### –stipulate the conditions of the management of funds entrusted to the european space agency , particularly with regard to public procurement , management procedures , the expected results measured by performance indicators , applicable measures in the event of deficient or fraudulent implementation of the contracts in terms of costs , schedule and results , as well as the communication strategy and the rules regarding ownership of all tangible and intangible assets ; these conditions shall be in conformity with titles iii and v of this regulation and the financial regulation ; ### –stipulate the conditions of the management of funds entrusted to the european space agency , including application of the union public procurement , when it is done in the name and on behalf of the commission or the agency , management procedures , the expected results measured by performance indicators , applicable measures in the event of deficient or fraudulent implementation of the contracts in terms of costs , schedule and results , as well as the communication strategy and the rules regarding ownership of all tangible and intangible assets ; these conditions shall be in conformity with titles iii and v of this regulation and the financial regulation ;


### when necessary for the smooth functioning of the programme and the smooth provision of the services provided by the programme ' s components , the commission shall , by means of implementing acts , determine the technical and operational specifications required for the implementation of and evolution of those components and of the services they provide after having consulted users and all the other relevant stakeholders . when determining those technical and operational specifications , the commission shall avoid reducing the general security level and to meet a backward compatibility imperative . those implementing acts shall be adopted in accordance with the examination procedure referred to in article107 . ### when necessary for the smooth functioning of the programme and the smooth provision of the services provided by the programme ' s components , the commission shall , by means of delegated acts , determine high - level requirements , for the implementation of and evolution of those components and of the services they provide after having consulted users , downstream players , and all the other relevant stakeholders . when determining those high - level requirements , the commission shall avoid reducing the general security level and to meet a backward compatibility imperative . those delegated acts shall be adopted in accordance with the examination procedure referred to in article107 .


### –clearly define the responsibilities and obligations of the european space agency with regard to the programme ; ### –clearly define the responsibilities and obligations of the commission , the agency and the european space agency with regard to the programme ;


### compatibility and interoperability ### compatibility , interoperability and standardisation


### member states shall collectively ensure that the share of energy from renewable sources in the union ' s gross final consumption of energy in 2030 is at least 27% . ### member states shall collectively ensure that the share of energy from renewable sources in the union ' s gross final consumption of energy in 2030 is at least 45% .


### subject to state aid rules , in order to reach the union target set in article 3 , member states may apply support schemes . support schemes for electricity from renewable sources shall be designed so as to avoid unnecessary distortions of electricity markets and ensure that producers take into account the supply and demand of electricity as well as possible grid constraints . ### in order to meet the union target set in article 3 , member states may apply support schemes . support schemes for electricity from renewable sources shall be designed primarily to help renewable self - consumers , renewable energy communities and to address energy poverty of low - income households as well as to incentivise producers to take into account the supply and demand of electricity as well as possible grid constraints . member states shall also avoid any retroactive change to renewable energy support schemes in order to ensure clear and fair legal conditions and the maintenance of a stable and transparent policy framework for the development of renewable energy projects . member states shall also remove support schemes and measures that directly or indirectly favour the use of polluting sources , such as fossil fuel and nuclear energy .


### support for electricity from renewable sources shall be designed so as to integrate electricity from renewable sources in the electricity market and ensure that renewable energy producers are responding to market price signals and maximise their market revenues . ### support for electricity from renewable sources shall be designed so as to integrate electricity from renewable sources in the electricity market and ensure the viability of investment projects in renewable sources as well as investment in increasingly efficient and sustainable technologies .


### in particular , increasing technological improvements , incentives for the use and expansion of public transport , the use of energy efficiency technologies and the promotion of the use of energy from renewable sources in the electricity , heating and cooling sectors as well as in the transport sector are very effective tools , together with energy efficiency measures , for reducing greenhouse gas emissions in the union and the union ' s dependence on imported gas and oil . ### in particular , increasing technological improvements , incentives for the use and expansion of public transport , the use of energy efficiency technologies and the promotion of the use of energy from renewable sources in the electricity , heating and cooling sectors as well as in the transport sector are very effective tools , together with energy efficiency measures , for reducing greenhouse gas emissions in the union and the union ' s dependence on imported coal , gas and oil .


### subject to state aid rules , in order to reach the union target set in article 3 , member states may apply support schemes . support schemes for electricity from renewable sources shall be designed so as to avoid unnecessary distortions of electricity markets and ensure that producers take into account the supply and demand of electricity as well as possible grid constraints . ### in order to meet the union target set in article 3 , member states may apply support schemes . support schemes for electricity from renewable sources shall be designed so as to avoid unnecessary distortions of electricity markets .


### ' learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; it may be accompanied by measures such as language support and training and / or be complemented by online learning and virtual cooperation . in some specific cases , it may take the form of learning through the use of information technology and communications tools ; ### ‘ learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; learning mobility activities are fully accessible , inclusive and adequately funded and shall accompanied by measures such as language support , including for national sign languages , and training and / or be complemented by accessible online learning of and virtual cooperation regarding all eu spoken and signed languages . in some specific cases , it may take the form of learning through the use of accessible information technology and accessible communications tools ;


### member states should endeavour to adopt all appropriate measures to remove legal and administrative obstacles to the proper functioning of the programme . this includes resolving , where possible , and without prejudice to union law on the entry and residence of third - country nationals issues that create difficulties in obtaining visas and residence permits . in line with directive 2016 / 801 of the european parliament and of the council39 , member states are encouraged to establish fast - track admission procedures . _________________ 39 directive 2016 / 801 of the european parliament and of the council of 11 may 2016 on the conditions of entry and residence of third - country nationals for the purposes of research , studies , training , voluntary service , pupil exchange schemes or educational projects and au pairing . ### member states should endeavour to adopt all appropriate measures to remove legal and administrative obstacles to the proper functioning of the programme . this includes exempting study grants from taxation and social levies , as well as resolving , where possible , and without prejudice to union law on the entry and residence of third - country nationals issues that create difficulties in obtaining visas and residence permits . in line with directive 2016 / 801 of the european parliament and of the council39 , member states are encouraged to establish fast - track admission procedures . _________________ 39 directive 2016 / 801 of the european parliament and of the council of 11 may 2016 on the conditions of entry and residence of third - country nationals for the purposes of research , studies , training , voluntary service , pupil exchange schemes or educational projects and au pairing .


### ' learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; it may be accompanied by measures such as language support and training and / or be complemented by online learning and virtual cooperation . in some specific cases , it may take the form of learning through the use of information technology and communications tools ; ### ' learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; it may take the form of traineeships , apprenticeships , youth exchanges , teaching or participation in a professional development activity ; it may be accompanied by measures such as language support , including sign languages , and training and / or be complemented by accessible online learning and virtual cooperation . in some specific cases , additional to physical mobility , it may take the form of learning through the use of accessible and / or specially adapted information technology and communications tools ;


### the programme should reinforce existing learning mobility opportunities , notably in those sectors where the programme could have the biggest efficiency gains , to broaden its reach and meet the high unmet demand . this should be done notably by increasing and facilitating mobility activities for higher education students , school pupils and learners in vocational education and training . mobility of low - skilled adult learners should be embedded in partnerships for cooperation . mobility opportunities for youth participating in non - formal learning activities should also be extended to reach more young people . mobility of staff in education , training , youth and sport should also be reinforced , considering its leverage effect . in line with the vision of a true european education area , the programme should also boost mobility and exchanges and promote student participation in educational and cultural activities by supporting digitalisation of processes , such as the european student card . this initiative can be an important step in making mobility for all a reality first by enabling higher education institutions to send and receive more exchange students while still enhancing quality in student mobility and also by facilitating students ' access to various services before arriving at the institution abroad . ### the programme should reinforce existing learning mobility opportunities , notably in those sectors where the programme could have the biggest efficiency gains , to broaden its reach and meet the high unmet demand . this should be done notably by increasing and facilitating mobility activities for under - represented groups , especially young people not in formal education and learners in vocational education and training , as well as school pupils . higher education students could continue to be targeted at the existing high level . mobility of learners with fewer opportunities should be embedded in partnerships for cooperation . mobility opportunities for youth participating in non - formal or informal learning activities should also be fundamentally extended to reach more young people , especially newcomers , those with fewer opportunities and hard - to - reach population groups . mobility of staff in education , training , youth and sport should also be reinforced , considering its leverage effect . in line with the vision of a true european education area , the programme should also boost mobility and exchanges and promote student participation in educational and cultural activities by supporting digitalisation of processes , such as the european student card . this initiative can be an important step in making mobility for all a reality first by enabling higher education institutions to send and receive more exchange students while still enhancing quality in student mobility and also by facilitating students ' access to various services before arriving at the institution abroad .


### the commission shall communicate the conclusions of the evaluations accompanied by its observations to the european parliament , the council , the european economic and social committee and the committee of the regions . ### the commission shall submit evaluation reports to the european parliament , the council , the european economic and social committee and the committee of the regions .


### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible learning mobility formats , and by fostering participation of small organisations , in particular newcomers and community - based grassroots organisations that work directly with disadvantaged learners of all ages . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted to reach more participants , in particular those with fewer opportunities and those for whom moving physically to a country other than their country of residence would be an obstacle . ### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible mobility formats , simplified administrative procedures , targeting of beneficiary organisations working with groups under - represented in erasmus + , youth - friendly and clear information and communication about the programme and by fostering and supporting the participation of local organisations and small organisations , in particular newcomers , youth organisations , volunteer - based and community - based grassroots organisations that work directly with learners with fewer opportunities of all ages , and organisations working with and supporting people from marginalised groups , such as people with an ethnic minority background , people with disabilities and lgbti people . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted to reach more participants and complement the mobility experience .


### the 2010 bruges communiqué called for support of vocational excellence for smart and sustainable growth . the 2017 communication on strengthening innovation in europe ' s regions points to linking vocational education and training to innovation systems , as part of smart specialisation strategies at regional level . the programme should provide the means to respond to these calls and support the development of transnational platforms of centres of vocational excellence closely integrated in local and regional strategies for growth , innovation and competitiveness . these centres of excellence should act as drivers of quality vocational skills in a context of sectorial challenges , while supporting overall structural changes and socio - economic policies in the union . ### the 2010 bruges communiqué called for support of vocational excellence for smart and sustainable growth . the 2017 communication on strengthening innovation in europe ' s regions points to linking vocational education and training to innovation systems , as part of smart specialisation strategies at regional level . the programme should provide the means to respond to these calls and support the development of transnational platforms of centres of vocational excellence closely integrated in local and regional strategies for sustainable development , social inclusion , growth , innovation and competitiveness . these centres of excellence should act as drivers of quality vocational skills in a context of sectorial challenges , while supporting overall structural changes and socio - economic policies in the union .


### policy dialogue and cooperation with relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the eu youth dialogue as well as support to the european youth forum ; ### policy dialogue , cooperation with and support for relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the structured dialogue as well as structural support to the european youth forum and other european youth organisations ;


### the programme should also enhance the learning of languages , in particular through widened use of online tools , as e - learning offers additional advantages for language learning in terms of access and flexibility . ### the programme should also enhance the learning of languages , including on - site language courses and widened use of online tools , as e - learning offers additional advantages for language learning in terms of access and flexibility . the erasmus online linguistic support should be tailored to the specific needs of participants of the programme and open to everybody .


### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible learning mobility formats , and by fostering participation of small organisations , in particular newcomers and community - based grassroots organisations that work directly with disadvantaged learners of all ages . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted to reach more participants , in particular those with fewer opportunities and those for whom moving physically to a country other than their country of residence would be an obstacle . ### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible learning mobility formats , simplified administrative procedures , youth - friendly and clear information and communication about the programme and by fostering and supporting the participation of local organisations , in particular newcomers and volunteer - based grassroots organisations that work directly with disadvantaged learners of all ages . simplified procedures , such as accreditation through compliance with quality charters , should be put in place to allow experienced mobility providers to support institutions and organisations with limited resources and capacities , with a view to enhancing outreach , inclusion and quality of learning mobility . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted as a complementary aspect of a physical mobility to reach more participants , in particular those with fewer opportunities and those for whom moving physically to a country other than their country of residence would be an obstacle .


### appropriate outreach , publicity and dissemination of the opportunities and results of the actions supported by the programme should be ensured at european , national and local level . the outreach , publicity and dissemination activities should rely on all the implementing bodies of the programme , including , when relevant , with the support of other key stakeholders . ### appropriate outreach , publicity and dissemination of the opportunities and results of the actions supported by the programme should be ensured at european , national and local level . the outreach , publicity and dissemination activities should rely on all the implementing bodies of the programme , including , when applicable , with the support of other relevant stakeholders .


### on 16 september 2016 in bratislava , leaders of twenty - seven member states stressed their determination to provide better opportunities for youth . in the rome declaration signed on 25 march 2017 , leaders of twenty - seven member states and of the european council , the european parliament and the european commission pledged to work towards a union where young people receive the best education and training and can study and find jobs across the union ; a union which preserves our cultural heritage and promotes cultural diversity . ### on 16 september 2016 in bratislava , leaders of twenty - seven member states stressed their determination to provide better opportunities for youth . in the rome declaration signed on 25 march 2017 , leaders of twenty - seven member states and of the european council , the european parliament and the european commission pledged to work towards a union where young people receive the best education and training and can work , learn , exchange , study and find jobs across the union ; a union which preserves our cultural heritage and promotes solidarity , democracy and cultural diversity .


### the programme should also enhance the learning of languages , in particular through widened use of online tools , as e - learning offers additional advantages for language learning in terms of access and flexibility . ### the programme should also enhance the learning of languages , including sign languages , minority and neighbouring languages , in particular through widened use of accessible online tools , as well as traditional classroom language teaching , in order to overcome one of the students ' mobility barriers .


### ' learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; it may be accompanied by measures such as language support and training and / or be complemented by online learning and virtual cooperation . in some specific cases , it may take the form of learning through the use of information technology and communications tools ; ### ‘ learning mobility ' means moving physically to country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; it is fully accessible , inclusive and adequately funded and shall be accompanied by measures such as language support , including for national sign languages , and training and / or be complemented by accessible online learning of and virtual cooperation regarding all eu spoken and signed languages . in some specific cases , it may take the form of learning through the use of accessible information technology and accessible communications tools ;


### in its communication on ' a modern budget for a union that protects , empowers and defends - the multiannual financial framework for 2021 - 2027 ' 26 adopted on 2 may 2018 , the commission called for a stronger “youth” focus in the next financial framework , notably by more than doubling the size of the 2014 - 2020 erasmus + programme , one of the union’s most visible success stories . the focus of the new programme should be on inclusiveness , and to reach more young people with fewer opportunities . this should allow more young people to move to another country to learn or work . ### in its communication on ' a modern budget for a union that protects , empowers and defends - the multiannual financial framework for 2021 - 2027 ' 26adopted on 2 may 2018 , the commission called for a stronger “youth” focus in the next financial framework , notably by more than doubling the size of the 2014 - 2020 erasmus + programme , one of the union’s most visible success stories . in its resolution of 14 march 2018 on the next multiannual financial framework , the european parliament called for the programme’s budget to be tripled on order to maintain its success , achieve its goals including increased inclusiveness , as well as reduce its shortcomings and barriers to participation . the focus of the new programme should be on inclusiveness , and to reach more young people with fewer opportunities . this should allow more young people to move to another country to learn or work .


### the programme should be coherent with the new european union youth strategy30 , the framework for european cooperation in the youth field for 2019 - 2027 , based on the commission ' s communication of 22 may 2018 on ' engaging , connecting and empowering young people : a new eu youth strategy ' 31 . _________________ 30 [ reference - to be adopted by the council by the end of 2018 ] . 31 com 269 final . ### the programme should be coherent with the new european union youth strategy30 , the framework for european cooperation in the youth field for 2019 - 2027 , based on the commission ' s communication of 22 may 2018 on ' engaging , connecting and empowering young people : a new eu youth strategy’31 , including the strategy’s aspirations to support quality youth work and non - formal and informal learning . this entails attention to mobility , inclusiveness , capacity - building , innovation and recognition of youth work and non - formal or informal learning within the context of the 2012 council recommendation on the validation of non - formal and informal learning . this also calls for the promotion of quality tools and systems that should be used in the training of youth workers and that correspond to the changing circumstances of young people’s lives . these should be embedded in a broader quality approach to empower youth organisations . _________________ 30 [ reference - to be adopted by the council by the end of 2018 ] . 31 com 269 final .


### as a way to ensure cooperation with other union instruments and support to other policies of the union , mobility opportunities should be offered to people in various sectors of activity , such as the public sector , agriculture and enterprise , to have a learning experience abroad allowing them , at any stage of their life , to grow and develop professionally but also personally , in particular by developing an awareness of their european identity and an understanding of european cultural diversity . the programme should offer an entry point for union transnational mobility schemes with a strong learning dimension , simplifying the offer of such schemes for beneficiaries and those taking part in these activities . the scaling - up of erasmus projects should be facilitated ; specific measures should be put in place to help promoters of erasmus projects to apply for grants or develop synergies through the support of the european structural and investment funds and the programmes relating to migration , security , justice and citizenship , health and culture . ### as a way to ensure cooperation with other union instruments and support to other policies of the union , mobility opportunities should be offered to people in various sectors of activity , such as the public sector , agriculture and enterprise , to have a learning experience abroad allowing them , at any stage of their life , to grow and develop professionally but also personally , in particular by developing an awareness and an understanding of cultural diversity . the programme should offer an entry point for union transnational mobility schemes with a strong learning dimension , simplifying the offer of such schemes for beneficiaries and those taking part in these activities . the scaling - up of erasmus projects should be facilitated ; specific measures should be put in place to help promoters of erasmus projects to apply for grants or develop synergies through the support of the european structural and investment funds and the programmes relating to migration , security , justice and citizenship , health and culture .


### synergies with horizon europe should ensure that combined resources from the programme and the horizon europe programme33 are used to support activities dedicated to strengthening and modernising european higher education institutions . horizon europe will , where appropriate , complement the programme ' s support for the european universities initiative , in particular its research dimension as part of developing new joint and integrated long term and sustainable strategies on education , research and innovation . synergies with horizon europe will help to foster the integration of education and research in higher education institutions . ### synergies with horizon europe should ensure that combined resources from the programme and the horizon europe programme33 are used to support activities dedicated to strengthening and modernising european higher education institutions . horizon europe will , where appropriate , complement the programme ' s support for the european universities initiative , in particular its research dimension as part of developing new joint and integrated long term and sustainable strategies on education , research and innovation . synergies with horizon europe will help to foster the integration of education and research in higher education institutions . the programming of synergies should be coherent and synchronised in all relevant programmes . the simplified procedures for application should be applied for beneficiaries at the implementation level .


### ' learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; it may be accompanied by measures such as language support and training and / or be complemented by online learning and virtual cooperation . in some specific cases , it may take the form of learning through the use of information technology and communications tools ; ### ' learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training or non - formal or informal learning , including teaching or professional development activities . it may be accompanied by measures such as language support and training and / or be complemented by online learning and virtual cooperation . in some specific cases , it may take the form of learning through the use of information technology and communication tools , but not to the exclusion of physical mobility .


### not for profit sport events aiming at further developing the european dimension of sport . ### not for profit and grassroots sport events aiming at further developing the european dimension of sport .


### policy dialogue and cooperation with relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the eu youth dialogue as well as support to the european youth forum ; ### policy dialogue , support and cooperation with relevant key stakeholders , including union - wide networks , european non - governmental organisations , and international organisations in the field of youth , the eu youth dialogue as well as support to the european youth forum ;


### have premises in which it keeps its core business documents , in particular its commercial contracts , accounting documents , personnel management documents , labour contracts , documents containing data relating to driving time and rest and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this regulation ; ; ### have premises in which it keeps its core business documents , in particular its commercial contracts , accounting documents , personnel management documents , labour contracts , documents containing data relating to posted workers , driving time and rest and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this regulation ; ;


### applications shall be submitted electronically . for applications submitted in accordance with the centralised marketing authorisation procedure , the formats made available by the agency shall be used . ### applications shall be submitted electronically using a single digital portal . for all applications submitted under this regulation , the formats made available by the agency shall be used .


### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care , and only in the amount required for the treatment concerned . ### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail prescription only products only for animals which are under their immediate care , subject to a veterinary diagnosis based on clinical examination of the animals concerned or , exceptionally , frequent monitoring of its health , and only in the amount required for the treatment concerned .


### in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans , it may be necessary to reserve those antimicrobials for humans only . therefore it should be possible to decide that certain antimicrobials , following the scientific recommendations of the agency , should not be available on the market in the veterinary sector . ### in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans , it may be necessary to reserve those antimicrobials for humans only . therefore it should be possible to decide that certain antimicrobials , following the scientific recommendations of the agency , should not be available on the market in the veterinary sector ; the decisive criteria should be that the antibiotic is used in human medicine when other antibiotic therapies are no longer effective and that there is evidence that resistance in human beings cannot be excluded by use in animals .


### ' verification that the third country national is in possession of a document valid for crossing the border and that the document is accompanied , where applicable , by the requisite visa or residence permit . verification of the document shall include the consultation of relevant databases , in particular the schengen information system ; the interpol database on stolen and lost travel documents ; and national databases containing information on stolen , misappropriated , lost and invalidated travel documents . [ 23 ] except for third country nationals whose exit is subject to a registration in the ees , if the travel document contains a facial image recorded in the electronic storage medium and if the facial image recorded in the chip can be legally and technically accessed , this verification shall include the verification of the facial image recorded in the chip , by comparing electronically this image with the live facial image of the concerned third country national . ” _________________ 23 this conditions is foreseen in the proposal 670 / 2 ) amending article 7 of the sbc and will be part of the compulsory checks for persons enjoying the right of free movement . depending on the final version of the text adopted , this sentence may require adjustments . ### ' verification that the third country national is in possession of a document valid for crossing the border and that the document is accompanied , where applicable , by the requisite visa or residence permit . verification of the document shall include the consultation of relevant databases , in particular the schengen information system ; the interpol database on stolen and lost travel documents ; and national databases containing information on stolen , misappropriated , lost and invalidated travel documents .


### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . in exceptional cases the court may decide that a hearing should be held publicly after it has taken due account of the best interests of the child . ### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . only in exceptional cases should the court be allowed , taking into account the best interests of the child , to hold a hearing in public . member states should seek to protect the privacy of children in connection with criminal proceedings and their outcome , having regard also to breaches that might be committed through the media , including the internet , and to facilitate the re - integration into society of children involved in criminal proceedings , to that end taking steps to prevent discrimination and marginalisation .


### in case of deprivation of liberty of a child , member states shall ensure that the child has access to a medical examination with a view , in particular , to assessing the general mental and physical condition of the child with the aim to determine the capacity of the child to face questioning or other investigative or evidence gathering acts or any measures taken or envisaged against the child . ### member states shall ensure , when a child has been deprived of liberty or when the proceedings so require , that the child has access without delay to a medical examination with a view , in particular , to assessing the general mental and physical condition of the child with the aim of determining the capacity of the child to face questioning or other investigative or evidence gathering acts or any measures taken or envisaged against the child .


### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . in exceptional cases the court may decide that a hearing should be held publicly after it has taken due account of the best interests of the child . ### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . only in exceptional cases , if in the best interests of the child , should the court be allowed to hold a hearing in public . member states should seek to protect the privacy of children in connection with criminal proceedings and their outcome , having regard also to breaches that might be committed through the media , including the internet . member states should facilitate the re - integration into society of children involved in criminal proceedings , and should actively take steps in order to prevent discrimination and marginalisation of these children .


### member states may derogate from the obligation in paragraph 1 when it is not proportionate to carry out an individual assessment taking into account the circumstances of the case and whether or not the child has previously come to the attention of member state authorities in the context of criminal proceedings . ### member states may derogate from the obligation to carry out an individual assessment or to provide in so doing for the close involvement of the child if the derogation is warranted by the circumstances of the case or is in the best interests of the child .


### the individual assessment shall take place at an appropriate stage of the proceedings and in any event before indictment . ### the individual assessment shall take place at the earliest appropriate stage of the proceedings and in any event before indictment or the imposition of measures involving deprivation of liberty , except where this is impossible .


### this directive should be implemented taking into account the provisions of directive 2012 / 13 / eu and directive 2013 / 48 / eu . information with regard to minor offences should be provided under the same conditions as provided for by article 2 of directive 2012 / 13 / eu . however , this directive provides further complementary safeguards with regard to information to be provided to the holder of parental responsibility and mandatory access to a lawyer in order to take into account the specific needs of children . ### this directive should be implemented taking into account the provisions of directive 2012 / 13 / eu and directive 2013 / 48 / eu . however , information should also be provided with regard to minor offences , taking into account the specific vulnerabilities of children .


### member states shall ensure that criminal proceedings involving children take place in the absence of the public , unless , after due consideration of the best interest of the child , exceptional circumstances justify a derogation . ### member states shall ensure that criminal proceedings involving children take place in the absence of the public , unless in exceptional circumstances the best interests of the child justify a derogation .


### participation in educational measures . ### participation in educational programmes .


### it shall apply to animals of the bovine , porcine , ovine , caprine and equine species kept and reproduced for farming purposes . ### it shall apply to all species of animals kept and reproduced for farming purposes or for sporting or cultural events .


### proposal for a directive of the european parliament and of the council on the cloning of animals of the bovine , porcine , ovine , caprine and equine species kept and reproduced for farming purposes ### proposal for a regulation of the european parliament and of the council prohibiting the cloning of animals kept and reproduced for farming purposes or for sporting or cultural events


### taking into account the objectives of the union ' s agricultural policy , the results of the recent scientific assessments of efsa and the animal welfare requirement provided in article 13 of the treaty , it is prudent to provisionally prohibit the use of cloning in animal production for farm purposes of certain species . ### taking into account the objectives of the union ' s common agricultural policy , the results of the recent scientific assessments of efsa , the animal welfare requirement provided in article 13 tfeu , and the fact that the majority of union citizens disapprove of cloning for food production due to animal welfare and general ethical concerns , it is prudent to fully prohibit the use of cloning in animal production for farming purposes or for sporting or cultural events .


### scientific and technical progress , in particular relating to the animal welfare aspects of cloning ; ### all available scientific and technical evidence of progress , in particular relating to the animal welfare aspects of cloning and food safety issues ;


### taking into account the objectives of the union ' s agricultural policy , the results of the recent scientific assessments of efsa and the animal welfare requirement provided in article 13 of the treaty , it is prudent to provisionally prohibit the use of cloning in animal production for farm purposes of certain species . ### taking into account the objectives of the union ' s common agricultural policy , the results of the recent assessments of efsa , based on all available scientific studies , and the animal welfare requirement provided in article 13 tfeu , it is prudent to prohibit the use of cloning in animal production for farming purposes .


### proposal for a directive of the european parliament and the council on the cloning of animals of the bovine , porcine , ovine , caprine and equine species kept and reproduced for farming purposes ### proposal for a regulation of the european parliament and the council on the cloning of animals kept and reproduced for farming purposes


### the member states shall periodically review and assess the functioning of their type - approval activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public , in particular the number of type - approval granted and the identity of the corresponding manufacturers . ### the member states shall periodically review and assess the functioning of their type - approval activities and the quality of the type - approvals issued . such reviews and assessments shall be carried out at least every three years and the results thereof shall be communicated to the other member states , the commission and third parties upon request . the member state concerned shall make a summary of the results accessible to the general public , in particular the number of type - approval granted or rejected and the identity of the corresponding manufacturers and vehicle types .


### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public . ### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every two years and the results thereof shall be communicated to the other member states , the commission and third parties upon request . the member state concerned shall make a summary of the results easily accessible to the general public .


### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public . ### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every three years and the results thereof shall be communicated to the other member states , the commission and third parties upon request . the member state concerned shall make a summary of the results accessible to the general public .


### the member states shall periodically review and assess the functioning of their type - approval activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public , in particular the number of type - approval granted and the identity of the corresponding manufacturers . ### the member states shall periodically review and assess the functioning of their type - approval activities and the quality of the type - approvals issued . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . third parties will have access to the results upon request . the member state concerned shall make a summary of the results accessible to the general public , in particular the number of type - approvals granted or rejected and the identity of the corresponding manufacturers and vehicle types .


### ‘ market surveillance’ means the activities carried out and measures taken by the market surveillance authorities to ensure that vehicles , systems , components or separate technical units as well as parts and equipment made available on the market comply with the requirements set out in the relevant union legislation and do not endanger health , safety or any other aspect of public interest protection ; ### ‘ market surveillance’ means the activities carried out and measures taken by the market surveillance authorities to ensure that vehicles , systems , components or separate technical units as well as parts and equipment made available on the market comply with the requirements set out in the relevant union legislation and do not endanger health , safety , the environment or any other aspect of public interest protection including consumer rights ;


### the approval authority and technical services shall have access to the software and algorithms of the vehicle . ### the approval authority and technical services shall have a list of the software and algorithms of the vehicle as well access to the software and algorithms .


### that notification shall include the name of those authorities , their address , including their electronic address , and their competences . the commission shall publish on its website a list and details of the approval authorities and the market surveillance authorities . ### that notification shall include the name of those authorities , their address , including their electronic address , and their audited competences . the commission shall publish on its website a list and details of the approval authorities and the market surveillance authorities .


### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public . ### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every two years and the results thereof shall be communicated to the other member states and to the european authority . throughout the review , member states shall pay particular attention to the level of independence of market surveillance activities and to the technological level of the tests performed . the member state concerned shall make a summary of the results accessible to the general public , in particular as regards the number of vehicles , systems , components or separate technical units that are found not to be in compliance with this regulation , together with the identity of the corresponding manufacturers .


### the peer - review shall include an on - site visit to a technical service under the responsibility of the reviewed authority . the commission may participate in the review and decide on its participation on the basis of a risk assessment analysis . ### the audit shall include a verification of the type approval procedures and correct implementation of the requirements of this regulation , a random sample check of the type approvals issued and an on - site visit to a technical service under the responsibility of the reviewed authority . the commission may participate in the audit and decide on its participation on the basis of a risk assessment analysis .


### the member state may refuse to register such vehicles until the economic operator has taken all appropriate corrective measures . ### the member state shall refuse to register such vehicles until the economic operator has taken all appropriate corrective measures .


### where vehicles , systems , components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the approved type , or are not in conformity with this regulation or were approved on the basis of incorrect data , the approval authorities , market surveillance authorities or the commission may take the necessary restrictive measures in accordance with article 21 of regulation no 765 / 2008 , to prohibit or restrict the making available on the market , registration or entry into service on the market of non - compliant vehicles , systems , components or separate technical units , or to withdraw them from that market or to recall them , including the withdrawal of the type - approval by the approval authority that granted the eu type - approval , until the relevant economic operator has taken all appropriate corrective measures to ensure that vehicles , systems , components or separate technical units are brought into conformity . ### where vehicles , systems , components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the approved type , or are not in conformity with this regulation or were approved on the basis of incorrect data , the approval authorities , market surveillance authorities or the commission shall take the necessary restrictive measures in accordance with article 21 of regulation no 765 / 2008 , to prohibit or restrict the making available on the market , registration or entry into service on the market of non - compliant vehicles , systems , components or separate technical units , or to withdraw them from that market or to recall them , including the withdrawal of the type - approval by the approval authority that granted the eu type - approval , until the relevant economic operator has taken all appropriate corrective measures to ensure that vehicles , systems , components or separate technical units are brought into conformity .


### this regulation respects fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union . in particular , this regulation seeks to ensure full respect for the right to property in article 17 of the charter by maintaining the core rights of the supplementary protection certificate , by confining the exception to certificates granted on or after a specified date after entry into force of this regulation and by imposing certain conditions on the application of the exception , ### this regulation respects fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union . in particular , this regulation seeks to ensure full respect for the right to property in article 17 of the charter by maintaining the core rights of the supplementary protection certificate , the right to health care in article 35 of the charter by making medicines more accessible to eu patients , and the principle of proportionality in article 52 of the charter , while allowing a reasonable predictability for applicants and other relevant market players , by confining the exception to certificates granted after the entry into force of this regulation and by imposing certain conditions on the application of the exception ,


### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate , and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union . ### it is necessary and appropriate for the achievement of the basic objective of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules enabling the making of the product in question during the term of the certificate . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union .


### this regulation respects fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union . in particular , this regulation seeks to ensure full respect for the right to property in article 17 of the charter by maintaining the core rights of the supplementary protection certificate , by confining the exception to certificates granted on or after a specified date after entry into force of this regulation and by imposing certain conditions on the application of the exception . ### this regulation respects fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union . in particular , this regulation seeks to ensure full respect for the right to property in article 17 of the charter by maintaining the core rights of the supplementary protection certificate , the right to health care in article 35 of the charter by making medicines more accessible to eu patients , the principle of proportionality in article 52 of the charter , point of article 6 tfeu on the right to health protection for european citizens , while allowing a reasonable predictability for applicants and other relevant market players , by confining the exception to certificates for which the basic patent expires after the entry into force of this regulation and by imposing certain conditions on the application of the exception .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to overcome the above mentioned unintended effects deriving from a supplementary protection certificate so as to allow making for the exclusive purposes of export to third countries and entry onto the union market immediately after expiry of the relevant supplementary protection certificate , as well as any related acts strictly necessary for that making or for the actual export or that entry onto the union market itself .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purpose of export or day - 1 entry on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting , i . e . their re - export from third countries to the union .


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired , and to ensure the entry of generics and biosimilar medicines onto the union market from day - 1 after the expiry of the relevant supplementary protection certificate , thus fostering access to medicines . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate , namely the day - 1 entry . it would also help to serve the aim of fostering access to medicines in the union and thereby help to prevent shortages of certain medicines , by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries , and / or day - 1 entry , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself or for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , or temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### the information for the purposes of paragraph 2 shall be as follows : the name and address of the maker ; the address , or addresses , of the premises where the making is to take place in the relevant member state ; the number of the certificate granted in the relevant member state , and identification of the product , by reference to the proprietary name used by the holder of that certificate ; the number of the authorisation granted in accordance with article 40 of directive 2001 / 83 / ec or article 44 of directive 2001 / 82 / ec for the manufacture of the corresponding medicinal product or , in the absence of such authorisation , a valid certificate of good manufacturing practice as referred to in article 111 of directive 2001 / 83 / ec or article 80 of directive 2001 / 82 / ec covering the premises where the making is to take place ; the intended start date of making in the relevant member state ; an indicative list of the intended third country or third countries to which the product is to be exported . ### the information for the purposes of paragraph 2 shall be treated as strictly confidential and be as follows : the name and address of the maker ; the relevant member state where the making is to take place ; the number of the certificate granted in the relevant member state , and identification of the product , by reference to the proprietary name used by the holder of that certificate ; the start date of making in the relevant member state ;


### any related act that is strictly necessary for that making or for the actual export itself ; ### any related act that is strictly necessary for that making or for the export , and / or for effectively entering the market of members states immediately after expiry of the certificate in these members states .


### making for the exclusive purpose of export to third countries ; or ### making for the exclusive purpose of export to third countries ; and / or entry onto the market of member states after expiry of the certificate in those member states ; and / or


### safeguards should accompany the exception in order to increase transparency , to help the holder of a supplementary protection certificate to enforce its protection in the union and to reduce the risk of illicit diversion onto the union market during the term of the certificate . ### reasonable and proportionate safeguards should accompany the exception , for the exclusive purpose of helping the holder of a supplementary protection certificate to check compliance with the conditions set out hereunder . those safeguards should not negatively affect competition among companies and should allow the exception to work effectively with no disruption on the main objectives of the exception . at the same time the safeguards should also ensure the necessary confidentiality and protection of commercially sensitive information of the applicant .


### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , even for the exclusive purpose of exporting to third country markets in which such protection does not exist or has expired . a further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the union market immediately after expiry of the certificate , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired . ### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established within the union from manufacturing , with a view to enter the union market immediately after expiry of the certificate and / or export to countries outside the union in which protection does not exist or has expired , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired .


### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . ### by limiting the scope of the exception to making for the purposes of day - 1 entry and of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not conflict with normal exploitation of the product in the member state where the certificate is in force , nor prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . in this regard , the commission’s study1a states that “neither the production for export , nor the production for stockpiling purposes run counter to the legal objectives of the spc system” , and “arguably the only effect of prohibiting stockpiling would be to boost the business opportunities of non - eu companies to the disadvantage of generic manufacturers established here . ”


### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . ### the scope of the exception is limited to making for day - 1 entry and for the purpose of export outside the union and to acts strictly necessary for such making or for the actual export itself , and therefore the exception introduced by this regulation will not conflict with normal exploitation of the product or medicinal product in the member state where the certificate is in force , nor prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purpose of export and day - 1 entry on the market in a member state where a supplementary protection certificate is in force , nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting .


### safeguards should accompany the exception in order to increase transparency , to help the holder of a supplementary protection certificate to enforce its protection in the union and to reduce the risk of illicit diversion onto the union market during the term of the certificate . ### reasonable , proportionate and appropriate safeguards should accompany the exception , for the exclusive purpose of helping the holder of a supplementary protection certificate to check compliance with the conditions set out hereunder , but without affecting fair competition among companies . the safeguards should ensure the necessary confidentiality and protection of commercially sensitive information of the applicant , in compliance with existing eu legislation and recommendations , such as directive 2016 / 943 of the european parliament and of the council of 8 june 2016 on trade secrets and the ema / hma guidance document on the identification of commercially confidential information and personal data .


### the certificate referred to in paragraph 1 shall not confer protection against a particular act against which the basic patent conferred protection if , with respect to that particular act , the following conditions are met : the act comprises : making for the exclusive purpose of export to third countries ; or any related act that is strictly necessary for that making or for the actual export itself ; the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; the maker ensures that a logo , in the form set out in annex - i , is affixed to the outer packaging of the product or , if there is no outer packaging , to its immediate packaging ; the maker complies with the requirements of paragraph 4 . ### the certificate referred to in paragraph 1 shall not confer protection against a particular act against which the basic patent conferred protection if , with respect to that particular act , the following conditions are met : the act comprises : making for either : the exclusive purpose of export to countries outside the european union where no protection for the medicinal product exists or has expired ; or b . the exclusive purpose of selling or offering to sell in the union market immediately after expiry of the certificate ; any related act that is strictly necessary for that making , storing , or for the actual export itself ; importing for the purposes of the authority referred to in article 9 of the member state where making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 60 days before the intended start date of making in that member state ; the certificate holder is informed , in writing , by the maker , that a notification has been sent pursuant to paragraph 2 and is provided with the information listed in of paragraph 3 of this article no later than 60 days before the start date of making in that member state and in advance of any related act prior to that making that would otherwise be prohibited by the protection conferred by a certificate ; the spc holder should keep the warning letter and the information it contains strictly confidential and should not use them for any other purpose than ensuring that the maker has complied with the scope the maker complies with the requirements of paragraph 4 . if the information referred to in point of the first subparagraph changes , the maker shall notify the authority referred to in article 9 before these changes take effect . the notification and the information it contains should be kept confidential . the authority may only disclose the information to the spc holder if disclosure is ordered by a court .


### this regulation does not affect the application of union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights , including directive 2004 / 48 / ec of the european parliament and of the council41 and regulation no 608 / 2013 of the european parliament and of the council42 . __________________ 41 directive 2004 / 48 / ec of the european parliament and of the council of 29 april 2004 on the enforcement of intellectual property rights . 42 regulation no 608 / 2013 of the european parliament and of the council of 12 june 2013 concerning customs enforcement of intellectual property rights . ### this regulation does not affect the application of union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights , including directive 2004 / 48 / ec of the european parliament and of the council41 , regulation no 608 / 2013 of the european parliament and of the council42 and the unique identifier established in commission delegated regulation 2016 / 161 . __________________ 41 directive 2004 / 48 / ec of the european parliament and of the council of 29 april 2004 on the enforcement of intellectual property rights . 42 regulation no 608 / 2013 of the european parliament and of the council of 12 june 2013 concerning customs enforcement of intellectual property rights .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , and to offer better access to generic and biosimilar medicines to union citizens , it is appropriate to overcome the above mentioned unintended effects deriving from a supplementary protection certificate so as to enable the making exclusively for export to third countries and entry onto the union market immediately after expiry of the relevant supplementary protection certificate , as well as and any related acts strictly necessary for that making or for the actual export or that entry onto the union market itself .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state for the exclusive purpose of export to third countries or countries and / or day - 1 entry on the union’s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export or for the actual export itself or for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , or temporary storage of the product or medicinal product or other activities necessary for the purpose of export to third country destinations or day - 1 entry .


### a wide range of policy approaches and measures to tackle undeclared work have been introduced across the member states . member states have also concluded bilateral agreements and carried out multilateral projects on certain aspects of undeclared work . the platform will not prevent the application of bilateral agreements or arrangements concerning administrative cooperation . ### undeclared work has negative effects also on the functioning of the internal market . a wide range of policy approaches and measures to tackle undeclared work have been introduced across the member states . member states have also concluded bilateral agreements and carried out multilateral projects on certain aspects of undeclared work . the platform will not prevent the application of bilateral agreements or arrangements concerning administrative cooperation . the main responsibility for tackling undeclared work should remain with the member states .


### the abuse of the status of self - employed , either at national level or in cross - border situations , is frequently associated with undeclared work . bogus self - employment occurs when a person is declared as self - employed while fulfilling the conditions characteristic of an employment relationship , in order to avoid certain legal or fiscal obligations . bogus self - employment is , therefore , falsely declared work and should come under the scope of the platform . ### in addition to undeclared work , the platform should deal with falsely declared work . that concept refers to paid activities that are lawful as regards their nature , but that are not declared correctly to public authorities . a specific form of falsely declared work is the abuse of the status of self - employed , either at national level or in cross - border situations . bogus self - employment occurs when a person is declared as self - employed while fulfilling the conditions characteristic of an employment relationship , in order to avoid certain legal or fiscal obligations . bogus self - employment is , therefore , falsely declared work and should come under the scope of the platform .


### at european level undeclared work is defined as ' any paid activities that are lawful as regards their nature but not declared to public authorities , taking into account differences in the regulatory systems of the member states ' 7 , thus excluding all illegal activities . __________________ 7 communication from the commission ' stepping up the fight against undeclared work ' com 628 of 24 october 2007 http : / / eur - lex . europa . eu / lexuriserv / lexuriserv . do ? uri=celex : 52007dc0628 : en : html ### undeclared work is defined in the commission communication of 24 october 2007 entitled “stepping up the fight against undeclared work” as “any paid activities that are lawful as regards their nature but not declared to public authorities , taking into account differences in the regulatory systems of the member states ' 7 , thus excluding all illegal activities . __________________ 7 communication from the commission ' stepping up the fight against undeclared work ' com 628 of 24 october 2007 http : / / eur - lex . europa . eu / lexuriserv / lexuriserv . do ? uri=celex : 52007dc0628 : en : html


### adopt non - binding guidelines for inspectors , handbooks of good practice and common principles of inspections to tackle undeclared work , ### adopt guidelines for inspectors , handbooks of good practice and common principles of inspections to tackle undeclared work ,


### improving cooperation between member states ' different enforcement authorities at eu level to prevent and deter undeclared work , including bogus self - employment , more efficiently and effectively , ### improving cooperation between member states ' different enforcement authorities at eu level to prevent , control&#160 ; and deter&#160 ; more efficiently and effectively undeclared work , including bogus self - employment&#160 ; falsely or partly declared work - in&#160 ; terms of working hours , salaries&#160 ; and the true nature of work - &#160 ; ,


### adopt non - binding guidelines for inspectors , handbooks of good practice and common principles of inspections to tackle undeclared work , ### adopt non - binding guidelines for inspectors , handbooks of good practice and common principles of inspections to tackle undeclared work , which are comprehensive in terms of the differences between the working conditions of women and men ,


### examine ways to improve data sharing in compliance with the union data protection rules , including exploring possibilities to use of the internal market information system and the electronic exchange of social security information . ### examine and propose ways to develop a reliable and efficient system of rapid information exchange and improve data sharing in compliance with the union data protection rules , including exploring possibilities to make use of the internal market information system established by regulation no 1024 / 2012 of the european parliament and of the council1aand the electronic exchange of social security information . __________________ 1a regulation no 1024 / 2012 of the european parliament and of the council of 25 october 2012 on administrative cooperation through the internal market information system and repealing commission decision 2008 / 49 / ec .


### the platform , as set out in article 1 , shall contribute to better enforcement of eu and national law , to the reduction of undeclared work and the emergence of formal jobs , hence avoiding the deterioration of quality of work , and to promote integration in the labour market and social inclusion by : ### the overriding objective of the platform shall be to provide value - added input at union level to member states ' and union institutions ' efforts , together with the social partners , to successfully tackle the complex problem of undeclared work and the regularisation of jobs , and their manifold implications and consequences . the platform , as set out in article 1 , shall to that end contribute to better enforcement of eu and national law , to the reduction of undeclared work and the emergence of formal jobs , hence avoiding the deterioration of quality of work , and to promote integration in the labour market and social inclusion by :


### improving cooperation between member states ' different enforcement authorities at eu level to prevent and deter undeclared work , including bogus self - employment , more efficiently and effectively , ### improving effective and close cooperation between member states ' different enforcement authorities and other actors involved at eu level to prevent and deter undeclared work , including bogus self - employment , more efficiently and effectively and to regularise jobs ,


### the commission will take the necessary administrative steps to set up the network . ### the commission will take the necessary administrative steps to set up the platform .


### at european level undeclared work is defined as ‘ any paid activities that are lawful as regards their nature but not declared to public authorities , taking into account differences in the regulatory systems of the member states’28 , thus excluding all illegal activities . __________________ 28 communication from the commission ‘ stepping up the fight against undeclared work’ com 628 of 24 october 2007 http : / / eur - lex . europa . eu / lexuriserv / lexuriserv . do ? uri=celex : 52007dc0628 : en : html ### at european level undeclared work is actually defined as ‘ any paid activities that are lawful as regards their nature but not declared to public authorities , taking into account differences in the regulatory systems of the member states’28 , thus excluding all illegal activities ; this definition though dating from 1998 28 a has to be adequately adjusted as to follow all latest developments and evolutions in the labour markets . __________________ 28 communication from the commission ‘ stepping up the fight against undeclared work’ com 628 of 24 october 2007 http : / / eur - lex . europa . eu / lexuriserv / lexuriserv . do ? uri=celex : 52007dc0628 : en : html 28 acom 219 communication from the commission on undeclared work


### a platform to enhance eu cooperation in the prevention and deterrence of undeclared work , hereinafter referred to as ' the platform ' , is hereby established . ### a european platform to enhance eu cooperation in the prevention and deterrence of undeclared work , and in the regularisation of jobs , is hereby established .


### the platform will aim to facilitate the exchange of best practices and information , provide a framework at eu level to develop expertise and analysis , and improve operational coordination of actions between the different national enforcement authorities of the member states . ### the strengthening of active cooperation based on mutual assistance , transparency and confidentiality among member states at eu level is necessary to help member states to prevent and deter undeclared work more efficiently and effectively . additionally , the platform will aim to share best practices of clear and simple regulation between member states with a view to reducing the risk of unintended errors especially among self - employed persons and smes .


### a maximum of 10 observers representing social partners in sectors with a high incidence of undeclared work . ### a maximum of 10 social partners’ representatives in sectors with a high incidence of undeclared work .


### all statements of support shall be collected within a period not exceeding 12 months from a date chosen by the group of organisers , without prejudice to article 11 . that date must be not later than three months from the registration of the initiative in accordance with article 6 . ### all statements of support shall be collected within a period not exceeding 18 months from a date chosen by the group of organisers , without prejudice to article 11 . that date must be not later than six months from the registration of the initiative in accordance with article 6 .


### ‘ low - carbon benchmark’ means a benchmark where the underlying assets , for the purposes of point 1 of this paragraph , are selected so that the resulting benchmark portfolio has less carbon emissions when compared to the assets that comprise a standard capital - weighted benchmark and which is constructed in accordance with the standards laid down in the delegated acts referred to in article 19a ; ### ' paris agreement - aligned benchmark ' means a broadly diversified benchmark that seeks to ensure a representation of a given market compatible with a decarbonisation pathway based on a climate scenario associated with at least a 75% probability to limit global warming to well below 2°c at the end of the 21st century , as per the objectives of the paris agreement , and which is constructed in accordance with the standards laid down in the delegated acts referred to in article 19a . such benchmarks over - weigh the economic activities contributing to accelerate the decarbonisation of the given market , and under - weigh the economic activities meant to decline in the decarbonised market , in line with the proportions set in the selected decarbonisation pathway ;


### the method for the calculation of carbon emissions and carbon savings associated with the underlying assets . ; ### the science - based methodological framework and decarbonisation pathway selected for the benchmark ; the related metrics and thresholds used to select , weight and exclude the economic activities in line with the decarbonisation pathway , and to assess the exposure of the underlying assets to such economic activities ;


### this regulation should not prevent the application of existing union legislation relating to aspects of protection of health , safety and the environment not covered by this regulation . this regulation should therefore apply without prejudice to council directive 86 / 278 / eec22 , council directive 89 / 391 / eec23 , regulation no 1907 / 2006 of the european parliament and of the council24 , regulation no 1272 / 2008 of the european parliament and of the council25 , commission regulation no 1881 / 200626 , council directive 2000 / 29 / ec27 , regulation no 98 / 2013 of the european parliament and of the council28 , and regulation no 1143 / 2014 of the european parliament and of the council29 . __________________ 22 council directive 86 / 278 / eec of 12 june 1986 on the protection of the environment , and in particular of the soil , when sewage sludge is used in agriculture . 23 council directive 89 / 391 / eec of 12 june 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work . 24 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals . 25 regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures . 26 commission regulation no 1881 / 2006 of 19 december 2006 setting maximum levels for certain contaminants in foodstuffs . 27 council directive 2000 / 29 / ec of 8 may 2000 on protective measures against the introduction into the community of organisms harmful to plants or plant products and against their spread within the community . 28 regulation no 98 / 2013 of the european parliament and of the council of 15 january 2013 on the marketing and use of explosives precursors . 29 regulation no 1143 / 2014 of the european parliament and of the council of 22 october 2014 on the prevention and management of the introduction and spread of invasive alien species . ### this regulation should not prevent the application of existing union legislation relating to aspects of protection of health , safety and the environment not covered by this regulation . this regulation should therefore apply without prejudice to council directive 86 / 278 / eec22 , council directive 91 / 676 / eec22a , council directive 2000 / 60 / ec 22b , council directive 89 / 391 / eec23 , regulation no 1907 / 2006 of the european parliament and of the council24 , regulation no 1272 / 2008 of the european parliament and of the council25 , commission regulation no 1881 / 200626 , council directive 2000 / 29 / ec27 , regulation no 98 / 2013 of the european parliament and of the council28 , regulation no 1143 / 2014 of the european parliament and of the council29 and council regulation no 834 / 2007 29a . __________________ 22 council directive 86 / 278 / eec of 12 june 1986 on the protection of the environment , and in particular of the soil , when sewage sludge is used in agriculture . 22a council directive 91 / 676 / eec of 12 december 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources . 22b directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy . 23 council directive 89 / 391 / eec of 12 june 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work . 24 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals . 25 regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures . 26 commission regulation no 1881 / 2006 of 19 december 2006 setting maximum levels for certain contaminants in foodstuffs . 27 council directive 2000 / 29 / ec of 8 may 2000 on protective measures against the introduction into the community of organisms harmful to plants or plant products and against their spread within the community . 28 regulation no 98 / 2013 of the european parliament and of the council of 15 january 2013 on the marketing and use of explosives precursors . 29 regulation no 1143 / 2014 of the european parliament and of the council of 22 october 2014 on the prevention and management of the introduction and spread of invasive alien species . 29a council regulation no 834 / 2007 of 28 june 2007 on organic production and labelling of organic products .


### a more social europe implementing the european pillar of social rights ; ### a more social europe implementing the european pillar of social rights and combating poverty , inequality and social exclusion ;


### financial rules for the european regional development fund , the european social fund plus , the cohesion fund , , the european maritime and fisheries fund , the asylum and migration fund , the internal security fund and the border management and visa instrument ; ### financial rules for the european regional development fund , the european social fund plus , the cohesion fund , the european agricultural fund for rural development , the european maritime and fisheries fund , the asylum and migration fund , the internal security fund and the border management and visa instrument ;


### it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . ### it is of particular importance that the commission carry out transparent and appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts .