### the interest shall be calculated on the basis of the reference rate applied by the european central bank to its main refinancing operations . the reference rate applicable shall be that in force on the first day of the month on which the payment is due . ### in article 68 , paragraph 2 is replaced by the following : ' 2 . the interest shall be calculated on the basis of the reference rate applied by the european central bank to its main refinancing operations plus 8 percentage points . the reference rate applicable shall be that in force on the first day of the month on which the payment is due . '


### article 65 unemployed persons who resided in a member state other than the competent state an unemployed person who , during his or her last activity as an employed or self - employed person resided in a member state other than the competent member state shall make himself or herself available to the former employer or to the employment services in the competent member state . such a person shall receive benefits in accordance with the legislation of the competent member state as if he or she were residing in that member state . these benefits shall be provided by the institution of the competent member state . 2 . by way of derogation from paragraph 1 , a wholly unemployed person who , during the last activity as an employed or self - employed person , resided in a member state other than the competent member state , and who had not completed at least 12 months of unemployment insurance exclusively under the legislation of the competent member state shall make himself or herself available to the employment service of the member state of residence . such a person shall receive benefits in accordance with the legislation of the member state of residence as if he or she had completed all periods of insurance under the legislation of that member state . those benefits shall be provided by the institution of the member state of residence . alternatively , a wholly unemployed person referred to in this paragraph , who would be entitled to an unemployment benefit solely under the national legislation of the competent member state if he or she resided there , may instead opt to make themselves available to the employment services in that member state and to receive benefits in accordance with the legislation of that member state as if he or she were residing there . 3 . if a wholly unemployed person referred to in paragraphs 1 or 2 does not wish to become or remain available to the employment services of the competent member state after having been registered there , and wishes to seek work in the member state of residence or the member state of last activity article 64 shall apply mutatis mutandis , except article 64 . the competent institution may extend the period referred to in the first sentence of article 64 up to the end of the period of entitlement to benefits . 4 . a wholly unemployed person referred to in this article may in addition to making themselves available to the employment services of the competent member state also make themselves available to the employment services of the other member state . 5 . paragraphs 2 to 4 of this article shall not apply to a person who is partially or intermittently unemployed . ### article 65 unemployed persons who resided in a member state other than the competent state a person who is partially or intermittently unemployed and who , during his / her last activity as an employed or self - employed person , resided in a member state other than the competent member state shall make himself or herself available to the employer or to the employment services in the competent member state . such a person shall receive benefits in accordance with the legislation of the competent member state as if he or she were residing in that member state . those benefits shall be provided by the institution of the competent member state . 2 . a wholly unemployed person who , during the last activity as an employed or self - employed person , resided in a member state other than the competent member state , and who continues to reside in that member state or returns to that member state shall make himself or herself available to the employment services in the member state of residence . without prejudice to article 64 , a wholly unemployed person may , as a supplementary step , make himself or herself available to the employment services of the member state in which he or she pursued his or her last activity as an employed or self - employed person . an unemployed person , other than a frontier worker , who does not return to his or her member state of residence , shall make himself or herself available to the employment services in the member state to whose legislation he or she was last subject . 3 . the unemployed person referred to in the first sentence of paragraph 2 shall register as a person seeking work with the competent employment services of the member state in which he or she resides , shall be subject to the control procedure organised there and shall adhere to the conditions laid down under the legislation of that member state . if he or she chooses also to register as a person seeking work in the member state in which he or she pursued his or her last activity as an employed or self - employed person , he or she shall comply with the obligations applicable in that state . 4 . the implementation of the second sentence of paragraph 2 and of the second sentence of paragraph 3 , as well as the arrangements for exchanges of information , cooperation and mutual assistance between the institutions and services of the member state of residence and the member state in which he or she pursued his or her last occupation , shall be laid down in the implementing regulation . 5 . the unemployed person referred to in the first and second sentences of paragraph 2 shall receive benefits in accordance with the legislation of the member state of residence as if he or she had been subject to that legislation during his or her last activity as an employed or self - employed person . those benefits shall be provided by the institution of the place of residence . 5a . however , a worker other than a frontier worker who has been provided benefits at the expense of the competent institution of the member state to whose legislation he or she was last subject shall first receive , on his or her return to the member state of residence , benefits in accordance with article 64 , receipt of the benefits in accordance with paragraph 5a being suspended for the period during which he or she receives benefits under the legislation to which he or she was last subject . 5b . the benefits provided by the institution of the place of residence under paragraph 5a and 5b shall continue to be at its own expense . the competent institution of the member state to whose legislation he / she was last subject shall reimburse to the institution of the place of residence the full amount of the benefits provided by the latter institution during the first four months . reimbursement for that period shall be claimed only on condition that the person concerned has , during the 12 months preceding the reimbursement period , completed periods of at least three months in the member state to whose legislation he or she was previously subject and where such periods would qualify for the purposes of establishing entitlement to unemployment benefits in that member state . the amount of the reimbursement during that period shall not be higher than the amount payable , according to the following rules : number of calendar days subject to the reimbursement period ; multiplied by : the average amount per calendar day of the unemployment benefits of the competent member state of the previous calendar year . 5c . a second request for reimbursement by the same unemployed person shall be admissible no earlier than one year after expiry of the previous reimbursement period . 5d . from the end of the 18 - month period referred to in article 67 of the implementing regulation , interest may be charged by the creditor institution on outstanding claims . the interest shall be calculated in accordance with article 68 of the implementing regulation with a supplement of 8 % above the base rate . 5e . during the reimbursement procedure requests or reactions to requests or notifications have to be answered within a period of six months . should the deadline be exceeded , the reimbursement request is considered to be accepted . 5f . the arrangements for reimbursement are laid down in the implementing regulation . 5f . for the purposes of paragraphs 5b to 5e , two or more member states , or their competent authorities , may provide for other methods of reimbursement or waive all reimbursement between the institutions falling under their jurisdiction . ”


### 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 . '


### –the elements to verified before the document can be issued , ### –the elements to be verified before the document can be issued , rectified or withdrawn ,


### for the determination of the applicable legislation under paragraphs 8 and 9 , the institutions concerned shall take into account the situation projected for the following 12 calendar months . ### paragraph 10 is replaced with the following : ‘ 10 . the determination of the applicable legislation within the meaning of article 13 of the basic regulation shall apply for a maximum period of 24 months . once that period has elapsed , the applicable legislation must be reassessed in the light of the employee’s situation . ’


### article 26 scheduled treatment authorisation procedure for the purposes of the application of article 20 of the basic regulation , the insured person shall present a document issued by the competent institution to the institution of the place of stay . for the purposes of this article , the competent institution shall mean the institution which bears the cost of the scheduled treatment ; in the cases referred to in article 20 and 27 of the basic regulation , in which the benefits in kind provided in the member state of residence are reimbursed on the basis of fixed amounts , the competent institution shall mean the institution of the place of residence . 2 . if an insured person does not reside in the competent member state , he shall request authorisation from the institution of the place of residence , which shall forward it to the competent institution without delay . in that event , the institution of the place of residence shall certify in a statement whether the conditions set out in the second sentence of article 20 of the basic regulation are met in the member state of residence . the competent institution may refuse to grant the requested authorisation only if , in accordance with the assessment of the institution of the place of residence , the conditions set out in the second sentence of article 20 of the basic regulation are not met in the member state of residence of the insured person , or if the same treatment can be provided in the competent member state itself , within a time - limit which is medically justifiable , taking into account the current state of health and the probable course of illness of the person concerned . the competent institution shall inform the institution of the place of residence of its decision . in the absence of a reply within the deadlines set by its national legislation , the authorisation shall be considered to have been granted by the competent institution . 3 . if an insured person who does not reside in the competent member state is in need of urgent vitally necessary treatment , and the authorisation cannot be refused in accordance with the second sentence of article 20 of the basic regulation , the authorisation shall be granted by the institution of the place of residence on behalf of the competent institution , which shall be immediately informed by the institution of the place of residence . the competent institution shall accept the findings and the treatment options of the doctors approved by the institution of the place of residence that issues the authorisation , concerning the need for urgent vitally necessary treatment . 4 . at any time during the procedure granting the authorisation , the competent institution shall retain the right to have the insured person examined by a doctor of its own choice in the member state of stay or residence . 5 . the institution of the place of stay shall , without prejudice to any decision regarding authorisation , inform the competent institution if it appears medically appropriate to supplement the treatment covered by the existing authorisation . b . meeting the cost of benefits in kind incurred by the insured person b . meeting the cost of benefits in kind incurred by the insured person 6 . without prejudice to paragraph 7 , article 25 and of the implementing regulation shall apply mutatis mutandis . 7 . if the insured person has actually borne all or part of the costs for the authorised medical treatment him or herself and the costs which the competent institution is obliged to reimburse to the institution of the place of stay or to the insured person according to paragraph 6 are lower than the costs which it would have had to assume for the same treatment in the competent member state , the competent institution shall reimburse , upon request , the cost of treatment incurred by the insured person up to the amount by which the notional cost exceeds the actual cost . the reimbursed sum may not , however , exceed the costs actually incurred by the insured person and may take account of the amount which the insured person would have had to pay if the treatment had been delivered in the competent member state . c . meeting the costs of travel and stay as part of scheduled treatment 8 . where the national legislation of the competent institution provides for the reimbursement of the costs of travel and stay which are inseparable from the treatment of the insured person , such costs for the person concerned and , if necessary , for a person who must accompany him / her , shall be assumed by this institution when an authorisation is granted in the case of treatment in another member state . d . family members 9 . paragraphs 1 to 8 shall apply mutatis mutandis to the members of the family of the insured persons . ### article 26 is replaced by the following : ' article 26 scheduled treatment authorisation procedure for the purposes of the application of article 20 of the basic regulation , the insured person shall present a document issued by the competent institution to the institution of the place of stay . for the purposes of this article , the competent institution shall mean the institution which bears the cost of the scheduled treatment or long - term care ; in the cases referred to in article 20 and 27 of the basic regulation , in which the benefits in kind provided in the member state of residence are reimbursed on the basis of fixed amounts , the competent institution shall mean the institution of the place of residence . 2 . if an insured person does not reside in the competent member state , he shall request authorisation from the institution of the place of residence , which shall forward it to the competent institution without delay . in that event , the institution of the place of residence shall certify in a statement whether the conditions set out in the second sentence of article 20 of the basic regulation are met in the member state of residence . the competent institution may refuse to grant the requested authorisation only if , in accordance with the assessment of the institution of the place of residence , the conditions set out in the second sentence of article 20 of the basic regulation are not met in the member state of residence of the insured person , or if the same treatment or long - term care can be provided in the competent member state itself , within a time - limit which is medically justifiable , taking into account the current state of need of long - term care and the probable course of need of long - term care of the person concerned . the competent institution shall inform the institution of the place of residence of its decision . in the absence of a reply within the deadlines set by its national legislation , the authorisation shall be considered to have been granted by the competent institution . 3 . if an insured person who does not reside in the competent member state is in need of urgent vitally necessary treatment , and the authorisation cannot be refused in accordance with the second sentence of article 20 of the basic regulation , the authorisation shall be granted by the institution of the place of residence on behalf of the competent institution , which shall be immediately informed by the institution of the place of residence . the competent institution shall accept the findings and the treatment options of the doctors approved by the institution of the place of residence that issues the authorisation , concerning the need for urgent vitally necessary treatment . 4 . at any time during the procedure granting the authorisation , the competent institution shall retain the right to have the insured person examined by a doctor of its own choice or , in the case of the need for long - term care , by a doctor or another expert of its own choice in the member state of stay or residence . 5 . the institution of the place of stay shall , without prejudice to any decision regarding authorisation , inform the competent institution if it appears medically appropriate or appropriate taking into account the current state of need for long - term care to supplement the treatment or long - term care covered by the existing authorisation . b . meeting the cost of benefits in kind incurred by the insured person 6 . without prejudice to paragraph 7 , article 25 and of the implementing regulation shall apply mutatis mutandis . 7 . if the insured person has actually borne all or part of the costs for the authorised medical treatment or long - term care him or herself and the costs which the competent institution is obliged to reimburse to the institution of the place of stay or to the insured person according to paragraph 6 are lower than the costs which it would have had to assume for the same treatment or long - term care in the competent member state , the competent institution shall reimburse , upon request , the cost of treatment or long - term care incurred by the insured person up to the amount by which the notional cost exceeds the actual cost . the reimbursed sum may not , however , exceed the costs actually incurred by the insured person and may take account of the amount which the insured person would have had to pay if the treatment or long - term care had been delivered in the competent member state . c . meeting the costs of travel and stay as part of scheduled treatment or long - term care 8 . where the national legislation of the competent institution provides for the reimbursement of the costs of travel and stay which are inseparable from the treatment or long - term care of the insured person , such costs for the person concerned and , if necessary , for a person who must accompany him / her , shall be assumed by this institution when an authorisation is granted in the case of treatment or long - term care in another member state . d . family members 9 . paragraphs 1 to 8 shall apply mutatis mutandis to the members of the family of the insured persons . '


### the claims shall be paid to the liaison body of the creditor member state referred to in article 66 of the implementing regulation by the debtor institution within 18 months of the end of the month during which they were introduced to the liaison body of the debtor member state . this does not apply to the claims which the debtor institution has rejected for a relevant reason within that period . ### in article 67 , paragraph 5 is replaced by the following : ' 5 . the claims shall be paid to the liaison body of the creditor member state referred to in article 66 of the implementing regulation by the debtor institution within 12 months of the end of the month during which they were introduced to the liaison body of the debtor member state . this does not apply to the claims which the debtor institution has rejected for a relevant reason within that period . '


### article 25 pensions under the legislation of one or more member states other than the member state of residence , where there is a right to benefits in kind in the latter member state where the person receiving a pension or pensions under the legislation of one or more member states resides in a member state under whose legislation the right to receive benefits in kind is not subject to conditions of insurance , or of activity as an employed or self - employed person , and no pension is received from that member state , the cost of benefits in kind provided to him / her and to members of his / her family shall be borne by the institution of one of the member states competent in respect of his / her pensions determined in accordance with article 24 , to the extent that the pensioner and the members of his / her family would be entitled to such benefits if they resided in that member state . ### article 25 is replaced by the following : “article 25 pensions under the legislation of one or more member states other than the member state of residence , where there is a right to benefits in kind in the latter member state where the person receiving a pension or pensions under the legislation of one or more member states resides in a member state under whose legislation the right to receive benefits in kind is not subject to conditions of insurance , or of activity as an employed or self - employed person , and no pension is received from that member state , the cost of benefits in kind provided to him / her and to members of his / her family shall be borne by the institution of one of the member states competent in respect of his / her pensions determined in accordance with article 24 , to the extent that the pensioner and the members of his / her family would be entitled to benefits if they resided in that member state . ”


### areas of intervention : health throughout the life course ; environmental and social health determinants ; non - communicable and rare diseases ; infectious diseases ; tools , technologies and digital solutions for health and care ; health care systems ### areas of intervention : health throughout the life course ; environmental and social health determinants ; non - communicable and rare diseases ; infectious diseases ; tools , technologies and digital solutions for health and care ; person - centred and equitable health care systems .


### cluster ' health ' : improving and protecting the health of citizens at all ages , by developing innovative solutions to prevent , diagnose , monitor , treat and cure diseases ; mitigating health risks , protecting populations and promoting good health ; making public health systems more cost - effective , equitable and sustainable ; and supporting and enabling patients ' participation and self - management . ### cluster ' health ' : improving and protecting the health of citizens at all ages , by developing innovative , effective , safe and accessible solutions to prevent , diagnose , monitor , treat and cure diseases ; mitigating health risks , protecting populations and promoting good health ; making public health systems more cost - effective , person - centred , equitable and sustainable ; and supporting and enabling patients ' participation and self - management .


### veterinary medicinal products for animal species other than cattle , sheep , pigs , chickens , dogs and cats ; ### veterinary medicinal products for animal species other than cattle , pigs , chickens , dogs and cats ;


### the development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials . given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible . the use of antimicrobials in veterinary medicinal products may accelerate the emergence and spread of resistant micro - organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections . therefore the misuse of antimicrobials should not be allowed . ### the development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials . given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible . the use of antimicrobials in veterinary medicinal products may accelerate the emergence and spread of resistant micro - organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections . therefore the misuse of antimicrobials should not be allowed . preventive treatments using antimicrobials should be regulated more strictly and recommended only in certain specific , well - defined cases , in compliance with animal health , biosecurity and nutritional requirements .


### where a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in that article shall be prolonged by 1 year for each additional target species , provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in article 34 . ### where a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in that article shall be prolonged by two years for each additional target species , provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in article 34 .


### a competent authority or the agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 july 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product . ### a competent authority or the agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment if a potential environmental risk has been identified for that product .


### applications for mutual recognition of marketing authorisations shall be submitted to the member state that granted the first national marketing authorisation . ### applications for mutual recognition of marketing authorisations shall be submitted to the member state that granted the first national marketing authorisation and the member states where the applicant seeks to obtain recognition of the marketing authorisation .


### a veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law . ### a veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law , a veterinarian where appropriate and only after a veterinary diagnosis . these persons shall , by reason of their initial and continuing training , have the skills necessary to prescribe and issue veterinary medicinal products for all the species they treat .


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


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


### antimicrobial medicinal products shall only be used in accordance with articles 115 and 116 to treat conditions for which there is no other treatment available , and the use of which would not present a risk to public or animal health . ### antimicrobial medicinal products shall only be used in accordance with articles 115 and 116 to treat conditions for which there is no other treatment available , and the proper use of which would not present a risk to public or animal health .


### a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec of the european parliament and of the council30 or regulation no 726 / 2004 ; __________________ 30 directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use . ### a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec of the european parliament and of the council30 or regulation no 726 / 2004 . antimicrobial medicinal products for human use may only be employed , subject to the issuing of a prescription by a veterinarian and approval by the veterinary authority responsible for monitoring the work of the veterinarian in question , if treatment with a medicinal product as referred to in letter or is not possible ; __________________ 30 directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use .


### if an antimicrobial is administered and used incorrectly , this presents a risk to public or animal health . therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription . persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced , directly or indirectly , by economic incentives when prescribing those products . therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care . ### if an antimicrobial is administered and used incorrectly , this presents a risk to public or animal health . therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription . persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials . veterinarians have a legal obligation which is part of their professional code of conduct . they should not be influenced , directly or indirectly , by economic incentives when prescribing those products . the animal health industry and the veterinarians should together promote responsible use . therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care .


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


### the period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation shall not exceed 18 years . ### the period of the protection of the first marketing authorisation shall not be prolonged by any additional periods due to any variations or new authorisations belonging to the same marketing authorisation . the variations or new authorisation should have their own period of protection . this protection shall be three years for each variation or new authorisation .


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


### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide . many of the antimicrobials used in animals are also used in humans . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . it needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials . use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products . ### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide . many of the antimicrobials used in animals are also used in humans . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . it needs to be ensured that measures are proportionally applied in both the humane and animal sector . and appropriate warnings and guidance are included on the labels of antimicrobials . use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products .


### a marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time . ### a marketing authorisation for a veterinary medicinal product shall be valid for five years . the authorisation may be renewed after five years on the basis of a re - evaluation of the risk - benefit balance . once renewed , the marketing authorisation shall be valid for an unlimited period , unless the competent authority decides , on justified grounds relating to pharmacovigilance , to proceed with one additional five - year renewal .


### 10 years for the veterinary medicinal products for cattle , sheep , pigs , chickens , dogs and cats ; ### 10 years for the veterinary medicinal products for cattle , pigs , chickens , dogs and cats ;


### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide . many of the antimicrobials used in animals are also used in humans . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . it needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials . use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products . ### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide . many of the antimicrobials used in animals are also used in humans . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . better information is necessary regarding the utilisation and effects of antimicrobial medicines . it needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials . use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products .


### ‘ 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 positive therapeutic effects of the veterinary medicinal product in relation to the following risks relating to the use of that product :


### smes may choose to draw up a prospectus under the minimum disclosure regime for smes in the case of an offer of securities to the public provided that they have no securities admitted to trading on a regulated market . ### issuers may choose to draw up a prospectus under the proportionate disclosure regime set out in this article in the case of an offer of securities to the public provided that they have no securities admitted to trading on a regulated market .


### the competent authority of each host member state may require that the summary referred to in article 7 be translated into its official language or languages but it shall not require the translation of any other part of the prospectus . ### the competent authority of each host member state shall not require the translation of any part of the prospectus .


### an offer of securities with a total consideration in the union of less than eur 500 000 , which shall be calculated over a period of 12 months ; ### an offer of securities with a total consideration in the union of less than eur 1 000 000 , which shall be calculated over a period of 12 months ;


### an offer of securities addressed to fewer than 150 natural or legal persons per member state , other than qualified investors ; ### addressed to fewer than 500 natural or legal persons per member state , other than qualified investors ; existing shareholders and employees shall not be included when calculating the number of persons to whom the offer is addressed ;


### the summary shall be drawn up as a short document written in a concise manner and of a maximum of six sides of a4 - sized paper when printed . it shall : ### the introductory summary shall be drawn up as a short document written in a concise manner . it shall :


### esma shall develop guidelines on the assessment by competent authorities of the specificity and materiality of risk factors and on the allocation of risk factors across categories . ### esma shall develop guidelines on the assessment of the specificity and materiality of risk factors . in addition , esma shall develop guidelines to assist competent authorities in their review of risk factors in a manner which encourages appropriate and focused risk factor disclosure by issuers .


### under a sub - section titled ' what are the key risks that are specific to the issuer ? ' a brief description of no more than five of the most material risk factors specific to the issuer contained in the category of highest materiality according to article 16 . ### under a sub - section titled ' what are the key risks that are specific to the issuer ? ' a brief description of the most material risk factors specific to the issuer .


### the competent authority of each host member state may require that the summary referred to in article 7 be translated into its official language or languages , but it shall not require the translation of any other part of the prospectus . ### the competent authority of each host member state shall not require the translation of any part of the prospectus .


### minimum disclosure regime for smes ### proportionate disclosure regime


### under a sub - section titled ' what are the key risks that are specific to the securities ? ' a brief description of no more than five of the most material risk factors specific to the securities , contained in the category of highest materiality according to article 16 . ### under a sub - section titled ' what are the key risks that are specific to the securities ? ' a brief description of the most material risk factors specific to the securities .


### 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 . ### the measures provided for in directive 98 / 41 / ec and directive 2010 / 65 / ec entail the processing of personal data . this processing is governed by union law on the protection of personal data , in particular regulation 2016 / 679 of the european parliament and of the council , and regulation no 45 / 2001 of the european parliament and of the council , which applies to the processing of personal data recorded in the single window and safeseanet . in particular , personal data collected for the purposes of directive 98 / 41 / ec to facilitate search and rescue operations and the efficient handling of the aftermath of an accident should not be further processed and used for any other purpose and should not be retained longer than necessary for the specific purposes of directive 98 / 41 / ec as specified therein . personal data should therefore be immediately destroyed after the ship ' s voyage has been safely completed or when an investigation or judicial proceedings in the aftermath of an accident or emergency have been concluded .


### 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 . ### the measures provided for in directive 98 / 41 / ec and directive 2010 / 65 / ec entail the processing of personal data . this processing is governed by union law on the protection of personal data , in particular regulation 2016 / 679 of the european parliament and of the council20a , and regulation no 45 / 2001 of the european parliament and of the council20b , which applies to the processing of personal data recorded in the single window and safeseanet . in particular , personal data collected for the purposes of directive 98 / 41 / ec to facilitate search and rescue operations and the efficient handling of the aftermath of an accident should not be further processed and used for any other purpose and should not be retained longer than necessary for the specific purposes of directive 98 / 41 / ec as specified therein . personal data should therefore be immediately destroyed after the ship ' s voyage has been safely completed or when an investigation or judicial proceedings in the aftermath of an accident or emergency have been concluded . __________________ 20a regulation 2016 / 679 of the european parliament and of the council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec . 20b regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data .


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


### without prejudice to other reporting obligations , once the information is no longer needed for these purposes , it shall be destroyed . ; ### without prejudice to other specific reporting obligations under union or national law , including for statistical purposes , once the information is no longer needed for that purpose , it shall be immediately 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 . 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 .


### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . joint clinical assessments should also be carried out on certain medical devices within the meaning of regulation 2017 / 745 of the european parliament and of the council12 which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views . a selection of medical devices for joint clinical assessment should be made based on specific criteria . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . 12 regulation 2017 / 745 of the european parliament and of the council of 5 april 2017 on medical devices , amending directive 2001 / 83 / ec , regulation no 178 / 2002 and regulation no 1223 / 2009 and repealing council directives 90 / 385 / eec and 93 / 42 / eec . ### in order to ensure a wide application of harmonised rules on clinical aspects of hta and enable pooling of expertise and resources across hta bodies , it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under regulation no 726 / 2004 of the european parliament and of the council , 11 which incorporate a new active substance , and where those medicinal products are subsequently authorised for a new therapeutic indication . joint clinical assessments should also be carried out on certain medical devices classified as high risk class iib implantable devices and class iii devices pursuant to article 51 of regulation 2017 / 745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to article 54 of that regulation and which have already been marketed in at least one member state . _________________ 11 regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency .


### the coordination group shall act by consensus , or , where necessary , vote by simple majority . there shall be one vote per member state . ### the coordination group shall act by consensus , or , where necessary , vote by a two - thirds majority . there shall be one vote per member state .


### the outcome of hta is used to inform decisions concerning the allocation of budgetary resources in the field of health , for example , in relation to establishing the pricing or reimbursement levels of health technologies . hta can therefore assist member states in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients . ### the outcome of hta is used to inform decisions concerning the allocation of budgetary resources in the field of health , for example , in relation to establishing the pricing or reimbursement levels of health technologies . hta can therefore assist member states in creating and maintaining sustainable healthcare systems and to stimulate innovation that delivers better outcomes for patients , while patients have the right to health protection and protection against the financial , social and medical consequences of the disease , as well as unrestrained access to the latest therapeutic discoveries , which should be guaranteed by law in all member states .


### the commission shall adopt implementing acts concerning : ### the coordination group shall adopt :


### the commission shall adopt implementing acts concerning : ### the commission shall be empowered to adopt implementing acts in accordance with article 31&#160 ; concerning :


### although emissions of methane are not known to have a direct harmful effect on human health , methane is a strong greenhouse gas . therefore , in line with the communication of the commission on the application and future development of community legislation concerning vehicle emissions from light - duty vehicles and access to repair and maintenance information 2 and with article 14 of regulation 715 / 2007 of the european parliament and of the council3 , the commission should consider including methane emissions in the calculation of co2 emissions . __________________ 2 oj c 182 , 19 . 7 . 2008 , p . 17 . 3 regulation 715 / 2007 of the european parliament and of the council of 20 june 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles and on access to vehicle repair and maintenance information . ### although emissions of methane are not known to have a direct harmful effect on human health , methane is a strong greenhouse gas . therefore , in line with the commission communication 2008 / c 182 / 08 on the application and future development of community legislation concerning vehicle emissions from light - duty vehicles and access to repair and maintenance information 2 and with article 14 of regulation 715 / 2007 of the european parliament and of the council3 , the commission should consider including methane emissions as co2 equivalent in the calculation of co2 emissions . __________________ 2 oj c 182 , 19 . 7 . 2008 , p . 17 . 3 regulation 715 / 2007 of the european parliament and of the council of 20 june 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles and on access to vehicle repair and maintenance information .


### the treaty of lisbon introduced the possibility for the legislator to delegate power to the commission to adopt non - legislative acts of general application to supplement or amend certain non - essential elements of a legislative act . the measures which can be covered by delegations of powers , as referred to in article 290 tfeu , correspond in principle to those covered by the regulatory procedure with scrutiny established by article 5a of council decision 1999 / 468 / ec6 . it is therefore necessary to adapt to article 290 tfeu the provisions in regulation no 715 / 2007 which provide for the use of the regulatory procedure with scrutiny . __________________ 6 council decision 1999 / 468 / ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission . ### tfeu introduced the possibility for the legislator to delegate power to the commission to adopt non - legislative acts of general application to supplement or amend certain non - essential elements of a legislative act . the measures which can be covered by delegations of powers , as referred to in article 290 tfeu , correspond in principle to those covered by the regulatory procedure with scrutiny established by article 5a of council decision 1999 / 468 / ec6 . it is therefore necessary to adapt to article 290 tfeu the relevant provisions set out in regulation no 715 / 2007 which provide for the use of the regulatory procedure with scrutiny . such delegation of power should be conferred on the commission from the entry into force of this regulation for four year period and could be tacitly extended for periods of an identical duration . __________________ 6 council decision 1999 / 468 / ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission .


### in order to achieve eu air quality objectives and to ensure a continuous effort to reduce vehicle emissions , the power to adopt delegated 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 the detailed rules on the application of regulation no 715 / 2007 to vehicles of categories m1 , m2 , n1 and n2 with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 5 000 kg , the specific procedures , tests and requirements for type approval , the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems , the measures necessary for the implementation of the obligation of a manufacturer to provide unrestricted and standardised access to vehicle repair and maintenance information , the replacement of the information on the mass of co2 emissions in the certificate of conformity with information on total mass of co2 emissions equivalents , the increase or removal of the limit value of total hydrocarbons emissions for positive ignition vehicles , the amendment of regulation no 715 / 2007 for the purposes of recalibrating the particulate mass based limit values and introducing particle number based limit values that would correlate broadly with the petrol and diesel mass limit values , the adoption of a revised measurement procedure for particulates and a particle number limit value , a limit value for emissions of no2 and limits for tailpipe emissions at cold temperatures for vehicles approved as complying with the euro 6 emission limits . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to achieve union air quality objectives and to ensure a continuous effort to reduce vehicle emissions , 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 the detailed rules on the application of regulation no 715 / 2007 to vehicles of categories m1 , m2 , n1 and n2 with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 7 500 kg , the specific procedures , tests and requirements for type approval , the requirements for the implementation of the prohibition on the use of defeat devices that reduce the effectiveness of emission control systems , the measures necessary for the implementation of the obligation of a manufacturer to provide unrestricted and standardised access to vehicle repair and maintenance information , including remote diagnostic support , the replacement of the information on the mass of co2 emissions in the certificate of conformity with information on total mass of co2 emissions equivalents , the increase or removal of the limit value of total hydrocarbons emissions for positive ignition vehicles , the amendment of regulation no 715 / 2007 for the purposes of recalibrating the particulate mass based limit values and introducing particle number based limit values that would correlate broadly with the petrol and diesel mass limit values , the adoption of a revised measurement procedure for particulates , including nano - particulates , and a particle number limit value , a limit value for emissions of no2 and limits for tailpipe emissions at cold temperatures for vehicles approved as complying with the euro 6 emission limits . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### the commission shall be empowered to adopt delegated acts in accordance with article 14a concerning the detailed rules on the application of this regulation to vehicles of categories m1 , m2 , n1 and n2 as defined in annex ii to directive 2007 / 46 / ec with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 5 000 kg . the delegated acts shall ensure in particular that at chassis dynamometer tests the actual operational mass of the vehicle is appropriately considered for determining the equivalent inertia as well as other default power and load parameters . ### the commission shall be empowered to adopt delegated acts in accordance with article 14a concerning the detailed rules on the application of this regulation to vehicles of categories m1 , m2 , n1 and n2 as defined in annex ii to directive 2007 / 46 / ec with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 7 500 kg . the delegated acts shall ensure in particular that at chassis dynamometer tests the actual operational mass of the vehicle is appropriately considered for determining the equivalent inertia as well as other default power and load parameters .


### after publication of the delegated acts adopted in accordance with the second subparagraph and at the manufacturer ' s request , this regulation shall apply to vehicles of categories m1 , m2 , n1 and n2 as defined in annex ii to directive 2007 / 46 / ec of the european parliament and of the council* with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 5 000 kg . ____________________ *oj l 263 , 9 . 10 . 2007 , p . 1 . ### after publication of the delegated acts adopted in accordance with the second subparagraph and at the manufacturer ' s request , this regulation shall apply to vehicles of categories m1 , m2 , n1 and n2 as defined in annex ii to directive 2007 / 46 / ec of the european parliament and of the council* with a reference mass exceeding 2 610 kg but with a maximum vehicle mass not exceeding 7 500 kg . ____________________ * oj l 263 , 9 . 10 . 2007 , p . 1 .


### the commission shall be empowered to adopt delegated acts in accordance with article 14a in order to implement articles 6 and 7 . this shall include the definition and updating of technical specifications relating to the way in which obd and vehicle repair and maintenance information shall be provided , with special attention being paid to the specific needs of smes . ### the commission shall be empowered to adopt delegated acts in accordance with article 14a in order to implement articles 6 and 7 . this shall include the definition and updating of technical specifications relating to the way in which obd and vehicle repair and maintenance information , including remote diagnostic support , shall be provided , with special attention being paid to the specific needs of smes .


### the power to adopt delegated acts referred to in the second subparagraph of article 2 , article 5 , article 8 and in article 14 to shall be conferred on the commission for an indeterminate period of time from [ … ] [ publications office , please insert the exact date of entry into force ] . ### the power to adopt delegated acts referred to in the second subparagraph of article 2 , article 5 , article 8 and in article 14 to shall be conferred on the commission for a period of four years from . . . * . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of four year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period . ___________ * oj : please insert the date of entry into force of this regulation .


### proposals shall be ranked according to the evaluation results . the selection shall be made by the prima - is on the basis of this ranking . the participating states shall agree on an adequate funding mode that allows maximising the number of proposals to be funded on the basis of this ranking , in particular by providing reserve amounts to the national contributions for calls for proposals . ### proposals shall be ranked according to the evaluation results . the selection shall be made by the prima - is and shall follow this ranking . the participating states shall agree on an adequate funding mode that allows maximising the number of proposals to be funded on the basis of this ranking , in particular by providing reserve amounts to the national contributions for calls for proposals . in case one or more projects cannot be funded , the projects following directly in the ranking list may be selected .


### derogations from point of article 9 and from article 9 of regulation no 1290 / 2013 are necessary in order to account for the specificities resulting from the geographical scope of prima , by further adjusting the minimum eligibility conditions for participation in indirect actions . in order to ensure balanced core participation in indirect actions under a north - south configuration , as a derogation from point of article 9 of regulation no 1290 / 2013 , the minimum number of participants should be three legal entities established in three different participating states of which one is established in a member state or in a country associated to horizon 2020 , and one is established in a third country , associated or not to horizon 2020 . derogation from article 9 of regulation no 1290 / 2013 is necessary in order to ensure that the minimum eligibility conditions for participation in indirect actions are not discriminatory for entities established in third countries participating in prima as participating states . in order to ensure that funding conditions are not discriminatory for entities established in third countries participating in prima as participating states , it should be provided for that legal entities established in the participating states are eligible for funding in addition to entities referred to in article 10 of regulation no 1290 / 2013 . derogations from article 12 of regulation no 1290 / 2013 are necessary in order to allow broadening cooperation through joint calls launched by the prima - is with legal entities other than third countries and international organisations . ### derogations from point of article 9 and from article 9 of regulation no 1290 / 2013 are necessary in order to account for the specificities resulting from the geographical scope of prima , by further adjusting the minimum eligibility conditions for participation in indirect actions . in order to ensure balanced core participation in indirect actions under a north - south configuration , as a derogation from point of article 9 of regulation no 1290 / 2013 , the minimum number of participants should be three legal entities established in three different participating states , fostering a balance euro - mediterranean cooperation . derogation from article 9 of regulation no 1290 / 2013 is necessary in order to ensure that the minimum eligibility conditions for participation in indirect actions are not discriminatory for entities established in third countries participating in prima as participating states . in order to ensure that funding conditions are not discriminatory for entities established in third countries participating in prima as participating states , it should be provided for that legal entities established in the participating states are eligible for funding in addition to entities referred to in article 10 of regulation no 1290 / 2013 . derogations from article 12 of regulation no 1290 / 2013 are necessary in order to allow broadening cooperation through joint calls launched by the prima - is with legal entities other than third countries and international organisations .


### the proposals shall be for transnational projects , with minimum participation of at least three independent legal entities established in three different participating states , of which : ### the proposals shall be for transnational projects , with minimum participation of at least three independent legal entities established in three different countries considered as participating states in accordance with this decision by the submission deadline under the relevant call for proposals , of which :


### one established in a third country considered as a participating state in accordance with this decision by the submission deadline under the relevant call for proposals . ### one established in a third country listed in article 1 or bordering the mediterranean sea .


### 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 create social and economic development on both sides of the mediterranean sea by building research and development capacities and develop common innovative agri - food and water - management solutions for water , including treatment and reuse , and food systems in the mediterranean region , to increase the efficiency , also by reducing losses and waste , climate resiliency and sustainability of food productions and water provision and to contribute to solving water - scarcity , food - security , nutrition , health , well - being , environmental and migration problems upstream .


### by way of derogation from point of article 9 of regulation no 1290 / 2013 , the minimum number of participants shall be three legal entities established in three different participating states of which : ### by way of derogation from point of article 9 of regulation no 1290 / 2013 , the minimum number of participants shall be three legal entities established in three different countries considered as participating states in accordance with this decision by the submission deadline under the relevant call for proposals , of which :


### prima shall be implemented on the basis of annual work plans , to be adopted by the prima - is , after obtaining approval by the commission , by the end of the previous year . as an exception , the prima annual work plan for 2018 may be adopted by 31 march 2018 . the prima - is shall make the annual work plan publicly available . ### prima shall be implemented on the basis of annual work plans , to be adopted by the prima - is , after obtaining approval by the commission . the prima - is shall forward these plans to the commission by the end of the previous year . as an exception , the prima annual work plan for 2018 must be sent by 31 march 2018 . the prima - is shall make the annual work plan publicly available .


### the orientation of all national r&i programmes towards the implementation of the strategic agenda ; ### the orientation of relevant national r&i programmes towards the implementation of the strategic agenda , and the coordination of those programmes ;


### the structural involvement of all relevant public and private sector actors in implementing the strategic agenda by pooling knowledge and financial resources to achieve the necessary critical mass ; ### the involvement of all relevant public and private sector actors in implementing the strategic agenda by pooling knowledge and financial resources to achieve the necessary critical mass ;


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


### it is necessary for providing an information society service requested by the end - user ; or ### it is strictly technically necessary for providing an information society service requested by the user ; or


### if end - users that are natural persons give their consent to their data being included in such directories , they should be able to determine on a consent basis which categories of personal data are included in the directory . in addition , providers of publicly available directories should inform the end - users of the purposes of the directory and of the search functions of the directory before including them in that directory . end - users should be able to determine by consent on the basis of which categories of personal data their contact details can be searched . the categories of personal data included in the directory and the categories of personal data on the basis of which the end - user ' s contact details can be searched should not necessarily be the same . ### if end - users that are natural persons give their consent to their data being included in such directories , they should be able to determine on a consent basis which categories of personal data are included in the directory . in addition , upon giving their consent the end - users should be informed of the purposes of the directory and of the search functions of the directory before including them in that directory . end - users should be able to determine by consent on the basis of which categories of personal data their contact details can be searched . the categories of personal data included in the directory and the categories of personal data on the basis of which the end - user ' s contact details can be searched should not necessarily be the same . the providers of publicly available directories should provide information about the search options , as well as if new options and functions of the directories are available in the publicly available directories .


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


### without prejudice to point of article 6 and points and of article 6 , the provider of the electronic communications service shall erase electronic communications content or make that data anonymous after receipt of electronic communication content by the intended recipient or recipients . such data may be recorded or stored by the end - users or by a third party entrusted by them to record , store or otherwise process such data , in accordance with regulation 2016 / 679 . ### without prejudice to article 6 and points and of article 6 , the provider of the electronic communications service shall erase electronic communications content or make that data anonymous after receipt of electronic communication content by the intended recipient or recipients . such data may be recorded or stored by the end - users or by a third party entrusted by them to record , store or otherwise process such data , in accordance with regulation 2016 / 679 .


### electronic communications data shall be confidential . any interference with electronic communications data , such as by listening , tapping , storing , monitoring , scanning or other kinds of interception , surveillance or processing of electronic communications data , by persons other than the end - users , shall be prohibited , except when permitted by this regulation . ### electronic communications shall be confidential . any interference , with electronic communications at rest or in transit , such as by listening , tapping , storing , monitoring , scanning or other kinds of interception , surveillance or any processing of electronic communications , by persons other than the users , shall be prohibited , except when permitted by this regulation .


### electronic communications data should be treated as confidential . this means that any interference with the transmission of electronic communications data , whether directly by human intervention or through the intermediation of automated processing by machines , without the consent of all the communicating parties should be prohibited . the prohibition of interception of communications data should apply during their conveyance , i . e . until receipt of the content of the electronic communication by the intended addressee . interception of electronic communications data may occur , for example , when someone other than the communicating parties , listens to calls , reads , scans or stores the content of electronic communications , or the associated metadata for purposes other than the exchange of communications . interception also occurs when third parties monitor websites visited , timing of the visits , interaction with others , etc . , without the consent of the end - user concerned . as technology evolves , the technical ways to engage in interception have also increased . such ways may range from the installation of equipment that gathers data from terminal equipment over targeted areas , such as the so - called imsi catchers , to programs and techniques that , for example , surreptitiously monitor browsing habits for the purpose of creating end - user profiles . other examples of interception include capturing payload data or content data from unencrypted wireless networks and routers , including browsing habits without the end - users’ consent . ### any processing of electronic communications data or any interference with the transmission of electronic communications data , whether directly by human intervention or through the intermediation of automated processing by machines , by persons other than the end - users , should be prohibited . when the processing is allowed under any exception to the prohibitions under the this regulation , any other processing of the electronic communications data on the basis of article 6 of the regulation 2016 / 679 shall be considered as prohibited , including processing for another purpose on the basis of article 6 of that regulation . this would not prevent controllers from asking for additional consent for new processing operations . the prohibition of interception of communications data should apply also during their conveyance , i . e . until receipt of the content of the electronic communication by the intended addressee and any temporary files in the network after receipt . interception of electronic communications data may occur , for example , when someone other than the communicating parties , listens to calls , reads , scans or stores the content of electronic communications , or the associated metadata for purposes other than the exchange of communications . interception also occurs when third parties monitor websites visited , timing of the visits , interaction with others , etc . , without the consent of the end - user concerned . as technology evolves , the technical ways to engage in interception have also increased . such ways may range from the installation of equipment that gathers data from terminal equipment over targeted areas , such as the so - called imsi catchers , to programs and techniques that , for example , surreptitiously monitor browsing habits for the purpose of creating end - user profiles . other examples of interception include capturing payload data or content data from unencrypted wireless networks and routers , and analysis of end users’ electronic communications metadata , including browsing habits without the end - users’ consent .


### permitted processing of electronic communications data ### lawful processing of electronic communications data


### the providers of publicly available directories shall obtain the consent of end - users who are natural persons to include their personal data in the directory and , consequently , shall obtain consent from these end - users for inclusion of data per category of personal data , to the extent that such data are relevant for the purpose of the directory as determined by the provider of the directory . providers shall give end - users who are natural persons the means to verify , correct and delete such data . ### the providers of electronic communication services shall obtain the consent of end - users who are natural persons to share their personal data with the providers of publicly available directories to include them in the directory and , consequently , shall provide end - users who are natural persons with information about inclusion of data per category of personal data , to the extent that such data are relevant for the purpose of the directory as determined by the provider of the directory . providers shall give end - users who are natural persons the means to verify , correct and delete such data .


### accessing electronic communications networks requires the regular emission of certain data packets in order to discover or maintain a connection with the network or other devices on the network . furthermore , devices must have a unique address assigned in order to be identifiable on that network . wireless and cellular telephone standards similarly involve the emission of active signals containing unique identifiers such as a mac address , the imei , the imsi etc . a single wireless base station , such as a wireless access point , has a specific range within which such information may be captured . service providers have emerged who offer tracking services based on the scanning of equipment related information with diverse functionalities , including people counting , providing data on the number of people waiting in line , ascertaining the number of people in a specific area , etc . this information may be used for more intrusive purposes , such as to send commercial messages to end - users , for example when they enter stores , with personalized offers . while some of these functionalities do not entail high privacy risks , others do , for example , those involving the tracking of individuals over time , including repeated visits to specified locations . providers engaged in such practices should display prominent notices located on the edge of the area of coverage informing end - users prior to entering the defined area that the technology is in operation within a given perimeter , the purpose of the tracking , the person responsible for it and the existence of any measure the end - user of the terminal equipment can take to minimize or stop the collection . additional information should be provided where personal data are collected pursuant to article 13 of regulation 2016 / 679 . ### accessing electronic communications networks requires the regular emission of certain data packets in order to discover or maintain a connection with the network or other devices on the network . furthermore , devices must have a unique address assigned in order to be identifiable on that network . wireless and cellular telephone standards similarly involve the emission of active signals containing unique identifiers such as a mac address , the imei , the imsi etc . a single wireless base station , such as a wireless access point , has a specific range within which such information may be captured . service providers have emerged who offer tracking services based on the scanning of equipment related information with diverse functionalities , including people counting , providing data on the number of people waiting in line , ascertaining the number of people in a specific area , etc . this information may be used for more intrusive purposes , such as to send commercial messages to end - users , for example when they enter stores , with personalized offers . information emitted by terminal equipment should be considered a separate category from metadata and information from the consumer’s terminal equipment itself . nevertheless , collection of such information should be subject to specific transparency measures and safeguards . entities deploying such solutions should display or make available prominent notices located on the edge of the area of coverage informing end - users prior to entering the defined area that the technology is in operation within a given perimeter , the purpose of the tracking , the person responsible for it and the existence of any measure the end - user of the terminal equipment can take to minimize or stop the collection . additional information should be provided where personal data are collected pursuant to article 13 of regulation 2016 / 679 and the processing of such personal data will also be subject to the regulation .


### service providers who offer electronic communications services should inform end - users of measures they can take to protect the security of their communications for instance by using specific types of software or encryption technologies . the requirement to inform end - users of particular security risks does not discharge a service provider from the obligation to take , at its own costs , appropriate and immediate measures to remedy any new , unforeseen security risks and restore the normal security level of the service . the provision of information about security risks to the subscriber should be free of charge . security is appraised in the light of article 32 of regulation 2016 / 679 . ### service providers who offer electronic communication services shall comply with security obligations as prescribed in article 32 of regulation 2016 / 679 and article 40 of [ european electronic communications code ] .


### the services used for communications purposes , and the technical means of their delivery , have evolved considerably . end - users increasingly replace traditional voice telephony , text messages and electronic mail conveyance services in favour of functionally equivalent online services such as voice over ip , messaging services and web - based e - mail services . in order to ensure an effective and equal protection of end - users when using functionally equivalent services , this regulation uses the definition of electronic communications services set forth in the [ directive of the european parliament and of the council establishing the european electronic communications code24 ] . that definition encompasses not only internet access services and services consisting wholly or partly in the conveyance of signals but also interpersonal communications services , which may or may not be number - based , such as for example , voice over ip , messaging services and web - based e - mail services . the protection of confidentiality of communications is crucial also as regards interpersonal communications services that are ancillary to another service ; therefore , such type of services also having a communication functionality should be covered by this regulation . _________________ 24 commission proposal for a directive of the european parliament and of the council establishing the european electronic communications code ) . ### the services used for communications purposes , and the technical means of their delivery , have evolved considerably . users and subscribers increasingly replace traditional voice telephony , text messages and electronic mail conveyance services in favour of functionally equivalent online services such as voice over ip , messaging services and web - based e - mail services , also known as “over - the - top services” . this regulation aims at ensuring an effective and equal protection of users and subscribers when using functionally equivalent services , so as to ensure the confidentiality of their communication , irrespective of the technological medium chosen . . that definition encompasses not only internet access services and services consisting wholly or partly in the conveyance of signals but also interpersonal communications services , which may or may not be number - based , such as for example , voice over ip , messaging services and web - based e - mail services . the protection of confidentiality of communications is crucial also as regards interpersonal communications services that are ancillary to another service , such as internal messaging , newsfeeds , timelines and similar functions in online services where messages are exchanged with other users within or outside that service ; therefore , such type of services also having a communication functionality should be covered by this regulation .


### natural or legal persons may use electronic communications services for the purposes of sending direct marketing communications to end - users who are natural persons that have given their consent . ### the use by natural or legal persons of electronic communications services , including voice - to - voice calls , automated calling and communications systems , including semi - automated systems that connect the call person to an individual , faxes , e - mail or other use of electronic communications services for the purposes of presenting unsolicited or direct marketing communications to end - users , shall be allowed only in respect of end - users who have given their prior consent .


### electronic communications data should be treated as confidential . this means that any interference with the transmission of electronic communications data , whether directly by human intervention or through the intermediation of automated processing by machines , without the consent of all the communicating parties should be prohibited . the prohibition of interception of communications data should apply during their conveyance , i . e . until receipt of the content of the electronic communication by the intended addressee . interception of electronic communications data may occur , for example , when someone other than the communicating parties , listens to calls , reads , scans or stores the content of electronic communications , or the associated metadata for purposes other than the exchange of communications . interception also occurs when third parties monitor websites visited , timing of the visits , interaction with others , etc . , without the consent of the end - user concerned . as technology evolves , the technical ways to engage in interception have also increased . such ways may range from the installation of equipment that gathers data from terminal equipment over targeted areas , such as the so - called imsi catchers , to programs and techniques that , for example , surreptitiously monitor browsing habits for the purpose of creating end - user profiles . other examples of interception include capturing payload data or content data from unencrypted wireless networks and routers , including browsing habits without the end - users’ consent . ### electronic communications data should be treated as confidential . this means that any interference with the transmission of electronic communications data , whether directly by human intervention or through the intermediation of automated processing by machines , without the consent of all the communicating parties should be prohibited . the prohibition of interception of communications data should apply during their conveyance . for non - real - time electronic communication such as email or messaging , the transmission starts with the submission of the content for delivery and finishes with the receipt of the content of the electronic communication by the service provider of the intended recipient . interception of electronic communications data may occur , for example , when someone other than the communicating parties , listens to calls , reads , scans or stores the content of electronic communications , or the associated metadata for purposes other than the exchange of communications . as technology evolves , the technical ways to engage in interception have also increased . such ways may range from the installation of equipment that gathers data from terminal equipment over targeted areas , such as the so - called imsi catchers , to programs and techniques that , for example , surreptitiously monitor browsing habits for the purpose of creating end - user profiles . other examples of interception include capturing payload data or content data from unencrypted wireless networks and routers , including browsing habits without the end - users’ consent .


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


### the principles of data protection by design and by default were codified under article 25 of regulation 2016 / 679 . currently , the default settings for cookies are set in most current browsers to ‘ accept all cookies’ . therefore providers of software enabling the retrieval and presentation of information on the internet should have an obligation to configure the software so that it offers the option to prevent third parties from storing information on the terminal equipment ; this is often presented as ‘ reject third party cookies’ . end - users should be offered a set of privacy setting options , ranging from higher to lower and intermediate . such privacy settings should be presented in an easily visible and intelligible manner . ### the principles of data protection by design and by default were codified under article 25 of regulation 2016 / 679 . currently , the default settings for cookies are set in most current browsers to ‘ accept all cookies’ . therefore providers of software enabling the retrieval and presentation of information on the internet should have an obligation to inform the end - user about the possibility to express his or her consent using appropriate technical settings . the end - user should be offered multiple options to choose from , including to prevent third parties from storing information on the terminal equipment . end - users should be offered a set of privacy setting options , ranging from , for example , rejecting tracking that is not necessary for the functionality of the website or other software to , for example , accepting tracking necessary for the functionality of the website or other software as well as for other purposes or , for example , accepting tracking necessary for the functionality of the website or other software and tracking for other purposes by parties that demonstrate the compliance with the eu data protection and privacy legislation , for instance in line with article 40 and 42 of regulation 2016 / 679 .