### before proposing the adoption of any measure pursuant to this regulation , the commission should inform the member state concerned why it considers that a generalised deficiency regarding the rule of law might exist in that member state . the member state should be allowed to submit its observations . the commission and the council should take those observations into account . ### before any measure pursuant to this regulation is proposed for adoption , the european court of justice should have ruled on the situation regarding breach of the rule of law . however , the commission must inform the member state concerned why it considers that a generalised deficiency regarding the rule of law might exist in that member state . the member state must be allowed to submit its observations . the commission , parliament and the council should take those observations into account .


### the identification of a generalised deficiency requires a qualitative assessment by the commission . that assessment could be based on the information from all available sources and recognized institutions , including judgments of the court of justice of the european union , reports of the court of auditors , and conclusions and recommendations of relevant international organisations and networks , such as the bodies of the council of europe and the european networks of supreme courts and councils for the judiciary . ### the identification of a potential generalised deficiency requires an impartial , transparent , qualitative assessment at the initiative of the commission , under the same conditions applicable to all member states . that assessment should factor in all the information from all available sources and recognised institutions , including judgments of the court of justice of the european union , which is the only institution which can rule on fulfilment or otherwise of the conditions set out in the eu treaties , reports of the court of auditors , and conclusions and recommendations of relevant international organisations and networks , such as the bodies of the council of europe and the european networks of supreme courts and councils for the judiciary .


### where the commission finds that it has reasonable grounds to believe that the conditions of article 3 are fulfilled , it shall send a written notification to that member state , setting out the grounds on which it based its finding ### where the commission finds that it has proved and clearly identified&#160 ; grounds to believe that the conditions of article 3 are fulfilled , it shall send a written notification to that member state , setting out the grounds on which it based its finding


### where the commission finds that it has reasonable grounds to believe that the conditions of article 3 are fulfilled , it shall send a written notification to that member state , setting out the grounds on which it based its finding ### where the commission finds that it has reasonable grounds to believe that the conditions of article 3 are fulfilled , it shall ask for an assessment by the independent panel of experts , and send a written notification to the member state concerned , setting out the grounds on which it based its finding . the commission shall also inform the european parliament and the council of this notification .


### the identification of a generalised deficiency requires a qualitative assessment by the commission . that assessment could be based on the information from all available sources and recognized institutions , including judgments of the court of justice of the european union , reports of the court of auditors , and conclusions and recommendations of relevant international organisations and networks , such as the bodies of the council of europe and the european networks of supreme courts and councils for the judiciary . ### the identification of a potential generalised deficiency requires an impartial , transparent , qualitative assessment at the initiative of the commission , under the same conditions applicable to all member states . that assessment should factor in all the information from all available sources and recognised institutions , including judgments of the court of justice of the european union , which is the only institution that can rule on fulfilment or otherwise of the conditions set out in the eu treaties , reports of the court of auditors , and conclusions and recommendations of relevant international organisations and networks , such as the bodies of the council of europe and the european networks of supreme courts and councils for the judiciary .


### where the commission finds that it has reasonable grounds to believe that the conditions of article 3 are fulfilled , it shall send a written notification to that member state , setting out the grounds on which it based its finding ### where , based on a ruling of the european court of justice , the commission finds there are reasonable grounds to believe that the conditions of article 3 are fulfilled , it shall send a written notification to the member state concerned , setting out the grounds on which it based its findings , but only after first informing parliament and the council .


### before proposing the adoption of any measure pursuant to this regulation , the commission should inform the member state concerned why it considers that a generalised deficiency regarding the rule of law might exist in that member state . the member state should be allowed to submit its observations . the commission and the council should take those observations into account . ### before any measure pursuant to this regulation is proposed for adoption , the european court of justice should have ruled on the situation regarding a breach of the rule of law . however , the commission must inform the member state concerned why it considers that a generalised deficiency regarding the rule of law might exist in that member state . the member state must be allowed to submit its observations . the commission , parliament and the council should take those observations into account .


### 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 .


### 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 .


### 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 . ### in light of the increasing convergence between sectors providing electronic communication services and the horizontal dimension of regulatory issues related to their development , berec should coordinate the work , and 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 , the european union agency for network and information security32 , the consumer protection cooperation network , and european standardisation organisations ; 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 .


### article 2 tasks the tasks of berec shall be to : assist , advise and cooperate with the commission as well as nras , on request or on its own initiative , on any technical matter within its mandate , and assist and advise the european parliament and the council on request ; issue decisions : - on the identification of transnational markets in accordance with article 63 of the directive ; - on a contract summary template in accordance with article 95 of the directive ; develop an economic model in order to assist the commission in determining the maximum termination rates in the union in accordance with article 73 of the directive ; issue opinions as referred to in the directive and regulation no 531 / 2012 , in particular : - on the resolution of cross - border disputes in accordance with article 27 of the directive ; - on draft national measures related to the internal market procedures for market regulation in accordance with articles 32 , 33 and 66 of the directive ; - on draft national measures related to the internal market procedures for radio spectrum peer review in accordance with article 35 of the directive ; - on draft decisions and recommendations on harmonisation in accordance with article 38 of the directive ; issue guidelines as referred to in the directive , regulation no 531 / 2012 and regulation no 2015 / 2120 : - on the implementation of nras’ obligations as regards geographical surveys in accordance with article 22 of the directive ; - on common approaches to the identification of the network termination point in different network topologies in accordance with article 59 of the directive ; - on common approaches to meet transnational end - user demand in accordance with article 64 of the directive ; - on the minimum criteria for a reference offer in accordance with article 67 of the directive ; - on the technical details of the cost model to be applied by nras when setting maximum symmetric termination rates in accordance with article 73 of the directive ; - on common criteria for the assessment of the ability to manage numbering resources and the risk of exhaustion of numbering resources in accordance with article 87 of the directive ; - on relevant quality of service parameters and the applicable measurement methods in accordance with article 97 of the directive ; - on the implementation of nras’ obligations as regards open internet access in accordance with article 5 of regulation no 2015 / 2120 ; - on wholesale roaming access in accordance with article 3 of regulation no 531 / 2012 ; 2 . berec shall also carry out the following tasks : monitor and coordinate the action of nras in applying regulation no 531 / 2012 , in particular as regards the provision of regulated retail roaming services at domestic prices in the interests of end - users ; report on technical matters within its competence , in particular : - on the practical application of the opinions and guidelines referred to in article 2 and 2 ; - on the level of interoperability between interpersonal communications services , threat to effective access to emergency services or to end - to - end connectivity between end - users in accordance with article 59 of the directive ; - on the evolution of retail and wholesale charges for roaming services and on transparency and comparability of tariffs in accordance with article 19 of regulation no 531 / 2012 ; - on the outcomes of the annual reports that nras shall provide in accordance with article 5 of regulation no 2015 / 2120 , through the publication of an annual synthesis report . keep a register of : - undertakings providing electronic communications networks and services in accordance with article 12 of the directive . berec shall also issue standardised declarations on notifications by undertakings in accordance with article 14 of the directive ; - numbers with a right of extraterritorial use in accordance with article 87 of the directive ; carry out other tasks conferred on it by legal acts of the union in particular by the directive , regulation no 531 / 2012 and regulation no 2015 / 2120 . 3 . without prejudice to compliance with relevant union law , nras shall comply with any decision and take the utmost account of any opinion , guideline , recommendation and best practice adopted by berec with the aim of ensuring a consistent implementation of the regulatory framework for electronic communications within the scope referred to in article 1 . 4 . in so far as is necessary in order to achieve the objectives set out in this regulation and perform its tasks , berec may cooperate with competent union bodies , agencies , offices and advisory groups , with competent authorities of third countries and / or with international organisations , in accordance to article 26 . ### article 2 tasks of berec the tasks of berec shall be to : assist , advise and cooperate with nras and the commission , on request or on its own initiative , on any technical matter within its mandate , and provide opinions or recommendations to the european parliament , the council and the commission on request or on its own initiative on any issue within its competences ; promote cooperation between nras , and between nras and the commission ; issue recommendations and best practices addressed to the nras in order to encourage consistent implementation on any technical matter within its mandate ; issue decisions in accordance with the relevant provisions of the directive ; develop an economic model in order to assist the commission in determining the maximum termination rates in the union in accordance with article 73 of the directive ; issue opinions as referred to in the directive and regulation no 531 / 2012 ; issue guidelines as referred to in the directive , regulation no 531 / 2012 and regulation no 2015 / 2120 ; monitor and coordinate the action of nras in applying regulation no 531 / 2012 , in particular as regards the provision of regulated retail roaming services at domestic prices in the interests of end - users , the evolution of retail and wholesale charges for roaming services and the transparency and comparability of tariffs , and where necessary make recommendations to the commission ; report on technical matters within berec ' s competence ; 2 . berec shall also carry out other tasks conferred to it by legal acts of the union , in particular by the directive , regulation no 531 / 2012 and regulation no 2015 / 2120 . 2a . berec may , upon a reasoned request from the commission , decide unanimously to take on other specific tasks necessary for the accomplishment of its role as provided for in article 1 . 3 . without prejudice to compliance with relevant union law , nras shall comply with any decision and take the utmost account of any opinion , guideline , recommendation and best practice adopted by berec with the aim of ensuring a consistent implementation of the regulatory framework for electronic communications within the scope referred to in article 1 . 4 . in so far as is necessary in order to achieve the objectives set out in this regulation and perform its tasks , berec may cooperate with competent union bodies , agencies , offices and advisory groups , with competent authorities of third countries and / or with international organisations , in accordance to article 26 . 4a . berec may consult relevant stakeholders in the preparation of its decisions , reports or other types of deliverables . without prejudice to article 28 , the main results of that consultation shall be made public . 4b . without prejudice to article 27 , berec shall make relevant information related to the result of it work available and easily accessible to the public and interested parties .


### the management board shall be composed of one representative from each member state and two representatives of the commission , all with voting rights . each nra shall be responsible for nominating its respective representative amongst the head or members of the collegiate body of the nra . ### the management board shall be composed of one representative from each member state , all with voting rights . each nra shall be responsible for nominating its respective representative amongst the head or members of the collegiate body of the nra . the representatives of the commission shall take part in the deliberations , with the right to vote on administrative matters and without the right to vote on regulatory matters as referred to in article 2 .


### experience has shown that most of berec’s tasks are better carried out through working groups , therefore the management board should be in charge of setting up working groups and appointing their members . in order to ensure a balanced approach , the working groups should be coordinated and moderated by members of the berec staff . lists of qualified experts should be prepared in advance to ensure a quick set - up of certain working groups , in particular those related to internal market procedures for draft national measures on market regulation and on assignments of rights of use for radio spectrum , due to the time limits of those procedures . ### experience has shown that most of berec’s tasks are better carried out through working groups , therefore the management board should be in charge of setting up working groups and appointing their members . in order to ensure a balanced approach , the working groups should be coordinated and moderated by members of the berec staff . lists of qualified experts should be prepared in advance to ensure a quick set - up of certain working groups , in particular those related to internal market procedures for draft national measures on market regulation and on assignments of rights of use for radio spectrum , due to the time limits of those procedures . lists of qualified expert members of working groups , together with their declaration of interests , should be made publicly available .


### 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 .


### the commission and the european external action service shall monitor the fulfilment of this pre - condition throughout the life - cycle of the union ' s macro - financial assistance . ### the commission and the european external action service shall monitor the fulfilment of the pre - condition laid down in paragraph 1 of this article throughout the life - cycle of the union ' s macro - financial assistance . before any instalment is released , they shall report to the european parliament and the council on the level of fulfilment of this pre - condition , against clearly defined benchmarks . should 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 be insufficient , the release of instalments shall be immediately suspended .


### the commission shall regularly inform the european parliament and the council of developments regarding the union ' s macro - financial assistance , including disbursements thereof , and shall provide those institutions with the relevant documents in due time . ### the commission shall regularly inform the european parliament and the council of developments regarding the union ' s macro - financial assistance , including disbursements thereof , and shall provide those institutions with the relevant documents , including the draft memorandum of understanding , in due time .


### the prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease . the person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds . furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra - indication or interaction where several medicinal products are used . ### the prescribed medicated feed may be used only for animals examined by the veterinarian who issued the prescription and only for a diagnosed disease . the veterinarian who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds . furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra - indication or interaction where several medicinal products are used .


### medicated feed and intermediate products shall be placed on the market only in sealed packages or containers . packages or containers shall be sealed in such a way that , when the package or container is opened , the seal is damaged and cannot be reused . ### medicated feed and intermediate products shall be placed on the market only in properly labelled and sealed packages or containers . packages or containers shall be sealed in such a way that , when the package or container is opened , the seal is damaged and cannot be reused .


### 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 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 . '


### 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 clarity regarding the terminology in eu law , the term “posting” should only be used for the posting of workers within the meaning of 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 services . 34 in addition , to achieve consistency in treatment between employed and self - employed persons it is necessary that the special rules for the determination of applicable legislation in the cases of workers who are temporarily posted or sent to another member state should apply consistently to both employed and self - employed persons . __________________ 34 oj l 018 , 21 . 01 . 1997 p . 1 . ### to achieve consistency in treatment between employed and self - employed persons it is necessary that the special rules for the determination of applicable legislation in the cases of workers who are temporarily sent to another member state should apply consistently to both employed and self - employed persons .


### the competent institution of the member state whose legislation is determined to be applicable either provisionally or definitively shall without delay inform the person concerned and / or his or her employer . ### the competent institution of the member state whose legislation is determined to be applicable either provisionally or definitively shall without delay inform the person concerned and his or her employer .


### if a recipient of long - term care benefits in cash , which have to be treated as sickness benefits and are therefore provided by the member state competent for cash benefits under articles 21 or 29 , is , at the same time and under this chapter , entitled to claim benefits in kind intended for the same purpose from the institution of the place of residence or stay in another member state , and an institution in the first member state is also required to reimburse the cost of these benefits in kind under article 35 , the general provision on prevention of overlapping of benefits laid down in article 10 shall be applicable , with the following restriction only : if the person concerned claims and receives the benefit in kind , the amount of the benefit in cash shall be reduced by the amount of the benefit in kind which is or could be claimed from the institution of the first member state required to reimburse the cost . ### in article 34 , paragraph 1 is replaced by the following : “1 . if a recipient of long - term care benefits in cash , provided under articles 21 or 29 , is , at the same time and under this chapter , entitled to claim benefits in kind intended for the same purpose from the institution of the place of residence or stay in another member state , and an institution in the first member state is also required to reimburse the cost of these benefits in kind under article 35 , the general provision on prevention of overlapping of benefits laid down in article 10 shall be applicable , with the following restriction only : if the person concerned claims and receives the benefit in kind , the amount of the benefit in cash shall be reduced by the amount of the benefit in kind which is or could be claimed from the institution of the first member state required to reimburse the cost . ”


### –the issuance , the format and the contents of a portable document certifying the social security legislation which applies to the holder , ### –the issuance , the format and the contents of a portable electronic document certifying the social security legislation which applies to the holder ,


### for the purposes of the application of article 19 of the basic regulation , the insured person shall present to the health care provider in the member state of stay a document issued by the competent institution indicating his entitlement to benefits in kind . if the insured person does not have such a document , the institution of the place of stay , upon request or if otherwise necessary , shall contact the competent institution in order to obtain one . ### in article 25 , paragraph 1is replaced by the following : for the purposes of the application of article 19 of the basic regulation , the insured person shall present to the health care or long - term care provider in the member state of stay a document issued by the competent institution indicating his entitlement to benefits in kind . if the insured person does not have such a document , the institution of the place of stay , upon request or if otherwise necessary , shall contact the competent institution in order to obtain one .


### a frontier worker who has retired because of old - age or invalidity is entitled in the event of sickness to continue to receive benefits in kind in the member state where he / she last pursued his / her activity as an employed or self - employed person , in so far as this is a continuation of treatment which began in that member state . ' continuation of treatment ' means the continued investigation , diagnosis and treatment of an illness for its entire duration . ### in article 28 , the first subparagraph is replaced by the following : “1 . a frontier worker who has retired because of old - age or invalidity is entitled in the event of sickness or the need for long - term care to continue to receive benefits in kind in the member state where he / she last pursued his / her activity as an employed or self - employed person , in so far as this is a continuation of treatment or long - term care which began in that member state . ‘ continuation of treatment’ means the continued investigation , diagnosis and treatment of an illness for its entire duration ; ' continuation of long - term care ' means the continued granting of long - term care benefits in kind due to the need of care which was established already before retirement and which continues beyond that date . ”


### in order to ensure clarity regarding the terminology in eu law , the term “posting” should only be used for the posting of workers within the meaning of 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 services . 34 in addition , to achieve consistency in treatment between employed and self - employed persons it is necessary that the special rules for the determination of applicable legislation in the cases of workers who are temporarily posted or sent to another member state should apply consistently to both employed and self - employed persons . __________________ 34 oj l 018 , 21 . 01 . 1997 p . 1 . ### in order to ensure clarity regarding the terminology in eu law , the term “posting” should only be used for the posting of workers within the meaning of 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 services . 34 in addition , to achieve consistency in treatment between employed and self - employed persons it is necessary that the special rules of this regulation for the determination of applicable legislation in the cases of workers and self - employed who are temporarily sent to another member state should apply consistently to both employed and self - employed persons . __________________ 34 oj l 018 , 21 . 01 . 1997 p . 1 .


### 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 .


### –the determination of situations in which the document shall be issued , ### –the determination of situations in which the document shall be issued , rectified or withdrawn ,


### article 30 contributions by pensioners the institution of a member state which is responsible under the legislation it applies for making deductions in respect of contributions for sickness , maternity and equivalent paternity benefits , may request and recover such deductions , calculated in accordance with the legislation it applies , only to the extent that the cost of the benefits pursuant to articles 23 to 26 is to be borne by an institution of the said member state . 2 . where , in the cases referred to in article 25 , the acquisition of sickness , maternity and equivalent paternity benefits is subject to the payment of contributions or similar payments under the legislation of a member state in which the pensioner concerned resides , these contributions shall not be payable by virtue of such residence . ### article 30 is replaced by the following : “article 30 contributions by pensioners the institution of a member state which is responsible under the legislation it applies for making deductions in respect of contributions for sickness , long - term care , maternity and equivalent paternity benefits , may request and recover such deductions , calculated in accordance with the legislation it applies , only to the extent that the cost of the benefits pursuant to articles 23 to 26 is to be borne by an institution of the said member state . 2 . where , in the cases referred to in article 25 , the acquisition of sickness , long - term care , maternity and equivalent paternity benefits is subject to the payment of contributions or similar payments under the legislation of a member state in which the pensioner concerned resides , these contributions shall not be payable by virtue of such residence . ”


### if a recipient of long - term care benefits in cash , which have to be treated as sickness benefits and are therefore provided by the member state competent for cash benefits under articles 21 or 29 , is , at the same time and under this chapter , entitled to claim benefits in kind intended for the same purpose from the institution of the place of residence or stay in another member state , and an institution in the first member state is also required to reimburse the cost of these benefits in kind under article 35 , the general provision on prevention of overlapping of benefits laid down in article 10 shall be applicable , with the following restriction only : if the person concerned claims and receives the benefit in kind , the amount of the benefit in cash shall be reduced by the amount of the benefit in kind which is or could be claimed from the institution of the first member state required to reimburse the cost . ### in article 34 , paragraph 1 is replaced by the following : “1 . if a recipient of long - term care benefits in cash , provided by the member state competent for cash benefits under articles 21 or 29 , is , at the same time and under this chapter , entitled to claim benefits in kind intended for the same purpose from the institution of the place of residence or stay in another member state , and an institution in the first member state is also required to reimburse the cost of these benefits in kind under article 35 , the general provision on prevention of overlapping of benefits laid down in article 10 shall be applicable , with the following restriction only : if the person concerned claims and receives the benefit in kind , the amount of the benefit in cash shall be reduced by the amount of the benefit in kind which is or could be claimed from the institution of the first member state required to reimburse the cost . ”


### article 23 regime applicable in the event of the existence of more than one regime in the member state of residence or stay if the legislation of the member state of residence or stay comprises more than one scheme of sickness , maternity and paternity insurance for more than one category of insured persons , the provisions applicable under articles 17 , 19 , 20 , 22 , 24 and 26 of the basic regulation shall be those of the legislation on the general scheme for employed persons . ### article 23 is replaced by the following ; ' article 23 regime applicable in the event of the existence of more than one regime in the member state of residence or stay if the legislation of the member state of residence or stay comprises more than one scheme of sickness , long - term care , maternity and paternity insurance for more than one category of insured persons , the provisions applicable under articles 17 , 19 , 20 , 22 , 24 and 26 of the basic regulation shall be those of the legislation on the general scheme for employed persons . '


### article 30 contributions by pensioners the institution of a member state which is responsible under the legislation it applies for making deductions in respect of contributions for sickness , maternity and equivalent paternity benefits , may request and recover such deductions , calculated in accordance with the legislation it applies , only to the extent that the cost of the benefits pursuant to articles 23 to 26 is to be borne by an institution of the said member state . 2 . where , in the cases referred to in article 25 , the acquisition of sickness , maternity and equivalent paternity benefits is subject to the payment of contributions or similar payments under the legislation of a member state in which the pensioner concerned resides , these contributions shall not be payable by virtue of such residence . ### article 30 is replaced by the following : “article 30 contributions by pensioners the institution of a member state which is responsible under the legislation it applies for making deductions in respect of contributions for sickness , maternity and equivalent paternity and long - term care benefits , may request and recover such deductions , calculated in accordance with the legislation it applies , only to the extent that the cost of the benefits pursuant to articles 23 to 26 is to be borne by an institution of the said member state . 2 . where , in the cases referred to in article 25 , the acquisition of sickness , maternity and equivalent paternity and long - term care benefits is subject to the payment of contributions or similar payments under the legislation of a member state in which the pensioner concerned resides , these contributions shall not be payable by virtue of such residence . ”


### a frontier worker who retires is entitled in case of sickness to continue to receive benefits in kind in the member state where he last pursued his activity as an employed or self - employed person , insofar as this is a continuation of treatment which began in that member state . the term ' continuation of treatment ' means the continued investigation , diagnosis and treatment of an illness for its entire duration . ### in article 28 , the first subparagraph is replaced by the following : “1 . a frontier worker who retires because of old - age or invalidity is entitled in the event of sickness or the need for long - term care to continue to receive benefits in kind in the member state where he / she last pursued his or her activity as an employed or self - employed person , in so far as this is a continuation of treatment or long - term care which began in that member state . the term ' continuation of treatment ' means the continued investigation , diagnosis and treatment of an illness for its entire duration . the term ' continuation of long - term care ' means the continued granting of long - term care benefits in kind due to the need of care which was established before retirement and which continues beyond that date . ”


### 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 .


### a frontier worker who has retired because of old - age or invalidity is entitled in the event of sickness to continue to receive benefits in kind in the member state where he / she last pursued his / her activity as an employed or self - employed person , in so far as this is a continuation of treatment which began in that member state . ' continuation of treatment ' means the continued investigation , diagnosis and treatment of an illness for its entire duration . ### in article 28 , the first subparagraph is replaced by the following : “1 . a frontier worker who has retired because of old - age or invalidity is entitled in the event of sickness or the need for long - term care to continue to receive benefits in kind in the member state where he / she last pursued his / her activity as an employed or self - employed person , in so far as this is a continuation of treatment for sickness or of provision of long - term care which began in that member state . ‘ continuation of treatment’ in the case of sickness means the continued investigation , diagnosis and treatment of an illness for its entire duration . ‘ continuation of provision of long - term care’ means the continued granting of long - term care benefits in kind where entitlement to such benefits was established prior to retirement . ”


### a wholly unemployed person referred to in this article may in addition to making themselves available to the employment services of the competent member state also make themselves available to the employment services of the other member state . ### a wholly unemployed person referred to in this article may in addition to making themselves available to the employment services of the competent member state also make themselves available to the employment services of the other member state . he or she shall as well be able to make himself or herself available to a cross - border employment service , providing that such a service exists in the geographic area of his or her job research .


### the benefits in kind referred to in article 19 of the basic regulation shall refer to the benefits in kind which are provided in the member state of stay , in accordance with its legislation , and which become necessary on medical grounds with a view to preventing an insured person from being forced to return , before the end of the planned duration of stay , to the competent member state to obtain the necessary treatment . ### article 25 paragraph 3 is replaced by the following : ' 3 . the benefits in kind referred to in article 19 of the basic regulation shall refer to the benefits in kind which are provided in the member state of stay , in accordance with its legislation , and which become necessary on medical grounds or due to the need for long - term care with a view to preventing an insured person from being forced to return , before the end of the planned duration of stay , to the competent member state to obtain the necessary treatment . '


### 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 sending member state in accordance with title ii of the basic regulation .


### 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 . '


### eur 2 400 000 000 for research infrastructures ; ### eur 3 900 000 000 for research infrastructures ;


### eur 3 000 000 000 for the european institute of innovation and technology ; ### eur 4 000 000 000 for the european institute of innovation and technology ;


### to deliver scientific , economic and societal impact in pursuit of this general objective , the union should invest in research and innovation through horizon europe - a framework programme for research and innovation 2021 - 2027 to support the creation and diffusion of high - quality knowledge and technologies , to strengthen the impact of research and innovation in developing , supporting and implementing union policies , to support the uptake of innovative solutions in industry and society to address global challenges and promote industrial competitiveness ; to foster all forms of innovation , including breakthrough innovation , and strengthen market deployment of innovative solutions ; and optimise the delivery of such investment for increased impact within a strengthened european research area . ### to deliver scientific , economic and societal impact in pursuit of this general objective , the union should invest in research and innovation through horizon europe - a framework programme for research and innovation 2021 - 2027 to support the creation and diffusion of high - quality knowledge and technologies , to strengthen the impact of research and innovation in developing , supporting and implementing union policies , to support the uptake of innovative solutions in industry and society to address global challenges , to actively accompany our transition towards sustainable growth and promote industrial competitiveness ; to foster all forms of innovation , including breakthrough innovation , and strengthen market deployment of innovative solutions ; and optimise the delivery of such investment for increased impact within a strengthened european research area .


### eur 1 700 000 000 for ' sharing excellence ' ; ### eur 3 400 000 000 for ' sharing excellence ' ;


### eur 15 000 000 000 for cluster ' digital and industry ' ; ### eur 18 100 000 000 for cluster ' digital and industry ' ;


### the financial envelope for the implementation of the framework programme for the period 2021 &#8211 ; 2027 shall be eur 94 100 000 000 in current prices for the specific programme referred to in article 1 and , in addition , the amount for the specific programme referred to in article 1 , as laid down in regulation&#8230 ; . establishing the european defence fund . ### the financial envelope for the implementation of the framework programme for the period 2021 &#8211 ; 2027 shall be eur 120 000 000 000 in constant prices for the specific programme referred to in article 1 and , in addition , the amount for the specific programme referred to in article 1 , as laid down in regulation&#8230 ; . establishing the european defence fund .


### eur 13 500 000 000 for pillar iii ' open innovation ' for the period 2021 - 2027 , of which ### eur 13 800 000 000 for pillar iii ' open innovation ' for the period 2021 - 2027 , of which


### eur 2 800 000 000 for cluster ' inclusive and secure society ' ; ### eur 1 800 000 000 for cluster ' inclusive and creative society ' ;


### the commission ' s communication on the interim evaluation of horizon 2020 2 final ) has provided a set of recommendations for this programme , including its rules for participation and dissemination , building on the lessons learnt from the previous programme as well as input from eu institutions and stakeholders . those recommendations include to invest more ambitiously in order to reach critical mass and maximise impact ; to support breakthrough innovation ; to prioritise union research and innovation investments in areas of high added value , notably through mission - orientation , citizen involvement and wide communication ; to rationalise the union funding landscape , including by streamlining the range of partnership initiatives and co - funding schemes ; the development of more and concrete synergies between different union funding instruments , notably with the aim of helping to mobilise under - exploited r&i potential across the union ; to strengthen international cooperation and reinforce openness to third countries ' participation ; and to continue simplification based on implementation experiences from horizon 2020 . ### the commission ' s communication on the interim evaluation of horizon 2020 2 final ) has provided a set of recommendations for this programme , including its rules for participation and dissemination , building on the lessons learnt from the previous programme as well as input from eu institutions and stakeholders . those recommendations include substantially more ambitious investment in order to reach critical mass and maximise impact ; to support breakthrough innovation ; to prioritise union research and innovation investments in areas of high added value , notably through mission - orientation , citizen involvement and wide communication ; to rationalise the union funding landscape , including by streamlining the range of partnership initiatives and co - funding schemes ; the development of more and concrete synergies between different union funding instruments , notably with the aim of helping to mobilise under - exploited r&i potential across the union ; to ensure closer interaction between union funding instruments with a view to achieving objectives such as mobilising under - utilised r&i in the eu , to strengthen international cooperation and reinforce openness to third countries ' participation ; and to continue simplification based on implementation experiences from horizon 2020 .


### eur 6 800 000 000 for marie skłodowska - curie actions ; ### eur 11 300 000 000 for marie skłodowska - curie actions ;


### the commission ' s communication on the interim evaluation of horizon 2020 2 final ) has provided a set of recommendations for this programme , including its rules for participation and dissemination , building on the lessons learnt from the previous programme as well as input from eu institutions and stakeholders . those recommendations include to invest more ambitiously in order to reach critical mass and maximise impact ; to support breakthrough innovation ; to prioritise union research and innovation investments in areas of high added value , notably through mission - orientation , citizen involvement and wide communication ; to rationalise the union funding landscape , including by streamlining the range of partnership initiatives and co - funding schemes ; the development of more and concrete synergies between different union funding instruments , notably with the aim of helping to mobilise under - exploited r&i potential across the union ; to strengthen international cooperation and reinforce openness to third countries ' participation ; and to continue simplification based on implementation experiences from horizon 2020 . ### the commission ' s communication on the interim evaluation of horizon 2020 2 final ) has provided a set of recommendations for this programme , including its rules for participation and dissemination , building on the lessons learnt from the previous programme as well as input from eu institutions and stakeholders . those recommendations include to invest more effectively ambitiously in order to reach critical mass and maximise impact ; to support breakthrough innovation ; to prioritise union research and innovation investments in areas of high added value , notably through mission - orientation , citizen involvement and wide communication ; to rationalise the union funding landscape , including by streamlining the range of partnership initiatives and co - funding schemes ; the development of more and concrete synergies between different union funding instruments , notably with the aim of helping to mobilise under - exploited r&i potential across the union ; to ensure closer interaction between union funding instruments with a view to achieving objectives such as mobilising under - utilised r&i in the eu , to strengthen international cooperation and reinforce openness to third countries ' participation ; and to continue simplification based on implementation experiences from horizon 2020 .


### there is still a lack of sufficiently detailed and comparable data at union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced . therefore it is important to collect data on the sales and use of antimicrobials in animals , data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals , humans and food . to ensure that the information collected can be used effectively , appropriate rules should be laid down concerning the collection and the exchange of data . the member states should be responsible for collecting data on the use of antimicrobials under the coordination of the agency . ### there is still a lack of sufficiently detailed and comparable data at union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced . therefore it is important to collect data on the sales and use of antimicrobials in animals , data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals , humans and food . in particular , better data is needed on how , when , where and why antimicrobials are being used . to ensure that the information collected can be used effectively , appropriate rules should be laid down concerning the collection and the exchange of data . the member states should be responsible for collecting data on the use of antimicrobials under the coordination of the agency .


### a veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law . ### a veterinary prescription of a veterinary medicinal product , other than those listed in article 109 , shall only be issued by a person qualified to do so in accordance with applicable national law .


### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care , and only in the amount required for the treatment concerned . ### veterinarians qualified to prescribe veterinary medicinal products in accordance with applicable national law shall dispense antimicrobial products only for animals which are under their immediate care after appropriate examination and diagnosis , and only in the amount required for the treatment concerned .


### where medicinal products are authorised within a member state and have been prescribed in that member state by a member of a regulated animal health profession for an individual animal or group of animals , it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another member state . the removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription . ### where medicinal products are authorised within a member state and have been prescribed in that member state by a veterinarian for an individual animal or group of animals , it should in principle be possible for that veterinary prescription to be recognised and for the medicinal product to be dispensed in another member state . the removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription .


### member states shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products . ### member states shall collect relevant , comparable and sufficiently detailed data on the volume of sales and the use of veterinary antimicrobial medicinal products .


### any observation of a lack of efficacy of a veterinary medicinal product following administration to an animal in accordance with the summary of product characteristics ; ### any observation of a lack of efficacy of a veterinary medicinal product , including signs of antimicrobial resistance , following administration to an animal in accordance with the summary of product characteristics ;


### documentation on the direct or indirect risks to public or animal health of use of the antimicrobial veterinary medicinal product in animals , ### documentation on the direct or indirect risks to public or animal health or the environment of use of the antimicrobial veterinary medicinal product in animals ,


### member states shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the agency . the agency shall analyse the data and publish an annual report . ### member states shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the agency . the agency shall analyse the data and publish an annual report which shall contain guidelines and recommendations as appropriate .


### the commission shall evaluate the implementation of this directive and submit the results of the evaluation to the european parliament and the council no later than [ seven years after the date referred to in the second subparagraph of article 3 ] . ### the commission shall evaluate the implementation of this directive and submit the results of the evaluation to the european parliament and the council no later than [ two years after the date referred to in the second subparagraph of article 3 ] .


### 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 ] .


### the power to adopt delegated acts referred to in articles 9 and 12 shall be conferred on the commission for an indeterminate period of time from [ the date of entry into force ] . ### the power to adopt delegated acts referred to in articles 9 and 12 shall be conferred on the commission for a period of five years , which may be extended , from [ the date of entry into force ] .


### personal data collected for the purposes of this directive should not be processed and used for any other purpose . ### personal data collected for the purposes of this directive should not be processed or used for any other purpose and must be destroyed automatically .


### that information shall be collected before departure and recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu upon the passenger ship’s departure but in no case later than thirty minutes after its departure . ### that information shall be collected before departure and recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu upon the passenger ship’s departure but in no case later than 10 minutes after its departure .


### 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 .


### 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 .


### 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 .


### 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 .


### 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 / 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 classified as high risk class iib implantable devices and class iii devices pursuant to article 51 of regulation 2017 / 745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to article 54 of that regulation and which have already been marketed in at least one member state . _________________ 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 .


### the consultation of patients , clinical experts , and other stakeholders in clinical assessments . ### the consultation of patients , healthcare professionals , clinical experts , and other stakeholders in clinical assessments .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### 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 . ### 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 agro - food systems as well as minimization of food losses and agro - food waste and water provision including reuse and treatment of waste water 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 formulation of a stable , long - term , common strategic agenda in the area of water provision and food systems ; ### the formulation of a stable , long - term , common strategic agenda in the area of water provision including reuse and treatment of waste water and food systems as well as minimization of food losses and agro - food waste ;


### on 23 december 2014 , a group of 19 countries of the mediterranean area submitted to the commission a proposal for a joint programme initiative ' partnership for research and innovation in the mediterranean area ' . among these countries , 14 countries have agreed to jointly undertake the prima initiative by committing financial contributions : cyprus , czech republic , france , greece , italy , luxembourg , malta , portugal and spain , member states of the union ; israel and tunisia , third countries associated to horizon 2020 ; egypt , lebanon and morocco , third countries not associated to horizon 2020 . ### on 23 december 2014 , a group of 19 countries of the mediterranean area submitted to the commission a proposal for a joint programme initiative ' partnership for research and innovation in the mediterranean area ' . among these countries , 14 countries have agreed to jointly undertake the prima initiative by committing financial contributions : cyprus , germany , france , greece , italy , luxembourg , malta , portugal and spain , member states of the union ; israel and tunisia , third countries associated to horizon 2020 ; egypt , lebanon and morocco , third countries not associated to horizon 2020 .


### in order to protect the union ' s financial interests , the commission should have the right to reduce , suspend or terminate the union’s financial contribution if prima is implemented inadequately , partially or late , or if the participating states do not contribute , or contribute partially or late , to the financing of prima . ### in order to protect the union ' s financial interests , the commission should have the right to reduce or suspend the union’s financial contribution if prima is implemented inadequately , partially or late , or if the participating states do not contribute , or contribute partially or late , to the financing of prima .


### the objective of this decision is to strengthen the integration and alignment of research and innovation systems and activities in the mediterranean countries in the fields of water provision and food systems . the scale of the research and innovation necessary to address the challenges in the mediterranean area is immense due to the systemic character of the major bottlenecks . the scope of research and innovation is complex , multidisciplinary and requires a multi - actor and cross - border approach . a collaborative approach with a wide set of participating states can help to increase the required scale and scope , by pooling financial and intellectual resources . since the objective can therefore be better achieved at union level by integrating national efforts into a consistent union approach , by bringing together compartmentalised national research programmes , by helping design common research and funding strategies across national borders , and by achieving the critical mass of actors and investments required , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary in order to achieve those objectives . ### the objective of this decision is to strengthen the integration and alignment of research and innovation systems and activities in the mediterranean countries in the fields of agro - food systems , minimisation food losses and agro - food waste and water provision including reuse and treatment of waste water . the scale of the research and innovation necessary to address the challenges in the mediterranean area is immense due to the systemic character of the major bottlenecks . the scope of research and innovation is complex , multidisciplinary and requires a multi - actor and cross - border approach . a collaborative approach with a wide set of participating states can help to increase the required scale and scope , by pooling financial and intellectual resources . since the objective can therefore be better achieved at union level by integrating national efforts into a consistent union approach , by bringing together compartmentalised national research programmes , by helping design common research and funding strategies across national borders , and by achieving the critical mass of actors and investments required , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this decision does not go beyond what is necessary in order to achieve those objectives .


### the processing of electronic communications data can be useful for businesses , consumers and society as a whole . vis - à - vis directive 2002 / 58 / ec , this regulation broadens the possibilities for providers of electronic communications services to process electronic communications metadata , based on end - users consent . however , end - users attach great importance to the confidentiality of their communications , including their online activities , and that they want to control the use of electronic communications data for purposes other than conveying the communication . therefore , this regulation should require providers of electronic communications services to obtain end - users’ consent to process electronic communications metadata , which should include data on the location of the device generated for the purposes of granting and maintaining access and connection to the service . location data that is generated other than in the context of providing electronic communications services should not be considered as metadata . examples of commercial usages of electronic communications metadata by providers of electronic communications services may include the provision of heatmaps ; a graphical representation of data using colors to indicate the presence of individuals . to display the traffic movements in certain directions during a certain period of time , an identifier is necessary to link the positions of individuals at certain time intervals . this identifier would be missing if anonymous data were to be used and such movement could not be displayed . such usage of electronic communications metadata could , for example , benefit public authorities and public transport operators to define where to develop new infrastructure , based on the usage of and pressure on the existing structure . where a type of processing of electronic communications metadata , in particular using new technologies , and taking into account the nature , scope , context and purposes of the processing , is likely to result in a high risk to the rights and freedoms of natural persons , a data protection impact assessment and , as the case may be , a consultation of the supervisory authority should take place prior to the processing , in accordance with articles 35 and 36 of regulation 2016 / 679 . ### the processing of electronic communications data can be useful for businesses , consumers and society as a whole . however , end - users attach great importance to the confidentiality of their communications , including their online activities , and they want to control the use of electronic communications data for purposes other than conveying the communication . therefore , this regulation should require providers of electronic communications services to obtain end - users’ consent to process electronic communications metadata , which should include data on the location of the device generated for the purposes of granting and maintaining access and connection to the service . location data that is generated other than in the context of providing electronic communications services should not be considered as metadata . examples of usages of electronic communications metadata by providers of electronic communications services may include the provision of heatmaps ; a graphical representation of data using colors to indicate the presence of individuals . such usage of electronic communications metadata could , for example , benefit public authorities and public transport operators to define where to develop new infrastructure , based on the usage of and pressure on the existing structure . where a type of processing of electronic communications metadata , in particular using new technologies , and taking into account the nature , scope , context and purposes of the processing , is likely to result in a high risk to the rights and freedoms of natural persons , a data protection impact assessment and , as the case may be , a consultation of the supervisory authority should take place prior to the processing , in accordance with articles 35 and 36 of regulation 2016 / 679 .


### without prejudice to paragraph 1 , where technically possible and feasible , for the purposes of point of article 8 , consent may be expressed by using the appropriate technical settings of a software application enabling access to the internet . ### where technically possible and feasible for the purposes of point of article 8 consent may be expressed by using the appropriate technical setting of software application enabling access to the internet or by the continued use of the information society service after having been provided with accessible and comprehensive information about this action of the end - user .


### ‘ direct marketing communications’ means any form of advertising , whether written or oral , sent to one or more identified or identifiable end - users of electronic communications services , including the use of automated calling and communication systems with or without human interaction , electronic mail , sms , etc . ; ### ‘ direct marketing communications’ means any form of commercial communication , whether written or oral , sent to one or more identified or identifiable end - users of electronic communications services , including the use of automated calling and communication systems with or without human interaction , electronic mail , sms , etc . ;


### when the processing of electronic communications data by providers of electronic communications services falls within its scope , this regulation should provide for the possibility for the union or member states under specific conditions to restrict by law certain obligations and rights when such a restriction constitutes a necessary and proportionate measure in a democratic society to safeguard specific public interests , including national security , defence , public security and the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , including the safeguarding against and the prevention of threats to public security and other important objectives of general public interest of the union or of a member state , in particular an important economic or financial interest of the union or of a member state , or a monitoring , inspection or regulatory function connected to the exercise of official authority for such interests . therefore , this regulation should not affect the ability of member states to carry out lawful interception of electronic communications or take other measures , if necessary and proportionate to safeguard the public interests mentioned above , in accordance with the charter of fundamental rights of the european union and the european convention for the protection of human rights and fundamental freedoms , as interpreted by the court of justice of the european union and of the european court of human rights . providers of electronic communications services should provide for appropriate procedures to facilitate legitimate requests of competent authorities , where relevant also taking into account the role of the representative designated pursuant to article 3 . ### when the processing of electronic communications data by providers of electronic communications services falls within its scope , this regulation is without prejudice to the possibility for the union or member states under specific conditions to restrict by law certain obligations and rights set out in this regulation when such a restriction is targeted at persons suspected of having committed a criminal offence and constitutes a necessary and proportionate measure in a democratic society to safeguard specific public interests , including national security , defence , public security and the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , including the safeguarding against and the prevention of threats to public security . therefore , this regulation should not affect the ability of member states to carry out lawful interception of electronic communications or take other measures , if necessary and proportionate to safeguard the public interests mentioned above , in accordance with the charter of fundamental rights of the european union and the european convention for the protection of human rights and fundamental freedoms , as interpreted by the court of justice of the european union and of the european court of human rights .


### in the case of a particular risk that may compromise the security of networks and electronic communications services , the provider of an electronic communications service shall inform end - users concerning such risk and , where the risk lies outside the scope of the measures to be taken by the service provider , inform end - users of any possible remedies , including an indication of the likely costs involved . ### in the case of a particular risk that may compromise the security of networks , electronic communications services , information society services , hardware or software , the relevant provider or manufacturer shall inform all end - users of such a risk and , where the risk lies outside the scope of the measures to be taken by the service provider , inform subscribers of any possible remedies .


### the providers of a publicly available directory shall inform end - users who are natural persons whose personal data are in the directory of the available search functions of the directory and obtain end - users’ consent before enabling such search functions related to their own data . ### the providers of a publicly available directory shall provide accessible and intelligible information to end - users who are natural persons whose personal data are in the directory of the available search functions of the directory and provide the end - users ' the option to disable such search functions related to their own data .


### voice - to - voice direct marketing calls that do not involve the use of automated calling and communication systems , given that they are more costly for the sender and impose no financial costs on end - users . member states should therefore be able to establish and or maintain national systems only allowing such calls to end - users who have not objected . ### voice - to - voice direct marketing calls that do not involve the use of automated calling and communication systems should be allowed only if the end - user has not objected . to this end , member states should ensure that an effective do not call register is in place . the service providers enabling marketing calls should offer new subscribers the choice between accepting marketing calls with the designated prefix and having such calls automatically blocked by the service provider .


### the principles of data protection by design and by default were codified under article 25 of regulation 2016 / 679 . currently , the default settings for cookies are set in most current browsers to ‘ accept all cookies’ . therefore providers of software enabling the retrieval and presentation of information on the internet should have an obligation to configure the software so that it offers the option to prevent third parties from storing information on the terminal equipment ; this is often presented as ‘ reject third party cookies’ . end - users should be offered a set of privacy setting options , ranging from higher to lower and intermediate . such privacy settings should be presented in a an easily visible and intelligible manner . ### the principles of data protection by design and by default were codified under article 25 of regulation 2016 / 679 . currently , the default settings for cookies are set in most current browsers to ‘ accept all cookies’ . therefore providers of software enabling the retrieval and presentation of information on the internet should have an obligation to configure the software so that it offers the option to prevent by default the cross - domain tracking and storing of information on the terminal equipment by other parties ; this is often presented as ‘ reject third party trackers and cookies’ . users should be offered , by default , a set of privacy setting options , ranging from higher to lower and intermediate . these options may also be more fine - grained . privacy settings should also include options to allow the user to decide for example , whether flash , javascript or similar software can be executed , if a website can collect geo - location data from the user , or if it can access specific hardware such as a webcam or microphone . such privacy settings should be presented in an easily visible , objective and intelligible manner .


### exceptions to the obligation to obtain consent to make use of the processing and storage capabilities of terminal equipment or to access information stored in terminal equipment should be limited to situations that involve no , or only very limited , intrusion of privacy . for instance , consent should not be requested for authorizing the technical storage or access which is strictly necessary and proportionate for the legitimate purpose of enabling the use of a specific service explicitly requested by the end - user . this may include the storing of cookies for the duration of a single established session on a website to keep track of the end - user’s input when filling in online forms over several pages . cookies can also be a legitimate and useful tool , for example , in measuring web traffic to a website . information society providers that engage in configuration checking to provide the service in compliance with the end - user’s settings and the mere logging of the fact that the end - user’s device is unable to receive content requested by the end - user should not constitute access to such a device or use of the device processing capabilities . ### exceptions to the obligation to obtain consent to make use of the processing and storage capabilities of terminal equipment or to access information stored in terminal equipment should be limited to situations that involve no , or only very limited , intrusion of privacy . for instance , consent should not be requested for authorizing the technical storage or access which is strictly necessary and proportionate for the legitimate purpose of enabling the use of a specific service explicitly requested by the end - user . this may include the storing of cookies for the duration of a single established session on a website to keep track of the end - user’s input when filling in online forms over several pages . cookies can also be a legitimate and useful tool , for example , in measuring web traffic to a website . information society providers that engage in configuration checking to provide the service in compliance with the end - user’s settings and the mere logging of the fact that the end - user’s device is unable to receive content requested by the end - user should not constitute access to such a device or use of the device processing capabilities for which consent is required .


### providers of electronic communications services may process electronic communications metadata if : ### providers of electronic communications services may process electronic communications metadata only if :


### if it is necessary for web audience measuring , provided that such measurement is carried out by the provider of the information society service requested by the end - user . ### if it is necessary for audience measurement , including measurement with the purposes of determining collective rights , remuneration or other payment systems or