### clinical trial data submitted in an application dossier shall be based on clinical trials which have been registered prior to their start in a public register which is a primary registry of the international clinical trials registry platform of the world health organisation . ### clinical trial data based on clinical trials conducted as from . . . [ date of application of this regulation ] and submitted in an application dossier shall be based on clinical trials which have been registered prior to their start in a public register which is a primary or partnered registry of the international clinical trials registry platform of the world health organisation .


### where the sponsor so requests , the application for authorisation of a clinical trial , its assessment and the decision shall be limited to the aspects covered by part i of the assessment report . ### where the sponsor so requests , the application for authorisation of a clinical trial shall be limited to the aspects covered by part i of the assessment report .


### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator in accordance with his or her age and maturity ; ### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator


### unless other union legislation requires archiving for a longer period , the sponsor and the investigator shall archive the content of the clinical trial master file for at least five years after the end of the clinical trial . however , the medical files of subjects shall be archived in accordance with national legislation . ### the sponsor and the investigator shall archive the content of the clinical trial master file for an indefinite period of time after concluding the clinical trial . however , the medical files of subjects shall be archived in accordance with national legislation . if the sponsor is unable to archive the master file , it may be archived in the eu database .


### within four days following submission of the application dossier , the reporting member state shall notify the sponsor through the eu portal of the following : ### within ten days following submission of the application dossier , the reporting member state shall notify the sponsor through the eu portal of the following :


### according to the protocol of the clinical study , the investigational medicinal products are not used in accordance with the terms of the marketing authorisation of the member state concerned ; ### according to the protocol of the clinical study , the investigational medicinal products are not used in accordance with the terms of the marketing authorisation of the member state concerned and their use does not fall within normal clinical practice ;


### within one year from the end of a clinical trial , the sponsor shall submit to the eu database a summary of the results of the clinical trial . however , where , for scientific reasons , it is not possible to submit a summary of the results within one year , the summary of results shall be submitted as soon as it is available . in this case , the protocol shall specify when the results are going to be submitted , together with an explanation . ### within one year from the end of a clinical trial , the sponsor shall submit to the eu database the clinical study report , including a lay summary of the clinical trial . however , where , for scientific reasons , it is not possible to submit the clinical study report within one year , it shall be submitted as soon as it is available . in this case , the protocol shall specify when the results are going to be submitted , together with an explanation .


### 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 . ### in the assessment , the view of an ethics committee shall be taken into account . the commission shall develop guidelines on patient involvement , drawing upon existing good practices .


### if elderly persons or women are excluded from the clinical trial , an explanation and justification for these exclusion criteria ; ### if the trial subjects do not reflect a balanced distribution in age and / or gender , this must be justified and explained ;


### ‘ informed consent’ : a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial , after having been informed of all aspects of the trial that are relevant to the subject ' s decision to participate ; ### ' informed consent ' : a process by which a subject freely and voluntarily confirms his or her willingness to participate in a particular trial , after having been informed of all aspects of the trial that are relevant to the subject ' s decision to participate ;


### written information given to the subject and / or the legal representative for the purposes of obtaining his or her informed consent shall be kept concise , clear , relevant , and understandable to a lay person . it shall include both medical and legal information . it shall inform the subject about his or her right to revoke his or her informed consent . ### any written information given to the subject and / or the legal representative prior to obtaining his or her informed consent shall be concise , clear , relevant , and understandable to a layperson . special attention should be given to the information needs of individual subjects and specific patient populations , as well as to the methods used to give the information . it shall include both medical and legal information . it shall inform the subject about his or her right to revoke his or her informed consent at any time .


### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator in accordance with his or her age and maturity ; ### the investigator duly takes into consideration , in accordance with the age and maturity of the minor concerned , the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , without giving a reason and with no liability or prejudice whatsoever being incurred by the minor concerned or their legal representative as a result ;


### in a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust . ### in a clinical trial the safety , rights and well - being of subjects should be protected and the data generated should be reliable and robust .


### in a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust . ### in a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable , robust and reflect the diversity of the population in terms of age and gender balance .


### any sponsor may delegate any or all of its tasks to an individual , a company , an institution or an organisation . such delegation shall be without prejudice to the responsibility of the sponsor . ### any sponsor may delegate any or all of its logistic tasks to an individual , a company , an institution or an organisation . such delegation shall be without prejudice to the scientific and ethical responsibility of the sponsor .


### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , and the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor .


### in accordance with international guidelines , the free and informed consent of the subject should be in writing , save in exceptional situations . it should be based on information which is clear , relevant and understandable to the subject . ### in accordance with international guidelines , the free and informed consent of the subject should be given in writing , save in exceptional situations . it should be based on information which is clear , relevant and understandable to the subject . where possible , such information should be given orally , with the opportunity for the subject to ask questions , and the subject should be provided with comprehensive written information which he or she is allowed to keep . adequate time should be provided for the subject to consider his or her decision .


### where the proposed reporting member state has not notified the sponsor according to points to of paragraph 2 within three days following receipt of the comments or of the completed application , the application shall be considered complete , the clinical trial shall be considered as falling within the scope of this regulation , the clinical trial shall be considered as a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the proposed reporting member state has not notified the sponsor according to points to of paragraph 2 within five days following receipt of the comments or of the completed application , the application shall be considered complete , the clinical trial shall be considered as falling within the scope of this regulation , the clinical trial shall be considered as a low - intervention clinical trial if this is claimed by the sponsor .


### within one year from the end of a clinical trial , the sponsor shall submit to the eu database a summary of the results of the clinical trial . ### within one year from the end of a clinical trial , the sponsor shall submit to the eu database a summary of the results of the clinical trial , the clinical study report and the full dataset of clinical trial data . these elements shall be made publicly accessible through the eu database .


### this chapter is without prejudice to the possibility for the sponsor to submit , following the refusal to grant an authorisation or the withdrawal of an application , an application for authorisation to any intended member state concerned . that application shall be considered as a new application for authorisation of another clinical trial . ### this chapter is without prejudice to the possibility for the sponsor to submit , following the refusal to grant an authorisation or the withdrawal of an application , an application for authorisation to any intended member state . that application shall be considered as a resubmission of the application for authorisation of another clinical trial . it shall be accompanied by any previous assessment report , by the considerations of the concerned members states , and it shall highlight the changes or the reasons justifying the resubmission of the application dossier .


### this chapter is without prejudice to the possibility for the sponsor to submit , following the refusal to grant an authorisation or the withdrawal of an application , an application for authorisation to any intended member state concerned . that application shall be considered as a new application for authorisation of another clinical trial . ### this chapter is without prejudice to the possibility for the sponsor to submit , following the refusal to grant an authorisation or the withdrawal of an application , an application for authorisation to any intended member state . that application shall be considered as a resubmission of the application . it must be accompanied by any previous assessment report , by the considerations of concerned members states , and it must highlight the changes or the reasons justifying the resubmission of the application file .


### in order to streamline and facilitate the flow of information between sponsors and member states as well as between member states , the commission should set up and maintain a database , accessed through a portal . ### in order to streamline and facilitate the flow of information between sponsors and member states as well as between member states , the commission should set up and maintain a database , accessed through a portal . the commission and the member states should raise awareness among the general public about the existence of this portal .


### the sponsor shall propose one of the member states concerned as reporting member state . ### the reporting member state shall be chosen among those five member states concerned where most of the subjects participating in the clinical trial in question live . this decision shall be taken in line with a procedure which the commission shall develop , establish and control . the decision procedure shall ensure that the chosen reporting member state has the capacities and scientific infrastructure to assess the possible clinical trial in question .


### – the reliability and robustness of the data generated in the clinical trial , taking account of statistical approaches , design of the trial and methodology ; ### – the reliability and robustness of the data generated in the clinical trial , taking account of statistical approaches , design of the trial , methodology and the prevalence of the condition , especially for rare diseases , and ultra - rare diseases .


### the member states concerned should cooperate in assessing a request for authorisation of a clinical trial . this cooperation should not include aspects of an intrinsically national nature , nor ethical aspects of a clinical trial , such as informed consent . ### the member states concerned should cooperate in assessing a request for authorisation of a clinical trial . this cooperation may exclude aspects of an intrinsically national nature .


### the sponsor shall propose one of the member states concerned as reporting member state . ### within six days following the submission of the application dossier , member states shall collectively appoint a reporting member state .


### ‘ subject’ : an individual who participates in a clinical trial , either as recipient of an investigational medicinal product or as a control ; ### ' subject ' : an individual who freely and voluntarily participates in a clinical trial , either as recipient of an investigational medicinal product or as a control ;


### within 10 days from the validation date for low - intervention clinical trials ; ### within 25 days , but no earlier than 15 days after receipt of the successfully validated application , for low - intervention clinical trials ;


### informed consent shall be written , dated and signed and given freely by the subject or his or her legal representative after having been duly informed of the nature , significance , implications and risks of the clinical trial . it shall be appropriately documented . where the subject is unable to write , oral consent in the presence of at least one impartial witness may be given in exceptional cases . the subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given . ### informed consent shall be written , dated and signed and given freely by the subject or his or her legal representative after having been comprehensively and comprehensibly informed of the nature , significance , implications and risks of the clinical trial , and after having received the corresponding information in writing . it shall be appropriately documented . where the subject is unable to write , oral consent in the presence of at least one impartial witness may be given in exceptional cases . the subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given .


### by way of derogation from paragraph 1 , all sponsors shall be responsible for establishing one sponsor responsible for each of the following : ### by way of derogation from paragraph 1 , all sponsors shall be responsible for establishing one or more sponsors responsible for each of the following :


### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator in accordance with his or her age and maturity ; ### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator


### the anticipated therapeutic and public health benefits justify the foreseeable risks and inconveniences ; ### the anticipated therapeutic , public health and quality of life benefits justify the foreseeable risks and inconveniences ;


### the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time is considered by the investigator ; ### the investigator considers the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , without giving a reason and with no liability or prejudice whatsoever being incurred by the subject or their legal representative as a result ;


### where the clinical trial has been conducted outside the union , it shall comply with principles equivalent to those of this regulation as regards subject rights and safety and reliability and robustness of data generated in the clinical trial . ### where the clinical trial referred to in paragraph 4 has been conducted outside the union , it shall comply with this regulation and respect the ethical principles of the world medical association’s declaration of helsinki , and the international ethical guidelines for biomedical research involving human subjects by the council for international organizations of medical sciences , as regards subject rights , safety and well - being , and the reliability and robustness of data generated in the clinical trial .


### the sponsor may withdraw the application at any time until the assessment date . in such a case , the application may only be withdrawn with respect to all member states concerned . ### the sponsor may withdraw the application at any time until the assessment date . in such a case , the application may only be withdrawn with respect to all member states concerned . the reasons for the withdrawal shall be communicated to all member states concerned and submitted to the eu portal .


### for the purposes of this article , a ‘ serious breach’ means a breach likely to affect to a significant degree the safety and rights of the subjects or the reliability and robustness of the data generated in the clinical trial . ### for the purposes of this article , a ‘ serious breach’ means a breach likely to affect to a significant degree the safety , rights and well - being of the subjects or the reliability and robustness of the data generated in the clinical trial .


### where the proposed reporting member state has not notified the sponsor according to points to of paragraph 2 within three days following receipt of the comments or of the completed application , the application shall be considered complete , the clinical trial shall be considered as falling within the scope of this regulation , the clinical trial shall be considered as a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the proposed reporting member state has not notified the sponsor according to points to of paragraph 2 within five days following receipt of the comments or of the completed application , the application shall be considered complete , the clinical trial shall be considered as falling within the scope of this regulation , the clinical trial shall be considered as a low - intervention clinical trial if this is claimed by the sponsor .


### according to the protocol of the clinical trial , the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any of the member states concerned ; ### according to the protocol of the clinical trial , the investigational medicinal products are used in accordance with the terms of the marketing authorisation in any of the member states concerned or , where the use of a medicinal product is outside the terms of the marketing authorisation , their use is supported by sufficient published evidence and / or standard treatment guidelines ;


### within 25 days from the validation date for clinical trials other than low - intervention clinical trials ; ### within 35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low - intervention clinical trials ;


### notification shall be done by way of one single decision within ten days from the assessment date or the last day of the assessment referred to in article 22 , whichever is later . ### notification shall be done by way of one single decision , already comprising the views of the concerned ethics committee , within fifteen days from the assessment date or the last day of the assessment referred to in article 22 , whichever is later .


### in accordance with international guidelines , the free and informed consent of the subject should be in writing , save in exceptional situations . it should be based on information which is clear , relevant and understandable to the subject . ### in accordance with international guidelines , the free and informed consent of the subject should be given in writing , save in exceptional situations . it should be based on information which is clear , relevant and understandable to the subject . where possible , such information should be given orally , with the opportunity for the subject to ask questions , and the subject should be provided with comprehensive written information which he or she is allowed to keep . adequate time should be provided for the subject to consider his or her decision .


### informed consent shall be written , dated and signed and given freely by the subject or his or her legal representative after having been duly informed of the nature , significance , implications and risks of the clinical trial . it shall be appropriately documented . where the subject is unable to write , oral consent in the presence of at least one impartial witness may be given in exceptional cases . the subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given . ### informed consent shall be written , dated and signed and given freely by the subject or his or her legal representative after having been fully informed of the nature , significance , implications and risks of the clinical trial . where possible , information on the nature , significance , implications and risks of the clinical trial shall be given orally , with the opportunity for the subject to ask questions , and the subject shall be provided with comprehensive information which he or she is allowed to keep ; otherwise that information may be given in writing . it shall be appropriately documented . adequate time shall be given for the subject to consider the decision . where the subject is unable to write , oral consent in the presence of at least one impartial witness may be given in exceptional cases . the subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given .


### written information given to the subject and / or the legal representative for the purposes of obtaining his or her informed consent shall be kept concise , clear , relevant , and understandable to a lay person . it shall include both medical and legal information . it shall inform the subject about his or her right to revoke his or her informed consent . ### written information given to the subject and / or the legal representative for the purposes of obtaining his or her informed consent shall be kept concise , clear , relevant , and understandable to a lay person . it shall include both medical and legal information that shall be explained orally by a medical doctor to the subject . it shall inform the subject about his or her right to revoke his or her informed consent .


### the human dignity and right to the integrity of the person are recognized in the charter of fundamental rights of the european union . in particular , the charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned . directive 2001 / 20 / ec contained an extensive set of rules for the protection of subjects . these rules should be upheld . regarding the rules concerning the determination of the legal representative of incapacitated persons and minors , those rules diverge in member states . it should therefore be left to member states to determine the legal representative of incapacitated persons and minors . ### the human dignity and right to the integrity of the person are recognized in the charter of fundamental rights of the european union . in particular , the charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned . directive 2001 / 20 / ec contained an extensive set of rules for the protection of subjects . these rules should be upheld . subjects from vulnerable population groups such as incapacitated subjects , minors or other vulnerable people , require additional protection measures . regarding the rules concerning the determination of the legal representative of incapacitated persons and minors , those rules diverge in member states . it should therefore be left to member states to determine the legal representative of incapacitated subjects and minors .


### the sponsor shall propose one of the member states concerned as reporting member state . ### the reporting member state shall be chosen among those five member states concerned where most of the subjects participating in the clinical trial in question live . this decision shall be taken in line with a procedure which the commission shall develop , establish and control . the decision procedure shall ensure that the chosen reporting member state has the capacities and scientific infrastructure to assess the possible clinical trial in question .


### within six days following submission of the application dossier , the proposed reporting member state shall notify the sponsor through the eu portal of the following : ### within fifteen days following appointment , this member state shall notify the sponsor through the eu portal of the following :


### ‘ sponsor’ : an individual , company , institution or organisation which takes responsibility for the initiation and management of the clinical trial ; ### ‘ sponsor’ : an individual , company , institution or organisation which takes responsibility for the initiation , management and / or financing of the clinical trial ;


### the contribution to the union objective of at least 20 million fewer people at risk of poverty and social exclusion by 2020 , having regard to the selected type of material deprivation to be addressed , taking into account national circumstances in terms of poverty and social exclusion and material deprivation ; ### the contribution to the union objective of at least 20 million fewer people at risk of poverty and social exclusion by 2020 , having regard to the selected type of material deprivation to be addressed , taking into account national circumstances in terms of poverty and social exclusion and material deprivation as well as people with negative income and property and those most in need and endangered by poverty ;


### upon request from one or more competent authorities , from the commission or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged incorrect application of community law . ### upon request from one or more competent authorities , from the commission , from the european parliament , the council or a member of the securities and markets stakeholder group , or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged incorrect application of union law .


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


### upon request from one or more competent authorities , from the commission or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged incorrect application of community law . ### upon request from one or more competent authorities from the european parliament , the council , the commission or the securities and markets stakeholder group , or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged breach or non - application of union law .


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


### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the commission , upon its own initiative or following a request by the authority , the council , or the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation . ### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the esrb , upon its own initiative or following a request by the authority , the council , the european parliament or the commission , may issue a warning declaring the existence of an emergency situation in order to enable the authority without further requirements to adopt the individual decisions referred to in paragraph 3 .


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


### before submitting them to the commission , the authority shall , where appropriate , conduct open public consultations on technical standards and analyse the potential related costs and benefits . ### the authority shall conduct open public consultations on technical standards and analyse the potential related costs and benefits before adopting draft technical standards . the authority shall also request an opinion or advice of the securities and markets stakeholder group referred to in article 22 .


### the implementation phase shall last for a minimum of five years . during the implementation phase at least three calls for proposals shall be published with a view to funding projects which address the objectives of the bonus - 169 . these calls shall be targeted at multi - partner and trans - national projects , and include research , technological development , training and dissemination activities . projects shall be selected according to the principles of equal treatment , transparency , independent evaluation , co - financing , no - profit , financing not cumulated with other community sources , as well as the principle of non - retroactivity ### the implementation phase shall last for a minimum of five years . during the implementation phase at least three calls for proposals shall be published with a view to funding projects which address the objectives of the bonus - 169 . these calls shall be targeted at multi - partner and transnational projects , and include research , technological development , training and dissemination activities . projects shall be selected according to the principles of equal treatment , transparency , independent evaluation , no - profit , and financing not cumulated with other union sources , as well as the principle of non - retroactivity .


### the implementation phase shall last for a minimum of five years . during the implementation phase at least three calls for proposals shall be published with a view to funding projects which address the objectives of the bonus - 169 . these calls shall be targeted at multi - partner and trans - national projects , and include research , technological development , training and dissemination activities . projects shall be selected according to the principles of equal treatment , transparency , independent evaluation , co - financing , no - profit , financing not cumulated with other community sources , as well as the principle of non - retroactivity . ### the implementation phase shall last for a minimum of five years . during the implementation phase at least three calls for tender for research contracts shall be published with a view to funding projects which address the necessary scientific objectives . these calls shall be targeted at multi - partner and transnational projects ; at least two states from the south - east of the baltic sea region must participate in each project . the projects in question shall include research , technological development , training and dissemination activities . projects shall be selected in keeping with the main objectives of the strategic part , proceeding from the principles of equal treatment , transparency , independent evaluation by experts from all participating states , co - financing , no - profit , and financing not cumulated with other community sources , as well as the principle of non - retroactivity .


### preparation of the strategic research agenda &#8211 ; defining the part on scientific content of the programme focusing on calls for proposals , in conformity with the objectives set in the seventh framework programme ; ### preparation of the strategic research agenda &#8211 ; defining the part on scientific content of the programme focusing on calls for proposals , in conformity with the common goal of sustainable ecosystem - based management in the baltic sea region and with the objectives set in the seventh framework programme ;


### at the end of the strategic phase , the commission , assisted by independent expert should evaluate the maturity and the readiness of the initiative to enter the implementation phase . ### at the end of the strategic phase , the commission should verify that the strategic research agenda , stakeholder consultation platforms and implementation modalities are in place for the initiative to enter the implementation phase . the commission should , if appropriate , make recommendations for improving the strategic research agenda . the transition to the implementation phase should be seamless and without delays .


### the community financial contribution and the cash contribution of the participating states to bonus - 169 shall be pooled and administered centrally by the bonus eeig . ### the community financial contribution and the cash contribution of the participating states to bonus shall be pooled and administered centrally by the bonus eeig , with the possibility for participating states to devote their cash contributions exclusively to domestic research projects .


### in order to ensure adequate transparency to the market of their remuneration structures and the associated risk , credit institutions and investments forms should disclose information on their remuneration policies and practices for those staff whose professional activities have a material impact on the risk profile of the institution . however , this obligation should be without prejudice to directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with the regard to the processing of personal data and the free movement of such data . ### in order to ensure adequate transparency to the market of their remuneration structures and the associated risk , credit institutions and investments forms should disclose detailed information on their remuneration policies , practices and , for reasons of confidentiality , aggregated amounts for those members of staff whose professional activities have a material impact on the risk profile of the institution . that information should be available to all stakeholders . however , this obligation should be without prejudice to directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with the regard to the processing of personal data and the free movement of such data . the european workers councils should be respected in regard to the right of information and consultation of employees .


### payment of the major part of a significant bonus is deferred for an appropriate period and is linked to the future performance of the firm . ### at least 40 % of the variable remuneration component , is deferred over a period of no less than three years and is correctly aligned with the nature of the business , its risks and the activities of the member of staff in question ; remuneration payable under deferral arrangements vests no faster than on a pro - rata basis ; in the case of a variable remuneration component of a particularly high amount , at least 60&#160 ; % of the amount is deferred .


### member states shall take all necessary measures to ensure that , in accordance with this article , providers of support services can compete within the union on the basis of equitable , non - discriminatory and transparent conditions for the purpose of providing these services . ### member states shall take all necessary measures to ensure that , in accordance with this article , there are no statutory impediments to the providers of terminal air navigation and / or support services that would prevent their ability to compete within the union on the basis of equitable , non - discriminatory and transparent conditions for the purpose of providing these services .


### the national supervisory authorities that are not legally distinct from any air navigation service providers or any private or public entity having an interest in the activities of such providers , as provided for in paragraph 2 , on the date of entry into force of this regulation shall meet this requirement by 1 january 2020 at the latest . ### the national supervisory authorities that are not legally distinct from any air navigation service providers or any private or public entity having an interest in the activities of such providers , as provided for in paragraph 2 , on the date of entry into force of this regulation shall meet this requirement by 1 july 2017 at the latest .


### member states shall take all necessary measures to ensure that , in accordance with this article , providers of support services can compete within the union on the basis of equitable , non - discriminatory and transparent conditions for the purpose of providing these services . ### member states shall take all necessary measures to ensure that , in accordance with this article , there are no statutory impediments to the providers of terminal air navigation and / or support services that would prevent their ability to compete within the union on an equitable and non - discriminatory basis . the requirement set out in this article shall be achieved not later than five years after publication of the study referred to in paragraph 2 of this article .


### the provision of communication , navigation and surveillance services , as well as meteorological and aeronautical information services , should be organised under market conditions whilst taking into account the special features of such services and maintaining a high level of safety . ### the provision of communication , navigation and surveillance services , as well as meteorological and aeronautical information services , could be organised under market conditions and a specific study into the impacts of such a reform should be undertaken ahead of deciding , due to the special features of such services and to ensure a high level of safety .


### in choosing the provider of support services , in particular cost efficiency , overall service quality and safety of services shall be taken into account by the entity procuring those services . ### in cases of support services provided under market conditions , the entity procuring those services shall do so in accordance with directive 2004 / 18 / ec with particular focus on cost efficiency , overall service quality , interoperability and safety of services .


### in choosing the provider of support services , in particular cost efficiency , overall service quality and safety of services shall be taken into account by the entity procuring those services . ### in case of choosing an external provider of support services , in particular cost efficiency , overall service quality and safety of services shall be taken into account by the entity procuring those services .


### in choosing the provider of support services , in particular cost efficiency , overall service quality and safety of services shall be taken into account by the entity procuring those services . ### when choosing an external provider of support services , in particular cost efficiency , overall service quality and safety of services , as well as transparency of the procurement process , shall be ensured by the entity procuring those services .


### national plans or plans for functional airspace blocks , including performance targets , ensuring compliance with the union - wide and associated local performance targets ; and ### national plans or plans for functional airspace blocks , including performance targets consistent with the union - wide performance targets ; and


### monitoring the implementation of the charging scheme in accordance with articles 12 and 13 ; ### monitoring the implementation of the charging scheme in accordance with articles 12 and 13 , including the provisions on cross - subsidisation referred to in article 13 ;


### the national supervisory authorities shall exchange information about their work and decision - making principles , practices and procedures as well as implementation of union law . they shall cooperate for the purpose of coordinating their decision - making across the union . the national supervisory authorities shall participate and work together in a network that convenes at regular intervals . the commission and the european union agency for aviation shall be members , coordinate and support the work of the network and make recommendations to the network , as appropriate . the commission and eaa shall facilitate active cooperation of the national supervisory authorities and exchanges and use of staff between the national supervisory authorities based on a pool of experts to be set up by eaa in accordance with article 17 of regulation no 216 / 2008 . ### the national supervisory authorities shall exchange information about their work and decision - making principles , practices and procedures as well as implementation of union law . they shall cooperate for the purpose of coordinating their decision - making across the union . the national supervisory authorities shall participate and work together in a network that convenes at regular intervals and at least once a year . the commission and the european union agency for aviation shall be members , coordinate and support the work of the network , as appropriate . the commission and eaa shall facilitate active cooperation of the national supervisory authorities and exchanges and use of staff between the national supervisory authorities based on a pool of experts to be set up by eaa in accordance with article 17 of regulation no 216 / 2008 . this network may , among other things : produce and disseminate streamlined methodologies and guidelines for the implementation of the authority tasks listed in article 4 . provide assistance to individual nsas on regulatory issues ; provide opinions to the commission and eaa on rulemaking and certification ; provide opinions , guidelines and recommendations on facilitating cross - border service provision ; develop plans for the consolidation and integration of national supervisory authorities ;


### criteria to impose sanctions for non - compliance with the union - wide and associated local performance targets during the reference period and to support alert mechanisms ; ### criteria defined in cooperation with the single sky committee referred to in article 27 to stimulate compliance with the union - wide and associated local performance targets and to impose sanctions in case of non - compliance during the reference period and to support alert mechanisms ;


### the air navigation service providers shall establish consultation mechanisms to consult the relevant groups of airspace users and aerodrome operators on all major issues related to services provided , or relevant changes to airspace configurations . the airspace users shall also be involved in the process of approving strategic investment plans . the commission shall adopt measures detailing the modalities of the consultation and of the involvement of airspace users in approving investment plans . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 27 . ### the air navigation service providers shall establish consultation mechanisms to consult the relevant groups of airspace users and aerodrome operators on all major issues related to services provided , strategic investment plans or relevant changes to airspace configurations . the commission shall adopt measures detailing the modalities of the consultation . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 27 .


### be selected in a transparent procedure on the basis of their specific qualifications , including appropriate competence and relevant experience inter alia in the field of auditing , air navigation services and systems ; ### be selected using transparent criteria on the basis of their profiles and specific qualifications , including appropriate competence and , as regards security and interoperability , relevant experience inter alia in the field of auditing , air navigation services and systems ; persons who do not have previous professional experience in some of these areas may be recruited on the condition that they receive suitable training , including a practical learning component , until they are deemed to possess the requisite level of knowledge and skills ;


### establishment and revision of union - wide and associated local performance targets that shall be defined taking into consideration inputs identified at national level or at the level of functional airspace blocks ; ### establishment and revision of union - wide performance targets that shall be defined taking into consideration inputs identified at national level or at the level of functional airspace blocks ;


### the compliance of the national or functional airspace block plans and local targets with the union - wide performance targets shall be assessed by the commission in co - operation with the performance review body . ### the consistency of the national or functional airspace block plans and local targets with the union - wide performance targets shall be assessed by the commission in co - operation with the performance review body .


### the national supervisory authorities that are not legally distinct from any air navigation service providers or any private or public entity having an interest in the activities of such providers , as provided for in paragraph 2 , on the date of entry into force of this regulation shall meet this requirement by 1 january 2020 at the latest . ### the national supervisory authorities that are not independent from any air navigation service providers , as provided for in paragraph 2 , on the date of entry into force of this regulation shall meet this requirement by 1 january 2020 at the latest .


### the procurement of support services should be carried out , as applicable , in accordance with directive 2004 / 18 / ec of the european parliament and of the council of 31 march 2004 on the coordination of procedures for the award of public works contracts , public supply contracts and public service contracts23 and directive 2004 / 17 / ec of the european parliament and of the council of 31 march 2004 coordinating the procurement procedures of entities operating in the water , energy , transport and postal services sectors24 . account should also be taken of the guidelines set out in the commission interpretative communication 2006 / c179 / 02 on the community law applicable to contract awards not or not fully subject to the provisions of the public procurement directives25 , as appropriate __________________ 23 oj l 134 , 30 . 4 . 2004 , p . 114 . 24 oj l 134 , 30 . 4 . 2004 , p . 1 25 oj c 179 , 1 . 8 . 2006 , p . 2 . ### where relevant , the procurement of support services should be carried out , as applicable , in accordance with directive 2004 / 18 / ec of the european parliament and of the council of 31 march 2004 on the coordination of procedures for the award of public works contracts , public supply contracts and public service contracts23 and directive 2004 / 17 / ec of the european parliament and of the council of 31 march 2004 coordinating the procurement procedures of entities operating in the water , energy , transport and postal services sectors24 . account should also be taken of the guidelines set out in the commission interpretative communication 2006 / c179 / 02 on the community law applicable to contract awards not or not fully subject to the provisions of the public procurement directives25 , as appropriate __________________ 23 oj l 134 , 30 . 4 . 2004 , p . 114 . 24 oj l 134 , 30 . 4 . 2004 , p . 1 25 oj c 179 , 1 . 8 . 2006 , p . 2 .


### the issue of certificates shall confer on air navigation service providers the possibility of offering their services to member states , other air navigation service providers , airspace users and airports within the union . with regard to support services this possibility shall be subject to the compliance with article 10 . ### the issue of certificates shall confer on air navigation service providers the possibility of offering their services to member states , other air navigation service providers , airspace users and airports within the union .


### in the field of energy , the specific eligibility conditions of actions implementing projects of common interest for union financial aid in the form of financial instruments and grants under this regulation are set out in article 15 of regulation no xxxx / 2012 [ guidelines for trans - european energy infrastructure ] . ### in the field of energy , the specific eligibility conditions of actions implementing projects of common interest for union financial support in the form of financial instruments and grants under this regulation are as follows : projects of common interest falling within the categories set out in points 1 and 2 of annex ii to regulation no xxxx / 2012 [ energy infrastructure guidelines ] are eligible for union financial support in the form of grants for studies ; projects of common interest falling within the categories set out in points 1 and 2 of annex ii to regulation no xxxx / 2012 [ energy infrastructure guidelines ] which according to the business plan and other assessments carried out , notably by potential investors or creditors , are commercially viable but just below the risk rating that would lead to an investment decision are eligible for union financial support in the form of financial instruments for works ; projects of common interest falling within the categories set out in points 1 to and point 2 of annex ii to regulation no xxxx / 2012 [ energy infrastructure guidelines ] shall be eligible for union financial support in the form of grants for works if they fulfil all of the following criteria : the project is commercially not viable according to the business plan and other assessments carried out , notably by potential investors or creditors . the decision on incentives and its justification referred to in article 14 of regulation no xxxx / 2012 [ energy infrastructure guidelines ] shall be taken into account when assessing the project ' s commercial viability ; the project has received a cross - border cost allocation decision pursuant to article 13 of regulation no xxxx / 2012 [ energy infrastructure guidelines ] or , for projects that have received an exemption pursuant to article 36 of directive 2009 / 73 / ec or article 17 of regulation no 714 / 2009 , an opinion from the competent national regulatory authorities and the agency on the commercial viability of the project ; the project specific cost - benefit analysis pursuant to article 13 of regulation no xxxx / 2012 [ energy infrastructure guidelines ] provides evidence concerning the existence of at least one of the following significant positive externalities : - projects promoting the further integration of the internal energy market and the interoperability of electricity and gas networks across borders through interconnection of member states ' networks and removal of internal constraints , through enhancing cross - border transmission power in relation to installed energy generation capacity or through increased demand coverage between member states by reverse flow interconnectors for gas ; - projects that enhance the security of energy supply and / or solidarity by diversification of supply sources , supplying counter parts and routes , increasing storage capacity , prevention or reduction of disruptions , avoiding spillage of renewable energy due to a lack of cross - border connections or by reducing or eliminating member states ' energy isolation by connecting these markets with more diversified supply sources and / or by installing reverse flow interconnectors for gas ; - projects contributing to sustainable development and protection of the environment by ensuring transmission of renewable electricity from generation to major consumption centres and storage sites ; projects of common interest falling within the categories set out in points 1 of annex ii to regulation no xxxx / 2012 [ energy infrastructure guidelines ] shall be eligible for union financial support in the form of grants for works if they are not commercially viable in accordance with point of point c of this article and can prove at least one of the positive externalities under point of point c of this article .


### the financial envelope for the implementation of the connecting europe facility for the period 2014 to 2020 shall be eur 50 000 000 0001 . that amount shall be distributed among the sectors referred to in article 3 as follows : transport : eur 31 694 000 000 , out of which eur 10 000 000 000 shall be transferred from the cohesion fund to be spent in line with this regulation in member states eligible for funding from the cohesion fund ; energy : eur 9 121 000 000 ; telecommunications : eur 9 185 000 000 . __________________ 1all figures in constant 2011 prices . the corresponding amounts , expressed in current prices , can be found in the legislative financial statement . ### the estimated investment requirement for trans - european networks in the transport , energy and telecommunications sectors for the period up to 2020 is eur&#160 ; 970&#160 ; 000&#160 ; 000&#160 ; 000 . the financial envelope for the implementation of the connecting europe facility for the period 2014 to 2020 shall be [ eur 50 000 000 000 ] 1 . that amount shall be distributed among the sectors referred to in article 3 as follows : transport : [ eur 31 694 000 000 ] , out of which [ eur 10 000 000 000 ] shall be transferred from the cohesion fund to be spent in line with this regulation in member states eligible for funding from the cohesion fund ; energy : [ eur 9 121 000 000 ] ; telecommunications : [ eur 9 185 000 000 ] . __________________ 1 pending agreement on the multiannual financial framework for the period 2014 - 2020 . all figures in constant 2011 prices . the corresponding amounts , expressed in current prices , can be found in the legislative financial statement .


### ‘ bottleneck’ means a physical barrier that leads to a system break affecting the continuity of long - distance flows . such a barrier can be absorbed by new infrastructure such as bridges or tunnels that address problems as for example gradients , curve radii , gauge . the need to upgrade existing infrastructure shall not be considered as a bottleneck ; ### ‘ bottleneck’ in the transport sector means a physical or technical barrier that leads to a system break affecting the continuity and disruption of long - distance and cross - border flows . such a barrier can be absorbed by creating new , or substantially upgrading existing infrastructure in order to increase its capacity such as bridges or tunnels that address problems as for example gradients , curve radii , gauge . the need to upgrade existing infrastructure shall not be considered as a bottleneck ;


### major investments are needed to modernise and expand europe ' s energy infrastructure and to interconnect networks across borders to meet the union ' s energy and climate policy objectives of competitiveness , sustainability and security of supply in a cost - effective way . the estimated investment needs in energy infrastructure up to 2020 amount to eur 1 trillion , of which ca . eur 200 billion in electricity and gas transmission and storage infrastructures considered of european relevance . among projects of european relevance , approximately eur 100 billion of investments is at risk of not being delivered due to obstacles related to permit granting , regulation and financing . ### major investments are needed to modernise and expand europe ' s energy infrastructure and to interconnect networks across borders to meet the union ' s energy and climate policy objectives of competitiveness , sustainability and security of supply in a cost - effective way . the estimated investment needs in energy infrastructure up to 2020 amount to eur 1 trillion , of which ca . eur 200 billion in electricity and gas transmission and storage infrastructures considered of european relevance . among projects of european relevance , approximately eur 100 billion of investments is at risk of not being delivered due to obstacles related to permit granting , regulation and financing according to the commission staff working paper to the transport , telecommunications and energy council of 10 june 2011 ' energy infrastructure investment needs and financing requirements ' .


### the european parliament in its resolution of 6 july 2010 on a sustainable future for transport emphasised that an efficient transport policy required a financial framework that was appropriate to the challenges arising and that , to that end , the current resources for transport and mobility should be increased ; it further considered necessary the creation of a facility to coordinate the use of different sources of transport funding , funds available under cohesion policy , public - private partnerships or other financial instruments such as guarantees . ### the european parliament in its resolution of 6 july 2010 on a sustainable future for transport emphasised that an efficient transport policy required a financial framework that was appropriate to the challenges arising and that , to that end , the current resources for transport and mobility should be increased , in the various budget lines relating to them ; it further considered necessary the creation of a facility to coordinate and optimise the use of different sources of transport funding and of all the financial means and mechanisms available at eu level .


### following the mid - term evaluation according to article 26 . 1 , the commission may transfer appropriations between the sectors of the allocation set out in paragraph 1 , with the exception of the eur 10 000 000 000 transferred from the cohesion fund to finance transport sector projects in the cohesion fund eligible member states . ### following the mid - term evaluation according to article 26 . 1 , the commission shall be empowered to adopt delegated acts in accordance with article 25 in order to transfer appropriations between the sectors of the allocation set out in paragraph 1 , with the exception of the eur [ 10 000 000 000 ] 1 transferred from the cohesion fund to finance transport sector projects in the cohesion fund eligible member states . __________________ 1 pending agreement on the multiannual financial framework for the period 2014 - - 2020 .


### ' bottleneck ' means a physical barrier that leads to a system break affecting the continuity of long - distance flows . such a barrier can be absorbed by new infrastructure such as bridges or tunnels that address problems as for example gradients , curve radii , gauge . the need to upgrade existing infrastructure shall not be considered as a bottleneck ; ### ' transport bottleneck ' means a physical and / or functional barrier that leads to a system break affecting the continuity of long - distance flows and which can be surmounted by creating new infrastructure


### the european rail traffic management system : the amount of union financial aid shall not exceed 50% of the eligible cost ; ### the european rail traffic management system , including both track - side equipment and onboard equipment , river information services and vessel traffic monitoring and information systems : the amount of union financial aid shall not exceed 50% of the eligible cost ;


### actions supported by means of financial instruments shall be selected on a first come first served basis and shall seek sectoral diversification in accordance with articles 3 and 4 as well as gradual geographical diversification across the member states . ### actions eligible for support by means of financial instruments , in accordance with article 17 of this regulation , shall seek sectoral and geographical diversification among the member states and shall comply with the following criteria : respond to the objectives of the europe 2020 strategy ; represent european added value ; ensure non - distortion of competition in the internal market ; present a leverage / multiplier effect with regard to union support .


### acting in accordance with the procedure referred to in paragraph 1 , the commission , when establishing multiannual and sectoral annual work programmes , shall establish the selection and award criteria in line with the objectives and priorities laid down : for transport in regulation no xxxx / 2012 [ ten - t guidelines ] ; for energy in regulation no xxxx / 2012 [ guidelines for trans - european energy infrastructure ] ; for telecommunications in regulation no xxxx / 2012 [ infso guidelines ] . ### acting in accordance with the procedure referred to in paragraph 1 , the commission , when establishing multiannual and sectoral annual work programmes , shall establish the selection and award criteria in line with the objectives and priorities laid down in articles 3 and 4 of this regulation and in regulation no xxxx / 2012 [ ten - t guidelines ] , no xxx 2012 [ guidelines for trans - european energy infrastructure ] or no xxx / 2012 infso guidelines ] . all projects shall be assessed on the basis of the following criteria : the maturity of the action in the project development and preparation stages and the soundness of the implementation proposed ; the leverage effect of union support on public and private investment and the single market ; the need to overcome specific financial obstacles and lack of market - finance , linked to the nature or urgency of the project ; the costs and benefits including economic , social , greenhouse gas and / or other environmental impacts , and accessibility ; for transports and for energy : the cross - border dimension .


### following the mid - term evaluation according to article 26 . 1 , the commission may transfer appropriations between the sectors of the allocation set out in paragraph 1 , with the exception of the eur 10 000 000 000 transferred from the cohesion fund to finance transport sector projects in the cohesion fund eligible member states . ### following the mid - term evaluation according to article 26 , the commission may propose to transfer appropriations between the sectors of the allocation set out in paragraph 1 , with the exception of the eur 10 000 000 000 transferred from the cohesion fund to finance transport sector projects in the cohesion fund eligible member states , without prejudice to the powers of the budgetary authority in the annual budgetary procedure .


### optimise the integration and interconnection of transport modes and enhancing interoperability of transport services . the achievement of this objective will be measured by the number of ports and airports connected to the railway network . ### optimise the integration and interconnection of transport modes . the achievement of this objective will be measured by the number of inland and maritime ports and airports connected to the railway network , and by the number of multimodal logistics platforms and ‘ motorways of the sea’ created .


### ensuring sustainable and efficient transport in the long run , to be measured by the length of the conventional railway network in the eu - 27 and the length of high - speed railway network in the eu - 27 ; ### ensuring sustainable and efficient transport systems in the long run . the achievement of this objective shall be measured by the length of the railway network in the eu - 27 complying with the requirements set out in article 45 of regulation no xxxx / 2012 [ ten - t guidelines ] , the length of high - speed railway network in the eu - 27 , the length of inland waterway network and the length by class in the eu - 27 , the length of roads of the core network that has adequate coverage with infrastructure to supply alternative fuels to vehicles in the eu - 27 and the reduction in casualties on the road network in the eu - 27 ;


### inland transport connections to ports and airports , actions to reduce rail freight noise by retrofitting of existing rolling stock , as well as development of ports and multi - modal platforms : the amount of union financial aid shall not exceed 20% of the eligible cost . ### inland transport connections to ports and airports , as well as development of ports and multi - modal platforms : the amount of union financial aid shall not exceed 20% of the eligible cost .


### co - financing rates mentioned above may be increased by up to 10 percentage points for actions having cross - sector synergies , reaching climate mitigation objectives , enhancing climate resilience or reducing the greenhouse gas emissions . this increase should not apply to co - financing rates referred to in article 11 . ### co - financing rates mentioned above may be increased by up to 10 percentage points over the percentages laid down in paragraphs 2 to 4 of this article for each of the following actions : any action with synergies between at least two of the sectors covered by the cef . the union financial aid shall be drawn from the sectoral budgets provided for in article 5 , in proportion to each sector ' s involvement in the action . actions helping to achieve climate mitigation objectives , enhancing climate resilience or reducing the greenhouse gas emissions . this increase should not apply to co - financing rates referred to in article 11 .


### in the field of telecommunication , all actions implementing the projects of common interest and programme support actions set out in the annex of the regulation no xxxx / 2012 [ infso guidelines ] shall be eligible to receive union financial aid in the form of a grant , procurement and financial instruments under this regulation . ### in the field of telecommunication , only actions contributing to projects of common interest in accordance with regulation no xxx / 2012 [ telecom infrastructure guidelines ] , shall be eligible for support through union financial aid in the form of grants for generic services and horizontal priorities , including programme support actions , in the form of grants and procurement for core service platforms . actions in the field of broadband deployment , including actions generating demand for broadband , shall be eligible for union financial support in the form of financial instruments .


### on 28 march 2011 , the commission adopted the white paper ' ' a roadmap to a single transport area ― towards a competitive and resource - efficient transport system ' ' . the white paper aims at reducting by at least 60% the greeenhouse gas emissions of the transport sector by 2050 with respect to 1990 . as far as infrastructure is concerned , the white paper aims at establishing a fully functional and union - wide multimodal ten - t ‘ core network’ by 2030 . the white paper also aims at optimising the performance of multimodal logistic chains , including by making greater use of more energy - efficient modes . therefore , it sets the following relevant targets for ten - t policy : 30% of road freight over 300 km should shift to other modes by 2030 , and more than 50% by 2050 ; the length of the existing high - speed rail network should triple by 2030 and by 2050 the majority of medium - distance passenger transport should go by rail ; by 2050 , all core network airports should be connected to the rail network ; all seaports to the rail freight and , where possible , to the inland waterway system . ### on 28 march 2011 , the commission adopted the white paper ' ' a roadmap to a single transport area ― towards a competitive and resource - efficient transport system ' ' . the white paper aims at reducing by at least 60% the greenhouse gas emissions of the transport sector by 2050 with respect to 1990 . as far as infrastructure is concerned , the white paper aims at establishing a fully functional and interoperable union - wide multimodal ten - t ‘ core network’ by 2030 . the white paper also aims at optimising the performance of multimodal logistic chains , including by making greater use of more energy - efficient modes . therefore , it sets the following relevant targets for ten - t policy : 30% of road freight over 300 km should shift to other modes by 2030 , and more than 50% by 2050 ; the length of the existing high - speed rail network should triple by 2030 and by 2050 the majority of medium - distance passenger transport should go by rail ; by 2050 , all core network airports should be connected to the rail network ; all seaports to the rail freight and , where possible , to the inland waterway system .


### the financial envelope of the connecting europe facility may cover expenses pertaining to , preparatory , monitoring , control , audit and evaluation activities which are required for the management of the programme and the achievement of its objectives , in particular studies , meetings of experts , as far as they are related to the general objectives of this regulation , expenses linked to it networks focusing on information processing and exchange , together with all other technical and administrative assistance expenses incurred by the commission for the management of the programme . the financial allocation may also cover the technical and administrative assistance expenses necessary to ensure the transition between the programme and the measures adopted under regulation no 680 / 2007 . if necessary , appropriations could be entered in the budget beyond 2020 to cover similar expenses , in order to enable the management of actions not yet completed by 31 december 2020 . ### the financial envelope of the connecting europe facility shall cover expenses pertaining to : actions in support of projects of common interest , as defined in article 7 of this regulation ; programme support actions , as defined in article 2 of this regulation , up to 1 . 5% ; the technical and administrative assistance expenses necessary to ensure the transition between the programme and the measures adopted under regulation no 680 / 2007 .


### co - financing rates mentioned above may be increased by up to 10 percentage points for actions having cross - sector synergies , reaching climate mitigation objectives , enhancing climate resilience or reducing the greenhouse gas emissions . this increase should not apply to co - financing rates referred to in article 11 . ### co - financing rates mentioned above may be increased by up to 10 percentage points over the percentages laid down in paragraphs 2 to 4 for the following actions : with synergies between at least two of the sectors covered by the cef . the amount of union financial aid shall be taken from the amounts allocated for each sector set out in article 5 , and weighted according to their relative involvement in the action . b ) any action helping to achieve objectives in the fields of climate mitigation , enhancing climate resilience or reducing greenhouse gas emissions . this increase should not apply to co - financing rates referred to in article 11 . the commission shall propose , in the annual and multiannual programmes under article 17 , the criteria for the granting of the cofinancing rates laid down in this article .


### any other financial instruments . ### other financial instruments , provided the following conditions are met : - conformity with regulation no xxxx / 2012 [ new financial regulation ] ; and - conformity with the objectives of this regulation ; this procedure may be applied by means of delegated acts , in accordance with article 25 of this regulation .


### the financial envelope for the implementation of the connecting europe facility for the period 2014 to 2020 shall be eur 50 000 000 0001 . that amount shall be distributed among the sectors referred to in article 3 as follows : transport : eur 31 694 000 000 , out of which eur 10 000 000 000 shall be transferred from the cohesion fund to be spent in line with this regulation in member states eligible for funding from the cohesion fund ; energy : eur 9 121 000 000 ; telecommunications : eur 9 185 000 000 . __________________ 1all figures in constant 2011 prices . the corresponding amounts , expressed in current prices , can be found in the legislative financial statement . ### the estimated investment requirement for trans - european networks in the transport , energy and telecommunications sectors for the period up to 2020 is eur&#160 ; 970&#160 ; 000&#160 ; 000&#160 ; 000 . the financial envelope for the implementation of the connecting europe facility for the period 2014 to 2020 shall be [ eur 50 000 000 000 ] 1 . that amount shall be distributed among the sectors referred to in article 3 as follows : transport : [ eur 31 694 000 000 ] , out of which [ eur 10 000 000 000 ] shall be transferred from the cohesion fund to be spent in line with this regulation in member states eligible for funding from the cohesion fund ; energy : [ eur 9 121 000 000 ] ; telecommunications : [ eur 9 185 000 000 ] . __________________ 1 pending agreement on the multiannual financial framework for the period 2014 - 2020 . all figures in constant 2011 prices . the corresponding amounts , expressed in current prices , can be found in the legislative financial statement .


### based on an analysis of the transport infrastructure plans of member states , the commission estimates that investment needs in transport amount to eur 500 billion in the entirety of the ten - t network for the period 2014 - 2020 , of which an estimated eur 250 billion will need to be invested in the core network of the ten - t . given the resources available at union level , concentration on the projects with the highest european added value is necessary to achieve the desired impact . support should therefore be focussed on the core network and on the projects of common interest in the field of traffic management systems . ### based on an analysis of the transport infrastructure plans of member states , the commission estimates that investment needs in transport amount to eur 500 billion in the entirety of the ten - t network for the period 2014 - 2020 , of which an estimated eur 250 billion will need to be invested in the core network of the ten - t .


### the amount of financial aid to be granted to the actions selected will be modulated based on a cost - benefit analysis of each project , availability of budget resources , and the need to maximise the leverage of eu funding . ### the amount of financial aid to be granted to the actions selected may be modulated based on a cost - benefit analysis of each project , availability of budget resources , and the need to maximise the leverage of eu funding .


### applicable rules for the transport sector under this regulation shall apply to these specific calls . when implementing these calls , greatest possible priority shall be given to projects respecting the national allocations under the cohesion fund . ### applicable rules for the transport sector under this regulation shall apply to these specific calls . until 31 december 2016 , the selection of projects eligible for financing shall respect the national allocations under the cohesion fund . as of 1 january 2017 , resources transferred to the connecting europe facility which have not been committed to a transport infrastructure project , shall be made available to all member states eligible to the cohesion fund to finance transport infrastructure projects according to the regulation establishing the connecting europe facility .


### accelerating the deployment of fast and ultrafast broadband networks and their uptake , including by small and medium sized enterprises , to be measured by the level of broadband and ultrafast broadband coverage and the number of households having subscribed for broadband connections for above 100 mbps ; ### stimulating and generating the demand for fast and ultrafast broadband networks by promoting the interconnection and interoperability of national public services online as well as access to such networks , to be measured by the percentage of citizens and businesses using public services online and the availability of such services across borders . accelerating the deployment of fast and ultrafast broadband networks and their uptake through financial instruments in order to meet existing and rising demand , including by small and medium sized enterprises , to be measured by the level of broadband and ultrafast broadband coverage and the number of households having subscribed for broadband connections for above 100 mbps ;


### the amount of union financial aid shall not exceed 50% of the eligible cost of studies and / or works ; ### the amount of union financial aid shall not exceed 50% of the eligible cost of studies and / or of works ;


### ‘ programme support actions’ means accompanying measures necessary for the implementation of the connecting europe facility and individual sector specific guidelines , such as services , as well as preparatory , feasibility , coordination , monitoring , control , audit and evaluation activities which are required directly for the management of this facility and the achievement of its objectives , and in particular studies , meetings , information , infrastructure mapping , twinning , dissemination , awareness raising and communication actions , expenses linked to it networks focusing on information exchange , together with all other technical and administrative assistance expenses that may be required for the management of this facility or implementation of the individual sector specific guidelines ; ### ' programme support actions ' means all accompanying measures necessary for the implementation of the connecting europe facility and individual sector specific guidelines , such as services , as well as preparatory , feasibility , coordination , monitoring , control , audit and evaluation activities , which are required in order to facilitate the preparation of projects of common interests notably in cohesion countries in view of obtaining financing under this regulation or on the financial market , or directly for the management of this facility and the achievement of its objectives . this shall include in particular studies , meetings , information , infrastructure mapping , dissemination , awareness raising , communication and concerted actions , expenses linked to it networks focusing on information exchange about the facility , together with all other technical and administrative assistance expenses incurred by the commission that may be required for the management of this facility or implementation of the individual sector specific guidelines ;


### acting in accordance with the procedure referred to in paragraph 1 , the commission , when establishing multiannual and sectoral annual work programmes , shall establish the selection and award criteria in line with the objectives and priorities laid down : for transport in regulation no xxxx / 2012 [ ten - t guidelines ] ; for energy in regulation no xxxx / 2012 [ guidelines for trans - european energy infrastructure ] ; for telecommunications in regulation no xxxx / 2012 [ infso guidelines ] . ### acting in accordance with the procedure referred to in paragraph 1 , the commission , when establishing multiannual and sectoral annual work programmes , shall establish the selection and award criteria in line with the objectives and priorities laid down in articles 3 and 4 of this regulation and in regulation no xxxx / 2012 [ ten - t guidelines ] , no xxx 2012 [ guidelines for trans - european energy infrastructure ] or no xxx / 2012 infso guidelines ] . all projects shall be assessed on the basis of the following criteria : the maturity of the action in the project development and preparation stages and the soundness of the implementation proposed ; the leverage effect of union support on public and private investment and the single market ; the need to overcome specific financial obstacles and lack of market - finance , linked to the nature or urgency of the project ; the costs and benefits including economic , social , greenhouse gas and / or other environmental impacts , and accessibility ; for transports and for energy : the cross - border dimension .


### contribute to smart , sustainable and inclusive growth by developing modern and high performing trans - european networks , thus bringing forward benefits for the entire european union in terms of competitiveness and economic , social and territorial cohesion within the single market and creating an environment more conducive to private and public investment through a combination of financial instruments and union direct support and by exploiting synergies across the sectors . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest , and in particular the volume of public and private investments in projects of common interest realised through the financial instruments under this regulation . ### contribute to smart , sustainable and inclusive growth , in line with the europe 2020 strategy , by developing modern and high performing trans - european networks , thus bringing forward benefits for the entire european union in terms of competitiveness on the global market and economic , social and territorial cohesion within the single market , and creating an environment more conducive to private and public investment through a combination of financial instruments and union direct . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest .


### in the field of energy , the specific eligibility conditions of actions implementing projects of common interest for union financial aid in the form of financial instruments and grants under this regulation are set out in article 15 of regulation no xxxx / 2012 [ guidelines for trans - european energy infrastructure ] . ### in the field of energy , the specific eligibility conditions of actions implementing projects of common interest for union financial support in the form of financial instruments and grants under this regulation are as follows : projects of common interest falling within the categories set out in points 1 and 2 of annex ii to regulation no xxxx / 2012 [ energy infrastructure guidelines ] are eligible for union financial support in the form of grants for studies ; projects of common interest falling within the categories set out in points 1 and 2 of annex ii to regulation no xxxx / 2012 [ energy infrastructure guidelines ] which according to the business plan and other assessments carried out , notably by potential investors or creditors , are commercially viable but just below the risk rating that would lead to an investment decision are eligible for union financial support in the form of financial instruments for works ; projects of common interest falling within the categories set out in points 1 to and point 2 of annex ii to regulation no xxxx / 2012 [ energy infrastructure guidelines ] shall be eligible for union financial support in the form of grants for works if they fulfil all of the following criteria : the project is commercially not viable according to the business plan and other assessments carried out , notably by potential investors or creditors . the decision on incentives and its justification referred to in article 14 of regulation no xxxx / 2012 [ energy infrastructure guidelines ] shall be taken into account when assessing the project ' s commercial viability ; the project has received a cross - border cost allocation decision pursuant to article 13 of regulation no xxxx / 2012 [ energy infrastructure guidelines ] or , for projects that have received an exemption pursuant to article 36 of directive 2009 / 73 / ec or article 17 of regulation no 714 / 2009 , an opinion from the competent national regulatory authorities and the agency on the commercial viability of the project ; the project specific cost - benefit analysis pursuant to article 13 of regulation no xxxx / 2012 [ energy infrastructure guidelines ] provides evidence concerning the existence of at least one of the following significant positive externalities : - projects promoting the further integration of the internal energy market and the interoperability of electricity and gas networks across borders through interconnection of member states ' networks and removal of internal constraints , through enhancing cross - border transmission power in relation to installed energy generation capacity or through increased demand coverage between member states by reverse flow interconnectors for gas ; - projects that enhance the security of energy supply and / or solidarity by diversification of supply sources , supplying counter parts and routes , increasing storage capacity , prevention or reduction of disruptions , avoiding spillage of renewable energy due to a lack of cross - border connections or by reducing or eliminating member states ' energy isolation by connecting these markets with more diversified supply sources and / or by installing reverse flow interconnectors for gas ; - projects contributing to sustainable development and protection of the environment by ensuring transmission of renewable electricity from generation to major consumption centres and storage sites ; projects of common interest falling within the categories set out in points 1 of annex ii to regulation no xxxx / 2012 [ energy infrastructure guidelines ] shall be eligible for union financial support in the form of grants for works if they are not commercially viable in accordance with point of point c of this article and can prove at least one of the positive externalities under point of point c of this article .


### the committee shall ensure a horizontal overview of the work programmes referred to in article 18 to ensure consistency and that synergies are identified and exploited between sectors . ### the committee shall ensure a horizontal overview of the work programmes referred to in article 17 to ensure consistency and that synergies are identified and exploited between sectors , and shall seek in particular to ensure a fair contribution from the financial envelopes of each sector in cross - sectoral calls for proposals and when establishing the cofinancing rates for actions with synergies between the sectors .


### helsinki – tallinn – riga – kaunas – warszawa – katowice gdynia – katowice katowice – ostrava – brno – wien katowice – žilina – bratislava – wien wien – graz – klagenfurt – villach – udine – venezia – bologna – ravenna ### helsinki – tallinn – riga – kaunas – warszawa – katowice gdynia – katowice katowice – ostrava – brno – wien katowice – žilina – bratislava – wien wien – graz – klagenfurt – villach – udine – venezia – bologna – ravenna graz – maribor –ljubljana – koper / trieste


### contributing to sustainable development and protection of the environment , notably by fostering the integration of energy from renewable sources into the transmission network and developing carbon dioxide networks , to be measured by the transmission of renewable energy from generation to major consumption centres and storage sites , and the sum of co2 emissions prevented by the construction of the projects which benefited from cef . ### contributing to sustainable development and protection of the environment , notably by reducing greenhouse gas emissions and fostering the integration of energy from renewable sources into the transmission network , to be measured by the transmission of renewable energy from generation to major consumption centres and storage sites , and the sum of co2 emissions prevented by the construction of the projects which benefited from cef .


### helsinki – tallinn – riga – kaunas – warszawa – katowice gdynia – katowice katowice – ostrava – brno – wien katowice – žilina – bratislava – wien wien – graz – klagenfurt – villach – udine – venezia – bologna – ravenna graz – ljubljana – koper / trieste ### helsinki – tallinn – riga – kaunas – warszawa – katowice gdynia – katowice katowice – ostrava – brno – wien katowice – žilina – bratislava – wien wien – graz – klagenfurt – villach – udine – venezia – bologna – ravenna graz – ljubljana – koper / trieste szczecin / świnoujście - poznań / zielona góra - wrocław - ostrava


### traffic management systems , freight transport services , secure parkings on the road core network , as well as actions to support the development of motorways of the seas : the amount of union financial aid shall not exceed 20% of the eligible cost . ### traffic management systems , freight transport services , secure parkings on the road core network : the amount of union financial aid shall not exceed 20% of the eligible cost .


### the european parliament in its resolution of 6 july 2010 on a sustainable future for transport emphasised that an efficient transport policy required a financial framework that was appropriate to the challenges arising and that , to that end , the current resources for transport and mobility should be increased ; it further considered necessary the creation of a facility to coordinate the use of different sources of transport funding , funds available under cohesion policy , public - private partnerships or other financial instruments such as guarantees . ### the european parliament in its resolution of 6 july 2010 on a sustainable future for transport emphasised that an efficient transport policy required a financial framework that was appropriate to the challenges arising and that , to that end , the current resources for transport and mobility should be increased , in the various budget lines relating to them ; it further considered necessary the creation of a facility to coordinate and optimise the use of different sources of transport funding and of all the financial means and mechanisms available at eu level .


### the financial envelope of the connecting europe facility may cover expenses pertaining to , preparatory , monitoring , control , audit and evaluation activities which are required for the management of the programme and the achievement of its objectives , in particular studies , meetings of experts , as far as they are related to the general objectives of this regulation , expenses linked to it networks focusing on information processing and exchange , together with all other technical and administrative assistance expenses incurred by the commission for the management of the programme . the financial allocation may also cover the technical and administrative assistance expenses necessary to ensure the transition between the programme and the measures adopted under regulation no 680 / 2007 . if necessary , appropriations could be entered in the budget beyond 2020 to cover similar expenses , in order to enable the management of actions not yet completed by 31 december 2020 . ### the financial envelope of the connecting europe facility shall cover expenses pertaining to : actions in support of projects of common interest , as defined in article 7 of this regulation ; programme support actions , as defined in article 2 of this regulation , up to 1 . 5% ; the technical and administrative assistance expenses necessary to ensure the transition between the programme and the measures adopted under regulation no 680 / 2007 .


### the following financial instruments may be used : ### in particular , the following financial instruments may be used :


### ' bottleneck ' means a physical barrier that leads to a system break affecting the continuity of long - distance flows . such a barrier can be absorbed by new infrastructure such as bridges or tunnels that address problems as for example gradients , curve radii , gauge . the need to upgrade existing infrastructure shall not be considered as a bottleneck ; ### ' transport bottleneck ' means a physical and / or functional barrier that leads to a system break affecting the continuity of long - distance flows and which can be surmounted by creating new infrastructure


### rail and inland waterways : the amount of union financial aid shall not exceed 20% of the eligible cost ; the funding rate may be increased to 30% for actions addressing bottlenecks ; the funding rate may be increased to 40% for actions concerning cross - border sections ; ### for rail and inland waterways and for road networks in the case of member states with no railway network established in their territory or in the case of a member state with an isolated network as defined in regulation no xxxx / 2012 [ ten - t guidelines ] , the amount of union financial aid shall not exceed 20% of the eligible cost ; the funding rate may be increased to 30% for actions addressing bottlenecks ; the funding rate may be increased to 40% for actions concerning cross - border sections ;