### in order to maintain a level playing field for all undertakings active in the internal market , funding provided by horizon 2020 should be designed in accordance with state aid rules so as to ensure the effectiveness of public spending and prevent market distortions such as crowding - out of private funding , creating ineffective market structures or preserving inefficient firms . ### in order to maintain a level playing field for all undertakings active in the internal market , funding provided by horizon 2020 should be designed to ensure the effectiveness of public spending and prevent market distortions such as crowding - out of private funding , creating ineffective market structures or preserving inefficient firms .


### the financial interests of the union should be protected through proportionate measures throughout the expenditure cycle . ### open accessibility of all patent applications , standards , scientific publications or any other dissemination tools relating to project results funded by horizon 2020 requires the set up of digital central repositories and the use of open digital formats . the financial interests of the union should be protected through proportionate measures throughout the expenditure cycle .


### the financial interests of the union should be protected through proportionate measures throughout the expenditure cycle . ### the financial interests of the union should be protected through proportionate measures throughout the expenditure cycle , ensuring an appropriate balance between trust and control .


### a funding body may establish rules which depart from those laid down in this regulation or regulation no xx / 2012 [ the financial regulation ] if this is provided for in the basic act or , subject to the consent of the commission , if its specific operating needs so require . ### the eit may establish rules which depart from those laid down in this regulation or regulation no xx / 2012 [ the financial regulation ] if this is provided for in the basic act or , subject to the consent of the commission , if its specific operating needs so require , in particular in relation to ownership , access rights , exploitation and dissemination of results .


### ' affiliated entity’ means any legal entity that is under the direct or indirect control of a participant , or under the same direct or indirect control as the participant , or is directly or indirectly controlling a participant ; ### ' affiliated entity’ means any legal entity that is under the direct or indirect control of a participant , or under the same direct or indirect control as the participant , or is directly or indirectly controlling a participant . control may take any of the forms set out in article 7 ;


### ' background ' means any data , know - how and / or information whatever their form or nature as well as any rights such as intellectual property rights which are held by participants prior to their accession to the action and identified by the participants in accordance with article 42 ; ### ' background ' means any data , know - how and / or information whatever their form or nature as well as any rights such as intellectual property rights which are held by participants prior to their accession to a grant agreement or generated outside the action and contributed to the action by the participant holding the rights and which in both cases and are necessary in order to implement the action or use the results of the action ;


### ' funding body’ means a body or authority , other than the commission , to which the commission has entrusted budget implementation tasks in accordance with article 9 of regulation no xx / xx [ horizon 2020 ] ; ### ' funding body’ means a body or authority , other than the commission , as referred to in article [ 55 ] of regulation no xx / xx [ the financial regulation ] , to which the commission has entrusted budget implementation tasks ;


### ' programme co - fund action’ means an action funded through a grant the main purpose of which is supplementing individual calls or programmes funded by entities , other than union bodies , managing research and innovation programmes ; ### ' programme co - fund action’ means an action funded through a grant the main purpose of which is supplementing individual calls or programmes funded by entities , other than union bodies , managing research and innovation programmes . an action may include complementary activities of networking and coordination between programmes in different countries ;


### ‘ work plan’ means the document similar to the commission work programme adopted by funding bodies entrusted with part of the implementation of horizon 2020 in accordance with article 9 of regulation no xx / xx [ horizon 2020 ] . ### deleted


### for the purposes of this regulation an entity which does not have legal personality under the applicable national law is assimilated to a legal entity provided that the conditions set out in regulation no xx / 2012 [ the financial regulation ] are complied with . ### for the purposes of this regulation an entity which does not have legal personality under the applicable national law is assimilated to a legal entity provided that the conditions set out in article 114 of regulation no xx / 2012 [ the financial regulation ] and article 174a of the implementing rules therefore are complied with .


### without prejudice to article 3 , the commission shall , upon request , make available to the union institutions and bodies , any member state or associated country , any useful information in its possession on results of a participant that has received union funding , provided that both the following conditions are met : ### without prejudice to article 3 , the commission shall , upon request , make available to the union institutions and bodies , any member state or associated country , any useful information in its possession on results of a participant that has received union funding and before disseminating information , the commission shall systematically ask the opinion of the participant concerned , provided that both the following conditions are met :


### the participants have not provided sound and sufficient reasons for withholding the information concerned . ### upon prior notice of the intended communication by the commission , the participants have not provided sound and sufficient reasons for withholding the information concerned .


### in actions under the activity ‘ secure societies’ within the specific objective ‘ inclusive , innovative and secure societies’ , the commission may make available to union institutions and bodies or member states ' national authorities any useful information in its possession on results of a participant that has received union funding . ### in actions under the activity ‘ secure societies’ within the specific objective ‘ inclusive , innovative and secure societies’ , the commission may make available to union institutions and bodies or member states ' national authorities any useful information at its disposal on results of a participant that has received union funding .


### the provision of information pursuant to paragraph 1 shall not be deemed to transfer to the recipient any rights or obligations of the commission or of the participants . however , the recipient shall treat any such information as confidential unless it becomes public or is made available publicly by the participants , or unless it was communicated to the commission without restrictions concerning confidentiality . the commission rules on security shall apply regarding classified information . ### the commission shall ensure the following : the provision of information pursuant to paragraph 1 shall not be deemed to transfer to the recipient any rights or obligations of the commission or of the participants , the recipient shall treat any such information as confidential unless it becomes public or is made available publicly by the participants , or unless it was communicated to the commission without restrictions concerning confidentiality , and that the commission rules on security shall apply regarding classified information .


### at least three legal entities shall participate in an action ; ### at least two legal entities shall participate in an action ;


### each of the three shall be established in a member state or associated country ; ### each of the two shall be established in a member state or associated country ;


### no two of the three may be established in the same member state or associated country ; ### they shall not be established in the same member state or associated country ;


### all three legal entities shall be independent of each other within the meaning of article 7 . ### they shall be independent of each other within the meaning of article 7 .


### work programmes or work plans may provide for additional conditions according to specific policy requirements or to the nature and objectives of the action , including inter alia conditions regarding the number of participants , the type of participant and the place of establishment . ### if necessary and fully justified , work programmes or work plans may provide for additional conditions according to specific policy requirements or to the nature and objectives of the action , including inter alia conditions regarding the number of participants , the type of participant and the place of establishment .


### the participation is deemed essential for carrying out the action by the commission or the relevant funding body ; ### the participation is deemed essential for carrying out the action by the commission or the relevant funding body , following consultation of the european parliament and the council ;


### such funding is provided for under a bilateral scientific and technological agreement or any other arrangement between the union and the international organisation or , for entities established in third countries , the country in which the legal entity is established . ### such funding is provided for under a bilateral scientific and technological agreement or any other arrangement between the union and the international organisation or , for entities established in third countries , the country in which the legal entity is established . this agreement should ensure equal treatment of all member states regardless their membership in the international organisation .


### without prejudice to the other cases provided for in regulation no xx / 2012 [ financial regulation ] and in regulation no xx / 2012 [ delegated regulation ] , calls for proposals shall not be issued for coordination and support actions and programme co - fund actions to be carried out by legal entities identified in the work programmes provided that the action does not fall under the scope of a call for proposals . ### without prejudice to the other cases provided for in regulation no xx / 2012 [ financial regulation ] and in regulation no xx / 2012 [ delegated regulation ] , calls for proposals shall not be issued for coordination and support actions and programme co - fund actions to be carried out by legal entities identified in the work programmes provided that the action does not fall under the scope of a call for proposals . calls for proposals may take all forms , including open calls , which are necessary to ensure the level of flexibility imposed by the diversity of research and innovation sectors and activities , from long - term projects to short - term opportunity - seizing activities .


### legal entities receiving funding from the union shall conclude a grant agreement with the union or the relevant funding body . that grant agreement shall include the description of work to be done by those participants and by the participating legal entities from the third countries involved . ### legal entities receiving funding from the union shall conclude a grant agreement with the union or the relevant funding body . that grant agreement shall include the description of work to be done by those participants and by the participating legal entities from the third countries involved and framework conditions notably on access rights , exploitation and dissemination .


### where appropriate , proposals shall include a draft plan for the exploitation and dissemination of the results . ### proposals shall include a draft plan for the exploitation and dissemination of the results . where appropriate , the work programme or work plan shall explicitly mention that no draft plan is needed .


### any proposal for research on human embryonic stem cells shall include , as appropriate , details of licensing and control measures that will be taken by the competent authorities of the member states as well as details of the ethical approvals that will be provided . as regards the derivation of human embryonic stem cells , institutions , organisations and researchers shall be subject to strict licensing and control in accordance with the legal framework of the member states involved . ### any proposal for research on human embryonic stem cells shall include details of licensing and control measures that will be taken by the competent authorities of the member states as well as details of the ethical approvals that will be provided , as appropriate . as regards the derivation of human embryonic stem cells , institutions , organisations and researchers shall be subject to strict licensing and control in accordance with the legal framework of the member states involved .


### ethics review ### ethics and gender review


### the commission shall systematically carry out ethics reviews for proposals raising ethical issues . this review shall verify the respect of ethical principles and legislation and , in the case of research carried out outside the union , that the same research would have been allowed in a member state . ### the commission shall systematically carry out ethics reviews for proposals raising ethical issues . this review shall verify the respect of ethical principles and legislation and , in the case of research carried out outside the union , that the same research would have been allowed in a member state . when relevant , the commission should also systematically carry out gender reviews for proposals , using a template with a check list , particularly for those dealing with human beings as either subjects or users .


### the work programme or work plan shall lay down further details of the application of the award criteria laid down in paragraph 1 , and specify weightings and thresholds . ### the work programme or work plan shall lay down further details of the application of the award criteria laid down in paragraph 1 , and specify sub - criteria , weightings and thresholds . evaluation shall ensure gender equality and non - discrimination .


### the commission or the relevant funding body shall verify the financial capacity in advance only for coordinators when the requested funding from the union for the action is equal or superior to eur 500 000 , unless where , on the basis of available information , there are grounds to doubt the financial capacity of the coordinator or other participants . ### the commission or the relevant funding body shall verify the financial capacity in advance when the requested funding from the union for the participant is equal or superior to eur 500 000 , unless where , on the basis of available information , there are grounds to doubt the financial capacity of the coordinator or other participants .


### re - evaluation of the proposal ; ### re - evaluation of the proposal by evaluators not involved in the previous evaluation ;


### the commission or the relevant funding body shall provide an evaluation review procedure for applicants who consider that the evaluation of their proposal has not been carried out in accordance with the procedures set out in these rules , the relevant work programme or work plan and the call for proposals . ### the commission or the relevant funding body shall provide an evaluation review procedure for applicants who consider that the evaluation of their proposal has not been carried out in accordance with the procedures set out in these rules , the relevant work programme or work plan , the call for proposals and the commission ' s guide to the selection process .


### the commission or the relevant funding body shall enter into a grant agreement with the participants . ### the commission or the relevant funding body shall enter into a grant agreement with the participants . the commission shall draw up , in close consultation with the member states , a model agreement in accordance with this regulation .


### the grant agreement shall establish the rights and obligations of the participants , of the commission or the relevant funding bodies . it shall also establish the rights and obligations of legal entities which become participants during the implementation of the action . ### considering and complying with the stipulations of this regulation , the grant agreement shall establish the rights and obligations of the participants , of the commission or the relevant funding bodies . it shall also establish the rights and obligations of legal entities which become participants during the implementation of the action .


### the grant agreement shall establish the rights and obligations of the participants , of the commission or the relevant funding bodies . it shall also establish the rights and obligations of legal entities which become participants during the implementation of the action . ### the grant agreement shall establish the rights and obligations of the participants and either of the commission or the relevant funding bodies . it shall also establish the rights and obligations of legal entities which become participants during the implementation of the action as well as the role and tasks of a consortium coordinator .


### the grant agreement may establish rights and obligations of the participants with regard to access rights , exploitation and dissemination , additional to those laid down in this regulation . ### on the basis of a work programme requirement , the grant agreement may establish rights and obligations of the participants with regard to access rights , exploitation and dissemination , additional to those laid down in this regulation .


### the grant agreement shall , where appropriate , reflect the general principles laid down in commission recommendation on the european charter for researchers and the code of conduct for the recruitment of researchers . ### the grant agreement shall , where appropriate , reflect the general principles laid down in commission recommendation on the european charter for researchers and the code of conduct for the recruitment of researchers as well as gender equality principle laid down in article 15 of regulation n° xx / xx [ horizon 2020 ] .


### where appropriate the commission , in accordance with article x of regulation no xx / 2012 [ financial regulation ] , or the relevant funding body may adopt grant decisions instead of entering into grant agreements . the provisions of this regulation referring to grant agreements shall apply mutatis mutandis . ### where appropriate and necessary for a streamlined approach to the action funded , the commission , in accordance with article x of regulation no xx / xx [ the financial regulation ] , or the relevant funding body may adopt grant decisions instead of entering into grant agreements . the provisions of this regulation referring to grant agreements shall apply mutatis mutandis .


### participants shall make no commitments which are incompatible with the grant agreement . where a participant fails to comply with its obligations regarding the technical implementation of the action , the other participants shall comply with the obligations without any additional union funding unless the commission or funding body expressly relieves them of that obligation . the financial responsibility of each participant shall be limited to its own debt , subject to the provisions relating to the fund . the participants shall ensure that the commission or funding body is informed of any event which might affect the implementation of the action or the interests of the union . ### participants shall make no commitments which are incompatible with this regulation and the grant agreement . where a participant fails to comply with its obligations regarding the technical implementation of the action , the other participants shall comply with the obligations without any additional union funding unless the commission or funding body expressly relieves them of that obligation . the financial responsibility relevant to the technical development of activities of the action of each participant shall be limited to its own debt , subject to the provisions relating to the fund . the financial responsibility of each participant relevant to the breach of confidential agreements set by the grant agreement and / or the consortium agreement is not limited by the own debt of the participants . the participants shall ensure that the commission or funding body is informed of any event which might affect the implementation of the action or the interests of the union .


### participants shall make no commitments which are incompatible with the grant agreement . where a participant fails to comply with its obligations regarding the technical implementation of the action , the other participants shall comply with the obligations without any additional union funding unless the commission or funding body expressly relieves them of that obligation . the financial responsibility of each participant shall be limited to its own debt , subject to the provisions relating to the fund . the participants shall ensure that the commission or funding body is informed of any event which might affect the implementation of the action or the interests of the union . ### participants shall make no commitments which are incompatible with the grant agreement . where a participant fails to comply with its obligations regarding the technical implementation of the action , the other participants shall comply with the obligations without any additional union funding unless the commission or funding body expressly relieves them of that obligation . the financial responsibility of each participant shall be limited to its own debt , subject to the provisions relating to the fund . the participants shall ensure that the commission or funding body is informed of any serious event which might affect the implementation of the action or the interests of the union .


### participants shall make no commitments which are incompatible with the grant agreement . where a participant fails to comply with its obligations regarding the technical implementation of the action , the other participants shall comply with the obligations without any additional union funding unless the commission or funding body expressly relieves them of that obligation . the financial responsibility of each participant shall be limited to its own debt , subject to the provisions relating to the fund . the participants shall ensure that the commission or funding body is informed of any event which might affect the implementation of the action or the interests of the union . ### participants shall make no commitments which are incompatible with the grant agreement . where a participant fails to comply with its obligations regarding the technical implementation of the action , the other participants shall comply with the obligations without any additional union funding unless the commission or funding body expressly relieves them of that obligation . the funding provided to , or reserved for , the defaulting party shall be made available to the remaining partners in order to cover their costs in undertaking the work originally allocated to the defaulting party . the funding shall be released to the coordinator when action due by the defaulting party is scheduled to start . the financial responsibility of each participant shall be limited to its own debt , subject to the provisions relating to the fund . the participants shall ensure that the commission or funding body is informed of any event which might affect the implementation of the action or the interests of the union in due time .


### the award of subcontracts for carrying out certain elements of the action shall be limited to the cases provided for in the grant agreement . ### the award of subcontracts for carrying out certain elements of the action shall be limited to the cases provided for in the model grant agreement .


### participants shall comply with national legislation , regulations and ethical rules in the countries where the action will be carried out . where appropriate , participants shall seek the approval of the relevant national or local ethics committees prior to the start of the action . ### participants shall comply with national legislation , regulations and ethical rules in the union and associated countries where the action will be carried out . where appropriate , participants shall seek the approval of the relevant national or local ethics committees prior to the start of the action . actions which are carried out by third countries and funded by the commission shall comply with the union legislation .


### grants may take any of the forms provided for in article [ 116 ] of regulation no xx / 2012 [ the financial regulation ] . ### grants may take any of the forms provided for in article [ 116 ] of regulation no xx / xx [ the financial regulation ] , taking into account the objectives of the action .


### in accordance with article x of regulation no xx / xx [ financial regulation ] , the commission may establish methods to determine scales of unit costs based on : statistical data or similar objective means ; b ) auditable historical data of the participant . ### in accordance with article x of regulation no xx / xx [ financial regulation ] , the commission may establish methods to determine scales of unit costs based on : statistical data or similar objective means ; b ) auditable historical data of the participant . once they are agreed upon , scales of unit costs are not subject to the verification that they are actually incurred .


### the certificate on financial statements shall cover the total amount of the grant claimed by a participant under the form of reimbursement of actual costs and under the form of scale of unit costs referred to article 27 . the certificate shall only be submitted when that amount is equal to or greater than eur 325 000 at the time of claiming the payment of the balance of the grant . ### the certificate on financial statements shall cover the total amount of the grant claimed by a participant under the form of reimbursement of actual costs and under the form of scale of unit costs referred to article 27 . the certificate shall only be submitted when that amount of the union ' s contribution , excluding contribution paid in forms of flat rates , lump sums or scale of units costs is equal to or greater than eur 325 000 at the time of claiming the payment of the balance of the grant .


### participants that calculate and claim direct personnel costs on the basis of scale of unit costs may submit to the commission a certificate on the methodology . that methodology shall comply with the conditions set out in article 27 and meet the requirements of grant agreement . ### participants that calculate and claim direct personnel costs on the basis of scale of unit costs or participants that claim indirect eligible costs actually incurred shall submit to the commission a certificate on the methodology . the commission shall accept such a certificate where it complies with the conditions set out in articles 24 or 27 .


### where the commission accepts a certificate on the methodology , it shall be valid for all actions financed under regulation no xx / xx [ horizon 2020 ] and the participant shall calculate and claim costs on its basis . ### when examining certificates on the methodology , usual accounting practices should be fully taken into account by the commission . where the commission accepts a certificate on the methodology , it shall be valid for all actions financed under regulation no xx / xx [ horizon 2020 ] and the participant shall calculate and claim costs on its basis . once the commission has accepted a certificate on the methodology , it will not be possible to attribute to the beneficiary any systemic or recurrent error related to the beneficiary methodology .


### upon request by the commission , the court of auditors or the european anti - fraud office , the auditor who delivers the certificate on the financial statements and on the methodology shall grant access to the supporting documents and audit working papers on the basis of which a certificate on the financial statements was issued . ### the commission and the court of auditors shall accept the certificates referred to in paragraph 1 , unless there is reasonable doubt regarding their integrity . upon request by the commission , the court of auditors or the european anti - fraud office , the auditor who delivers the certificate on the financial statements and on the methodology shall grant access to the supporting documents and audit working papers on the basis of which a certificate on the financial statements was issued .


### an action for which a grant from the union budget has been awarded may also give rise to the award of a grant on the basis of regulation no xx / xx [ horizon 2020 ] provided that the grants do not cover the same cost items . ### an action for which a grant from the union budget has been awarded may also give rise to the award of a grant on the basis of regulation no xx / xx [ horizon 2020 ] provided that the grants do not cover the same cost items . this applies especially to a grant from the structural funds .


### independent experts shall be chosen on the basis of skills , experience and knowledge appropriate to carry out the tasks assigned to them . in cases where independent experts have to deal with classified information , the appropriate security clearance shall be required before appointment . ### independent experts shall be chosen on the basis of skills , experience and knowledge , including knowledge of languages , appropriate to carry out the tasks assigned to them . this will help ensure that proposals for projects submitted in languages other than english can also be evaluated . the skills , experience and knowledge of the experts concerned shall correspond to the priority addressed by the project in question . in cases where independent experts have to deal with classified information , the appropriate security clearance shall be required before appointment .


### independent experts shall be identified and selected on the basis of calls for applications from individuals and calls addressed to relevant organisations such as national research agencies , research institutions , standardisation organisations or enterprises with a view to establishing a database of candidates . ### independent experts shall be identified and selected on the basis of calls for applications from individuals and calls addressed to relevant organisations such as national and regional research agencies , research and technology institutions , standardisation organisations or enterprise organisations and enterprises with a view to establishing a database of candidates .


### where participants in an action have jointly generated results and where their respective share of the work cannot be ascertained , they shall have joint ownership of those results . the joint owners shall establish an agreement regarding the allocation and terms of exercise of that joint ownership in accordance with their obligations under the grant agreement . ### where participants in an action jointly generate results and where their respective share of the work cannot be ascertained , they shall have joint ownership of those results . the joint owners shall establish an agreement regarding the allocation of that joint ownership and / or the terms of exercise of joint ownership in accordance with their obligations under the grant agreement .


### where results are capable of commercial or industrial application , the participant owning these results shall examine the possibility for protection and , if possible and justified given the circumstances , shall adequately protect them for an appropriate period of time and with an appropriate territorial coverage , having due regard to its legitimate interests and the legitimate interests , particularly the commercial interests , of the other participants in the action . ### where results are capable or may reasonably be expected to be capable of commercial or industrial application , the participant owning these results shall examine the possibility for protection and , if possible and justified given the circumstances , shall adequately protect them for an appropriate period of time and with an appropriate territorial coverage , having due regard to its legitimate interests and the legitimate interests , particularly the commercial interests , of the other participants in the action .


### where a participant that has received union funding intends not to protect results generated by it for reasons other than impossibility under union or national law or the lack of potential for commercial exploitation , and unless the participant intends to transfer them to another legal entity established in a member state or associated country in view of their protection , it shall inform the commission or funding body before any dissemination relating to these results takes place . the commission on behalf of the union or the funding body may assume ownership of these results and take the necessary steps for their adequate protection . ### where a participant that has received union funding intends not to protect results generated by it for reasons other than impossibility under union or national law or the lack of potential for commercial exploitation , and unless the participant intends to transfer them to another legal entity established in a member state or associated country in view of their protection , it shall inform the commission or funding body before any dissemination relating to these results takes place . the commission on behalf of the union or the funding body , with the consent of the owning participant , may assume ownership of these results and take the necessary steps for their adequate protection .


### where a participant that has received union funding intends to abandon the protection of results or not to seek extension of such protection for reasons other than the lack of potential for commercial exploitation , it shall inform the commission or the funding body which may continue or extend protection by assuming ownership thereof . the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . the grant agreement shall lay down time - limits in this respect . ### where a participant that has received union funding intends to abandon the protection of results or not to seek extension of such protection for reasons other than the lack of potential for commercial exploitation , it shall inform the commission or the funding body which may continue or extend protection by assuming ownership thereof . the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . the model grant agreement shall lay down time - limits in this respect .


### where results are capable of commercial or industrial application , the participant owning these results shall examine the possibility for protection and , if possible and justified given the circumstances , shall adequately protect them for an appropriate period of time and with an appropriate territorial coverage , having due regard to its legitimate interests and the legitimate interests , particularly the commercial interests , of the other participants in the action . ### where results are capable of commercial application , the participant owning these results shall examine the possibility for protection and , if possible and justified given the circumstances , shall adequately protect them for an appropriate period of time and with an appropriate territorial coverage , having due regard to its legitimate interests and the legitimate interests , particularly the commercial interests , of the other participants in the action .


### where a participant that has received union funding intends not to protect results generated by it for reasons other than impossibility under union or national law or the lack of potential for commercial exploitation , and unless the participant intends to transfer them to another legal entity established in a member state or associated country in view of their protection , it shall inform the commission or funding body before any dissemination relating to these results takes place . the commission on behalf of the union or the funding body may assume ownership of these results and take the necessary steps for their adequate protection . ### where a participant that has received union funding intends not to protect results generated by it for reasons other than impossibility under union or national law or the lack of potential for commercial exploitation , and unless the participant intends to transfer them to another legal entity established in a member state or associated country in view of their protection , it shall inform the commission or funding body before any dissemination relating to these results takes place . the commission on behalf of the union or the funding body may , with the consent of the owning participant , assume ownership of these results and take the necessary steps for their adequate protection .


### with regard to dissemination through research publications , open access shall apply under the terms and conditions laid down in the grant agreement . with regard to dissemination of other results , including research data , the grant agreement may lay down the terms and conditions under which open access to such results shall be provided , in particular in erc frontier research or in other appropriate areas . ### with regard to dissemination through scientific publications , open access shall apply under the terms and conditions laid down in the grant agreement . with regard to dissemination of other results , including research data , the model grant agreement .


### prior notice of any dissemination activity shall be given to the other participants . following notification , a participant may object if it demonstrates that its legitimate interests in relation to its results or background would suffer significant harm by the intended dissemination . in such cases , the dissemination activity may not take place unless appropriate steps are taken to safeguard these legitimate interests . the grant agreement may lay down time - limits in this respect . ### prior notice of any dissemination activity shall be given to the other participants . following notification , a participant may object if it demonstrates that its legitimate interests in relation to its results or background would suffer significant harm by the intended dissemination . in such cases , the dissemination activity may not take place unless appropriate steps are taken to safeguard these legitimate interests . the model grant agreement shall lay down time - limits in this respect .


### additional exploitation obligations may be laid down in the grant agreement . any such additional obligations shall be indicated in the work programme or work plan . ### additional exploitation obligations may be laid down in the grant agreement . the model grant agreement shall include a list of possible additional exploitation obligations .


### all patent applications , standards , publications or any other dissemination , also in electronic form , relating to results shall include a statement , which may include visual means , that the action received financial support from the union . the terms of that statement shall be established in the grant agreement . ### all patent applications , standards , publications or any other dissemination , also in electronic form , relating to results shall include a statement , which may include visual means , that the action received financial support from the union . the terms of that statement shall be established in the model grant agreement .


### without prejudice to confidentiality obligations arising from laws or regulations in the case of mergers and acquisitions , where other participants still enjoy access rights to the results to be transferred , the participant who intends to transfer the results shall give prior notice to those other participants , together with sufficient information concerning the intended new owner of the results to permit the other participants to analyse the effect of the intended transfer on the possible exercise of their access rights . ### without prejudice to confidentiality obligations arising from laws , regulations or contractual undertakings in the case of mergers and acquisitions , where other participants still enjoy access rights to the results to be transferred , the participant who intends to transfer the results shall give prior notice to those other participants , together with sufficient information concerning the intended new owner of the results to permit the other participants to analyse the effect of the intended transfer on the possible exercise of their access rights .


### without prejudice to confidentiality obligations arising from laws or regulations in the case of mergers and acquisitions , where other participants still enjoy access rights to the results to be transferred , the participant who intends to transfer the results shall give prior notice to those other participants , together with sufficient information concerning the intended new owner of the results to permit the other participants to analyse the effect of the intended transfer on the possible exercise of their access rights . ### without prejudice to confidentiality obligations arising from laws or regulations in the case of mergers and acquisitions , where other participants still enjoy access rights to the results to be transferred , unless otherwise agreed in the consortium agreement , the participant who intends to transfer the results shall give prior notice to those other participants , together with sufficient information concerning the intended new owner of the results to permit the other participants to analyse the effect of the intended transfer on the possible exercise of their access rights .


### provided that any access rights to the results can be exercised and that any additional exploitation obligations are complied with , the participant who owns results may grant licences or otherwise give the right to exploit them to any legal entity , including on an exclusive basis . ### provided that any access rights to the results can be exercised , that any additional exploitation obligations are complied with , and that the results are transferred to a legal entity established within a member state or associated country , participant who owns results may grant licences or otherwise give the right to exploit them to any legal entity , including on an exclusive basis . where a participant intends to transfer a result to a legal entity established in a country not associated to horizon 2020 , that participant shall seek the approval of all the other participants in the action . where participants intend to exploit the results through an exclusivity scheme they shall indicate it in their submitted proposal .


### provided that any access rights to the results can be exercised and that any additional exploitation obligations are complied with , the participant who owns results may grant licences or otherwise give the right to exploit them to any legal entity , including on an exclusive basis . ### provided that any access rights to the results can be exercised and that any additional exploitation obligations are complied with by the participant who owns results , the participant who owns results may grant licences or otherwise give the right to exploit the results to any legal entity , including on an exclusive basis . exclusive licences for results may be granted subject to written confirmation by all the other participants that they waive their access rights thereto .


### with regard to results which are generated by participants that have received union funding , the commission or funding body may object to transfers of ownership or to grants of an exclusive licence , to third parties established in a third country not associated to horizon 2020 , if it considers that the grant or transfer is not in accordance with the interests of developing the competitiveness of the union economy or is inconsistent with ethical principles or security considerations . ### with regard to results which are generated by participants that have received union funding , the grant agreement may provide that the commission or funding body or any participant in the action may object to transfers of ownership or to grants of an exclusive licence , to third parties established in a third country not associated to horizon 2020 , if it considers that the grant or transfer is not in accordance with the interests of developing the competitiveness of the union economy or is inconsistent with ethical principles or security considerations .


### in such cases , the transfer of ownership or grant of exclusive licence shall not take place unless the commission or funding body is satisfied that appropriate safeguards will be put in place . ### in such cases , the transfer of ownership or grant of exclusive licence shall not take place unless the commission or funding body or the participant in the action is satisfied that appropriate safeguards will be put in place .


### where appropriate , the grant agreement shall provide that the commission or funding body is to be notified in advance of any such transfer of ownership or grant of an exclusive licence . the grant agreement shall lay down time - limits . ### where appropriate , the grant agreement shall provide that the commission or funding body or any participant in the action is to be notified in advance of any such transfer of ownership or grant of an exclusive licence . the model grant agreement shall lay down time - limits .


### without prejudice to confidentiality obligations arising from laws or regulations in the case of mergers and acquisitions , where other participants still enjoy access rights to the results to be transferred , the participant who intends to transfer the results shall give prior notice to those other participants , together with sufficient information concerning the intended new owner of the results to permit the other participants to analyse the effect of the intended transfer on the possible exercise of their access rights . ### without prejudice to confidentiality obligations arising from laws or regulations in the case of mergers and acquisitions , where other participants still enjoy access rights to the results to be transferred , and where the results concerned are not exclusively owned by the participant who intends to transfer the results , that participant shall give prior notice to those other participants , together with sufficient information concerning the intended new owner of the results to permit the other participants to analyse the effect of the intended transfer on the possible exercise of their access rights .


### participants shall identify the background for their action in any manner in a written agreement . ### participants shall identify the necessary background for their action in any manner in a written agreement .


### participants shall identify the background for their action in any manner in a written agreement . ### participants shall identify the background for their action in writing .


### a participant shall enjoy access rights to background of another participant in the same action , if such access is needed by the former to carry out its work under the action and subject to any restrictions pursuant to article 43 . ### a participant shall enjoy access rights to background of another participant in the same action , if such background is needed by the former to carry out its own work under the action and subject to any restrictions pursuant to article 43 .


### a participant shall enjoy access rights to background of another participant in the same action , if such access is needed by the former to exploit its results and subject to any restrictions or limits pursuant to article 43 . ### a participant shall enjoy access rights to background of another participant in the same action , if such background is needed by the former to exploit its own results and subject to any restrictions or limits pursuant to article 43 .


### subject to agreement , such access shall be granted under fair and reasonable conditions . ### subject to agreement , such access shall be granted under fair and reasonable conditions or under royalty - free conditions


### an affiliated entity established in a member state or associated country shall , unless otherwise provided for in the consortium agreement , also have access rights to results or background under the same conditions if such access is needed to exploit the results generated by the participant to which it is affiliated . ### subject to article 43 , an affiliated entity established in a member state or associated country shall , unless otherwise provided for in the consortium agreement , also have access rights to results and background under fair and reasonable conditions if such results or background are needed to exploit the results generated by the participant to which it is affiliated .


### specific provisions ### specific provisions for particular types of actions


### in the case of actions to support existing or new research infrastructures , the grant agreement may lay down specific provisions relating to users of the infrastructure . ### in the case of actions to support existing or new research infrastructures or institutes , the grant agreement may lay down specific provisions relating to the use of the infrastructure or institute .


### in the case of actions to support existing or new research infrastructures , the grant agreement may lay down specific provisions relating to users of the infrastructure . ### in the case of actions to support the operation of existing or new research infrastructures , the grant agreement may lay down specific provisions relating to users ' access of the infrastructure .


### in the case of erc frontier research actions , the grant agreement may lay down specific provisions , in particular on access rights , portability and dissemination , relating to participants , researchers and any party concerned by the action . ### in the case of erc frontier research actions or research actions within the pillar ' societal challenges ' , the grant agreement may lay down specific provisions , in particular on access rights , portability and dissemination , relating to participants , researchers and any party concerned by the action .


### eures ' scope should be widened to develop and support targeted mobility schemes at union level with a view to filling vacancies where labour market shortcomings have been identified . in accordance with article 47 of the treaty , the scheme should facilitate mobility among young workers . ### eures ' scope should be widened to develop and support targeted mobility schemes at union level with a view to filling vacancies where labour market shortcomings have been identified . in the light of high youth unemployment and in accordance with article 47 of the treaty , the scheme should especially facilitate mobility among young workers in the union .


### 60 % to the progress axis , of which at least 17 % shall be allocated to promoting social experimentation as a method for testing and evaluating innovative solutions with a view to scaling them up ; ### 50 % to the progress axis ;


### the commission may make use of the appropriations referred to paragraph 1 to finance technical and / or administrative assistance , in particular relating to auditing , outsourcing of translation , meetings of experts , and information and communication activities for the mutual benefit of the commission and the beneficiaries . ### the commission may make use of the appropriations referred to paragraph 1 to finance technical and / or administrative assistance , in particular relating to auditing , outsourcing of translation , meetings of experts , and information and communication activities for the mutual benefit of the commission and the beneficiaries , thereby ensuring that the control of spending is strengthened .


### evaluations and impact assessments ; ### independent evaluations and impact assessments ;


### council presidency events , conferences and seminars ; ### important council presidency events , conferences and seminars duly justified ;


### organisation of working groups of national officials to monitor the implementation of union law ; ### organisation of working groups of national officials to monitor the proper implementation of union law ;


### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . ### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy as well as the needs of the internal market , thereby strengthening its good functioning .


### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up biennial monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities . ### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up annual monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities . the report shall be published and made available for the public in the interests of better transparency .


### a mid - term evaluation of the programme shall be carried out by the end of 2017 to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . ### a mid - term evaluation of the programme shall be carried out by the end of 2017 to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . the report shall be forwarded after that evaluation to the european parliament and to the council . the report shall be published and made available for the public in the interests of better transparency .


### two years after the expiry of the programme at the latest , the commission shall carry out an ex - post evaluation measuring its impact and union added value and shall forward a report on that evaluation to the european parliament , the council , the european economic and social committee and the committee of the regions . ### two years after the expiry of the programme at the latest , the commission shall carry out an independent ex - post evaluation measuring its impact and union added value and shall forward a report on that evaluation to the european parliament , the council , the european economic and social committee and the committee of the regions .


### facilitate effective and inclusive information - sharing , mutual learning and dialogue on union employment and social policy and working conditions legislation at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in implementing union law ; ### facilitate effective and inclusive information - sharing , mutual learning and dialogue on union employment and social policy and working conditions legislation at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in properly implementing union law ;


### the annual work plans , including the criteria for the selection of beneficiaries following calls for proposals . ### the annual work plans , including the criteria for the selection of beneficiaries following calls for proposals . the criteria for the selection of beneficiaries should take into account the needs of the internal market .


### to reach out to the final beneficiaries and create competitive , viable micro - enterprises , public and private bodies that carry out activities as referred to in paragraph 1 shall cooperate closely with organisations representing the interests of the final beneficiaries of microcredit and with organisations , in particular those supported by the esf , which provide mentoring and training programmes to such final beneficiaries . ### to reach out to the final beneficiaries and create competitive , viable micro - enterprises , public and private bodies that carry out activities as referred to in paragraph 1 shall cooperate closely with organisations representing the interests of the final beneficiaries of microcredit and with organisations , in particular those supported by the esf , which provide mentoring and training programmes to such final beneficiaries . the training programmes should take into account the needs of the internal market .


### the information provided in these annual implementation reports shall feed into the biennial monitoring reports provided for in article 13 . such monitoring reports shall include the annual reports provided for in article 8 of decision no 283 / 2010 / eu . ### the information provided in these annual implementation reports shall feed into the annual monitoring reports provided for in article 13 . such monitoring reports shall include the annual reports provided for in article 8 of decision no 283 / 2010 / eu .


### in article 1 , point 1 is replaced by the following : ' ‘ drug’ means : any of the substances covered by the 1961 united nations single convention on narcotic drugs and the 1971 united nations convention on psychotropic substances ; any of the substances listed in the annex ; any new psychoactive substance posing severe health , social and safety risks , subjected to permanent market restriction on the basis of [ article 13 of regulation no … / … on new psychoactive substances ] ; ' ### in article 1 , point 1 is replaced by the following : ' ‘ drugs’ : shall mean any of the following substances : any of the substances covered by the 1961 united nations single convention on narcotic drugs and the 1971 united nations convention on psychotropic substances ; any of the substances listed in the annex ; any new psychoactive substance posing severe health , social and safety risks , subjected to permanent market restriction on the basis of [ article 13 of regulation no … / … on new psychoactive substances ] ; any mixture or solution containing one or more substances listed in points , and ; '


### with the aim of strengthening trade mark protection and combatting counterfeiting more effectively , the proprietor of a registered trade mark should be entitled to prevent third parties from bringing goods into the customs territory of the member state without being released for free circulation there , where such goods come from third countries and bear without authorization a trade mark which is essentially identical to the trade mark registered in respect of such goods . ### with the aim of strengthening trade mark protection and combating counterfeiting more effectively , the proprietor of a registered trade mark , assisted by the national authorities , should be entitled to prevent third parties from bringing goods into the customs territory of the member state without being released for free circulation there , where such goods come from third countries and bear without authorization a trade mark which is essentially identical to the trade mark registered in respect of such goods .


### being represented in a manner which enables the competent authorities and the public to determine the precise subject of the protection afforded to its proprietor . ### being represented , in its published form and its inscription in the register , in a manner which enables the competent authorities and the public to determine clearly and exactly the subject of the protection afforded to its proprietor .


### trade marks which are excluded from registration pursuant to union legislation or international agreements to which the union is party , providing for protection of traditional terms for wine and traditional specialities guaranteed . ### trade marks which are excluded from registration pursuant to union legislation or international agreements to which the union is party , providing for protection of spirit drinks , traditional terms for wine and traditional specialities guaranteed .


### a trade mark shall not be refused registration or be declared invalid in accordance with paragraph 1 , or if , before the date of application for registration or after the date of registration , and following the use which has been made of it , it has acquired a distinctive character . ### a trade mark shall not be refused registration or be declared invalid in accordance with paragraph 1 , or if it has acquired a distinctive character at the time of registration .


### a trade mark shall not be refused registration or be declared invalid in accordance with paragraph 1 , or if , before the date of application for registration or after the date of registration , and following the use which has been made of it , it has acquired a distinctive character . ### a trade mark shall not be refused registration in accordance with paragraph 1 , or if , before the date of application for registration following use which has been made of it , it has acquired a distinctive character . a trade mark shall not be declared invalid for the same reasons if , before the date of application for invalidity , following use which has been made of it , it has acquired a distinctive character .


### if it is identical with an earlier trade mark , and the goods or services for which the trade mark is applied for or is registered are identical with the goods or services for which the earlier trade mark is protected ; ### if it is identical with , or similar to , an earlier trade mark irrespective of whether the goods or services for which it is applied or registered are identical with , similar to or not similar to those for which the earlier trade mark is registered , where the earlier trade mark has a reputation in the member state of registration or , in the case of a european union trade mark , has a reputation in the union and the use of the later trade mark without due cause would take unfair advantage of , or be detrimental to , the distinctive character or the repute of the earlier trade mark ;


### the proprietor of a registered trade mark shall also be entitled to prevent all third parties from bringing goods , in the context of commercial activity , into the customs territory of the member state where the trade mark is registered without being released for free circulation there , where such goods , including packaging , come from third countries and bear without authorization a trade mark which is identical to the trade mark registered in respect of such goods , or which cannot be distinguished in its essential aspects from that trade mark . ### the proprietor of a registered trade mark , assisted by the national authorities , shall also be entitled to prevent all third parties from bringing goods infringing this registered trade mark into the customs territory of the member state where the trade mark is validly registered , where such goods , including packaging : come from third countries and bear without authorization a trade mark which is identical to the trade mark registered in respect of such goods , or which cannot be distinguished in its essential aspects from that trade mark ; and are intended to be the subject of commercial activity without being released for free circulation in that territory .


### the sign is identical , or similar to , the trade mark and is used for goods or services which are identical with or similar to the goods or services for which the trade mark is registered , if there exists a likelihood of confusion on the part of the public ; the likelihood of confusion includes the likelihood of association between the sign and the trade mark ; ### without prejudice to point a , the sign is identical , or similar to , the trade mark and is used for goods or services which are identical with or similar to the goods or services for which the trade mark is registered , if there exists a likelihood of confusion on the part of the public ; the likelihood of confusion includes the likelihood of association between the sign and the trade mark ;


### importing or exporting the goods under the sign ; ### manufacturing or placing under a suspensive procedure , importing , exporting , re exporting or transhipping the goods under that sign ;


### using the sign as a trade or company name or part of a trade or company name ; ### using the sign as a trade or company name or part of a trade or company name , or domain names ;


### the first subparagraph shall only apply where the use made by the third party is in accordance with honest practices in industrial or commercial matters . ### this paragraph shall only apply where the use made by the third party is in accordance with honest practices in industrial or commercial matters .


### an applicant for a collective mark shall submit the regulations governing its use . ### an applicant for a collective mark shall submit the regulations governing its use to the office .


### an application for registration of a trade mark shall contain : ### an application for registration of a trade mark shall contain at least :


### the administrative procedure referred to in paragraph 1 shall provide that at least the proprietor of an earlier right referred to in article 5 and shall be able to file a notice of opposition . ### the administrative procedure referred to in paragraph 1 shall provide that at least the proprietor of an earlier right referred to in article 4 , article 5 and shall be able to file a notice of opposition .


### the parties shall be granted a period of time of at least two months before the opposition proceedings commence in order to negotiate the possibility of an amicable settlement between the opposing party and the applicant . ### the parties shall be granted , at their joint request , a minimum of two months in the opposition proceeding in order to negotiate the possibility of an amicable settlement between the opposing party and the applicant .


### member states shall provide for an administrative procedure before their offices for revocation or declaration of invalidity of a trade mark . ### member states may provide for an administrative procedure before their offices for revocation or declaration of invalidity of a trade mark .


### member states shall ensure that the offices cooperate with each other and with the agency in order to promote convergence of practices and tools and achieve coherent results in the examination and registration of trade marks . ### member states shall ensure that the offices may effectively cooperate with each other and with the agency in order to promote convergence of practices and tools and achieve coherent results in the examination and registration of trade marks .


### member states shall ensure that the offices cooperate with the agency in all areas of their activities other than those referred to in article 52 which are of relevance for the protection of trade marks in the union . ### member states shall take steps to ensure that the offices cooperate with the agency in areas of activity which they consider to be of relevance for the protection of trade marks in the union , but other than those referred to in article 52 .


### member states shall ensure that the offices cooperate with the agency in all areas of their activities other than those referred to in article 52 which are of relevance for the protection of trade marks in the union . ### member states shall ensure that the offices may effectively cooperate with the agency in all areas of their activities other than those referred to in article 52 which are of relevance for the protection of trade marks in the union .


### the resources of the european refugee fund and of the european asylum support office should be mobilised to provide adequate support to the member states ' efforts relating to the implementation of the standards set in the second phase of the common european asylum system , in particular to those member states which are faced with specific and disproportionate pressures on their asylum systems , due in particular to their geographical or demographic situation . ### the resources of the european refugee fund and of the european asylum support office must be mobilised , inter alia , to provide adequate support to the member states ' efforts relating to the implementation of the standards set in the second phase of the common european asylum system , in particular to those member states which are faced with specific and disproportionate pressures on their asylum systems , due in particular to their geographical or demographic situation . in member states that accept a disproportionately large number of asylum applications in relation to the size of their population , financial support and administrative / technical support must be mobilised immediately under the european refugee fund and the european asylum support office respectively in order to enable them to comply with the provisions of this directive .


### it is essential that decisions on all applications for international protection be taken on the basis of the facts and , in the first instance , by authorities whose personnel has the appropriate knowledge or receives the necessary training in the field of asylum and refugee matters . ### it is essential that decisions on all applications for international protection be taken on the basis of the facts and , in the first instance , by authorities whose personnel has the appropriate knowledge and receives the necessary training in the field of asylum and refugee matters .


### in addition , special procedural guarantees for vulnerable applicants , such as minors , unaccompanied minors , persons who have been subjected to torture , rape or other serious acts of violence or disabled persons , should be laid down in order to create the conditions necessary for their effective access to procedures and presenting the elements needed to substantiate the application for international protection . ### in addition , particular attention should be paid to the special needs of vulnerable applicants , such as minors , unaccompanied minors , persons who have been subjected to torture , rape or other serious acts of violence or disabled persons , in order to create the conditions necessary for their effective access to procedures and presenting the elements needed to substantiate the application for international protection .


### with a view to ensuring substantive equality between female and male applicants , examination procedures should be gender sensitive . in particular , personal interviews should be organised in a way which makes its possible for both female and male applicants to speak about their past experiences in cases involving gender based persecution . the complexity of gender related claims should be properly taken into account in procedures based on the safe third country concept , the safe country of origin concept or the notion of subsequent applications . ### with a view to ensuring substantive equality between female and male applicants , examination procedures should be sensitive to the specificities of the two sexes . in particular , personal interviews should be organised in a way which makes its possible for both female and male applicants to speak about their past experiences in cases involving sex - based persecution . the complexity of sex - related claims should be properly taken into account in procedures based on the safe third country concept , the safe country of origin concept or the notion of subsequent applications .


### ‘ applicant with special needs’ means an applicant who due to age , gender , disability , mental health problems or consequences of torture , rape or other serious forms of psychological , physical or sexual violence is in need of special guarantees in order to benefit from the rights and comply with the obligations in accordance with this directive ; ### ‘ applicant with special needs’ means an applicant who due to age , gender , disability , physical or mental illnesses or consequences of torture , rape or other serious forms of psychological , physical or sexual violence is in need of special guarantees in order to benefit from the rights and comply with the obligations in accordance with this directive ;


### gender , trauma and age awareness ; ### gender , trauma and age awareness , with particular attention being paid to unaccompanied minors ;


### member states shall ensure that a minor has the right to make an application for international protection either on his / her own behalf , or through his / her parents or other adult family members . ### member states shall ensure that a minor has the right to make an application for international protection either on his / her own behalf – if he / she is considered under national law as capable of bringing proceedings – or through his / her legal representative or the latter’s authorised representative . in all other cases article 6 shall apply .


### member states may provide for rules covering the presence of such organizations in the areas referred to in this article . ### member states may provide for rules covering the presence of such organizations in the areas referred to in this article , as long as they do not limit access by applicants to advice and counselling .


### paragraph 3 shall not apply to cases where disclosure of particular circumstances of a person to members of his / her family can jeopardize the interests of that person , including cases involving gender and / or age based persecution . in such cases , a separate decision shall be issued to the person concerned . ### paragraph 3 shall not apply to cases where disclosure of particular circumstances of a person to members of his / her family can jeopardize the interests of that person , including cases involving sex and / or age based persecution . in such cases , a separate decision shall be issued to the person concerned .


### applicants for international protection shall cooperate with the competent authorities with a view to establishing their identity and other elements referred to in article 4 of directive [ &#8230 ; . / . . / ec ] [ the qualification directive ] . member states may impose upon applicants other obligations to cooperate with the competent authorities insofar as these obligations are necessary for the processing of the application . ### applicants for international protection shall be required to assist in clarifying the situation and to reveal their identity , nationality and other elements referred to in article 4 of directive [ &#8230 ; . / . . / ec ] [ the qualification directive ] to the competent authorities . if they are not in possession of a valid passport or a document in lieu of a passport , applicants shall be required to cooperate in obtaining an identity document . so long as applicants are permitted to remain in the member state under international protection during consideration of the application , they shall not be required to enter into contact with authorities of their country of origin if there is reason to fear persecution by the state . member states may impose upon applicants other obligations to cooperate with the competent authorities insofar as these obligations are necessary for the processing of the application .


### ensure that interviews with minors are conducted in a child - friendly manner . ### ensure that interviews with minors are conducted in a child - friendly manner and by a person with the necessary knowledge of the special needs and rights of minors .


### member states shall provide for relevant arrangements in order to ensure that impartial and qualified medical expertise is made available for the purpose of a medical examination referred to in paragraph 2 . ### member states shall provide for relevant arrangements in order to ensure that impartial and qualified medical expertise – for example , medical officers or medical specialists – is made available for the purpose of a medical examination referred to in paragraph 2 .


### member states shall provide for relevant arrangements in order to ensure that impartial and qualified medical expertise is made available for the purpose of a medical examination referred to in paragraph 2 . ### member states shall provide for relevant arrangements in order to ensure that impartial and qualified medical expertise is made available for the purpose of a medical examination referred to in paragraph 2 and that the less invasive medical examination is selected when the applicant is a minor .


### as soon as possible take measures to ensure that a representative represents and assists the unaccompanied minor with respect to the lodging and&#160 ; the examination of the application . the representative shall be impartial and have the necessary expertise in the field of childcare . this representative can also be the representative referred to in directive [ &#8230 ; / &#8230 ; / ec ] 17 [ the reception conditions directive ] ; ### as soon as possible take measures to ensure that a representative of the competent national body represents and assists the unaccompanied minor with respect to the lodging and&#160 ; the examination of the application . the representative shall be impartial and have the necessary expertise in the field of childcare . this representative can also be the representative referred to in directive [ &#8230 ; / &#8230 ; / ec ] 17 [ the reception conditions directive ] ;


### if an unaccompanied minor has a personal interview on his / her application for international protection as referred to in articles 13 , 14 and 15 that interview is conducted by a person who has the necessary knowledge of the special needs of minors ; ### if an unaccompanied minor has a personal interview on his / her application for international protection as referred to in articles 13 , 14 and 15 that interview is conducted by a person who has the necessary knowledge of the special needs and rights of minors ;


### an official with the necessary knowledge of the special needs of minors prepares the decision by the determining authority on the application of an unaccompanied minor . ### an official with the necessary knowledge of the special needs and rights of minors prepares the decision by the determining authority on the application of an unaccompanied minor .


### unaccompanied minors are informed prior to the examination of their application for international protection&#160 ; , and in a language which they understand , of the possibility that their age may be determined by medical examination . this shall include information on the method of examination and the possible consequences of the result of the medical examination for the examination of the application for international protection&#160 ; , as well as the consequences of refusal on the part of the unaccompanied minor to undergo the medical examination ; ### unaccompanied minors are informed prior to the examination of their application for international protection , and in a language which they may reasonably be supposed to understand , of the possibility that their age may be determined by medical examination . this shall include information on the method of examination and the possible consequences of the result of the medical examination for the examination of the application for international protection , as well as the consequences of refusal on the part of the unaccompanied minor to undergo the medical examination ;


### member states may prioritise an examination of an application for international protection in accordance with the basic principles and guarantees of chapter ii : ### member states may prioritise or accelerate an examination of an application for international protection in accordance with the basic principles and guarantees of chapter ii :


### where the applicant has special needs ; ### where the applicant has special needs , in particular unaccompanied minors ;


### the fact that an application for international protection was submitted after an irregular entry into the territory or at the border , including in transit zones , as well as the lack of documents or use of forged documents , shall not per se entail an automatic recourse to an accelerated examination procedure . ### the fact that an application for international protection was submitted after an irregular entry into the territory or at the border , including in transit zones , as well as the lack of documents on entry or the use of forged documents , shall not per se entail an automatic recourse to an accelerated examination procedure .


### no later than [ … ] , the commission shall report to the european parliament and the council on the application of this directive in the member states and shall propose any amendments that are necessary . member states shall send the commission all the information that is appropriate for drawing up this report . after presenting the report , the commission shall report to the european parliament and the council on the application of this directive in the member states at least every five years . ### no later than [ … ] , the commission shall report to the european parliament and the council on the application of this directive in the member states and shall propose any amendments that are necessary . member states shall send the commission all the information that is appropriate for drawing up this report . after presenting the report , the commission shall report to the european parliament and the council on the application of this directive in the member states at least every two years .


### no later than [ … ] , the commission shall report to the european parliament and the council on the application of this directive in the member states and shall propose any amendments that are necessary . member states shall send the commission all the information that is appropriate for drawing up this report . after presenting the report , the commission shall report to the european parliament and the council on the application of this directive in the member states at least every five years . ### no later than [ … ] , the commission shall report to the european parliament and the council on the application and the financial cost of this directive in the member states and shall propose any amendments that are necessary . member states shall send the commission all the information and financial data that is appropriate for drawing up this report . after presenting the report , the commission shall report to the european parliament and the council on the application of this directive in the member states at least every five years .


### it should be the responsibility of the member states to decide on a case - by - case basis whether or not a product falls within the scope of this regulation . if necessary , the commission may decide , on a case - by - case basis , whether or not a product falls within the definition of an in vitro diagnostic medical device or of an accessory to an in vitro diagnostic medical device . ### it should be the responsibility of the member states to decide on a case - by - case basis whether or not a product falls within the scope of this regulation . if necessary , the commission may decide , when necessary , as for example when for a same product the decisions taken at national level vary between member states , on a case - by - case basis , whether or not a product falls within the definition of an in vitro diagnostic medical device or of an accessory to an in vitro diagnostic medical device .


### for high - risk in vitro diagnostic medical devices , manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available . ### for diagnostic medical devices classified as class c and d , manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available .


### - diagnosis , prevention , monitoring , treatment or alleviation of disease , ### - diagnosis , prevention , prediction , monitoring , treatment or alleviation of disease ,


### ‘ companion diagnostic’ means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy ; ### ‘ companion diagnostic’ means a device specifically intended to and essential in selecting patients with a previously diagnosed condition or predisposition as suitable or not suitable eligible for a targeted therapy with a medicinal product or a range of medicinal products ;


### the commission may at the request of a member state or on its own initiative by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of an in vitro diagnostic medical device or ' accessory to an in vitro diagnostic medical device . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 84 . ### the commission may on its own initiative or shall at the request of a member state , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of an in vitro diagnostic medical device or accessory to a an in vitro diagnostic medical device . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 84 .


### with the exception of article 59 , the requirements of this regulation shall not apply to devices classified as class a , b and c , in accordance with the rules set out in annex vii , and manufactured and used only within a single health institution , provided manufacture and use occur solely under the health institution ' s single quality management system , and the health institution is compliant with standard en iso 15189 or any other equivalent recognised standard . member states may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements . ### with the exception of article 59 , the requirements of this regulation shall not apply to devices classified as class a , b and c , in accordance with the rules set out in annex vii , and manufactured and used only within a single health institution , provided manufacture and use occur solely under the health institution ' s single quality management system , and the health institution is compliant with standard en iso 15189 or an equivalent recognised standard . however , the requirements of this regulation shall continue to apply to clinical or commercial pathology laboratories which do not have health care or the promotion of public health as their primary purpose . member states may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements .


### where no harmonised standards exist or where relevant harmonised standards are not sufficient , the commission shall be empowered to adopt common technical specifications in respect of the general safety and performance requirements set out in annex i , the technical documentation set out in annex ii or the clinical evidence and post - market clinical follow - up set out in annex xii . the cts shall be adopted by means of implementing acts in accordance with the examination procedure referred to in article 84 . ### the commission shall be empowered to adopt common technical specifications in respect of the general safety and performance requirements set out in annex i , the technical documentation set out in annex ii or the clinical evidence and post - market clinical follow - up set out in annex xii . the cts shall be adopted by means of implementing acts in accordance with the examination procedure referred to in article 84 .


### manufacturers shall ensure that the device is accompanied by the information to be supplied in accordance with section 17 of annex i in an official union language which can be easily understood by the intended user . the language of the information to be supplied by the manufacturer may be determined by the law of the member state where the device is made available to the user . ### manufacturers shall ensure that the device is accompanied by the instructions and safety information to be supplied in accordance with section 17 of annex i in a language which can be easily understood by the intended user as determined by the member state concerned .


### manufacturers shall , in response to a reasoned request from a competent authority , provide it with all the information and documentation necessary to demonstrate the conformity of the device , in an official union language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service . ### manufacturers shall , in response to a reasoned request from a competent authority , provide it with all the information and documentation necessary to demonstrate the conformity of the device , in an official union language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service . if a competent authority considers or has reason to believe that a device has caused damages , it shall ensure that the potentially harmed user , the user ' s successor in title , the user ' s health insurance company or other third parties affected by the damage caused to the user may also request the information referred to in the first subparagraph from the manufacturer .


### that an authorised representative in accordance with article 9 has been designated by the manufacturer ; ### that a manufacturer is identified and , that an authorised representative in accordance with article 9 has been designated by the manufacturer ;


### importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately inform the manufacturer and his authorised representative and , if appropriate , take the necessary corrective action to bring that device into conformity , withdraw or recall it . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available and , if applicable , the notified body that issued a certificate in accordance with article 43 for the device in question , giving details , in particular , of the non - compliance and of any corrective action taken . ### importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately inform the manufacturer , and where applicable his authorised representative and , if appropriate , ensure that the necessary corrective action to bring that device in conformity , withdraw or recall it , is taken and , implement that action . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available and , if applicable , the notified body that issued a certificate in accordance with article 43 for the device in question , giving details , in particular , of the non - compliance and of any corrective action they have implemented .


### any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re - establish the function of the device without significantly changing its performance or safety characteristics , shall ensure that the article does not adversely affect the safety and performance of the device . substantiating evidence shall be kept available to the competent authorities of the member states . ### any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re - establish the function of the device without changing its performance or safety characteristics , shall ensure that the article does not adversely affect the safety and performance of the device . substantiating evidence shall be kept available to the competent authorities of the member states .


### an article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics of the device shall be considered a device . ### an article that is intended specifically to replace a part or component of a device and that changes the performance or safety characteristics of the device shall be considered as a device and shall meet the requirements laid down in this regulation .


### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a summary of safety and performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body . ### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a summary of safety and performance . it shall be written in a way that is clear to the intended user and in the language of the country where the device is made available on the market . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body .


### notified bodies shall satisfy the organisational and general requirements and the quality management , resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this regulation . minimum requirements to be met by notified bodies are set out in annex vi . ### notified bodies shall satisfy the organisational and general requirements and the quality management , resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this regulation . requirements to be met by notified bodies are set out in annex vi .


### the commission shall be empowered to adopt delegated acts in accordance with article 85 amending or supplementing the minimum requirements in annex vi , in the light of technical progress and considering the minimum requirements needed for the assessment of specific devices , or categories or groups of devices ### the commission shall be empowered to adopt delegated acts in accordance with article 85 amending or supplementing the requirements in annex vi , in the light of technical progress and considering the requirements needed for the assessment of specific devices , or categories or groups of devices


### the notification shall clearly specify the scope of the designation indicating the conformity assessment activities , the conformity assessment procedures and the type of devices which the notified body is authorised to assess . ### the notification shall clearly specify the scope of the designation indicating the conformity assessment activities , the conformity assessment procedures , the risk - class and the type of devices which the notified body is authorised to assess .


### the commission may , by means of implementing acts , set up a list of codes and the corresponding types of devices to define the scope of the designation of notified bodies which the member states shall indicate in their notification . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 84 . ### the commission may , by means of implementing acts , set up a list of codes and the corresponding risk - classes and types of devices to define the scope of the designation of notified bodies which the member states shall indicate in their notification . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 84 .