### at least 14 days prior to any decision , the competent authority shall notify the mdcg and the commission of its envisaged decision . ### at least 14 days prior to any decision , the competent authority shall notify the mdcg and the commission of its envisaged decision . that decision shall be made publically available in the european databank .


### the commission may , at the request of a member state , on its own initiative , by means of implementing acts , decide on the application of the classification criteria set out in annex vii to a given device , or category or group of devices , with a view to determining their classification . ### the commission may on its own initiative or shall at the request of a member state , by means of implementing acts , decide on the application of the classification criteria set out in annex vii to a given device , or category or group of devices , with a view to determining their classification . such a decision shall in particular be taken in order to resolve divergent decisions as regards the classification of devices between member states .


### where the conformity assessment procedure requires the involvement of a notified body , the manufacturer may apply to a notified body of his choice , provided that the body is notified for the conformity assessment activities , the conformity assessment procedures and the devices concerned . an application may not be lodged in parallel with more than one notified body for the same conformity assessment activity ### where the conformity assessment procedure requires the involvement of a notified body , the manufacturer may apply to a notified body of his choice , provided that the body is notified for the conformity assessment activities , the conformity assessment procedures and the devices concerned . an application shall not be lodged in parallel with more than one notified body for the same conformity assessment activity


### the member states shall take all appropriate measures to encourage healthcare professionals , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident . the manufacturer shall ensure the appropriate follow - up . ### the member states shall take all appropriate measures to encourage healthcare professionals , including pharmacists , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident . the manufacturer shall ensure the appropriate follow - up .


### the member states shall coordinate between them the development of standard web - based structured forms for reporting of serious incidents by healthcare professionals , users and patients . ### the member states shall coordinate between them the development of standard web - based structured forms for reporting of serious incidents by healthcare professionals , users and patients . the member states shall also provide healthcare professionals , users and patients with another forms for reporting of suspected incidents to national competent authorities .


### if in the case of reports received in accordance with article 59 the competent authority ascertains that the reports relate to a serious incident it shall notify without delay those reports to the electronic system referred to in article 60 , unless the same incident has already been reported by the manufacturer . ### if in the case of reports received in accordance with article 59 the competent authority ascertains that the reports relate to an incident it shall notify without delay those reports to the electronic system referred to in article 60 .


### the competent authorities shall perform appropriate checks on the characteristics and performance of devices including , where appropriate , review of documentation and physical or laboratory checks on the basis of adequate samples . they shall take account of established principles regarding risk assessment and risk management , vigilance data and complaints . the competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and , where necessary and justified , enter the premises of economic operators and take the necessary samples of devices . they may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary . ### the competent authorities shall perform appropriate checks on the characteristics and performance of devices including , where appropriate , review of documentation and physical or laboratory checks on the basis of adequate samples . they shall take account of established principles regarding risk assessment and risk management , vigilance data and complaints . the competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and enter the premises of economic operators and take the necessary samples of devices for analysis by an official laboratory . they may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary .


### minimum requirements to be met by notified bodies ### requirements to be met by notified bodies


### - the product identification procedures drawn up and kept up to date from drawings , specifications or other relevant documents at every stage of manufacture ; ### - the product identification and traceability procedures drawn up and kept up to date from drawings , specifications or other relevant documents at every stage of manufacture ;


### the notified body shall randomly perform unannounced factory inspections to the manufacturer and , if appropriate , at the manufacturer ' s suppliers and / or subcontractors , which may be combined with the periodic surveillance assessment referred to in section 4 . 3 . or be performed in addition to this surveillance assessment . the notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer . ### the notified body shall randomly perform at least once every five years and for each manufacturer and generic device group unannounced inspections at the relevant manufacturing sites and , if appropriate , at the manufacturer ' s suppliers and / or subcontractors , the notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer . at the time of such inspections , the notified body shall carry out the tests or ask to carry them in order to check that the quality management system is working properly . it shall provide the manufacturer with an inspection report and with a test report .


### the notified body shall examine the application employing staff with proven knowledge and experience regarding the technology concerned . the notified body may require the application to be completed by further tests or other evidence to allow assessment of conformity with the requirements of the regulation . the notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests . ### the notified body shall examine the application employing staff with proven knowledge and experience regarding the technology concerned . the notified body shall ensure that the manufacturer’s application adequately describes the design , manufacture and performance of the device , allowing assessment of whether the product conforms with the requirements set out in this regulation . the notified bodies shall comment on the conformity of the following : - general description of the product , - design specifications , including a description of the solutions adopted to fulfil the essential requirements , - systematic procedures used for the design process and techniques used to control , monitor and verify the design of the device . the notified body may require the application to be completed by further tests or other evidence to allow assessment of conformity with the requirements of the regulation . the notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests .


### the notified body shall give due consideration to the opinion , if any , expressed by the medicinal products competent authority concerned or the ema when making its decision . it shall convey its final decision to the medicinal products competent authority concerned or to the ema . the design - examination certificate shall be delivered in accordance with point of section 6 . 1 . ### the notified body shall give due consideration to the opinion , if any , expressed by the medicinal products competent authority concerned or the ema when making its decision . if the notified body deviates from that position , it shall justify its final decision to the medicinal products competent authority concerned or to the ema . if no compromise is reached , the matter shall be referred to the mdcg . the design - examination certificate shall be delivered in accordance with point of section 6 . 1 .


### the erdf should contribute to the europe 2020 strategy , thus ensuring greater concentration of erdf support on the priorities of the union . according to the category of regions supported , the support from the erdf should be concentrated on research and innovation , small and medium - sized enterprises and climate change mitigation . the degree of concentration should take into account the level of development of the region as well as the specific needs of regions whose gdp per capita for the 2007 - 13 period was less than 75% of the average gdp of the eu - 25 for the reference period . ### the erdf should contribute to the europe 2020 strategy , thus ensuring greater concentration of erdf support on the priorities of the union . according to the category of regions supported , the support from the erdf should be concentrated on research and innovation , small and medium - sized enterprises and climate change mitigation . the degree of concentration should take into account the level of development of the region as well as the specific needs of regions which were supported under the convergence objective in the 2007 - 13 period .


### within the framework of sustainable urban development , it is considered necessary to support integrated actions to tackle the economic , environmental , climate and social challenges affecting urban areas and to define a procedure to establish the list of cities covered by such actions and the financial allocation set aside for such actions . ### within the framework of integral sustainable urban development , it is considered necessary to support integrated actions to tackle the economic , environmental , climate and social challenges affecting urban areas , to adapt cities to the challenges of climate change , and to define a procedure to establish the list of cities covered by such actions and the financial allocation set aside for such actions .


### in order to identify or test new solutions to issues relating to sustainable urban development which are of relevance at union level , the erdf should support innovative actions in the field of sustainable urban development . ### in order to identify or test new solutions to issues relating to sustainable urban development which are of relevance at union level , the erdf should support innovative actions in the field of integral sustainable urban development .


### productive investment , which contributes to creating and safeguarding sustainable jobs , through direct aid to investment in small and medium - sized enterprises ; ### productive investment , which contributes to creating and safeguarding sustainable jobs , through direct aid to investment in small and medium - sized enterprises in particular ;


### support for and services to enterprises , in particular smes ; ### support for and services to enhance innovation in enterprises , in particular smes and commercial activity in the city centres ;


### support to public research and innovation bodies and investment in technology and applied research in enterprises ; ### support to public research and innovation bodies and investment in technology and applied research in enterprises ; this includes the creation of top research institutions , for example as part of a corresponding competition under the horizon 2020 programme , and support for all appropriate measures that will make these institutions internationally attractive , including internationally competitive salaries ;


### networking , cooperation and exchange of experience between regions , towns , and relevant social , economic and environmental actors ; ### networking , cooperation and exchange of experience between regions , towns , and relevant social , economic and environmental , scientific and research actors ;


### technical assistance . ### technical assistance in all levels of administrations and management bodies dealing with innovation .


### strengthening research , technological development and innovation : ### strengthening research , technological development , innovation and the improvement of training in european education centres .


### enhancing research and innovation infrastructure and capacities to develop r&amp ; i excellence and promoting centres of competence , in particular those of european interest ; ### enhancing research , innovation infrastructure , investments in technology and capacities to develop r&amp ; i excellence and promoting centres of competence , in particular those of european interest ;


### supporting technological and applied research , pilot lines , early product validation actions , advanced manufacturing capabilities and first production in key enabling technologies and diffusion of general purpose technologies ; ### supporting technological and applied research , pilot lines , human resources , early product validation actions , advanced manufacturing capabilities and first production in key enabling technologies and diffusion of general purpose technologies ;


### promoting energy efficiency and renewable energy use in smes ; ### promoting energy efficiency and renewable energy use in and by smes ;


### the list shall contain a maximum number of 300 cities , with a maximum number of 20 per member state . cities shall be selected based on the following criteria : ### the list shall contain a maximum number of 300 cities , with a maximum number of 20 per member state . this number of cities shall also include medium and smaller sized cities . cities shall be selected based on the following criteria :


### to ensure correct and consistent interpretation of provisions and to contribute to the legal certainty of member states and beneficiaries , it is necessary to define certain terms that are used in the regulation . ### to ensure correct and consistent interpretation of provisions and to contribute to the legal certainty of member states and beneficiaries , it is necessary to define certain terms that are used in the regulation and to simplify the provisions applicable to the csf funds .


### under article 317 of the treaty , and in the context of shared management , the conditions allowing the commission to exercise its responsibilities for implementation of the general budget of the european union should be specified and the responsibilities of cooperation by the member states clarified . those conditions should enable the commission to obtain assurance that member states are using the csf funds in a legal and regular manner and in accordance with the principle of sound financial management within the meaning of council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities . member states and the bodies designated by them for that purpose should be responsible for implementing programmes at the appropriate territorial level , in accordance with the institutional , legal and financial framework of the member state . these provisions also ensure that attention is drawn to the need to ensure complementarity and consistency of union intervention , the proportionality of administrative arrangements and a reduction of the administrative burden of beneficiaries of the csf funds . ### under article 317 of the treaty , and in the context of shared management , the conditions allowing the commission to exercise its responsibilities for implementation of the general budget of the european union should be specified and the responsibilities of cooperation by the member states clarified . those conditions should enable the commission to obtain assurance that member states are using the csf funds in a legal and regular manner and in accordance with the principle of sound financial management within the meaning of council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities . member states and the bodies designated by them for that purpose should be responsible for implementing programmes at the appropriate territorial level , in accordance with the institutional , legal and financial framework of the member state . these provisions should ensure complementarity and consistency of union intervention , the proportionality of administrative arrangements and a reduction of the administrative burden of beneficiaries of the csf funds .


### the commission should adopt by delegated act a common strategic framework which translates the objectives of the union into key actions for the csf funds , in order to provide clearer strategic direction to the programming process at the level of member states and regions . the common strategic framework should facilitate sectoral and territorial coordination of union intervention under the csf funds and with other relevant union policies and instruments . ### the commission should submit a legislative proposal to the european parliament and the council with a view to adoption of a common strategic framework which translates the objectives of the union into key actions for the csf funds , in order to provide clearer strategic direction to the programming process at the level of member states and regions . the common strategic framework should facilitate sectoral and territorial coordination of union intervention under the csf funds and with other relevant union policies and instruments .


### on the basis of the common strategic framework adopted by the commission , each member state should prepare , in cooperation with its partners and in dialogue with the commission , a partnership contract . the partnership contract should translate the elements set out in the common strategic framework into the national context and set out firm commitments to the achievement of union objectives through the programming of the csf funds . ### on the basis of the common strategic framework , each member state should prepare , in cooperation with its partners and in dialogue with the commission , a partnership contract . the partnership contract should translate the elements set out in the common strategic framework into the national context and set out firm commitments to the achievement of union objectives through the programming of the csf funds .


### with a view to monitoring progress of programmes , an annual review meeting should take place between the member state and the commission . the member state and the commission should however be able to agree not to organize the meeting in order to avoid unnecessary administrative burden . ### with a view to monitoring progress of programmes , an annual review meeting should take place between the member state , the european parliament and the commission . they should however be able to agree not to organize the meeting in order to avoid unnecessary administrative burden .


### in order to ensure an effective use of union resources , and avoid the over - financing of revenue generating operations , it is necessary to set out the rules for calculating the contribution from the csf funds to a revenue - generating operation . ### in order to ensure an effective use of union resources , avoid the over - financing of revenue generating operations , but also not hinder the carrying out of useful projects , it is necessary to set out appropriate rules for calculating the contribution from the csf funds to a revenue - generating operation .


### to ensure the availability of essential and up to date information on programme implementation , it is necessary that member states provide the commission with the key data on a regular basis . in order to avoid an additional burden on member states , this should be limited to data collected continuously , and the transmission should be performed by way of electronic data exchange . ### to ensure the availability of essential and up to date information on programme implementation , it is necessary that member states provide the commission with the key data on a regular basis . in order to avoid an additional burden on member states and to protect the environment , this should be limited to data collected continuously , and the transmission should be performed by way of electronic data exchange .


### without prejudice to the commission ' s powers as regards financial control , cooperation between the member states and the commission in this field should be increased and criteria should be established which allow the commission to determine , in the context of its strategy of control of national systems , the level of assurance it should obtain from national audit bodies . ### without prejudice to the commission ' s powers as regards financial control , cooperation between the member states and the commission in this field should be increased and criteria should be established which allow the commission to determine , in the context of its strategy of proportionate control of national systems , the level of assurance it should obtain from national audit bodies .


### the frequency of audits on operations should be proportionate to the extent of the union ' s support from the funds . in particular , the number of audits carried out should be reduced where the total eligible expenditure for an operation does not exceed eur 100 000 . nevertheless , it should be possible to carry out audits at any time where there is evidence of an irregularity or fraud , or , following closure of a completed operation , as part of an audit sample . in order that the level of auditing by the commission is proportionate to the risk , the commission should be able to reduce its audit work in relation to operational programmes where there are no significant deficiencies or where the audit authority can be relied on . ### the frequency of audits on operations should be proportionate to the extent of the union ' s support from the funds and to the risks established . in particular , the number of audits carried out should be reduced where the total eligible expenditure for an operation does not exceed eur 200 000 . nevertheless , it should be possible to carry out audits at any time where there is evidence of an irregularity or fraud , or , following closure of a completed operation , as part of an audit sample . in order that the level of auditing by the commission is proportionate to the risk , the commission should be able to reduce its audit work in relation to operational programmes where there are no significant deficiencies or where the audit authority can be relied on .


### support from the csf funds shall be implemented in close cooperation between the commission and the member states . ### support from the csf funds shall be implemented in close cooperation between the commission and the member states in accordance with the principle of subsidiarity .


### arrangements for the implementation and use of the csf funds , and in particular the financial and administrative resources required for the implementation of the csf funds , in relation to the reporting , evaluation , management and control shall take into account the principle of proportionality having regard to the level of support allocated . ### arrangements for the implementation and use of the csf funds , and in particular the financial and administrative resources required for the implementation of the csf funds , in relation to the reporting , evaluation , management and control shall take into account the principle of proportionality having regard to the level of support allocated and to the risks established .


### in accordance with their respective responsibilities , the commission and the member states shall ensure coordination among the csf funds , and with other union policies and instruments , including those in the framework of the union ' s external action . ### in accordance with their respective responsibilities , the commission and the member states shall ensure coordination among the csf funds , and with other union policies and instruments , including those in the framework of the union ' s external action . special attention shall be given and , where relevant , resources be allocated for areas in which other union funds explicitly provide for an integrated approach , such as joint funding for integrated projects in the field of environment and climate .


### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 . ### the member states and the commission shall ensure that environmental , biodiversity , and ecosystem protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change and biodiversity objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 .


### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 . ### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , protection of biodiversity and ecosystems , climate change mitigation and adaptation , disaster resilience and prevention and management of ecosystem - based risk are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change and biodiversity objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 .


### the commission shall be empowered to adopt a delegated act in accordance with article 142 on the common strategic framework within 3 months of the adoption of this regulation . ### the commission shall submit a legislative proposal to the european parliament and the council with a view to adoption of a common strategic framework . once adopted , it shall be annexed to this regulation .


### the mechanisms at national and regional level that ensure coordination between the csf funds and other union and national funding instruments and with the eib ; ### the mechanisms at national and regional level that ensure coordination between the csf funds and other union and national funding instruments , especially where those provide for a structured cooperation such as the life programme , and with the eib ;


### member states shall set out the detailed actions relating to the fulfilment of ex ante conditionalities , including the timetable for their implementation , in the relevant programmes . ### member states shall set out the detailed actions relating to the fulfilment of ex ante conditionalities , including the timetable for their implementation , in the relevant programmes . with regards to the implementation of plans or strategies under the thematic objectives 4 , 5 and 6 , member states shall consider integrated projects in the field of climate and environment as a potential model for an efficient , coherent and well coordinated implementation .


### the commission shall participate in the work of the monitoring committee in an advisory capacity . ### the commission and the european parliament shall participate in the work of the monitoring committee in an advisory capacity .


### a citizen ' s summary of the contents of the annual and the final implementation reports shall be made public . ### a citizen ' s summary of the contents of the annual and the final implementation reports shall be made public in order to increase transparency .


### an annual review meeting shall be organised every year from 2016 until and including 2022 between the commission and each member state to examine the performance of each programme , taking account of the annual implementation report and the commission ' s observations and recommendations , where applicable . ### an annual review meeting shall be organised every year from 2016 until and including 2022 between the commission and each member state to examine the performance of each programme , taking account of the annual implementation report and the commission ' s observations and recommendations , where applicable . the european parliament shall participate in that meeting .


### the commission shall satisfy itself on the basis of available information , including the accreditation procedure , annual management declaration , annual control reports , annual audit opinion , annual implementation report and audits carried out by national and union bodies , that the member states have set up management and control systems that comply with this regulation and the fund - specific rules and that these systems function effectively during the implementation of programmes . ### the commission shall satisfy itself on the basis of available information , including the accreditation procedure , annual management declaration , annual control reports , annual audit opinion , annual implementation report and audits carried out by national and union bodies , that the member states have set up management and control systems that comply with this regulation and the fund - specific rules and that these systems function effectively and proportionately to the risks established during the implementation of programmes .


### the actions supported by the funds shall contribute to the union strategy for smart , sustainable and inclusive growth . ### the actions supported by the funds shall contribute to the union strategy for smart , sustainable and inclusive growth and to a strategy of improvement of smart specialization in the regions .


### the three categories of regions are determined on the basis of how their gdp per capita , measured in purchasing power parities and calculated on the basis of union figures for the period 2006 to 2008 , relates to the average gdp of the eu - 27 for the same reference period . ### the three categories of regions are determined on the basis of how their gdp per capita , measured in purchasing power parities and calculated on the basis of union figures for the period 2007 to 2009 , relates to the average gdp of the eu - 27 for the same reference period .


### the mechanisms that ensure coordination between the funds , the eafrd , the emff and other union and national funding instruments , and with the eib ; ### the mechanisms that ensure coordination between the funds , the eafrd , the emff and other union and national funding instruments , especially where those provide for a structured cooperation such as the life programme , and with the eib ;


### member states shall submit an opinion of the national equality bodies on the measures set out in points and with the proposal for an operational programme under the investment for growth and jobs goal . ### member states shall submit an opinion of the national environmental bodies on the measures set out in point , and an opinion of the national equality bodies on the measures set out in points and , with the proposal for an operational programme under the investment for growth and jobs goal .


### ensuring the establishment of a single website or a single website portal providing information on , and access to , all operational programmes in that member state ; ### ensuring the establishment of : - a single website or a single website portal providing information on , and access to , all operational programmes in that member state ; - a website for each operational programme which is accessible from the single website or website portal ;


### the information and communication officer shall coordinate and chair meetings of a national network of funds ' communicators , including relevant european territorial cooperation programmes , the creation and maintenance of the website or website portal referred to in annex v and the obligation to provide an overview about communication measures undertaken at national level . ### the information and communication officer shall coordinate and chair meetings of a national network of funds ' communicators , including relevant european territorial cooperation programmes , the creation and maintenance of the websites referred to in annex v and the obligation to provide an overview about communication measures undertaken at national level .


### the systems shall facilitate interoperability with national and union frameworks and allow for the beneficiaries to submit all information referred to in the first sub - paragraph only once . ### the systems shall facilitate interoperability with national and union frameworks , shall allow for the beneficiaries to submit all information referred to in the first sub - paragraph only once , and shall contribute towards protection of the environment .


### are non - discriminatory and transparent ; ### are clear , non - discriminatory and transparent ;


### operations for which the total eligible expenditure does not exceed eur&#160 ; 100&#160 ; 000 shall not be subject to more than one audit by either the audit authority or the commission prior to the closure of all the expenditure concerned under article 131 . other operations shall not be subject to more than one audit per accounting year by the audit authority and the commission prior to the closure of all the expenditure concerned under article 131 . these provisions are without prejudice to paragraph 4 . ### operations for which the total eligible expenditure does not exceed eur&#160 ; 200 000 shall not be subject to more than one audit by either the audit authority or the commission prior to the closure of all the expenditure concerned under article 131 . other operations shall not be subject to more than one audit per accounting year by the audit authority and the commission prior to the closure of all the expenditure concerned under article 131 . these provisions are without prejudice to paragraph 4 .


### directive 2001 / 20 / ec aimed to simplify and harmonise the administrative provisions governing clinical trials in the european union . however , experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved . this makes it in particular difficult to perform a clinical trial in several member states . scientific development however , suggests that future clinical trials will target more specific patient populations , such as subgroups identified through genomic information . in order to include a sufficient number of patients for such trials it may be necessary to involve many , or all , member states . the new procedures for the authorisation of clinical trials should stimulate the inclusion of as many member states as possible . therefore , in order to simplify submission procedures , the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier through a single submission portal to all the member states concerned . ### directive 2001 / 20 / ec aimed to simplify and harmonise the administrative provisions governing clinical trials in the european union . however , experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved . this makes it in particular difficult to perform a clinical trial in several member states . scientific development however , suggests that future clinical trials will target more specific patient populations , such as subgroups identified through genomic information . in order to include a sufficient number of patients for such trials it may be necessary to involve many , or all , member states . the new procedures for the authorisation of clinical trials should stimulate the inclusion of as many member states as possible . therefore , in order to simplify submission procedures , the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier through a single submission portal to all the member states concerned . the application dossier related to a clinical trial conducted in a single member state should also be submitted through that single submission portal .


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


### the assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits and the risk and inconveniences for the subject . regarding the relevance , numerous aspects should be taken into account , including whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products . ### the assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits and the risk and inconveniences for the subject . regarding the relevance , numerous aspects should be taken into account , such as the subpopulations to be studied and the potential differences in efficacy and / or safety for specific subpopulations notably gender and age differences , or whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products .


### the assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits and the risk and inconveniences for the subject . regarding the relevance , numerous aspects should be taken into account , including whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products . ### the assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits and the risk and inconveniences for the subject . regarding the relevance , numerous aspects should be taken into account , such as the population groups to be studied and the potential differences in efficacy and / or safety for specific patient groups notably gender and age differences , or whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products .


### the authorisation procedure should provide for the possibility to suspend the assessment in order to allow the sponsor to address questions or comments raised during the assessment of the application dossier . the maximum duration of the suspension should reflect whether the clinical trial is a low - intervention clinical trial or not . moreover , it should be ensured that , following the end of the suspension , there is always sufficient time for assessing the additional information submitted . ### the authorisation procedure should provide for the possibility to suspend the assessment in order to allow the sponsor to address questions or comments raised during the assessment of the application dossier . the maximum duration of the suspension should reflect whether the clinical trial poses only a low risk or not . moreover , it should be ensured that , following the end of the suspension , there is always sufficient time for assessing the additional information submitted .


### some aspects in a clinical trial application relate to issues of an intrinsic national nature or to ethical aspects of a clinical trial . those issues should not be assessed in cooperation among all member states concerned . ### some aspects in a clinical trial application relate to issues of an intrinsic national nature of a clinical trial or to ethical aspects , such as informed consent . those aspects should not be assessed in cooperation among all member states concerned .


### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . this decision is a matter of internal organisation of each member state . member states , when determining the appropriate body or bodies , should ensure the involvement of lay persons and patients . they should also ensure that the necessary expertise is available . in any case , however , and in accordance with international guidelines , the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . the persons assessing the application should be independent from the sponsor , the institution of the trial site , and the investigators involved , as well as free of any other undue influence . ### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . this decision is a matter of internal organisation of each member state . however , irrespective of the organisation of the assessment process and the bodies involved , member states should make sure that the assessment is entirely completed within the deadlines provided for in this regulation and that no further assessment can prevent the sponsor from starting the clinical trial after the notification of the decision granting the authorisation .


### the human dignity and right to the integrity of the person are recognized in the charter of fundamental rights of the european union . in particular , the charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned . directive 2001 / 20 / ec contained an extensive set of rules for the protection of subjects . these rules should be upheld . regarding the rules concerning the determination of the legal representative of incapacitated persons and minors , those rules diverge in member states . it should therefore be left to member states to determine the legal representative of incapacitated persons and minors . ### the human dignity and right to the integrity of the person are recognized in the charter of fundamental rights of the european union . in particular , the charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned . directive 2001 / 20 / ec contained an extensive set of rules for the protection of subjects . these rules should be upheld . the rules concerning the determination of the legal representative of incapacitated persons and minors , the definition of incapacitated persons and vulnerable persons and the resulting provisions diverge in member states . it should therefore be left to member states to determine the legal representative of incapacitated persons and minors and , where applicable , to introduce more restrictive provisions at national level .


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


### in order to allow patients to assess possibilities to participate in a clinical trial , and to allow for effective supervision of a clinical trial by the member state concerned , the start of the clinical trial , the end of recruitment for the clinical trial and the end of the clinical trial should be notified . in accordance with international standards , the results of the clinical trial should be reported to the competent authorities within one year of the end of the clinical trial . ### in order to allow patients to assess possibilities to participate in a clinical trial , and to allow for effective supervision of a clinical trial by the member state concerned , the start of the clinical trial , the end of recruitment for the clinical trial and the end of the clinical trial should be notified .


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


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


### the investigational medicinal products are not authorised ; ### the investigational medicinal products have not been granted a marketing authorisation ;


### the investigational medicinal products are authorised ; ### the investigational medicinal products have been granted a marketing authorisation ;


### the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study ; ### the decision to prescribe the investigational medicinal product is determined by the research protocol ;


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


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


### ‘ incapacitated subject’ : a subject who is , for other reasons than the age of legal competence to give informed consent , legally incapable of giving informed consent according to the laws of the member state concerned ; ### ‘ incapacitated subject’ : a subject who is , legally or de facto , incapable of giving informed consent according to the laws of the member state concerned ;


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


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


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


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


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


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


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


### this chapter is without prejudice to the possibility for the sponsor to submit , following the refusal to grant an authorisation or the withdrawal of an application , an application for authorisation to any intended member state concerned . that application shall be considered as a new application for authorisation of another clinical trial . ### following the refusal to grant an authorisation or the withdrawal of an application , the sponsor may submit a new application for authorisation to any intended member state concerned . that application shall be considered as a new application for authorisation of another clinical trial . the new application shall , however , specify the grounds on which the original application was rejected or withdrawn and the changes made to the original version of the protocol .


### the application may be submitted only after the notification date of the initial authorisation decision . ### the application may be submitted only after the notification date of the initial authorisation decision by all member states concerned .


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


### where the reporting member state has not notified the sponsor according to points to of paragraph 2 within three days following receipt of the comments or of the completed application , the application shall be considered complete and , where the clinical trial is a low - intervention clinical trial , that it will remain a low - intervention clinical trial after its substantial modification . ### where the reporting member state has not notified the sponsor according to points to of paragraph 2 within three days following receipt of the comments or of the completed application , the application shall be considered complete and , where the clinical trial poses a minimal risk , that it will remain a minimal - risk clinical trial after its substantial modification .


### the anticipated therapeutic and public health benefits justify the foreseeable risks and inconveniences ; ### does not affect english version .


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


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


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


### the incapacitated subject has received adequate information in relation to his or her capacity for understanding regarding the trial , the risks and the benefits ; ### the incapacitated subject has received adequate information in relation to his or her capacity for understanding regarding the trial , the risks and the benefits from the investigator or his / her representative , in accordance with the legislation of the member state concerned ;


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


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


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


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


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


### due to the urgency of the situation , caused by a sudden life - threatening or other sudden serious medical condition , it is impossible to obtain prior informed consent from the subject and it is impossible to supply prior information to the subject ; ### due to the urgency of the situation , it is impossible to obtain prior informed consent from the subject and it is impossible to supply prior information to the subject ;


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


### regarding incapacitated subjects and minors , the informed consent referred to in paragraph 1 shall be obtained as soon as possible from the legal representative and the information referred to in paragraph 1 shall be given as soon as possible to the subject ; ### regarding incapacitated subjects and minors , the informed consent referred to in paragraph 1 shall be obtained as soon as possible from the legal representative and the information referred to in paragraph 1 shall be given as soon as possible to the subject by the investigator or his / her representative ;


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


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


### where a sponsor , due to a lack of resources , does not have the possibility to report to the electronic database referred to in article 36 , it may report to the member state where the suspected unexpected serious adverse reaction occurred . that member state shall report the suspected unexpected serious adverse reaction in accordance with paragraph 1 . ### where a sponsor is unable to report directly to the electronic database referred to in article 36 , it may report to the member state where the suspected unexpected serious adverse reaction occurred . that member state shall report the suspected unexpected serious adverse reaction in accordance with paragraph 1 .


### regarding non - authorised investigational medicinal products other than placebo , and authorised investigational medicinal products which , according to the protocol , are not used in accordance with the terms of the marketing authorisation , the sponsor shall submit annually by electronic means to the agency a report on the safety of each investigational medicinal product used in a clinical trial for which it is the sponsor . ### 1 regarding non - authorised investigational medicinal products other than placebo , and authorised investigational medicinal products which , according to the protocol , are not used in accordance with the terms of the marketing authorisation , the sponsor shall submit annually by electronic means to the agency a report on the safety of each investigational medicinal product used in one or more clinical trials for which it is the sponsor . where relevant , that report shall clearly identify any safety aspects concerning a specific gender or age group .


### regarding authorised medicinal products which , according to the protocol , are used in accordance with the terms of the marketing authorisation , the sponsor shall inform annually the marketing authorisation holder of all suspected serious adverse reactions . ### regarding authorised medicinal products which , according to the protocol , are used in accordance with the terms of the marketing authorisation , the sponsor shall inform annually the marketing authorisation holder of all suspected serious adverse reactions , including , where relevant , those reactions concerning a specific gender or age group .


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


### whether the clinical trial is a low - intervention clinical trial ; ### whether the clinical trial is a minimal - risk clinical trial ;


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


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


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


### the language of the information on the label shall be determined by the member state concerned . the medicinal product may be labelled in several languages . ### the information on the label shall appear in at least one of the official languages of the member state concerned , which is also a union official language . the medicinal product may be labelled in several languages .


### for clinical trials other than low - intervention clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator . ### for clinical trials other than low - intervention clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator , including by means of insurance , is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator . where damage compensation is provided by means of insurance , a sponsor may use a single insurance policy to cover one or more clinical trials within the same member state .


### member states shall provide for a national indemnification mechanism for compensating damage as referred to in article 72 . ### for clinical trials which , for objective reasons , were not intended , at the time of submission of the application for authorisation , to be used for obtaining a marketing authorisation for a medicinal product , member states shall provide for a national indemnification mechanism for compensating damage as referred to in article 72 . the use of the national indemnification system shall be free of charge or subject to a nominal fee .


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


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


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


### if elderly persons or women are excluded from the clinical trial , an explanation and justification for these exclusion criteria ; especially when subjects are incapable of giving informed consent ; ### if patients from a specific gender or age group are excluded from the clinical trial , an explanation and justification for these exclusion criteria ;


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


### the subject identification number / treatment number and , where relevant , the visit number ; ### either the subject identification number or treatment number and , where relevant , the visit number ;


### any of the particulars listed in sections 1 , 2 , and 3 may be omitted and replaced by other means provided that subject safety and the reliability and robustness of data are not compromised . this shall be justified in the protocol . ### any of the particulars listed in sections 1 , 2 , and 3 may be omitted and replaced by other means provided that subject safety and the reliability and robustness of data are not compromised . this shall be justified in the protocol or in a separate document .


### a common set of rights to third country workers legally residing in a member state . ### a common set of rights to third country workers legally residing in a member state , irrespective of the purposes for which they were initially admitted to the territory of that member state , based on equal treatment with nationals of that member state .


### ' single permit ' means any authorisation issued by the authorities of a member state allowing a third - country national to stay and work legally in its territory ; ### ' single permit ' means a residence permit issued by the authorities of a member state allowing a third - country national to stay legally in its territory in order to work there ;


### ' single application procedure ' means any procedure leading , on the basis of one application for the authorisation of a third - country national ' s residence and work in the territory of a member state , to a decision on the single permit for that third - country national . ### ' single application procedure ' means any procedure leading , on the basis of a single application made by a third country national or by his or her employer for the authorisation of residence and work in the territory of a member state , to a decision giving a ruling on that third - country national’s application for the single permit .


### to third - country nationals seeking to reside and work in the territory of a member state , and ### to third - country nationals seeking to reside in the territory of a member state in order to work there ,


### who are family members of union citizens who have exercised , or are exercising , their right to free movement within the community ; ### who are family members of union citizens who have exercised , or are exercising , their right to free movement within the community in conformity with directive 2004 / 38 / ec of the european parliament and of the council of 29 april 2004 on the right of citizens of the union and their family members to move and reside freely within the territory of the member states1 ; __________ 1 oj l 229 , 29 . 6 . 2004 , p . 1 .


### entering a member state under commitments contained in an international agreement facilitating the entry and temporary stay of certain categories of trade and investment - related natural persons in particular to intra - corporate transferees , contractual service suppliers and graduate trainees under the european community ' s gats commitments ; ### who enter a member state under commitments contained in an international agreement facilitating the entry and temporary stay of certain categories of trade and investment - related natural persons ;


### member states shall examine the application and adopt a decision to grant , to modify or to renew the single permit if the applicant fulfils the requirements specified in national law . the decision granting , modifying or renewing the single permit shall constitute one combined title encompassing both residence and work permit within one administrative act . ### member states shall examine the application and adopt a decision to grant , to modify or to renew the single permit if the applicant fulfils the requirements specified by national or union law . the decision granting , modifying or renewing the single permit shall constitute a single administrative act combining a residence permit and a work permit .


### the designated authority shall notify the decision to the applicant in writing in accordance with the notification procedures laid down in the relevant legislation . ### the relevant authority shall notify the decision to the applicant in writing in accordance with the notification procedures laid down in the relevant provisions of national law .


### if the information supporting the application is inadequate , the designated authority shall notify the applicant of the additional information that is required . the period referred to in paragraph 2 shall be suspended until the authorities have received the additional information required . ### if the information or documents supporting the application are inadequate , the designated authority shall notify the applicant of the additional information or documents that are required and may set a reasonable deadline to provide them . the period referred to in paragraph 2 shall be suspended until the authorities have received the additional information or documents required .


### member states shall issue the single permit using the uniform format as laid down in regulation no 1030 / 2002 and shall indicate the information relating to the permission to work in accordance with its annex , a , 7 . 5 - 9 . ### member states shall issue the single permit using the uniform format as laid down in regulation no 1030 / 2002 and shall indicate information relating to the permission to work in accordance with its annex , a , 7 . 5 - 9 . member states may issue an additional document to the single permit holding all relevant information specific to the right to work . this additional document must be optional and purely informative in nature . it shall have no effect on the validity of the single permit . this additional document may be updated when the single permit holder ' s labour market situation changes .


### member states shall not issue any additional permits , in particular work permits of any kind , as proof of the access given to the labour market . ### when issuing residence permits in accordance with regulation no 1030 / 2002 , member states shall not issue any additional permits as proof of authorisation to access the labour market .


### reasons shall be given in the written notification for a decision rejecting the application , not granting , not modifying or not renewing , suspending or withdrawing the single permit on the basis of criteria specified in national or community law . ### reasons shall be given in the written notification for a decision rejecting the application for a single permit , not modifying or not renewing the single permit , or withdrawing the single permit on the basis of criteria provided for by national or union law .


### member states shall take the necessary measures to inform the third - country national and the future employer on all the documentary evidence they need in order to complete the application . ### member states shall provide upon request adequate information to the third - country national and the future employer on the documents required to make a complete application .


### member states may request applicants to pay fees for handling applications in accordance with this directive . the level of fees must be proportionate and may be based on the principle of the service actually provided . ### member states may request applicants to pay fees . where appropriate , these fees are collected for handling applications in accordance with this directive . in such cases , the level of fees must be proportionate and be based on the principle of the service actually provided .


### during the period of its validity , the single permit shall entitle its holder as a minimum to : ### where a single permit has been issued in accordance with national law and during its period of validity , it shall authorise its holder as a minimum to :


### enter , re - enter and stay in the territory of the member state issuing the single permit ; ### enter and stay in the territory of the member state issuing the single permit , provided that he or she meets all admission requirements in accordance with national law ;


### exercise of the activities authorised under the single permit ; ### exercise of the specific professional activity authorised under the single permit in accordance with national law ;


### be informed about his / her own rights linked to the permit conferred by this directive or by national legislation . ### be informed about his / her own rights linked to the permit conferred by this directive and / or by national legislation .


### each member state shall ensure that a regularly updated set of information , concerning the conditions of third - country nationals ' entry into and stay in its territory for the purpose of work , is made available to the general public . ### each member state shall make available to the general public a regularly updated set of information concerning the conditions of third - country nationals ' entry into and stay in its territory in order to work there .


### periodically , and for the first time no later than three years after the date specified in article 16 , 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 deemed necessary . ### periodically , and for the first time no later than three years after the date specified in article 16 , the commission shall present a report to the european parliament and the council on the application of this directive in the member states and shall propose any amendments it deems necessary .


### annually , and for the first time no later than 1 april of [ one year after the date of transposition of this directive ] , member states shall communicate to the commission and the other member states through the network established by decision 2006 / 688 / ec statistics on the volumes of third - country nationals who have been granted , renewed or withdrawn a single permit during the previous calendar year , indicating their nationality and their occupation . statistics on admitted family members shall be communicated likewise . ### annually , and for the first time no later than 1 july [ one year after the date of transposition of this directive ] , member states shall communicate to the commission statistics on the volumes of third - country nationals who have been granted a single permit during the previous calendar year , in accordance with regulation no 862 / 2007 of the european parliament and of the council on community statistics on migration and international protection1 . __________ 1 oj l 199 , 31 . 7 . 2007 , p . 1 .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by &#8230 ; . . at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ two years after the entry into force of this directive ] at the latest . they shall forthwith communicate to the commission the text of those provisions .


### member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive . ### member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field governed by this directive .


### the power to adopt delegated acts referred to in articles 4 and 6 shall be conferred on the commission for an indeterminate period of time from . . ### the power to adopt delegated acts referred to in article 4 shall be conferred on the commission for a period of five years from . . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council oppose such extension no later than three months before the end of each period .


### the delegation of power referred to in articles 4 and 6 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication in the official journal of the european union or at a later date specified therein . it shall not affect the validity of the delegated acts already in force . ### the delegation of powers referred to in article 4 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### in view of the union ' s objectives to further reduce greenhouse gas emissions and the significant contribution that road transport fuels make to those emissions , article 7a of directive 98 / 70 / ec relating to the quality of petrol and diesel fuels and amending council directive 93 / 12 / ec requires fuel suppliers to reduce by at least 6% by 31 december 2020 the life cycle greenhouse gas emissions per unit of energy of fuels used in the union by road vehicles , non - road mobile machinery , agricultural and forestry tractors and recreational craft when not at sea . the blending of biofuels is one of the methods available for fossil fuel suppliers to reduce the greenhouse gas intensity of the fossil fuels supplied . ### in view of the union ' s objectives to further reduce greenhouse gas emissions and the significant contribution that road transport fuels make to those emissions , article 7a of directive 98 / 70 / ec relating to the quality of petrol and diesel fuels and amending council directive 93 / 12 / ec requires fuel suppliers to reduce by at least 6% by 31 december 2020 the life cycle greenhouse gas emissions per unit of energy of fuels used in the union by road vehicles , non - road mobile machinery , agricultural and forestry tractors and recreational craft when not at sea . the target of directive 2009 / 28 / ec on the promotion of the use of energy from renewable sources to ensure that the share of energy from renewable energy sources in all forms of transport in 2020 is at least 10% of their final energy consumption , should be consistent with article 7a of directive 98 / 70 / ec in order to avoid any market distortion . the blending of biofuels is one of the methods available for fossil fuel suppliers to reduce the greenhouse gas intensity of the fossil fuels supplied .


### article 17 of directive 2009 / 28 / ec establishes sustainability criteria that biofuels and bioliquids need to comply with in order to be counted towards the targets in the directive and to qualify for inclusion in public support schemes . these criteria include requirements on the minimum greenhouse gas emission savings that biofuels and bioliquids need to achieve compared to fossil fuels . identical sustainability criteria are established for biofuels under article 7b of directive 98 / 70 / ec . ### article 17 of directive 2009 / 28 / ec establishes sustainability criteria that biofuels and bioliquids need to comply with in order to be counted towards the targets in the directive and to qualify for inclusion in public support schemes . these criteria include requirements concerning the protection of biodiversity - rich land and land with high carbon stock . these criteria also include requirements on the minimum greenhouse gas emission savings that biofuels and bioliquids need to achieve compared to fossil fuels . identical sustainability criteria are established for biofuels under article 7b of directive 98 / 70 / ec .


### where pasture or agricultural land previously destined for the food , feed and fibre markets is diverted to biofuel production , the non - fuel demand will still need to be satisfied either through intensification of current production or by bringing non - agricultural land into production elsewhere . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emissions . directives 98 / 70 / ec and 2009 / 28 / ec should therefore include provisions to address indirect land use change given that current biofuels are mainly produced from crops grown on existing agricultural land . ### where pasture or agricultural land previously destined for food , feed and fibre markets is diverted to biofuel production , the non - fuel demand will still need to be satisfied either through intensification of current production or by bringing non - agricultural land into production in elsewhere . in the former case , the excess market outlet created by biofuel producers may result in higher yields , as acknowledged by the ifpri report1 and the impact assessment of the commission2 . biofuels produced from biomass which is a result of higher yield do not require additional land and therefore have no indirect land - use change effects . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emission . ________________________ 1 international food policy research institute : assessing the land use change consequences of european biofuel policies . final report , october 2011 2 european commission : impact assessment - accompanying the document proposal for a directive of the european parliament and the council amending directive 98 / 70 / ec and directive 2009 / 28 / ec . swd 343 final .


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities by means of greater incentives . establishing progressively more ambitious mandatory targets for advanced biofuels will send a clear signal of support for them at union level . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework , together with biofuels from cereals and other starch rich crops , sugars and oil crops .


### in order to ensure the long - term competitiveness of bio - based industrial sectors , and in line with the 2012 communication ' innovating for sustainable growth : a bioeconomy for europe ' and the roadmap to a resource efficient europe promoting integrated and diversified biorefineries across europe , enhanced incentives under directive 2009 / 28 / ec should be set in a way that gives preference to the use of biomass feedstocks that do not have a high economic value for other uses than biofuels . ### in order to ensure the long - term competitiveness and investment security of bio - based industrial sectors , and to provide a stable regulatory environment for existing and new investments , in line with the 2012 communication ' innovating for sustainable growth : a bioeconomy for europe ' and the roadmap to a resource efficient europe promoting integrated and diversified biorefineries across europe , enhanced incentives under directive 2009 / 28 / ec should be set in a way that promotes resource - efficient use of biomass feedstocks and gives preference to second - generation biofuels . commitment should be encouraged by ensuring that the provisions of directive 2009 / 28 / ec will be maintained in the subsequent years after 2020 .


### the objectives of this directive , to ensure a single market for fuel for road transport and non - road mobile machinery and ensure respect for minimium levels of environmental protection from use of this fuel , cannot be sufficiently achieved by the member states and can therefore be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the functioning of the european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve those objectives . ### the objectives of this directive should ensure a single market for fuel for the transport sector and ensure that minimum levels of environmental protection are respected and adverse effects on food security and land use rights are avoided in connection with the production and use of such fuel . since these objectives cannot be sufficiently achieved by the member states and can therefore be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on the functioning of the european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve those objectives .


### ' 2 . the greenhouse gas emission saving from the use of biofuels and bioliquids taken into account for the purposes referred to in paragraph 1 shall be at least 60 % for biofuels and bioliquids produced in installations starting operation after 1st july 2014 . an installation is “in operation” if the physical production of biofuels or bioliquids has taken place . in the case of installations that were in operation on or before 1st of july 2014 , for the purposes referred to in paragraph 1 , biofuels and bioliquids shall achieve a greenhouse gas emission saving of at least 35% until 31 december 2017 and at least 50% from 1 january 2018 . the greenhouse gas emission saving from the use of biofuels and bioliquids shall be calculated in accordance with article 19 . ' ### ' 2 . the greenhouse gas emission saving from the use of biofuels and bioliquids taken into account for the purposes referred to in paragraph 1 shall be at least 35 % . with effect from 1 january 2017 , the greenhouse gas emission saving from the use of biofuels and bioliquids taken into account for the purposes referred to paragraph 1 shall be at least 50 % . from 1 january 2018 that greenhouse gas emission saving shall be at least 60 % for biofuels and bioliquids produced in installations in which production started on or after 1 january 2017 . the greenhouse gas emission saving from the use of biofuels and bioliquids shall be calculated in accordance with article 19 . '