### in its communication “a european solidarity corps” of 7 december 201618 , the commission emphasised the need to strengthen the foundations for solidarity work across europe , to provide young people with more and better opportunities for solidarity activities covering a broad range of areas , and to support national and local actors , in their efforts to cope with different challenges and crises . the communication launched a first phase of the european solidarity corps whereby different union programmes have been mobilised to offer volunteering , traineeship or job opportunities to young people across the eu . these activities , whether implemented before or after the entry into force of this regulation , should continue to apply the rules and conditions set by the respective union programmes that have financed them under the first phase of the european solidarity corps . _________________ 18 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions a european solidarity corps , com 942 final of 7 . 12 . 2016 . ### in its communication “a european solidarity corps” of 7 december 201618 , the commission emphasised the need to strengthen the foundations for solidarity work across europe , to provide young people with more and better opportunities for solidarity activities covering a broad range of areas , and to support national , regional and local actors , in their efforts to cope with different challenges and crises . the communication launched a first phase of the european solidarity corps whereby different union programmes have been mobilised to offer volunteering , traineeship or job opportunities to young people across the eu . these activities , whether implemented before or after the entry into force of this regulation , should continue to apply the rules and conditions set by the respective union programmes that have financed them under the first phase of the european solidarity corps . _________________ 18 communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions a european solidarity corps , com 942 final of 7 . 12 . 2016 .


### young people should be provided with easily accessible opportunities to engage in solidarity activities , which could enable them to express their commitment to the benefit of communities while acquiring useful experience , skills and competences for their personal , educational , social , civic and professional development , thereby improving their employability . those activities would also support the mobility of young volunteers , trainees and workers . ### young people should be provided with easily accessible opportunities to engage in solidarity activities , which could enable them to express their commitment to the benefit of communities while acquiring useful experience , knowledge , skills and competences for their personal , educational , social , civic and professional development , thereby improving their employability . those activities would also support the mobility of young volunteers , trainees and workers .


### the european solidarity corps would provide a single entry point for solidarity activities throughout the union . consistency and complementarity of that framework should be ensured with other relevant union policies and programmes . the european solidarity corps should build on the strengths and synergies of existing programmes , notably the european voluntary service . it should also complement the efforts made by member states to support young people and ease their school - to - work transition under the youth guarantee19 by providing them with additional opportunities to make a start on the labour market in the form of traineeships or jobs in solidarity - related areas within their respective member state or across borders . complementarity with existing union level networks pertinent to the activities under the european solidarity corps , such as the european network of public employment services , eures and the eurodesk network , should also be ensured . furthermore , complementarity between existing related schemes , in particular national solidarity schemes and mobility schemes for young people , and the european solidarity corps should be ensured , building on good practices where appropriate . _________________ 19 council recommendation of 22 april 2013 on establishing a youth guarantee . ### the european solidarity corps would provide a single entry point for solidarity activities throughout the union . consistency and complementarity of that framework should be ensured with other relevant union policies and programmes . the european solidarity corps should build on the strengths and synergies of existing programmes , notably the european voluntary service . it should also complement the efforts made by member states , regions and cities to support young people and ease their school - to - work transition under the youth guarantee19 by providing them with additional opportunities to make a start on the labour market in the form of traineeships or jobs in solidarity - related areas within their respective member state or across borders . complementarity with existing union level networks pertinent to the activities under the european solidarity corps , such as the european network of public employment services , eures and the eurodesk network , should also be ensured . furthermore , complementarity between existing related schemes , in particular national solidarity schemes and mobility schemes for young people , and the european solidarity corps should be ensured , building on good practices where appropriate . _________________ 19 council recommendation of 22 april 2013 on establishing a youth guarantee .


### in order to maximise the impact of the european solidarity corps , provisions should be made to allow other union programmes such as the asylum , migration and integration fund , the europe for citizens programme , the european regional development fund and the health programme to contribute to the objectives of the european solidarity corps by supporting activities within its scope . this contribution should be financed in accordance with the respective basic acts of the concerned programmes . once they have obtained a valid european solidarity corps quality label , the beneficiaries should be given access to the european solidarity corps portal and receive the quality and support measures provided according to the type of activity offered . ### in order to maximise the impact of the european solidarity corps , provisions should be made to allow other union programmes such as the asylum , migration and integration fund , the europe for citizens programme , the european social fund , the european regional development fund and the health programme to contribute to the objectives of the european solidarity corps by supporting activities within its scope . this contribution should be financed in accordance with the respective basic acts of the concerned programmes . once they have obtained a valid european solidarity corps quality label , the beneficiaries should be given access to the european solidarity corps portal and receive the quality and support measures provided according to the type of activity offered .


### the european solidarity corps should open up new opportunities for young people to carry out volunteering , traineeship or job placements in solidarity - related areas as well as to devise and develop solidarity projects based on their own initiative . those opportunities should contribute to enhancing their personal , educational , social , civic and professional development . the european solidarity corps should also support networking activities for european solidarity corps participants and organisations as well as measures to ensure the quality of the supported activities and to enhance the validation of their learning outcomes . ### the european solidarity corps should open up new opportunities for young people to carry out volunteering , traineeship or job placements in solidarity - related areas as well as to devise and develop solidarity programmes and projects based on their own initiative . those opportunities should contribute to enhancing their personal , educational , social , civic and professional development . the european solidarity corps should also support networking activities for european solidarity corps participants and organisations as well as measures to ensure the quality of the supported activities and to enhance the validation of their learning outcomes .


### in order to ensure continuity in the activities supported by the programmes contributing to the european solidarity corps , the financial support to solidarity placements and projects should indicatively follow an 80% - 20% split between volunteering placements and solidarity projects on the one hand and traineeship and job placements on the other hand . ### in order to ensure continuity in the activities supported by the programmes contributing to the european solidarity corps , the financial support to solidarity placements and projects should indicatively follow a 75% - 25% split between volunteering placements and solidarity projects on the one hand and traineeship and job placements on the other hand .


### the european solidarity corps should target young people aged 18 - 30 . participation in the activities offered by the european solidarity corps should require prior registration in the european solidarity corps portal . ### the european solidarity corps should target young people , irrespective their sex , their gender or their physical and mental abilities , aged 18 - 30 . participation in the activities offered by the european solidarity corps should require prior registration in the european solidarity corps portal .


### an entity willing to apply for funding to offer placements under the european solidarity corps should have first received a quality label as a precondition . this requirement should not apply to natural persons seeking financial support on behalf of an informal group of european solidarity corps participants for their solidarity projects . ### an entity willing to apply for funding to offer placements under the european solidarity corps should have first received a quality label as a precondition . this requirement should not apply to natural persons seeking financial support on behalf of an informal group of european solidarity corps participants for their programmes and solidarity projects .


### “traineeship” means a period of work practice from two to twelve months , remunerated by the organisation hosting the european solidarity corps participant , based on a written traineeship agreement , which includes a learning and training component , and undertaken in order to gain practical and professional experience with a view to improving employability and facilitating transition to regular employment ; ### “traineeship” means a period of work practice from two to twelve months , remunerated by the organisation hosting the european solidarity corps participant , based on a written traineeship agreement , which includes a learning and training component , and undertaken in order to gain practical and professional knowledge and experience with a view to improving employability and facilitating transition to regular employment ;


### to provide young people , with the support of participating organisations , with easily accessible opportunities for engagement in solidarity activities while improving their skills and competences for personal , educational , social , civic and professional development , as well as their employability and facilitating transition into the labour market , including by supporting the mobility of young volunteers , trainees and workers ; ### to provide young people , with the support of participating organisations , with easily accessible opportunities for engagement in solidarity activities while improving their knowledge , skills and competences for personal , educational , social , civic and professional development , as well as their employability and facilitating transition into the labour market , including by supporting the mobility of young volunteers , trainees and workers ;


### the financial support to solidarity placements and projects referred to in paragraphs and of article 7 shall indicatively be 80% for volunteering placements and solidarity projects ; and 20% for traineeship and job placements . ### the financial support to solidarity placements and projects referred to in paragraphs and of article 7 shall indicatively be 75% for volunteering placements and solidarity projects ; and 25% for traineeship and job placements .


### young people aged 17 to 30 years willing to participate in the european solidarity corps shall register in the european solidarity corps portal . however , at the moment of commencing a placement or a project a registered young person shall be at least 18 years of age and not older than 30 . ### young people , irrespective of&#160 ; their sex , their gender or their physical and mental abilities , aged 17 to 30 years willing to participate in the european solidarity corps shall register in the european solidarity corps portal . however , at the moment of commencing a placement or a project a registered young person shall be at least 18 years of age and not older than 30 .


### the commission , in cooperation with the participating countries , shall ensure the dissemination of information , publicity and follow - up with regard to all actions supported in the framework of the european solidarity corps . ### the commission , in cooperation with the participating countries , shall ensure the dissemination of information&#160 ; publicity and follow - up with regard to all actions supported in the framework of the european solidarity corps , with special attention to the debriefing of participants after their participation .


### given the expertise of unhcr in facilitating the different forms of admission of persons in need of international protection from third countries , to which they have been displaced , to member states willing to admit them , unhcr should continue to play a key role in resettlement efforts conducted under the union resettlement framework . in addition to unhcr , other international actors such as the international organisation for migration should be called upon to assist member states in the implementation of the union resettlement framework . ### given the expertise of unhcr in facilitating the different forms of admission of persons in need of international protection from third countries , to which they have been displaced , to member states willing to admit them , unhcr should continue to play a key role in resettlement efforts conducted under the union resettlement framework . in addition to unhcr , other international organisations and non - governmental organisations such as the international organisation for migration and the eu delegations should be called upon to assist member states in the implementation of the union resettlement framework .


### [ the european union agency for asylum ] should assist member states in the implementation of union resettlement framework in accordance with its mandate . ### [ the european union agency for asylum ] should assist member states in the implementation of union resettlement framework in accordance with its mandate , including by providing practical and technical assistance and operational support .


### the rule of law is a prerequisite for the protection of the other fundamental values on which the union is founded , such as freedom , democracy , equality and respect for human rights . respect for the rule of law is intrinsically linked to respect for democracy and for fundamental rights : there can be no democracy and respect for fundamental rights without respect for the rule of law and vice versa . ### the rule of law is a prerequisite for the protection of the other fundamental values on which the union is founded , such as freedom , democracy , equality and respect for human rights as well as non - discrimination of its citizens and its member states . respect for the rule of law is intrinsically linked to respect for democracy and for fundamental rights : there can be no democracy and respect for fundamental rights without respect for the rule of law and vice versa .


### the commission may take into account all relevant information , including decisions of the court of justice of the european union , reports of the court of auditors , and conclusions and recommendations of relevant international organisations . ### the commission shall take into account all relevant proved information , including from governmental entities , decisions of the court of justice of the european union , reports of the court of auditors , and conclusions and recommendations of relevant international organisations .


### for emergency , post - emergency or thematic actions , the commission may create , after informing the european parliament and the council , trust funds under an agreement concluded with other donors . the constitutive act of each trust fund shall define the objectives of the trust fund . the commission decision establishing the trust fund shall include a description of the fund ' s objectives , the justification for its creation in accordance with paragraph 3 , an indication of its duration and the preliminary agreements with other donors . ### for emergency , post - emergency or thematic actions , the commission may create , after informing the european parliament and the council , trust funds under an agreement concluded with other donors , when , following the agreement of the european parliament and the council , &#160 ; the union ' s external financing instruments are deemed to be insufficiently equipped for dealing with a certain situation . the constitutive act of each trust fund shall define the objectives of the trust fund . the commission decision establishing the trust fund shall include a description of the fund ' s objectives , the justification for its creation in accordance with paragraph 3 , an indication of its duration and the preliminary agreements with other donors .


### a board chaired by the commission shall be established for each union trust fund to ensure the fair representation of the donors , and of the non - contributing member states as observers , and to decide upon the use of the funds . the rules for composition of the board and its internal rules shall be laid down in the constitutive act of the trust fund adopted by the commission and adhered to by the donors . those rules shall include the requirement to have the positive vote of the commission for the final decision on the use of the funds . ### a board chaired by the commission shall be established for each union trust fund to ensure the fair representation of the donors , the relevant bodies of the european parliament and of the non - contributing member states as observers , and to decide upon the use of the funds . the rules for composition of the board and its internal rules shall be laid down in the constitutive act of the trust fund adopted by the commission and adhered to by the donors . those rules shall include the requirement to have the positive vote of the commission for the final decision on the use of the funds .


### the tallinn digital summit55 of september 2017 and the conclusions of the european council56 of 19 october 2017 indicated the need for europe to invest in digitising our economies and addressing the skills gap to maintain and enhance european competitiveness , our quality of life and social fabric . the european council concluded that the digital transformation offers immense opportunities for innovation , growth and jobs , will contribute to our global competitiveness , and enhance creative and cultural diversity . seizing these opportunities requires collectively tackling some of the challenges posed by the digital transformation and reviewing policies affected by the digital transformation . __________________ 55 https : / / www . eu2017 . ee / news / insights / conclusions - after - tallinn - digital - summit 56 https : / / www . consilium . europa . eu / media / 21620 / 19 - euco - final - conclusions - en . pdf ### the tallinn digital summit55 of september 2017 and the conclusions of the european council56 of 19 october 2017 indicated the need for europe to invest in efficient digitalisation of our economies and addressing the skills gap to maintain and enhance european competitiveness and innovation , our quality of life and social fabric . the european council concluded that the digital transformation offers immense opportunities for innovation , growth and jobs , will contribute to our global competitiveness , and enhance creative and cultural diversity . seizing these opportunities requires collectively tackling the challenges posed by the digital transformation in several ways , including by ensuring that the essential building blocks on which new technologies rely are put in place , by creating effective and easily enforceable legal rules , by reviewing policies affected by the digital transformation , and by creating an innovation - friendly environment in which the interests of users are fully safeguarded . __________________ 55 https : / / www . eu2017 . ee / news / insights / conclusions - after - tallinn - digital - summit 56 https : / / www . consilium . europa . eu / media / 21620 / 19 - euco - final - conclusions - en . pdf


### the communication “towards a common european data space”58 , addresses the new measure to be taken as a key step towards a common data space in the eu - a seamless digital area with a scale that will enable the development of new products and services based on data . _________________ 58 com 125 final ### the communication “towards a common european data space”58 , addresses the new measure to be taken as a key step towards a common data space in the eu - a seamless digital area with a scale that will enable the development and innovation of new products and services based on data . _________________ 58 com 125 final


### the programme should be implemented through projects reinforcing essential digital capacities and their wide use . this should involve co - investments with member states and , when needed , the private sector . this should notably require reaching a critical mass in procurement to obtain better value for money and guarantee that suppliers in europe stay at the forefront of technology advancements . ### the programme should be implemented through projects reinforcing essential digital capacities and the union ' s strategic autonomy . this should involve co - investments with member states and , when needed , the private sector . this should notably require reaching a critical mass in procurement to obtain better value for money and guarantee that suppliers in europe stay at the forefront of technology advancements .


### cybersecurity is a challenge for the whole union that cannot continue to be addressed only with fragmented national initiatives . europe ' s cybersecurity capacity should be reinforced to endow europe with the necessary capacities to protect its citizens and businesses from cyber threats . in addition consumers should be protected when using connected products that can be hacked and compromise their safety . this should be achieved together with member states and private sector by developing , and ensuring coordination between , projects reinforcing europe ' s capacities in cybersecurity and ensuring the wide deployment of latest cybersecurity solutions across the economy , as well as by aggregating the competences in this field to ensure critical mass and excellence . ### cybersecurity is a challenge for the whole union that cannot continue to be addressed only with fragmented national initiatives . europe ' s cybersecurity capacity should be reinforced to endow europe with the necessary capacities to protect its citizens , its strategic networks and its businesses from cyber threats . in addition consumers should be protected when using connected products that can be hacked and compromise their safety and that of their data . this should be achieved together with member states and private sector by developing , and ensuring coordination between , projects reinforcing europe ' s capacities in cybersecurity and ensuring the wide deployment of the latest cybersecurity solutions across the economy , as well as by aggregating the competences in this field to ensure critical mass and excellence .


### trust is a prerequisite for the digital single market to function . cybersecurity technologies such as digital identities , cryptography or intrusion detection , and their application in areas such as finance , industry 4 . 0 , energy , transportation , healthcare , or e - government are essential to safeguard the security and trust of online activity and transactions by both citizens , public administrations , and companies . ### trust is a prerequisite for the digital single market to function . cybersecurity technologies such as digital identities , cryptography , encryption or intrusion detection , and their application in areas such as finance , industry 4 . 0 , energy , transportation , healthcare , or e - government are essential to safeguard the security and trust of online activity and transactions by both citizens , public administrations , and companies .


### trust is a prerequisite for the digital single market to function . cybersecurity technologies such as digital identities , cryptography or intrusion detection , and their application in areas such as finance , industry 4 . 0 , energy , transportation , healthcare , or e - government are essential to safeguard the security and trust of online activity and transactions by both citizens , public administrations , and companies . ### trust is a prerequisite for the digital single market to function . cybersecurity technologies such as digital identities , cryptography or intrusion detection , and their application in areas such as finance , industry 4 . 0 , logistics , energy , transportation , tourism , healthcare , or e - government are essential to safeguard the security and trust of online activity and transactions by both citizens , public administrations , and companies .


### the advanced digital technologies supported by this programme , such as high performance computing , cybersecurity and artificial intelligence are now sufficiently mature to move beyond the research arena and be deployed , implemented and scaled - up at union level . just as the deployment of these technologies require a union response so does the skills dimension . training opportunities in advanced digital skills need to be scaled up , increased and made accessible throughout the eu . failing this could impede the smooth deployment of advanced digital technologies and hamper the overall competitiveness of union ' s economy . the actions supported by this programme are complementary to those supported by the esf , erdf and horizon europe programmes . ### the advanced digital technologies supported by this programme , such as high performance computing , cybersecurity and artificial intelligence are now sufficiently mature to move beyond the research arena and be deployed , implemented and scaled - up at union level , however should continue to be supported also at member states level . just as the deployment of these technologies requires a union response so does the skills dimension . bearing in mind the impact new technologies may have on the job market , training opportunities in advanced digital skills need to be scaled up , increased and made accessible throughout the eu , in particular for employees in the sectors that will be most affected by digital innovations . failing this could impede the smooth deployment of advanced digital technologies and hamper the overall competitiveness of union ' s economy . the actions supported by this programme are complementary to those supported by the esf , erdf and horizon europe programmes .


### reflecting the importance of tackling climate change in line with the union’s commitments to implement the paris agreement and the united nations sustainable development goals , this programme will contribute to mainstream climate actions and lead to the achievement of an overall target of 25% of the eu budget expenditures supporting climate objectives74 . relevant actions will be identified during the programme ' s preparation and implementation , and reassessed in the context of the relevant evaluations and review processes . _________________ 74 com 321 final , page 1 ### reflecting the importance of tackling climate change in line with the union’s commitments to implement the paris agreement and the united nations sustainable development goals , this programme will contribute to mainstream climate actions and lead to the swift achievement of an overall target of at least 25% of the eu budget expenditures supporting climate objectives74 over the mff 2021 - 2027 period and 30% as soon as possible at the latest by 2027 . relevant actions will be identified during the programme ' s preparation and implementation , and reassessed in the context of the relevant evaluations and review processes . it is imperative that the eu delivers on its commitment to be a frontrunner in implementing the un sustainable development goals although there is a lack of a clear and visible commitment to that end in the mff proposals , therefore , the mainstreaming of the sdgs should be present in all eu policies and initiatives of the next mff . _________________ 74 com 321 final , page 1


### the programme may provide funding in any of the forms laid down in the financial regulation , including notably procurement as a primary form as well as grants and prizes . it may also provide financing in the form of financial instruments within blending operations . ### the programme may provide funding in any of the forms laid down in the financial regulation , including notably procurement by the commission or funding body , by grant beneficiaries individually or jointly as a primary form of the action as well as grants and prizes . procurements may authorise the award of multiple contracts within the same procedure and may provide for place of performance conditions in line with applicable international procurement agreements . the programme may also provide financing in the form of financial instruments within blending operations .


### the performance reporting system shall ensure that data for monitoring programme implementation and results are collected efficiently , effectively , and in a timely manner . to that end , proportionate reporting requirements shall be imposed on recipients of union funds and member states . ### the performance reporting system shall ensure that data for monitoring programme implementation and results are suitable for an in - depth analysis of the progress achieved and the difficulties encountered and are collected efficiently , effectively , and in a timely manner . to that end , proportionate reporting requirements shall be imposed on recipients of union funds and member states .


### evaluations shall be carried out in a timely manner to feed into the decision - making process . ### evaluations shall be carried out in a timely manner to feed into the decision - making process . the evaluations shall also provide for a qualitative assessment of the progress towards achieving the general objectives set out in article 3 .


### berec and the berec office have made a positive contribution towards a consistent implementation of the regulatory framework for electronic communications . notwithstanding , there are still significant disparities between member states as regards regulatory practice . moreover , the governance structure of berec and the berec office is cumbersome and gives rise to unnecessary administrative burden . in order to ensure efficiency gains and synergies and to further contribute to the development of the internal market for electronic communications throughout the union as well as to the promotion of access to , and take - up of , very high capacity data connectivity , competition in the provision of electronic communications networks , services and associated facilities and the interests of the citizens of the union , this regulation aims to strengthen the role of berec and enhance its governance structure by establishing berec as a union decentralised agency . this also corresponds to the need to reflect the significantly enhanced role played by berec following regulation no 531 / 2012 which establishes tasks for berec in relation to union - wide roaming , regulation no 2015 / 2120 which establishes tasks for berec in relation to open internet access and union - wide roaming , and the directive which establishes a significant number of new tasks for berec such as issuing decisions and guidelines on several topics , reporting on technical matters , keeping registers and delivering opinions on internal market procedures for draft national measures on market regulation as well as on assignments of rights of use for radio spectrum . ### berec and the berec office have made a positive contribution towards a consistent implementation of the regulatory framework for electronic communications . notwithstanding , there are still significant disparities between member states as regards regulatory practice . moreover , the governance structure of berec and the berec office is cumbersome and gives rise to unnecessary administrative burden . in order to ensure efficiency gains and synergies and to further contribute to the development of the internal market for electronic communications throughout the union as well as to the promotion of access to , and take - up of , very high capacity data connectivity , competition , transparency and non - discrimination in the provision of electronic communications networks , services and associated facilities and the interests of the citizens of the union , this regulation aims to strengthen the role of berec and enhance its governance structure by establishing berec as a union decentralised agency . this also corresponds to the need to reflect the significantly enhanced role played by berec following regulation no 531 / 2012 which establishes tasks for berec in relation to union - wide roaming , regulation no 2015 / 2120 which establishes tasks for berec in relation to open internet access and union - wide roaming , and the directive which establishes a significant number of new tasks for berec such as issuing decisions and guidelines on several topics , reporting on technical matters , keeping registers and delivering opinions on internal market procedures for draft national measures on market regulation as well as on assignments of rights of use for radio spectrum .


### the need for the regulatory framework for electronic communications to be consistently applied in all member states is essential for the successful development of an internal market for electronic communications throughout the union and the promotion of access to , and take - up of , very high capacity data connectivity , of competition in the provision of electronic communications networks , services and associated facilities and of the interests of the citizens of the union . in view of market and technological developments , which often entails an increased cross - border dimension , and to the experience so far in ensuring a consistent implementation in the electronic communications field , it is necessary to build on the work of berec and the berec office and further develop them into a fully - fledged agency . ### the need for the regulatory framework for electronic communications to be consistently applied in all member states is essential for the successful development of an internal market for electronic communications throughout the union and the promotion of access to , and take - up of , very high capacity data connectivity , of competition , transparency and non - discrimination in the provision of electronic communications networks , services and associated facilities and of the interests of the citizens of the union . in view of market and technological developments , which often entails an increased cross - border dimension , and to the experience so far in ensuring a consistent implementation in the electronic communications field , it is necessary to build on the work of berec and the berec office and further develop them into a fully - fledged agency .


### berec should be allowed if necessary to cooperate with , and without prejudice to the role of , other union bodies , agencies , offices and advisory groups , in particular the radio spectrum policy group29 , the european data protection board30 , the european regulators group for audiovisual media services31 and the european union agency for network and information security32 ; as well as with existing committees . it should also be allowed to cooperate with competent authorities of third countries , in particular , regulatory authorities competent in the field of electronic communications and / or groups of those authorities , as well as with international organisations when necessary for the performance of its tasks . __________________ 29 decision 2002 / 622 / ec establishing a radio spectrum policy group . 30 established under regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec . 31 directive [ . . . ] . 32 regulation no 526 / 2013 of the european parliament and of the council of 21 may 2013 concerning the european union agency for network and information security and repealing regulation no 460 / 2004 . ### berec should be allowed if necessary to cooperate with , and without prejudice to the role of , other union bodies , agencies , offices and advisory groups , in particular the radio spectrum policy group29 , the european data protection board30 , the european data protection supervisor , the european regulators group for audiovisual media services31 , the european union agency for network and information security32 and the european agency for fundamental rights ; as well as with existing committees . it should also be allowed to cooperate with competent authorities of third countries , in particular , regulatory authorities competent in the field of electronic communications and / or groups of those authorities , as well as with international organisations when necessary for the performance of its tasks . __________________ 29 decision 2002 / 622 / ec establishing a radio spectrum policy group . 30 established under regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec . 31 directive [ . . . ] . 32 regulation no 526 / 2013 of the european parliament and of the council of 21 may 2013 concerning the european union agency for network and information security and repealing regulation no 460 / 2004 .


### in order to carry out its tasks effectively , berec should have the right to request all necessary information from the commission , the nras and , as a last resort , other authorities and undertakings . requests for information should be proportionate and not impose an undue burden on the addressees . nras , which are closest to the electronic communications markets , should cooperate with berec and have a timely and accurate provision of information to ensure that berec is able to fulfil its mandate . berec should also share with the commission and the nras the necessary information based on the principle of sincere cooperation . ### in order to carry out its tasks effectively , berec should have the right to request all necessary information from the commission , the nras and , where necessary to perform its tasks , other authorities and undertakings . requests for information should be proportionate and not impose an undue burden on the addressees . for that purpose , berec should establish a common information and communication system to avoid duplication of information requests and facilitate communication between all authorities involved . nras , which are closest to the electronic communications markets , should cooperate with berec and have a timely and accurate provision of information to ensure that berec is able to fulfil its mandate . berec should also share with the commission and the nras the necessary information based on the principle of sincere cooperation .


### berec shall pursue the same objectives as those of national regulatory authorities referred to in article 3 of the directive . in particular , berec shall ensure a consistent implementation of the regulatory framework for electronic communications within the scope referred to in paragraph 2 and thereby contribute to the development of the internal market . it shall also promote access to , and take - up of , very high capacity data connectivity ; competition in the provision of electronic communications networks , services and associated facilities ; and the interests of the citizens of the union . ### berec shall pursue the same objectives as those of national regulatory authorities referred to in article 3 of the directive . in particular , berec shall ensure a consistent , transparent and non - discriminatory implementation of the regulatory framework for electronic communications within the scope referred to in paragraph 2 and thereby contribute to the development of the internal market . it shall also promote access to , and take - up of , very high capacity data connectivity ; competition in the provision of electronic communications networks , services and associated facilities ; and the interests and rights of the citizens of the union .


### berec shall pursue the same objectives as those of national regulatory authorities referred to in article 3 of the directive . in particular , berec shall ensure a consistent implementation of the regulatory framework for electronic communications within the scope referred to in paragraph 2 and thereby contribute to the development of the internal market . it shall also promote access to , and take - up of , very high capacity data connectivity ; competition in the provision of electronic communications networks , services and associated facilities ; and the interests of the citizens of the union . ### berec shall as primary objectives ensure a consistent implementation of the regulatory framework for electronic communications within the scope referred to in paragraph 2 and contribute to the development of the internal market , thereby contributing to the objectives referred to in article 3 of the directive of promoting access to , and take - up of , very high capacity data connectivity , competition in the provision of electronic communications networks , services and associated facilities , and the interests of the citizens of the union .


### adopt and proceed with an assessment of the consolidated annual activity report on berec’s activities and send both the report and its assessment , by 1 july each year to the european parliament , the council , the commission and the court of auditors . the consolidated annual activity report shall be made public ; ### adopt and proceed with an assessment of the consolidated annual activity report on berec’s activities and send both the report and its assessment , by 1 july each year to the european parliament , the council , the commission and the court of auditors . the annual report on berec ' s activities shall be presented to the european parliament and to the council by the executive director during a public session . the consolidated annual activity report shall be made public ;


### adopt and proceed with an assessment of the consolidated annual activity report on berec’s activities and send both the report and its assessment , by 1 july each year to the european parliament , the council , the commission and the court of auditors . the consolidated annual activity report shall be made public ; ### adopt and proceed with an assessment of the consolidated annual activity report on berec ' s activities and send both the report and its assessment , by 1 july each year to the european parliament , the council , the commission and the court of auditors . the annual report on berec ' s activities shall be presented to the parliament and council by the executive director during a public session . the consolidated annual activity report shall be made public ;


### the declarations shall be accurate and complete , made in writing and updated whenever necessary . the declarations of interests made by the members of the management board and the executive director shall be made public . ### the declarations shall be accurate and complete , made in writing and updated whenever necessary . the declarations of interests made by the members of the management board , the executive director and members of the working groups shall be made public .


### the union ' s macro - financial assistance should support moldova ' s commitment to values shared with the union , including democracy , the rule of law , good governance , respect for human rights , sustainable development and poverty reduction , as well as its commitment to the principles of open , rules - based and fair trade . ### the union ' s macro - financial assistance should support moldova ' s commitment to values shared with the union , including democracy , the rule of law , good governance , including the de - politicisation of appointments in public administration , respect for human rights and free , independent and pluralistic media , sustainable development and poverty reduction , as well as its commitment to the principles of open , rules - based and fair trade .


### a pre - condition for granting the union ' s macro - financial assistance should be that moldova respects effective democratic mechanisms – including a multi - party parliamentary system – and the rule of law , and guarantees respect for human rights . in addition , the specific objectives of the union ' s macro - financial assistance should strengthen the efficiency , transparency and accountability of the public finance management systems , the governance and supervision of the financial sector in moldova and promote structural reforms aimed at supporting sustainable and inclusive growth , employment creation and fiscal consolidation . both the fulfilment of the preconditions and the achievement of those objectives should be regularly monitored by the commission and the european external action service . ### a pre - condition for granting the union ' s macro - financial assistance should be that moldova respects effective democratic mechanisms – including a multi - party parliamentary system – and the rule of law , including the independence of the judiciary , guarantees respect for human rights , supports free , independent and pluralistic media , and ensures an effective fight against corruption and a thorough , result - orientated investigation into the “bank fraud” . in addition , the specific objectives of the union ' s macro - financial assistance should strengthen the efficiency , transparency and accountability of the public finance management systems , the governance and supervision of the financial sector in moldova and promote structural reforms aimed at supporting sustainable and inclusive growth , employment creation and fiscal consolidation . both the fulfilment of the pre - condition and the achievement of those objectives should be regularly monitored by the commission and the european external action service . before any instalment is released , the commission and the european external action service should report to the european parliament and the council on the level of fulfilment of that pre - condition and the achievement of those objectives against clearly defined benchmarks . in the event that progress towards the objectives set out in the council conclusions of 15 february 2016 on moldova , the eu - moldova association agenda and the memorandum of understanding is insufficient , the release of instalments should be suspended immediately .


### in order to ensure that the union’s financial interests linked to the union’s macro - financial assistance are protected efficiently , moldova should take appropriate measures relating to the prevention of , and fight against , fraud , corruption and any other irregularities linked to the assistance . in addition , provision should be made for the commission to carry out checks and for the court of auditors to carry out audits . ### in order to ensure that the union’s financial interests linked to the union’s macro - financial assistance are protected efficiently , moldova should fully implement appropriate measures relating to the prevention of , and fight against , fraud , corruption and any other irregularities linked to the assistance . in addition , provision should be made for the commission to carry out checks and for the court of auditors to carry out audits .


### the union ' s macro - financial assistance should be managed by the commission . in order to ensure that the european parliament and the council are able to follow the implementation of this decision , the commission should regularly inform them of developments relating to the assistance and provide them with relevant documents . ### the union ' s macro - financial assistance should be managed by the commission . in order to ensure that the european parliament and the council are able to follow the implementation of this decision , the commission should regularly inform them of developments relating to the assistance and provide them with relevant documents including the draft memorandum of understanding .


### ensuring the protection of the union ' s financial interests , in particular providing for specific measures in relation to the prevention of , and fight against , fraud , corruption and any other irregularities affecting the union ' s macro - financial assistance , in accordance with council regulation no 2988 / 9511 , council regulation no 2185 / 9612 and regulation no 883 / 2013 of the european parliament and of the council13 ; __________________ 11 council regulation no 2988 / 95 of 18 december 1995 on the protection of the european communities financial interests . 12 council regulation no 2185 / 96 of 11 november 1996 concerning on - the - spot checks and inspections carried out by the commission to protect the communities ' financial interests against fraud and other irregularities . 13 regulation no 883 / 2013 of the european parliament and of the council of 11 september 2013 concerning investigations conducted by the european anti - fraud office and repealing regulation no 1073 / 1999 of the european parliament and of the council and council regulation no 1074 / 1999 . ### ensuring the protection of the union ' s financial interests , in particular fully implementing specific measures in relation to the prevention of , and fight against , fraud , corruption and any other irregularities affecting the union ' s macro - financial assistance , in accordance with council regulation no 2988 / 9511 , council regulation no 2185 / 9612 and regulation no 883 / 2013 of the european parliament and of the council13 ; __________________ 11 council regulation no 2988 / 95 of 18 december 1995 on the protection of the european communities financial interests . 12 council regulation no 2185 / 96 of 11 november 1996 concerning on - the - spot checks and inspections carried out by the commission to protect the communities ' financial interests against fraud and other irregularities . 13 regulation no 883 / 2013 of the european parliament and of the council of 11 september 2013 concerning investigations conducted by the european anti - fraud office and repealing regulation no 1073 / 1999 of the european parliament and of the council and council regulation no 1074 / 1999 .


### medicated feed should be marketed in sealed containers for safety reasons and to protect user’s interest . ### medicated feed should be marketed in specially labelled sealed containers for safety reasons and to protect the user’s interest .


### a system for the collection of unused or expired products should be put in place in order to control any risk that such products might raise with regard to the protection of animal , human health or the environment . ### a system for the collection of unused or expired products should be put in place in order to control any risk that such products might raise with regard to the protection of animal health , human health or the environment . member states should set up such a system as and where necessary , in cooperation with regional and local authorities .


### the supply of medicated feed to animal holders shall be subject to the presentation and , in case of manufacturing by on - farm mixers , the possession of a veterinary prescription and to the conditions laid down in paragraphs 2 to 6 . ### the supply of medicated feed to animal holders shall be subject to the presentation and , in case of manufacturing by on - farm mixers , the possession of a veterinary prescription issued by a veterinarian and to the conditions laid down in paragraphs 2 to 6 .


### feed business operators feeding food - producing animals with medicated feed shall keep records in accordance with article 69 of directive 2001 / 82 / ec . those records shall be kept for five years after the date of administration of medicated feed , including when the animal is slaughtered during the five - year period . ### feed business operators feeding food - producing animals with medicated feed shall keep records in accordance with article 69 of directive 2001 / 82 / ec . those records shall be kept for five years after the date of administration of medicated feed , including when the animal is slaughtered during the five - year period . member states shall ensure that the data in those records is collected and transferred to the union database on veterinary medicinal products ) .


### in order to enable a timely update of this regulation to the developments at the national level , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the european commission in respect of amending the annexes to this regulation and regulation no 987 / 2009 . 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 . 43 in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and 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 . __________________ 43 com 216 final . ### in order to enable a timely update of this regulation to the developments at the national level , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the european commission in respect of amending the annexes to this regulation and regulation no 987 / 2009 , and establish a fair and optional adjustment mechanism for the calculation of exporting family benefits by member states for children residing in another member state other than the competent member state . 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 . 43 in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and 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 . __________________ 43 com 216 final .


### in the field of sickness , maternity and equivalent paternity benefits , insured persons , as well as the members of their families , living or staying in a member state other than the competent member state , should be afforded protection . ### recital 20 is replaced by the following : “in the field of sickness , long - term care , maternity and equivalent paternity benefits , insured persons , as well as the members of their families , living or staying in a member state other than the competent member state , should be afforded protection . ”


### sickness , maternity and equivalent paternity benefits ### in title iii , the title of chapter 1 is replaced by the following : “sickness , long - term care , maternity and equivalent paternity benefits”


### long - term care benefits for insured persons and members of their families need to be coordinated according to specific rules which , in principle , follow the rules applicable to sickness benefits , in line with the case law of the court of justice . it is also necessary to provide for specific provisions in case of overlapping of long - term care benefits in kind and in cash . ### long - term care benefits for insured persons and members of their families should , in principle , continue to be coordinated according to the rules applicable to sickness benefits , taking the specific nature of long - term care benefits into account and in line with the case law of the court of justice . it is also necessary to provide for specific provisions in case of overlapping of long - term care benefits in kind and in cash .


### article 19 stay outside the competent member state unless otherwise provided for by paragraph 2 , an insured person and the members of his / her family staying in a member state other than the competent member state shall be entitled to the benefits in kind which become necessary on medical grounds during their stay , taking into account the nature of the benefits and the expected length of the stay . these benefits shall be provided on behalf of the competent institution by the institution of the place of stay , in accordance with the provisions of the legislation it applies , as though the persons concerned were insured under the said legislation . 2 . the administrative commission shall establish a list of benefits in kind which , in order to be provided during a stay in another member state , require for practical reasons a prior agreement between the person concerned and the institution providing the care . ### article 19 is replaced by the following ; “article 19 stay outside the competent member state unless otherwise provided for by paragraph 2 , an insured person and the members of his / her family staying in a member state other than the competent member state shall be entitled to the benefits in kind which become necessary on either medical grounds or due to the need for long - term care during their stay , taking into account the nature of the benefits and the expected length of the stay . these benefits shall be provided on behalf of the competent institution by the institution of the place of stay , in accordance with the provisions of the legislation it applies , as though the persons concerned were insured under the said legislation . 2 . the administrative commission shall establish a list of benefits in kind which , in order to be provided during a stay in another member state , require for practical reasons a prior agreement between the person concerned and the institution providing the benefit . ”


### in order to ensure the correct determination of the applicable legislation , the competent authorities shall promote the cooperation between institutions and labour inspectorates in their member states . . ### in order to ensure the correct determination of the applicable legislation , the competent authorities shall promote the cooperation between the appropriate institutions such as tax authorities and labour inspectorates in their member states .


### long - term care benefits in cash provided in derogation from article 35a of chapter 1a ### long - term care benefits in cash provided in derogation from article 33a of chapter 1


### this regulation provides for measures and procedures to promote the mobility of employees and unemployed persons . frontier workers who have become wholly unemployed may make themselves available to the employment services in both their country of residence and the member state where they were last employed . however , they should be entitled to benefits only from their member state of residence . ### - 1 . recital 13 is amended as follows : ' this regulation provides for measures and procedures to promote the mobility of employees and unemployed persons . frontier workers who have become wholly unemployed may make themselves available to the employment services in both their country of residence and the member state where they were last employed . '


### documents issued by the institution of a member state and showing the position of a person for the purposes of the application of the basic regulation and of the implementing regulation , and supporting evidence on the basis of which the documents have been issued , shall be accepted by the institutions of the other member states for as long as they have not been withdrawn or declared to be invalid by the member state in which they were issued . such documents shall only be valid if all sections indicated as compulsory are filled in . ### documents issued by the institution of a member state and showing the position of a person for the purposes of the application of the basic regulation and of the implementing regulation shall be accepted by the institutions of the other member states for as long as they have not been withdrawn or declared to be invalid by the member state in which they were issued .


### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is posted within the meaning of the directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services52 or sent by that employer to another member state ' shall include a person who is recruited with a view to being posted or sent to another member state , provided that immediately before the start of his employment , the person concerned is already subject to the legislation of the sending member state in accordance with title ii of the basic regulation . . __________________ 52 oj l 018 , 21 . 01 . 1997 p . 1 . ### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is sent by that employer to another member state ' shall include a person who is recruited with a view to being sent to another member state , provided that , immediately before the start of his employment , the person concerned is already subject to the legislation of the member state in which his employer is established .


### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is posted within the meaning of the directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services52 or sent by that employer to another member state ' shall include a person who is recruited with a view to being posted or sent to another member state , provided that immediately before the start of his employment , the person concerned is already subject to the legislation of the sending member state in accordance with title ii of the basic regulation . . __________________ 52 oj l 18 , 21 . 01 . 1997 p . 1 . ### for the purposes of the application of article 12 of the basic regulation , a ' person who pursues an activity as an employed person in a member state on behalf of an employer which normally carries out its activities there and who is posted by that employer to another member state ' shall include a person who is recruited with a view to being posted to another member state , provided that immediately before the start of his employment , the person concerned is already subject to the legislation of the member state in accordance with title ii of the basic regulation . .


### if that institution determines that the legislation of another member state applies , it shall do so provisionally and shall without delay inform the institution of the member state which it considers to be competent of this provisional decision . the decision shall become definitive within two months after the institution designated by the competent authorities of the member state concerned has been informed of it , unless the latter institution informs the first institution and the persons concerned that it cannot yet accept the provisional determination or that it takes a different view on this . ### if that institution determines that the legislation of another member state applies , it shall do so provisionally and shall without delay inform the institution of the member state which it considers to be competent of this provisional decision . the decision shall become definitive within two months after the institution designated by the competent authorities of the member state concerned has been informed of it , unless the latter institution informs the first institution , the persons and the employer concerned that it cannot yet accept the provisional determination or that it takes a different view on this .


### sickness , maternity and equivalent paternity benefits , and long - term care benefits . ### sickness , long - term care , maternity and equivalent paternity benefits .


### when a person or a group of persons are exempted upon request from compulsory sickness insurance and such persons are thus not covered by a sickness insurance scheme to which the basic regulation applies , the institution of another member state shall not , solely because of this exemption , become responsible for bearing the costs of benefits in kind or in cash provided to such persons or to a member of their family under title iii , chapter i , of the basic regulation . ### in article 32 , paragraph 1 is replaced by the following : ' 1 . when a person or a group of persons are exempted upon request from compulsory sickness or long - term care insurance and such persons are thus not covered by a sickness or long - term care insurance scheme to which the basic regulation applies , the institution of another member state shall not , solely because of this exemption , become responsible for bearing the costs of benefits in kind or in cash provided to such persons or to a member of their family under title iii , chapter i , of the basic regulation . '


### in order to be able to supplement or amend the impact pathway indicators , where considered necessary , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . 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 . ### in order to be able to supplement or amend the impact pathway indicators , where considered necessary , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . 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 promptly at the same time as member states ' experts , and their experts be systematically invited to meetings of commission expert groups dealing with the preparation of delegated acts .


### reflecting the importance of tackling climate change in line with the union ' s commitments to implement the paris agreement and the united nations sustainable development goals , this programme will contribute to mainstream climate actions and to the achievement of an overall target of 25 % of the eu budget expenditures supporting climate objectives . ### reflecting the importance of tackling climate change in line with the union ' s commitments to implement the paris agreement and the united nations sustainable development goals , this programme will contribute actively to mainstream climate actions and to the achievement of an overall target of 25 % of the eu budget expenditures supporting climate objectives .


### a pharmacovigilance database at union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the union . that database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work - sharing between the competent authorities . ### a pharmacovigilance database at union level should be established to record and integrate information of adverse events for all veterinary medicinal products authorised in the union . that database should improve detection of adverse events and should allow and facilitate the pharmacovigilance surveillance and work - sharing between the competent authorities and other authorities concerned such as environmental protection agencies and food safety authorities both at national and union level .


### ‘ benefit - risk balance’ means an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product : ### ‘ benefit - risk balance’ means an evaluation of the risk of damage to animal health caused by the absence of the product in relation to the following risks relating to the use of that product :


### 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 . for applications submitted in accordance with the centralised marketing authorisation procedure , the decentralised procedure or the procedure for mutual recognition , the formats made available by the agency shall be used .


### the package leaflet shall be written and designed to be clear and understandable , in terms that are comprehensible to the general public . ### the package leaflet shall be written and designed to be clear , readable and understandable , in terms that are comprehensible to the general public .


### for the purpose of this section , where the active substance consists of salts , esters , ethers , isomers and mixtures of isomers , complexes or derivatives differing from the active substance used in the reference veterinary medicinal product , it shall be considered to be the same active substance as that used in the reference veterinary medicinal product , unless it differs significantly in respect of properties with regard to safety or efficacy . where it differs significantly in respect of those properties , the applicant shall submit additional information in order to prove the safety and / or efficacy of the various salts , esters or derivatives of the authorised active substance of the reference veterinary medicinal product . ### for the purpose of this section , where the active substance consists of salts , esters , ethers , isomers and mixtures of isomers , complexes or derivatives differing from the active substance used in the reference veterinary medicinal product , it shall be considered to be the same active substance as that used in the reference veterinary medicinal product , unless it differs significantly in respect of properties with regard to safety , efficacy and residue behaviour . where it differs significantly in respect of those properties , the applicant shall submit additional information in order to prove the safety and / or efficacy of the various salts , esters or derivatives of the authorised active substance of the reference veterinary medicinal product .


### competent authorities and the agency shall provide the general public , veterinarians and other healthcare professionals with all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication . ### competent authorities and the agency shall make public all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication .


### competent authorities and the agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit - risk balance of veterinary medicinal products with a view to detecting risks to animal health , public health and protection of the environment . ### competent authorities , other authorities concerned&#160 ; and the agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit - risk balance of veterinary medicinal products with a view to detecting risks to animal health , public health and protection of the environment .


### persons permitted to supply veterinary medicinal products in accordance with article 107 may offer veterinary medicinal products by means of information society services in the meaning of directive 98 / 34 / ec of the european parliament and of the council28 to natural or legal persons established in the union under the condition that those medicinal products comply with the legislation of the destination member state . __________________ 28 directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services . ### persons permitted to supply veterinary medicinal products in accordance with article 107 may offer veterinary medicinal products which are not subject to veterinary prescription by means of information society services in the meaning of directive 98 / 34 / ec of the european parliament and of the council28 to natural or legal persons established in the union under the condition that those medicinal products comply with the legislation of the destination member state . __________________ 28 directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services .


### identification of the animal under treatment ; ### identification of the animal under treatment and the diagnosis of the disease to be treated ;


### any necessary warnings ; ### any necessary warnings including , when relevant , the risks entailed by not applying a responsible use of antimicrobials ;


### veterinary prescriptions shall be recognised throughout the union . a veterinary medicinal product prescribed shall be supplied in accordance with applicable national law . ### veterinary prescriptions issued by a veterinarian shall be recognised throughout the union . a veterinary medicinal product prescribed shall be supplied in accordance with applicable national law .


### veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation . ### veterinary medicinal products shall be used responsibly in accordance with the principle of good animal husbandry and with the terms of the marketing authorisation .


### identification of the animals treated ; ### identification of the animals treated and the diagnosis of the disease treated ;


### the competent authorities shall cooperate with each other in the performance of their tasks under this regulation and shall give the competent authorities of other member states necessary and useful support to this end . competent authorities shall communicate the appropriate information to each other , particularly regarding compliance with the requirements for the manufacturing and wholesale distribution authorisations , for the certificates of good manufacturing practice or for marketing authorisations . ### the competent authorities shall cooperate with each other in the performance of their tasks under this regulation and shall give the competent authorities of other member states necessary and useful support to this end . competent authorities shall communicate the appropriate information to each other and other authorities concerned , particularly regarding compliance with the requirements for the manufacturing and wholesale distribution authorisations , for the certificates of good manufacturing practice or for marketing authorisations .


### over the past 17 years , key technological progress has been made in the means of communicating and storing data on ship movements allowing the use of automatic identification systems on board of ships for enhanced ship monitoring . as a result , the related costs of equipment to carry out these functions have been significantly reduced . a number of mandatory ship reporting systems have been set up along europe’s coasts , in accordance with the relevant rules adopted by the international maritime organisation . union and national law ensure that ships comply with the reporting requirements in force under those systems . ### over the past 17 years , key technological progress has been made in the means of communicating and storing data on ship movements allowing the use of automatic identification systems on board ships for enhanced ship monitoring . as a result , the related costs of equipment to carry out these functions have been significantly reduced . a number of mandatory ship reporting systems have been set up along europe’s coasts , in accordance with the relevant rules adopted by the international maritime organisation . union and national law ensure that ships comply with the reporting requirements in force under those systems . to that end , progress should be made as regards technological innovation , building on the results achieved thus far , and ensuring that neutrality is always maintained .


### in view of ensuring compliance with the principle of proportionality , smaller operators that do not yet use the national single window and that operate mainly on very short domestic voyages below 20 nautical miles , should have a choice as regards the means of making such number available either via the national single window or the ais . ### in view of ensuring compliance with the principle of proportionality , smaller operators that do not yet use the national single window and that operate mainly on very short domestic voyages below 20 nautical miles , should have a choice as regards the means of making such number available either via the national single window , the ais or another electronic system approved by the member state .


### in as much as measures entail the processing of personal data , those shall be carried out in accordance with union law on the protection of personal data20 . in particular , personal data collected for the purposes of directive 98 / 41 / ec should not be processed and used for any other purpose and should not be retained longer than necessary for the purposes of directive 98 / 41 / ec as specified therein . __________________ 20 in particular regulation no xxx / 2016 of xxx of the european parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data and regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data . ### in as much as measures entail the processing of personal data , those shall be carried out in accordance with union law on the protection of personal data20 . in particular , personal data collected for the purposes of directive 98 / 41 / ec should not be processed or used for any other purpose , should not be retained longer than necessary for the purposes of directive 98 / 41 / ec as specified therein , and should be destroyed automatically . __________________ 20 in particular regulation no xxx / 2016 of xxx of the european parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data and regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data .


### in order to take account of developments at international level and to increase transparency , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of excluding amendments to the international instruments from the scope of this directive if necessary and establishing conditions of access for the database kept by the commission to host notifications by member states of exemptions and requests for derogation . 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 . ### in order to take account of developments and technological innovation at international level and to increase transparency , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of excluding amendments to the international instruments from the scope of this directive if necessary and establishing conditions of access for the database kept by the commission to host notifications by member states of exemptions and requests for derogation . 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 .


### in view of the full monitoring cycle of european maritime safety agency visits , the commission should evaluate the implementation of directive 98 / 41 / ec no later than [ seven years after the date referred to in the second subparagraph of article 3 ] and report to the european parliament and the council thereon . member states should cooperate with the commission to gather all information necessary for this evaluation . ### in view of the full monitoring cycle of european maritime safety agency visits , the commission should evaluate the implementation of directive 98 / 41 / ec no later than [ two years after the date referred to in the second subparagraph of article 3 ] and report to the european parliament and the council thereon . member states should cooperate with the commission to gather all information necessary for this evaluation .


### before the passenger ship departs the number of persons on board shall be communicated to the master of the passenger ship and recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu of the european parliament and of the council* or made available to the designated authority by means of automatic identification system . ### before the passenger ship departs the number of persons on board shall be communicated to the master of the passenger ship and recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu of the european parliament and of the council or otherwise made available to the designated authority by means of the automatic identification system . until [ insert date two years after the entry into force of this amending directive ] , if the journey is 20 miles or less , the number of persons on board may , by way of derogation from the first subparagraph , be made available to the designated authority by means of another electronic system provided that that system is approved by the member state and was already in place before [ insert date of entry into force of this amending directive ] .


### before the passenger ship departs the number of persons on board shall be communicated to the master of the passenger ship and recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu of the european parliament and of the council* or made available to the designated authority by means of automatic identification system . ### before the passenger ship departs the number of persons on board shall be communicated to the master of the passenger ship and recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu of the european parliament and of the council* when the journey exceeds 20 miles or made available to the designated authority by means of the automatic identification system or , for all shorter journeys , via another electronic system approved by the member state .


### –when volunteered by a passenger , information concerning the need for special care or assistance in emergency situations . ### –information concerning special care or assistance that may be needed in an emergency .


### each company assuming responsibility for operating a passenger ship shall , where required under articles 4 and 5 of this directive , appoint a passenger registrar responsible for recording the information referred to in those provisions in the single window established pursuant to article 5 of directive 2010 / 65 / eu or making it available by means of automatic identification system . ### each company assuming responsibility for operating a passenger ship shall , where required to record information under articles 4 and 5 of this directive , appoint a passenger registrar responsible for recording that information in accordance with those articles .


### personal data collected in accordance with article 5 shall not be kept by the company longer than necessary for the purposes of this directive namely until the moment the data is recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu . without prejudice to other reporting obligations , once the information is no longer needed for this purpose , it shall be destroyed . ### personal data collected in accordance with article 5 shall not be kept by the company longer than necessary for the purposes of this directive , namely until the moment the data is recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu . once recorded , the data shall be destroyed automatically . without prejudice to other specific reporting obligations required by law , including for statistical purposes , once the information is no longer needed for this purpose , it shall be destroyed automatically .


### without prejudice to other reporting obligations , once the information is no longer needed for this purpose , it shall be destroyed . ### without prejudice to other reporting obligations , once the information is no longer needed for this purpose , it shall be destroyed automatically .


### personal data collected in accordance with article 5 shall not be kept by member states longer than necessary for the purposes of this directive , that is : ### personal data collected in accordance with article 5 shall be kept by member states :


### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . joint clinical assessments should also be carried out on certain medical devices within the meaning of regulation 2017 / 745 of the european parliament and of the council12 which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views . a selection of medical devices for joint clinical assessment should be made based on specific criteria . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . 12 regulation 2017 / 745 of the european parliament and of the council of 5 april 2017 on medical devices , amending directive 2001 / 83 / ec , regulation no 178 / 2002 and regulation no 1223 / 2009 and repealing council directives 90 / 385 / eec and 93 / 42 / eec . ### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency .


### in the preparation of the study , the coordination group shall consult : ### in the preparation of the study , the coordination group shall be conscious of breakthrough innovations and seek the input of all relevant stakeholders with the aim of exploring new possibilities in innovation . the coordination group shall consult all relevant stakeholders , including but not limited to :


### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors . ### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product sector .


### public - public partnerships should aim to develop closer synergies , increase coordination and avoid unnecessary duplication with union , international , national and regional research programmes , and should fully respect the horizon 2020 general principles , in particular those relating to openness and transparency . ### public - public partnerships must aim to develop closer synergies , increase coordination and avoid unnecessary duplication and fragmentation with union , international , national and regional research programmes , and should fully respect the horizon 2020 general principles , in particular those relating to openness and transparency . a good , timely dissemination of comprehensive information together with the transparency of results and of the financial management are crucial for the success of prima .


### regulation no 1291 / 2013 acknowledges that international cooperation with third countries is necessary to address effectively common challenges . international cooperation in research and innovation is a key aspect of the union’s global commitments and has an important role to play in the union’s partnership with neighbourhood countries . this cooperation follows the approach taken in the european neighbourhood policy to differentiate the level of cooperation with each country in the neighbourhood based on their commitment towards the union . ### regulation no 1291 / 2013 acknowledges that international cooperation with third countries is necessary to address effectively common challenges . international cooperation in research , science and innovation is a key aspect of the union’s global commitments and has an important role to play in the union’s partnership with neighbourhood countries . this cooperation follows the approach taken in the european neighbourhood policy to differentiate the level of cooperation with each country in the neighbourhood based on their commitment towards the union .


### prima aims at implementing a joint programme for the development and the adoption of innovative and integrated solutions for improving the efficiency , safety , security and sustainability of food production and water provision in the mediterranean area . prima should contribute to the achievement of the recently agreed sustainable development goals and to the forthcoming european sustainable development strategy . ### the lack of clean water and nutritious food has adverse effects on the health and stability of the populations , and prima aims at implementing a joint programme for the development and the adoption of innovative multi - dimensional and integrated common solutions for improving the efficiency , safety , security and sustainability of agri - food production and water provision , treatment and reuse in the mediterranean area based on principles of co - ownership , mutual interest and shared benefit . taking into account that access to water and sanitation constitutes a fundamental human right and since securing food and water availability is of paramount importance in the region , prima must contribute to the achievement of the recently agreed sustainable development goals and to the forthcoming european sustainable development strategy , as well as to contribute to the goals of the paris agreement .


### in order to ensure the joint implementation of prima , an implementation structure should be set up . the prima - is should be the recipient of the union’s financial contribution and it should ensure the efficient implementation of prima . ### in order to ensure the joint implementation of prima , an implementation structure should be set up . the prima - is should be the recipient of the union’s financial contribution and it should ensure the efficient and transparent implementation of prima .


### a ceiling should be established for the union’s contribution in prima with funding from horizon 2020 . within that ceiling , the union contribution should be equal to the contribution of the participating states to prima in order to achieve a high leverage effect and ensure a stronger integration of the participating states ' programmes . it should be possible to use a limited part of the union contribution to cover administrative costs of the prima - is . ### a ceiling should be established for the union’s contribution in prima with funding from horizon 2020 . within that ceiling , the union contribution should be equal to the contribution of the participating states to prima in order to achieve a high leverage effect and ensure a stronger integration of the participating states ' programmes . it should be possible to use a limited part of the union contribution to cover administrative costs of the prima - is . an efficient administration of the programme should be ensured and administrative costs should be kept at minimum .


### calls for proposals managed by the prima - is should also be published on the single portal for participants , as well as through other horizon 2020 electronic means of dissemination managed by the commission . ### calls for proposals and reasoned decisions regarding the selection of projects managed by the prima - is should also be published on the single portal for participants , as well as through other horizon 2020 electronic means of dissemination managed by the commission .