egtc , such accession shall be approved by all the member states that have already approved the convention . paragraph 3a of this article shall apply . ' ### any amendment to the convention or to the statutes shall be notified by the egtc to the member states under whose law its members are established . any amendment to the convention , except solely in the cases of accession of a new member covered by paragraph 7 , shall be approved by those member states according to the procedure set out in this article . 6a . the following provisions shall apply in the case of accession of new members to an existing egtc : in case of accession of a new member from a member state that has already approved the convention , such participation shall only be approved by the member state under whose laws the new member is established in accordance with the procedure set out in paragraph 3 and notified to the member state where the egtc has its registered office . in case of the accession of a new member from a member state that has not already approved the convention , the procedure set out in paragraph 6 shall apply . in the case of accession of a new member from a third country to an existing egtc , such accession shall be subject of examination by the member state where the registered office of the egtc is located in accordance with the procedure set out in paragraph 3a . '


### the convention and the statutes and any subsequent amendments thereto shall be registered or published , or both , according to the applicable national law in the member state where the egtc concerned has its registered office . the egtc shall acquire legal personality on the day of registration or publication , whichever occurs first . the members shall inform the member states concerned , the commission and the committee of the regions of the registration or publication of the convention . 2 . the egtc shall ensure that , within ten working days from the registration or publication of the convention , a request is sent to the commission following the template set out in the annex to this regulation . the commission shall then transfer this request to the publications office of the european union for publication of a notice in the c series of the official journal of the european union announcing the establishment of the egtc , with the details set out in the annex to this regulation . ” ### the convention and the statutes and any subsequent amendments thereto shall be registered or published , or both , according to the applicable national law in the member state where the egtc concerned has its registered office . the egtc shall acquire legal personality on the day of registration or publication in the member state where the egtc concerned has its registered office , whichever occurs first . the members shall inform the member states concerned and the committee of the regions of the registration or publication of the convention . 2 . the egtc shall ensure that , within ten working days from the registration or publication of the convention , a request is sent to the committee of the regions following the template set out in the annex to this regulation . the committee of the regions shall then transfer this request to the publications office of the european union for publication of a notice in the c series of the official journal of the european union announcing the establishment of the egtc , with the details set out in the annex to this regulation . '


### article 7 is amended as follows : paragraphs 2 and 3 are replaced by the following : “2 . an egtc shall act within the confines of the tasks given to it , which shall be the facilitation and promotion of territorial cooperation to strengthen economic , social and territorial cohesion and be determined by its members on the basis that they fall within the competence under national law of at least one member from each member state represented in that egtc . 3 . an egtc may carry out specific actions of territorial cooperation between its members in pursuit of the objective referred to in article 1 , with or without a financial support from the union . 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 . member states may limit the actions that egtcs may carry out without a financial support from the union . however , member states shall not exclude those actions covered by the investment priorities under the cohesion policy of the union as adopted for the period 2014 - 2020 . ” ### article 7 is amended as follows : paragraphs 2 and 3 are replaced by the following : ' 2 . an egtc shall act within the confines of the tasks given to it , which shall be the facilitation and promotion of territorial cooperation to strengthen economic , social and territorial cohesion , overcoming internal market barriers , and be determined by its members so that they fall within the competence of every member , unless the member state or third country approves the participation of a member formed under its national law even where that member is not competent for all the tasks specified in the convention . 3 . an egtc may carry out specific actions of territorial cooperation between its members in pursuit of the objective referred to in article 1 , with or without a financial support from the union . primarily , 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 . member states may limit the tasks that egtcs may carry out without a financial support from the union . however , without prejudice to article 13 , member states shall not exclude those tasks concerning the investment priorities referred to in article 6 of regulation no . . . [ etc ] . '


### “however , the assembly referred to in article 10 of an egtc may define the terms and conditions of the use of an item of infrastructure the egtc is managing , including the tariffs and fees to be paid by the users . ” ### ' however , in compliance with applicable national or union law , the assembly of an egtc referred to in article 10 of an egtc may define the terms and conditions of the use of an item of infrastructure the egtc is managing , or the terms and conditions according to which a service of general economic interest is provided , including the tariffs and fees to be paid by the users . '


### “2 . the convention shall specify : the name of the egtc and its registered office ; the extent of the territory in which the egtc may execute its tasks ; the objective and the tasks of the egtc ; its duration and the conditions for its dissolution ; the list of its members ; the specific union or national law applicable to the interpretation and enforcement of the convention ; the arrangement for the involvement of members from third countries or overseas territories if appropriate ; the specific union or national law applicable to its activities , while the latter may be the law of the member state where statutory organs exercise their powers or where the egtc carries out its activities ; the rules applicable to the egtc ' s staff as well as the principles governing the arrangements concerning personnel management and recruitment procedures ; in case of an egtc liabilitywith limited , the arrangements for liability of the members in accordance with article 12 ; the appropriate arrangements for mutual recognition , including for financial control of the management of public funds ; and the procedures for amending the convention , including compliance with the obligations set out in articles 4 and 5 . however , where an egtc is only managing a cooperation programme or part thereof under the cohesion policy of the european union , or where an egtc concerns interregional cooperation or networks , information under point is not required . the following rules shall apply to the egtc’s staff as referred to in point , those of the member state where the egtc has its registered office ; those of the member state where the egtc’s staff is actually located ; or those of the member state of which the staff member is a national . to allow equal treatment of all staff working at the same location , the national laws and rules , whether of public or private law , may be subject to additional ad hoc rules fixed by the egtc . ” ### “2 . the convention shall specify : the name of the egtc and its registered office ; the extent of the territory in which the egtc may execute its tasks ; the objective and the tasks of the egtc ; the duration of the egtc and the conditions for its dissolution ; the list of the egtc’s members ; the list of the egtc’s organs and their respective competences ; the applicable union law and national law of the member state where the egtc has its registered office for the purposes of interpretation and enforcement of the convention ; the applicable union and national law of the member state where the statutory organs of the egtc act ; the arrangement for the involvement of members from third countries or in octs if appropriate including the identification of applicable law where an egtc carries out tasks in third countries or in octs ; the applicable union and national law directly relevant to the egtc activities carried out under the tasks specified in the convention ; the rules applicable to the egtc ' s staff as well as the principles governing the arrangements concerning personnel management and recruitment procedures ; the arrangements for liability of the egtc and its members in accordance with article 12 ; the appropriate arrangements for mutual recognition , including for financial control of the management of public funds ; and the procedures for adoption of the statutes and amendment of the convention , including compliance with the obligations set out in articles 4 and 5 . where the tasks of an egtc concern only the management of a cooperation programme or part thereof under regulation no . . . [ etc ] , or where an egtc concerns interregional cooperation or networks , information under paragraph 2 , point is not required . deleted


### in article 8 , paragraph 2 is replaced by the following : “2 . the convention shall specify : the name of the egtc and its registered office ; the extent of the territory in which the egtc may execute its tasks ; the objective and the tasks of the egtc ; its duration and the conditions for its dissolution ; the list of its members ; the specific union or national law applicable to the interpretation and enforcement of the convention ; the arrangement for the involvement of members from third countries or overseas territories if appropriate ; the specific union or national law applicable to its activities , while the latter may be the law of the member state where statutory organs exercise their powers or where the egtc carries out its activities ; the rules applicable to the egtc ' s staff as well as the principles governing the arrangements concerning personnel management and recruitment procedures ; in case of an egtc liabilitywith limited , the arrangements for liability of the members in accordance with article 12 ; the appropriate arrangements for mutual recognition , including for financial control of the management of public funds ; and the procedures for amending the convention , including compliance with the obligations set out in articles 4 and 5 . however , where an egtc is only managing a cooperation programme or part thereof under the cohesion policy of the european union , or where an egtc concerns interregional cooperation or networks , information under point is not required . the following rules shall apply to the egtc’s staff as referred to in point , those of the member state where the egtc has its registered office ; those of the member state where the egtc’s staff is actually located ; or those of the member state of which the staff member is a national . to allow equal treatment of all staff working at the same location , the national laws and rules , whether of public or private law , may be subject to additional ad hoc rules fixed by the egtc . ” ### in article 8 , paragraph 2 is replaced by the following : “2 . the convention shall specify : the name of the egtc and its registered office ; the extent of the territory in which the egtc may execute its tasks ; the objective and the tasks of the egtc ; the duration of the egtc and the conditions for its dissolution ; the list of the egtc’s members ; the list of the egtc’s organs and their respective competences ; the applicable union law and national law of the member state where the egtc has its registered office for the purposes of interpretation and enforcement of the convention ; the applicable union and national law of the member state where the statutory organs of the egtc act ; the arrangement for the involvement of members from third countries or in octs if appropriate including the identification of applicable law where an egtc carries out tasks in third countries or in octs ; the applicable union and national law where the egtc carries out its tasks , which is directly relevant to the tasks carried out ; the rules applicable to the egtc ' s staff as well as the principles governing the arrangements concerning personnel management and recruitment procedures ; the arrangements for liability of the egtc and its members in accordance with article 12 ; the appropriate arrangements for mutual recognition , including for financial control of the management of public funds ; and the procedures for adoption of the statutes and amendment of the convention , including compliance with the obligations set out in articles 4 and 5 . 3 . where the tasks of an egtc concern only the management of a cooperation programme or part thereof under regulation no . . . [ etc ] , or where an egtc concerns interregional cooperation or networks , information under paragraph 2 , point is not required . the following rules shall apply to the egtc’s staff as referred to in point , those of the member state where the egtc has its registered office ; those of the member state where the egtc’s staff is actually located ; or those of the member state of which the staff member is a national . to allow equal treatment of all staff working at the same location , the national laws and rules , whether of public or private law , may be subject to additional ad hoc rules fixed by the egtc . ”


### in article 9 , paragraph 2 is replaced by the following : “2 . the statutes shall contain , as a minimum , the following : the operating provisions of the egtc ' s organs and their competences , as well as the number of representatives of the members in the relevant organs ; the decision - making procedures of the egtc ; the working language or languages ; the arrangements for its functioning ; the specific arrangements concerning personnel management and recruitment procedures ; the arrangements for members ' financial contributions ; the applicable accounting and budgetary rules of each of the members of the egtc with respect to it ; the designation of the independent external auditor of the accounts of the egtc ; the arrangements for the liability of the members in accordance with article 12 ; and the procedures for amending the statutes , including compliance with the obligations set out in articles 4 and 5 . ” ### article 9 is replaced by the following : ' 1 . the statutes of an egtc shall be adopted on the basis of and in accordance with the convention by its members acting unanimously . 2 . the statutes shall contain , as a minimum , the following : the operating provisions of the egtc ' s organs and their competences , as well as the number of representatives of the members in the relevant organs ; the decision - making procedures of the egtc ; the working language or languages ; the arrangements for its functioning ; the procedures concerning personnel management and recruitment ; the arrangements for members ' financial contributions ; the applicable accounting and budgetary rules of the members of the egtc ; the designation of the independent external auditor of the accounts of the egtc ; and ; the procedures for amending the statutes , including compliance with the obligations set out in articles 4 and 5 . '


### article 12 is amended as follows : in paragraph 1 the following subparagraph is added : “an egtc shall be liable for all its debts . ' paragraph 2 is replaced by the following : ' 2 . notwithstanding paragraph 3 , to the extent that the assets of an egtc are insufficient to meet its liabilities , its members shall be liable for the debts of the egtc of whatever nature , each member ' s share being fixed in proportion to its financial contribution . the arrangements for financial contributions shall be fixed in the statutes . the members may provide in the statutes that they will be liable , after they have ceased to be members of an egtc , for obligations arising out of activities of the egtc during their membership . 2a . if the liability of at least one member of an egtc is limited or excluded as a result of the national law under which it is established , the other members may also limit their liability in the convention . the name of an egtc whose members have limited liability shall include the word ' limited ' . the requirements for the publicity of the convention , statutes and accounts of an egtc whose members have limited liability shall be at least equal to those required for other legal entities with limited liability of their members established under the laws of the member state where that egtc has its registered office . in case of an egtc whose members have limited liability , the member states may require that the egtc shall take appropriate insurance to cover the risks specific to the activities of the egtc . ” ### article 12 is amended as follows : in paragraph 1 the following subparagraph is added : ' an egtc shall be liable for all its debts . ' paragraph 2 is replaced by the following : ' 2 . without prejudice to paragraph 3 , to the extent that the assets of an egtc are insufficient to meet its liabilities , its members shall be liable for the debts of the egtc of whatever nature , each member ' s share being fixed in proportion to its financial contribution . the arrangements for financial contributions shall be fixed in the statutes . the members may provide in the statutes that they will be liable , after they have ceased to be members of an egtc , for obligations arising out of activities of the egtc during their membership . 2a . if the liability of at least one member of an egtc from a member state is limited as a result of the national law under which it is established , the other members may also limit their liability in the convention where the national law implementing this regulation enables them to do so . the name of an egtc whose members have limited liability shall include the word ' limited ' . the requirements for the publicity of the convention , statutes and accounts of an egtc whose members have limited liability shall be at least equal to that required for other legal entities with limited liability under the laws of the member state where that egtc has its registered office . in case of an egtc whose members have limited liability , any member state concerned may require that the egtc shall take appropriate insurance or that it shall be subject to a guarantee provided by a bank or other financial institution established in a member state or be covered by a facility provided as a guarantee by a public entity or by the member state to cover the risks specific to the activities of the egtc . '


### “1 . member states shall make such provisions as are appropriate to ensure the effective application of this regulation . ### ' 1 . member states shall make such provisions as are appropriate to ensure the effective application of this regulation , including the determination of the competent authorities responsible for the approval in accordance with their legal and administrative arrangements .


### article 17 is replaced by the following : ' by mid - 2018 the commission shall forward to the european parliament , the council and the committee of the regions an evaluation report on the application , effectiveness , efficiency , relevance , european added value and scope for simplification of this regulation . the evaluation reports shall be based on indicators the commission shall adopt by delegated acts in accordance with article 17a . ' ### article 17 shall be replaced by the following : ' by 1 august 2018 the commission shall forward to the european parliament , the council and the committee of the regions a report on the application of this regulation , evaluating , based on indicators , its effectiveness , efficiency , relevance , european added value and scope for simplification ] . the commission shall be empowered to adopt delegated acts , in accordance with article 17a , laying down the list of indicators referred to in the first subparagraph . '


### the following article 17a is inserted : “article 17a exercise of the delegation the powers to adopt delegated acts are conferred on the commission subject to the conditions laid down in this article . 2 . the delegations of power referred to in this regulation shall be conferred for an indeterminate period of time from the date of entry into force of this regulation . 3 . the delegations of power referred to in article 17 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 . 4 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 5 . the delegated acts shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 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 2 months at the initiative of the european parliament or the council . if , on expiry of that period , neither the european parliament nor the council has objected to the delegated act , it shall be published in the official journal of the european union and shall enter into force at the date stated therein . the delegated act may be published in the official journal of the european union and enter into force before the expiry of that period if the european parliament and the council have both informed the commission of their intention not to raise objections . if the european parliament or the council objects to a delegated act , the act shall not enter into force . the institution that objects to the delegated act shall state the reasons for its objections . ' ### the following article 17a shall be inserted : ' article 17a exercise of the delegation the powers to adopt delegated acts are conferred on the commission subject to the conditions laid down in this article . 2 . the delegations of power referred to in article 17 shall be conferred on the commission for a period of 5 years from the date of entry into force of this regulation . 3 . the delegations of power referred to in article 17 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 . 4 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 5 . a delegated act adopted pursuant to article 17 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 3 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 3 months at the initiative of the european parliament or the council . if , on expiry of that period , neither the european parliament nor the council has objected to the delegated act , it shall be published in the official journal of the european union and shall enter into force at the date stated therein . the delegated act may be published in the official journal of the european union and enter into force before the expiry of that period if the european parliament and the council have both informed the commission of their intention not to raise objections . if the european parliament or the council objects to a delegated act , the act shall not enter into force . the institution that objects to the delegated act shall state the reasons for its objections . '


### the measures in connection with the modernisation of the eu fleet referred to in article 8 of regulation no 718 / 1999 concern only social matters . other types of support measure for creating a context favourable to innovation and the environment are not provided for . ### the measures in connection with the modernisation of the eu fleet referred to in article 8 of regulation no 718 / 1999 concern only social matters and safety of the working environment . other types of support measure for creating a context favourable to innovation and the environment are not provided for .


### the adaptation to scientific and technical progress of certain provisions of the directive , the selective treatment for materials and components of weee , the technical requirements for collection , storage and treatment of weee and the symbol for the marking of eee should be effected by the commission under a committee procedure . ### according to article 291 tfeu , rules and general principles concerning mechanisms for control , by member states , of the commission ' s exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure . pending the adoption of that new regulation , and given the necessity to adopt and implement as soon as possible this directive , control by member states should be exercised in accordance with the provisions of council decision 1999 / 468 / ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission , insofar as those provisions remain compatible with the amended treaties . references to those provisions should nevertheless be replaced with references to the rules and principles set out in the new regulation as soon as that regulation enters into force .


### the measures necessary for the implementation of this directive should be adopted in accordance with council decision 1999 / 468 / ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission the commission should be empowered to adapt the annexes and to adopt rules for monitoring compliance . since those measures are of general scope and are designed to amend non - essential elements of directive 2002 / 96 / ec , inter alia , by supplementing it with new non - essential elements , they must be adopted in accordance with the regulatory procedure with scrutiny provided for in article 5a of decision 1999 / 468 / ec . ### in order to allow the provisions of this directive to be adapted to technical and scientific progress and to adopt other necessary measures , the commission should be empowered to adopt delegated acts in accordance with article 290 in respect of the adaptation of annexes and rules for monitoring compliance .


### this directive shall apply to electrical and electronic equipment falling under the categories set out in annex i&#160 ; of directive 20xx / xx / ec . ### this directive shall apply to all electrical and electronic equipment .


### ' electrical and electronic equipment ' or ' eee ' means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation , transfer and measurement of such currents and fields falling under the categories set out in annex i&#160 ; of directive 20xx / xx / ec and designed for use with a voltage rating not exceeding 1000 volt for alternating current and 1500 volt for direct current ; ### ' electrical and electronic equipment ' means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation , transfer and measurement of such currents and fields which is designed for use with a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current ;


### manufactures electrical and electronic equipment under his own name or trademark , or has electrical and electronic equipment designed or manufactured and markets that electronic equipment under his name or trade mark ### manufactures electrical and electronic equipment under his own name or trademark , or has electrical and electronic equipment designed or manufactured and places on the market that electronic equipment under his name or trade mark .


### member states shall adopt appropriate measures to minimise the disposal of weee in the form of&#160 ; unsorted municipal waste and to achieve a high level of separate collection of weee , notably , and as a matter of priority , for cooling and freezing equipment containing ozone depleting substances and fluorinated greenhouse gases . ### to achieve a high level of separate collection of weee and correct treatment for all types of weee , notably the cooling and freezing equipment containing ozone depleting substances and fluorinated greenhouses gases , mercury containing lamps , and small appliances , member states shall ensure that all weee is separately collected and not mixed with bulky or unsorted household waste , and that untreated weee is not sent to landfill or incineration .


### a common methodology shall be established for the calculation of the total weight of electrical and electronic equipment placed on the national market . this measure designed to amend non essential elements of this directive , by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 18 . ### in order to ensure the functioning of efficient collection schemes , the commission shall adopt , by means of delegated acts in accordance with article 18a , 18b and 18c , a common methodology for the calculation of the total weight of electrical and electronic equipment placed on the national market .


### annex ii may be amended in order to introduce other treatment technologies ensuring at least the same level of protection for human health and the environment . those measures , designed to amend non - essential elements of this directive by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 18 . the commission shall evaluate as a matter of priority whether the entries regarding printed circuit boards for mobile phones and liquid crystal displays are to be amended . ### in order to introduce other treatment technologies ensuring at least the same level of protection for human health and the environment the commission shall adopt , by means of delegated acts in accordance with article 18a , 18b and 18c , adaptations of annex ii . the commission shall evaluate as a matter of priority whether the entries regarding printed circuit boards for mobile phones and liquid crystal displays are to be amended .


### weee exported out of the community in line with regulation no 1013 / 2006 on shipments of waste , and commission regulation no 1418 / 2007 of 29 november 2007 concerning the export for recovery of certain waste listed in annex iii or annex iiia to regulation no 1013 / 2006 of the european parliament and of the council to certain countries to which the oecd decision on the control of transboundary movements of wastes does not apply shall only count for the fulfilment of obligations and targets of article 11 of this directive if the exporter can prove that the treatment took place under conditions that are equivalent to the requirements of this directive . ### weee exported out of the community in line with regulation no 1013 / 2006 on shipments of waste , and commission regulation no 1418 / 2007 of 29 november 2007 concerning the export for recovery of certain waste listed in annex iii or annex iiia to regulation no 1013 / 2006 of the european parliament and of the council to certain countries to which the oecd decision on the control of transboundary movements of wastes does not apply shall only count for the fulfilment of obligations and targets of article 11 of this directive if the exporter can prove by submitting conclusive evidence , prior to shipment , that preparation for re - use , recycling and recovery takes place under conditions that are equivalent to the requirements of this directive . after preparation for re - use , recycling or recovery has taken place , compliance with those equivalent conditions shall be confirmed .


### detailed rules for the implementation of paragraph 1 and 2 , in particular criteria for the assessment of equivalent conditions , shall be laid down . those measures designed to amend non - essential elements of this directive , by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 18 . ### in order to allow treatment operations outside the community at an equivalent level of protection , the commission shall adopt , by means of delegated acts in accordance with article 18a , 18b and 18c , detailed rules for paragraphs 1 and 2 , in particular criteria for the assessment of equivalent conditions .


### 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 10 of annex ia to this directive , - 85% shall be recovered , and - 80% shall be prepared for reuse and recycled ;


### 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 10 of annex i to directive 20xx / xx / ec , – 85% shall be recovered , – 75% shall be recycled , and


### 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 categories 3 and 4 of annex ia to this directive 20x , – 80% shall be recovered , and – 70% shall be prepared for reuse and recycled ;


### 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 categories 3 and 4 of annex i to directive 20xx / xx / ec , – 80% shall be recovered , – 65% shall be recycled , and - 5% shall be prepared for reuse ;


### 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 re - use and recycled ; ### for weee falling under categories 1 and 4 of annex - ia , – 85% shall be recovered , and – 80% shall be prepared for re - use and recycled ;


### 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 re - use and recycled ; ### for weee falling under category 2 of annex - ia , – 80% shall be recovered , and – 70% shall be prepared for re - use and recycled ;


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


### for gas discharge lamps , 85% shall be prepared for re - use and recycled . ### for gas discharge lamps , 80% shall be recycled .


### 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 . where appropriate , to increase the collection of weee from households , 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 collectors obliged by law to act as collection points shall hand over all the weee collected to producer responsibility schemes . this provision for the financing of weee collection from households should not fall under the individual producer responsibility for financing provided for in article 12 . 2 .


### the return and collection systems available to them ; ### the return and collection systems available to them , encouraging the coordination of information serving to identify all available collection points , irrespective of the producers which have set them up ;


### member states shall ensure that any producer on their territory can enter in their national register all relevant information , including reporting requirements and fees , reflecting its activities across all other member states . ### member states shall ensure that any producer on their territory can enter in electronic form in their national register all relevant information , including reporting requirements and fees , reflecting its activities across all other member states .


### the registers shall be inter - operational to exchange such information , including on quantities of electrical and electronic equipment placed on the national market and for the transfer of money related to the intra - community transfers of products or weee . ### the registers shall be inter - operational to exchange such information , including on quantities of electrical and electronic equipment placed on the national market , as well as information enabling the transfer of money related to the intra - community transfers of products or weee .


### the format for registration and reporting and the frequency of reporting shall be established . those measures designed to amend non - essential elements of this directive , by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 18 . ### in order to ensure the smooth functioning of the registration , information and reporting system , the commission shall adopt , by means of delegated acts in accordance with article 18a , 18b and 18c , the format for registration and reporting and the frequency of reporting .


### amendments may be made if necessary in order to adapt article 16 and the annexes to scientific and technical progress . those measures designed to amend non - essential elements of this directive , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 18 . ### in order to allow the provisions of this directive to be adapted to scientific and technical progress , the commission may adopt , by means of delegated acts in accordance with article 18a , 18b and 18c , adaptations to article 16 and the annexes .


### those inspections shall at least cover exports of weee outside the community in accordance with the waste shipment regulation and the operations at treatment facilities in accordance with directive 2008 / xx / ec on waste and annex ii of this directive . ### those inspections shall at least cover the reported quantities of eee placed on the market , in order to check the amount of the financial guarantees required under article 12 , exports of weee outside the community in accordance with the waste shipment regulation and the operations at treatment facilities in accordance with directive 2008 / xx / ec on waste and annex ii of this directive .


### member states shall carry out the monitoring of shipments of weee in accordance with the minimum monitoring requirements in annex i . ### member states shall ensure that shipments of used eee suspected of being weee are carried out in accordance with the minimum requirements in annex i and shall monitor such shipments accordingly .


### additional rules on inspections and monitoring may be laid down . those measures designed to amend non - essential elements of this directive , by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 18 . ### in order to ensure the proper functioning of inspections and monitoring , the commission may adopt , by means of delegated acts in accordance with article 18a , 18b and 18c , additional rules on inspections and monitoring .


### obstacles to trade deriving from the co - existence of several legal requirements and technical standards on electronic invoices and from the lack of interoperability should be removed or reduced . in order to achieve this objective , a common european standard for the semantic data model of the core electronic invoice should be developed . ### obstacles to trade deriving from the co - existence of several legal requirements and technical standards on electronic invoices and from the lack of interoperability should be removed or reduced in the case of crossborder trade . in order to achieve this objective , a common european standard for the semantic data model of the key elements of the electronic invoice should be developed . this standard should describe the key elements of electronic invoicing and map these elements to the various technical standards , thus facilitating the sending and receipt of electronic invoices between systems based on different technical standards . existing national technical standards should neither be replaced nor impaired by this standard , and it should remain possible to continue to apply them in parallel with this standard .


### the commission should apply the relevant provisions of regulation no 1025 / 2012 of the european parliament and of the council of 25 october 2012 on european standardisation3 to request the relevant european standardisation organisation to draft a european standard for the semantic data model of the core electronic invoice . in its request to the relevant european standardisation organisation , the commission should require that such european standard is technologically neutral , in order to avoid any distortion of competition . since electronic invoices may contain personal data , the commission should also require that such european standard guarantees personal data protection in accordance with directive 95 / 46 / ec of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data4 . in addition to these minimum requirements , the commission should determine , in its request to the relevant european standardisation organisation , further requirements as to the content of such european standard and a deadline for its adoption . __________________ 3 oj l 316 , 14 . 11 . 2012 , p . 12 . 4 oj l 281 , 23 . 11 . 1995 , p . 31 . ### the commission should apply the relevant provisions of regulation no 1025 / 2012 of the european parliament and of the council of 25 october 2012 on european standardisation3 to request the relevant european standardisation organisation to draft a european standard for the semantic data model of the key elements of the electronic invoice . in its request to the relevant european standardisation organisation , the commission should require that such european standard is technologically neutral , in order to avoid any distortion of competition . since electronic invoices may contain personal data , the commission should also require that such european standard guarantees personal data protection in accordance with directive 95 / 46 / ec of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data4 . in addition to these minimum requirements , the commission should determine , in its request to the relevant european standardisation organisation , further requirements as to the content of such european standard and a deadline of 30 months for its adoption . __________________ 3 oj l 316 , 14 . 11 . 2012 , p . 12 . 4 oj l 281 , 23 . 11 . 1995 , p . 31 .


### the european standard for the semantic data model of the core electronic invoice should build on existing specifications , including in particular those developed by european or international organisations such as cen , iso , and un / cefact . it should not require electronic signatures . such european standard should define semantic data elements referring to , in particular , complementary seller and buyer data , process identifiers , invoice attributes , invoice item details , delivery information , payment details and terms . it should also be compatible with the existing standards for payments in order to allow for automatic processing of payments . ### the european standard for the semantic data model of the electronic invoice should build on , and be compatible with , existing specifications , including in particular those developed by european or international organisations such as cen , iso , and un / cefact . it should not require electronic signatures . it should also be compatible with the existing standards for payments in order to allow for automatic processing of payments .


### where the european standard drawn up by the relevant european standardisation organisation satisfies the requirements contained in the commission’s request , the references of such european standard should be published in the official journal of the european union . ### where the european standard drawn up by the relevant european standardisation organisation satisfies the requirements contained in the commission’s request and the council has approved the standard , the commission should have the references of such european standard published in the official journal of the european union .


### contracting authorities and contracting entities should not refuse the reception of electronic invoices which comply with such common european standard on the grounds of non - compliance with other technical requirements . ### contracting authorities and contracting entities should be in a position to process electronic invoices which comply with such common european standard . once the deadline laid down in this directive has passed , reception of invoices should not be refused on the grounds of non - compliance with other technical requirements . other compelling grounds for refusal should not be affected by this provision .


### in order to allow contracting authorities and contracting entities to take the technical measures that , following the establishment of the european standard , are necessary to comply with the provisions of this directive , a transposition deadline of 48 months is justified . ### in order to allow contracting authorities and contracting entities to take the technical measures that , following the establishment of the european standard , are necessary to comply with the provisions of this directive , a transposition deadline of 18 months after publication of the european standard in the official journal of the european union is justified . central government authorities and central purchasing bodies should apply the provisions of this directive transposed by member states within 18 months of the entry into force of this directive . sub - central contracting authorities and contracting entities should apply these provisions within 36 months after the entry into force of this directive .


### ' electronic invoice ' means an invoice that has been issued and received in any electronic format ; ### ' electronic invoice ' means an invoice that has been issued , forwarded and received in a structured electronic format ;


### ‘ semantic data model’ means a structured and logically interrelated set of terms and meanings that specify the content exchanged in electronic invoices ; ### ‘ semantic data model’ means a structured and logically interrelated set of terms and their meanings that specify the content of the key components of electronic invoices ;


### ‘ core electronic invoice’ means a subset of information contained in an electronic invoice that is essential to enable cross - border interoperability , including the necessary information to ensure legal compliance ; ### ‘ key components of an electronic invoice’ means the key components which an electronic invoice must contain that is essential to enable cross - border interoperability , including the necessary information to ensure legal compliance ;


### the commission shall request the relevant european standardisation organisation to draw up a european standard for the semantic data model of the core electronic invoice . ### the commission shall request the relevant european standardisation organisation to draw up a european standard for the semantic data model of the key components of an electronic invoice . the commission shall set the european standardisation organisation a deadline of 30 months to complete this process .


### where the european standard drawn up following the request referred to in paragraph 1 satisfies the requirements contained therein , the commission shall publish the reference to such european standard in the official journal of the european union . ### once the member states have approved the european standard drawn up following the request referred to in paragraph 1 , the commission shall have the reference to such european standard published in the official journal of the european union .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by 48 months following the entry into force at the latest . they shall forthwith communicate to the commission the text of those provisions . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by 18 months from the date of publication of the references of the european standard in the official journal of the european union at the latest . member states shall forthwith communicate the text of these provisions to the commission . member states shall apply these laws , regulations and administrative provisions to central government authorities and central procurement entities from the first day of the 19th month following publication of the references of the european standard in the official journal of the european union . member states shall apply these laws , regulations and administrative provisions to sub - central public contracting authorities and contracting entities from the first day of the 37th month following publication of the references of the european standard in the official journal of the european union .


### for the sake of clarity , the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses , but also medication errors and uses outside the authorised summary of the product characteristics , including the misuse and abuse of the product . ### for the sake of clarity , the definition of adverse reaction should be amended to ensure that it covers noxious and unintended effects derived not only from the authorised use of a medicinal product at the normal doses , but also from medication errors and uses outside the authorised summary of the product characteristics , including the misuse and abuse of the product .


### for the sake of clarity , the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses , but also medication errors and uses outside the authorised summary of the product characteristics , including the misuse and abuse of the product . ### for the sake of clarity , the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived from the authorised use of a medicinal product at the normal doses , but also those derived from medication errors and from uses outside the authorised summary of the product characteristics , including the misuse and abuse of the product .


### the marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products , recorded in a pharmacovigilance system master file permanently accessible for inspection . the competent authorities should undertake the supervision of those systems . a summary of the pharmacovigilance system should be therefore submitted with the marketing authorisation application and include a reference to the site where the pharmacovigilance system master file for the medicinal product concerned is maintained and accessible for inspection . ### the marketing authorisation holder should establish a pharmacovigilance system to ensure the monitoring and supervision of one or more of its authorised medicinal products , recorded in a pharmacovigilance system master file permanently accessible for inspection . the competent authorities should undertake the supervision of those systems . a summary of the pharmacovigilance system should be therefore submitted with the marketing authorisation application and include a reference to the site where the pharmacovigilance system master file for the medicinal product concerned is maintained and accessible for inspection by the competent authorities .


### where a medicinal product is authorized subject to the requirement to conduct a post - authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be intensively monitored on the market . patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products , and a publicly available list of such medicinal products should be maintained up to date by the european medicines agency established by regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . ### for newly authorised medicinal products and for medicinal products that are authorised subject to the requirement to conduct a post - authorisation safety study or are subject to conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be intensively monitored on the market . patients and healthcare professionals should be encouraged to report all suspect adverse reactions to all newly authorised medicinal products on the market for less then 3 years , identified as such by a black triangle and a corresponding explanatory sentence on the summary of product characteristics and on the patient information leaflet , and a publicly available list of such medicinal products should be maintained up to date by the european medicines agency established by regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency .


### in order to simplify the reporting of suspected adverse reactions the marketing authorisation holders and the member states should report those reactions only to the community pharmacovigilance database and data - processing network referred to in article 57 of regulation no 726 / 2004 . ### in order to simplify the reporting of suspected adverse reactions and to enable member states to access the same information simultaneously , the marketing authorisation holders and the member states should report those reactions only to the community pharmacovigilance database and data - processing network referred to in article 57 of regulation no 726 / 2004 . from this perspective , and in order to achieve the objectives referred to above , member states should not impose any further requirements on marketing authorisation holders in respect of the prompt and regular reporting of suspected adverse reactions .


### the following point 3a is inserted : “ a summary of the essential information necessary to use the medicine safely and effectively ; ” the following subparagraph is added : “for the purposes of point of the first subparagraph , for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the summary shall include the statement : “this medicinal product is under intensive monitoring . all suspected adverse reactions should be reported to . &#8221 ; ### the following subparagraph is added : “for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the summary shall include the statement : “this medicinal product is under intensive monitoring . all suspected adverse reactions should be reported to . &#8221 ;


### a summary of the essential information necessary to use the medicine safely and effectively ; ### deleted


### a summary of the essential information necessary to use the medicine safely and effectively ; ### a reference to the existence of a free - phone number provided by the competent authorities and / or the marketing authorisation holder or a website which , for each medicinal product , includes a section with concise essential information about the medicine , as well as advice on how to maximise its benefits whilst minimising any risks associated with its use ;


### “3 . the national competent authorities shall make publicly available without delay the marketing authorisation together with the summary of the product characteristics and any conditions established in accordance with articles 21a , 22 and 22a , together with any deadlines for their fulfilment , for each medicinal product which they have authorised . ### “3 . the national competent authorities shall make publicly available without delay the marketing authorisation together with the package leaflet , summary of the product characteristics and any conditions established in accordance with articles 21a , 22 and 22a , together with any deadlines for their fulfilment , for each medicinal product which they have authorised .


### the national competent authorities shall make publicly accessible without delay the assessment report , together with the reasons for their opinion , after deletion of any information of a commercially confidential nature . the justification shall be provided separately for each indication applied for . ### the national competent authorities shall make publicly accessible without delay the final assessment report , together with the reasons for their opinion , after deletion of any information of a commercially confidential nature . the justification shall be provided separately for each indication applied for .


### after the granting of a marketing authorisation , the national competent authority may require a marketing authorisation holder to conduct a post - authorisation safety study if there are concerns about the risks of an authorised medicinal product . the requirement shall be made in writing , provide a detailed justification and include the objectives and timeframe for submission and conduct of the study . ### after the granting of a marketing authorisation , the national competent authority may require a marketing authorisation holder to conduct a post - authorisation safety study if there are concerns about the risks of an authorised medicinal product . the requirement shall be made in writing , provide a detailed scientific justification and include the objectives and timeframe for submission and conduct of the study .


### once renewed , the marketing authorisation shall be valid for an unlimited period , unless the national competent authority decides , on justified grounds relating to pharmacovigilance or to insufficient exposure to the product , to proceed with one additional five - year renewal in accordance with paragraph 2 . ” ### once renewed , the marketing authorisation shall be valid for an unlimited period , unless the competent authority decides , on justified grounds relating to pharmacovigilance , to proceed with one additional five - year renewal in accordance with paragraph 2 . ”


### each member state shall designate a competent authority for the conduct of pharmacovigilance tasks ### each member state shall designate one or more competent authorities for the conduct of pharmacovigilance tasks .


### take all appropriate measures to encourage doctors , pharmacists and other health - care professionals to report suspected adverse reactions to the national competent authority or the marketing authorisation holder ; ### take all appropriate measures to encourage patients , doctors , pharmacists and other health - care professionals to report suspected adverse reactions to the national competent authority or the marketing authorisation holder ; those measures shall include training for health professionals and for patients and a public information campaign for patients ;


### the marketing authorisation holder shall be required to perform a regular audit of his pharmacovigilance system . he shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and , based on the audit findings , ensure that an appropriate corrective action plan is prepared and followed . ### the marketing authorisation holder shall be required to perform a regular audit of his pharmacovigilance system . he shall place a note on the pharmacovigilance system master file concerning any modifications made following the audit in accordance with an appropriate corrective action plan .


### web - based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in article 25 of regulation no 726 / 2004 . ### web - based structured forms for the reporting of suspected adverse reactions by healthcare professionals , if applicable , and patients based on the forms referred to in article 25 of regulation no 726 / 2004 .


### member states shall ensure that reports of such reactions are submitted by means of the national medicines safety web - portals . ### member states shall ensure that reports of such reactions are submitted by means of the national medicines safety web - portals , or by any other appropriate means .


### a member state shall initiate the procedure under this section , by informing the other member states , the agency and the commission , in any of the following cases : it considers suspending or revoking of a marketing authorisation ; it considers prohibiting the supply of a medicinal product ; it considers refusing the renewal of a marketing authorisation ; it is informed by the marketing authorisation holder that , on the basis of safety concerns , he has interrupted the placing on the market of a medicinal product or withdrawn a marketing authorisation , or that he intends to do so ; it considers that new contraindications , a reduction in the recommended dose , or a restriction to the indications is necessary ; it has conducted a pharmacovigilance inspection and found serious deficiencies . ### a member state shall initiate the procedure under this section , by informing the other member states , the agency , the commission and the marketing authorisation holders potentially affected , in any of the following cases : it considers , in the light of the outcome of the assessment of pharmacovigilance data , one of the following regulatory measures : – suspending or revoking of a marketing authorisation ; – prohibiting the supply of a medicinal product ; – refusing the renewal of a marketing authorisation ; it is informed by the marketing authorisation holder that , on the basis of safety concerns , he has interrupted the placing on the market of a medicinal product or withdrawn a marketing authorisation , or that he intends to do so ; it has conducted a pharmacovigilance inspection and found serious deficiencies .


### the pharmacovigilance risk assessment advisory committee shall assess the matter which has been submitted . for the purposes of that assessment , it may hold a public hearing . ### the pharmacovigilance risk assessment committee shall assess the matter which has been submitted . for the purposes of that assessment , it may hold a public hearing , if objective criteria are met on the basis of scientific data , taking account of the effectiveness and benefits of the product concerned and of earlier risk / benefit assessments conducted by the committee for medicinal products for human use or the coordination group in accordance with the procedure for granting marketing authorisations described in article 107l , which must involve the rapporteur of the committee for medicinal products for human use on the product in question , or the rapporteur of the coordination group . the agency , in consultation with the parties concerned , shall draw up guidelines on the organisation and conduct of public hearings .


### within 60 days of the information submitted , the pharmacovigilance risk assessment advisory committee shall make a recommendation , stating the reasons on which it is based . the recommendation shall be any or a combination of the following : ### within 60 days of the information submitted , the pharmacovigilance risk assessment advisory committee shall make a recommendation , stating the reasons on which it is based , and also taking account of the benefits of the medicinal product as assessed by the committee for medicinal products for human use or the coordination group in accordance with the procedure for granting marketing authorisations described in article 107l . the recommendation shall be any or a combination of the following :


### the agency shall make public the recommendations , opinions and decisions referred to in articles 107b to 107l by means of the european medicines safety web - portal . ### the agency shall make public the final conclusions referred to in articles 107b to 107l by means of the european medicines safety web - portal .


### it is appropriate to exclude from the scope of this regulation transfers of funds that represent a low risk of money laundering or terrorist financing . such exclusions should cover credit or debit cards , mobile telephones or other digital or information technology devices , automated teller machine withdrawals , payments of taxes , fines or other levies , and transfers of funds where both the payer and the payee are payment service providers acting on their own behalf . in addition , in order to reflect the special characteristics of national payment systems , member states may exempt electronic giro payments , provided that it is always possible to trace the transfer of funds back to the payer . however , there must be no exemption when a debit or credit card , a mobile telephone or other digital or it prepaid or postpaid device is used in order to effect a person - to - person transfer . ### it is appropriate to exclude from the scope of this regulation transfers of funds that represent a low risk of money laundering or terrorist financing . such exclusions should cover credit or debit cards , mobile telephones or other digital or information technology devices , automated teller machine withdrawals , payments of taxes , fines or other levies , and transfers of funds where both the payer and the payee are payment service providers acting on their own behalf . in addition , in order to reflect the special characteristics of national payment systems , member states may exempt electronic giro payments , provided that it is always possible to trace the transfer of funds back to the payer . however , there must be no exemption when a debit or credit card , a mobile telephone or other digital or it prepaid or postpaid device is used in order to effect a person - to - person transfer . taking into account the dynamically evolving technological progress , consideration should be given to extend the scope of the regulation to cover e - money and other new payment methods .


### until technical limitations that may prevent intermediary payment service providers from satisfying the obligation to transmit all the information they receive on the payer are removed , those intermediary payment service providers should keep records of that information . such technical limitations should be removed as soon as payment systems are upgraded . ### until technical limitations that may prevent intermediary payment service providers from satisfying the obligation to transmit all the information they receive on the payer are removed , those intermediary payment service providers should keep records of that information . such technical limitations should be removed as soon as payment systems are upgraded . in order to overcome technical limitations , the use of the sepa credit transfer scheme could be encouraged in interbank transfers between eu member states and third countries .


### payer’ means a natural or legal person who either carries out a transfer of funds from his or her own account or who places an order for a transfer of funds ; ### ‘ payer’ means a payer as defined in article 4 of directive 2007 / 64 / ec


### ‘ payee’ means a natural or legal person who is the intended recipient of transferred funds ; ### ‘ payee’ means a payee as defined in article 4 of directive 2007 / 64 / ec ;


### ‘ payment service provider’ means a natural or legal person who provides the service of transferring funds in his or her professional capacity ; ### ‘ payment service provider’ means a payment service provider as defined in article 4 of directive 2007 / 64 / ec ;


### ‘ unique transaction identifier’ means a combination of letters or symbols determined by the payment service provider , in accordance with the protocols of the payment and settlement systems or messaging systems used for the fund transfer , which permits traceability of the transaction back to the payer and the payee ; ### ‘ unique identifier’ means a unique identifier as defined in article 4 of directive 2007 / 64 / ec ;


### ‘ a person - to - person’ transfer of funds means a transaction between two natural persons . ### ‘ a person - to - person’ transfer of funds means a transaction between two natural persons , who , as consumers , act for purposes other than their trade , business or profession .


### this information need not be verified for accuracy , unless there is a suspicion of money laundering or terrorist financing . ### this information shall be verify according to the rules established under article 4 and 4


### for transfers amounting to eur 1 000 or less , where the payment service provider of the payer is established outside the union , the payment service provider of the payee need not verify the information pertaining to the payee , unless there is a suspicion of money laundering or terrorist financing . ### for transfers amounting to eur 1 000 or less , where the payment service provider of the payer is established outside the union , the payment service provider of the payee need not verify the information pertaining to the payee , unless there is a suspicion of money laundering or terrorist financing . member states can reduce or remove the threshold when the national risk assessment advises to intensify the control over the transfers of funds not made from an account . member states making use of this derogation shall inform the commission thereof .


### member states shall require competent authorities to effectively monitor , and take necessary measures with a view to ensuring , compliance with the requirements of this regulation . ### member states shall require competent authorities to effectively monitor , and take necessary measures with a view to ensuring , compliance with the requirements of this regulation . the european banking authority could provide more specific guidance on the implementation process , including guidelines on the definition of certain terms and practices . in order to produce such guidelines , the best practice examples of countries that have satisfactorily implemented the regulation should be published .


### 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 increase the level of employment , promote education and life - long learning and develop active , complex and sustainable 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 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 , inequality and poverty , and a high level of education , training and protection of human health .


### at the same time , it is crucial to support the development and competitiveness of european small and medium - sized enterprises and to ensure that people can adapt , through acquiring appropriate skills and through lifelong learning opportunities , to new challenges such as the shift to a knowledge - based economy , the digital agenda , and the transition to a low - carbon and more energy - efficient economy . by pursuing its primary thematic objectives , the esf should contribute to addressing these challenges . in this context , the esf should support the labour force transition towards greener skills and jobs , in particular in the energy efficiency , renewable energy and sustainable transport sectors , taking into account the union ' s intention to increase the proportion of the eu budget that is related to climate mainstreaming to at least 20% , with contributions from different policy fields . ### at the same time , it is crucial to support the development , competitiveness and pan - european mobility of european small and medium - sized enterprises and to ensure that people can adapt , through acquiring appropriate skills and through lifelong learning opportunities , to changing economic and social conditions as well as new challenges such as the shift to a knowledge - based economy , the digital agenda , and the transition to a low - carbon and more energy - efficient economy . by pursuing its primary thematic objectives , the esf should contribute to addressing these challenges . in this context , the esf should support the labour force transition towards greener skills and jobs , in particular in the energy efficiency , renewable energy and sustainable transport sectors , taking into account the union ' s intention to increase the proportion of the eu budget that is related to climate mainstreaming to at least 20% , with contributions from different policy fields .


### 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 . the esf should in particular increase its support for the active 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 .


### regulation no [ … ] provides that rules on eligibility of expenditure are to be established at national level , with certain exceptions for which it is necessary to lay down specific provisions with regard to the esf . ### regulation no [ … ] provides that rules on eligibility of expenditure are to be established at national level , with certain exceptions for which it is necessary to lay down specific provisions for each fund .


### mission ### missions


### 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 job quality , support the geographical and occupational mobility of workers , facilitate their adaptation to change , encourage a high level of lifelong education and training that is available to all age groups , 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 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 job quality , support the geographical and occupational mobility of workers , encourage a high level of education and training and facilitate workers ' adaptation to change in companies and production systems . the esf shall also contribute to enhancing economic , social and territorial cohesion in the union , to combating poverty and social exclusion , to promoting gender equality , to equal opportunities and to eliminating all forms of discrimination .


### 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 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 . in this context it is necessary to promote lifelong learning in order to improve the employment prospects of people in unskilled jobs .


### promoting employment and supporting labour mobility through : ### for the thematic objective ' promoting employment and supporting labour mobility ' through :


### reducing early school - leaving and promoting equal access to good - quality early - childhood , primary and secondary education ; ### reducing early school - leaving and promoting equal access to good - quality and inclusive early - childhood , primary and secondary education ;


### reducing early school - leaving and promoting equal access to good - quality early - childhood , primary and secondary education ; ### preventing and reducing early school - leaving , promoting equal access to good - quality early - childhood , primary and secondary education and reintegrating young people who leave school without qualifications through the support of personal projects allowing them to rejoin education and training pathways .


### 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 vocational training , tertiary and equivalent education with a view to increasing participation and attainment levels ;


### promoting social inclusion and combating poverty through : ### for the thematic objective ‘ promoting social inclusion and combating poverty’ through :


### community - led local development strategies ; ### inclusive community - led local development strategies ;


### enhancing institutional capacity and efficient public administration through : ### for the thematic objective ‘ enhancing institutional capacity and efficient public administration’ through :


### capacity building for stakeholders delivering employment , education and social policies and sectoral and territorial pacts to mobilise for reform at national , regional and local level . ### capacity building for stakeholders delivering education , training and employment and social policies , including by means of sectoral , national and territorial pacts and local development initiatives ;