### 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 . the rules concerning the determination of the legal representative of incapacitated persons and minors , the definition of incapacitated and vulnerable persons and the provisions resulting from that definition , diverge in member states . it should therefore be left to member states to determine the legal representative of incapacitated persons and minors and where necessary to enact rules affording greater protection at national level .


### 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 and by the judgment in case c - 34 / 10 . 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 . 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 . 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 . therefore , this regulation should be without prejudice to national provisions which may require that the consent of more than one legal representative of a minor is required .


### the sponsor should assess the information received from the investigator , and report safety information on serious adverse events which are suspected unexpected serious adverse reactions to the agency . ### the sponsor should assess the information received from the investigator , and immediately report safety information on serious adverse events which are suspected unexpected serious adverse reactions to the agency via the electronic database referred to in article 36 .


### in clinical trials with non - authorised investigational medicinal products , or where the intervention poses more than an insignificant risk to subject safety , compensation should be ensured for damages successfully claimed in accordance with the applicable laws . ### in clinical trials with non - authorised investigational medicinal products , or with authorised investigational medicinal products used outside the terms of the marketing authorisation in a treatment regimen distinct from the standard of care , or where the diagnostic procedure poses more than an insignificant risk to subject safety , compensation should be ensured for damages successfully claimed in accordance with the applicable laws .


### 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 . ### in order to ensure a sufficient level of transparency in clinical trials , the database should contain all relevant information as regards the clinical trial submitted through the eu portal . 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 .


### without prejudice to the national systems for the cost and reimbursement of medical treatments , subjects should not have to pay for investigational medicinal products . ### without prejudice to the national systems for the cost and reimbursement of medical treatments , subjects should not have to pay for investigational medicinal products . for the low - risk trial , and the medium - risk trials , and when registration is not the initial objective of the investigator - initiated trial , the cost of the investigational medicinal product should be borne by the national healthcare system .


### since the objective of this regulation , namely to ensure that , throughout the union , clinical trial data are reliable and robust while ensuring the safety and rights of subjects , cannot sufficiently be achieved by the member states and can , by reason of the scale of the measure , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective , ### since the objective of this regulation , namely to ensure that , throughout the union , clinical trial data are reliable and robust while ensuring the safety and rights and well - being of subjects , cannot sufficiently be achieved by the member states and can , by reason of the scale of the measure , be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this regulation does not go beyond what is necessary in order to achieve that objective ,


### this regulation shall apply to clinical trials conducted in the union . ### this regulation shall apply to all clinical trials conducted in the union .


### the investigational medicinal products are not authorised ; ### there is no marketing authorisation for the investigational medicinal products ;


### the investigational medicinal products are authorised ; ### there is marketing authorisation for the investigational medicinal products ;


### according to the protocol of the clinical study , the investigational medicinal products are not used in accordance with the terms of the marketing authorisation of the member state concerned ; ### according to the protocol of the clinical trial , the investigational medicinal products are not used in accordance with the terms of the marketing authorisation of the member state concerned or the marketing authorisation granted by the commission ;


### ‘ 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 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 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 , i . e . modifications that change the interpretation of the scientific documents used to support the conduct of the 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 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 , including early termination of the trial and change in number of subjects participating in the trial , which is made after notification of the decision referred to in articles 8 , 14 , 19 , 20 and 23 and which could 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 , e . g . change the interpretation of the scientific documents used to support the conduct of the trial , or if the modifications are otherwise significant .


### ‘ 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 ;


### ‘ serious adverse event’ : any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation , results in persistent or significant disability or incapacity , or is a congenital anomaly or birth defect , is life - threatening or results in death ; ### ‘ serious adverse event’ : any untoward medical occurrence , or other event deemed serious by the investigator in the context of the trial , that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation , results in persistent or significant disability or incapacity , or is a congenital anomaly or birth defect , is life - threatening or results in death ;


### the rights , safety and well - being of subjects are protected ; and ### the rights , safety , dignity and well - being of subjects are protected ; and


### – the data generated in the clinical trial are going to be reliable and robust . ### – the data generated in the clinical trial can be expected to be reliable and robust .


### in order to obtain an authorisation , the sponsor shall submit an application dossier to the intended member states concerned through the portal referred to in article 77 . ### in order to obtain an authorisation , the sponsor shall submit an application dossier to the intended member states concerned through the portal referred to in article&#160 ; 77 . at this stage the application dossier shall not be accessible to the public on the eu portal . it shall be made public only on completion of the part&#160 ; i assessment referred to in article&#160 ; 6 of this regulation .


### the sponsor shall propose one of the member states concerned as reporting member state . ### the sponsor shall propose one of the member states concerned as reporting member state . the member states concerned shall be free to choose one of their number as the reporting member state .


### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the proposed reporting member state has not notified the sponsor within 14 days , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state .


### where the proposed reporting member state 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 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 . the reporting member state may not infer ethical concerns as a justification for considering the application not complete or not falling within the scope of this regulation .


### 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 .


### 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 that the clinical trial application dossier is complete in accordance with paragraphs 2 or 4 shall be the validation date of the application .


### – 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 ;


### – 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 expected from the clinical trial , taking account of statistical approaches , design of the trial and methodology ;


### – the risk to subject health posed by the medical condition for which the investigational medicinal product is being investigated ; ### the risk to subject health , mental or physical , posed by the medical condition for which the investigational medicinal product is being investigated ;


### the reporting member state shall submit part i of the assessment report , including its conclusion , to the sponsor and to the other member states concerned within the following time periods : ### the reporting member state shall submit part i of the assessment report , including its conclusion , to the sponsor and to the other member states concerned , via the eu portal referred to in article 77 of this regulation , within the following time periods :


### within 10 days from the validation date for low - intervention clinical trials ; ### within 10 days from the validation date for low - risk clinical trials and medium - risk clinical trials using treatment regimens supported by published evidence and / or standard treatment guidelines ;


### within 10 days from the validation date for low - intervention clinical trials ; ### within 10 days from the validation date for low - intervention clinical trials ; the time for the joint assessment and for consolidation by member states concerned and the reporting member state shall not be shorter than 5 days ;


### within 25 days from the validation date for clinical trials other than low - intervention clinical trials ; ### within 25 days from the validation date for clinical trials other than low - risk clinical trials and medium - risk clinical trials using treatment regimens supported by published evidence and / or standard treatment guidelines ;


### within 25 days from the validation date for clinical trials other than low - intervention clinical trials ; ### within 25 days from the validation date for clinical trials other than low - intervention clinical trials ; the time for the joint assessment and for consolidation by member states concerned and the reporting member state shall not be shorter than 10 days ;


### for the purposes of this chapter , the assessment date shall be the date on which the assessment report is submitted to the sponsor and to the other member states concerned . ### for the purposes of this chapter , the assessment date shall be the date on which the assessment report is submitted to the sponsor and to the other member states concerned . as of that date , the assessment report shall be accessible on 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 .


### for the purpose of obtaining those additional explanations , the reporting member state may suspend the relevant 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 relevant 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 . the reporting member state shall inform the sponsor , via the eu portal , of the suspension of the time period .


### 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 .


### where , upon receipt of the additional explanations , the remaining time period for notifying the decision referred to in paragraph 4 is less than three days in the case of low - intervention clinical trials , and less than five days for other than low - intervention clinical trials , it shall be extended to three and five days respectively . ### where , upon receipt of the additional explanations , the remaining time period for notifying the decision referred to in paragraph 4 is less than three days in the case of low - risk clinical trials and medium - risk clinical trials using treatment regimens supported by published evidence and / or standard treatment guidelines , and less than five days for other than low - risk clinical trials and medium - risk clinical trials using treatment regimens supported by published evidence and / or standard treatment guidelines , it shall be extended to three and five days respectively .


### compliance with the requirements for informed consent as set out in chapter v ; ### compliance with the requirements for the protection of subjects and informed consent as set out in chapter v ;


### the request and the additional explanations shall be submitted through the eu portal . ### the request for additional explanations and the additional explanations shall be submitted through the eu portal .


### decision on the clinical trial ### final decision on the clinical trial


### each member state concerned shall notify the sponsor through the eu portal as to whether the clinical trial is authorised , whether it is authorised subject to conditions , or whether authorisation is refused . ### each member state concerned shall notify the sponsor through the eu portal of its final decision to authorise the clinical trial , to authorise it subject to conditions , or to refuse authorisation .


### persons assessing the application ### persons assessing parts i and ii of the application file


### 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 . ### an institutional review board / independent ethics committee is in charge of the assessment described in this chapter . according to the rules governing the composition and responsibilities of the irb / iecs , 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 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 chapter is without prejudice to the possibility for the sponsor to submit , following the refusal to grant an authorisation or the withdrawal of an application , an application for authorisation to any intended member state concerned . that application shall be considered as a new application for authorisation of another clinical trial . ### following the refusal to grant an authorisation or the withdrawal of an application , the sponsor may submit a new application for authorisation to any intended member state concerned . that application shall be considered as a new application for authorisation of another clinical trial . the new application shall , however , specify the grounds on which the original application was rejected or withdrawn and the changes made to the original version of the protocol .


### the application may be submitted only after the notification date of the initial authorisation decision . ### the application may be submitted in any member state only after the notification date of the initial authorisation decision .


### between the date of submission of the application referred to in paragraph 1 and the expiry of the relevant time period referred to in paragraph 3 , the additional member state concerned may communicate to the reporting member state any considerations relevant to the application . ### the additional member state concerned may communicate to the reporting member state any considerations relevant to part 1 of the application within the timelines laid down in paragraph 3 starting from the date of submission referred to in paragraph 1 .


### the reporting member state , and only the reporting member state , may , between the date of submission of the application referred to in paragraph 1 and the expiry of the relevant time period referred to in paragraph 3 , request additional explanations from the sponsor concerning part i of the assessment report , taking into account the considerations referred to in paragraph 5 . ### the reporting member state , and only the reporting member state , may , within the timelines specified in paragraph 5 , request additional explanations from the sponsor concerning part i of the assessment report .


### until the assessment date , any member state concerned may communicate to the reporting member state any considerations relevant to the application . the reporting member state shall take those considerations duly into account . ### until the assessment date the reporting member state shall develop and circulate to the member states concerned an initial assessment report . no later than 2 days before the reporting date , the member states concerned may communicate to the reporting member state and all other member states concerned any considerations relevant to the application . the reporting member state shall take those considerations duly into account in finalising the assessment report .


### notification shall be done by way of one single decision within ten days from the validation date . ### notification shall be done by way of one single decision within ten days from the assessment date according to article 6 .


### 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 fully comply with the principles of this regulation as regards subject rights and wellbeing , and the reliability and robustness of data generated in the clinical trial .


### clinical trial data submitted in an application dossier shall be based on clinical trials which have been registered prior to their start in a public register which is a primary registry of the international clinical trials registry platform of the world health organisation . ### data , from clinical trials conducted on patients , submitted in an application dossier shall be based on clinical trials which have been registered prior to their start in a public register which is a primary registry or data provider of the international clinical trials registry platform of the world health organisation .


### clinical trial data submitted in an application dossier shall be based on clinical trials which have been registered prior to their start in a public register which is a primary registry of the international clinical trials registry platform of the world health organisation . ### clinical trial data submitted in an application dossier shall be based on clinical trials which have been registered in a public register which is a primary registry of the international clinical trials registry platform of the world health organisation .


### the subject or , where the subject is not able to give informed consent , his or her legal representative has had the opportunity , in a prior interview with the investigator or a member of the investigating team , to understand the objectives , risks and inconveniences of the clinical trial , and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment ; ### the subject or , where the subject is not able to give informed consent , his or her legal representative has had the opportunity , in a prior interview with a medical doctor who is the investigator or a member of the investigating team , to understand the objectives , risks and inconveniences of the clinical trial , and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment ;


### any subject may , without any resulting detriment , withdraw from the clinical trial at any time by revoking his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal . ### any subject or his legal representative may , without any resulting detriment , withdraw from the clinical trial at any time by revoking his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal .


### 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 .


### 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 for each trial 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 witness who represents the subject ' s interests 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 .


### the informed consent of the legal representative has been obtained , whereby consent shall represent the subject ' s presumed will ; ### the informed consent of the legal representative has been obtained ; consent shall represent the subject ' s presumed will and may be revoked at any time , without detriment to the subject ;


### the informed consent of the legal representative has been obtained , whereby consent shall represent the minor ' s presumed will ; ### the informed consent of the legal representative or representatives has been obtained , whereby consent shall represent the minor ' s presumed will ;


### the informed consent of the legal representative has been obtained , whereby consent shall represent the minor ' s presumed will ; ### the written informed consent of the legal representative has been obtained ;


### the clinical trial poses a minimal risk to , and imposes a minimal burden on , the subject . ### there are grounds for expecting that participation in the clinical trial will produce a benefit to the subject outweighing the risks or will produce only a minimal risk .


### the clinical trial poses a minimal risk to , and imposes a minimal burden on , the subject . ### the clinical trial poses a minimal risk to , and imposes a minimal burden on , the subject , although this should be judged in proportion to the underlying medical condition .


### 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 .


### the minor has received all relevant information in a way adapted to his or her age and maturity , from professionals trained or experienced in working with children , regarding the trial , the risks and the benefits ; ### the minor has received all relevant information in a way adapted to his or her age and maturity , from a medical doctor trained or experienced in working with children , regarding the trial , the risks and the benefits ;


### some direct benefit for the group of patients is obtained from the clinical trial . ### the goal of the clinical trial is to improve the management of a subject ' s condition or related problems .


### 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 .


### however , where , for scientific reasons , it is not possible to submit a summary of the results within one year , the summary of results shall be submitted as soon as it is available . in this case , the protocol shall specify when the results are going to be submitted , together with an explanation . ### however , where , for scientific reasons , it is not possible to submit a summary of the results within two years , the summary of results shall be submitted as soon as it is available . in this case , the protocol shall specify when the results are going to be submitted , together with an explanation .


### 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 , extended to include the period during which the trial subjects are subject to monitoring under the terms of the protocol , 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 .


### the european medicines agency established by regulation no 726 / 2004 shall set up and maintain an electronic database for the reporting provided for in articles 38 and 39 . ### the european medicines agency established by regulation no 726 / 2004 shall set up and maintain an electronic database for the reporting provided for in articles 38 and 39 . that electronic database shall be a module of the database referred to in article 25 of regulation no 726 / 2004 .


### the european medicines agency established by regulation no 726 / 2004 shall set up and maintain an electronic database for the reporting provided for in articles 38 and 39 . ### the european medicines agency established by regulation no 726 / 2004 shall set up and maintain an electronic database for the reporting provided for in articles 38 and 39 . that electronic database shall be a module of the database referred to in article 24 paragraph 1 of regulation no 726 / 2004 .


### the sponsor shall report electronically and without delay to the electronic database referred to in article 36 all relevant information about suspected unexpected serious adverse reactions to investigational medicinal products insofar as the suspected unexpected serious adverse reaction occurred in a clinical trial conducted by the sponsor , or occurred in a clinical trial related to the sponsor . ### the sponsor shall report electronically and within the time limits specified in annex iii to the electronic database referred to in article 36 all relevant information about suspected unexpected serious adverse reactions to investigational medicinal products insofar as the suspected unexpected serious adverse reaction occurred in a clinical trial conducted by the sponsor or by another sponsor who is either part of the same mother company or with whom the sponsor jointly develops the medicinal product on the basis of a formal agreement .


### the sponsor shall report electronically and without delay to the electronic database referred to in article 36 all relevant information about suspected unexpected serious adverse reactions to investigational medicinal products insofar as the suspected unexpected serious adverse reaction occurred in a clinical trial conducted by the sponsor , or occurred in a clinical trial related to the sponsor . ### the sponsor shall report electronically and without delay to the electronic database referred to in article 36 all relevant information about suspected unexpected serious adverse reactions to investigational and auxiliary medicinal products insofar as the suspected unexpected serious adverse reaction occurred in a clinical trial conducted by the sponsor , or occurred in a clinical trial related to the sponsor .


### 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 .


### 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 . ### 1 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 one or more clinical trials for which it is the sponsor . where relevant , that report shall clearly identify any safety aspects concerning a specific gender or age group .


### member states shall cooperate in assessing the information reported in accordance with articles 38 and 39 . ### member states shall cooperate in assessing the information reported in accordance with articles 38 , 39 and 41 .


### annual reporting by the sponsor to the marketing authorisation holder ### article 39 annual reporting by the sponsor to the agency


### regarding authorised medicinal products which , according to the protocol , are used in accordance with the terms of the marketing authorisation , the sponsor shall inform annually the marketing authorisation holder of all suspected serious adverse reactions . ### regarding authorised medicinal products which , according to the protocol , are used in accordance with the terms of the marketing authorisation , the sponsor shall inform annually the agency of all suspected serious adverse reactions .


### monitoring ### risk assessment , quality management and monitoring


### other individuals involved in conducting a clinical trial shall be suitably qualified by education , training and experience to perform their tasks . ### other individuals involved in conducting and monitoring a clinical trial shall be suitably qualified by education , training and experience to perform their tasks .


### 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 .


### 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 received , traceable , stored , administered , 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 .


### the relevant information regarding the traceability , storage , destruction and return of medicinal products referred to in paragraph 1 shall be contained in the application dossier . ### the relevant information regarding the traceability , storage , administration , destruction and return of medicinal products referred to in paragraph 1 shall be contained in the application dossier .


### 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 health of the subjects or the reliability and robustness of the data generated in the clinical trial .


### the sponsor shall notify the member states concerned through the eu portal and without undue delay , of all unexpected events which affect the benefit - risk balance of the clinical trial , but are not suspected unexpected serious adverse reactions as referred to in article 38 . ### the sponsor shall notify the member states concerned through the eu portal and without undue delay , of all unexpected events which affect the benefit - risk balance of the clinical trial .


### the sponsor shall notify the member states concerned through the eu portal and without undue delay , of all unexpected events which affect the benefit - risk balance of the clinical trial , but are not suspected unexpected serious adverse reactions as referred to in article 38 . ### the sponsor shall notify the competent bodies of the member states concerned through the eu portal and without undue delay , of all unexpected events which affect the benefit - risk balance of the clinical trial , but are not suspected unexpected serious adverse reactions as referred to in article 38 .


### the sponsor and the investigator shall keep a clinical trial master file . ### the sponsor or the investigator shall keep a clinical trial master file .


### the language of the information on the label shall be determined by the member state concerned . the medicinal product may be labelled in several languages . ### the language of the information on the label shall be determined by the member state concerned and shall be one of the official languages of the eu . the medicinal product may be labelled in several languages .


### the language of the information on the label shall be determined by the member state concerned . the medicinal product may be labelled in several languages . ### the language of the information on the label shall be determined by the member state concerned and shall be one of the official languages of the union . the medicinal product may be labelled in several languages .


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


### damage compensation ### insurance and damage compensation


### the commission shall set up and maintain a portal at union level as a single entry point for the submission of data and information relating to clinical trials in accordance with this regulation . ### the commission shall set up and maintain a portal at union level as a single entry point for the submission of data and information relating to clinical trials in accordance with this regulation . the portal shall be technically advanced and user - friendly so as to avoid unnecessary work .


### this regulation shall be without prejudice to the possibility for member states to levy a fee for the activities set out in this regulation , provided that the level of the fee is set in a transparent manner and on the basis of cost recovery principles . ### this regulation shall be without prejudice to the possibility for member states to levy a fee for the activities set out in this regulation , provided that the level of the fee is set in a transparent manner and on the basis of cost recovery principles . member states may establish reduced fees for non - profit clinical trials .


### one fee per activity per member state ### fees per activity per member state


### a member state shall not require , for an assessment as referred to in chapters ii and iii , multiple payments to different bodies involved in this assessment . ### a member state shall require , for an assessment as referred to in chapters ii and iii , payments to different bodies involved in this assessment in accordance with its national practices .


### a member state shall not require , for an assessment as referred to in chapters ii and iii , multiple payments to different bodies involved in this assessment . ### a member state shall not require , for an assessment as referred to in chapters ii , iii and vii , multiple payments to different bodies involved in this assessment . member states shall consider waiving non - commercial sponsors from these fees .


### this regulation shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells , or the sale , supply or use of medicinal products containing , consisting of or derived from those cells , on grounds not dealt with in this regulation . the member states shall communicate the national legislation concerned to the commission . ### this regulation shall not affect the application of national legislation prohibiting or restricting the use of any specific type of human or animal cells , or the sale , supply or use of medicinal products containing , consisting of or derived from those cells , on grounds not dealt with in this regulation . the member states shall communicate the national legislation concerned to the commission . no gene therapy trials may be carried out which result in modifications to the subject ' s germ line genetic identity .


### in the case of a resubmission , the cover letter shall highlight the changes as compared to the previous submission . ### in the case of a resubmission , the cover letter shall highlight the grounds on which the original application was rejected and the changes as compared to the original version of the protocol .


### · an evaluation of the anticipated benefits and risks to allow assessment in accordance with article 6 ; ### · an evaluation of the anticipated benefits and risks , including for specific subpopulations , to allow assessment in accordance with article 6 ;


### the applicant may submit the current version of the smpc as the impd if the imp is authorised . the exact requirements are detailed in table 1 . ### the applicant may submit the current version of the smpc as the impd if the clinical trial is low - risk or if the clinical trial involves a moderate level of risk and concerns an imp for which the treatment strategies are based on published data and / or standard treatment recommendations issued by learned societies or official bodies . the exact requirements are detailed in table 1 .


### serious adverse events occurring to a subject after the end of the trial with regard to the subjects treated by him shall be reported to the sponsor if the investigator becomes aware of them . ### serious adverse events occurring to a subject after the end of the trial with regard to the subjects treated by him and which may be related to the medicinal product used in the clinical trial shall be reported to the sponsor if the investigator becomes aware of them .


### serious adverse events occurring to a subject after the end of the trial with regard to the subjects treated by him shall be reported to the sponsor if the investigator becomes aware of them . ### serious adverse reactions occurring to a subject after the end of the trial with regard to the subjects treated by him shall be reported to the sponsor if the investigator becomes aware of them


### the definition implies a reasonable possibility of a causal relationship between the event and the imp . this means that there are facts or arguments to suggest a causal relationship . ### the definition implies a reasonable possibility of a causal relationship between the event and the imp and / or the auxiliary medicinal product . this means that there are facts or arguments to suggest a causal relationship .


### in order to safeguard the union ' s financial interests , there should be measures limited in time that allow the authorising officer by delegation to interrupt payments where there is evidence to suggest a significant deficiency in the functioning of the management and control system , evidence of irregularities linked to a payment application , or a failure to submit documents for the purpose of the examination and acceptance of accounts . ### in order to safeguard the union ' s financial interests , there should be measures limited in time that allow the authorising officer by delegation to interrupt payments where there is evidence to suggest a significant deficiency in the functioning of the management and control system , evidence of irregularities linked to a payment application , or a failure to submit documents for the purpose of the examination and acceptance of accounts or serious delays in project implementation , with substantiated evidence that the objectives set for the projects in question are not being met .


### the fund shall promote social cohesion in the union by contributing to achieving the poverty reduction target of at least 20 million of the number of persons at risk of poverty and social exclusion in accordance with the europe 2020 strategy . the fund shall contribute to achieving the specific objective of alleviating the worst forms of poverty in the union by providing non - financial assistance to the most deprived persons . this objective shall be measured by the number of persons receiving assistance from the fund . ### the fund shall promote social cohesion in the union by contributing to achieving the poverty reduction target of at least 20 million of the number of persons at risk of poverty and social exclusion in accordance with the europe 2020 strategy . the fund shall contribute to achieving the specific objective of alleviating the worst forms of poverty in the union by providing non - financial assistance to the most deprived persons . this objective shall be measured by the number of persons receiving assistance from the fund . the fund shall seek to ensure that nobody in the union goes hungry .


### the fund shall support national schemes whereby food products and basic consumer goods for the personal use of homeless persons or of children are distributed to the most deprived persons through partner organisations selected by member states . ### the fund shall support national schemes whereby food products and basic consumer goods for the use of the most deprived persons , and in particular homeless persons and children , are distributed to the most deprived persons through partner organisations selected by member states .


### 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


### the commission and the member states and the beneficiaries shall apply the principle of sound financial management in accordance with article 26 of the financial regulation . ### the commission and the member states and the beneficiaries shall apply the principle of sound financial management in accordance with article 30 of the financial regulation .


### each member state shall submit to the commission one operational programme covering the period between 1 january 2014 and 31 december 2020 within three months of the entry into force of this regulation , containing the following items : ### each member state shall submit to the commission one operational programme covering the period between 1 january 2014 and 31 december 2020 within four months of the entry into force of this regulation , containing the following items :


### the commission shall , by means of implementing acts , approve the amendment of an operational programme no later than five months after their formal submission by the member state provided that any observations made by the commission have been satisfactorily taken into account . ### the commission shall , by means of implementing acts , approve the amendment of an operational programme no later than three months after their formal submission by the member state provided that any observations made by the commission have been satisfactorily taken into account .


### in addition , the commission shall consult , at least once a year , the organisations which represent the partner organisations at union level on the implementation of support from the fund . ### in addition , the commission shall consult , at least once a year , the organisations which represent the partner organisations at union level on the implementation of support from the fund . the outcome of these consultations shall be reported to parliament .


### the managing authority shall carry out a structured survey on end recipients in 2017 and 2021 , in accordance with the template provided by the commission . the commission shall adopt the template by means of an implementing act . this implementing act shall be adopted in accordance with the advisory procedure referred to in article 60 . ### the managing authority shall carry out a structured survey on end recipients in 2017 and 2021 , in accordance with the template provided by the commission . the commission shall adopt the template by means of an implementing act . this implementing act shall be adopted in accordance with the advisory procedure referred to in article 60 . the template , while corresponding to the objectives of the assessment process , shall comply with the principle of administrative simplification .


### the food and the goods for homeless persons or for children may be purchased by the partner organisations themselves . ### the food and the goods for the most deprived persons , and in particular for homeless persons or children , may be purchased by the partner organisations themselves .


### the costs of purchasing food and basic consumer goods for personal use of homeless persons or of children ; ### the costs of purchasing food and basic consumer goods for the personal use of the most deprived persons , and in particular homeless persons or children ;


### where a public body purchases the food or basic consumer goods for personal use of homeless persons or of children and provide them to partner organisations , the costs of transporting of food or goods to the storage depots of the partner organisations at a flat rate of 1 % of the costs referred to in point ; ### where a public body purchases the food or basic consumer goods for the use of the most deprived persons , and in particular homeless persons or children , and provides them to partner organisations , the costs of transporting of food or goods to the storage depots of the partner organisations at a flat rate of 1 % of the costs referred to in point ;


### the member state shall designate a national public authority or body , functionally independent from the managing authority and the certifying authority , as audit authority . ### the member state shall designate a national public authority or body , functionally independent from the managing authority and the certifying authority , as audit authority . the national audit office or the national court of auditors may be designated as the audit authority .


### draw up the management declaration and annual summary referred to in article 56 and of the financial regulation . ### draw up the management declaration and annual summary referred to in article 59 and of the financial regulation .


### the budget commitments of the union in respect of each operational programme shall be made in annual instalments during the period between 1 january 2014 and 31 december 2020 . the decision of the commission adopting the operational programme shall constitute the financing decision within the meaning of article 81 of the financial regulation and once notified to the member state concerned , a legal commitment within the meaning of that regulation . ### the budget commitments of the union in respect of each operational programme shall be made in annual instalments during the period between 1 january 2014 and 31 december 2020 . the decision of the commission adopting the operational programme shall constitute the financing decision within the meaning of article 84 of the financial regulation and once notified to the member state concerned , a legal commitment within the meaning of that regulation .


### the financial crisis in 2007 / 2008 exposed important shortcomings in financial supervision , both in particular cases and in relation to the financial system as a whole . nationally - based supervisory models have lagged behind the integrated and interconnected reality of european financial markets , in which many financial firms operate across borders . the crisis exposed shortcomings in the area of cooperation , coordination , consistent application of community law and trust between national supervisors . ### the financial crisis in 2007 / 2008 exposed important shortcomings in financial supervision , both in particular cases and in relation to the financial system as a whole . nationally - based supervisory models have lagged behind the integrated and interconnected reality of european financial markets , in which many financial firms operate across borders . the crisis exposed shortcomings in the area of cooperation , coordination , consistent application of eu law and trust between national supervisors .


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


### there is a need to introduce an effective instrument to establish harmonised technical standards in financial services to ensure , also through a single rulebook , a level playing field and an adequate protection of investors and consumers across europe . as a body with highly specialised expertise , it is efficient and appropriate to entrust the authority , in areas defined by community law , with the elaboration of draft technical standards , which do not involve policy choices . the commission should endorse those draft technical standards in accordance with community law in order to give them binding legal effect . the draft technical standards have to be adopted by the commission . they would be subject to amendment if , for example , the draft technical standards were incompatible with community law , would not respect the principle of proportionality or would run counter to the fundamental principles of the internal market for financial services as reflected in the acquis of community financial services legislation . to ensure a smooth and expedited adoption process for those standards , the commission should be subject to a time limit for its decision on the endorsement . ### there is a need to introduce an effective instrument to establish harmonised technical standards in financial services to ensure , also through a single rulebook , a level playing field and an adequate protection of investors and consumers across europe . as a body with highly specialised expertise , it is efficient and appropriate to entrust the authority , in areas defined by eu law , with the elaboration of draft technical standards , which do not involve policy choices . the commission should be empowered to adopt delegated acts in accordance with the procedure referred to in article 290 of the treaty on the functioning of the european union concerning technical standards in financial services .


### the process for the development of technical standards in this regulation is without prejudice to the commission ' s powers to adopt on its own initiative implementing measures under comitology procedures at level 2 of the lamfalussy structure as laid out in the relevant community legislation . the matters concerned by the technical standards do not involve policy decisions , and their content is framed by the community acts adopted at level 1 . development of the draft standards by the authority ensures that they fully benefit from the specialised expertise of national supervisory authorities . ### the commission should endorse those draft technical standards in order to give them binding legal effect . they will be subject to amendment if , for example , they are incompatible with eu law , do not respect the principle of proportionality or run counter to the fundamental principles of the internal market for financial services as reflected in the acquis of european union financial services legislation . to ensure a smooth and expeditious adoption process for those standards , the commission should be subject to a time limit for its decision on the endorsement .


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


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


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


### in order to ensure efficient and effective supervision and a balanced consideration of the positions of the competent authorities in different member states , the authority should be able to settle disagreements between those competent authorities with binding effect , including within colleges of supervisors . a conciliation phase should be provided for , during which the competent authorities may reach an agreement . the authority ' s competence should cover disagreements on procedural obligations in the cooperation process as well as on the interpretation and application of community law in supervisory decisions . existing conciliation mechanisms provided for in sectoral legislation have to be respected . in the event of inaction by the national supervisory authorities concerned , the authority should be empowered to adopt , as a last resort , decisions directly addressed to financial market participants in areas of community law directly applicable to them . ### in order to ensure efficient and effective supervision and a balanced consideration of the positions of the competent authorities in different member states , the authority should be able to settle disagreements between those competent authorities with binding effect , including within colleges of supervisors . a conciliation phase should be provided for , during which the competent authorities may reach an agreement . the authority ' s competence should cover disagreements on procedural obligations in the cooperation process as well as on the interpretation and application of union law in supervisory decisions . existing conciliation mechanisms provided for in sectoral legislation have to be respected . in the event of inaction by the national supervisory authorities concerned , the authority should be empowered to adopt , as a last resort , decisions directly addressed to financial market participants in areas of union law directly applicable to them . this also applies to disagreements within a college of supervisors .


### 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 the authority or 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 .


### peer reviews are an efficient and effective tool for fostering consistency within the network of financial supervisors . the authority should therefore develop the methodological framework for such reviews and conduct them on a regular basis . reviews should focus not only on convergence of supervisory practices but also on the capacity of supervisors to achieve high quality supervisory outcomes as well as the independence of competent authorities . ### peer reviews are an efficient and effective tool for fostering consistency within the network of financial supervisors . the authority should therefore develop the methodological framework for such reviews and conduct them on a regular basis . reviews should focus not only on convergence of supervisory practices but also on the capacity of supervisors to achieve high quality supervisory outcomes as well as the independence of competent authorities . the outcome of peer reviews should be made public and best practices should be identified and also made public .


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


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


### a full time chairperson , selected by the board of supervisors through an open competition , should represent the authority . the management of the authority should be entrusted to an executive director , who should have the right to participate in meetings of the board of supervisors and the management board without the right to vote . ### a full - time chairperson , selected by the european parliament following an open competition managed by the commission and the subsequent drawing - up of a shortlist by the commission , should represent the authority . the management of the authority should be entrusted to an executive director , who should have the right to participate in meetings of the board of supervisors and the management board without the right to vote .


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


### 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 .


### 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 .


### 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 .


### 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 or from the european parliament , the council , the commission 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 .


### 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 .


### where the competent authority has not complied with community law within one month from receipt of the authority ' s recommendation , the commission may , after having been informed by the authority or on its own initiative , take a decision requiring the competent authority to take the action necessary to comply with community law . ### where the competent authority has not complied with eu law within the 10 working days set out in paragraph 3 from receipt of the authority ' s recommendation , the authority shall take a decision requiring the competent authority to take the action necessary to comply with eu law .


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


### the commission shall ensure that the right to be heard of the addressees of the decision is respected . ### the authority shall ensure that the right to be heard of the addressees of the decision is respected .


### the authority and the competent authorities shall provide the commission with all necessary information . ### the competent authorities shall provide the authority with all necessary information .


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


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


### 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 .


### 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 .


### the authority shall set a time limit for conciliation between the competent authorities taking into account any relevant time periods specified in the legislation referred to in article 1 and the complexity and urgency of the matter . ### the authority shall set a time limit for conciliation between the competent authorities taking into account any relevant time periods specified in the legislation referred to in article 1 and the complexity and urgency of the matter . at that stage the authority shall at act as a mediator .


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


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


### the authority shall participate as an observer in colleges of supervisors as it deems appropriate . for the purpose of that participation , it shall be considered a ' competent authority ' within the meaning of the relevant legislation and , at its request , shall receive all relevant information shared with any member of the college . ### the authority shall participate in colleges of supervisors as it deems appropriate . for the purpose of that participation , it shall be considered a ' competent authority ' within the meaning of the relevant legislation and , at its request , shall receive all relevant information shared with any member of the college .


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


### the authority shall cooperate closely with the esrb . it shall provide the esrb with regular and up - to - date information necessary for the achievement of its tasks . any data necessary for the achievement of its tasks that are not in summary or collective form shall be provided without delay to the esrb upon a reasoned request , as specified in article [ 15 ] of regulation no … . / … [ esrb ] . ### the authority shall cooperate closely with the esrb . it shall provide the esrb with regular and up - to - date information necessary for the achievement of its tasks . any data necessary for the achievement of its tasks that are not in summary or collective form shall be provided without delay to the esrb upon a reasoned request , as specified in article [ 15 ] of regulation no … . / … [ esrb ] . the authority shall develop an adequate protocol for the disclosure of confidential information regarding individual financial institutions .


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


### in its notification , the member state shall justify why and clearly demonstrate how the decision impinges on its fiscal responsibilities . ### in its notification , the member state shall justify why and provide an impact assessment on how much the decision impinges on its fiscal responsibilities .


### the chairperson shall be appointed by the board of supervisors on the basis of merit , skills , knowledge of financial market participants and markets , and experience relevant to financial supervision and regulation , following an open selection procedure . ### the chairperson shall be appointed by the board of supervisors on the basis of merit , skills , knowledge of financial market participants and markets , and experience relevant to financial supervision and regulation , following an open selection procedure organised and managed by the commission .


### the executive director shall be appointed by the board of supervisors on the basis of merit , skills , knowledge of financial market participants and markets , and experience relevant to financial supervision and regulation and managerial experience , following an open selection procedure . ### the executive director shall be appointed by the board of supervisors on the basis of merit , skills , knowledge of financial market participants and markets , and experience relevant to financial supervision and regulation and managerial experience , following an open selection procedure organised and managed by the commission and after confirmation by the european parliament .


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


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


### joint committee of european supervisory authorities ### european supervisory authorities joint committee