### in order to ensure that adr entities function properly and effectively , they should be closely monitored . the commission and competent authorities under this directive should publish and update a list of adr entities that comply with this directive . other bodies , such as adr entities , consumer associations , business associations and the european consumer centre network , should also publish this list . in addition , competent authorities should publish regular reports on the development and functioning of adr entities . adr entities should notify to competent authorities specific information on which those reports should be based . member states should encourage adr entities to provide such information using commission recommendation 2010 / 304 / eu on the use of a harmonised methodology for classifying and reporting consumer complaints and enquiries26 . ### in order to ensure that adr entities function properly and effectively , they should be closely monitored . for this purpose , member states should designate a competent authority . this directive does not prevent member states from designating more than one competent authority in case of sectoral adr bodies . when doing so , member states should determine which of the competent authorities will be the single contact point for the commission . the commission and competent authorities under this directive should publish and update a list of adr entities that comply with this directive . competent authorities cannot refuse the notification of adr entities which comply with this directive , including regional and pan - european adr entities , irrespective of their legal status . other bodies , such as adr entities , consumer associations , business associations and the european consumer centre network , should also publish this list . in addition , competent authorities should publish regular reports on the development and functioning of adr entities . adr entities should notify to competent authorities specific information on which those reports should be based . member states should encourage adr entities to provide such information using commission recommendation 2010 / 304 / eu on the use of a harmonised methodology for classifying and reporting consumer complaints and enquiries . 26 .


### in order to ensure that adr entities function properly and effectively , they should be closely monitored . the commission and competent authorities under this directive should publish and update a list of adr entities that comply with this directive . other bodies , such as adr entities , consumer associations , business associations and the european consumer centre network , should also publish this list . in addition , competent authorities should publish regular reports on the development and functioning of adr entities . adr entities should notify to competent authorities specific information on which those reports should be based . member states should encourage adr entities to provide such information using commission recommendation 2010 / 304 / eu on the use of a harmonised methodology for classifying and reporting consumer complaints and enquiries . ### in order to ensure that adr entities function properly and effectively , they should be closely monitored . for this purpose , member states should designate a competent authority . as it might be difficult in the case of sectoral adr to entrust the monitoring tasks to only one authority , member states , in this case , should be able to designate a competent authority for each sector . the commission and competent authorities under this directive should publish and update a list of adr entities that comply with this directive . member states should ensure that adr entities , consumer associations , business associations and the european consumer centre network , also publish this list . in addition , competent authorities should publish regular reports on the development and functioning of adr entities . adr entities should notify to competent authorities specific information on which those reports should be based . member states should encourage adr entities to provide such information using commission recommendation 2010 / 304 / eu on the use of a harmonised methodology for classifying and reporting consumer complaints and enquiries .


### since the objective of this directive , namely to contribute to the proper functioning of the internal market by ensuring a high level of consumer protection , cannot be sufficiently achieved by the member states and can therefore be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective . ### since the objective of this directive , namely to contribute , by achieving a high level of consumer protection , to the proper functioning of the internal market , cannot be sufficiently achieved by the member states and can therefore be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective .


### this directive is to contribute to the functioning of the internal market and to the achievement of a high level of consumer protection by ensuring that disputes between consumers and traders can be submitted to entities offering impartial , transparent , effective and fair alternative dispute resolution procedures . ### this directive is to contribute to the functioning of the internal market and to the achievement of a high level of consumer protection by ensuring that disputes between consumers and traders can be submitted to entities offering impartial , transparent , effective and fair alternative dispute resolution procedures , realising that adr remains voluntary and successful submission will remain dependent of the willingness of the parties to agree on engagement to adr .


### – if the entity is operated by a legal person or association of natural or legal persons , at the place where that legal person or association of natural or legal persons carries out alternative dispute resolution activities or has its statutory seat ; ### – if the entity is operated by a legal person or association of natural or legal persons , including in the form of a collegial body as referred to in article 6 , at the place where that legal person or association of natural or legal persons carries out alternative dispute resolution activities or has its statutory seat ;


### have a website enabling the parties to submit a complaint online ; ### have a website enabling the parties to submit an application for adr online ;


### have a website enabling the parties to submit a complaint online ; ### maintain an up - to - date website enabling the parties to get information about adr procedures and to submit a complaint online , and that website shall be functionally linked to the european online dispute resolution platform in accordance with regulation no&#160 ; [ . . . ] / 2012 of the european parliament and of the council of [ . . . ] [ on online dispute resolution for consumer disputes ] ;


### member states may fulfil their obligation under paragraph 1 by ensuring the existence of a residual adr entity which is competent to deal with disputes as referred to in paragraph 1 for the resolution of which no existing adr entity is competent . ### member states may fulfil their obligation under paragraph 1 by ensuring the existence of a residual adr entity which is competent to deal with disputes as referred to in paragraph 1 for the resolution of which no existing adr entity is competent . member states may also fulfil this obligation by using sectorial adr entities established in another member state .


### expertise and impartiality member states shall ensure that the natural persons in charge of alternative dispute resolution possess the necessary expertise and are impartial . this shall be guaranteed by ensuring that they : possess the necessary knowledge , skills and experience in the field of alternative dispute resolution ; are not liable to be relieved from their duties without just cause ; have no conflict of interest with either party to the dispute . ### expertise , independence and impartiality member states shall ensure that all natural persons in charge of alternative dispute resolution possess the necessary expertise and are operationally independent and impartial . this shall be guaranteed by ensuring that they : possess the necessary knowledge and skills in the field of alternative or judicial resolution of consumer disputes , as well as an understanding of law ; are appointed for a fixed term and are not liable to be relieved from their duties without just cause ; have no conflict of interest with either party to the dispute . 1a . for the purposes of paragraph 1 , point , member states shall ensure that specific training schemes for natural persons in charge of alternative dispute resolution are available . the commission shall assist member states in developing such training schemes and quality - control mechanisms . 1b . for the purposes of paragraph 1 , point , member states shall ensure that the natural persons in charge of alternative dispute resolution disclose any circumstances that may , or may be seen to , affect their independence or give rise to a conflict of interest . member states shall ensure that , in such circumstances the person concerned only agrees to act or continue to act if the parties explicitly consent and he or she is certain of being able to carry out the adr procedure in full independence in order to ensure complete impartiality . member states shall ensure that the obligation to disclose in accordance with this paragraph is a continuing obligation throughout the adr procedure . 1c . where the natural persons in charge of alternative dispute resolution are independent third parties , the circumstances to be disclosed in accordance with paragraph 1b include : any personal or business relationship with one or more of the parties during the last three years prior assuming the post ; any financial or other interest , direct or indirect , in the outcome of the adr procedure ; the person concerned having acted during the last three years prior assuming the post in any capacity other than for the purposes of adr for one or more of the parties , for a professional organisation or a business association of which one of the parties is a member or for any other member thereof . 1d . for the purposes of paragraph 1 , point , where the natural persons in charge of dispute resolution are employed exclusively by the trader or by a professional organisation or a business association of which the trader is a member , member states shall ensure that , unless those natural persons comply with the requirements in paragraph 1e , they are part of a collegial body composed of an equal number of representatives of consumer organisations and of representatives of the trader or , where appropriate , the professional organisation or business association : 1e . where the natural persons in charge of the dispute resolution are employed exclusively by the trader or by a professional organisation or a business association of which the trader is a member , and are not part of a collegial body as referred to paragraph 1d , member states shall ensure that they comply with following requirements : they are appointed for a sufficient duration to ensure the independence of their action ; they cannot receive any instructions from the trader either directly or indirectly ; their remuneration is entirely independent from the results of the adr procedure ; their autonomy is guaranteed through a dedicated budget separate from the trader ' s general budget , or , where appropriate , the general budget of the professional organisation or business association , providing the appropriate resources to ensure the effectiveness of adr procedures .


### the types of disputes they are competent to deal with ; ### the types of disputes they are competent to deal with ; including the minimum value of the claim , where applicable ;


### the types of disputes they are competent to deal with ; ### the types of disputes they are competent to deal with , including the minimum value of the claim where applicable ;


### any preliminary requirements the parties may have to meet before an adr procedure can be instituted ; ### any preliminary requirements the parties may have to meet before an adr procedure can be instituted , including the requirement to attempt to reach an amicable solution directly with the trader ;


### any recurrent problems leading to disputes between consumers and traders ; ### any recurrent problems leading to disputes between consumers and traders which may be accompanied by guiding solutions , including in particular suggestions how those issues should be addressed ;


### the rate of compliance , if known , with the outcomes of the adr procedures ; ### the rate of compliance with the outcomes of the adr procedures ;


### the outcome of the adr procedure is made available to both parties in writing or on a durable medium , stating the grounds on which the outcome is based . ### the outcome of an adr procedure cannot have any binding effect on the parties involved unless they are informed before the commencement of the procedure about the binding nature of that outcome and explicitly state their consent to it . this provision shall not apply where national rules provide that solutions are binding on the trader .


### the consumer , before agreeing to a suggested solution , is informed that : ### immediately after receipt of the application for adr , the consumer is informed that :


### the parties , before agreeing to a suggested solution , are informed of the legal effect of such agreement ; ### when the recommended solution is communicated to the parties , they are :


### cooperation between adr entities on the resolution of cross - border disputes ### cooperation and exchanges of experience between adr entities


### the commission shall publish a list containing the names and contact details of the networks referred to in paragraph 1 . the commission shall , if necessary , update this list every two years . ### the commission shall publish a list containing the names and contact details of the networks referred to in paragraph 1 . the commission shall update this list every two years .


### each member state shall designate a competent authority in charge of monitoring the functioning and development of adr entities established on its territory . each member state shall communicate the authority it has designated to the commission . ### each member state shall designate a competent authority in charge of monitoring the functioning and development of adr entities established on its territory . in the case of sectoral adr , member states may designate a competent authority for each sector . each member state shall communicate the authorities it has designated to the commission .


### each competent authority shall , on the basis of the assessment referred to in paragraph 1 , establish a list of the adr entities that fulfil the conditions set out in paragraph 1 . ### each competent authority shall , on the basis of the assessment referred to in paragraph 1 , establish a list of all the adr entities that have been notified to it and fulfil the conditions set out in paragraph 1 .


### every two years , each competent authority shall publish a report on the development and functioning of adr entities . the report shall in particular : ### every two years , each competent authority shall publish and send to the commission a report on the development and functioning of adr entities . the report shall in particular :


### member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to article 10 and article 16 and of this directive and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . ### member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to article 10 and article 16 and of this directive in the event of a required initial warning being issued but without success , and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ office of publications insert date : 18 months after entry into force ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . ### member states shall bring into force the laws , regulations and administrative provisions , or arrangements of self - regulation , necessary to comply with this directive by [ office of publications insert date : 18 months after entry into force ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive .


### no later than [ office of publications insert date : five years after the entry into force ] , and every three years thereafter , the commission shall submit to the european parliament , the council and the european economic and social committee a report on the application of this directive . the report shall consider the development and the use of adr entities and the impact of this directive on consumers and traders . the report shall be accompanied , where appropriate , by proposals for amendment of this directive . ### no later than [ office of publications insert date : five years after the entry into force ] , and every three years thereafter , the commission shall submit to the european parliament , the council and the european economic and social committee a report on the application of this directive . the report shall consider the development and the use of adr entities and the impact of this directive on consumers and traders . the report shall include in particular provisions relating to the scope of the directive , and consider the need to extend the scope to legal disputes initiated by traders against consumers . in that case proposals for amendment of this directive shall be attached to the report .


### safeguard measures should be considered only if the product in question is imported into the union in such increased quantities , in absolute terms or relative to union production , and under such conditions as to cause , or threaten to cause , serious injury to union producers of like or directly competitive products as laid down in article 48 of the agreement . ### safeguard measures should be considered only if the product in question is imported into the union in such increased quantities , in absolute terms or relative to union production , and under such conditions as to cause , or threaten to cause , serious injury to union producers of like or directly competitive products as laid down in article 48 of the agreement . pursuant to article 349 of the treaty on the functioning of the european union and with regard to the products and economic sectors of the outermost regions , safeguard measures should be introduced as soon as imports into the union of the product in question cause or threaten to cause injury to producers of like or directly competitive products in the outermost regions of the union .


### safeguard measures should take one of the forms referred to in article 50 of the agreement . ### safeguard measures should take one of the forms referred to in article 50 of the agreement . specific safeguard measures should be provided for when there is a threat to the products or economic sectors of the outermost regions , pursuant to article 349 of the treaty on the functioning of the european union .


### there should be detailed provisions on the initiation of proceedings . the commission should receive information including available evidence from the member states of any trends in imports which might call for the application of safeguard measures . ### there should be detailed provisions on the initiation of proceedings . the commission should receive from the member states , and request from the sectors involved , information including available evidence of any trends in imports which might call for the application of safeguard measures .


### safeguard measures should be applied only to the extent , and for such time , as may be necessary to prevent serious injury and to facilitate adjustment . the maximum duration of safeguard measures should be determined and specific provisions regarding extension and review of such measures should be laid down , as referred to in article 52 of the agreement . ### safeguard measures should be applied only to the extent , and for such time , as may be necessary to prevent serious injury and to facilitate adjustment . the maximum duration of safeguard measures should be determined and specific provisions regarding extension and review of such measures should be laid down , as referred to in article 52 of the agreement . specific provisions should apply with regard to safeguard measures triggered to protect produce and economic sectors in the outermost regions , in accordance with article 349 of the treaty on the functioning of the european union .


### an investigation shall be initiated upon request by a member state , by any legal person or any association not having legal personality , acting on behalf of the union industry , or on the commission ' s own initiative if it is apparent to the commission that there is sufficient prima facie evidence , as determined on the basis of factors referred to in article 4 , to justify such initiation . ### an investigation shall be initiated upon request by a member state , by any legal person or any association not having legal personality , acting on behalf of the union industry , by the european parliament or on the commission ' s own initiative if it is apparent to the commission that there is sufficient prima facie evidence , as determined on the basis of factors referred to in article 4 , to justify such initiation .


### in the investigation , the commission shall evaluate all relevant factors of an objective and quantifiable nature having a bearing on the situation of the union industry , in particular , the rate and amount of the increase in imports of the product concerned in absolute and relative terms , the share of the domestic market taken by increased imports and changes in the level of sales , production , productivity , capacity utilisation , profits and losses , and employment . this list is not exhaustive and other relevant factors may also be taken into consideration by the commission for its determination of the existence of serious injury or threat of serious injury , such as stocks , prices , return on capital employed , cash flow , and other factors which are causing or may have caused serious injury , or threaten to cause serious injury to the union industry . ### in the investigation the commission shall evaluate all relevant factors of an objective and quantifiable nature having a bearing on the situation of the union industry , in particular , the rate and amount of the increase in imports of the product concerned in absolute and relative terms , the share of the domestic market taken by increased imports and changes in the level of sales , production , productivity , capacity utilisation , profits and losses , and employment . this list is not exhaustive and other relevant factors may also be taken into consideration by the commission for its determination of the existence of serious injury or threat of serious injury , such as stocks , prices , return on capital employed , cash flow , and other factors which are causing , or may have caused serious injury , or threaten to cause serious injury to the union industry , e . g . reaching the activation levels provided for within the framework of the stabilisation mechanism for bananas included in chapter ii of this regulation .


### this financing instrument contributes to achieving the objectives of the union’s external action , including those of the european development policy . ### this financing instrument contributes to achieving the objectives of the union’s external action , including those of the european development policy , based on the european consensus on development1 , policy coherence for development and a human rights based approach to development . _______________ 1 oj c 46 , 24 . 2 . 2006 , p . 1 .


### democracy and human rights are inextricably linked , as recalled in the council conclusions of 18 november 2009 , on democracy support in the eu’s external relations . the fundamental freedoms of expression and association are the preconditions for political pluralism and democratic processes , whereas democratic control and separation of powers are essential to sustain an independent judiciary and the rule of law which in turn are required for effective protection of human rights . ### democracy , democratic governance , development and respect for all human rights are interdependent and mutually reinforcing , as recalled in the council conclusions of 18 november 2009 , on democracy support in the eu’s external relations . the fundamental freedoms of expression and association are the preconditions for political pluralism and democratic processes , whereas democratic control and separation of powers are essential to sustain an independent judiciary and legislature and the rule of law which in turn are required for effective protection of human rights .


### the task of building and sustaining a culture of human rights and making democracy work for citizens , though especially urgent and difficult in emerging democracies , is essentially a continuous challenge , belonging first and foremost to the people of the country concerned but without diminishing the commitment of the international community . it also requires a range of institutions , in particular national democratic parliaments that should ensure participation , representation , responsiveness and accountability . ### the task of building and sustaining a culture of human rights and good financial , social , administrative and fiscal governance , and making democracy work for citizens , though especially urgent and difficult in emerging democracies , is essentially a continuous challenge , belonging first and foremost to the people of the country concerned but without diminishing the commitment of the international community . it also requires a range of institutions , in particular national democratic parliaments that should ensure participation , representation , responsiveness and accountability .


### the task of building and sustaining a culture of human rights and making democracy work for citizens , though especially urgent and difficult in emerging democracies , is essentially a continuous challenge , belonging first and foremost to the people of the country concerned but without diminishing the commitment of the international community . it also requires a range of institutions , in particular national democratic parliaments that should ensure participation , representation , responsiveness and accountability . ### the task of building and sustaining a culture of human rights and making democracy work for citizens , though especially urgent and difficult in emerging democracies , is essentially a continuous challenge , belonging first and foremost to the people of the country concerned but without diminishing the commitment of the international community to promoting the right to a process of development in which all human rights and fundamental freedoms can be fully realised . it also requires a range of institutions , in particular national democratic parliaments that should ensure participation , representation , responsiveness and accountability .


### under this regulation , the union will provide assistance to address global , regional , national and local human rights and democratisation issues in partnership with civil society understood to span all types of social action by individuals or groups that are independent from the state and active in the field of human rights and democracy support . ### under this regulation , the union will provide assistance to address global , regional , national and local challenges with a view to promoting democracy , democratic governance , development and respect for all human rights in partnership with civil society understood to span all types of social action by individuals or groups that are independent from the state and active in the field of human rights and democracy support .


### furthermore , whilst democracy and human rights objectives must be increasingly mainstreamed in all external assistance financing instruments , union assistance under this regulation will have a specific complementary and additional role by virtue of its global nature and its independence of action from the consent of third country governments and other public authorities . this will allow for cooperation with civil society on sensitive human rights and democracy issues possible , providing the flexibility to respond to changing circumstances . it should also provide union capacity to articulate and support specific objectives and measures at international level which are neither geographically linked nor crisis related and which may require a transnational approach or involve operations both within the union and in a range of third countries . moreover , it will provide the necessary framework for operations , such as support for independent european union election observation missions requiring policy coherence , a unified management system and common operating standards . ### furthermore , whilst democracy and human rights objectives must be increasingly mainstreamed in all external assistance financing instruments , union assistance under this regulation will have a specific complementary and additional role by virtue of its global nature and its independence of action from the consent of third country governments and other public authorities . this will allow for cooperation with civil society on sensitive human rights and democracy issues possible , applying good financial , social , administrative and fiscal governance principles , thus providing the flexibility to respond to changing circumstances . it should also provide union capacity to articulate and support specific objectives and measures at international level which are neither geographically linked nor crisis related and which may require a transnational approach or involve operations both within the union and in a range of third countries . moreover , it will provide the necessary framework for operations , such as support for independent european union election observation missions requiring policy coherence , a unified management system and common operating standards .


### supporting and consolidating democratic reforms in third countries , by enhancing participatory and representative democracy , strengthening the overall democratic cycle , and improving the reliability of electoral processes , in particular by means of election observation missions . ### supporting and consolidating democratic reforms and governance in third countries , by enhancing participatory and representative democracy , in particular through the key role played by national parliaments and civil society , strengthening the overall democratic cycle , and improving the reliability of electoral processes , in particular by means of election observation missions and local civil society election observation activities .


### strengthening the rule of law , promoting the independence of the judiciary , encouraging and evaluating legal and institutional reforms , and promoting access to justice ; ### strengthening the rule of law , promoting the independence of the judiciary and of the legislature – in particular national parliaments , encouraging and evaluating legal and institutional reforms , and promoting access to justice ; promoting civil society ' s role in monitoring the performance of the public sector ;


### supporting reforms to achieve effective and transparent democratic accountability and oversight , including that of the security and justice sectors , and encouraging measures against corruption ; ### supporting reforms to achieve effective and transparent democratic accountability and oversight , including that of the security and justice sectors , and encouraging measures against corruption , in particular good financial and fiscal governance ;


### promoting political pluralism and democratic political representation , and encouraging political participation by citizens , in particular marginalised groups , in democratic reform processes at local , regional and national level ; ### promoting political pluralism and democratic political representation , and encouraging political participation by citizens , in particular women and marginalised groups , in democratic reform processes at local , regional and national level ;


### the rights of women as proclaimed in the convention on the elimination of all forms of discrimination against women and its optional protocols , including measures to combat female genital mutilation , forced marriages , crimes of honour , trafficking , and any other form of violence against women ; ### the rights of women as proclaimed in the convention on the elimination of all forms of discrimination against women and its optional protocols , particularly access to education and healthcare and the right to decide freely and independently about their bodies , including measures to combat female genital mutilation , forced marriages , crimes of honour , trafficking , and any other form of violence against women ;


### education , training and monitoring in the area of human rights and democracy , and in the area covered by point ; ### education , training and monitoring in the area of human rights and democracy ;


### strengthening of the international framework for the protection of human rights , justice , the rule of law and democracy , and for the promotion of international humanitarian law , in particular by : ### strengthening of the international framework for the protection of human rights , justice , the rule of law and democracy , and for the promotion of international humanitarian law and the right to a process of development in which all human rights and fundamental freedoms can be fully realised , in particular by :


### by contributing to the development of the electoral observation capacity of civil society organisations at regional and local levels , and supporting their initiatives to enhance participation in , and the follow - up to , the electoral process ; ### by contributing to the development of the electoral observation capacity of civil society organisations and supporting their initiatives to enhance participation in , and the follow - up to , the electoral process , and by channelling part of democracy assistance through civil society organisations at regional and local levels ;


### by supporting measures aimed at the consistent integration of electoral processes into the democratic cycle and at implementing recommendations made by union election observation missions ; ### by supporting measures aimed at the consistent integration of electoral processes into the democratic cycle and at implementing recommendations made by union election observation missions and by the european parliament election observation delegations ;


### the promotion and protection of gender equality , the rights of the child , rights of indigenous peoples , rights of persons with disabilities , and principles such as empowerment , participation , non - discrimination of vulnerable groups and accountability shall be taken into account whenever relevant for all assistance measures referred to in this regulation . ### in the framework of a human rights - based approach to development , the promotion and protection of gender equality , the rights of the child , rights of indigenous peoples , rights of persons with disabilities , and principles such as empowerment , participation , non - discrimination of vulnerable groups and accountability shall be taken into account for all assistance measures referred to in this regulation .


### the assistance measures shall take into account the specific features of crisis or urgency situations and countries or situations where there is a serious lack of fundamental freedoms , where human security is most at risk or where human rights organisations and defenders operate under the most difficult conditions . ### the assistance measures shall take into account the specific features of crisis or urgency situations and countries or situations where there is a serious lack of fundamental freedoms , where human security is most at risk or where human rights organisations and defenders operate under the most difficult conditions , or where there is a serious threat to an environment allowing citizen participation .


### telecommunications networks and services are increasingly becoming internet - based infrastructures , with broadband networks and digital services closely interrelated . the internet is becoming the dominant platform for communication , services , and doing business . therefore , the trans - european availability of fast internet access and digital services in the public interest is essential for economic growth and the single market . ### telecommunications networks and services are increasingly becoming internet - based infrastructures , with broadband networks and digital services closely interrelated . the internet is becoming the dominant platform for communication , services , education , cultural content and doing business . therefore , the trans - european availability of fast internet access at affordable prices and digital services in the public interest is essential for economic growth , the single market and the digital integration of people and of entire economically and culturally deprived areas .


### on 26 march 2010 , the european council welcomed the commission ' s proposal to launch the strategy europe 2020 . one of the three priorities of europe 2020 is smart growth through the development of an economy based on knowledge and innovation . investments in telecommunications , notably broadband networks and digital service infrastructures , are a necessary condition for smart but also sustainable and inclusive economic growth of the union . ### on 26 march 2010 , the european council welcomed the commission ' s proposal to launch the strategy europe 2020 . one of the three priorities of europe 2020 is smart growth through the development of an economy based on knowledge and innovation . investments in telecommunications , notably broadband networks and digital service infrastructures , are a necessary condition for smart but also sustainable and inclusive economic growth of the union . europe 2020 will contribute to increasing the competitiveness of smes , increasing interoperability and access to interconnections between national systems , and , in the long term , developing a single digital market .


### on 26 march 2010 , the european council welcomed the commission ' s proposal to launch the strategy europe 2020 . one of the three priorities of europe 2020 is smart growth through the development of an economy based on knowledge and innovation . investments in telecommunications , notably broadband networks and digital service infrastructures , are a necessary condition for smart but also sustainable and inclusive economic growth of the union . ### on 26 march 2010 , the european council welcomed the commission ' s proposal to launch the strategy europe 2020 . one of the three priorities of europe 2020 is smart growth through the development of an economy based on knowledge and innovation . investments in telecommunications , notably broadband networks and digital service infrastructures , are a necessary condition for smart but also sustainable and inclusive economic growth and social and cultural participation by citizens in the union .


### the communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions - european broadband : investing in digitally driven growth9 concludes that the critical role of the internet means that the benefits for society as a whole appear to be much greater than the private incentives to invest in faster networks . public support for this area is therefore necessary , but should not unduly distort competition . ### communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions - european broadband : investing in digitally driven growth9 concludes that the critical role of the internet means that the benefits for society as a whole appear to be much greater than the private incentives to invest in faster networks . public support for this area is therefore necessary , particularly in rural areas , but should not unduly distort competition .


### within the framework of a system of open and competitive markets , the union ' s intervention is necessary where market failures need to be overcome . by providing financial support and additional financing leverage to infrastructure projects the union can contribute to the establishment and development of trans - european networks in the area of telecommunications , thus generating higher benefits in terms of market impact , administrative efficiency and resource utilisation . ### within the framework of a system of open and competitive markets , the union ' s intervention is necessary where market failures need to be overcome . by providing financial support and additional financing leverage to infrastructure projects the union can contribute to the establishment and development of trans - european networks in the area of telecommunications , thus generating higher benefits in terms of market impact , administrative efficiency and resource utilisation . in the projects to be financed , account should be taken of the principle of technological neutrality , which is vital for an open internet .


### substantial economic and social benefits , which cannot be captured nor monetised by investors , are associated with higher broadband speeds . fast and ultra - fast broadband is the key enabling infrastructure for the development and deployment of digital services , which rely on the availability , speed , reliability and resilience of the physical networks . the deployment and take - up of faster networks opens the way for innovative services exploiting higher speeds . action at union level is necessary to maximise the synergies and interactions between those two components of digital telecommunications networks . ### substantial economic , social and cultural benefits , which cannot be captured nor monetised by investors , are associated with higher broadband speeds . fast and ultra - fast broadband is the key enabling infrastructure for the development and deployment of digital services , which rely on the availability , speed , reliability and resilience of the physical networks . the comprehensive deployment and take - up of faster networks opens the way for innovative services exploiting higher speeds . action at union level is necessary to maximise the synergies and interactions between those two components of digital telecommunications networks .


### the deployment of ultra - fast broadband will particularly benefit small and medium enterprises which often cannot benefit from web - based services such as ' cloud computing ' due to inadequate connectivity and speed of existing broadband connections . this will unlock the potential for substantial productivity gains for smes . ### innovative internet services , modern software and communications applications and mobile devices with internet connections call for constantly rising data rates . the deployment of ultra - fast broadband will particularly benefit small and medium enterprises and the cultural and creative industries , which often cannot benefit from web - based services such as ' cloud computing ' due to inadequate connectivity and speed of existing broadband connections . this will unlock the potential for substantial productivity gains for smes and the cultural and creative industries . the aim should therefore be to create connections with high data rates even in rural areas .


### in order to take into account the developments in the areas of information and communication technologies , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of amending the annex to this regulation . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level . the objective of this delegation is to address new technological and market developments , emerging political priorities or opportunities for exploiting synergies between different infrastructures , including those in the fields of transport and energy . the scope of delegation is limited to modifying the description of projects of common interest , adding a project of common interest or removing an obsolete project of common interest according to pre - established , clear and transparent criteria . ### in order to take into account the developments in the areas of information and communication technologies , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of amending the annex to this regulation . it is of particular importance that the commission carries out appropriate consultations during its preparatory work , including at expert level and at regional and local level . the objective of this delegation is to address new technological and market developments , emerging political priorities or opportunities for exploiting synergies between different infrastructures , including those in the fields of transport and energy . the scope of delegation is limited to modifying the description of projects of common interest , adding a project of common interest or removing an obsolete project of common interest according to pre - established , clear and transparent criteria .


### contribute to economic growth and support the development of the single market resulting in the improvement of the competitiveness of the european economy , including small and medium sized enterprises . ### contribute to economic growth , support the development of the single market and promote the digital integration of entire economically and culturally deprived areas , resulting in the improvement of the competitiveness of the european economy , including small and medium sized enterprises .


### contribute to improvements in daily life for citizens , businesses and governments through the promotion of the interconnection and interoperability of national telecommunication networks as well as access to such networks . ### contribute to improvements in daily life for citizens , businesses and governments through the promotion of the interconnection and interoperability of national telecommunication networks and by guaranteeing universal access to such networks .


### stimulate europe - wide deployment of fast and ultra - fast broadband networks which , in turn , shall facilitate the development and deployment of trans - european digital services . ### stimulate the europe - wide deployment of fast and ultra - fast broadband networks in accordance with the principle of technological neutrality with the emphasis on rural areas , which , in turn , shall facilitate the development and deployment of trans - european digital services .


### the deployment of ultra fast broadband networks ensuring the speed of data transmission of 100 mbps and above ; ### the deployment of comprehensive ultra fast broadband networks ensuring the speed of data transmission of 100 mbps and above ;


### actions contributing to projects of common interest shall be eligible for eu financial support under the conditions and instruments available under the regulation establishing the connecting europe facility [ ref ] . financial support shall be provided in accordance with the relevant rules and procedures adopted by the union , funding priorities and the availability of resources . ### actions contributing to projects of common interest shall be eligible for eu financial support under the conditions and instruments available under the regulation establishing the connecting europe facility [ ref ] . financial support shall be provided in accordance with the relevant rules and procedures adopted by the union , funding priorities and the availability of resources . this support shall come on top of assistance provided under other community programmes and initiatives , including the structural funds . the commission shall make sure that measures to support projects of common interest do not act as a disincentive to the implementation of public - and / or private - sector initiatives which are already under way or are being prepared and may not receive funding under other community and national instruments .


### the union may establish contacts , discuss , exchange information and cooperate with public authorities or any other organisations in third countries to achieve any objective pursued by these guidelines where such cooperation gives rise to a european added value . among other objectives , this cooperation shall seek to promote the interoperability between the trans - european telecommunication networks and telecommunication networks of third countries . ### the union may establish contacts , discuss , exchange information and cooperate with public authorities or any other organisations in third countries to achieve any objective pursued by these guidelines where such cooperation gives rise to a european added value . among other objectives , this cooperation shall seek to promote the interoperability between the trans - european telecommunication networks and telecommunication networks of third countries . this cooperation shall be coordinated with the strategies drawn up in the context of the union ' s external policies , in particular those covered by the european neighbourhood instrument , and any macro - regional strategies which are already being implemented or are being prepared .


### the deployment and enhancement of trans - european telecommunication networks shall contribute to fostering economic growth , creating jobs and achieving a vibrant digital single market . in particular , their deployment will grant faster access to the internet , bring about information technology - enabled improvements in daily life for citizens , including children and young persons , businesses and governments , increase interoperability and facilitate the alignment or convergence to commonly agreed standards . ### the deployment and enhancement of trans - european telecommunication networks shall contribute to fostering economic growth , creating jobs , promoting europe’s cultural heritage and achieving a vibrant digital single market . in particular , their deployment will grant faster access to the internet , bring about information technology - enabled improvements in daily life for citizens , including children and young persons , businesses and governments , increase interoperability and facilitate the alignment or convergence to commonly agreed standards .


### in addition , high speed connections to public internet access points , notably in public facilities , such as schools , hospitals , local government offices and libraries , shall also be supported . ### in addition , high speed connections to public internet access points , notably in public facilities , such as schools , hospitals , local government offices , libraries and museums , shall also be supported .


### the provisions on pharmacovigilance relating to medicinal products of human use laid down in regulation no 726 / 2004 and directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use12 were amended by directive 2010 / 84 / eu of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance , directive 2001 / 83 / ec on the community code relating to medicinal products for human use13 , regulation no 1235 / 2010 of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance of medicinal products for human use , regulation no 726 / 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency , and regulation no 1394 / 2007 on advanced therapy medicinal products14 , directive 2012 / 26 / eu of the european parliament and of the council of 25 october 2012 amending directive 2001 / 83 / ec as regards pharmacovigilance15 and regulation no 1027 / 2012 of the european parliament and of the council of 25 october 2012 amending regulation no 726 / 2004 as regards pharmacovigilance16 . those amendments only cover medicinal products for human use . those amendments provide for new pharmacovigilance tasks for the agency including union - wide pharmacovigilance procedures , the monitoring of literature cases , the improved information technology tools and the provision of more information to the general public . furthermore , the pharmacovigilance legislation stipulates that the agency should be enabled to fund those activities from fees charged to marketing authorisation holders . new categories of fees should therefore be created to cover the new and specific tasks of the agency . __________________ 12 oj l 311 , 28 . 11 . 2001 , p . 67 . 13 oj l 348 , 31 . 12 . 2010 , p . 74 . 14 oj l 348 , 31 . 12 . 2010 , p . 1 . 15 oj l 299 , 27 . 10 . 2012 , p . 1 . 16 oj l 316 , 14 . 11 . 2012 , p . 38 . ### the provisions on pharmacovigilance relating to medicinal products of human use laid down in regulation no 726 / 2004 and directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use12 were amended by directive 2010 / 84 / eu of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance , directive 2001 / 83 / ec on the community code relating to medicinal products for human use13 , regulation no 1235 / 2010 of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance of medicinal products for human use , regulation no 726 / 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency , and regulation no 1394 / 2007 on advanced therapy medicinal products14 , directive 2012 / 26 / eu of the european parliament and of the council of 25 october 2012 amending directive 2001 / 83 / ec as regards pharmacovigilance15 and regulation no 1027 / 2012 of the european parliament and of the council of 25 october 2012 amending regulation no 726 / 2004 as regards pharmacovigilance16 . those amendments only cover medicinal products for human use . those amendments provide for new pharmacovigilance tasks for the agency including union - wide pharmacovigilance procedures , the monitoring of literature cases , the improved information technology tools and the provision of more information to the general public . furthermore , the pharmacovigilance legislation stipulates that the agency should be enabled to fund those activities from fees charged to marketing authorisation holders . however , taking into account the benefit for society as a whole , due respect should be given to pharmacovigilance as a sovereign task . therefore , the percentage share of eu funding in the financing of the ema budget should be kept , at least , at the status quo before the implementation of this regulation . the contribution should be used to reduce the costs for financing the routine tasks and hence the annual flat fee . new categories of fees should therefore be created to cover the new and specific tasks of the agency . __________________ 12 oj l 311 , 28 . 11 . 2001 , p . 67 . 13 oj l 348 , 31 . 12 . 2010 , p . 74 . 14 oj l 348 , 31 . 12 . 2010 , p . 1 . 15 oj l 299 , 27 . 10 . 2012 , p . 1 . 16 oj l 316 , 14 . 11 . 2012 , p . 38 .


### the provisions on pharmacovigilance relating to medicinal products of human use laid down in regulation no 726 / 2004 and directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use12 were amended by directive 2010 / 84 / eu of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance , directive 2001 / 83 / ec on the community code relating to medicinal products for human use13 , regulation no 1235 / 2010 of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance of medicinal products for human use , regulation no 726 / 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency , and regulation no 1394 / 2007 on advanced therapy medicinal products14 , directive 2012 / 26 / eu of the european parliament and of the council of 25 october 2012 amending directive 2001 / 83 / ec as regards pharmacovigilance15 and regulation no 1027 / 2012 of the european parliament and of the council of 25 october 2012 amending regulation no 726 / 2004 as regards pharmacovigilance16 . those amendments only cover medicinal products for human use . those amendments provide for new pharmacovigilance tasks for the agency including union - wide pharmacovigilance procedures , the monitoring of literature cases , the improved information technology tools and the provision of more information to the general public . furthermore , the pharmacovigilance legislation stipulates that the agency should be enabled to fund those activities from fees charged to marketing authorisation holders . new categories of fees should therefore be created to cover the new and specific tasks of the agency . __________________ 12 oj l 311 , 28 . 11 . 2001 , p . 67 . 13 oj l 348 , 31 . 12 . 2010 , p . 74 . 14 oj l 348 , 31 . 12 . 2010 , p . 1 . 15 oj l 299 , 27 . 10 . 2012 , p . 1 . 16 oj l 316 , 14 . 11 . 2012 , p . 38 . ### the provisions on pharmacovigilance relating to medicinal products of human use laid down in regulation no 726 / 2004 and directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use12 were amended by directive 2010 / 84 / eu of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance , directive 2001 / 83 / ec on the community code relating to medicinal products for human use13 , regulation no 1235 / 2010 of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance of medicinal products for human use , regulation no 726 / 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency , and regulation no 1394 / 2007 on advanced therapy medicinal products14 , directive 2012 / 26 / eu of the european parliament and of the council of 25 october 2012 amending directive 2001 / 83 / ec as regards pharmacovigilance15 and regulation no 1027 / 2012 of the european parliament and of the council of 25 october 2012 amending regulation no 726 / 2004 as regards pharmacovigilance16 . those amendments only cover medicinal products for human use . those amendments provide for new pharmacovigilance tasks for the agency including union - wide pharmacovigilance procedures , the monitoring of literature cases , the improved information technology tools and the provision of more information to the general public . furthermore , the pharmacovigilance legislation stipulates that the agency should be enabled to fund those activities from fees charged to marketing authorisation holders and a contribution from the union . new categories of fees should therefore be created to cover the new and specific tasks of the agency . the european parliament and the council should examine the level of the union contribution on the basis of an evaluation of needs and taking account of the level of fees . the level of the fees charged to marketing authorisation holders will take into account the current financial situation and entrepreneurial environment of member states . __________________ 12 oj l 311 , 28 . 11 . 2001 , p . 67 . 13 oj l 348 , 31 . 12 . 2010 , p . 74 . 14 oj l 348 , 31 . 12 . 2010 , p . 1 . 15 oj l 299 , 27 . 10 . 2012 , p . 1 . 16 oj l 316 , 14 . 11 . 2012 , p . 38 .


### the provisions on pharmacovigilance relating to medicinal products of human use laid down in regulation no 726 / 2004 and directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use12 were amended by directive 2010 / 84 / eu of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance , directive 2001 / 83 / ec on the community code relating to medicinal products for human use13 , regulation no 1235 / 2010 of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance of medicinal products for human use , regulation no 726 / 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency , and regulation no 1394 / 2007 on advanced therapy medicinal products14 , directive 2012 / 26 / eu of the european parliament and of the council of 25 october 2012 amending directive 2001 / 83 / ec as regards pharmacovigilance15 and regulation no 1027 / 2012 of the european parliament and of the council of 25 october 2012 amending regulation no 726 / 2004 as regards pharmacovigilance16 . those amendments only cover medicinal products for human use . those amendments provide for new pharmacovigilance tasks for the agency including union - wide pharmacovigilance procedures , the monitoring of literature cases , the improved information technology tools and the provision of more information to the general public . furthermore , the pharmacovigilance legislation stipulates that the agency should be enabled to fund those activities from fees charged to marketing authorisation holders . new categories of fees should therefore be created to cover the new and specific tasks of the agency . __________________ 12 jo l 311 , 28 . 11 . 2001 , p . 67 . 13 jo l 348 , 31 . 12 . 2010 , p . 74 . 14 jo l 348 , 31 . 12 . 2010 , p . 1 . 15 jo l 299 , 27 . 10 . 2012 , p . 1 . 16 jo l 316 , 14 . 11 . 2012 , p . 38 . ### the provisions on pharmacovigilance relating to medicinal products of human use laid down in regulation no 726 / 2004 and directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use12 were amended by directive 2010 / 84 / eu of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance , directive 2001 / 83 / ec on the community code relating to medicinal products for human use13 , regulation no 1235 / 2010 of the european parliament and of the council of 15 december 2010 amending , as regards pharmacovigilance of medicinal products for human use , regulation no 726 / 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency , and regulation no 1394 / 2007 on advanced therapy medicinal products14 , directive 2012 / 26 / eu of the european parliament and of the council of 25 october 2012 amending directive 2001 / 83 / ec as regards pharmacovigilance15 and regulation no 1027 / 2012 of the european parliament and of the council of 25 october 2012 amending regulation no 726 / 2004 as regards pharmacovigilance16 . those amendments only cover medicinal products for human use . those amendments provide for new pharmacovigilance tasks for the agency including union - wide pharmacovigilance procedures , the monitoring of literature cases , the improved information technology tools and the provision of more information to the general public . furthermore , the pharmacovigilance legislation stipulates that the agency should be enabled to fund those activities from fees charged to marketing authorisation holders , in addition to public funding provided from the eu budget . new categories of fees should therefore be created to cover the new and specific tasks of the agency . __________________ 12 jo l 311 du 28 . 11 . 2001 , p . 67 . 13 jo l 348 du 31 . 12 . 2010 , p . 74 . 14 jo l 348 du 31 . 12 . 2010 , p . 1 . 15 jo l 299 du 27 . 10 . 2012 , p . 1 . 16 jo l 316 du 14 . 11 . 2012 , p . 38 .


### fees referred to in this regulation should be transparent , fair and proportionate to the work carried out . ### fees referred to in this regulation should be transparent , fair and proportionate to the work carried out . information on these fees should be publicly available .


### this regulation should only refer to fees which are to be levied by the agency , whereas the competence to decide on possible fees levied by the competent authorities of the member states should remain with the member states . marketing authorisation holders should not be charged twice for the same pharmacovigilance activity . member states should therefore not levy fees for the activities which are covered by this regulation . ### this regulation should only refer to fees which are to be levied by the agency , whereas the competence to decide on possible fees levied by the competent authorities of the member states should remain with the member states . marketing authorisation holders should not , however , be charged twice for the same pharmacovigilance activity . member states should therefore not levy fees for the activities which are covered by this regulation .


### generic medicinal products , medicinal products authorised under the provisions relating to well - established medicinal use , authorised homeopathic medicinal products and authorised herbal medicinal products should be subject to a reduced annual flat fee as those products generally have a well - established safety profile . however , in cases where these products are part of any of the union - wide pharmacovigilance procedures , the full fee should be charged in view of the work involved . as the legislation on pharmacovigilance encourages the conduct of joint post authorisation safety studies , marketing authorisation holders should share the applicable fee in case a joint study is submitted . ### generic medicinal products , medicinal products authorised under the provisions relating to well - established medicinal use , medicinal products authorised in the union for at least 10 years and authorised homeopathic and herbal medicinal products should be subject to a reduced annual flat fee as those products generally have a well - established safety profile . however , in cases where these products are part of any of the union - wide pharmacovigilance procedures , the full fee should be charged in view of the work involved . as the legislation on pharmacovigilance encourages the conduct of joint post authorisation safety studies , marketing authorisation holders should share the applicable fee in case a joint study is submitted .


### where a fee is levied by the agency in accordance with paragraph 1 , the agency shall remunerate the rapporteur in the pharmacovigilance risk assessment committee appointed by the member state or the rapporteur in the coordination group for the work they carry out for the agency or the coordination group . this remuneration shall be paid in accordance with article 9 . ### where a fee is levied by the agency in accordance with paragraph 1 , the agency shall remunerate the rapporteur and the co - rapporteur in the pharmacovigilance risk assessment committee appointed by the member state or the member state who act as the rapporteur in the coordination group for the work they carry out for the agency or the coordination group . this remuneration shall be paid to the member state appointing or acting as the rapporteur or co - rapporteur in accordance with article 9 .


### the agency shall levy a fee for post - authorisation safety studies referred to in article 21 a or article 22a of directive 2001 / 83 / ec and article 9 or article 10a of regulation no 726 / 2004 for the assessment thereof carried out under articles 107n to 107q of directive 2001 / 83 / ec and article 28b of regulation no 726 / 2004 . ### the agency shall levy a fee for post - authorisation safety studies referred to in article 21a or article 22a of directive 2001 / 83 / ec and article 9 or article 10a of regulation no 726 / 2004 that have been conducted in more than one member states for the assessment thereof carried out under articles 107n to 107q of directive 2001 / 83 / ec and article 28b of regulation no 726 / 2004 .


### marketing authorisation holders who are charged the fee under this article shall be exempted from any other fee charged by a competent authority for the submission of studies referred to in paragraph 1 . ### marketing authorisation holders who are charged the fee under this article shall be exempted from any other fee charged by a competent authority for the submission of studies referred to in paragraph 1 , including , but not limited to , fees for variations submitted in accordance with articles 107p and 107q of directive 2001 / 83 / ec .


### for its pharmacovigilance activities relating to information technology systems under article 24 , article 25a , article 26 , article 57 of regulation no 726 / 2004 , monitoring of selected medical literature under article 27 thereof and signal detection under article 28a thereof , the agency shall levy once per year a flat fee as laid down in part iv of the annex . ### for its pharmacovigilance activities relating to information technology systems under article 24 , article 25a , article 26 , article 57 of regulation no 726 / 2004 , monitoring of selected medical literature under article 27 thereof and signal detection under article 28a thereof , the agency shall levy once a flat fee as laid down in part iv of the annex .


### a reduced annual flat fee , as laid down in part iv of the annex , shall apply in respect of medicinal products referred to in article 10 and article 10a of directive 2001 / 83 / ec and in respect of authorised homeopathic medicinal products and authorised herbal medicinal products , as defined respectively in article 1 and article 1 of directive 2001 / 83 / ec . ### a reduced annual flat fee , as laid down in part iv of the annex , shall apply in respect of medicinal products referred to in article 10 and article 10a of directive 2001 / 83 / ec and in respect of authorised herbal medicinal products , as defined in article 1 of directive 2001 / 83 / ec . for authorised homeopathic medicinal products , as defined in article 1 of directive 2001 / 83 / ec , no flat fee shall apply .


### a reduced annual flat fee , as laid down in part iv of the annex , shall apply in respect of medicinal products referred to in article 10 and article 10a of directive 2001 / 83 / ec and in respect of authorised homeopathic medicinal products and authorised herbal medicinal products , as defined respectively in article 1 and article 1 of directive 2001 / 83 / ec . ### a reduced annual flat fee , as laid down in part iv of the annex shall apply to generic medicinal products referred to in article 10 and medicinal products authorised under the provisions relating to well - established medicinal use referred to in article 10a of directive 2001 / 83 / ec , all products authorised in the community for at least 10 years , and in respect of authorised homeopathic medicinal products and authorised herbal medicinal products , as defined respectively in article 1 and article 1 of directive 2001 / 83 / ec .


### any marketing authorisation holder claiming to be entitled to a reduced annual flat fee under article 7 shall make a declaration to that effect to the agency . the agency shall apply the reduction on the basis of that declaration where the required conditions are met . where the declaration is made by the marketing authorisation holder after the receipt of the invoice from the agency , the declaration shall be done within 30 calendars days from the receipt of that invoice . ### any marketing authorisation holder claiming to be entitled to a reduced annual flat fee under article 7 shall make a declaration to that effect to the agency ; the commission shall publish guidelines on how this declaration is to be formulated by the marketing authorisation holder . the agency shall apply the reduction on the basis of that declaration where the required conditions are met , . where the declaration is made by the marketing authorisation holder after the receipt of the invoice from the agency , the declaration shall be done within 30 calendars days from the receipt of that invoice .


### the executive director of the agency shall provide the commission and the management board annually with information on the components that may have a bearing on the costs to be covered by the fees provided for in this regulation . this information shall include a cost breakdown related to the previous year and a forecast for the following year . the executive director of the agency shall also provide the commission and the management board once per year with the performance information set out in part v of the annex based on the performance indicators referred to in paragraph 3 . ### the executive director of the agency shall provide in the annual report delivered to the european parliament , the council , the commission , the european economic and social committee , the court of auditors and the member states according to article 65 paragraph 10 of regulation no 726 / 2004 with information on the components that may have bearing on the costs to be covered by the fees provided for in this regulation . this information shall include a cost breakdown related to the previous year and a forecast for the following year . the agency shall also publish this overview in its public annual report . the executive director of the agency shall also provide the commission and the management board once per year with the performance information set out in part v of the annex based on the performance indicators referred to in paragraph 3 .


### this regulation does not apply to the activity of a member state , the european commission or any other officially designated body , or of any person acting on their behalf , which concerns emission allowances and which is undertaken in the pursuit of the union ' s climate policy . ### this regulation does not apply to the activity of a member state , the european commission or any other officially designated body , or of any person acting on their behalf , which concerns emission allowances and which is undertaken solely in the pursuit of the union ' s climate policy .


### the first subparagraph shall not apply to an emission allowance market participant where the installations or aviation activities that it owns , controls or is responsible for , in the preceding year have had emissions not exceeding a minimum threshold of carbon dioxide equivalent and , where they carry out combustion activities , have had a rated thermal input not exceeding a minimum threshold . ### the first subparagraph shall not apply to a eu ets operator where the installations or aviation activities that it owns , controls or is responsible for , in the preceding year have had emissions not exceeding a minimum threshold of 3 million tonnes of carbon dioxide equivalent and , where they carry out combustion activities , have had a rated thermal input not exceeding a minimum threshold of 300 mw .


### the commission shall adopt , by means of a delegated act in accordance with article 31 , measures establishing a minimum threshold of carbon dioxide equivalent and a minimum threshold of rated thermal input for the purposes of application of the exemption provided for in the second subparagraph . ### the commission shall be empowered to adopt , by means of a delegated act in accordance with article 31 , measures modifying the minimum threshold of carbon dioxide equivalent and the minimum threshold of rated thermal input for the purposes of application of the exemption provided for in the second subparagraph . while adopting the delegated act referred to in this subparagraph , the commission shall assess whether modifying the minimum threshold of carbon dioxide equivalent or the minimum threshold of rated thermal input responds to the needs arising from new technological and market developments .


### a competent authority may permit the delay by an issuer of a financial instrument of the public disclosure of inside information provided that the following conditions are satisfied : ### a competent authority may permit the delay by an issuer of a financial instrument or an emission allowance market participant of the public disclosure of inside information provided that the following conditions are satisfied :


### it is of particular importance that the commission carry out appropriate consultations during its preparatory work prior to adopting delegated acts , 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 to the council ### it is of particular importance that the commission carry out appropriate consultations during its preparatory work prior to adopting delegated acts , 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 to the council . the commission should provide full information and documentation on its meetings with national experts within the framework of its work on the preparation and implementation of delegated acts . in this respect , the commission should ensure that the european parliament is duly involved , drawing on best practices from previous experience in other policy areas in order to create the best possible conditions for future scrutiny of delegated acts by the european parliament .


### the commission may , by means of implementing acts , determine the processed agricultural products listed in annex iv to which , when imported subject to the rate of duty laid down in the common customs tariff , an additional import duty shall apply in order to prevent or counteract adverse effects on the union market which may result from those imports , if : ### the commission may , by means of implementing acts , determine the processed agricultural products listed in annex iv to which , when imported subject to the rate of duty laid down in the common customs tariff , an additional import duty or an import restriction based on environmental or health standards shall apply in order to prevent or counteract adverse effects on all or part of the union market which may result from those imports , if :


### additional import duties shall not be imposed in accordance with paragraph 1 where the imports are unlikely to disturb the union market , or where the effects would be disproportionate to the intended objective . ### additional import duties shall not be imposed in accordance with paragraph 1 where the imports are unlikely to disturb all or part of the union market , or where the effects would be disproportionate to the intended objective .


### the commission shall , subject to paragraph 3 of this article , by means of implementing acts , take safeguard measures against imports of processed agricultural products into the union in accordance with regulations no 260 / 2009 and no 625 / 2009 . ### the commission shall , subject to paragraph 3 of this article , by means of implementing acts , take safeguard measures against imports of processed agricultural products into the union in accordance with regulations no 260 / 2009 and no 625 / 2009 , as amended by regulation no &#8230 ; / &#8230 ; 1 . ___________ 1 com0082


### transmitting or making information and documents available to the member states , the competent authorities in third countries , or the public . ### transmitting or making information and documents available to the member states , the competent authorities in third countries , or the european parliament .


### the power to adopt the delegated acts referred to in articles 8 , 12 , 15 , 19 , 27 , 32 , article 34 , article 37 , article 38 and article 39 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation . ### the power to adopt the delegated acts referred to in articles 8 , 12 , 15 , 19 , 27 , 32 , article 34 , article 37 , article 38 and article 39 shall be conferred on the commission for a period of seven years from . . . * . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period . ––––––––––––––––– * oj : please insert the date of entry into force of the single cmo regulation no … / … [ com 626 final ] .


### a delegated act adopted pursuant to articles 8 , 12 , 15 , 19 , 27 , 32 , article 34 , article 37 , article 38 and article 39 shall enter into force only if no objection has been expressed either by the european parliament or by the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act adopted pursuant to articles 8 , 12 , 15 , 19 , 27 , 32 , article 34 , article 37 , article 38 and article 39 shall enter into force only if no objection has been expressed either by the european parliament or by the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by four months at the initiative of the european parliament or of the council .


### it shall apply from 1 january 2014 . ### it shall apply from 1 january 2015 .


### the union ' s financial interests can be negatively affected where individual tenderers provide information to contracting or grant awarding authorities based on information unduly obtained directly or indirectly from the tendering body , with the aim of circumventing or skewing rules applicable to a public procurement or grant procedure . such conduct is very similar to fraud , but does not necessarily need to constitute a full fraud offence on the side of the tenderer , since the provided bid may be completely in line with all requirements . bid - rigging behaviour between tenderers violates union competition rules and equivalent national laws ; it is subject to public enforcement action and sanctions throughout the union and should remain outside the scope of this directive . ### the union ' s financial interests can be negatively affected where individual tenderers provide information to contracting or grant awarding authorities based on information illegally obtained directly or indirectly from the tendering body , with the aim of circumventing or violating rules applicable to a public procurement or grant procedure . such conduct is very similar to fraud , but does not necessarily need to bear all the hallmarks of a full fraud offence on the side of the tenderer , since the provided bid may meet all the necessary criteria . bid - rigging behaviour between tenderers violates union competition rules and equivalent national laws ; it is subject to public enforcement action and sanctions throughout the union and should remain outside the scope of this directive .


### corruption constitutes a particularly serious threat against the union ' s financial interests , which can in many cases also be linked to fraudulent conduct . a particular criminalisation in this area is therefore needed . it must be ensured that the relevant offences are covered by the definition irrespective of whether conduct is in breach of official duties or not . as regards the offences of passive corruption and misappropriation , there is a need to include a definition of public officials covering all relevant officials , whether appointed , elected or employed on the basis of a contract , holding a formal office , as well as persons exercising the function of providing service from government and other public bodies to citizens , or for the public interest in general , without holding a formal office , such as contractors involved in the management of eu funds . ### corruption constitutes a particularly serious threat against the union ' s financial interests , which can in many cases also be linked to fraudulent conduct . a particular criminalisation in this area is therefore needed . it must be ensured that the relevant offences are covered by the definition irrespective of whether conduct is in breach of official duties or not . as regards the offences of passive corruption and misappropriation , there is a need to include a definition of public officials covering all relevant officials , whether appointed , elected or employed on the basis of a contract , holding a formal office in the union , in the member states or in third countries . private persons are increasingly involved in the management of union funds . in order to adequately protect union funds from corruption and misappropriation , the definition of ' public official ' for the purposes of this directive therefore needs to cover also persons that do not hold a formal office , but nonetheless are assigned and exercising , in a similar manner , a public service function in relation to union funds , such as contractors involved in the management of such funds .


### the union ' s financial interests can be negatively affected by certain types of conduct of a public official which aim at misappropriating funds or assets contrary to the purpose foreseen , and with the intention to damage the union ' s financial interests . there is therefore a need to introduce a precise definition of offences covering such conduct . ### the union ' s financial interests can be negatively affected by certain types of conduct of a public official which aim at misappropriating funds or assets contrary to the purpose foreseen , and with the intention to damage the union ' s financial interests . there is therefore a need to introduce a precise and unambiguous definition of offences covering such conduct .


### for the purposes of this directive , ‘ the union ' s financial interests’ means all revenues and expenditures covered by , acquired through , or due to : ### for the purposes of this directive , ' the union ' s financial interests ' means all revenues and expenditures covered by , acquired through , or due to :


### for the purposes of this directive , ‘ the union ' s financial interests’ means all revenues and expenditures covered by , acquired through , or due to : ### for the purposes of this directive , ‘ the union ' s financial interests’ means all the assets and liabilities managed by or on behalf of the union and its institutions , bodies and agencies ; and all its financial operations , including borrowing and lending activities , as well as , in particular , all revenues and expenditures covered by , acquired through , or due to :


### the budgets of institutions , bodies , offices and agencies established under the treaties or budgets managed and monitored by them . ### the budgets of institutions , bodies , offices and agencies established pursuant to the treaties or budgets managed and monitored by them .


### member states shall take the necessary measures to ensure that any provision of information , or failure to provide such information , to contracting or grant awarding entities or authorities in a public procurement or grant procedure involving the union ' s financial interests , by candidates or tenderers , or by persons responsible for or involved in the preparation of replies to calls for tenders or grant applications of such participants , when committed intentionally and with the aim of circumventing or skewing the application of the eligibility , exclusion , selection or award criteria , is punishable as a criminal offence . ### member states shall take the necessary measures to ensure that any provision of information , or failure to provide such information , to contracting or grant awarding entities or authorities in a public procurement or grant procedure involving the union ' s financial interests , by candidates or tenderers , or by persons responsible for or involved in the preparation of replies to calls for tenders or grant applications of such participants , when committed intentionally and with the aim of circumventing or skewing the application of the eligibility , exclusion , selection or award criteria , or of distorting or destroying the natural competition among bidders , is punishable as a criminal offence .


### member states shall take the necessary measures to ensure that the intentional act by a public official to commit or disburse funds , or appropriate or use assets , contrary to the purpose for which they were intended and with the intent to damage the union ' s financial interests , is punishable as a criminal offence . ### member states shall take the necessary measures to ensure that misappropriation , when committed intentionally , is punishable as a criminal offence . for the purposes of this directive , misappropriation shall consist of an act by a public official to commit or disburse funds , or appropriate or use assets , contrary to the purpose for which they were intended , and which damages the union ' s financial interests .


### for the purpose of this article , ' public official ' means : any person exercising a public service function for the union or in member states or third countries by holding a legislative , administrative or judicial office ; any other person exercising a public service function for the union or in member states or third countries , not holding such an office , participating in the management of or decisions concerning the union ' s financial interests . ### for the purpose of this article , ' public official ' means : any ' union ' or ' national official ' , including any national official of another member state and any national official of a third country ; the term ' union official ' shall mean : - any person who is an official or other contracted employee within the meaning of the staff regulations of officials of the european union or the conditions of employment of other servants of the european union , - any person seconded to the european union by the member states or by any public or private body , who carries out functions equivalent to those performed by union officials or other servants . members of bodies set up in accordance with the treaties and the staff of such bodies shall be treated as union officials , inasmuch as the staff regulations of the european union or the conditions of employment of other servants of the european union do not apply to them ; the term ' national official ' shall be understood by reference to the definition of ' official ' or ' public official ' in the national law of the state in which the person in question performs the function . nevertheless , in the case of proceedings involving a member state ' s official , or a national official of a third country , initiated by another member state the latter shall not be bound to apply the definition of ' national official ' except in so far as the definition is compatible with its national law ; any other person assigned and exercising a public service function involving the management of or decisions concerning the union ' s financial interests in member states or third countries .


### member states shall take the necessary measures to ensure that inciting , aiding or abetting the criminal offences referred to in title ii is punishable as a criminal offence . ### member states shall take the necessary measures to ensure that inciting , aiding or abetting the commission of any of the criminal offences referred to in articles 3 and 4 is punishable as a criminal offence .


### member states shall take the necessary measures to ensure that an attempt to commit the criminal offence referred to in article 3 or in article 4 , paragraph 4 , is punishable as a criminal offence . ### member states shall take the necessary measures to ensure that an attempt to commit any of the criminal offences referred to in article 3 and in article 4 , is punishable as a criminal offence .


### member states shall take the necessary measures to ensure that legal persons can be held liable for any of the criminal offences referred to in title ii committed for their benefit by any person , acting either individually or as part of an organ of the legal person , and having a leading position within the legal person , based on : ### member states shall take the necessary measures to ensure that legal persons can be held liable for any of the criminal offences referred to in articles 3 , 4 and 5 committed for their benefit by any person , acting either individually or as part of an organ of the legal person , and having a leading position within the legal person , based on :


### member states shall also take the necessary measures to ensure that legal persons can be held liable where the lack of supervision or control by a person referred to in paragraph 1 has made possible the commission , of any of the criminal offences referred to in title ii for the benefit of that legal person by a person under its authority . ### member states shall also take the necessary measures to ensure that legal persons can be held liable where the lack of supervision or control by a person referred to in paragraph 1 has made possible the commission , of any of the criminal offences referred to in articles 3 , 4 and 5 for the benefit of that legal person by a person under its authority .


### liability of a legal person under paragraphs 1 and 2 shall not exclude criminal proceedings against natural persons who are perpetrators of the criminal offences referred to in title ii or criminally liable under article 5 . ### liability of a legal person under paragraphs 1 and 2 shall not exclude criminal proceedings against natural persons who are perpetrators of the criminal offences referred to in articles 3 and 4 or criminally liable under article 5 .


### in cases of minor offences involving damages of less than eur 10 , 000 and advantages of less than eur 10 , 000 and not involving particularly serious circumstances , member states may provide instead for other than criminal penalties . ### in cases of offences involving damages of less than eur 5 000 and advantages of less than eur 5 000 and not involving aggravating circumstances , member states may provide instead for sanctions other than criminal penalties .


### paragraph 1 shall be without prejudice to the exercise of disciplinary powers by the competent authorities against public officials . ### paragraph 1 shall be without prejudice to the exercise of disciplinary powers by the competent authorities against public officials , as defined in article 4 .


### member states shall take the necessary measures to ensure that the criminal offences referred to in title ii shall be punishable by a maximum penalty of at least 10 years of imprisonment where the offence was committed within a criminal organisation in the sense of framework decision 2008 / 841 . ### member states shall take the necessary measures to ensure that the criminal offences referred to in articles 3 , 4 and 5 shall be punishable by a maximum penalty of at least 10 years of imprisonment where the offence was committed within a criminal organisation within the meaning of framework decision 2008 / 841 .


### member states shall take the necessary measures to establish their jurisdiction over the criminal offences referred to in title ii where : the offence is committed in whole or in part within their territory ; or the offender is one of their nationals . ### member states shall take the necessary measures to establish their jurisdiction over the criminal offences referred to in articles 3 , 4 and 5 where : the offence is committed in whole or in part within their territory ; the offender is one of their own nationals or is resident in their territory ; or the offender is subject to the staff regulations of the european union or the conditions of employment of other servants of the european union .