### in paragraph 2 , the points and are replaced by the following : ' he shall prepare the multi - annual strategy of the agency and submit it to the administrative board after consultation of the commission at least 8 weeks before the relevant board meeting ; he shall prepare the multi - annual staff policy plan of the agency and submit it to the administrative board after consultation of the commission ; he shall prepare the annual work programme and the detailed plan for the agency ' s pollution preparedness and response activities , and submit them to the administrative board after consultation of the commission at least 8 weeks before the relevant board meeting . he shall take the necessary steps for their implementation . he shall respond to any requests for assistance from a member state in accordance with article 10 ; he shall decide to carry out the inspections provided for in article 3 , after consultation of the commission and in line with the requirements referred to in the same article 3 . he shall cooperate closely with the commission in the preparation of the measures referred to in article 3 ; ### in paragraph 2 , the points and are replaced by the following : ' he shall prepare the multi - annual strategy of the agency and submit it to the administrative board after consultation of the parliament and of the commission at least 8 weeks before the relevant board meeting ; he shall prepare the multi - annual staff policy plan of the agency and submit it to the administrative board after consultation of the commission ; he shall prepare the annual work programme , with an indication of the anticipated human and financial resources allocated to each activity , and the detailed plan for the agency ' s pollution preparedness and response activities , and submit them to the administrative board after consultation of the commission at least 8 weeks before the relevant board meeting . he shall reply positively to any invitation by the european parliament ' s competent committee to present and hold an exchange of views on the annual work programme . he shall take the necessary steps for their implementation . he shall respond to any requests for assistance from a member state in accordance with article 10 ; he shall decide to carry out the inspections provided for in article 3 , after consultation of the commission and in line with the requirements referred to in the same article 3 . he shall cooperate closely with the commission in the preparation of the measures referred to in article 3 ; '


### ' he shall organise an effective monitoring system in order to be able to compare the agency ' s achievements with its objectives and tasks as laid down in this regulation . he shall ensure that the agency ' s organisational structure will be regularly adapted to the evolving needs within the available financial and human resources . on this basis the executive director shall prepare a draft general report each year and submit it to the administrative board . the report shall include a dedicated section concerning the financial execution of the detailed plan for the agency ' s pollution preparedness and response activities and give an update of the status of all actions funded under that plan . he shall establish regular evaluation procedures that meet recognised professional standards ; ' ### ' he shall organise an effective monitoring system in order to be able to compare the agency ' s achievements with its objectives and tasks as laid down in this regulation . to this end , he shall establish , in agreement with the commission , tailored performance indicators allowing for an effective assessment of the results achieved . he shall ensure that the agency ' s organisational structure will be regularly adapted to the evolving needs within the available financial and human resources . on this basis the executive director shall prepare a draft general report each year and submit it to the administrative board . the report shall include a dedicated section concerning the financial execution of the detailed plan for the agency ' s pollution preparedness and response activities and give an update of the status of all actions funded under that plan . he shall establish regular evaluation procedures that meet recognised professional standards ; '


### the executive director shall be appointed and dismissed by the administrative board . the appointment shall be made from a list of candidates proposed by the commission for a period of five years on grounds of merit and documented administrative and managerial skills , as well as competence and experience relevant for maritime safety , maritime security , prevention of pollution caused by ships and response to marine pollution . before appointment , the candidate selected by the administrative board may be invited to make a statement before the competent committee of the european parliament and answer questions put by its members . the administrative board shall take its decision by a four - fifths majority of all members with the right to vote . ### the executive director shall be appointed and dismissed by the administrative board . the appointment shall be made from a list of candidates proposed by the commission for a period of five years on grounds of merit and documented administrative and managerial skills , as well as competence and experience relevant for maritime safety , maritime security , prevention of pollution caused by ships and response to marine pollution . before appointment , the candidate selected by the administrative board may be invited to make a statement before the competent committee of the european parliament and answer questions put by its members . its opinion , if any , shall be considered before formal appointment . the administrative board shall take its decision by a four - fifths majority of all members with the right to vote .


### the administrative board , acting on a proposal from the commission , taking into account the evaluation report may extend the term of office of the executive director for not more than three years . the administrative board shall take its decision by a four - fifths majority of all members with the right to vote . the administrative board shall inform the european parliament about its intention to extend the executive director ' s term of office . within a month before the extension of his / her term of office , the executive director may be invited to make a statement before the competent committee of the european parliament and answer questions put by its members . if the term of office is not extended , the executive director shall remain in office until the appointment of his / her successor . ### the administrative board , acting on a proposal from the commission , taking into account the evaluation report may extend the term of office of the executive director for not more than five years . the administrative board shall take its decision by a four - fifths majority of all members with the right to vote . the administrative board shall inform the european parliament about its intention to extend the executive director ' s term of office . within a month before the extension of his / her term of office , the executive director may be invited to make a statement before the competent committee of the european parliament and answer questions put by its members . its opinion , if any , shall be considered before formal reappointment . if the term of office is not extended , the executive director shall remain in office until the appointment of his / her successor .


### in article 22 , paragraph 1 is replaced by the following : ' 1 . at regular intervals and at least every five years , the administrative board shall commission an independent external evaluation on the implementation of this regulation . the commission shall make available to the agency any information the latter considers relevant to that evaluation . ' ### in article 22 , paragraphs 1 and 2 are replaced by the following : ' 1 . at regular intervals and at least every five years , the administrative board shall commission an independent external evaluation on the implementation of this regulation . the commission shall make available to the agency any information the latter considers relevant to that evaluation . 2 . the evaluation shall assess the utility , relevance , achieved added value and effectiveness of the agency and its working practices . the evaluation shall take into account the views of stakeholders , at both european and national level . it shall , in particular , address the possible need to modify or extend the agency ' s tasks or to put an end to its activities in the event of its role having become superfluous . '


### the international commission for the conservation of atlantic tunas has adopted a recommendation 10 - 04 amending the multiannual recovery plan for bluefin tuna . in order to rebuild the stock , the recommendation provides for a further reduction of the total allowable catch , for strengthening measures to reduce the fishing capacity and for reinforcing the control measures , in particular as regards the transfer and the caging operations . ### the international commission for the conservation of atlantic tunas has adopted a recommendation 10 - 04 amending the multiannual recovery plan for bluefin tuna . in order to rebuild the stock , the recommendation provides for a further reduction of the total allowable catch , for strengthening measures to reduce the fishing capacity and for reinforcing the control measures , in particular as regards the transfer and the caging operations , and foresees additional advice on the identification of spawning grounds and creation of sanctuaries to be developed by 2012 .


### if the investigation is not concluded within 10 working days or if the outcome of the investigation indicates that the number and / or average weight of bluefin tuna is in excess of 10 % of that declared by the farm operator , the flag cpc or member state responsible for the catching vessel shall issue a release order for the quantities in excess . ### if the investigation is not concluded within 10 working days or if the outcome of the investigation indicates that the number and / or average weight of bluefin tuna is in excess of 10 % of that declared by the farm operator , the flag cpc or member state responsible for the catching vessel shall issue a release order for the number and / or weight in excess .


### an effect of the financial crisis has been that investors , including ucits and aifs , rely excessively on credit ratings to carry out their investments on debt instruments , without necessarily conducting their own assessments of the creditworthiness of issuers of such debt instruments . in order to improve the quality of the investments made by ucits and aifs and , therefore , to protect investors in those funds , it is appropriate to require the persons managing ucits and aifs to avoid relying exclusively and automatically on external credit ratings when assessing the risk involved in the investments made by the ucits and aifs they manage . the general principle on the avoidance of excessive reliance on external credit ratings should therefore be integrated into the risk management processes and systems of the managers of ucits and aifs , and adapted to their specificities . ### an effect of the financial crisis has been that investors , including ucits and aifs , rely excessively on credit ratings to carry out their investments on debt instruments , without necessarily conducting their own assessments of the creditworthiness of issuers of such debt instruments . in order to improve the quality of the investments made by ucits and aifs and , therefore , to protect investors in those funds , it is appropriate to require the persons managing ucits and aifs to avoid relying exclusively and automatically on external credit ratings when assessing the risk involved in the investments made by the ucits and aifs they manage . the internal risk management processes and systems of the managers of ucits and aifs should therefore be upgraded and the general principle adopted of avoiding excessive reliance on external credit ratings


### draft legislative resolution ### stresses that point 47 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management1 should apply for the extension of the mandate for the european agency for the management of operational cooperation at the external borders ; emphasises that any decision of the legislative authority in favour of such an extension shall be without prejudice to the decisions of the budgetary authority in the context of the annual budgetary procedure ; ________________ 1 oj c 139 , 14 . 6 . 2006 , p . 1 .


### draft legislative resolution ### requests that the commission present a new financial statement which fully takes into account the result of the legislative agreement between the european parliament and council to meet the budgetary and staff requirements in the agency and in commission ' s services ;


### the sixth community environment action programme confirmed that sound information on the state of the environment and on the key trends , pressures and drivers for environmental change is essential for the development of effective policy , its implementation , and the empowerment of citizens more generally . ### the sixth community environment action programme confirmed that sound information on the state of the environment and on the key trends , pressures and drivers for environmental change is essential for the development of effective policy , its implementation , and the empowerment of citizens more generally . instruments should be developed with a view to enhancing public awareness of the environmental effects of economic activity .


### the need to supplement already existing indicators with data that incorporate environmental and social aspects in order to allow more coherent and comprehensive policy making has been recognised in commission communication com 433 of august 2009 on gdp and beyond . to this end , environmental accounts offer a means of monitoring the pressures exerted by the economy on the environment and of exploring how these might be abated . in line with the tenets of sustainable development and the drive to achieve a low - carbon economy , embedded in the lisbon strategy and various major initiatives , developing a data framework that consistently includes environmental issues along with economic ones becomes all the more imperative . ### the need to supplement already existing indicators with data that incorporate environmental and social aspects in order to allow more coherent and comprehensive policy making has been recognised in commission communication com 433 of august 2009 on gdp and beyond . to this end , environmental accounts show the interaction between economic , household and environmental factors . environmental accounts are more informative than national accounts alone . they provide a significant database for environmental decisions and should be consulted for the drawing up by the commission of impact assessments . in line with the tenets of sustainable development and the drive to achieve a low - carbon economy , embedded in the europe 2020 strategy and various major initiatives , developing a data framework that consistently includes environmental issues along with economic ones becomes all the more imperative .


### satellite accounts allow the analytical capacity of national accounting to be expanded for selected areas of social concern , such as pressures on the environment stemming from human activity , in a flexible manner , without overburdening or disrupting the central system . ### satellite accounts allow the analytical capacity of national accounting to be expanded for selected areas of social concern , such as pressures on the environment stemming from human activity , in a flexible manner , without overburdening or disrupting the central system . member states should make available to the public regularly and in comprehensible form information contained in environmental accounts by publishing it together with gdp data , for example .


### as the different sets of environmental economic accounts are under development and at different stages of maturity , a modular structure providing adequate flexibility should be adopted . ### as the different sets of environmental economic accounts are under development and at different stages of maturity in the various member states , a modular structure providing adequate flexibility and facilitating the rapid introduction of additional modules should be adopted .


### the commission should be entitled to grant derogations to member states when major adaptations to their national statistical systems are required . ### the commission should be entitled to grant derogations to member states for a limited period when major adaptations to their national statistical systems are required .


### this regulation establishes a common framework for the collection , compilation , transmission and evaluation of european environmental economic accounts for the purpose of setting up environmental economic accounts as satellite accounts to esa 95 by providing methodology , common standards , definitions , classifications and accounting rules , intended to be used for compiling environmental economic accounts . ### this regulation establishes a common framework for the collection , compilation , transmission and evaluation of european environmental economic accounts for the purpose of setting up environmental economic accounts as satellite accounts pursuant to council regulation no 2223 / 96 of 23 june 1996 on the european system of national and regional accounts in the community to offer a means of monitoring the pressures exerted by the economy on the environment and of exploring how these might be abated .


### the commission shall adopt delegated acts in accordance with article 9 for the purpose of adjusting the modules to environmental , economic and technical developments , as well as providing methodological guidance . ### the commission shall adopt delegated acts in accordance with article 9 for the purpose of adjusting the modules to environmental , economic and other developments .


### member states shall collect the necessary data for the observation of the modules ' characteristics referred to in article 3 . 2 . member states shall collect the necessary data using a combination of the different sources specified below , applying the principle of administrative simplification : surveys ; statistical estimation procedures where some of the characteristics have not been observed for all of the units ; administrative sources . 3 . member states shall inform the commission and shall provide details concerning the methods used and the quality of the data from the sources listed in paragraph 2 . ### in accordance with the annexes of this regulation , member states shall collect the necessary data for the observation of the modules ' characteristics referred to in article 3 . 2 . member states shall collect the necessary data using a combination of the different sources specified below , applying the principle of administrative simplification : surveys ; statistical estimation procedures where some of the characteristics have not been observed for all of the units ; administrative sources . 3 . member states shall inform the commission and shall provide details concerning the methods and sources used . 3a . the commission may adopt , by means of delegated acts in accordance with article 9 and subject to the conditions of articles 10 and 11 , delegated acts to provide methodological guidance to facilitate the application of this article .


### the powers to adopt the delegated acts referred to in articles 3 and 4 shall be conferred on the commission for an indefinite period of time . ### the powers to adopt the delegated acts referred to in articles 3 and 5 shall be conferred on the commission for a period of five years following the entry into force of this regulation . the commission shall make a report in respect of the delegated powers at the latest 6 months before the end of the five - year period . the delegation of powers shall be automatically extended for periods of an identical duration , unless the european parliament or the council revokes it in accordance with article 10 .


### the delegation of power referred to in articles 3 and 4 may be revoked by the european parliament or by the council . 2 . the institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall inform the other legislator and the commission at the latest one month before the final decision is taken , stating the delegated powers which could be subject to revocation and the reasons for any such revocation . ### the delegation of powers referred to in articles 3 and 5 may be revoked at any time by the european parliament or by the council . 2 . the institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the commission within a reasonable time before the final decision is taken , indicating the delegated powers which could be subject to revocation and the reasons for any such revocation .


### the european parliament or the council may object to a delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period may be extended by one month . 2 . if , on expiry of that period , neither the european parliament nor the council has objected to the delegated act , or if , before that date , the european parliament and the council have both informed the commission that they have decided not to raise objections , the delegated act shall enter into force on the date stated in its provisions . ### the european parliament or the council may object to a delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period may be extended by two months . 2 . if , on expiry of that period , neither the european parliament nor the council has objected to the delegated act , it shall be published in the official journal of the european union and shall enter into force at the date stated therein . the delegated act may be published in the official journal of the european union and enter into force before the expiry of that period if the european parliament and the council have both informed the commission of their intention not to raise objections .


### risks however are associated with the use of organs in transplantation . the extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases . ### risks however are associated with the use of organs in transplantation . the extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimize any risks associated with the transmission of diseases . well - organized national transplant systems and use of the best available expertise , technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs for patients .


### risks however are associated with the use of organs in transplantation . the extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases . ### risks however are associated with the use of organs in transplantation . the extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases . well - organised national transplant systems and use of the best available expertise , technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs for patients .


### pre - transplant evaluation of potential donors is an essential part of organ transplantation . this evaluation must provide enough information for the transplant centre to undertake a proper risk - benefit analysis . the risks and characteristics of the organ must be identified and documented to allow allocation to a suitable recipient . information should be collected for complete characterisation of the organ and the donor . ### pre - transplant evaluation of potential donors is an essential part of organ transplantation . this evaluation must provide enough information for the transplant centre to undertake a proper risk - benefit analysis . the risks and characteristics of the organ must be identified and documented to allow allocation to a suitable recipient . information from clinical history , physical examination and complementary tests should be collected for complete characterisation of the organ and the donor . to obtain an accurate , reliable and objective history , the medical team should interview the living donor or the relatives of the deceased donor . this is essential since the time constraints of the process of deceased donation reduce the ability to rule out potentially serious transmissible diseases . during the interviews , the team should properly inform the interviewees of the risks and consequences of donation and transplantation so as to make them aware of the importance of providing the medical team with all relevant information .


### personnel directly involved in the donation , procurement , testing , preservation , transport and transplantation of human organs should be suitable qualified and trained . ### personnel directly involved in the donation , testing , characterisation , procurement , preservation , transport and transplantation of human organs should be suitably qualified and competent .


### this directive should respect the fundamental rights and observe the principles recognised in particular by the charter of fundamental rights of the european union11 . in line with that charter and to take account of , as appropriate the convention on human rights and biomedicine12 , organ transplantation programmes should be founded on the principles of voluntary and unpaid donation , altruism of the donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor and the recipient . ### to ensure the quality and safety of organs for transplantation , organ transplantation programmes should be founded on the principles of voluntary and unpaid donation . this is an essential aspect , since the violation of these principles might be associated with unacceptable risks and poor outcomes for recipients and living donors . when donation is not voluntary and / or provides for financial gain , the quality of the process of donation cannot be fully guaranteed , since improving the quality of life or saving the life of a person is not the main and / or the sole objective to be achieved . even if the process is developed in accordance with appropriate quality standards , the clinical history obtained either from the potential living donor or the relatives of the potential deceased donor might not be accurate enough in terms of those conditions and / or diseases which are potentially transmissible from donors to recipients when donors are seeking financial gain or are subjected to any kind of coercion . this would imply a safety problem for potential recipients since the team would have a limited capability for performing an appropriate risk analysis . this directive should respect the fundamental rights and observe the principles recognised in particular by the charter of fundamental rights of the european union . in line with that charter it should also take account of , as appropriate , the convention on human rights and biomedicine and the revised world health organisation guiding principles on human cell , tissue and organ transplantation .


### article 8 of directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data13 prohibits in principle the processing of data concerning health . limited exemptions to this prohibition principle are laid down . directive 95 / 46 / ec also requires the controller to implement appropriate technical and organisational measures to protect personal data against accidental or unlawful destruction or accidental loss , alteration , unauthorised disclosure or access and against all other unlawful forms of processing . ### article 8 of directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data prohibits in principle the processing of data concerning health . limited exemptions to this prohibition are laid down . directive 95 / 46 / ec also requires the controller to implement appropriate technical and organizational measures to protect personal data against accidental or unlawful destruction or accidental loss , alteration , unauthorised disclosure or access and against all other unlawful forms of processing . in line with that directive , strict confidentiality rules and security measures should be in place for the protection of the donors’ and the recipients’ personal data . moreover , the competent authority may also consult the national data protection authority in relation to developing a framework for the transfer of data concerning organs to and from third countries .


### ' authorisation ' means authorisation , accreditation , designation or licensing , depending of the concepts used in each member state ; ### authorization ' means authorization , accreditation , designation or licensing or registration , depending of the concepts used in each member state ;


### ' donor characterisation ' means the collection of the relevant information on the characteristics of the donor needed to undertake a proper risk assessment in order to minimise the risks for the recipient and to optimise organ allocation ; ### ‘ donor characterization’ means the collection of the relevant information on the characteristics of the donor needed to evaluate his / her suitability , to undertake a proper risk assessment and minimize the risks for the recipient , and to ensure an effective organ allocation ;


### ' organ characterisation ' means the collection of the relevant information on the characteristics of the organ needed to undertake a proper risk assessment in order to minimise the risks for the recipient and to optimise organ allocation ; ### ' organ characterisation ' means the collection of the relevant information on the characteristics of the organ needed to evaluate its suitability , to undertake a proper risk assessment and minimise the risks for the recipient , and to ensure an effective organ allocation ;


### ' european organ exchange organisation ' means a non - profit organisation , whether public or private , dedicated especially to cross - border organ exchange ; the countries members of such an organisation are in their majority member states of the community ; ### ' european organ exchange organisation ' means a non - profit organisation , whether public or private , dedicated to national and / or cross - border organ exchange ; the countries members of such an organisation are in their majority member states of the community ;


### ' organ ' means a differentiated and vital part of the human body , formed by different tissues , that maintains its structure , vascularisation , and capacity to develop physiological functions with an important level of autonomy ; ### ' organ ' means a differentiated part of the human body , formed by different tissues , that maintains its structure , vascularisation , and capacity to develop physiological functions with an important level of autonomy ; a part of an organ is also considered to fall within the scope of this definition if its function is to be used for the same purpose as the entire organ in the human body , maintaining the requirements of structure and vascularisation ;


### ' serious adverse reaction ' means an unintended response , including a communicable disease , in the donor or in the recipient associated with any stage of the chain from donation to transplantation that is fatal , life - threatening , disabling , incapacitating , or which results in , or prolongs , hospitalisation or morbidity ; ### ' serious adverse reaction ' means an unintended response , including a communicable disease , in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal , life - threatening , disabling , incapacitating , or which results in , or prolongs , hospitalisation or morbidity ;


### the quality and safety of organs ### framework for quality and safety


### national quality programmes ### framework for quality and safety


### the national quality programmes shall ### in addition , the framework for quality and safety shall ensure that the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal is suitably qualified and competent , and shall develop specific training programmes for such personnel


### standard operating procedures for the verification of the details of donor or donor family consent or authorisation in accordance with national rules ; ### procedures for the verification of the details of donor or donor family consent or authorisation in accordance with national rules applying where donation and procurement take place ;


### rules for the transportation of human organs in accordance with article 8 . ### procedures for the transportation of human organs in accordance with article 8 .


### member states shall ensure that there is a reporting system in place to report , investigate , register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the procurement , testing , and transport of organs , as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities . ### member states shall ensure that there is a reporting system in place to report , investigate , register and transmit relevant and necessary information concerning serious adverse events and reactions that may influence the quality and safety of human organs and which may be attributed to the testing , characterisation , procurement , preservation and transport of organs , as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities


### member states shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ transplantation activities , in conformity with community provisions on the protection of personal data , such as directive 95 / 46 / ec , and in particular articles 8 , 16 , 17 and 28 of that directive . ### member states shall ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ donation and transplantation activities , in conformity with community provisions on the protection of personal data , such as directive 95 / 46 / ec , and in particular articles 8 , 16 , 17 and 28 of that directive .


### member states shall report to the commission before &#8230 ; &#8230 ; &#8230 ; &#8230 ; . and every three years thereafter on the activities undertaken in relation to the provisions of this directive , and on the experience gained in implementing it . ### member states shall report to the commission before &#8230 ; &#8230 ; &#8230 ; &#8230 ; * . and every three years thereafter on the activities undertaken in relation to the provisions of this directive , and on the experience gained in implementing it . * 6 years after the entry into force of this directive .


### before …… . and every three years thereafter , the commission shall transmit to the european parliament , the council , the european economic and social committee and the committee of the regions , a report on the implementation of this directive ### before …… . ** and every three years thereafter , the commission shall transmit to the european parliament , the council , the european economic and social committee and the committee of the regions , a report on the implementation of this directive **5 years after the entry into force of this directive


### during the period 2014 - 2020 the eit should contribute to ‘ horizon2020 - the framework programme for research and innovation’ established by regulation no xx / xxxx of the european parliament and of the council objectives by integrating the knowledge triangle of research , innovation and education . ### during the period 2014 - 2020 the eit should contribute to ‘ horizon2020 - the framework programme for research and innovation’ established by regulation no xx / xxxx of the european parliament and of the council objectives by integrating the knowledge triangle of research , innovation and education in order to stimulate excellence and to accelerate innovation .


### the eit should directly engage with national and regional representatives and other stakeholders from across the innovation chain , generating beneficial effects on both sides . in order to render such dialogue and exchange more systematic , an eit stakeholder forum should be organised , bringing together the wider community of stakeholders around cross - cutting issues . ### the eit should directly engage with national and regional representatives and other stakeholders from across the innovation chain , generating beneficial effects on both sides . in order to render such dialogue and exchange more systematic , an eit stakeholder forum should be organised , bringing together the wider community of stakeholders including ngos around cross - cutting issues .


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


### new kics , including their priority fields and the organisation and timing of the selection process , should be launched on the basis of modalities defined in the strategic innovation agenda . ### the strategic innovation agenda defines the modalities according to which new kics are launched . part of the budget for new kics for the period 2014 - 2020 shall be spend on kics based on the themes defined in the strategic innovation agenda . the other part of the budget can be allocated freely by the eit to either enforce these kics or to launch kics on other themes . the eit has the freedom to choose the appropriate size , duration and time framework for all new kics .


### the kics should seek synergies with relevant european union initiatives . ### the kics should seek synergies and linkages with relevant and complementary research , development and innovation initiatives and instruments at european level , such as the european innovation partnerships and set - plans .


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


### ‘ stakeholder forum’ means a meeting open to representatives of national and regional authorities , organised interests and individual entities from business , higher education , and research , cluster organisations , as well as other interested parties from across the knowledge triangle . ### ‘ stakeholder forum’ means a platform open to representatives of national and regional authorities , organised interests and individual entities from business , higher education , research , civil society organisations and cluster organisations , as well as other interested parties from across the knowledge triangle .


### ' stakeholder forum ' means a meeting open to representatives of national and regional authorities , organized interests and individual entities from business , higher education , and research , cluster organisations , as well as other interested parties from across the knowledge triangle ' . ### ' stakeholder forum ' means a meeting open to representatives of national , regional and local authorities , organized interests and individual entities from business , higher education , and research , cluster organisations , as well as other interested parties from across the knowledge triangle ' .


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


### the eit ' s mission is to contribute to sustainable european economic growth and competitiveness by reinforcing the innovation capacity of the member states and the union . it shall do this by promoting and integrating higher education , research and innovation of the highest standards . the eit ' general objectives , specific objectives and result indicators for the period 2014 - 2020 are defined in horizon 2020 ' . ### the eit ' s mission is to contribute to sustainable european economic growth and competitiveness and to obtain solutions for the grand societal challenges facing the european society as mentioned in recital 9a , by reinforcing and accelerating the innovation capacity of the member states and the union . it shall do this by promoting and integrating higher education , research and innovation of the highest standards . the eit ' general objectives , specific objectives and result indicators for the period 2014 - 2020 are defined in horizon 2020 ' .


### readiness to establish synergies with other european union initiatives , ### readiness to establish synergies with other european union initiatives in the field of research , development and innovation ,


### the eit , shall on the basis of key performance indicators and in cooperation with the commission , organise continuous monitoring and periodic external evaluations of the outputs , results and impact of each kic . ### the eit , shall on the basis of key quantitative and qualitative performance indicators , organise monitoring and triennial external evaluations of the outputs , results and impact of each kic . this monitoring and evaluation shall be results - oriented .


### duration , continuation and termination of a kic ### duration , continuation , financing and termination of a kic


### the governing board may decide to extend the operation of a kic beyond the period initially set if this is the most appropriate way to achieve the objectives of the eit . ### subject to the outcomes of the monitoring and periodic evaluations , the governing board may decide every three years to extend the financing of the operation of a kic if it proves to achieve its objectives and those of the eit . the governing board shall apply a tailor - made approach , taking into account that not all kics would have the same financial needs , size or duration . the governing board can decide to award extra budget to a kic if it reaches its goals earlier than foreseen .


### an annual report by 30 june each year . the report shall outline the activities conducted by the eit and the kics during the preceding calendar year and assess the results with respect to the objectives , indicators and timetable set , the risks associated with the activities carried out , the use of resources and the general operation of the eit . ### an annual report to be made public by 30 june each year . the report shall outline the activities conducted by the eit and the kics during the preceding calendar year and assess the results with respect to the objectives , indicators and timetable set , the risks associated with the activities carried out , the use of resources and the general operation of the eit . every year , the eit director shall present the annual report to the competent committees of the european parliament .


### a rolling triennial work programme , based on the sia , once it is adopted , containing a statement of the major priorities and planned initiatives of the eit and the kics , including an estimate of financing needs and sources . it shall also contain appropriate indicators for monitoring the kics and eit activities . the preliminary rolling triennial work programme shall be submitted by the eit to the commission by 31 december each n - 2 . the commission shall deliver an opinion within three months with regard to eit specific objectives as defined in horizon 2020 and its complementarities with union policies and instruments . the eit shall take a due account of the commission opinion , and in case of disagreement justify its position . the final work programme shall be transmitted by the eit to the european parliament , the council , the commission , the european economic and social committee and the committee of the regions for information ; ### a rolling triennial work programme , based on the sia , once it is adopted , containing a statement of the major priorities and planned initiatives of the eit and the kics , including an estimate of financing needs and sources . it shall also contain appropriate indicators for monitoring the kics and eit activities , using a results - oriented approach . the preliminary rolling triennial work programme shall be submitted by the eit to the commission by 31 december each n - 2 . the commission shall deliver an opinion within three months with regard to eit specific objectives as defined in horizon 2020 and its complementarities with union policies and instruments . the eit shall take a due account of the commission opinion , and in case of disagreement justify its position . the final work programme shall be transmitted by the eit to the european parliament , the council , the commission , the european economic and social committee and the committee of the regions for information ;


### member states shall ensure that deposit guarantee schemes do not deviate from the coverage level laid down in paragraph 1 . however , member states may decide that the following deposits are covered provided that the costs for such repayments are not subject to article 9 , 10 and 11 : ### member states shall ensure that depositors have a legal entitlement to the coverage level laid down in paragraph 1 . however , member states may decide that the following deposits are covered provided that the costs for such repayments are not subject to article 9 , 10 and 11 :


### deposit guarantee schemes shall be in a position to repay unavailable deposits within 7 days of the date on which the competent authorities make a determination as referred to in article 2 or a judicial authority makes a ruling as referred to in article 2 . ### deposit guarantee schemes shall be in a position to repay unavailable deposits within four weeks of the date on which the competent authorities make a determination as referred to in article 2 or a judicial authority makes a ruling as referred to in article 2 . from 1 january 2017 , this period shall be reduced to one week . during the transitional period between the entry into force of the directive and the reduction of the payout delay , depositors shall be paid up to € 5 000 of their existing credit balances within a period of one week .


### the european parliament and the council may object to the delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by one month . ### the european parliament and the council may object to the delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by two months .


### proportionate to the risk class and the type of device , manufacturers of devices , other than custom - made devices , shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service and to apply any necessary corrective action , hereinafter referred to as ‘ post - market surveillance plan’ . the post - market surveillance plan shall set out the process for collecting , recording and investigating complaints and reports from healthcare professionals , patients or users on suspected incidents related to a device , keeping a register of non - conforming products and product recalls or withdrawals , and if deemed appropriate due to the nature of the device , sample testing of marketed devices . part of the post - market surveillance plan shall be a plan for post - market clinical follow - up in accordance with part b of annex xiii . where post - market clinical follow - up is not deemed necessary , this shall be duly justified and documented in the post - market surveillance plan . ### proportionate to the risk class and the type of device , manufacturers of devices , other than custom - made devices , shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service and to apply any necessary corrective action , hereinafter referred to as post - market surveillance plan’ . the post - market surveillance plan shall set out the process for collecting , recording , communicating to the electronic system on vigilance referred to in article 62 and investigating complaints and reports from healthcare professionals , patients or users on suspected incidents related to a device , keeping a register of non - conforming products and product recalls or withdrawals , and if deemed appropriate due to the nature of the device , sample testing of marketed devices . part of the post - market surveillance plan shall be a plan for post - market clinical follow - up in accordance with part b of annex xiii . where post - market clinical follow - up is not deemed necessary , this shall be duly justified and documented in the post - market surveillance plan and subject to approval by the competent authority . second subparagraph shall not apply to class iii medical devices .


### the legitimate interest in protecting commercially sensitive information ; ### the legitimate interest in protecting commercially sensitive information , providing that it does not conflict with public health protection ;


### in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . ### in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . this summary shall be accompanied by the dataset collected during the clinical investigation and the post - market clinical follow - up . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body .


### member states shall provide the commission and the other member states with information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto . ### member states shall provide the commission and the other member states with information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto . based on this exchange of information and on best practices established across member states , the commission shall define , within 2 years after the entry into force of this regulation , guidelines for the procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies to be carried out by national authorities concerned .


### the commission shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body of the requirements set out in annex vi or the obligations to which it is subject . it may also commence such investigations on its own initiative . ### the commission shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body of the requirements set out in annex vi or the obligations to which it is subject . it may also commence such investigations on its own initiative , including the unannounced inspection of the notified body by a joint assessment team whose composition meets the conditions set out in article 32 .


### the commission may , by means of implementing acts , specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects : ### the commission shall , by means of implementing acts , specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects :


### where demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate , adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body , the clinical performances intended and the claims of the manufacturer . the adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non - clinical testing methods alone , including performance evaluation , bench testing and pre - clinical evaluation , has to be duly substantiated in the technical documentation referred to in annex ii . ### except for class iii devices , where demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate , adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body , the clinical performances intended and the claims of the manufacturer . the adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non - clinical testing methods alone , including performance evaluation , bench testing and pre - clinical evaluation , has to be duly substantiated in the technical documentation referred to in annex ii . exemption from demonstration of conformity with general safety and performance requirements based on clinical data under the first subparagraph shall be subject to prior approval by the competent authority .


### clinical investigations shall be subject to articles 50 - 60 and annex xiv if they are conducted for one or more of the following purposes : ### clinical investigations whether they are carried out with the purpose of placing on the market of a medical device or its post - marketing study shall be subject to articles 50 - 60 and annex xiv if they are conducted for one or more of the following purposes :


### member states shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor , the institution of the investigation site and the investigators involved , as well as free of any other undue influence . ### member states shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor , the institution of the investigation site and the investigators involved , as well as free of any other undue influence . member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . realization of the clinical investigation shall be subject to a positive opinion by the responsible ethics committee .


### protection of commercially sensitive information ; ### protection of commercially sensitive information ; data on adverse events and safety data shall not be considered commercially sensitive information ;


### when setting up the electronic system referred in paragraph 1 , the commission shall ensure that it is interoperable with the eu database for clinical trials on medicinal products for human use set up in accordance with article [ … ] of regulation no [ … / … ] . with the exception of the information referred to in article 52 , the information collated and processed in the electronic system shall be accessible only to the member states and to the commission . ### when setting up the electronic system referred in paragraph 1 , the commission shall ensure that it is interoperable with the eu database for clinical trials on medicinal products for human use set up in accordance with article [ . . . ] of regulation no [ . . . / . . . ] . with the exception of the information referred to in article 52 , and point of article 53 the information collated and processed in the electronic system shall be accessible only to the member states and to the commission .


### the commission shall be empowered to adopt delegated acts in accordance with article 89 determining which other information regarding clinical investigations collated and processed in the electronic system shall be publicly accessible to allow interoperability with the eu database for clinical trials on medicinal products for human use set up by regulation no [ … / … ] . article 52 and shall apply . ### the commission shall be empowered to adopt delegated acts in accordance with article 89 for determining the technical requirements and parameters to allow interoperability with the eu database for clinical trials on medicinal products for human use set up by regulation no [ . . . / . . . ] .


### the sponsor may implement the modifications referred to in paragraph 1 at the earliest 30 days after notification , unless the member state concerned has notified the sponsor of its refusal based on considerations of public health , patient safety or public policy . ### the sponsor may implement the modifications referred to in paragraph 1 at the earliest 30 days after notification , unless the member state concerned has notified the sponsor of its duly justified refusal .


### where a member state has refused , suspended or terminated a clinical investigation , or has called for a substantial modification or temporary halt of a clinical investigation , or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds , that member state shall communicate its decision and the grounds therefor to all member states and the commission by means of the electronic system referred to in article 53 . ### where a member state has refused , suspended or terminated a clinical investigation , or has called for a substantial modification or temporary halt of a clinical investigation , or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds , that member state shall communicate such facts and its decision and the grounds therefor to all member states and the commission by means of the electronic system referred to in article 53 .


### if the investigation is conducted in more than one member state the sponsor shall notify all member states concerned of the overall end of the clinical investigation . that notification shall be made within 15 days from the overall end of the clinical investigation . ### if the investigation is conducted in more than one member state the sponsor shall notify all member states concerned of the early termination in one member state and of the overall end of the clinical investigation . that notification shall be made within 15 days from the end of the clinical investigation in one or more member states .


### within one year from the end of the clinical investigation , the sponsor shall submit to the member states concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in section 2 . 7 of chapter i of annex xiv . where , for scientific reasons , it is not possible to submit the clinical investigation report within one year , it shall be submitted as soon as it is available . in this case , the clinical investigation plan referred to in section 3 of chapter ii of annex xiv shall specify when the results of the clinical investigation are going to be submitted , together with an explanation . ### within one year from the end of the clinical investigation , the sponsor shall submit to the member states concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in section 2 . 7 of chapter i of annex xiv , together with all the data collected during the clinical investigation , including negative findings . where , for scientific reasons , it is not possible to submit the clinical investigation report within one year , it shall be submitted as soon as it is available . in this case , the clinical investigation plan referred to in section 3 of chapter ii of annex xiv shall specify when the results of the clinical investigation are going to be submitted , together with an explanation .


### in the single application , the sponsor shall propose one of the member states concerned as coordinating member state . if that member state does not wish to be the coordinating member state , it shall agree , within six days of submission of the single application , with another member state concerned that the latter shall be the coordinating member state . if no other member state accepts to be the coordinating member state , the member state proposed by the sponsor shall be the coordinating member state . if another member state than the one proposed by the sponsor becomes coordinating member state , the deadline referred to in article 51 shall start on the day following the acceptance . ### concerned member states shall agree , within six days of submission of the single application , which member state shall be the coordinating member state . member states and the commission shall agree , in the framework of the attributions of the mdcg , on clear rules for designating the coordinating member state .


### in the case of a clinical investigation for which the sponsor has used the single application referred to in article 58 , the sponsor shall report any event as referred to in paragraph 2 by means of the electronic system referred to in article 53 . upon receipt , this report shall be transmitted electronically to all member states concerned . ### in the case of a clinical investigation for which the sponsor has used the single application referred to in article 58 , the sponsor shall report any event as referred to in paragraphs 1 and 2 by means of the electronic system referred to in article 53 . upon receipt , this report shall be transmitted electronically to all member states concerned .


### members of the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . upon request , the declaration of interests shall be accessible to the public . this article shall not apply to the representatives of stakeholder organisations participating in the sub - groups of the mdcg . ### members of the mdcg , of the advisory panels to the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . upon request , the declaration of interests shall be accessible to the public . this article shall not apply to the representatives of stakeholder organizations participating in the sub - groups of the mdcg .


### 4 . the notified body shall randomly perform unannounced factory inspections to the manufacturer and , if appropriate , of the manufacturer’s suppliers and / or subcontractors , which may be combined with the periodic surveillance assessment referred to in section 4 . 3 . or be performed in addition to this surveillance assessment . the notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer . ### 4 . the notified body shall randomly perform unannounced factory inspections to the manufacturer and , if appropriate , of the manufacturer’s suppliers and / or subcontractors , which may be combined with the periodic surveillance assessment referred to in section 4 . 3 . or be performed in addition to this surveillance assessment . the notified body shall establish a plan for the unannounced inspections which shall not take a periodicity lower than one inspection per year and must not be disclosed to the manufacturer .


### post - market clinical follow - up , hereinafter : pmcf , is a continuous process to update the clinical evaluation referred to in article 49 and part a of this annex and shall be part of the manufacturer ' s post - market surveillance plan . to this end , the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is authorised to bear the ce marking , within its intended purpose as referred to in the relevant conformity assessment procedure , with the aim of confirming the safety and performance throughout the expected lifetime of the device , the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence . ### post - market clinical follow - up , hereinafter : pmcf , is a continuous process to update the clinical evaluation referred to in article 49 and part a of this annex and shall be part of the manufacturer ' s post - market surveillance plan . to this end , the manufacturer shall proactively collect , register in the electronic system on vigilance referred to in article 62 and evaluate clinical data from the use in or on humans of a device which is authorised to bear the ce marking , within its intended purpose as referred to in the relevant conformity assessment procedure , with the aim of confirming the safety and performance throughout the expected lifetime of the device , the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence .


### the manufacturer shall analyse the findings of the pmcf and document the results in a pmcf evaluation report that shall be part of the technical documentation . ### the manufacturer shall analyse the findings of the pmcf and document the results in a pmcf evaluation report that shall be part of the technical documentation and be sent periodically to the concerned member states .


### the conclusions of the pmcf evaluation report shall be taken into account for the clinical evaluation referred to in article 49 and part a of this annex and in the risk management referred to in section 2 of annex i . if through the pmcf the need for corrective measures has been identified , the manufacturer shall implement them . ### the conclusions of the pmcf evaluation report shall be taken into account for the clinical evaluation referred to in article 49 and part a of this annex and in the risk management referred to in section 2 of annex i . if through the pmcf the need for corrective measures has been identified , the manufacturer shall implement them and inform the concerned member states .


### every step in the clinical investigation , from first consideration of the need and justification of the study to the publication of the results , shall be carried out in accordance with recognised ethical principles , as for example those laid down in the world medical association declaration of helsinki on ethical principles for medical research involving human subjects , adopted by the 18th world medical association general assembly in helsinki , finland , in 1964 , and last amended by the 59th world medical association general assembly in seoul , korea , in 2008 . ### every step in the clinical investigation , from first consideration of the need and justification of the study to the publication of the results , shall be carried out in accordance with recognised ethical principles , as for example those laid down in the world medical association declaration of helsinki on ethical principles for medical research involving human subjects , adopted by the 18th world medical association general assembly in helsinki , finland , in 1964 , and last amended by the 59th world medical association general assembly in seoul , korea , in 2008 . accordance with these principles shall be guaranteed by means of a favourable opinion from an ethics committee .


### 7 . the clinical investigation report , signed by the medical practitioner or other authorised person responsible , shall contain a critical evaluation of all the data collected during the clinical investigation , including negative findings . ### 7 . the clinical investigation report , signed by the medical practitioner or other authorised person responsible , shall contain all clinical data collected during the clinical investigation and a critical evaluation of such data , including negative findings and must be publicly accessible through the electronic system referred to in article 53 .


### it is necessary to provide for transitional arrangements that allow making available on the market electrical equipment which has already been placed on the market in accordance with directive 2006 / 95 / ec . ### manufacturers and importers need to be given reasonable , but limited , time to exercise any rights under national rules in force before the date of application of national rules transposing this directive in order , for example , to sell their stocks of manufactured products . it is necessary to provide for transitional arrangements that allow making available on the market electrical equipment which has already been placed on the market in accordance with directive 2006 / 95 / ec .


### draft legislative resolution ### recalls its resolution of 8 june 2011 on investing in the future : a new multiannual financial framework for a competitive , sustainable and inclusive europe1 ; reiterates that sufficient additional resources are needed in the next mff in order to enable the union to fulfil its existing policy priorities and the new tasks provided for in the treaty of lisbon , as well as to respond to unforeseen events ; points out that even with an increase in the level of resources for the next mff of at least 5 % compared to the 2013 level only a limited contribution can be made to the achievement of the union’s agreed objectives and commitments and the principle of union solidarity ; challenges the council , if it does not share this approach , to clearly identify which of its policy priorities or projects could be dropped altogether , despite their proven european added value ; ___________ 1 texts adopted , p7_ta0266 .


### creating conditions for well managed mobility of people and promotion of people - to - people contacts ; ### creating conditions for well managed mobility of people , active participation of civil society and social stakeholders and promotion of people - to - people contacts , and ensuring that resources are used more efficiently to foster a leverage effect on regional integration and contribute to the resolution of internal conflicts and a reduction in migration ;


### union support provided under this regulation to each partner country shall be differentiated in form and amounts according to the partner country ' s commitment to reforms and its progress in implementing these reforms . such differentiation shall reflect the level of ambition of the country ' s partnership with the union , its progress in building deep and sustainable democracy , its progress in implementing agreed reform objectives , the country ' s needs and capacities , and the potential impact of union support . ### union support provided under this regulation to each partner country shall be differentiated in form and amounts according to the partner country ' s commitment to reforms and its progress in implementing these reforms . such differentiation shall reflect the level of ambition of the country ' s partnership with the union , its progress in building deep and sustainable democracy , respect for and compliance with the fundamental principles of the rule of law and a social market economy , its progress in implementing agreed reform objectives , the country ' s needs and capacities , and the potential impact of union support .


### the detection of fraud , identification of risk trends and the implementation of effective risk management procedures depend significantly on the identification and cross - analysis of relevant operational data sets . it is necessary therefore to establish , at european union level , a directory containing data on import , export and transit of goods including transit of goods within the member states and direct export . for that purpose , member states should allow systematic replication of data on import , export and transit of goods from the systems operated by the commission and should supply to the commission data relating to transit of goods within a member state and direct export . ### given the increase in the scale of customs fraud , it is crucial to increase detection and prevention simultaneously at national and european level . the detection of fraud , identification of risk trends and the implementation of effective risk management procedures depend significantly on the identification and cross - analysis of relevant operational data sets . it is necessary therefore to establish , at european union level , the fullest possible directory containing data on import , export and transit of goods by land , sea or air , including transit of goods within the member states and direct export . for that purpose , member states should allow systematic replication of data on import , export and transit of goods from the systems operated by the commission and should supply to the commission data relating to transit of goods within a member state and direct export without delay . the commission should each year submit the results obtained from this directory to the european parliament and to the council .


### the introduction of the e - customs in 2011 , by which documents supporting imports and exports are no longer kept by the customs administrations but by the economic operators , has led to delays in the conduct of european anti - fraud office investigations in the customs area , as olaf needs the intermediation of these administrations to obtain such documents . moreover , the 3 - year limitation period applicable to customs documents held by the administration , puts additional constraints to the successful conduct of investigations . in order to accelerate the conduct of investigations in the area of customs the commission should therefore have the right to request documents supporting import and export declarations directly from the economic operators concerned . these economic operators should be obliged to provide the commission with the requested documents . ### the introduction of the e - customs in 2011 , by which documents supporting imports and exports are no longer kept by the customs administrations but by the economic operators , has led to delays in the conduct of european anti - fraud office investigations in the customs area , as olaf needs the intermediation of these administrations to obtain such documents . moreover , the 3 - year limitation period applicable to customs documents held by the administration , puts additional constraints to the successful conduct of investigations . in order to accelerate the conduct of investigations in the area of customs the commission should therefore , in certain circumstances and following prior notification to the member states , have the right to request documents supporting import and export declarations directly from the economic operators concerned . these economic operators should be obliged to provide the commission with the requested documents .


### the introduction of the e - customs in 2011 , by which documents supporting imports and exports are no longer kept by the customs administrations but by the economic operators , has led to delays in the conduct of european anti - fraud office investigations in the customs area , as olaf needs the intermediation of these administrations to obtain such documents . moreover , the 3 - year limitation period applicable to customs documents held by the administration , puts additional constraints to the successful conduct of investigations . in order to accelerate the conduct of investigations in the area of customs the commission should therefore have the right to request documents supporting import and export declarations directly from the economic operators concerned . these economic operators should be obliged to provide the commission with the requested documents . ### the introduction of the e - customs in 2011 , by which documents supporting imports and exports are no longer kept by the customs administrations but by the economic operators , has led to delays in the conduct of european anti - fraud office investigations in the customs area , as olaf needs the intermediation of these administrations to obtain such documents . moreover , the 3 - year limitation period applicable to customs documents held by the administration , puts additional constraints to the successful conduct of investigations . in order to accelerate the conduct of investigations in the area of customs the commission should therefore have the right to request documents supporting import and export declarations directly from the economic operators concerned . these economic operators should be obliged to provide the commission with the requested documents in good time , following advance notification by the commission to the member states .


### information obtained by staff of one member state and communicated to another member state in the course of the assistance provided for in articles 13 to 15 may be invoked as evidence by the competent bodies of the member state receiving the information . ### the following article is inserted : ' article 16a documents , certified true copies of documents , attestations , all instruments or decisions which emanate from the administrative authorities , reports , and any other intelligence obtained by staff of one member state and communicated to another member state in the course of the assistance provided for in articles 13 to 15 may constitute admissible evidence in administrative and judicial proceedings of the member state receiving the information in the same way as if they had been obtained in the member state where the proceedings take place . '


### ' 1 . without prejudice to the competences of the member states , for the purpose of risk management as set out in article 4 , points 25 and 26 , and article 13 of regulation no 2913 / 92 , and with a view to assisting the authorities referred to in article 29 to detect movements of goods that are the object of operations in potential breach of customs and agricultural legislation and means of transport , including containers , used for that purpose , the commission shall establish and manage a directory of data received from public or private service providers active in the international supply chain . that directory shall be directly accessible to those authorities . ' ### ' 1 . without prejudice to the competences of the member states , for the purpose of risk management as set out in article 4 , points 25 and 26 , and article 13 of regulation no 2913 / 92 , and with a view to assisting the authorities referred to in article 29 to detect movements of goods that are the object of operations in potential breach of customs and agricultural legislation and means of air , sea or land transport , including containers , used for that purpose , the commission shall establish and manage a directory of data received from public or private service providers active in the international supply chain . that directory shall be directly accessible to those authorities . '


### to access or extract and store the contents of the data , by any means or in any form , and to use data for the purposes of an administrative or judicial procedure in compliance with legislation applicable to intellectual property rights . the commission shall put in place adequate safeguards against arbitrary interference by public authorities including technical and organisational measures and transparency requirements towards the data subjects . data subjects shall be provided with the right of access and correction in relation to data processed for this purpose ; ### to access or extract and store the contents of the data , by any means or in any form , and to use data for the purposes of an administrative or judicial procedure in compliance with legislation applicable to intellectual property rights . data subjects shall be provided with the right of access and correction in relation to data processed for this purpose ;


### the following paragraphs 5 and 6 are added : ' 5 . the european data protection supervisor shall supervise compliance of this directory with regulation no 45 / 2001 . the commission shall implement appropriate technical and organisational measures to protect personal data against accidental or unlawful destruction , accidental loss or unauthorised disclosure , alteration and access or any other unauthorised form of processing . ' ### the following paragraph 6 is added :


### data shall be transferred under this paragraph only for the general purposes of this regulation also including the protection of the financial interests of the union , and / or for the purpose of risk management as set out in article 4 points 25 and 26 and article 13 of regulation no 2913 / 92 . ### data shall be transferred under this paragraph only for the general purposes of this regulation including the protection of the financial interests of the union , and / or for the purpose of risk management as set out in article 4 points 25 and 26 and article 13 of regulation no 2913 / 92 .


### the arrangement or memorandum of understanding based on which the transfer of data may take place under this paragraph shall include , inter alia , data protection principles such as the possibility for data subjects to exercise their rights of access and correction and to seek administrative and judicial redress , as well as an independent oversight mechanism to ensure compliance with the data protection safeguards . ### the transfer of data under this paragraph shall respect data protection principles , the possibility for data subjects to exercise their rights of access and correction and to seek administrative and judicial redress , as well as an independent oversight mechanism to ensure compliance with the data protection safeguards .


### the findings and information obtained in the course of the community missions referred to in article 20 of this regulation , and in particular documents passed on by the competent authorities of the third countries concerned , shall be handled in accordance with article 45 of this regulation . ### article 21 is replaced by the following : ‘ 1 . the findings and information obtained in the course of the community missions referred to in article 20 of this regulation , and in particular documents passed on by the competent authorities of the third countries concerned , as well as the information obtained during the course of an administrative enquiry , including by the commission’s services , shall be handled in accordance with article 45 of this regulation . ’


### access to data included in the cis shall be reserved exclusively for the national authorities designated by each member state and the departments designated by the commission . these national authorities shall be customs administrations but may also include other authorities competent , according to the laws , regulations and procedures of the member state in question , to act in order to achieve the aim stated in article 23 . ### access to data included in the cis shall be reserved for the national authorities designated by each member state and the departments designated by the commission . these national authorities shall be customs administrations but may also include other authorities competent , according to the laws , regulations and procedures of the member state in question , to act in order to achieve the aim stated in article 23 .


### data obtained from the cis may , with the prior authorization of , and subject to any conditions imposed by , the member state which included them in the system , be communicated for use by national authorities other than those referred to in paragraph 2 , third countries and international or regional organizations wishing to make use of them . each member state shall take special measures to ensure the security of such data when they are being transmitted or supplied to departments located outside its territory . the provisions referred to in the first subparagraph shall apply mutatis mutandis to the commission where it has entered the data in the system . ### article 30 is replaced by the following : 4 . data obtained from the cis may , with the prior authorization of , and subject to any conditions imposed by , the member state which included them in the system , be communicated for use by national authorities other than those referred to in paragraph 2 , third countries and international or regional organizations and / or eu agencies which contribute to the protection of the financial interests of the union and correct application of customs legislation . each member state shall take special measures to ensure the security of such data when they are being transmitted or supplied to departments located outside its territory . the provisions referred to in the first subparagraph shall apply mutatis mutandis to the commission where it has entered the data in the system .


### the commission shall verify that the searches carried out were authorized and were carried out by authorised users . at least 1% of all searches made shall be verified . a record of such searches and verifications shall be entered into the system and shall be used only for the said verifications . it shall be deleted after six months . ### the commission shall verify that the searches carried out were authorized and were carried out by authorised users . the level of verification shall depend on the extent of the area to be verified , the severity of the infringement and expected amount of revenue affected , but shall always be equal to 1% or more of searches made . a record of such searches and verifications shall be entered into the system and shall be used only for the said verifications . it shall be deleted after six months .


### the commission shall act as a common designated authority for the administrative functions of the convention with reference to the pic procedure on behalf of and in close cooperation and consultation with all the designated national authorities of the member states . ### with regard to the union ' s participation in the convention , for the administrative functions of the convention with reference to the pic procedure and the export notification , the commission shall act as a common designated authority on behalf of and in close cooperation and consultation with all the designated national authorities of the member states .


### where appropriate , provide , with the agreement of the commission , assistance and technical and scientific guidance and tools for the industry in order to ensure the effective application of this regulation ; ### where appropriate , provide assistance and technical and scientific guidance and tools for the industry in order to ensure the effective application of this regulation ;


### provide the designated national authorities , with the agreement of the commission , with assistance and technical and scientific guidance in order to ensure the effective application of this regulation ; ### provide the designated national authorities with assistance and technical and scientific guidance in order to ensure the effective application of this regulation ;


### in the case of chemicals listed in parts 2 or 3 of annex i , the designated national authority of the exporter may , in consultation with the commission assisted by the agency and on a case - by - case basis , decide that the export may proceed if , after all reasonable efforts , no response to a request for explicit consent pursuant to paragraph 6 has been received within 60 days and there is evidence from official sources in the importing party or other country that the chemical has been licensed , registered or authorised or that it has in the last 5 years been used in , or imported into the importing party or importing other country and no regulatory action has been taken to prohibit its use . ### in the case of chemicals listed in part 2 of annex i , the designated national authority of the exporter may , in consultation with the commission assisted by the agency and on a case - by - case basis , decide that the export may proceed if , after all reasonable efforts , no response to a request for explicit consent pursuant to paragraph 6 has been received within 60 days and the following conditions have been met : there is evidence from official sources in the importing party or other country that the chemical has been licensed , registered or authorised ; and the substance listed in annex i has not been classified or does not meet the criteria to be classified as : - carcinogenic category 1a or 1b in accordance with regulation no 1272 / 20081 ; - mutagenic category 1a or 1b in accordance with regulation no 1272 / 2008 ; - toxic for reproduction category 1a or 1b in accordance with regulation no 1272 / 2008 ; - persistent , bioaccumulative and toxic or very persistant and very bioaccumulative in accordance with the criteria set out in annex xiii to regulation no 1907 / 20062 ; - having endocrine - disrupting properties that may cause adverse effects in humans on the basis of the assessment of union or internationally agreed test guidelines or other peer - reviewed scientific data and information , including a review of the scientific literature , reviewed by the agency , or is identified in accordance with articles 57 and 59 of regulation no 1907 / 2006 as having endocrine - disrupting properties . ____________ 1oj l 33 , 31 . 12 . 2008 2 oj l 136 , 29 . 5 . 2007


### this directive lays down minimum rules . member states may extend the rights set out in this directive in order to provide a higher level of protection . ### this directive lays down minimum rules . member states may extend the rights set out in this directive , in particular so as to give victims a comprehensive status of party in criminal proceedings , including the right to legal aid and access to the file , in order to provide a higher level of protection .


### when providing information , sufficient detail should be given to ensure that victims are treated in a respectful manner and to enable them to make informed decisions about their participation in proceedings and how to access their rights . in this respect , information allowing the victim to know about the current status of any proceedings and their progress is particularly important . this is equally relevant for information to enable a victim to decide whether to request a review of a decision not to prosecute . ### when providing information , victims should be permitted access to the relevant case files and sufficient detail should be given to ensure that victims are treated in a respectful manner and to enable them to make informed decisions about their participation in proceedings and how to access their rights . in this respect , information allowing the victim to know about the current status of any proceedings and their progress is particularly important . this is equally relevant for information to enable a victim to decide whether to request a review of a decision not to prosecute .


### member states shall ensure that victims are provided with the following information , without unnecessary delay , from their first contact with the authority competent to receive a complaint concerning a criminal offence : ### member states shall ensure that victims are provided with the following information , without unnecessary delay , from their first contact with any public authority following a complaint about a criminal offence :


### member states shall ensure that victims are notified of their right to receive the following information on their case and that they receive this information where they have expressed such a wish : ### member states shall ensure that victims are notified of their right to receive information on their case and that they are able to have access to the relevant case files where they have expressed such a wish , and that they thus receive the following information :


### member states shall ensure that victims and their family members , in accordance with their needs , have access to free of charge , confidential victim support services . ### member states shall ensure that victims and their family members , in accordance with their needs , have access to free of charge , confidential victim support services before , during , and for an appropriate amount of time after conclusion of any criminal proceedings .


### member states shall ensure that victims receive written acknowledgement of any complaint made by them to an appropriate authority of the member state . ### member states shall ensure that victims receive written acknowledgement in their own language of any complaint made by them to an appropriate authority of the member state .


### member states shall ensure that victims may be heard during criminal proceedings and may supply evidence . ### member states shall ensure that victims may take part in criminal proceedings and that they have the right to be heard during criminal proceedings and to supply evidence .


### member states shall take measures to encourage offenders to provide adequate compensation to victims . ### member states shall take measures to encourage offenders to provide adequate compensation to victims and shall assist victims in the timely enforcement of compensation orders .


### for the purposes of this directive , the following categories of victims are considered to be vulnerable due to their personal characteristics : ### for the purposes of this directive , the following categories of victims are considered to be vulnerable due to their personal characteristics or situation :


### children ; ### children and the elderly ;


### procedures for ensuring the correctness and regularity of expenditure declared ; ### procedures for ensuring the correctness and regularity of expenditure declared and respect for the principle of sound financial management ;


### procedures for ensuring the correctness and regularity of expenditure declared ; ### procedures for ensuring the legality and regularity and sound financial management of expenditure declared ;


### the payment deadline for an interim payment claim may be interrupted by the authorising officer by delegation within the meaning of the financial regulation for a maximum period of nine months if : ### the payment deadline for an interim payment claim may be interrupted by the authorising officer by delegation within the meaning of the financial regulation for a maximum period of nine months if one or more of the following conditions are met :