### in areas not covered by technical standards , the authority should have the power to issue non - binding guidelines and recommendations on the application of community legislation . in order to ensure transparency and strengthen compliance by national supervisory authorities with those guidelines and recommendations , national authorities should be obliged to state their reasons where they do not comply with those guidelines and recommendations . ### in areas not covered by technical standards , the authority should have the power to issue guidelines and recommendations on the application of eu legislation . in order to ensure transparency and strengthen compliance by national supervisory authorities with those guidelines and recommendations , national authorities should be obliged to state their reasons where they do not comply with those guidelines and recommendations publicly in order to be fully transparent with market participants . in areas not covered by technical standards , the authority should establish and promulgate best practices .


### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the commission , upon its own initiative or following a request by the authority , the council , or the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation . ### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the union , the commission , upon its own initiative or following a request by the authority , the european parliament , the council or the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation .


### the authority shall contribute to promote the efficient and consistent functioning of colleges of supervisors referred to in directive 2006 / 48 / ec and foster the coherence of the application of community legislation across colleges . ### the authority shall contribute to promote and monitor the efficient effective and consistent functioning of the colleges of supervisors referred to in directive 2006 / 48 / ec and foster the coherence of the application of union law across colleges .


### the commission shall take such a decision no later than three months from the adoption of the recommendation . the commission may extend this period by one month . ### the authority shall take such a decision no later than one month from the adoption of the recommendation .


### the standards shall be adopted by the commission by means of regulations or decisions and published in the official journal of the european union . ### the commission shall adopt technical standards in accordance with articles 7a to 7d , in the form of regulations or decisions .


### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , their employees , and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation . ### the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . before adopting draft technical standards , guidelines and recommendations the authority should carry out an impact study . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions union credit and investment institutions , their employees , academia and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or by eu legislation .


### the european banking authority should act with a view to improving the functioning of the internal market , including in particular by ensuring a high , effective and consistent level of regulation and supervision taking account of the varying interests of all member states , to protect depositors and investors , to ensure the integrity , efficiency and orderly functioning of financial markets , to safeguard the stability of the financial system , and to strengthen international supervisory coordination , for the benefit of the economy at large , including financial institutions and other stakeholders , consumers and employees . in order to be able to fulfil its objectives , it is necessary and appropriate that the authority should be a community body having legal personality and it should have legal , administrative and financial autonomy . ### the authority should act with a view to improving the functioning of the internal market , including in particular by ensuring a high , effective and consistent level of regulation and supervision taking account of the varying interests of all member states , to prevent regulatory arbitrage and guarantee a level playing field , to protect depositors and investors , to ensure the integrity , efficiency and orderly functioning of financial markets , to safeguard the stability of the financial system , and to strengthen international supervisory coordination , for the benefit of the economy at large , including financial institutions and other stakeholders , consumers and employees . its tasks also include promoting supervisory convergence and providing advice to the eu institutions in the areas of banking , payments , e - money regulation and supervision , and related corporate governance , auditing and financial reporting issues . in order to be able to fulfil its objectives , it is necessary and appropriate that the authority should be a community body having legal personality and it should have legal , administrative and financial autonomy .


### contribute to a consistent application of community legislation , in particular by contributing to a common supervisory culture , ensuring consistent , efficient and effective application of the legislation referred to in article 1 , preventing regulatory arbitrage , mediating and settling disagreements between competent authorities , promoting a coherent functioning of colleges of supervisors and taking actions in emergency situations ; ### contribute to a consistent application of community legislation , in particular by contributing to a common supervisory culture , ensuring consistent , efficient and effective application of the legislation referred to in article 1 , preventing regulatory arbitrage , mediating and settling disagreements between competent authorities , ensuring effective and consistent supervision of financial institutions with eu dimension and a coherent functioning of colleges of supervisors and taking actions , inter alia , in emergency situations ;


### the european system of financial supervisors should be a network of national and community supervisory authorities , leaving day - to - day supervision of financial institutions at the national level , and according a central role in the supervision of cross - border groups to colleges of supervisors . greater harmonisation and the coherent application of rules for financial institutions and markets across the community should also be achieved . a european banking authority should be established , along with a european insurance and occupational pensions authority and a european securities and markets authority . ### the european system of financial supervisors should be a network of national and union supervisory authorities , leaving day - to - day supervision of financial institutions that do not have a union dimension to the national level . colleges of supervisors should supervise cross - border institutions that do not have a union dimension . the european supervisory authority - should gradually take over the supervision of institutions with a union dimension . greater harmonisation and the coherent application of rules for financial institutions and markets across the union should also be achieved . in addition to the authority , a european supervisory authority and a european supervisory authority as well as a european supervisory authority should be established . the european systemic risk board should form part of a european system of financial supervision .


### ensuring the correct and full application of community law is a core prerequisite for the integrity , efficiency and orderly functioning of financial markets , the stability of the financial system , and for neutral conditions of competition for financial institutions in the community . a mechanism should therefore be established whereby the authority addresses instances of incorrect or insufficient application of community law . this mechanism should apply in areas where community legislation defines clear and unconditional obligations ### ensuring the correct and full application of union law is a core prerequisite for the integrity , transparency , efficiency and orderly functioning of financial markets , the stability of the financial system , and for neutral conditions of competition for financial institutions in the union . a mechanism should therefore be established whereby the authority addresses instances of incorrect or insufficient application of union law . this mechanism should apply in areas where union legislation defines clear and unconditional obligations .


### given the globalisation of financial services and the increased importance of international standards , the authority should foster the dialogue and cooperation with supervisors outside the community . it shall fully respect the existing roles and competences of the european institutions in relations with authorities outside the community and in international forums . ### given the globalisation of financial services and the increased importance of international standards , the authority should represent the european union in the dialogue and cooperation with supervisors outside the union .


### a joint committee of the european supervisory authorities is hereby established . ### the european supervisory authorities is hereby established and shall have its headquarters in frankfurt .


### the council , acting by qualified majority as defined in article 205 of the treaty , shall , within ten working days , decide whether the authority ' s decision is maintained or revoked . ### the council , acting by qualified majority as defined in paragraph 2 subparagraph 5 , shall , within ten working days , decide whether the authority ' s decision is maintained or revoked .


### the european system of financial supervisors should be a network of national and community supervisory authorities , leaving day - to - day supervision of financial institutions at the national level , and according a central role in the supervision of cross - border groups to colleges of supervisors . greater harmonisation and the coherent application of rules for financial institutions and markets across the community should also be achieved . a european banking authority should be established , along with a european insurance and occupational pensions authority and a european securities and markets authority . ### the european system of financial supervisors should be a network of national and community supervisory authorities , leaving day - to - day supervision of financial institutions that do not have an eu dimension to the national level . colleges of supervisors should exert supervision over cross - border institutions that do not have an eu dimension . the authority should gradually take over supervision of institutions with an eu dimension . greater harmonisation and the coherent application of rules for financial institutions and markets across the community should also be achieved . a european banking authority should be established , along with a european supervisory authority and a european supervisory authority as well as a european supervisory authority . the european systemic risk board shall form part of a european system of financial supervision .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority shall , pursuant to the legislation referred to in article 1 , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under union law including the cessation of any practice .


### the chair of the joint committee of european supervisory authorities shall be appointed on an annual rotational basis from among the chairpersons of the european banking authority , the european insurance and occupational pensions authority and the european securities and markets authority . ### the chair of the european supervisory authority shall be appointed on an annual rotational basis from among the chairpersons of the european supervisory authority , the european supervisory authority and the european supervisory authority .


### the executive director , the commission and the esrb shall be invited to the meetings of the joint committee of european supervisory authorities as well as the sub - committees mentioned in article 43 as observers . ### the executive director , a representative of the commission and the esrb shall be invited to the meetings of the board of the joint committee as well as the sub - committees mentioned in article 43 as observers .


### a member of the board of appeal , who was appointed by the management board of the authority , may not be removed during his term of office , unless he has been found guilty of serious misconduct , and the management board takes a decision to that effect after consulting the board of supervisors . ### a member of the board of appeal may not be removed during his term of office , unless he has been found guilty of serious misconduct , and the european parliament takes a decision to that effect after consulting the board of supervisors .


### it is essential that business secrets and other confidential information are protected . the confidentiality of information exchanged in the network should likewise be safeguarded . ### it is essential that business secrets and other confidential information are protected . the confidentiality of information made available to the authority and exchanged in the network should be subject to stringent and effective confidentiality rules .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty on the functioning of the european union , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non - compliance by the competent authority in order to maintain or restore neutral conditions of competition in the internal market or ensure the orderly functioning and integrity of the financial system in the internal market , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under union law including the cessation of any practice . before adopting an individual decision , the authority shall inform the commission thereof . the commission shall ensure that the right to be heard of the addressees of the decision is respected . the authority and the competent authorities shall provide the commission with all necessary information . within two weeks of receipt of the draft decision of the authority , the commission shall decide whether to endorse the draft decision . the commission may not extend that period . the commission may endorse the draft decision only in part or with amendments where the union interest so requires . where the commission does not endorse the draft decision or endorses it in part or with amendments , it shall inform the authority without delay in the form of a formal opinion . within one week of receipt of that formal opinion , the authority shall review and adapt its decision to the commission ' s formal opinion and transmit it without delay to the commission . within one week of receipt of the amended decision of the authority , the commission shall decide whether to endorse it or reject it . if the amended decision is rejected by the commission , the decision shall be deemed not to have been adopted .


### the european parliament may invite the chairperson or his alternate , while fully respecting his or her independence , to make a statement regularly before its competent committee and answer questions put by members of that committee . ### the chairperson shall at least quarterly , make a statement before the european parliament and answer any questions put by its members .


### without prejudice to the competences of the community institutions , the authority may develop contacts with supervisory authorities from third countries . it may enter into administrative arrangements with international organisations and the administrations of third countries . ### the authority shall develop contacts with supervisory authorities from third countries . it may enter into administrative arrangements with international organisations and the administrations of third countries .


### in order to ensure cross - sectoral consistency in the activities of the european supervisory authorities , those authorities should coordinate closely in a joint committee of european supervisory authorities and reach common positions where appropriate . the joint committee of european supervisory authorities should assume all of the functions of the joint committee on financial conglomerates . where relevant , acts also falling within the area of competence of the european insurance and occupational pensions authority or the european securities and markets authority should be adopted in parallel by the european supervisory authorities concerned . ### in order to ensure cross - sectoral consistency in the activities of the european supervisory authorities , those authorities should coordinate closely through the european supervisory authorities and reach common positions where appropriate . the joint committee should coordinate the functions of the three european supervisory authorities in relation to financial conglomerates . where relevant , acts also falling within the area of competence of the european supervisory authority or the european supervisory authority should be adopted in parallel by the european supervisory authorities concerned . the joint committee will be chaired on a yearly revolving basis by the chairpersons of the three european supervisory authorities . the chairperson of the joint committee should be a vice - chair of the european systemic risk board . the joint committee will have a permanent secretariat , staffed on secondment from the three european supervisory authorities , to allow for informal information sharing and the development of a common cultural approach across the three european supervisory authorities .


### a subsidy from the community , entered in the general budget of the european union ; ### a subsidy from the european union , shown in a separate budget heading in section [ xii ] of the general budget of the european union ;


### the authority should actively promote a coordinated community supervisory response , in particular where adverse developments could potentially jeopardise the orderly functioning and integrity of financial markets or the stability of the financial system in the community . in addition to its powers for action in emergency situations , it should therefore be entrusted with a general coordination function within the european system of financial supervisors . the smooth flow of all relevant information between competent authorities should be a particular focus of the authority ' s actions . ### the authority should actively promote a coordinated union supervisory response , in particular to ensure the orderly functioning and integrity of financial markets or the stability of the financial system in the union . in addition to its powers for action in emergency situations , it should therefore be entrusted with a general coordination function . the smooth flow of all relevant information between competent authorities should be a particular focus of the authority ' s actions .


### the joint committee shall be composed of the chairperson and the chairpersons of the european insurance and occupational pensions authority and the european securities and markets authority , and , where applicable , the chairperson of a sub - committee established under article 43 . ### the joint committee shall have a board composed of the chairpersons of the european supervisory authorities and , where applicable , the chairperson of a sub - committee established under article 43 .


### the chair of the joint committee of european supervisory authorities shall be appointed on an annual rotational basis from among the chairpersons of the european banking authority , the european insurance and occupational pensions authority and the european securities and markets authority . ### the chair of the joint committee shall be appointed on an annual rotational basis from among the chairpersons of the european banking authority , the european insurance and occupational pensions authority and the european securities and markets authority . the chairperson of the joint committee shall be a vice - chair of the european systemic risk board .


### the banking stakeholder group shall be composed of 30 members , representing in balanced proportions community credit and investment institutions , their employees as well as consumers and users of banking services . ### the banking stakeholder group shall be composed of 30 members , representing in balanced proportions union credit and investment institutions , their employees as well as consumers , users of banking services and representatives of smes . not less than 5 of the members shall be independent top - ranking academics . the number of members representing market participants shall not exceed 10 . not less than 10 members shall be elected by sme organisations .


### the banking stakeholder group shall be composed of 30 members , representing in balanced proportions community credit and investment institutions , their employees as well as consumers and users of banking services . ### the banking stakeholder group shall be composed of 30 members , representing in balanced proportions union credit and investment institutions , users of banking services including representatives of smes . not less than 5 of the members shall be independent top - ranking academics . the number of members representing users of banking services , including sme organisations , shall not exceed 10 . not less than 10 members shall represent union credit and investment institutions .


### in areas not covered by technical standards , the authority should have the power to issue non - binding guidelines and recommendations on the application of community legislation . in order to ensure transparency and strengthen compliance by national supervisory authorities with those guidelines and recommendations , national authorities should be obliged to state their reasons where they do not comply with those guidelines and recommendations . ### in areas not covered by technical standards , the authority should have the power to issue guidelines and recommendations on the application of eu legislation . in order to ensure transparency and strengthen compliance by national supervisory authorities with those guidelines and recommendations , national authorities should be obliged to state their reasons where they do not comply with those guidelines and recommendations publicly in order to be fully transparent with market participants . in areas not covered by technical standards , the authority should establish and promulgate best practices .


### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , their employees , and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation . ### the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . before adopting draft technical standards , guidelines and recommendations the authority should carry out an impact study . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions union credit and investment institutions , their employees , academia and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or by eu legislation .


### where the authority maintains its decision , the council , acting by qualified majority as defined in article 205 of the treaty , shall , within two months , decide whether the authority ' s decision is maintained or revoked . ### where the authority maintains its decision , the council shall take a decision whether the authority ' s decision is maintained or revoked on the basis of a qualified majority of its members , as defined in article 16 of the eu treaty and in article 3 of the protocol on transitional provisions annexed to the treaty on european union and to the treaty on the functioning of the european union , at a meetings no later than two months after the authority has informed the member state as set out in the fourth subparagraph .


### the authority shall ensure that no decision adopted under articles 10 or 11 impinges in any way on the fiscal responsibilities of member states . ### the authority shall ensure that no decision adopted under article 10 or 11 impinges directly on the fiscal responsibilities of member states .


### where the authority maintains its decision , the council , acting by qualified majority as defined in article 205 of the treaty , shall , within two months , decide whether the authority ' s decision is maintained or revoked . ### where the authority maintains its decision , the council shall take a decision by a majority of the votes cast , at one of its meetings at the latest two months after the authority has informed the member state as set out in the previous subparagraph , as to whether the authority ' s decision is maintained .


### the council , acting by qualified majority as defined in article 205 of the treaty , shall , within ten working days , decide whether the authority ' s decision is maintained or revoked . ### the council , acting by qualified majority as defined in article 205 of the treaty , shall , within ten working days , decide whether the authority ' s decision is revoked .


### when carrying out the tasks conferred upon it by this regulation , the chairperson and the voting members of the board of supervisors shall act independently and objectively in the community interest and shall neither seek nor take instructions from community institutions or bodies , from a government of a member state or from any other public or private body . ### when carrying out the tasks conferred upon it by this regulation , the chairperson and the voting members of the board of supervisors shall act independently and objectively in the union interest as a whole and shall neither seek nor take instructions from union institutions or bodies , from a government of a member state or from any other public or private body .


### the standards shall be adopted by the commission by means of regulations or decisions and published in the official journal of the european union . ### the commission shall adopt delegated acts in accordance with articles 7a to 7d , designed to establish the technical standards referred to in paragraph 1 . technical standards shall be devised by taking into account proportionality as an overarching principle . those acts shall be in the form of regulations and decisions and published in the official journal of the european union .


### where the national authority does not comply with the recommendation , the commission should be empowered to address a decision to the national supervisory authority concerned in order to ensure compliance with community law , creating direct legal effects which can be invoked before national courts and authorities and enforced under article 226 of the treaty . ### where the national authority does not comply with the recommendation within a deadline fixed by the authority , the authority should address a decision without delay to the national supervisory authority concerned in order to ensure compliance with eu law , creating direct legal effects which can be invoked before national courts and authorities and enforced under article 258 of the treaty .


### the authority shall promote a coordinated community response , inter alia by : ### the authority shall promote a coordinated and consolidated union response , inter alia by :


### before taking the decisions provided for in article 9 , article 10 and and article 11 and , the authority shall inform the addressee of its intention to adopt the decision , setting a time limit within which the addressee may express its views on the matter , taking full account of the urgency of the matter . ### before taking the decisions provided for in this regulation , the authority shall inform the addressee of its intention to adopt the decision , setting a time limit within which the addressee may express its views on the matter , taking full account of the urgency , complexity and potential consequences of the matter .


### in order to ensure cross - sectoral consistency in the activities of the european supervisory authorities , those authorities should coordinate closely in a joint committee of european supervisory authorities and reach common positions where appropriate . the joint committee of european supervisory authorities should assume all of the functions of the joint committee on financial conglomerates . where relevant , acts also falling within the area of competence of the european insurance and occupational pensions authority or the european securities and markets authority should be adopted in parallel by the european supervisory authorities concerned . ### in order to ensure cross - sectoral consistency in the activities of the european supervisory authorities , those authorities should coordinate closely through the european supervisory authorities and reach common positions where appropriate . the joint committee should coordinate the functions of the three european supervisory authorities in relation to financial conglomerates . where relevant , acts also falling within the area of competence of the european supervisory authority or the european supervisory authority should be adopted in parallel by the european supervisory authorities concerned . the joint committee will be chaired on a yearly revolving basis by the chairpersons of the three european supervisory authorities . the chairperson of the joint committee should be a vice - chair of the european systemic risk board . the joint committee will have a permanent secretariat , staffed on secondment from the three european supervisory authorities , to allow for informal information sharing and the development of a common cultural approach across the three european supervisory authorities .


### the decision of the authority shall be in conformity with the decision adopted by the commission pursuant to paragraph 4 . ### the decision of the authority shall be in conformity with the decision adopted pursuant to paragraph 4 .


### the european parliament may also call upon the chairperson to submit a report on the performance of his duties . ### the chairperson shall submit a report on the performance of his or her duties to the european parliament when requested and at least 15 days before making the statement referred to in paragraph 1 .


### the european system of financial supervisors should be a network of national and community supervisory authorities , leaving day - to - day supervision of financial institutions at the national level , and according a central role in the supervision of cross - border groups to colleges of supervisors . greater harmonisation and the coherent application of rules for financial institutions and markets across the community should also be achieved . a european banking authority should be established , along with a european insurance and occupational pensions authority and a european securities and markets authority . ### the european system of financial supervision should be an integrated network of national and european supervisory authorities , leaving ordinary day - to - day supervision of financial institutions at the competent authorities of member states , and according a central role in the supervision of cross - border groups to colleges of supervisors . greater harmonisation and consistent and coherent application of european rules and standards for financial institutions and markets across the european should also be achieved . a european supervisory authority on banking should be established , along with a european supervisory authority on insurance and occupational pensions and a european supervisory authority on securities and markets as well as a joint committee among them . the european systemic risk board , as european authority in macro supervision , completes the esfs . the authority shall evolve according to the best practices recognised at european and international level . one such approach could be the establishment of a new level of direct supervision by the authority . to avoid international distortions and to strengthen the european system of financial supervision , the introduction of direct supervision should be carefully evaluated and considered in order to add value to the supervision of large financial institutions , many of which are global in nature and operate in the eu . this applies above all to those large financial institutions with wholesale banking or other activities that could pose systemic risk to the internal market , and those systemic financial institutions defined and identified at an international level . this issue shall be further studied in the first revision of the present regulation , as set out in article 66 , which should take place not later than three years from its entry into force .


### the chair of the joint committee of european supervisory authorities shall be appointed on an annual rotational basis from among the chairpersons of the european banking authority , the european insurance and occupational pensions authority and the european securities and markets authority . ### the chair of the european supervisory authority shall be appointed on an annual rotational basis from among the chairpersons of the european supervisory authority , the european supervisory authority and the european supervisory authority .


### within three months of receipt of the draft standards , the commission shall decide whether to endorse the draft standards . the commission may extend that period by one month . the commission may endorse the draft standards only in part or with amendments where the community interest so requires . ### within three months of receipt of the draft standards , the commission shall decide whether to endorse , reject or amend the draft standards . the commission may extend that period by one month . the commission shall inform the european parliament and the council of its decision , stating the reasons .


### where appropriate , the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , their employees , and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or community legislation . ### the authority should consult interested parties on technical standards , guidelines and recommendations and provide them with a reasonable opportunity to comment on proposed measures . before adopting draft technical standards , guidelines and recommendations the authority should carry out an impact study . for reasons of efficiency , a banking stakeholder group should be established for that purpose , representing in balanced proportions community credit and investment institutions , trade unions , academics and consumers and other retail users of banking services , including smes . the banking stakeholder group should actively work as an interface with other user groups in the financial services area established by the commission or by eu legislation .


### ensuring the correct and full application of community law is a core prerequisite for the integrity , efficiency and orderly functioning of financial markets , the stability of the financial system , and for neutral conditions of competition for financial institutions in the community . a mechanism should therefore be established whereby the authority addresses instances of incorrect or insufficient application of community law . this mechanism should apply in areas where community legislation defines clear and unconditional obligations ### ensuring the correct and full application of union law is a core prerequisite for the integrity , transparency , efficiency and orderly functioning of financial markets , the stability of the financial system , and for neutral conditions of competition for financial institutions in the union . a mechanism should therefore be established whereby the authority addresses instances of incorrect or insufficient application of union law . this mechanism should apply in areas where union legislation defines clear and unconditional obligations .


### two members of the board of appeal and two alternates shall be appointed by the management board of the authority from a short - list proposed by the commission , following a public call for expression of interest published in the official journal of the european union , and after consultation of the board of supervisors . ### the members of the board of appeal and their alternates shall be appointed by the european parliament from a short - list proposed by the commission , following a public call for expression of interest published in the official journal of the european union , and after consultation of the board of supervisors . it shall include at least one member representing a consumer organisation , one member representing smes and one member representing the research community . the latter as well as his alternate shall be appointed by the banking stakeholder group .


### without prejudice to the powers laid down in article 9 , where a competent authority disagrees on the procedure or content of an action or inaction by another competent authority in areas where the legislation referred to in article 1 requires cooperation , coordination or joint decision making by competent authorities from more than one member state , the authority , at the request of one or more of the competent authorities concerned , may assist the authorities in reaching an agreement in accordance with the procedure set out in paragraph 2 . ### 1 without prejudice to the powers laid down in article 9 , where a competent authority disagrees on the procedure or content of an action or inaction by another competent authority in cases specified in the legislation referred to in article 1 , the authority , at the request of one or more of the competent authorities concerned , may assist the authorities in reaching an agreement in accordance with the procedure set out in paragraph 2 .


### ' financial institutions ' means ' credit institutions ' as defined in directive 2006 / 48 / ec , ' investment firms ' as defined in directive 2006 / 49 / ec , and ' financial conglomerates ' as defined in directive 2002 / 87 / ec ; ### ' financial institutions ' means undertakings and entities subject to any of the legislative acts mentioned in article&#160 ; 1 . however , with regard to directive 2005 / 60 / ec , ' financial institutions ' means only credit and financial institutions as defined in that directive ;


### serious threats to the orderly functioning and integrity of financial markets or the stability of the financial system in the community require a swift and concerted response at community level . the authority should therefore be able to require national supervisory authorities to take specific actions to remedy an emergency situation . as the determination of an emergency situation involves a significant degree of discretion , this power should be conferred on the commission . to ensure an effective response to the emergency situation , in the event of inaction by the competent national supervisory authorities , the authority should be empowered to adopt , as a last resort , decisions directly addressed to financial institutions in areas of community law directly applicable to them aimed at mitigating the effects of the crisis and restoring confidence in the markets . ### serious threats to the orderly functioning and integrity of financial markets or the stability of the financial system in the union require a swift and concerted response at union level . the authority should therefore be able to require national supervisory authorities to take specific actions to remedy an emergency situation . the european systemic risk board should establish when there is an emergency situation . to ensure an effective response to the emergency situation , in the event of inaction by the competent national supervisory authorities , the authority should be empowered to adopt , as a last resort , decisions directly addressed to financial institutions in areas of union law directly applicable to them aimed at mitigating the effects of the crisis and restoring confidence in the markets .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty on the functioning of the european union , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non - compliance by the competent authority in order to maintain or restore neutral conditions of competition in the internal market or ensure the orderly functioning and integrity of the financial system in the internal market , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under union law including the cessation of any practice . before adopting an individual decision , the authority shall inform the commission thereof . the commission shall ensure that the right to be heard of the addressees of the decision is respected . the authority and the competent authorities shall provide the commission with all necessary information . within two weeks of receipt of the draft decision of the authority , the commission shall decide whether to endorse the draft decision . the commission may not extend that period . the commission may endorse the draft decision only in part or with amendments where the union interest so requires . where the commission does not endorse the draft decision or endorses it in part or with amendments , it shall inform the authority without delay in the form of a formal opinion . within one week of receipt of that formal opinion , the authority shall review and adapt its decision to the commission ' s formal opinion and transmit it without delay to the commission . within one week of receipt of the amended decision of the authority , the commission shall decide whether to endorse it or reject it . if the amended decision is rejected by the commission , the decision shall be deemed not to have been adopted .


### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority may take a decision requiring them to take specific action or to refrain from action in order to settle the matter , in compliance with community law . ### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority shall in accordance with the procedure set out in the second subparagraph of article 29 take a decision to settle the disagreement and to require them to take specific action , in compliance with union law with binding effects on the competent authorities concerned .


### the authority , the european insurance and occupational pensions authority and the european securities and markets authority shall ensure adequate operational and secretarial support for the board of appeal . ### the authority , the european supervisory authority and the european supervisory authority shall ensure adequate operational and secretarial support for the board of appeal through the joint committee .


### in order to safeguard financial stability it is necessary to identify , at an early stage , trends , potential risks and vulnerabilities stemming from the micro - prudential level , across borders and across sectors . the authority should monitor and assess such developments in the area of its competence and , where necessary , inform the european parliament , the council , the commission , the other european supervisory authorities and the european systemic risk board on a regular and , as necessary , ad hoc basis . the authority should also coordinate community - wide stress tests to assess the resilience of financial institutions to adverse market developments , ensuring an as consistent as possible methodology is applied at the national level to such tests . ### in order to safeguard financial stability it is necessary to identify , at an early stage , trends , potential risks and vulnerabilities stemming from the micro - prudential level , across borders and across sectors . the authority should monitor and assess such developments in the area of its competence and , where necessary , inform the european parliament , the council , the commission , the other european supervisory authorities and the european systemic risk board on a regular and , as necessary , ad hoc basis . the authority should also coordinate community - wide stress tests to assess the resilience of financial institutions to adverse market developments , ensuring an as consistent as possible methodology is applied at the national level to such tests . in order to inform the discharge of its functions , the authority should undertake economic analysis of markets and the impact of potential market developments on them .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law including the cessation of any practice . ### without prejudice to the powers of the commission under article 226 of the treaty , where the decision referred to in paragraph 4 of this article within the period of time specified therein has not been not complied with , where such non - compliance significantly affects the financial system of member states other than that of the relevant competent authority , and where it is necessary to remedy in a timely manner the non compliance by that competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under community law including the cessation of any practice .


### the competent authority shall , within ten working days of receipt of the decision referred to in paragraph 4 , inform the commission and the authority of the steps it has taken or intends to take to implement the commission ' s decision . ### the competent authority shall , within ten working days of receipt of the decision referred to in paragraph 4 , inform the commission and the authority of the steps it has taken or intends to take to implement the authority ' s decision .


### in order to ensure cross - sectoral consistency in the activities of the european supervisory authorities , those authorities should coordinate closely in a joint committee of european supervisory authorities and reach common positions where appropriate . the joint committee of european supervisory authorities should assume all of the functions of the joint committee on financial conglomerates . where relevant , acts also falling within the area of competence of the european insurance and occupational pensions authority or the european securities and markets authority should be adopted in parallel by the european supervisory authorities concerned . ### in order to ensure cross - sectoral consistency in the activities of the european supervisory authorities , those authorities should coordinate closely through the joint committee and reach common positions where appropriate . the joint committee should coordinate the functions of the three european supervisory authorities in relation to financial conglomerates . where relevant , acts also falling within the area of competence of the european supervisory authority or the european supervisory authority should be adopted in parallel by the european supervisory authorities concerned . the joint committee should be chaired for a 12 - month term on a rotating basis by the chairpersons of the three european supervisory authorities . the chairperson of the joint committee should be a vice - chair of the european systemic risk board . the joint committee should have a permanent secretariat , staffed on secondment from the three european supervisory authorities , to allow for informal information - sharing and the development of a common cultural approach across the three european supervisory authorities .


### in order to ensure the necessary flexibility in collecting information on transactions in wholesale energy products , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty setting out the timing , form and content of the information which market participant are required to provide . reporting obligations should not create unnecessary costs for market participants . persons reporting transactions to a competent authority in accordance with the provisions of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments16 , and to trade repositories and competent authorities in accordance with the provisions of regulation . . / . . of the european parliament and the council on otc derivatives , central counterparties and trade repositories should therefore not be subject to additional reporting obligations under this regulation . ### in order to ensure the necessary flexibility in collecting information on transactions in wholesale energy products , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty setting out the timing , form and content of the information which market participant are required to provide . reporting obligations should not create unnecessary costs for market participants , but must ensure that the agency receives all the information necessary to effectively pursue its tasks . persons reporting transactions to a competent authority in accordance with the provisions of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments16 , and to trade repositories and competent authorities in accordance with the provisions of regulation . . / . . of the european parliament and the council on otc derivatives , central counterparties and trade repositories should therefore not be subject to additional reporting obligations under this regulation . it must however be ensured that these relevant authorities and trade repositories make all the necessary information available to the agency immediately . when preparing and drawing up delegated acts , the commission should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council and carry out appropriate and transparent consultations well in advance , including at expert level .


### national regulatory authorities should be responsible for ensuring that this regulation is enforced in the member states . to this end they should have the necessary investigatory powers to allow them to carry out this task efficiently . ### national regulatory authorities should be responsible for ensuring that this regulation is enforced in the member states . to this end they should have the necessary investigatory and enforcement powers to allow them to carry out this task efficiently . the agency should ensure that these investigatory powers are exercised consistently in a similar and proportionate manner . for this purpose , the agency may provide guidance to the national regulatory authorities .


### the agency shall be provided with a record of wholesale energy market transactions , including orders to trade . the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 , laying down the timing , form and content in which this information is reported and , where appropriate , defining thresholds for the reporting of transactions as well as specifying types of contracts for which transactions shall be reported . ### the agency shall be provided directly and in a timely manner with a record of wholesale energy market transactions , including orders to trade . for the purpose of monitoring trading in wholesale energy markets , such collected data should enable the agency to identify market abuses and to monitor the development of conditions under which market abuses are more likely or dangerous . the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 , laying down the timing , form and content in which this information is reported and defining thresholds for the reporting of transactions as well as specifying types of contracts for which transactions shall be reported .


### ' inside information ' means precise information which has not been made public , relating directly or indirectly to one or more wholesale energy products and which , if it were made public , could significantly affect the prices of such wholesale energy products ; for the purposes of applying the first subparagraph , information a reasonable market participant would be likely to use as part of the basis of his decision to enter into a transaction relating to a wholesale energy product is information which , if it were made public , would be likely to have a significant effect on the prices of such wholesale energy products . such information includes information related to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas , as well as information which is required to be disclosed in accordance with legal or regulatory provisions at union or national level , market rules , and contracts or customs on the relevant wholesale energy market . ### ' inside information ' means information of a precise nature which has not been made public , relating directly or indirectly to one or more wholesale energy products and which , if it were made public , could significantly affect the prices of such wholesale energy products ; for the purposes of applying the first subparagraph , inside information means information which : is required to be made public in accordance with the provisions of regulation no . 714 / 2009 , regulation no . 715 / 2009 or this regulation , including guidelines , network codes or delegated acts adopted pursuant to those regulations , or in accordance with other legislative or regulatory provisions at european union level , in particular directive 2009 / 72 / ec of the european parliament and of the council of 13 july 2009 concerning common rules for the internal market in electricity1 , and directive 2009 / 73 / ec of the european parliament and of the council of 13 july 2009 concerning common rules for the internal market in natural gas2 ; or a reasonable market participant would be likely to use as part of the basis of his decision to enter into transaction relating to a wholesale energy product , and which , if it were made public , would be likely to have a significant effect on the prices of such wholesale energy products . such information includes information related to updated estimates of energy reserves , the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas or lng - facility , as well as information which is routinely made available to the relevant wholesale energy market , or required to be disclosed in accordance with legal or regulatory provisions at union or national level , market rules , and contracts or customs on the relevant wholesale energy market . ______________ 1 oj l 211 , 14 . 8 . 2009 , p . 55 . 2 oj l 211 , 14 . 8 . 2009 , p . 94 .


### in order to ensure the necessary flexibility in collecting information on transactions in wholesale energy products , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty setting out the timing , form and content of the information which market participant are required to provide . reporting obligations should not create unnecessary costs for market participants . persons reporting transactions to a competent authority in accordance with the provisions of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments , and to trade repositories and competent authorities in accordance with the provisions of regulation . . / . . of the european parliament and the council on otc derivatives , central counterparties and trade repositories should therefore not be subject to additional reporting obligations under this regulation . ### in order to ensure the necessary flexibility in collecting information on transactions in wholesale energy products , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty setting out the timing , form and content of the information which market participant are required to provide . reporting obligations should not create unnecessary costs or administrative burdens for market participants , and should therefore undergo an ex ante cost - benefit analysis . persons reporting transactions to a competent authority in accordance with the provisions of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments , and to trade repositories and competent authorities in accordance with the provisions of regulation . . / . . of the european parliament and the council on otc derivatives , central counterparties and trade repositories should therefore not be subject to double reporting obligations . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council and ensure that the european parliament and the council are closely involved in the preparatory phase , notably by being invited to take part at the expert meetings .


### it is important that the penalties for breaches of this regulation are proportionate and dissuasive , and reflect the gravity of the infringements and the potential gains from trading on the basis of inside information and market manipulation . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec . ### it is important that the penalties for breaches of this regulation are proportionate and dissuasive , and reflect the gravity of the infringements , the potential gains from trading on the basis of inside information and market manipulation and the damage caused to consumers . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec . to avoid regulatory arbitrage , whereby contracts are concluded in countries where the risk of incurring penalties is the lowest , the commission should regularly review the situation and propose in time a system of minimum harmonised penalties in the european union .


### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive and reflect the damage caused to consumers . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them . the commission should every year review the effectiveness of the national systems of penalties with a view of proposing minimum standards for penalties within the european union .


### the agency shall be provided with a record of wholesale energy market transactions , including orders to trade . the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 , laying down the timing , form and content in which this information is reported and , where appropriate , defining thresholds for the reporting of transactions as well as specifying types of contracts for which transactions shall be reported . ### the agency shall be provided by market participants or , on their behalf , by one of the persons referred to in paragraph 3 to with a record of wholesale energy market transactions in standardised products . purely intra - group transactions shall not be required to be reported . in order to fulfil market participants ' reporting obligations , the required information shall , wherever possible , be reported by one of the persons referred to in paragraph 3 to . the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 after wide consultation with stakeholders and an impact assessment . the delegated acts shall : describe the wholesale energy products to which the reporting obligations shall apply ; lay down the content of the information to be reported , including precise identification of the product traded , the price agreed and the quantity , the dates and times of agreed execution , the parties to the transaction and the beneficiaries of the transaction ; lay down when and in what form the information is to be reported ; define appropriate minimum thresholds for the application of the reporting obligations .


### market participants shall publicly disclose inside information in respect of business or facilities which the participant concerned owns or controls or for which the participant is responsible for operational matters , either in whole or in part . such information shall include information relevant to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas . ### market participants shall make publicly available inside information in respect of business or facilities which the participant concerned owns or controls or for which the participant is responsible for operational matters , either in whole or in part . such information shall include information relevant to the capacity and utilisation of facilities for production , storage , consumption or transmission of electricity or natural gas or related to the capacity and utilisation of lng facilities .


### in order to take account of future developments on wholesale energy markets , the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 , specifying the definitions set out at article 2 to . ### in order to take account of future developments on wholesale energy markets and ensure coherence with other relevant eu legislation in the fields of financial services and energy , the commission following advice provided by the agency shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 an 17 , specifying the definitions set out at article 2 to . in preparing its advice , the agency shall carry out detailed public consultation , addressed at least to national regulatory authorities , market participants , transmission system operators and other interested parties .


### for the purposes of applying the first subparagraph , information a reasonable market participant would be likely to use as part of the basis of his decision to enter into a transaction relating to a wholesale energy product is information which , if it were made public , would be likely to have a significant effect on the prices of such wholesale energy products . such information includes information related to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas , as well as information which is required to be disclosed in accordance with legal or regulatory provisions at union or national level , market rules , and contracts or customs on the relevant wholesale energy market . ### for the purposes of applying the first subparagraph , ' inside information ' is information a reasonable market participant would be likely to use as part of the basis of his decision to enter into one or more transactions relating to a wholesale energy product , taking account of the laws or customs applicable on the relevant wholesale markets , or information which is required to be disclosed in accordance with legal or regulatory provisions at union or national level , market rules , and contracts or customs on the relevant wholesale energy market . information about trading strategies shall not be regarded as ' inside information ' within the meaning of this provision .


### when drawing up the programming documents for countries in crisis , post - crisis , or fragility situations , due account shall be taken of the vulnerability , special needs and circumstances of the countries or regions concerned . proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures . where partner countries or groups of partner countries are directly involved in , or affected by , a crisis , post - crisis or fragility situation , special emphasis shall be placed on stepping up coordination between relief , rehabilitation and development to help them make the transition from an emergency situation to the development phase . programmes for countries and regions in fragility or regularly subject to natural disasters shall provide for disaster preparedness and prevention and for managing the consequences of such disasters . ### when drawing up the programming documents for countries in crisis , post - crisis , fragility situations or prone to natural disasters , due account shall be taken of the vulnerability , special needs and circumstances of the countries or regions concerned . proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures , as well as to the role of women in those processes . where partner countries or regions are directly involved in , or affected by , a crisis , post - crisis or fragility situation , special emphasis shall be placed on stepping up coordination between relief , rehabilitation and development amongst all relevant actors to help the transition from an emergency situation to the development phase . programmes for countries and regions in fragility or regularly subject to natural disasters shall provide for disaster preparedness and prevention and for managing the consequences of such disasters and shall address vulnerability to shocks and strengthen people ' s resilience .


### sustainable agriculture and energy . ### sustainable agriculture and energy ; and


### strategy papers are documents drawn up by the union to provide a coherent framework for development cooperation between the union and the partner country or region concerned , consistent with the overall purpose and scope , objectives , principles and policy of the union . the preparation and implementation of strategy papers shall comply with the principles of aid effectiveness : national ownership , partnership , coordination , harmonisation , alignment with recipient country or regional systems , mutual accountability and results orientation as laid down in article 3 to . to that end , strategy papers shall , in principle , be based on a dialogue between the union and the partner country or region , involving where appropriate , the relevant member states , and the partner country or region , involving civil society and regional and local authorities , so as to ensure that the country or region concerned takes sufficient ownership of the process and to encourage support for national development strategies , particularly those for reducing poverty . ### strategy papers are documents drawn up by the union to provide a coherent framework for development cooperation between the union and the partner country or region concerned , consistent with the overall purpose and scope , objectives , principles and policy of the union . the preparation and implementation of strategy papers shall comply with the principles of aid effectiveness : national ownership , partnership , coordination , harmonisation , alignment with recipient country or regional systems , mutual accountability and results orientation as laid down in article 3 to . to that end , strategy papers shall , in principle , be based on a dialogue between the union and the partner country or region , involving the relevant member states , and the partner country or region , in consultation with the national / regional parliaments and involving civil society and regional and local authorities through thorough consultation , so as to ensure that the country or region concerned takes sufficient ownership of the process and to encourage support for national development strategies , particularly those for reducing poverty . this dialogue takes place following a consultation and information phase for local and regional authorities and civil society .


### business environment , regional integration and world markets ; and ### business environment , regional integration and world markets ;


### the objective of the programme on civil society organisations and local authorities in development shall be to finance initiatives in the area of development by or for civil society organisations and local authorities originating from partner countries , the union , candidate countries and potential candidates . ### the objective of the programme on civil society organisations and local authorities in development shall be to finance initiatives in the area of development by or for civil society organisations , especially local groups and women ' s organisations and organisations dealing with gender equality , women ' s empowerment and non - discrimination , and local authorities originating from partner countries , the union , candidate countries and potential candidates .


### the commission shall seek regular exchanges of information with civil society . ### the commission shall seek regular and timely exchanges of information with civil society and local and regional authorities .


### this regulation should provide an enabling framework for programming , allowing enhanced consistency between union policies by using a joint framework document as a basis for programming . it should enable full alignment with partner countries and regions by relying , where appropriate , on national development plans or similar comprehensive development documents ; and pursue a better coordination amongst donors , in particular between the union and its member states , through joint programming . ### this regulation should allow for enhanced consistency between union policies while respecting the overall requirement of policy coherence for development . it should enable full alignment with partner countries and regions by using , where possible , national development plans or similar comprehensive development documents as the basis for the programming of the union’s action ; and pursue a better coordination amongst donors , in particular between the union and its member states , through joint programming .


### the commission shall seek regular exchanges of information with civil society . ### the commission shall ensure regular exchanges of information with civil society organisations and with local authorities , and ensure that those actors are appropriately involved in the process of designing , implementing , monitoring and evaluating union support .


### the commission shall seek regular exchanges of information with civil society , ### the commission shall seek regular exchanges of information with civil society , especially local groups and organisations focusing on women ' s rights , and ensure that all sections of society are represented in and listened to during these exchanges ;


### within each country programme , the union will in principle concentrate its assistance on three sectors . ### within each country programme , the union will in principle concentrate its assistance on three sectors identified with the involvement of civil society , in order to respond to the real needs of the country and community .


### particular attention shall be given to strengthening the rule of law , improving access to justice and supporting civil society , trade and sustainable development , access to icts , health and food security , as well as promoting dialogue , participation and reconciliation , and institution - building . ### particular attention shall be given to strengthening the rule of law , improving access to justice and supporting civil society , supporting decentralisation , trade and sustainable development , access to icts , health and food security , as well as promoting dialogue , participation and reconciliation , and institution - building , including at regional and local level .


### the procedure referred to in paragraph 1 shall not apply to non - substantial modifications to strategy papers and multiannual indicative programmes , making technical adjustments , reassigning funds within the indicative allocations per priority area , or increasing or decreasing the size of the initial indicative allocation by less than 20% , provided that these modifications do not affect the priority areas and objectives set out in these documents . in such case , adjustments shall be communicated to the european parliament and to the council within one month . ### the procedure referred to in paragraph 1 shall not apply to non - substantial modifications to strategy papers and multiannual indicative programmes , making technical adjustments , reassigning funds within the indicative allocations per priority area , or increasing or decreasing the size of the initial indicative allocation within the relevant percentage limit set out in article 2 of the common implementing regulation , provided that these modifications do not affect the priority areas and objectives set out in these documents . in such case , adjustments shall be communicated to the european parliament and to the council within one month .


### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , nondiscrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids . ### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , entrepreneurship , rights of workers , environmental protection , gender equality , women empowerment , nondiscrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids .


### the union and the member states should improve the consistency and the complementarity of their respective policies on development cooperation , in particular by responding to partner countries ' and regions ' priorities at country and regional level . to ensure that the union ' s development cooperation policy and that of the member states complement and reinforce each other , it is appropriate to provide for joint programming procedures which should be implemented whenever possible and relevant . ### the union and the member states should improve the consistency , the complementarity and the efficiency of their respective policies on development cooperation , in particular by responding to partner countries ' and regions ' priorities at country and regional level . to ensure that the union ' s development cooperation policy and that of the member states complement and reinforce each other , it is appropriate to provide for joint programming procedures which should be implemented whenever possible and relevant .


### when drawing up the programming documents for countries in crisis , post - crisis , or fragility situations , due account shall be taken of the vulnerability , special needs and circumstances of the countries or regions concerned . proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures . where partner countries or groups of partner countries are directly involved in , or affected by , a crisis , post - crisis or fragility situation , special emphasis shall be placed on stepping up coordination between relief , rehabilitation and development to help them make the transition from an emergency situation to the development phase . programmes for countries and regions in fragility or regularly subject to natural disasters shall provide for disaster preparedness and prevention and for managing the consequences of such disasters . ### when drawing up the programming documents for countries in crisis , post - crisis , or fragility situations , due account shall be taken of the vulnerability of different social groups , special needs of women and circumstances of the countries or regions concerned . proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures . where partner countries or groups of partner countries are directly involved in , or affected by , a crisis , post - crisis or fragility situation , special emphasis shall be placed on stepping up coordination between relief , rehabilitation and development to help them make the transition from an emergency situation to the development phase . programmes for countries and regions in fragility or regularly subject to natural disasters shall provide for disaster preparedness and prevention and for managing the consequences of such disasters . special attention should be given to women , who are often the major victims in crisis situations .


### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . ### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , the rule of law , human rights and fundamental freedoms , women’s rights , gender equality , non - discrimination , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance .


### the commission may send its observations to the member state which has communicated the draft measure within three months . ### the commission may send its observations to the member state which has communicated the draft measure within three months , and the member state will then publish these in the form of an on - line database .


### additional proof of quality , safety , efficacy or bioequivalence ### non - reassessment of elements underpinning the market authorisation


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### when the member state concerned definitively adopts the draft measure , it shall communicate the final text to the commission without delay . if observations have been made by the commission in accordance with paragraph 4 , this communication shall be accompanied by a report on the actions taken in response to the observations of the commission . ### when the member state concerned definitively adopts the draft measure , it shall communicate the final text to the commission without delay . if observations have been made by the commission in accordance with paragraph 4 , this communication shall be accompanied by a report on the actions taken in response to the observations of the commission , which will publish it in the form of a public on - line database .


### irrespective of the organisation of their internal procedures , member states shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this article and the price approval procedure set out in article 3 does not exceed 120 days . however , with respect to the medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall not exceed 180 days . with respect to generic medicinal products , that time limit shall not exceed 30 days , provided that the reference medicinal product has already been included in the public health insurance system . those time - limits may be extended in accordance with paragraph 5 of this article or article 3 . ### irrespective of the organisation of their internal procedures , member states shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this article and the price approval procedure set out in article 3 does not exceed 120 days . however , with respect to the medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall not exceed 180 days . with respect to generic medicinal products , that time limit shall not exceed 60 days , provided that the reference medicinal product has already been included in the public health insurance system . those time - limits may be extended in accordance with paragraph 5 of this article or article 3 .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt or , where appropriate , of the formal receipt of the marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system .


### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states . ### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic or biosimilar medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic or biosimilar medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . similarly , in the case of orphan drugs , member states shall not re - assess the criteria of the orphan designation , including the significant benefit . however , if necessary for the pricing and reimbursement decision , including for health technology assessment or pharmaco - economic evaluation purposes , member states may take into account data on the assessment of these elements during the marketing authorisation procedure .