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### 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 . ”

### 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 . ”

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

### 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 .

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

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

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

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

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

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

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

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

### 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 . '

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

### in order to be able to supplement or amend the impact pathway indicators , where considered necessary , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . ### in order to be able to supplement or amend the impact pathway indicators , where considered necessary , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents promptly at the same time as member states ' experts , and their experts be systematically invited to meetings of commission expert groups dealing with the preparation of delegated acts .

### in order to be able to supplement or amend the impact pathway indicators , where considered necessary , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . ### in order to be able to supplement or amend the impact pathway indicators , where considered necessary , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents promptly at the same time as member states ' experts , and their experts be systematically invited to meetings of commission expert groups dealing with the preparation of delegated acts .

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

### in order to take account of developments at international level and to increase transparency , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of excluding amendments to the international instruments from the scope of this directive if necessary and establishing conditions of access for the database kept by the commission to host notifications by member states of exemptions and requests for derogation . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . ### in order to take account of developments and technological innovation at international level and to increase transparency , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of excluding amendments to the international instruments from the scope of this directive if necessary and establishing conditions of access for the database kept by the commission to host notifications by member states of exemptions and requests for derogation . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 2016 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states’ experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts .

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

### for the purpose of simplification , administrative burden should be reduced for all parties . double audits and disproportionate documentation and reporting should be avoided . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate . ### for the purpose of simplification , administrative burden should be strictly proportionate to the foreseen effects for all parties . double audits and disproportionate documentation and reporting should be avoided . harmonised methodology for data collection from the participating states should be set . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate .

### for the purpose of simplification , administrative burden should be reduced for all parties . double audits and disproportionate documentation and reporting should be avoided . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate . ### for the purpose of simplification , administrative burden should be strictly proportionate to the foreseen effects for all parties . double audits and disproportionate documentation and reporting should be avoided . harmonised methodology for data collection from the participating states should be set . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate .

### for the purpose of simplification , administrative burden should be reduced for all parties . double audits and disproportionate documentation and reporting should be avoided . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate . ### for the purpose of simplification , administrative burden should be strictly proportionate to the foreseen effects for all parties . double audits and disproportionate documentation and reporting should be avoided . harmonised methodology for data collection from the participating states should be set . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate .

### for the purpose of simplification , administrative burden should be reduced for all parties . double audits and disproportionate documentation and reporting should be avoided . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate . ### for the purpose of simplification , administrative burden should be strictly proportionate to the foreseen effects for all parties . double audits and disproportionate documentation and reporting should be avoided . harmonised methodology for data collection from the participating states should be set . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate .

### for the purpose of simplification , administrative burden should be reduced for all parties . double audits and disproportionate documentation and reporting should be avoided . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate . ### for the purpose of simplification , administrative burden should be strictly proportionate to the foreseen effects for all parties . double audits and disproportionate documentation and reporting should be avoided . harmonised methodology for data collection from the participating states should be set . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate .

### for the purpose of simplification , administrative burden should be reduced for all parties . double audits and disproportionate documentation and reporting should be avoided . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate . ### for the purpose of simplification , administrative burden should be strictly proportionate to the foreseen effects for all parties . double audits and disproportionate documentation and reporting should be avoided . harmonised methodology for data collection from the participating states should be set . when audits are conducted , the specificities of the national programmes should be taken into account , as appropriate .

### the general objective of prima is to develop the fully piloted and demonstrated common innovative solutions for water provision and food systems in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving nutrition , health , well - being and migration problems upstream . ### the general objective of prima is to develop the fully piloted and demonstrated common innovative solutions for water provision including reuse and treatment of waste water and agro - food systems as well as minimization of food losses and agro - food waste in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving nutrition , health , well - being and migration problems upstream .

### the general objective of prima is to develop the fully piloted and demonstrated common innovative solutions for water provision and food systems in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving nutrition , health , well - being and migration problems upstream . ### the general objective of prima is to develop the fully piloted and demonstrated common innovative solutions for water provision including reuse and treatment of waste water and agro - food systems as well as minimization of food losses and agro - food waste in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving nutrition , health , well - being and migration problems upstream .

### the general objective of prima is to develop the fully piloted and demonstrated common innovative solutions for water provision and food systems in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving nutrition , health , well - being and migration problems upstream . ### the general objective of prima is to develop the fully piloted and demonstrated common innovative solutions for water provision including reuse and treatment of waste water and agro - food systems as well as minimization of food losses and agro - food waste in the mediterranean region , to make them more climate resilient , efficient , cost - effective and sustainable , and to contribute to solving nutrition , health , well - being and migration problems upstream .

### 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 heat maps ; 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 . 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 heat maps ; a graphical representation of data using colours 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 further processing of metadata for purposes other than those for which they were initially collected should only be allowed in cases where the processing is compatible with the initial purpose for which consent was obtained and is subject to specific safeguards , especially pseudonymisation as set forth in point of article 6 of regulation 2016 / 679 .

### the content of electronic communications pertains to the essence of the fundamental right to respect for private and family life , home and communications protected under article 7 of the charter . any interference with the content of electronic communications should be allowed only under very clear defined conditions , for specific purposes and be subject to adequate safeguards against abuse . this regulation provides for the possibility of providers of electronic communications services to process electronic communications data in transit , with the informed consent of all the end - users concerned . for example , providers may offer services that entail the scanning of emails to remove certain pre - defined material . given the sensitivity of the content of communications , this regulation sets forth a presumption that the processing of such content data will result in high risks to the rights and freedoms of natural persons . when processing such type of data , the provider of the electronic communications service should always consult the supervisory authority prior to the processing . such consultation should be in accordance with article 36 and of regulation 2016 / 679 . the presumption does not encompass the processing of content data to provide a service requested by the end - user where the end - user has consented to such processing and it is carried out for the purposes and duration strictly necessary and proportionate for such service . after electronic communications content has been sent by the end - user and received by the intended end - user or end - users , it may be recorded or stored by the end - user , end - users or by a third party entrusted by them to record or store such data . any processing of such data must comply with regulation 2016 / 679 . ### the content of electronic communications pertains to the essence of the fundamental right to respect for private and family life , home and communications protected under article 7 of the charter . any interference with the content of electronic communications should be allowed only under very clear defined conditions , for specific purposes and be subject to adequate safeguards against abuse . this regulation provides for the possibility of providers of electronic communications services to process electronic communications data in transit , with the informed consent of all the end - users concerned . for example , providers may offer services that entail the scanning of emails to remove certain pre - defined material . for services that are provided to users engaged in purely personal or household activities , for example text to voice service , organisation of the mailbox or spam filter service , the consent of the end - user requesting the service should be sufficient . given the sensitivity of the content of communications , this regulation sets forth a presumption that the processing of such content data will result in high risks to the rights and freedoms of natural persons . when processing such type of data , the provider of the electronic communications service should always consult the supervisory authority prior to the processing . such consultation should be in accordance with article 36 and of regulation 2016 / 679 . the presumption does not encompass the processing of content data to provide a service requested by the end - user where the end - user has consented to such processing and it is carried out for the purposes and duration strictly necessary and proportionate for such service . after electronic communications content has been sent by the end - user and received by the intended end - user or end - users , it may be recorded or stored by the end - user , end - users or by a third party entrusted by them to record or store such data . any processing of such data must comply with regulation 2016 / 679 . where communications data are stored by a third party , this third party should ensure that any information whose processing is not necessary to provide the service requested by the end - user is protected with state of the art security measures applied from end to end , including cryptographic methods such as encryption .

### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage of third party tracking cookies , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept third party cookies’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , at the moment of installation , end - users are informed about the possibility to choose the privacy settings among the various options and ask them to make a choice . information provided should not dissuade end - users from selecting higher privacy settings and should include relevant information about the risks associated to allowing third party cookies to be stored in the computer , including the compilation of long - term records of individuals’ browsing histories and the use of such records to send targeted advertising . web browsers are encouraged to provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites party cookies are always or never allowed . ### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage or reading of tracking cookies for commercial purposes or for direct marketing for non - commercial purposes , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept tracking cookies for commercial purposes or for direct marketing for non - commercial purposes’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , before the first use , end - users are informed about the privacy by default settings and the possibility to change the privacy settings to other options . information provided should not dissuade end - users from maintaining high privacy settings and should include relevant information about the risks associated to allowing the different types of cookies or other tracking mechanisms , to be stored in , or read from , the app or device , including the compilation of long - term records of individuals’ browsing histories , the use of location data , the use of personal data by third parties and the use of such records to send targeted advertising . web browsers should provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites certain categories of cookies are always or never allowed .

### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage of third party tracking cookies , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept third party cookies’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , at the moment of installation , end - users are informed about the possibility to choose the privacy settings among the various options and ask them to make a choice . information provided should not dissuade end - users from selecting higher privacy settings and should include relevant information about the risks associated to allowing third party cookies to be stored in the computer , including the compilation of long - term records of individuals’ browsing histories and the use of such records to send targeted advertising . web browsers are encouraged to provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites party cookies are always or never allowed . ### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage or reading of tracking cookies for commercial purposes or for direct marketing for non - commercial purposes , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept tracking cookies for commercial purposes or for direct marketing for non - commercial purposes’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , before the first use , end - users are informed about the privacy by default settings and the possibility to change the privacy settings to other options . information provided should not dissuade end - users from maintaining high privacy settings and should include relevant information about the risks associated to allowing the different types of cookies or other tracking mechanisms , to be stored in , or read from , the app or device , including the compilation of long - term records of individuals’ browsing histories , the use of location data , the use of personal data by third parties and the use of such records to send targeted advertising . web browsers should provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites certain categories of cookies are always or never allowed .

### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage of third party tracking cookies , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept third party cookies’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , at the moment of installation , end - users are informed about the possibility to choose the privacy settings among the various options and ask them to make a choice . information provided should not dissuade end - users from selecting higher privacy settings and should include relevant information about the risks associated to allowing third party cookies to be stored in the computer , including the compilation of long - term records of individuals’ browsing histories and the use of such records to send targeted advertising . web browsers are encouraged to provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites party cookies are always or never allowed . ### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage or reading of tracking cookies for commercial purposes or for direct marketing for non - commercial purposes , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept tracking cookies for commercial purposes or for direct marketing for non - commercial purposes’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , before the first use , end - users are informed about the privacy by default settings and the possibility to change the privacy settings to other options . information provided should not dissuade end - users from maintaining high privacy settings and should include relevant information about the risks associated to allowing the different types of cookies or other tracking mechanisms , to be stored in , or read from , the app or device , including the compilation of long - term records of individuals’ browsing histories , the use of location data , the use of personal data by third parties and the use of such records to send targeted advertising . web browsers should provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites certain categories of cookies are always or never allowed .

### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage of third party tracking cookies , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept third party cookies’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , at the moment of installation , end - users are informed about the possibility to choose the privacy settings among the various options and ask them to make a choice . information provided should not dissuade end - users from selecting higher privacy settings and should include relevant information about the risks associated to allowing third party cookies to be stored in the computer , including the compilation of long - term records of individuals’ browsing histories and the use of such records to send targeted advertising . web browsers are encouraged to provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites party cookies are always or never allowed . ### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage or reading of tracking cookies for commercial purposes or for direct marketing for non - commercial purposes , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept tracking cookies for commercial purposes or for direct marketing for non - commercial purposes’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , before the first use , end - users are informed about the privacy by default settings and the possibility to change the privacy settings to other options . information provided should not dissuade end - users from maintaining high privacy settings and should include relevant information about the risks associated to allowing the different types of cookies or other tracking mechanisms , to be stored in , or read from , the app or device , including the compilation of long - term records of individuals’ browsing histories , the use of location data , the use of personal data by third parties and the use of such records to send targeted advertising . web browsers should provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites certain categories of cookies are always or never allowed .

### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage of third party tracking cookies , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept third party cookies’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , at the moment of installation , end - users are informed about the possibility to choose the privacy settings among the various options and ask them to make a choice . information provided should not dissuade end - users from selecting higher privacy settings and should include relevant information about the risks associated to allowing third party cookies to be stored in the computer , including the compilation of long - term records of individuals’ browsing histories and the use of such records to send targeted advertising . web browsers are encouraged to provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites party cookies are always or never allowed . ### for web browsers to be able to obtain end - users’ consent as defined under regulation 2016 / 679 , for example , to the storage or reading of tracking cookies for commercial purposes or for direct marketing for non - commercial purposes , they should , among others , require a clear affirmative action from the end - user of terminal equipment to signify his or her freely given , specific informed , and unambiguous agreement to the storage and access of such cookies in and from the terminal equipment . such action may be considered to be affirmative , for example , if end - users are required to actively select ‘ accept tracking cookies for commercial purposes or for direct marketing for non - commercial purposes’ to confirm their agreement and are given the necessary information to make the choice . to this end , it is necessary to require providers of software enabling access to internet that , before the first use , end - users are informed about the privacy by default settings and the possibility to change the privacy settings to other options . information provided should not dissuade end - users from maintaining high privacy settings and should include relevant information about the risks associated to allowing the different types of cookies or other tracking mechanisms , to be stored in , or read from , the app or device , including the compilation of long - term records of individuals’ browsing histories , the use of location data , the use of personal data by third parties and the use of such records to send targeted advertising . web browsers should provide easy ways for end - users to change the privacy settings at any time during use and to allow the user to make exceptions for or to whitelist certain websites or to specify for which websites certain categories of cookies are always or never allowed .