### 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 three calendar days following its appointment , the reporting member state shall notify the sponsor through the eu portal of the following :


### 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 .


### ' 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 voluntarily confirms his or her willingness to participate in a particular trial , after having been duly informed , according to the laws of the member state concerned , of all aspects of the trial that are relevant to the subject’s decision to participate ;


### the reporting member state , and only the reporting member state , may , between the validation date and the assessment date , request additional explanations from the sponsor , taking into account the considerations referred to in paragraph 5 . ### the reporting member state , and only the reporting member state , may , between the validation date and the assessment date , request additional explanations from the sponsor , taking into account considerations that it identifies , as well as considerations raised by the other member states concerned , as referred to in paragraph 5 .


### ‘ 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 ;


### such research relates directly to a life - threatening or debilitating medical condition from which the subject suffers ; ### such research relates directly to a medical condition from which the person concerned suffers ;


### regarding non - authorised investigational medicinal products other than placebo , and authorised investigational medicinal products which , according to the protocol , are not used in accordance with the terms of the marketing authorisation , the sponsor shall submit annually by electronic means to the agency a report on the safety of each investigational medicinal product used in a clinical trial for which it is the sponsor . ### the sponsor shall submit annually by electronic means to the agency a report on the safety of each investigational medicinal product - or of all the investigational medicinal products &#8211 ; used in a clinical trial for which it is the sponsor if the clinical trial involves authorised medicinal products being tested in accordance with treatment strategies which were not envisaged under the terms of their marketing authorisation and which are not supported by data or recommendations and if the clinical trial involves a high level of risk .


### member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . ### member states shall ensure that the assessment of part ii is done by a group of people at least half of whom meet the conditions laid down in article 46 of this regulation .


### this regulation should provide for clear rules concerning informed consent in emergency situations . such situations relate to cases where for example a patient has suffered a sudden life - threatening medical condition due to multiple traumas , strokes or heart attacks , necessitating immediate medical intervention . for such cases , intervention within an ongoing clinical trial , which has already been approved , may be pertinent . however , in certain circumstances , due to the unconsciousness of the patient and the absence of an immediately available legal representative , it is not possible to obtain informed consent prior to the intervention . the regulation should therefore set clear rules whereby such patients may be enrolled in the clinical trial under very strict conditions . in addition , the said clinical trial should relate directly to the medical condition which causes the impossibility of the patient to give informed consent . any previously expressed objection by the patient must be respected , and informed consent from the subject or the legal representative should be sought as soon as possible . ### this regulation should provide for clear rules concerning informed consent in emergency situations . such situations relate to cases where for example a patient has suffered a sudden life - threatening medical condition due to multiple traumas , strokes or heart attacks , necessitating immediate medical intervention . for such cases , intervention within an ongoing clinical trial , which has already been approved , may be pertinent . however , in certain circumstances , due to the unconsciousness of the patient and the absence of an immediately available legal representative , it is not possible to obtain informed consent prior to the intervention . the regulation should therefore set clear rules whereby such patients may be enrolled in the clinical trial under very strict conditions . for example , in cases where the research needs to start without delay and there is reason to expect that the potential benefit to the subject of taking part in the clinical trial outweighs the risks or the subject’s participation entails only a minimal risk , it should be possible for the clinical trial to begin without his or her prior consent . in addition , the said clinical trial should relate directly to the medical condition which causes the impossibility of the patient to give informed consent . any previously expressed objection by the patient must be respected , and informed consent from the subject or the legal representative should be sought as soon as possible


### – 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 appropriate statistical approaches , state of the art of clinical trial design and methodology ; the extent to which the clinical trial addresses issues identified as a priority by patients ;


### 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 or discontinuation of the development of a medicinal product , the sponsor shall submit to the eu database a summary of the positive and / or negative results of the clinical trial , as laid down in annex iiia . until the publication of the summary of the results in accordance with the provisions of this paragraph , it shall only be accessible to the competent authorities of the member states concerned .


### during a clinical trial , a sponsor may become aware of serious breaches of the rules for the conduct of the clinical trial . this should be reported to the member states concerned in order for action to be taken by those member states , where necessary . ### during a clinical trial , a sponsor may become aware of serious breaches of the rules for the conduct of the clinical trial . this should be reported to the member states concerned without delay in order for action to be taken by those member states , where necessary .


### 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 .


### some direct benefit for the group of patients is obtained from the clinical trial . ### some direct benefit for the category of patients concerned by the trial may be obtained from the clinical trial .


### each member state concerned shall assess , for its own territory , the application with respect to the following aspects : ### without prejudice to the aspects covered by part i as referred to in article 6 , each member state concerned shall assess , for its own territory , the application with respect to the following aspects :


### 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 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 regarded as posing a minimal risk 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 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 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 medium - risk or low - risk clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state .


### member states shall ensure that the persons validating and assessing the application do not have conflicts of interest , are independent of the sponsor , the institution of the trial site and the investigators involved , as well as free of any other undue influence . ### member states shall ensure that the persons validating and assessing parts i and ii of the application do not have conflicts of interest , are independent of the sponsor and the investigators involved , as well as free of any other undue influence .


### the investigator’s brochure shall be updated where new safety information becomes available , and at least once per year . ### the investigator’s brochure shall be updated whenever new and relevant safety information becomes available .


### the sponsor shall adequately monitor the conduct of a clinical trial . the extent and nature of the monitoring shall be determined by the sponsor on the basis of all characteristics of the clinical trial , including the following characteristics : ### the sponsor shall adequately monitor the conduct of a clinical trial . the extent and nature of the monitoring shall be determined by the sponsor on the basis of a risk assessment covering all the risk determinants of the clinical trial . the risk assessment shall determine the quality management and trial monitoring , taking into account the following characteristics :


### for the purpose of obtaining those additional explanations , the reporting member state may suspend the relevant time period referred to in paragraph 3 for a maximum of 10 days for low - intervention clinical trials and for a maximum of 20 days for trials other than low - intervention clinical trials . ### for the purpose of obtaining those additional explanations , the reporting member state may suspend the relevant time period referred to in paragraph 3 for a maximum of 10 days for low - risk clinical trials and medium - risk clinical trials using treatment regimens supported by published evidence and / or standard treatment guidelines , and for a maximum of 20 days for trials other than low - risk clinical trials and medium - risk clinical trials using treatment regimens supported by published evidence and / or standard treatment guidelines guidance .


### by way of derogation from points and of article 28 , from points and of article 30 and from points and of article 31 , informed consent may be obtained after the start of the clinical trial to continue the clinical trial and information on the clinical trial may be given after the start of the clinical trial provided that all of the following conditions are fulfilled : ### by way of derogation from points and of article 28 , from points and of article 30 and from points and of article 31 , informed consent , referred to in article 29 , shall be obtained as soon as possible after the start of the clinical trial and information on the clinical trial shall be given after the start of the clinical trial provided that all of the following conditions are fulfilled :


### for clinical trials other than low - intervention clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator . ### for clinical trials other than low - intervention clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator , even directly , without prior establishment of the liability of the sponsor or investigator . compensation may also cover medical care for the long or medium term physical injuries , pain and suffering . in order to facilitate patients ' access to the compensation system , clear and accessible information on the limits and conditions of the compensation system shall be provided to the patient .


### there are grounds for expecting that participation in the clinical trial will produce a benefit to the incapacitated subject outweighing the risks or will produce no risk at all . ### there are grounds for expecting that participation in the clinical trial will produce a benefit to the incapacitated subject outweighing the risks or will produce only a minimal risk .


### the eu database shall be established to enable the co - operation between the competent authorities of the member states to the extent that it is necessary for the application of this regulation and to search for specific clinical trials . it shall also enable sponsors to refer to previous submissions of an application for authorisation of a clinical trial or a substantial modification . ### the eu database shall be established to enable the co - operation between the competent authorities of the member states to the extent that it is necessary for the application of this regulation and to search for specific clinical trials . it shall also enable sponsors to refer to previous submissions of an application for authorisation of a clinical trial or a substantial modification . it shall also enable citizens of the union to have access to clinical information , in easily searchable form , about medicinal products in order to enable them to make informed decisions about their health . publicly available information contained in the database shall contribute to protecting public health and fostering the innovation capacity of european medical research , while recognising the legitimate economic interests of sponsors .


### 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 member state concerned disagrees with the conclusion on the basis of point of the second subparagraph , it shall communicate its disagreement , together with a detailed justification based on scientific and socio - economic arguments , and a summary thereof , through the eu portal to the commission , to all member states , and to the sponsor . ### where the member state concerned disagrees with the conclusion of the reporting member state on the basis of point of the second subparagraph , it shall communicate its disagreement , together with a detailed justification based on scientific and socio - economic arguments , and a summary thereof , through the eu portal to the commission , to all member states , and to the sponsor .


### 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


### where the sponsor does not provide additional explanations within the time period set by the member state in accordance with the first subparagraph , the application shall be considered as withdrawn . the withdrawal shall apply only with respect to the member state concerned . ### where , in response to a request from the member state concerned , the sponsor does not provide additional explanations within the time period set in accordance with the first subparagraph , the application for a clinical trial which is being assessed shall be considered as withdrawn . the withdrawal shall apply only with respect to the member state concerned .


### the sponsor shall propose one of the member states concerned as reporting member state . ### the member states concerned shall determine which state shall be the reporting member state according to an established procedure based on objective criteria which are set by the commission .


### the time period for reporting shall take account of the severity of the reaction . where necessary to ensure timely reporting , the sponsor may submit an initial incomplete report followed up by a complete report . ### the time period for reporting shall take account of the seriousness of the reaction . where necessary to ensure timely reporting , the sponsor may submit an initial incomplete report followed up by a complete report .


### the database should contain all relevant information as regards the clinical trial . no personal data of data subjects participating in a clinical trial should be recorded in the database . the information in the database should be public , unless specific reasons require that a piece of information should not be published , in order to protect the right of the individual to private life and the right to the protection of personal data , recognised by articles 7 and 8 of the charter of fundamental rights of the european union . ### the database should contain all relevant information as regards the clinical trial and allow public dissemination of objective information in order to support european research and to increase knowledge in the field of public health . it should not undermine innovation or competitiveness of european industries . no personal data of data subjects participating in a clinical trial should be recorded in the database , and the protection of commercial interests , including intellectual property , as foreseen by article 4 of regulation 1049 / 2001 , should not be hampered . the information in the database should be public , unless specific reasons require that a piece of information should not be published , in order to protect the right of the individual to private life and the right to the protection of personal data , recognised by articles 7 and 8 of the charter of fundamental rights of the european union , or commercially confidential information , as foreseen by article 4 of regulation 1049 / 2001 .


### safety reporting with regard to auxiliary medicinal products shall be made in accordance with chapter 3 of directive 2001 / 83 / ec . ### safety reporting with regard to auxiliary medicinal products shall be made in accordance with directive 2010 / 84 / eu .


### compliance with point is permanently observed ; ### the principles referred to in point are observed throughout the study ;


### investigational medicinal products shall be traceable , stored , destroyed and returned as appropriate and proportionate to ensure subject safety and the reliability and robustness of the data generated in the clinical trial , taking into account whether the investigational medicinal product is authorised , and whether the clinical trial is a low - intervention clinical trial . ### investigational medicinal products shall be traceable , stored , destroyed and returned as appropriate and proportionate to ensure subject safety and the reliability and robustness of the data generated in the clinical trial , taking into account whether the investigational medicinal product is authorised , and whether the clinical trial is a minimal - risk clinical trial .


### investigational medicinal products shall be traceable , stored , destroyed and returned as appropriate and proportionate to ensure subject safety and the reliability and robustness of the data generated in the clinical trial , taking into account whether the investigational medicinal product is authorised , and whether the clinical trial is a low - intervention clinical trial . ### investigational medicinal products shall be traceable , stored , destroyed and returned as appropriate and proportionate to ensure subject safety and the reliability and robustness of the data generated in the clinical trial , taking into account whether the clinical trial is a medium - risk or low - risk clinical trial .


### – 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 reporting member state for the application referred to in paragraph 1 shall be the reporting member state for the initial authorisation procedure . ### where there was a reporting member state for the initial authorisation procedure it shall be the reporting member state for the application referred to in paragraph 1 . where the initial application was submitted to one member state only , that member state shall be the 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 ;


### end of the clinical trial , early termination of the clinical trial ### end of the clinical trial , early termination of the clinical trial and submission of results


### for clinical trials other than low - intervention clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator . ### for all clinical trials the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator .


### 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 .


### in order to ensure compliance of the conduct of the clinical trial with the protocol , and in order for investigators to be informed about the investigational medicinal products they administer , the sponsor should supply the investigators with an investigator ' s brochure . ### in order to ensure compliance of the conduct of the clinical trial with the protocol , and in order for investigators to be informed about the investigational medicinal products they administer , the sponsor should supply the investigators with an investigator ' s brochure . this brochure should be updated whenever new safety information becomes available , including information about events other than suspected unexpected serious adverse reactions .


### for the purpose of this regulation , if a suspended or temporarily halted clinical trial is not restarted , the date of the decision of the sponsor not to restart the clinical trial shall be considered as the end of the clinical trial . in the case of early termination , the date of the early termination shall be considered as the date of the end of the clinical trial . ### for the purpose of this regulation , if a suspended or temporarily halted clinical trial is not restarted , the date of the decision of the sponsor not to restart the clinical trial shall be considered as the end of the clinical trial . in the case of early termination , the date of the early termination shall be considered as the date of the end of the clinical trial . if a clinical trial is discontinued , the sponsor shall notify the reasons thereof to the member state concerned through the eu portal within 15 days from the decision to discontinue the clinical trial .


### by way of derogation from points and of article 28 , from points and of article 30 and from points and of article 31 , informed consent may be obtained after the start of the clinical trial to continue the clinical trial and information on the clinical trial may be given after the start of the clinical trial provided that all of the following conditions are fulfilled : ### by way of derogation from points and of article 28 , from points and of article 30 and from points and of article 31 , informed consent , referred to in article 29 , shall be obtained as soon as possible after the start of the clinical trial and information on the clinical trial shall be given after the start of the clinical trial provided that all of the following conditions are fulfilled :


### 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 . ### 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 . it shall provide a clear and exhaustive information related to legal remedies and conditions to access to a system of indemnisation , in case of injuries incurred during the trial .


### 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 conduct of a clinical trial should be adequately monitored by the sponsor in order to ensure the reliability and robustness of the results . monitoring may also contribute to subject safety , taking into account the characteristics of the clinical trial and respect for fundamental rights of subjects . when establishing the extent of monitoring , the characteristics of the clinical trial should be taken into account . ### the conduct of a clinical trial should be adequately monitored by the sponsor in order to ensure the reliability and robustness of the results . monitoring may also contribute to subject safety , taking into account the characteristics of the clinical trial and respect for fundamental rights of subjects . monitoring should be adapted to the nature of the trial and focus on mitigating the key risks .


### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval . ### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ minimal - risk clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . given that minimal - risk clinical trials have only a very limited and temporary adverse effect – if any – on the subject’s health , they should be subject to less stringent rules , such as shorter deadlines for approval . they should , however , be subject to the vigilance and traceability rules governing normal clinical practice .


### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ' low - intervention clinical trials ' are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval . ### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ' low - risk clinical trials ' are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval .


### the database should contain all relevant information as regards the clinical trial . no personal data of data subjects participating in a clinical trial should be recorded in the database . the information in the database should be public , unless specific reasons require that a piece of information should not be published , in order to protect the right of the individual to private life and the right to the protection of personal data , recognised by articles 7 and 8 of the charter of fundamental rights of the european union . ### the database should contain all relevant information as regards the clinical trial and allow public dissemination of objective information in order to support european research and to increase knowledge in the field of public health . it should not undermine innovation or competitiveness of european industries . no personal data of data subjects participating in a clinical trial should be recorded in the database , and the protection of commercial interests , including intellectual property , as foreseen by article 4 of regulation 1049 / 2001 , should not be hampered . the information in the database should be public , unless specific reasons require that a piece of information should not be published , in order to protect the right of the individual to private life and the right to the protection of personal data , recognised by articles 7 and 8 of the charter of fundamental rights of the european union , or commercially confidential information , as foreseen by article 4 of regulation 1049 / 2001 .


### the investigator’s brochure shall be updated where new safety information becomes available , and at least once per year . ### the investigator’s brochure shall be updated whenever new and relevant safety information becomes available .


### member states shall ensure that the persons validating and assessing the application do not have conflicts of interest , are independent of the sponsor , the institution of the trial site and the investigators involved , as well as free of any other undue influence . ### member states shall ensure that the persons validating and assessing parts i and ii of the application do not have conflicts of interest , are independent of the sponsor and the investigators involved , as well as free of any other undue influence .


### where the proposed reporting member state finds that the application is not complete , that the clinical trial applied for does not fall within the scope of this regulation , or that the clinical trial is not a low - intervention clinical trial while this is claimed by the sponsor , it shall inform the sponsor thereof through the eu portal and shall set a maximum of six days for the sponsor to comment or to complete the application through the eu portal . ### where the proposed reporting member state finds that the application is not complete , that the clinical trial applied for does not fall within the scope of this regulation , or that the clinical trial is not a medium - risk or low - risk clinical trial while this is claimed by the sponsor , it shall inform the sponsor thereof through the eu portal and shall set a maximum of six days for the sponsor to comment or to complete the application through 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 .


### 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 ;


### apart from the reporting of suspected unexpected serious adverse reactions , there may be other events which are relevant in terms of benefit - risk balance and which should be reported in a timely manner to the member states concerned . ### apart from the reporting of suspected unexpected serious adverse reactions , there may be other events which are relevant in terms of benefit - risk balance and which should be reported in a timely manner to the competent bodies of the member states concerned , including those responsible for the assessment of ethical aspects .


### ‘ low - intervention clinical trial’ : a clinical trial which fulfils all of the following conditions : ### ‘ low - risk clinical trial’ : a clinical trial presents a low risk if , given the nature and extent of the intervention , it can be expected to have only a very small and temporary impact – if any – on the subject’s health . a low - risk clinical trial shall fulfil all of the following conditions :


### a sponsor shall not submit an application in accordance with this article where a procedure referred to in chapter iii as regards that clinical trial is pending . ### a sponsor shall not submit an application in accordance with this article where a procedure referred to in chapter iii as regards that clinical trial , and relating to an aspect covered by part i of the assessment report , is pending .


### 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 .


### for the purposes of this chapter , the date on which the sponsor is notified in accordance with paragraph 2 shall be the validation date of the application . where the sponsor is not notified , the validation date shall be the last day of the time periods referred to in paragraphs 2 and 4 . ### for the purposes of this chapter , the date on which the sponsor is notified in accordance with paragraph 2 shall be the admissibility date of the application . where the sponsor is not notified , the admissibility date shall be the last day of the time periods referred to in paragraphs 2 and 4 .


### ‘ low - intervention clinical trial’ : a clinical trial which fulfils all of the following conditions : ### ‘ minimal - risk clinical trial’ : a clinical trial presents a minimal risk if , given the nature and extent of the intervention , it can be expected to have only a very small and temporary impact - if any - on the subject’s health . a ‘ minimal - risk clinical trial’ fulfils all of the following conditions :


### the investigator’s brochure shall be updated where new safety information becomes available , and at least once per year . ### the investigator’s brochure shall be updated whenever new safety information becomes available .


### the reporting member state for the application referred to in paragraph 1 shall be the reporting member state for the initial authorisation procedure . ### where there was a reporting member state for the initial authorisation procedure it shall be the reporting member state for the application referred to in paragraph 1 . where the initial application was submitted to one member state only , that member state shall be the reporting member state .


### for clinical trials other than low - intervention clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator . ### for clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator .


### 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 .


### a description of the publication policy ; ### a description of the publication policy , clearly indicating any information that may be available from a source other than the eu database ;


### by way of derogation from points and of article 28 , from points and of article 30 and from points and of article 31 , informed consent may be obtained after the start of the clinical trial to continue the clinical trial and information on the clinical trial may be given after the start of the clinical trial provided that all of the following conditions are fulfilled : ### by way of derogation from points and of article 28 , from points and of article 30 and from points and of article 31 , informed consent , referred to in article 29 , shall be obtained as soon as possible after the start of the clinical trial and information on the clinical trial shall be given after the start of the clinical trial provided that all of the following conditions are fulfilled :


### the clinical trial poses a minimal risk to , and imposes a minimal burden on , the subject . ### there are grounds for expecting that the benefits of participating in the clinical trial are proportional to the risks for the subject or that it involves a minimal risk only and it doesn ' t impose a disproportionate burden on the subject .


### in order to obtain an authorization , the sponsor shall submit an application dossier to the intended member state concerned through the portal referred to in article 77 . ### for any clinical trial in the union , in order to obtain an authorization , the sponsor shall submit an application dossier to the intended member state concerned through the portal referred to in article 77 .


### 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 assent of the 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 , in accordance with his or her age and maturity , has been obtained ;


### where the proposed reporting member state finds that the application is not complete , that the clinical trial applied for does not fall within the scope of this regulation , or that the clinical trial is not a low - intervention clinical trial while this is claimed by the sponsor , it shall inform the sponsor thereof through the eu portal and shall set a maximum of six days for the sponsor to comment or to complete the application through the eu portal . ### where the proposed reporting member state finds that the application is not complete , that the clinical trial applied for does not fall within the scope of this regulation , or that the clinical trial is not a medium - risk or low - risk clinical trial while this is claimed by the sponsor , it shall inform the sponsor thereof through the eu portal and shall set a maximum of six days for the sponsor to comment or to complete the application through the eu portal .


### for the purpose of obtaining those additional explanations , the reporting member state may suspend the time period referred to in paragraph 4 for a maximum of 10 days for low - intervention clinical trials and for a maximum of 20 days for trials other than low - intervention clinical trials . ### for the purpose of obtaining those additional explanations , the reporting member state may suspend the time period referred to in paragraph 4 for a maximum of 10 days for low - risk clinical trials and medium - risk clinical trials using treatment regimens supported by published evidence and / or or standard treatment guidelines and for a maximum of 20 days for trials other than low - risk clinical trials and medium - risk clinical trials using treatment regimens supported by published evidence and / or standard treatment guidelines .


### 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 has been conducted outside the union , it shall comply with principles equivalent to those of this regulation as regards subject rights , and safety and well - being , and reliability and robustness of data generated in the clinical trial .


### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval . ### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ minimal - risk clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . given that minimal - risk clinical trials have only a very limited and temporary adverse effect – if any – on the subject’s health , they should be subject to less stringent rules , such as shorter deadlines for approval . they should , however , be subject to the vigilance and traceability rules governing normal clinical practice .


### ‘ substantial modification’ : any change to any aspect of the clinical trial which is made after notification of the decision referred to in articles 8 , 14 , 19 , 20 and 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial ; ### ‘ substantial modification’ : any change to any aspect of the clinical trial which is made after notification of the decision referred to in articles 8 , 14 , 19 , 20 and 23 and which is likely to have a substantial impact on the safety , rights or well - being of the subjects or on the reliability and robustness of the data generated in the clinical trial ;


### 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 , the elderly 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 , the elderly and minors .


### no legal representative is available ; ### the consent of the legal representative cannot be given within a period consistent with the methodological requirements of the research ;


### ‘ investigator’ : an individual responsible for the conduct of a clinical trial at a clinical trial site ; ### ‘ investigator’ : an individual whose training and experience meet the requirements laid down in article 46 of this regulation and who is responsible for the conduct of a clinical trial at a clinical trial site ;


### the part of the union budget allocated to the fund shall be implemented within the framework of shared management between the member states and the commission , in accordance with article&#160 ; 55 of the financial regulation , with the exception of technical assistance at the initiative of the commission , which shall be implemented in the framework of direct management in accordance with article 55 of the financial regulation . ### the part of the union budget allocated to the fund shall be implemented within the framework of shared management between the member states and the commission , in accordance with article&#160 ; 58 of the financial regulation , with the exception of technical assistance at the initiative of the commission , which shall be implemented in the framework of direct management in accordance with article&#160 ; 58 of the financial regulation .


### the part of the union budget allocated to the fund shall be implemented within the framework of shared management between the member states and the commission , in accordance with article&#160 ; 55 of the financial regulation , with the exception of technical assistance at the initiative of the commission , which shall be implemented in the framework of direct management in accordance with article 55 of the financial regulation . ### the part of the union budget allocated to the fund shall be implemented within the framework of shared management between the member states and the commission , in accordance with article 58 of the financial regulation , with the exception of technical assistance at the initiative of the commission , which shall be implemented in the framework of direct management in accordance with article 58 of the financial regulation


### drawing up the annual accounts referred to in article 56 of the financial regulation ; ### drawing up the annual accounts referred to in article 59 of the financial regulation ;


### an audit opinion in accordance with article 56 of the financial regulation ; ### an audit opinion in accordance with article 59 of the financial regulation ;


### for each year from 2015 until and including 2022 , by 15 february of the year following the end of the accounting period , the designated bodies shall submit to the commission the following documents and information in accordance with article 56 of the financial regulation : ### for each year from 2015 until and including 2022 , by 31 january of the year following the end of the accounting period , the designated bodies shall submit to the commission the following documents and information in accordance with article 56 of the financial regulation :


### for each year from 2015 until and including 2022 , by 15 february of the year following the end of the accounting period , the designated bodies shall submit to the commission the following documents and information in accordance with article 56 of the financial regulation : the certified annual accounts of the relevant bodies designated pursuant to article 32 as referred to in article 56 of the financial regulation ; the management declaration as referred to in article 56 of the financial regulation ; an annual summary of the final audit reports and of controls carried out , including an analysis of the nature and extent of errors and of weaknesses , as well as corrective actions taken or planned ; an audit opinion by the designated independent audit body as referred in article 56 of the financial regulation , accompanied by a control report setting out the findings of the audits carried out relating to the accounting year covered by the opinion . ### for each year from 2015 until and including 2022 , by 15 february of the year following the end of the accounting period , the designated bodies shall submit to the commission the following documents and information in accordance with article 59 of the financial regulation : the certified annual accounts of the relevant bodies designated pursuant to article 32 as referred to in article 59 of the financial regulation ; the management declaration as referred to in article 59 of the financial regulation ; an annual summary of the final audit reports and of controls carried out , including an analysis of the nature and extent of errors and of weaknesses , as well as corrective actions taken or planned ; an audit opinion by the designated independent audit body as referred in article 59 of the financial regulation , accompanied by a control report setting out the findings of the audits carried out relating to the accounting year covered by the opinion ;


### 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 .


### the delegation of tasks and responsibilities can be a useful instrument in the functioning of the network of supervisors in order to reduce the duplication of supervisory tasks , foster cooperation and thereby streamline the supervisory process as well as reduce the burden imposed on financial institutions . the regulation should therefore provide a clear legal basis for such delegation . delegation of tasks means that tasks are carried out by another supervisory authority instead of the responsible authority , while the responsibility for supervisory decisions remains with the delegating authority . by delegation of responsibilities one national supervisory authority , the delegatee , shall be able to decide upon a certain supervisory matter in its name in lieu of another national supervisory authority . delegations should be governed by the principle of allocating supervisory competence to a supervisor which is well placed to take action in the subject matter . a reallocation of responsibilities can be appropriate for example for reasons of economies of scale or scope , of coherence in group supervision , and of optimal use of technical expertise among national supervisory authorities . relevant community legislation may further specify the principles for reallocation of responsibilities upon agreement . the authority should facilitate delegation agreements between national supervisory authorities by all appropriate means . it should be informed in advance of intended delegation agreements to be able to express an opinion where appropriate . it should centralise the publication of such agreements to ensure timely , transparent and easily accessible information about agreements for all parties concerned . ### the delegation of tasks and responsibilities can be a useful instrument in the functioning of the network of supervisors in order to reduce the duplication of supervisory tasks , foster cooperation and thereby streamline the supervisory process as well as reduce the burden imposed on financial institutions . the regulation should therefore provide a clear legal basis for such delegation . delegation of tasks means that tasks are carried out by another supervisory authority instead of the responsible authority , while the responsibility for supervisory decisions remains with the delegating authority . by delegation of responsibilities one national supervisory authority , the delegatee , shall be able to decide upon a certain supervisory matter in its name in lieu of another national supervisory authority . delegations should be governed by the principle of allocating supervisory competence to a supervisor which is well placed to take action in the subject matter . a reallocation of responsibilities can be appropriate for example for reasons of economies of scale or scope , of coherence in group supervision , and of optimal use of technical expertise among national supervisory authorities . relevant eu legislation may further specify the principles for reallocation of responsibilities upon agreement . the authority should facilitate and monitor delegation agreements between national supervisory authorities by all appropriate means . it should be informed in advance of intended delegation agreements to be able to express an opinion where appropriate . it should centralise the publication of such agreements to ensure timely , transparent and easily accessible information about agreements for all parties concerned . it should identify and promulgate best practices regarding delegation and delegation agreements .


### the authority may develop technical standards in the areas specifically set out in the legislation referred to in article 1 . the authority shall submit its draft standards to the commission for endorsement . ### the authority may develop technical standards to complete , update and modify elements that are not essential to the legislative acts referred to in article 1 . the technical standards shall not involve strategic decisions and their content shall be delimited by the legislative acts on which they are based .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision of the authority , and thereby fails to ensure that a financial market participant complies with requirements directly applicable to it by virtue of the legislation referred to in article 1 , the authority may 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 of the authority , and thereby fails to ensure that a financial market participant complies with requirements directly applicable to it by virtue of the legislation referred to in article 1 , the authority shall 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 .


### where the commission has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial market participants and competent authorities satisfy the requirements laid down in that legislation . ### where the existence of an emergency situation is declared pursuant to paragraph 1 , the authority shall adopt individual decisions necessary to ensure that competent authorities take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial market participants and competent authorities satisfy the requirements laid down in that legislation .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision of the authority referred to in paragraph 2 within the period laid down therein , the authority may , where the relevant requirements laid down in 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 that legislation , 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 of the authority referred to in paragraph 2 within the period laid down therein , the authority shall , pursuant to the relevant requirements laid down in 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 that legislation , including the cessation of any practice .


### 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 .


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


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


### 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 .


### where a competent authority has not correctly applied the legislation referred to in article 1 , in particular by failing to ensure that a financial market participant satisfies the requirements laid down in that legislation , the authority shall have the powers set out in paragraphs 2 , 3 and 6 of this article . ### where a competent authority has not correctly applied the legislation referred to in article 1 , including the technical standards established in accordance with article 7 , in particular by failing to ensure that a financial market participant satisfies the requirements laid down in that legislation , the authority shall have the powers set out in paragraphs 2 , 3 and 6 of this article .


### 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 .


### the competent authorities shall make every effort to comply with those guidelines and recommendations . ### within two months of the issuance of a guideline or recommendation , each competent authority shall decide whether it intends to comply with that guideline or recommendation . in the event that it does not intend to comply , it shall inform the authority , stating reasons . the authority shall publish those reasons .


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


### proposal for a regulation of the european parliament and of the council establishing a european securities and markets authority ### proposal for a regulation of the european parliament and of the council establishing a european supervisory authority


### without prejudice to the powers laid down in article 9 , where a competent authority disagrees on the procedure or content of an action or inaction by another competent authority in areas where the legislation referred to in article 1 requires cooperation , coordination or joint decision making by competent authorities from more than one member state , the authority , at the request of one or more of the competent authorities concerned , may assist the authorities in reaching an agreement in accordance with the procedure set out in paragraph 2 . ### without prejudice to the powers laid down in article 9 , where a competent authority disagrees on the procedure or content of an action or inaction by another competent authority in areas where the legislation referred to in article 1 requires cooperation , coordination or joint decision making by competent authorities from more than one member state , the authority , on its own initiative or at the request of one or more of the competent authorities concerned , shall take the lead in assisting the authorities in reaching an agreement in accordance with the procedure set out in paragraphs 2 to 4 .


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


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


### provided that the results of the evaluation and the ex - ante audit of bonus eeig are positive , the commission and the bonus eeig shall conclude the implementation agreement . ### provided that the conditions as referred to in article 3 are in place and the ex - ante audit of the bonus eeig is positive , the commission and the bonus eeig shall conclude the implementation agreement .


### in order to efficiently implement bonus - 169 , during the implementation phase , financial support should be granted to participants in bonus - 169 projects selected at the central level under the responsibility of the bonus eeig following calls for proposals . ### in order to efficiently implement bonus , during the implementation phase , financial support should be granted to participants in bonus projects selected at the central level under the responsibility of the bonus eeig following calls for proposals . the grant of such financial support to participants in bonus and its payment should be transparent and unbureaucratic .


### 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 . ### as a general rule , the community financial contribution and the cash contribution of the participating states to bonus shall be pooled and administered centrally by the bonus eeig . however , in justified cases , a participating state may devote its cash contribution exclusively to domestic research .


### 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 .


### remuneration policy should aim at aligning the personal objectives of staff members with the long - term interests of the credit institution or investment firm concerned . the assessment of the performance - based components of remuneration should be based on longer - term performance and take into account the outstanding risks associated with the performance . the assessment of performance should be set in a multi - year framework , for example of three to five years , in order to ensure that the assessment process is based on longer - term performance and that the actual payment of performance - based components of remuneration is spread over the business cycle of the firm . ### remuneration policy should aim at aligning the personal objectives of staff members with the long - term interests of the credit institution or investment firm concerned . the assessment of the performance - based components of remuneration should be based on longer - term performance and take into account the outstanding risks associated with the performance . the assessment of performance should be set in a multi - year framework , for example of three to five years , in order to ensure that the assessment process is based on longer - term performance and that the actual payment of performance - based components of remuneration is spread over the business cycle of the firm . corporate social responsibility and sustainable development targets should be included in the assessment of longer - term performance justifying the payment of deferred variable remuneration .


### excessive and imprudent risk - taking in the banking sector has led to the failure of individual financial institutions and systemic problems in member states and globally . while the causes of such risk - taking are many and complex , there is agreement by supervisors and regulatory bodies , including the g20 and the committee of european banking supervisors , that the inappropriate remuneration structures of some financial institutions have been a contributory factor . remuneration policies which give incentives to take risks that exceed the general level of risk tolerated by the institution can undermine sound and effective risk management and exacerbate excessive risk - taking behaviour . ### excessive and imprudent risk - taking in the banking sector has led to the failure of individual financial institutions and systemic problems in member states and globally . while the causes of such risk - taking are many and complex , there is agreement by supervisors and regulatory bodies , including the g20 and the committee of european banking supervisors , that the inappropriate remuneration structures of some financial institutions have been a contributory factor . remuneration policies which give incentives to take risks that exceed the general level of risk tolerated by the institution can undermine sound and effective risk management and exacerbate excessive risk - taking behaviour . in this context , particular account should be taken of the internationally agreed and endorsed principles established by the financial stability board .


### the remuneration policy is consistent with and promotes sound and effective risk management and does not encourage risk - taking that exceeds the level of tolerated risk of the credit institution ; ### the remuneration policy is consistent with and promotes sound and effective risk management , does not encourage risk - taking that exceeds the level of tolerated risk of the credit institution and includes measures to avoid asymmetries of information and conflicts of interest ;


### 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 aviation 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 aviation authorities shall participate and work together in a network that convenes at regular intervals . the commission and eaa shall facilitate active cooperation of the national aviation authorities and exchanges and use of staff between the national aviation authorities .


### the commission shall be empowered to adopt delegated acts in accordance with article 26 in order to lay down detailed rules for the proper functioning of the performance scheme in accordance with the points listed in this paragraph . ### the commission shall be empowered to adopt delegated acts in accordance with article 26 in order to adopt the union - wide performance targets and lay down detailed rules for the proper functioning of the performance scheme in accordance with the points listed in this paragraph .


### be recruited under clear and transparent rules which guarantee their independence and as regards persons in charge of strategic decisions , be appointed by the national cabinet or council of ministers or another public authority which does not directly control , or benefit from the air navigation service providers ; ### be recruited under clear and transparent rules which guarantee their independence ;


### a functional airspace block that extend across the airspace under the responsibility of more than one member state shall be established by joint designation between all the member states , as well as , where appropriate , third countries that have responsibility for any part of the airspace included in the functional airspace block ### a functional airspace block shall be established by joint designation between all the member states , as well as , where appropriate , third countries that have responsibility for any part of the airspace included in the functional airspace block .


### the commission may , and in conformity with the implementing rules referred to in paragraph 4 , appoint eurocontrol , or another impartial and competent body , to carry out the tasks of the network manager . these tasks shall be executed in an impartial and cost - effective manner and performed on behalf of member states and stakeholders . they shall be subject to appropriate governance , which recognises the separate accountabilities for service provision and regulation , taking into consideration the needs of the whole atm network and with the full involvement of the airspace users and air navigation service providers . by 1 january 2020 , the commission shall designate the network manager as a self - standing service provider where possible set up as an industrial partnership . ### the commission may in conformity with the implementing rules referred to in paragraph 4 , appoint eurocontrol , or another impartial and competent body , to carry out the tasks of the network manager . these tasks shall be executed in an impartial and cost - effective manner and performed on behalf of the union , member states and stakeholders . they shall be subject to appropriate governance , which recognises the separate accountabilities for service provision and regulation , taking into consideration the needs of the whole atm network and with the full involvement of the airspace users and air navigation service providers . by 1 january 2016 , the commission shall designate the network manager as a self - standing service provider set up as an industrial partnership .


### ‘ certificate’ means a document issued by a national supervisory authority in any form complying with national law , which confirms that an air navigation service provider meets the requirements for providing a specific service ; ### ' certificate ' means a document issued by the european agency for aviation or by a national aviation authority in any form complying with relevant law , which confirms that an air navigation service provider meets the requirements for providing a specific activity ;


### ‘ functional airspace block’ means an airspace block based on operational requirements and established regardless of state boundaries , where the provision of air navigation services and related functions are performance - driven and optimised with a view to introducing , in each functional airspace block , enhanced cooperation among air navigation service providers or , where appropriate , an integrated provider ; ### ' functional airspace block ' means an airspace block established regardless of state boundaries , where the provision of air navigation services and related functions are performance - driven and optimised through enhanced cooperation among air navigation service providers or , where appropriate , an integrated provider ;


### as regards persons in charge of strategic decisions , audits or other functions directly linked to oversight or performance targets of air navigation service providers , have no professional position or responsibility with any of the air navigation service providers after their term in the national supervisory authority , for a period of at least one year . ### as regards persons who have been in charge of strategic decisions , audits or other functions directly linked to oversight or performance targets of air navigation service providers for more than six months , have no professional position or responsibility with any of the air navigation service providers after their term in the national supervisory authority , for a period of :


### the application of this regulation to the airport of gibraltar is understood to be without prejudice to the respective legal positions of the kingdom of spain and the united kingdom of great britain and northern ireland with regard to the dispute over sovereignty over the territory in which the airport is situated . ### the application of this regulation to gibraltar airport is understood to be without prejudice to the respective legal positions of the kingdom of spain and the united kingdom with regard to the controversy over sovereignty over the territory in which the airport is situated .


### the commission shall designate an independent , impartial and competent body to act as a ‘ performance review body’ . the role of the performance review body shall be to assist the commission , in coordination with the national supervisory authorities , and to assist the national supervisory authorities on request in the implementation of the performance scheme referred to in paragraph 1 . technical assistance to the performance review body may be provided by eaa and eurocontrol or another competent entity . ### the commission shall designate an independent , impartial and competent body to act as a ' performance review body ' . the prb shall be established as a european economic regulator under the supervision of the commission . the role of prb shall be to assist the commission , in coordination with the national aviation authorities , and to assist and monitor the national aviation authorities in the implementation of the performance scheme referred to in paragraph 1 . technical assistance to the prb may be provided by eaa , the network manager , eurocontrol or another competent entity .


### the commission shall establish detailed rules laying down the modalities of the recruitment and selection procedures for the application of paragraphs 6 and . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 27 . ### the commission shall establish detailed rules laying down the modalities of the recruitment and selection procedures for the application of paragraphs 6 and . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 27 , and shall specify :


### 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 aviation 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 commission and the eaa shall facilitate active cooperation , exchanges and secondment of staff between the national aviation authorities . subject to the rules on data protection provided for in article 22 of this regulation and in regulation no 45 / 2001 , the commission shall provide a platform for the exchange of such information among the members of the network , possibly through electronic tools , respecting the confidentiality of business secrets of any companies , organisations or entities involved .


### as regards persons in charge of strategic decisions , audits or other functions directly linked to oversight or performance targets of air navigation service providers , have no professional position or responsibility with any of the air navigation service providers after their term in the national supervisory authority , for a period of at least one year . ### as regards persons who have been in charge of strategic decisions , audits or other functions directly linked to oversight or performance targets of air navigation service providers for more than six months , have no professional position or responsibility with any of the air navigation service providers after their term in the national aviation authority , for a period of :


### the commission shall carry out regular assessments of the achievement of the union - wide and associated local performance targets . ### the financial incentive shall be determined in advance by the commission and consist of a portion of the route charge or of community resources from the multiannual financial framework .


### ensuring the supervision of the application of this regulation , in particular with regard to the safe and efficient operation of air navigation service providers which provide services relating to the airspace falling under the responsibility of the member state which nominated or established the relevant authority ; ### ensuring the supervision of the application of this regulation and regulation no 216 / 2008 , in particular with regard to the safe and efficient operation of air navigation service providers which provide services relating to the airspace falling under the responsibility of the member state which nominated or established the relevant authority


### 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 any member state , other air navigation service providers , airspace users and airports within the union and neighbouring third countries , if appropriate , within a functional airspace block , subject to mutual agreement between the relevant parties . with regard to support services this possibility shall be subject to the compliance with article 10 .


### member states shall take all necessary measures to ensure that the provision of air traffic services is separated from the provision of support services . this separation shall include the requirement that air traffic services and support services are provided by separate undertakings . ### providers of ans shall , when drawing up business plans , take into consideration offers from different support service providers . the performance review body provided for by article 11 shall , when evaluating the performance plans , monitor the level of compliance with the provisions of this paragraph .


### 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 for the imposition of sanctions for non - compliance with the union–wide and associated local performance targets during the reference periods and for supporting alert mechanisms ;


### ensuring the supervision of the application of this regulation , in particular with regard to the safe and efficient operation of air navigation service providers which provide services relating to the airspace falling under the responsibility of the member state which nominated or established the relevant authority ; ### the tasks arising from regulation no 216 / 2008 ;


### the national supervisory authorities shall be legally distinct and independent in particular in organisational , hierarchical and decision - making terms , from any air navigation service providers or any private or public entity having an interest in the activities of such providers . ### the national aviation authorities shall be legally distinct and independent , in particular in organisational , hierarchical and decision - making terms , from any company , organisation , public or private entity or staff falling within the scope of authority activity as provided for in article 1 of regulation no 216 / 2008 or having an interest in the activities of such entities .


### national supervisory authorities have a key role to play in the implementation of the single european sky and the commission should therefore facilitate cooperation among them in order to enable the exchange of best practices and to develop a common approach , including through enhanced cooperation at regional level . this cooperation should take place on a regular basis . ### national aviation authorities have a key role to play in the implementation of the single european sky . the commission and the european agency for aviation should therefore facilitate cooperation among them in order to enable the exchange of best practices and to develop a common approach , including through enhanced cooperation at regional level , by providing a platform for such exchanges . this cooperation should take place on a regular basis .


### 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 aviation 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 aviation authorities shall participate and work together in a network that convenes at regular intervals . the commission and eaa shall facilitate active cooperation of the national aviation authorities and exchanges and use of staff between the national aviation authorities .