### the reimbursements between the institutions of the member states , provided for in articles 35 and 41 of the basic regulation , shall be made via the liaison body . there may be a separate liaison body for reimbursements under article 35 and article 41 of the basic regulation . ### in article 66 , paragraph 2 is replaced by the following : ' 2 . the reimbursements between the institutions of the member states , provided for in articles 35 and 41 of the basic regulation , shall be made via the liaison body . there may be a separate liaison body for reimbursements under articles 35 and 41 of the basic regulation . mutual claims shall be off - set between the liaison bodies . the administrative commission shall establish detailed arrangements for such off - setting . '


### claims based on actual expenditure shall be introduced to the liaison body of the debtor member state within 12 months of the end of the calendar half - year during which those claims were recorded in the accounts of the creditor institution . ### in article 67 , paragraph 1 is replaced by the following : ' 1 . claims based on actual expenditure shall be introduced to the liaison body of the debtor member state within 12 months of the end of the calendar half - year during which those claims were recorded in the accounts of the creditor institution . claims shall be met , where possible , within one month , and in any event within six months , of the claim . '


### in the case referred to in article 6 second subparagraph of the implementing regulation , the deadline set out in paragraphs 1 and 2 of this article shall not start before the competent institution has been identified . ### in article 67 , paragraph 3 is replaced by the following : ' 3 . the period referred to in paragraphs 1 and 2 shall not commence until the date on which the creditor institution becomes aware of the claim of the debtor institution . claims may be introduced for benefit periods of no more than the previous five calendar years . the introduction of claims to the liaison body of the debtor member state shall be decisive . ”


### the audit board shall facilitate the final closing of accounts in cases where a settlement cannot be reached within the period set out in paragraph 6 , and , upon a reasoned request by one of the parties , shall give its opinion on a dispute within six months following the month in which the matter was referred to it . ### in article 67 , paragraph 7 is replaced by the following : ' 7 . the audit board shall facilitate the final closing of accounts in cases where a settlement cannot be reached within the period set out in paragraph 6 , and , upon a reasoned request by one of the parties , shall give its opinion on a dispute within nine months following the month in which the matter was referred to it . the audit board shall receive the request no later than nine months after expiry of the period set out in paragraph 6 . '


### if the amount of unduly paid contributions exceeds the amount the legal and / or natural person owes to the institution identified as being competent , the institution which unduly received contributions shall reimburse the amount in excess to the legal and / or natural person concerned . ### if the amount of unduly paid contributions exceeds the amount the legal and / or natural person owes to the institution identified as being competent , the institution which unduly received contributions shall reimburse the amount in excess to the legal and / or natural person concerned in accordance with national law .


### the existence of time limits under national legislation shall not be a valid ground for the refusal of the settlement of claims between institutions under this article . ### the existence of time limits and application procedures under national legislation shall not be a valid ground for the refusal of the settlement of claims between institutions under this article .


### by agreement between the applicant party and the requested party and in accordance with the arrangements laid down by the requested party , officials authorised by the applicant party may , with a view to promoting mutual assistance provided for in this section : ### by agreement between the applicant party and the requested party and in accordance with the arrangements laid down by the requested party resulting from existing national law or practice , officials authorised by the applicant party may , with a view to promoting mutual assistance provided for in this section :


### however , if the institution which was requested to carry out the check also uses the findings for the granting of benefits to the person concerned under the legislation it applies , it shall not claim the expenses referred to in the previous sentence . . ### however , if the institution which was requested to carry out the check also uses the findings for the granting of benefits on its own account to the person concerned under the legislation it applies , it shall not claim the expenses referred to in the previous sentence .


### the programme should maintain a balanced approach between bottom - up and top - down funding , according to the nature of the research and innovation communities that are engaged , the types and purpose of the activities carried out and the impacts that are sought . the mix of these factors should determine the choice of approach for the respective parts of the programme , all of which contribute to all of the programme’s general and specific objectives . ### the programme should maintain a balanced approach between bottom - up , top - down and territorially balanced funding , according to the nature of the research and innovation communities that are engaged , the types and purpose of the activities carried out and the impacts that are sought . the mix of these factors should determine the choice of approach for the respective parts of the programme , all of which contribute to all of the programme’s general and specific objectives .


### it is important to support industry to stay or become world leader in innovation , digitisation and decarbonisation , notably through investments in key enabling technologies that will underpin tomorrow ' s business . the programme ' s actions should be used to address market failures or sub - optimal investment situations , in a proportionate manner , without duplicating or crowding out private financing and have a clear european added value . this will ensure consistency between the actions of the programme and eu state aid rules , avoiding undue distortions of competition in the internal market . ### it is important to support industry to stay or become world leader in innovation , digitisation , resource efficiency , circular economy and decarbonisation , notably through investments in key enabling technologies that will underpin tomorrow ' s business . the programme ' s actions should be used to address market failures or sub - optimal investment situations , in a proportionate manner , without duplicating or crowding out private financing and have a clear european added value . this will ensure consistency between the actions of the programme and eu state aid rules , avoiding undue distortions of competition in the internal market .


### the activities developed under the programme should aim at eliminating gender inequalities and promoting equality between women and men in research and innovation , in compliance with articles 2 and 3 of the treaty on european union and article 8 of the tfeu . the gender dimension should be adequately integrated in research and innovation content and followed through at all stages of the research cycle . ### the activities developed under the programme should aim at eliminating gender inequalities and promoting equality between gender identities in research and innovation , in compliance with articles 2 and 3 of the treaty on european union and article 8 of the tfeu . the gender dimension should be adequately integrated in research and innovation content and followed through at all stages of the research cycle .


### participation in and financial contribution to research and innovation programmes undertaken by several member states in accordance with article 185 tfeu , or by bodies established pursuant to article 187 tfeu , such as joint undertakings , or by the eit knowledge and innovation communities in compliance with the [ eit regulation ] , to be implemented only where other forms of european partnerships would not achieve the objectives or would not generate the necessary expected impacts , and if justified by a long - term perspective and high degree of integration including central management of all financial contributions . ### participation in and financial contribution to research and innovation programmes undertaken by several member states in accordance with article 185 tfeu , or by bodies established pursuant to article 187 tfeu , such as joint undertakings , or by the eit knowledge and innovation communities in compliance with the [ eit regulation ] , to be implemented only where other forms of european partnerships would not achieve the objectives or would not generate the necessary expected impacts , and if justified by a long - term perspective and high degree of integration .


### adhere to the principles of union added value , transparency , openness , impact , leverage effect , long - term financial commitment of all the involved parties , flexibility , coherence and complementarity with union , local , regional national and international initiatives ; ### adhere to the principles of union added value , transparency , openness , impact , leverage effect , long - term financial and / or in - kind commitment of all the involved parties , flexibility , coherence and complementarity with union , local , regional national and international initiatives ;


### the conditions determining the level of financial contribution shall ensure an automatic correction of any significant imbalance compared to the amount that entities established in the associated country receive through participation in the programme , taking into account the costs in the management , execution and operation of the programme . ### every two years , the conditions determining the level of financial contribution shall ensure an automatic correction of any significant imbalance compared to the amount that entities established in the associated country receive through participation in the programme , taking into account the costs in the management , execution and operation of the programme .


### beneficiaries having received union funding shall use their best efforts to exploit their results , in particular in the union . exploitation may be done directly by the beneficiaries or indirectly in particular through the transfer and licensing of results in accordance with article 36 . ### beneficiaries having received union funding shall use their best efforts to exploit their results , preferably in the union . exploitation may be done directly by the beneficiaries or indirectly in particular through the transfer and licensing of results in accordance with article 36 .


### unless the work programme provides otherwise , proposals shall include a plan for the exploitation and dissemination of the results . if the expected exploitation entails developing , creating , manufacturing and marketing a product or process , or in creating and providing a service , the plan shall include a strategy for such exploitation . if the plan provides for exploitation primarily in non - associated third countries , the legal entities shall explain how that exploitation is still in the union interest . ### unless the work programme provides otherwise , proposals shall include a plan for the exploitation and dissemination of the results . if the expected exploitation entails developing , creating , manufacturing and marketing a product or process , or in creating and providing a service , the plan shall include a strategy for such exploitation . if the plan provides for exploitation primarily in non - associated third countries , the legal entities shall justify how that exploitation is still in the union interest . if the beneficiary fails to provide such justification , a non - exclusive licence may be granted to other legal entities seeking to exploit the results in the union or associated third countries . for the purposes of locating and selecting the candidates , the online platform referred to in article 35 shall be used .


### 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 solutions , including through policy research&#160 ; 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 .


### 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 , economic and social health determinants ; non - communicable and rare diseases ; infectious diseases ; tools , technologies and digital solutions for health and care ; health care systems


### dedicated reporting on quantitative and qualitative leverage effects , including on financial and in - kind contributions , visibility and positioning in the international context , impact on research and innovation related risks of private sector investments . ### dedicated reporting on quantitative and qualitative leverage effects , including on financial and / or in - kind contributions , visibility and positioning in the international context , impact on research and innovation related risks of private sector investments .


### where a member state or the commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment , a scientific evaluation of the product should be undertaken at union level , leading to a single decision on the area of disagreement , binding on the member states concerned , being taken on the basis of an overall benefit - risk assessment . ### where a member state or the commission considers that there are reasons to believe that a veterinary medicinal product may present a potential serious risk to human or animal health or to the environment , a scientific evaluation of the product should be undertaken at union level , leading to a single decision on the area of disagreement , binding on the member states concerned , being taken on the basis of an overall benefit - risk assessment . the authorisation procedure for veterinary medicinal products should be adjusted so as to eliminate bureaucratic procedures that might hamper the development of research and innovation for the purpose of identifying new medicines .


### however , there may be situations where no suitable authorised veterinary medicinal product is available . in those situations , by way of exception , veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only . in case of food - producing animals , veterinarians should ensure that an appropriate withdrawal period is prescribed , so that harmful residues of those medicinal products do not enter the food chain . ### however , there may be situations where no suitable authorised veterinary medicinal product is available . in those situations , by way of exception , veterinarians should be allowed to prescribe other medicinal products to the animals under their responsibility in conformity with strict rules and in the interest of animal health or animal welfare only , whereby antimicrobial medicinal products for human use may be employed only subject to the issuing of a prescription by a vet and authorisation by the veterinary authority responsible for monitoring the work of the vet in question . in case of food - producing animals , veterinarians should ensure that an appropriate withdrawal period is prescribed , so that harmful residues of those medicinal products do not enter the food chain .


### directive 2010 / 63 / eu of the european parliament and of the council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement , reduction and refinement . clinical trials for veterinary medicinal products are exempted from that directive . the design and performance of clinical trials , which provide essential information on the safety and efficacy of a veterinary medicinal product , should be such as to provide the most satisfactory results whilst using the minimum number of animals , the procedures should be the least likely to cause pain , suffering or distress to animals and should take into account the principles established by directive 2010 / 63 / eu . __________________ 15 directive 2010 / 63 / eu of the european parliament and of the council of 22 september 2010 on the protection of animals used for scientific purposes . ### directive 2010 / 63 / eu of the european parliament and of the council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement , reduction and refinement . clinical trials for veterinary medicinal products are exempted from that directive . the design and performance of clinical trials , which provide essential information on the safety and efficacy of a veterinary medicinal product , should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals , the procedures should be the least likely to cause pain , suffering or distress to animals and should take into account the principles established by directive 2010 / 63 / eu . __________________ 15 directive 2010 / 63 / eu of the european parliament and of the council of 22 september 2010 on the protection of animals used for scientific purposes .


### the conditions governing the supply of veterinary medicinal products to the public should be harmonised in the union . veterinary medicinal products should only be supplied by persons authorised to do so by the member state where they are established . at the same time , in order to improve access to veterinary medicinal products in the union , retailers that are authorised to supply veterinary medicinal products by the competent authority in the member state where they are established should be allowed to sell prescription and non - prescription veterinary medicinal products via the internet to buyers in other member states . ### the conditions governing the supply of veterinary medicinal products to the public should be harmonised in the union . veterinary medicinal products should only be supplied by persons - where appropriate , veterinarians - who are authorised to do so by the member state where they are established . at the same time , in order to improve access to veterinary medicinal products in the union , retailers that are authorised to supply veterinary medicinal products by the competent authority in the member state where they are established should be allowed to sell prescription and non - prescription veterinary medicinal products via the internet to buyers in other member states .


### its purpose is to be used in or administered to animals with a view to restoring , correcting or modifying physiological functions by exerting a pharmacological , immunological or metabolic action , or to making a medical diagnosis ; ### it may be used in , or administered to , animals with a view either to restoring , correcting or modifying physiological functions by exerting a pharmacological , immunological or metabolic action , or to making a medical diagnosis ;


### its purpose is to be used for euthanasia of animals ; ### it may be used for euthanasia of animals ;


### ‘ 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 :


### ‘ pharmacovigilance’ means the process of monitoring and investigating adverse events ; ### ‘ pharmacovigilance’ means the process of monitoring and investigating scientific , control and administrative activities relating to detection , reporting , assessment , understanding , prevention and communication of adverse events which include continuous evaluation of the benefit - risk balance of veterinary medicinal products ;


### ‘ veterinary prescription’ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law ; ### ‘ veterinary prescription’ means any prescription for a veterinary medicinal product , provided or dispensed by a veterinarian , to the owner or the person taking care of the animal only if he / she has examined the animals and made a diagnosis before the prescription or has personal knowledge of the condition of the animals in order to prescribe the correct medicine . a written or electronic prescription is always required when the medicine is not dispensed by the prescriber .


### by way of derogation from article 5 , a marketing authorisation for a limited market shall be granted for a period of 3 years . ### by way of derogation from article 5 , a marketing authorisation for a limited market shall be granted for a period of 3 years . at the end of that period , the holder may request , in the light of scientific data and on grounds of pharmacovigilance and efficiency , that this authorisation be converted into an open - ended authorisation .


### the competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and / or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with article 7 . ### the competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries comply with eu legislation applicable and are able to manufacture the veterinary medicinal product concerned and / or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with article 7 .


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


### the application shall list member states where the applicant seeks to obtain a marketing authorisation . ### the application shall list member states where the applicant seeks to obtain a marketing authorisation . the applicant shall send an application identical to that submitted to the reference member state , including an identical dossier as provided under article 7 , to all member states concerned .


### 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 . it shall also forward the applications to all member states for information .


### applications for mutual recognition of marketing authorisations shall be submitted to the member state that granted the first national marketing authorisation . ### applications and the dossier for mutual recognition of marketing authorisations shall be submitted to all the member states . the member state that granted the first national marketing authorisation is the .


### within 90 days of receipt of a valid application , the reference member state shall prepare an updated assessment report for the veterinary medicinal product . the updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all member states and the applicant , together with the list of member states where the applicant seeks to obtain recognition of the marketing authorisation . ### within 90 days of receipt of a valid application , the reference member state shall prepare an updated assessment report for the veterinary medicinal product . the updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all concerned member states and the applicant . , together with the list of member states where the applicant seeks to obtain recognition of the marketing authorisation .


### within 15 days after receipt of the assessment report referred to in article 46 or in article 48 the applicant may provide written notice to the agency requesting a re - examination of the assessment report . in that case the applicant shall forward to the agency detailed grounds for the request within 60 days of receipt of the assessment report . the application shall be accompanied by proof of payment of the fee payable to the agency for the re - examination . ### within 15 days after receipt of the assessment report referred to in article 46 or in article 48 the applicant may provide written notice to the coordination group requesting a re - examination of the assessment report . in that case the applicant shall forward to the agency detailed grounds for the request within 60 days of receipt of the assessment report . the application shall be accompanied by proof of payment of the fee payable to the agency for the re - examination


### competent authorities and the agency shall supervise the pharmacovigilance systems of marketing authorisation holders . ### competent authorities and the agency shall supervise the pharmacovigilance systems of marketing authorisation holders and authorise them .


### 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 ;


### marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the union or in a third country with regard to their authorised veterinary medicinal products , within 30 days following the receipt of the adverse event report . ### marketing authorisation holders shall notify electronically all serious adverse events and human events relating to the use of veterinary medicinal products that are brought to their attention or which they can reasonably be expected to have knowledge of to the competent authority of the member state on whose territory the incident occurred and no later than 15 days following receipt of the information . the rest of adverse events relating to the use of veterinary medicinal products that are brought to the attention of the marketing authorization holders or which they can reasonably be expected to have knowledge of , should be notified electronically to the pharmacovigilance database no later than 30 days following receipt of the information .


### the marketing authorisation holder shall not communicate information regarding adverse events to the general public in relation to the veterinary medicinal product without giving prior notification of his intention to the competent authority or authorities having granted the marketing authorisation or to the agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure . ### the marketing authorisation holder shall not communicate information regarding adverse events to the general public in relation to the veterinary medicinal product without sending in advance a copy of that communication to the competent authority or authorities having granted the marketing authorisation or to the agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure .


### communicating any regulatory measure that is taken in a third country and is based on pharmacovigilance data to the competent authorities and the agency within 15 days of receipt of such information . ### communicating any regulatory measure that is taken in a member state or a third country and is based on pharmacovigilance data to the competent authorities and the agency within 15 days of receipt of such information .


### competent authorities may impose specific requirements on veterinarians and other healthcare professionals in respect of the reporting of adverse events . the agency and the competent authorities may organise meetings or a network for groups of veterinarians or other healthcare professionals , where there is a specific need for collecting , collating or analysing specific pharmacovigilance data . ### competent authorities may impose specific requirements on marketing authorisation holders , veterinarians and other healthcare professionals in respect of the reporting of adverse events . the agency and the competent authorities may organise meetings or a network for groups of veterinarians or other healthcare professionals , where there is a specific need for collecting , collating or analysing specific pharmacovigilance data .


### the agency and the coordination group shall agree on sharing of the monitoring of data on groups of veterinary medicinal products recorded in the pharmacovigilance database . for each group of veterinary medicinal products a competent authority or the agency shall be appointed as responsible for the monitoring thereof . ### the agency and the veterinary pharmacovigilance group shall agree on sharing of the monitoring of data on groups of veterinary medicinal products recorded in the pharmacovigilance database . for each group of veterinary medicinal products a competent authority or the agency shall be appointed as responsible for the monitoring thereof .


### inform the competent authority if the qualified person referred to in article 100 is replaced ; ### give prior notice to the competent authority of any changes which he may wish to make to any of the particulars supplied pursuant to article 92 and inform the competent authority immediately if the qualified person referred to in article 100 is replaced ;


### the holder of a manufacturing authorisation shall have permanently and continuously at his disposal the services of at least one qualified person who fulfils the conditions laid down in this article and is responsible , in particular , for carrying out the duties specified in article 101 . ### the holder of a manufacturing authorisation shall have permanently and continuously at his disposal the services of at least one qualified person who fulfils the conditions laid down in this article and is responsible , in particular , for carrying out the duties specified in article 101 . the holder of the manufacturing authorisation may himself assume the responsibility referred to in this paragraph , if he personally fulfils the conditions for qualified persons provided for by this regulation .


### persons permitted to supply veterinary medicinal products in accordance with article 107 may offer veterinary medicinal products by means of information society services in the meaning of directive 98 / 34 / ec of the european parliament and of the council28 to natural or legal persons established in the union under the condition that those medicinal products comply with the legislation of the destination member state . __________________ 28 directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services . ### the member states may authorise persons permitted to supply veterinary medicinal products requiring a veterinary prescription to offer veterinary medicinal products by means of information society services to natural or legal persons established in the union


### a veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law . ### a veterinary medicinal product should only be prescribed by a veterinarian .


### veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation . ### veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation . nevertheless , the veterinarian should be able , in justified circumstances , to prescribe veterinary medicinal products in different terms to the ones authorised for the product .


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a non - food producing animal , the veterinarian responsible may , under his / her direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with the following : ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a non - food producing animal , the veterinarian responsible may , under his / her direct personal responsibility and in the interest of animal health and welfare , exceptionally treat the animal concerned with the following :


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following : ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in the interest of animal health and welfare exceptionally treat the animal concerned with any of the following :


### for the purpose of treatment in accordance with paragraphs 1 to 3 , the veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian ' s responsibility . ### for the purpose of treatment in accordance with paragraph 1 , the veterinarian may administer the medicinal product personally or allow another person to do so under the veterinarian ' s responsibility .


### member states shall designate the competent authorities to carry out tasks under this regulation . ### member states shall designate the competent authorities to carry out tasks under this regulation . the competent authorities shall be , inter alia , responsible for providing the scientific expertise for assessment of all applications under this regulation .


### disclosure of information in case of offers of securities to the public or admission of securities to trading on a regulated market is vital to protect investors by removing asymmetries of information between them and issuers . harmonising this disclosure allows for the establishment of a cross - border passport mechanism which facilitates the effective functioning of the internal market in a wide variety of securities . ### disclosure of information in case of offers of securities to the public or admission of securities to trading on a regulated market is vital to protect investors by reducing asymmetries of information between them and issuers . harmonising this disclosure allows for the establishment of a cross - border passport mechanism which facilitates the effective functioning of the internal market in a wide variety of securities .


### for offers of securities to the public of a consideration below eur 500 000 , the cost of producing a prospectus in accordance with this regulation is likely to be disproportionate to the envisaged proceeds of the offer . it is therefore appropriate that the requirement to draw up a prospectus under this regulation should not apply to offers of such small scale . member states should refrain to impose at national level disclosure requirements which would constitute a disproportionate or unnecessary burden in relation to such offers and thus increase fragmentation of the internal market . ### for offers of securities to the public with a total consideration in the union of less than eur 1 000 000 , the cost of producing a prospectus in accordance with this regulation is likely to be disproportionate to the envisaged proceeds of the offer . it is therefore appropriate that the requirement to draw up a prospectus under this regulation should not apply to offers of such small scale . member states can request issuers to provide a document , not subject to prior approval , describing the offer and setting out the general information relating to the issuer . member states should however refrain from imposing at national level disclosure requirements which would constitute a disproportionate or unnecessary burden in relation to such offers and thus increase fragmentation of the internal market .


### where offers of securities to the public are addressed only to domestic investors in one member state , and thus have no cross - border effects , and where such offers do not exceed a total consideration of eur 10 000 000 , the passport mechanism under this regulation is not needed and drawing up a prospectus may represent a disproportionate cost . therefore it is appropriate to allow member states to decide to exempt such kinds of offers from the prospectus obligation set out in this regulation , taking into account the level of domestic investor protection they deem to be appropriate . in particular , member states should be free to set out in their national law the threshold between eur 500 000 and eur 10 000 000 , expressed as the total consideration of the offer over a period of 12 months , from which this exemption should apply . ### for offers of securities to the public with a total consideration not exceeding eur 5 000 000 , issuers should be entitled to draw up a prospectus in accordance with article 15 . once approved , such prospectuses should benefit from the passporting regime under this regulation and should therefore be valid for the offer to the public in any number of host member states .


### one of the core objectives of the capital markets union is to facilitate access to financing on capital markets for smes in the union . as such companies usually need to raise relatively lower amounts than other issuers , the cost of drawing up a prospectus can be disproportionately high and may deter them from offering their securities to the public . at the same time , because of their size and shorter track record , smes might carry a higher investment risk than larger issuers and should disclose sufficient information for investors to take their investment decision . a proper balance should therefore be struck between the cost - efficient access to financial markets and investor protection when calibrating the content of a prospectus applying to smes and a specific disclosure regime should therefore be developed for smes to achieve that objective . ### one of the core objectives of the capital markets union is to facilitate access to financing on capital markets for smes which are the main driver of the eu economy in the union . as such companies usually need to raise relatively lower amounts than other issuers , the cost of drawing up a prospectus can be disproportionately high and complicated administrative procedures may deter them from offering their securities to the public . at the same time , because of their size and shorter track record , smes might carry a higher investment risk than larger issuers and should disclose sufficient information for investors to take their investment decision . a proper balance should therefore be struck between the cost - efficient access to financial markets and investor protection when calibrating the content of a prospectus applying to smes and a specific disclosure regime should therefore be developed for smes to achieve that objective .


### the minimum information required to be disclosed by smes under the specific disclosure regime should be calibrated in a way that focuses on information that is material and relevant for companies of such size and their investors , and should aim at ensuring proportionality between the size of the company and its fundraising needs , on the one hand , and the cost of producing a prospectus , on the other hand . in order to ensure smes can draw up prospectuses without incurring costs that are not proportionate to their size , and thus the size of their fundraising , the specific disclosure regime for smes should be more flexible than that applying to companies on regulated markets to the extent compatible with ensuring that the key information necessary to the investors is disclosed . ### the reduced information required to be disclosed by smes under the specific disclosure regime should focus on information that is material and relevant for companies of such size and their investors . it should aim at ensuring proportionality between the size of the company and its fundraising needs , on the one hand , and the cost of producing a prospectus , on the other hand . in order to ensure smes can draw up prospectuses without incurring costs that are not proportionate to their size , and thus the size of their fundraising , the specific disclosure regime for smes should be more flexible than that applying to companies on regulated markets to the extent compatible with ensuring that the key information necessary to the investors is disclosed .


### the introduction of the summary shall contain the name of the securities , the identity and contact details of the issuer , the offeror or the person seeking admission , the identity and contact details of the home competent authority and the date of the document . it shall contain warnings that : ### the section referred to in point of paragraph 4 shall contain the following information : the name of the securities , the identity and contact details of the issuer , the offeror or the person seeking admission , the identity and contact details of the home competent authority and the date of the document . it shall contain warnings that :


### 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 .


### 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 .


### 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 risk factors featured in a prospectus shall be limited to risks which are specific to the issuer and / or the securities and are material for taking an informed investment decision , as corroborated by the content of the registration document and the securities note . they shall be allocated across a maximum of three distinct categories which shall differentiate them by their relative materiality based on the issuer ' s assessment of the probability of their occurrence and the expected magnitude of their negative impact . ### the risk factors featured in a prospectus shall be limited to risks which are specific to the issuer and / or the securities and are material for taking an informed investment decision , as corroborated by the content of the registration document and the securities note .


### 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 .


### the level of fees charged by the competent authority of the home member state for the approval of prospectuses , registration documents , including universal registration documents , supplements and amendments , as well as for the filing of universal registration documents , amendments thereto and final terms , shall be disclosed to the public at least on the website of the competent authority . ### the level of fees charged by the competent authority of the home member state for the approval of prospectuses , registration documents , including universal registration documents , supplements and amendments , as well as for the filing of universal registration documents , amendments thereto and final terms , shall be proportionate and disclosed to the public at least on the website of the competent authority .


### without prejudice to article 30 of regulation no 1095 / 2010 , esma shall organise and conduct at least one peer review of the scrutiny and approval procedures of competent authorities , including notifications of approval between competent authorities . the peer review shall also assess the impact of different approaches with regard to scrutiny and approval by competent authorities on issuers ' ability to raise capital in the european union . the report on this peer review shall be published no later that three years after the date of application of this regulation . in the context of this peer review , esma shall , where appropriate , request opinions or advice from the securities and markets stakeholder group referred to in article 37 of regulation no 1095 / 2010 . ### without prejudice to article 30 of regulation no 1095 / 2010 , esma shall also organise and conduct at least one peer review of the scrutiny and approval procedures of competent authorities , including notifications of approval between competent authorities . the peer review shall also assess the impact of different approaches with regard to scrutiny and approval by competent authorities on issuers ' ability to raise capital in the european union . the report on this peer review shall be published no later than three years after the date of application of this regulation and be accessible online format too . in the context of this peer review , esma shall , where appropriate , request opinions or advice from the securities and markets stakeholder group referred to in article 37 of regulation no 1095 / 2010 .


### for the purpose of article 27 , and , where deemed necessary , for the purpose of article 26 , the competent authorities of member states shall conclude cooperation arrangements with supervisory authorities of third countries concerning the exchange of information with supervisory authorities in third countries and the enforcement of obligations arising under this regulation in third countries . those cooperation arrangements shall ensure at least an efficient exchange of information that allows the competent authorities to carry out their duties under this regulation . ### for the purpose of article 27 , and , where deemed necessary , for the purpose of article 26 , the competent authorities of member states shall conclude supervisory cooperation arrangements with the competent authorities of third countries concerning the exchange of information and the enforcement of obligations arising under this regulation in third countries . those supervisory cooperation arrangements shall ensure an efficient exchange of information that allows the competent authorities to carry out their duties under this regulation .


### taking into account the availability of electronic means of data recording and the fact that personal data should in any event be collected before the ship ' s departure , the 30 minutes delay currently provided for by directive 98 / 41 / ec should be considered as a maximum and used in exceptional cases only . ### taking into account the availability of electronic means of data recording and the fact that personal data should in any event be collected before the ship ' s departure , the 30 minutes delay currently provided for by directive 98 / 41 / ec should be considered as a maximum .


### in order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant , it is appropriate to establish conditions for the updating of assessments , in particular where additional data available subsequent to the initial assessment has the potential to increase the accuracy of the assessment . ### to ensure timely patient access to health technologies across the union , in order to ensure that joint clinical assessments carried out on health technologies remain accurate and relevant , and in order to avoid duplications between the regulatory assessments carried by the european medicines agency and the joint clinical assessments , it is appropriate to establish synergies , and conditions for the updating of assessments , in particular where additional data available subsequent to the initial assessment has the potential to increase the accuracy of the assessment .


### in order that the harmonised procedures fulfil their internal market objective , member states should be required to take full account of the results of joint clinical assessments and not repeat those assessments . compliance with this obligation does not prevent member states from carrying out non - clinical assessments on the same health technology , or from drawing conclusions on the added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non - clinical data and criteria . it also does not prevent member states from forming their own recommendations or decisions on pricing or reimbursement . ### in order that the harmonised procedures fulfil their internal market objective and at the same time support access to medical innovations , member states should be required to take full account of the results of joint clinical assessments and not repeat those assessments . compliance with this obligation does not prevent member states from carrying out non - clinical assessments on the same health technology , or from drawing conclusions on the clinical added value of the technologies concerned as part of national appraisal processes which may consider clinical as well as non - clinical data and criteria . it also does not prevent member states from forming their own recommendations or decisions on pricing or reimbursement .


### the time - frame for joint clinical assessments for medicinal products should , in as far as possible , be fixed by reference to the time - frame applicable to the completion of the central marketing authorisation procedure provided for under regulation no 726 / 2004 . such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients . as a rule , the process should be completed by the time of the publication of the commission decision granting marketing authorisation . ### the time - frame for joint clinical assessments for medicinal products should , in as far as possible , be fixed by reference to the time - frame applicable to the completion of the central marketing authorisation procedure provided for under regulation no 726 / 2004 . such coordination should ensure clinical assessments can effectively facilitate market access and contribute to the timely availability of innovative technologies for patients . in certain member states , clinical assessments can start even before the marketing authorization has been granted by the commission . to support the objectives of this regulation and to avoid that the joint clinical assessments results in delays in those member states compared to the status quo , as a rule , the process should be completed by the time of the publication of the commission decision granting marketing authorisation .


### this regulation establishes : ### taking into account the results of the work already undertaken in the eunethta joint actions , this regulation establishes :


### ' clinical assessment ' means a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment : the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem , the description and technical characterisation of the health technology , the relative clinical effectiveness , and the relative safety of the health technology ; ### ' clinical assessment ' means a compilation and analysis of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment : the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem , the description and technical characterisation of the health technology , the relative clinical effectiveness , and the relative safety of the health technology ;


### member states shall designate their national authorities and bodies responsible for health technology assessment as members of the coordination group and its sub - groups and inform the commission thereof and of any subsequent changes . member states may designate more than one authority or body responsible for health technology assessment as members of the coordination group and one or more of its sub - groups . ### member states shall designate their national authorities and bodies responsible for health technology assessment which inform decision - making at national level as members of the coordination group and its sub - groups and inform the commission thereof and of any subsequent changes . member states may designate more than one authority or body responsible for health technology assessment as members of the coordination group and one or more of its sub - groups . each member state may appoint to the coordination group at least one authority or body responsible with expertise in the field of medicinal products .


### ensure appropriate involvement of stakeholders in its work ; ### ensure appropriate and regular involvement of stakeholders in its work ;


### the joint clinical assessment report shall be accompanied by a summary report and they shall be prepared in accordance with the requirements in this article and the requirements established pursuant to articles 11 , 22 , and 23 . ### the joint clinical assessment report shall be accompanied by a summary report and they shall be prepared in accordance with the requirements in this article , the requirements established pursuant to articles 11 , 22 , and 23 , and taking into account the results of the work already undertaken in the eunethta joint actions and eunethta procedures for joint clinical assessments of medicinal products .


### an analysis of the relative effects of the health technology being assessed on the patient - relevant health outcomes chosen for the assessment ; ### a description&#160 ; of the relative effects of the health technology being assessed on the patient - relevant health outcomes&#160 ; agreed for the assessment ;


### select medicinal products referred to in article 5 for joint clinical assessment based on the selection criteria referred to in article 5 . ### select medicinal products referred to in article 5 for joint clinical assessment based on the following selection criteria :


### submissions of information , data and evidence by health technology developers ; ### submissions of information , data and evidence by health technology developers , including the protection of developers ' confidential information ;


### member states may carry out a clinical assessment using means other than the rules provided for in chapter iii of this regulation , on grounds related to the need to protect public health in the member state concerned and provided the measure is justified , necessary and proportionate as regards achieving that aim . ### member states may carry out a clinical assessment using means other than the rules provided for in chapter iii of this regulation , namely&#160 ; on grounds related to the need to protect public health in the member state concerned and provided the measure is justified , necessary and proportionate as regards achieving that aim .


### modern diesel vehicles emit high and increasing amounts of no2 as a share of the total nox emissions which were not anticipated when regulation no 715 / 2007 was adopted . most air quality problems in affected urban areas appear to be related to direct no2 emissions . therefore , an appropriate emission limit should be introduced . ### modern diesel vehicles emit high and increasing amounts of no2 as a share of the total nox emissions which were not anticipated when regulation no 715 / 2007 was adopted . most air quality problems in affected urban areas appear to be related to direct no2 emissions . for this reason , an appropriate emission limit should be introduced .


### 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 .


### after the completion of the un / ece particulate measurement programme , conducted under the auspices of the world forum for harmonisation of vehicle regulations , and at the latest upon entry into force of euro 6 , the commission shall be empowered to adopt delegated acts in accordance with article 14a in order to adopt the following measures , without lowering the level of environmental protection within the union : ### after the completion of the un / ece particulate measurement programme , conducted under the auspices of the world forum for harmonisation of vehicle regulations , and at the latest upon entry into force of euro 6 , the commission shall be empowered to adopt , without undue delay , delegated acts in accordance with article 14a in order to adopt the following measures , without lowering the level of environmental protection within the union :


### adoption of a revised measurement procedure for particulates and a particle number limit value . ### adoption of a revised measurement procedure for particulates , including nano - particulates , and a particle number limit value .


### the commission shall keep under review the procedures , tests and requirements referred to in article 5 as well as the test cycles used to measure emissions . if the review finds that those procedures , tests , requirements and test cycles are no longer adequate or no longer reflect real world emissions , the commission shall act in accordance with article 5 in order to adapt them so as to adequately reflect the emissions generated by real driving on the road . ### the commission shall , as soon as possible , review the procedures , tests and requirements referred to in article 5 as well as the test cycles used to measure emissions . following that review , the commission shall by means of delegated acts referred to in article 5 adapt procedures , tests cycles and requirements so as to adequately reflect the emissions generated by real driving on the road . that review shall be conducted every two years .


### 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 .


### ' . ### 6 , 0 x 1011 ' .


### the abrasion of tyres during use is a significant source of microplastics , which are harmful to the environment , and the commission’s communication “a european strategy for plastics in a circular economy”16 therefore mentions the need to address unintentional release of microplastics from tyres , inter alia through information measures such as labelling and minimum requirements for tyres . however , a suitable testing method to measure tyre abrasion is not currently available . therefore , the commission should mandate the development of such a method , taking into full consideration all state - of - the - art internationally developed or proposed standards or regulations , with a view to establishing a suitable testing method as soon as possible . __________________ 16 com 28 final ### the abrasion of tyres during use is a significant source of microplastics , which are harmful to the environment , and the commission’s communication “a european strategy for plastics in a circular economy”16 therefore mentions the need to address unintentional release of microplastics from tyres , inter alia through information measures such as labelling and minimum requirements for tyres . although the industry has started research on tyre abrasion and on the development of a testing method , a suitable testing method is not currently available . therefore , the commission should mandate the development of such a method , taking into full consideration the sector’s work and all state - of - the - art internationally developed or proposed standards or regulations , with a view to establishing a suitable testing method as soon as possible . __________________ 16 com 28 final


### suppliers shall ensure that the values , the related classes and any additional performance information they declare on the label for the essential parameters set out in annex i have been subject to the type approval process under regulation no 661 / 2009 . ### suppliers shall ensure that the values , the related classes , the model identifier and any additional performance information they declare on the label for the essential parameters set out in annex i and that the technical documentation parameters set out in annex 3 have been provided to the type approval authority before placing a tyre on the market . the type approval authority shall acknowledge the receipt of the documentation from the supplier .


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


### upon request from the commission , the prima - is and the participating states should submit any information the commission needs to include in the reports on the evaluation of prima . ### upon request from the commission , the prima - is and the participating states should submit , in a harmonised format , any information the commission needs to include in the reports on the evaluation of prima .


### if the country complies with the requirements set out in the first subparagraph , it shall be regarded as a participating state for the purposes of this decision . ### if the country complies with the requirements set out in this paragraph , it shall be regarded as a participating state for the purposes of this decision .


### 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 .


### the formulation of a stable , long - term , common strategic agenda in the area of water provision and food systems ; ### the formulation of a long - term , sustainable , common strategic agenda in line with the sustainable development goals and with the european sustainable development strategy in order to safeguards natural resources , in the area of the management , production and supply of water , including treatment and reuse , and in the area of agri - food products ;


### the commission shall assess the fulfilment of commitments undertaken by the participating states , in particular through the first two prima annual work plans . following that assessment the maximum union contribution referred to in article 3 shall be reviewed in accordance with article 9 . ### the commission shall assess the fulfilment of commitments undertaken by the participating states , in particular through the first two prima annual work plans . following that assessment the maximum union contribution referred to in article 3 may be reviewed in accordance with article 9 .


### in - kind contributions referred to in point of paragraph 2 of this article shall consist of costs incurred by the participating states through their national funding bodies in implementing activities referred to in article 6 , less any direct or indirect union financial contribution to those costs . ### in - kind contributions referred to in point of paragraph 2 of this article shall consist of costs incurred by the participating states through their national funding bodies in implementing activities referred to in article 6 or pertaining to the administrative budget of the prima - is , less any direct or indirect union financial contribution to those costs .


### activities to be funded by the participating states through their national funding bodies without union contribution may only be included in the prima annual work plan following the positive outcome of their external independent evaluation by international peer review with regard to the objectives of prima , as organised by the prima - is . ### activities to be funded by the participating states through their national funding bodies without union contribution may only be included in the prima annual work plan following a positive assessment by the prima - is of their contribution with regard to the objectives of prima ; in the event of doubt , the prima - is may request an external independent peer review .


### activities included in the prima annual work plan that are funded by the participating states through their national funding bodies without union contribution shall be implemented in compliance with common principles to be adopted by the prima - is , after obtaining approval by the commission . the common principles shall take into account the principles set out in this decision , in title vi of regulation no 966 / 2012 and in regulation no 1290 / 2013 , in particular the principles of equal treatment , transparency , independent peer review evaluation and selection . the prima - is shall also adopt , after obtaining approval by the commission , the reporting requirements of the participating states to the prima - is , including with regard to indicators inserted into each of those activities . ### activities included in the prima annual work plan shall be implemented in compliance with common principles to be adopted by the prima - is , after obtaining approval by the commission . the common principles shall take into account the balance between the interests of the northern and southern shores of the mediterranean and the principles set out in this decision , in title vi of regulation no 966 / 2012 and in regulation no 1290 / 2013 , in particular the principles of equal treatment , transparency , independent peer review evaluation and selection . the prima - is shall also adopt , after obtaining approval by the commission , the reporting requirements of the participating states to the prima - is , including with regard to indicators inserted into each of those activities .


### the proposals shall be selected following transnational calls for proposals and through a two - step procedure . step 1 shall consist of a review at national or transnational level of proposals submitted by legal entities eligible for funding under the relevant national programmes . step 2 shall consist of a single independent international peer review organised by the prima - is . under step 2 , the proposals shall be evaluated with the assistance of at least three independent experts , on the basis of the following award criteria : excellence , impact , quality and efficiency of the implementation . ### the proposals shall be selected following transnational calls for proposals . the proposals shall be evaluated with the assistance of at least three independent experts , on the basis of the following selection and award criteria : a fair balance between small and larger projects , relevance , scientific and technological excellence , impact , scientific quality and efficiency of the implementation .


### 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 on the basis of this ranking . the participating states shall agree on an adequate selection 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 the event that one or more projects cannot be financed owing to a lack of budgetary resources , the following projects may be selected ;


### 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 .


### 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 to be participating states in accordance with this decision , before the submission deadline under the relevant call for proposals , 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 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 :


### the general assembly shall approve the participation in prima of any third country not associated to horizon 2020 other than those listed in article 1 after examining the relevance of its participation for achieving the objectives of prima . ### the steering committee shall approve the participation in prima of any country neither a member state of union for the mediterranean nor associated to horizon 2020 , after examining the relevance of its participation for achieving the objectives of prima . the steering committee decides what is an adequate percentage of the total effort pursuant to point of article 4 .


### the general assembly shall determine the number of management board members , which shall not be less than five , and shall appoint them . the management board shall supervise the secretariat of the prima - is . ### the steering committee shall determine the number of governing board members , which shall not be less than five , and shall appoint them for a four - year renewable term . the governing board shall meet at least every three months or whenever deemed necessary . the governing board shall supervise the secretariat of the prima - is .


### article 7 of the charter of fundamental rights of the european union protects the fundamental right of everyone to the respect for his or her private and family life , home and communications . respect for the privacy of one ' s communications is an essential dimension of this right . confidentiality of electronic communications ensures that information exchanged between parties and the external elements of such communication , including when the information has been sent , from where , to whom , is not to be revealed to anyone other than to the parties involved in a communication . the principle of confidentiality should apply to current and future means of communication , including calls , internet access , instant messaging applications , e - mail , internet phone calls and personal messaging provided through social media . ### article 7 of the charter of fundamental rights of the european union protects the fundamental right of everyone to the respect for his or her private and family life , home and communications . respect for the privacy of one ' s communications is an essential dimension of this right . confidentiality of electronic communications ensures that information exchanged between parties and the external elements of such communication , including information regarding when the information has been sent , from where , to whom , is not to be revealed to anyone other than to the communicating parties . the principle of confidentiality should apply to current and future means of communication , including calls , internet access , instant messaging applications , e - mail , internet phone calls and inter - personal messaging provided through social media . it should also apply when the confidentiality of electronic communications and the privacy of the physical environment converge , i . e . where terminal devices for electronic communication can also listen into their physical environment or use other input channels such as bluetooth signalling or movement sensors .


### pursuant to article 8 of the charter and article 16 of the treaty on the functioning of the european union , everyone has the right to the protection of personal data concerning him or her . regulation 2016 / 679 lays down rules relating to the protection of natural persons with regard to the processing of personal data and rules relating to the free movement of personal data . electronic communications data may include personal data as defined in regulation 2016 / 679 . ### pursuant to article 8 of the charter and article 16 of the treaty on the functioning of the european union , everyone has the right to the protection of personal data concerning him or her . regulation 2016 / 679 lays down rules relating to the protection of natural persons with regard to the processing of personal data and rules relating to the free movement of personal data . since electronic communications data may include personal data as defined in regulation 2016 / 679 , the provisions related to the protection of natural persons apply to that extent in regard to the processing of personal data .


### the provisions of this regulation particularise and complement the general rules on the protection of personal data laid down in regulation 2016 / 679 as regards electronic communications data that qualify as personal data . this regulation therefore does not lower the level of protection enjoyed by natural persons under regulation 2016 / 679 . processing of electronic communications data by providers of electronic communications services should only be permitted in accordance with this regulation . ### the provisions of this regulation particularise and complement the general rules on the protection of personal data laid down in regulation 2016 / 679 as regards electronic communications data that qualify as personal data . this regulation therefore does not lower the level of protection enjoyed by natural persons under regulation 2016 / 679 . on the contrary , it aims to provide additional , and complementary , safeguards taking into account the need for additional protection as regards the confidentiality of communications . processing of electronic communications data should only be permitted in accordance with , and on a legal ground specifically provided under , this regulation .


### while the principles and main provisions of directive 2002 / 58 / ec of the european parliament and of the council22 remain generally sound , that directive has not fully kept pace with the evolution of technological and market reality , resulting in an inconsistent or insufficient effective protection of privacy and confidentiality in relation to electronic communications . those developments include the entrance on the market of electronic communications services that from a consumer perspective are substitutable to traditional services , but do not have to comply with the same set of rules . another development concerns new techniques that allow for tracking of online behaviour of end - users , which are not covered by directive 2002 / 58 / ec . directive 2002 / 58 / ec should therefore be repealed and replaced by this regulation . __________________ 22 directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector . ### while the principles and main provisions of directive 2002 / 58 / ec of the european parliament and of the council22 remain generally sound , that directive has not fully kept pace with the evolution of technological and market reality , resulting in an inconsistent or insufficient effective protection of privacy and confidentiality in relation to electronic communications using the new media . those developments include the entrance on the market of electronic communications services that from a consumer perspective are substitutable to traditional services , but do not have to comply with the same set of rules . another development concerns new techniques that allow for tracking of online behaviour of end - users , which are not covered by directive 2002 / 58 / ec . directive 2002 / 58 / ec should therefore be repealed and replaced by this regulation . __________________ 22 directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector .


### this regulation should apply to providers of electronic communications services , to providers of publicly available directories , and to software providers permitting electronic communications , including the retrieval and presentation of information on the internet . this regulation should also apply to natural and legal persons who use electronic communications services to send direct marketing commercial communications or collect information related to or stored in end - users’ terminal equipment . ### this regulation should apply to providers of electronic communications services , to providers of publicly available directories , and to software providers permitting electronic communications , including the retrieval and presentation of information on the internet . this regulation should also apply to natural persons who use electronic communications services to send direct marketing commercial communications or collect information related to or stored in consumers’ terminal equipment .


### 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 . 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 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 . _________________ 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 . 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 .


### the development of fast and efficient wireless technologies has fostered the increasing availability for the public of internet access via wireless networks accessible by anyone in public and semi - private spaces such as ' hotspots ' situated at different places within a city , department stores , shopping malls and hospitals . to the extent that those communications networks are provided to an undefined group of end - users , the confidentiality of the communications transmitted through such networks should be protected . the fact that wireless electronic communications services may be ancillary to other services should not stand in the way of ensuring the protection of confidentiality of communications data and application of this regulation . therefore , this regulation should apply to electronic communications data using electronic communications services and public communications networks . in contrast , this regulation should not apply to closed groups of end - users such as corporate networks , access to which is limited to members of the corporation . ### the development of fast and efficient wireless technologies has fostered the increasing availability for the public of internet access via wireless networks accessible by anyone in public and semi - private spaces such as ' hotspots ' situated at different places within a city , department stores , shopping malls and hospitals . to the extent that those communications networks are provided to an undefined group of end - users , the confidentiality of the communications transmitted through such networks should be protected . therefore , this regulation should apply to electronic communications data using electronic communications services which are targeting the general public , and public communications networks . in addition , this regulation should also apply to closed social media profiles and groups that the user has restricted or defined as private . this regulation should not apply to other kind of closed groups such as corporate networks , access to which is limited to members of the corporation . such networks are offered to a defined group of end - users . however , even if undefined end - users use the network in question in the context of the activities of the defined group of end - users it should not preclude them from being considered outside the material scope of the regulation . for example , an enterprise’s collaboration platform primarily used by its employees that allows third parties to call - in or otherwise engage in the workspace should not be covered . the mere act of requiring a password should not be considered as providing access to a closed group of end - users if the access is provided to an undefined group of end - users .


### the development of fast and efficient wireless technologies has fostered the increasing availability for the public of internet access via wireless networks accessible by anyone in public and semi - private spaces such as ‘ hotspots’ situated at different places within a city , department stores , shopping malls and hospitals . to the extent that those communications networks are provided to an undefined group of end - users , the confidentiality of the communications transmitted through such networks should be protected . the fact that wireless electronic communications services may be ancillary to other services should not stand in the way of ensuring the protection of confidentiality of communications data and application of this regulation . therefore , this regulation should apply to electronic communications data using electronic communications services and public communications networks . in contrast , this regulation should not apply to closed groups of end - users such as corporate networks , access to which is limited to members of the corporation . ### the development of fast and efficient wireless technologies has fostered the increasing availability for the public of internet access via wireless networks accessible by anyone in public and semi - private spaces such as ‘ hotspots’ situated at different places within a city , department stores , shopping malls and hospitals . to the extent that those communications networks are provided to an undefined group of end - users , the confidentiality of the communications transmitted through such networks should be protected . therefore , this regulation should apply to electronic communications data using electronic communications services which are targeting the general public and public communications networks . this regulation should not apply to closed groups of end - users such as corporate networks access to which is limited to members of the corporation . however , even if undefined end - users use the network in question in the context of the activities of the defined group of end - users , it should not preclude them from being considered outside the material scope of the regulation .