### the eu guarantee shall be granted for eib financing and investment operations approved by the investment committee referred to in article 3 or funding to the eif in order to conduct eib financing and investment operations in accordance with article 7 . the operations concerned shall be consistent with union policies and support any of the following general objectives : ### the eu guarantee shall be granted for eib financing and investment operations approved by the investment committee referred to in article 3 or funding to the eif in order to conduct eib financing and investment operations in accordance with article 7 . the efsi shall target projects with a higher risk profile than existing eib and union instruments or programmes so as to ensure additionality over existing operations . the operations concerned shall be consistent with union policies and support any of the following general objectives :


### development of infrastructure , including in the areas of transport , particularly in industrial centres ; energy , in particular energy interconnections ; and digital infrastructure ; ### development of a truly european single market by tackling missing infrastructure , including in the areas of transport , particularly in industrial , urban and rural&#160 ; centres ; energy , in particular energy interconnections and storage ; and digital and telecommunications infrastructure ;


### the efsi should support strategic investments with high economic value added contributing to achieving union policy objectives . ### the efsi should support strategic investments with high economic and social value added contributing to achieving union policy objectives . the efsi should improve access to finance and the competitiveness of enterprises , in particular for small and medium - sized enterprises as defined in recommendation 2003 / 361 / ec , and invest in projects which aim to strengthen the single market . the efsi should be complementary to existing eu programmes . in this context , the projects financed by the efsi should have a higher risk than projects financed by other eu programmes or by other eib operations .


### the purpose of the efsi shall be to support investments in the union and to ensure increased access to financing for companies having up to 3000 employees , with a particular focus on small and medium enterprises , through the supply of risk bearing capacity to the eib . ### the purpose of the efsi shall be to support investments in the union and to ensure increased access to financing for companies having up to 3000 employees , with a particular focus on micro , small and medium - size enterprises , through the supply of risk bearing capacity to the eib .


### provide finance in favour of micro - , small - and medium - sized enterprises with a particular focus on private sector development ; ### provide finance in favour of micro - , small - and medium - sized enterprises with a particular focus on developing a stable private sector that is viable over time ;


### it is essential for the proper functioning of the internal market to ensure that member states provide information to citizens , representative associations or other relevant stakeholders before introducing new measures restricting access to or pursuit of regulated professions and give them the opportunity to make known their views . ### it is essential for the proper functioning of the internal market to ensure that member states provide information to citizens , representative associations or other relevant stakeholders when introducing new or amending existing requirements restricting access to , or pursuit of regulated professions and give them the opportunity to make known their views . where necessary , member states are encouraged to carry out wider public consultation in order to gather adequate evidence necessary for designing reforms of professional services , especially in cases of reforms with a greater impact .


### the cumulative effect of restrictions to both access to and pursuit of the profession , and in particular how each of those requirements contributes to and whether it is necessary to achieve the same public interest objective . ### the effect of new or amended provisions , when combined with other provisions restricting access to or pursuit of the profession , and in particular how each of those requirements contributes to and whether it is necessary to achieve the same public interest objective .


### where a member state intends to regulate a profession or to amend existing rules , account should be taken of the nature of the risks related to the public interest objectives pursued , in particular the risks to consumers , to professionals or third parties . it should also be borne in mind that , in the field of professional services , there is usually an asymmetry of information between consumers and professionals . professionals display a high level of technical knowledge which consumers may not have and consumers therefore find it difficult to judge the quality of the services provided to them . ### where a member state intends to regulate a profession or to amend existing rules , account should be taken of the nature of the risks related to the public interest objectives pursued , in particular the risks to consumers , to professionals or third parties . it should also be borne in mind that , in the field of professional services , there is usually an asymmetry of information between consumers and professionals . professionals display a high level of technical knowledge , which consumers may not have and consumers therefore find it difficult to judge the quality of the services provided to them . member states should apply the proportionality criteria laid down in this directive when introducing new or amending existing legislative , regulatory or administrative provisions to the extent that those criteria are relevant for a given profession . the extent of the assessment should be proportionate to the nature , the content and the impact of the provision being introduced , and should take into account the entirety of the regulatory context for a given regulated profession .


### before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall assess whether those provisions are necessary and suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective . ### before introducing new , or amending existing , legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , member states shall assess whether those provisions are suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective . the extent of the assessment shall be proportionate to the nature , the content and the impact of the provision being introduced , in view of all regulation in place , taking into account the reasonable margin of appreciation of the member states within the limits of the principles of non - discrimination and proportionality .


### member states should carry out proportionality assessments in an objective and independent manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so . in particular , while the assessment of the local authorities , regulatory bodies or professional organisations , whose greater proximity to local conditions and specialised knowledge could in certain cases make them better placed to identify the best way of meeting the public interest objectives , there is particular reason for concern in cases where the policy choice made by those authorities or bodies provides benefits to established operators at the expense of new market entrants . ### member states should carry out proportionality assessments in an objective and independent manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so . the member states may obtain comments from any bodies they consider relevant and capable of providing such comments , especially bodies that are part of the national legislative process and have advisory powers , such as professional organisations , for example .


### member states should carry out a comparison between the national measure at issue and the alternative and less restrictive solutions that would allow the same objective to be attained but would impose fewer restrictions . where the measures are justified by consumer protection and where the risks identified are limited to the relationship between the professional and the consumer without negatively affecting third parties , the objective could be attained by less restrictive means than reserving activities to professionals , such as protection of the professional title or enrolment on a professional register . regulation by way of reserved activities should be used only in cases where the measures aim at preventing a risk of serious harm to public interest objectives . ### member states should carry out a comparison between the national measure at issue and the alternative and less restrictive solutions that would allow the same objective to be attained but would impose fewer restrictions . where the measures are justified by consumer protection and where the risks identified are limited to the relationship between the professional and the consumer without negatively affecting third parties , the objective should be attained by less restrictive means than reserving activities to professionals . for instance , where consumers can reasonably make a choice between using the services of qualified professionals or not , less restrictive means , such as protection of the professional title or enrolment on a professional register , should be used . regulation by way of reserved activities and protected professional title should be considered where the measures aim at preventing a risk of serious harm to public interest objectives .


### the national authorities should carry out a global assessment of the circumstances in which the restrictive measure is adopted and implemented and examine in particular the cumulative effect of imposing several requirements in addition to the specific professional qualification . the taking - up and pursuit of certain activities may be conditional on complying with certain provisions such as rules relating to the organisation of the profession , compulsory membership of a professional body , professional ethics , supervision and liability . therefore , when assessing the cumulative effect of the measures , the competent authorities should also take into account other existing requirements , such as continuous professional development , compulsory chamber membership , registration or authorisation schemes , quantitative restrictions , specific legal form requirements and shareholding requirements , territorial restrictions , multidisciplinary restrictions and incompatibility rules , requirements concerning insurance cover as well as language knowledge requirements , to the extent necessary to practise the profession . a measure introduced by a member state cannot be regarded as necessary to achieve the objective pursued if it essentially duplicates requirements which have already been introduced in the context of other rules or procedures . ### member states should carry out a comprehensive assessment of the circumstances in which the requirement is adopted and implemented and examine in particular the combined effect of imposing several requirements in addition to the specific professional qualification . the taking - up and pursuit of certain activities may be conditional on complying with several requirements such as rules relating to the organisation of the profession , compulsory membership of a professional body , professional ethics , supervision and liability . therefore , when assessing the effect of the measures , member states should take into account all existing requirements , including continuous professional development , compulsory chamber membership , registration or authorisation schemes , quantitative restrictions , specific legal form requirements and shareholding requirements , territorial restrictions , multidisciplinary restrictions and incompatibility rules , requirements concerning insurance cover as well as language knowledge requirements , to the extent necessary to practise the profession .


### the burden of proof of justification and proportionality lies on the member states . the reasons for regulation invoked by a member state by way of justification should thus be accompanied by an analysis of the appropriateness and proportionality of the measure adopted by that state and by specific evidence substantiating its arguments . ### the burden of proof of justification and proportionality lies on the member states . the reasons for regulation invoked by a member state by way of justification should thus be accompanied by an analysis of the proportionality of the measure adopted by that member state and by specific evidence substantiating its arguments . although a member state does not necessarily have to be able to produce a specific study or a specific form of evidence or materials establishing the proportionality of such measure prior to its adoption , it should carry out an objective and detailed analysis , capable of demonstrating , on the basis of consistent evidence , that there are genuine risks for the achievement of public interest objectives , in view of the specific circumstances of that member state .


### the link between the scope of activities covered by a profession or reserved to it and the professional qualification required ; ### the appropriate link between the scope of activities covered by a profession or reserved to it and the specific professional qualification required ;


### for the purposes of the efficient application of this directive , before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall encourage the exchange of information with competent authorities of other member states on matters covered by this directive , such as the particular way they regulate a profession or the effects of regulation identified in similar sectors of activities , on a regular basis , or , where appropriate , on an ad hoc basis . ### for the purposes of the efficient application of this directive , when assessing current legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , as well as before introducing new provisions or amending existing ones , member states shall encourage the exchange of information with competent authorities of other member states on matters covered by this directive , such as the particular way they regulate a profession or the effects of regulation identified in similar sectors of activities , on a regular basis , or , where appropriate , on an ad hoc basis .


### reserved activities , existing alongside protected professional title ; ### reserved activities , protected professional title , or any other form of regulation of one of the modes of pursuit of a profession ;


### it is essential for the proper functioning of the internal market to ensure that member states provide information to citizens , representative associations or other relevant stakeholders before introducing new measures restricting access to or pursuit of regulated professions and give them the opportunity to make known their views . ### it is essential for the proper functioning of the internal market to ensure that member states provide information to citizens , professional organisations and representative associations or other relevant stakeholders when introducing new or amending existing requirements restricting access to , or pursuit of , regulated professions , and give them the opportunity to make known their views .


### continuous professional development requirements ; ### obligation to undergo continuous professional development ;


### member states and other interested parties may submit comments to the commission or to the member state which has notified the provisions . ### member states may submit comments to the commission concerning the provisions and the reasons for considering that they are non - discriminatory , justified and proportionate . these observations shall be duly taken into account by the commission in its summary report pursuant to paragraph 8 of article 59 of directive 2005 / 36 / ec .


### for the purposes of paragraph 2 , where the measures are justified by consumer protection and where the risks identified are limited to the relationship between the professional and the consumer without negatively affecting third parties , the relevant competent authorities shall assess in particular whether the objective can be attained by protected professional title without reserving activities . ### for the purposes of paragraph 2 , where the measures are justified only by consumer protection and where the risks identified are limited to the relationship between the professional and the consumer without negatively affecting third parties , the member states shall assess in particular whether the objective can be attained by less restrictive means than reserving activities .


### the relevant competent authorities shall consider in particular whether those provisions are objectively justified on the basis of public policy , public security or public health , or by overriding reasons in the public interest , such as preserving the financial equilibrium of the social security system , the protection of consumers , recipients of services and workers , the safeguarding of the proper administration of justice , fairness of trade transactions , combating fraud and prevention of tax evasion and avoidance , road safety , the protection of the environment and the urban environment , the health of animals , intellectual property , the safeguarding and conservation of the national historic and artistic heritage , social policy objectives and cultural policy objectives . ### member states shall consider in particular whether those provisions are objectively justified on the basis of public policy , public security or public health , or by overriding reasons in the public interest , such as preserving the financial equilibrium of the social security system , the protection of consumers , recipients of services and workers , the safeguarding of the proper administration of justice , fairness of trade transactions , combating fraud and prevention of tax evasion and avoidance , road safety , guaranteeing the quality of craft work , research and development , the protection of the environment and the urban environment , the health of animals , intellectual property , the safeguarding and conservation of the national historic and artistic heritage , social policy objectives and cultural policy objectives .


### before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall assess whether those provisions are necessary and suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective . ### when introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall ensure that those provisions are suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective . the extent of the assessment shall be proportionate to the nature , the content and the impact of the provision being introduced , in view of all regulation in place , taking into account the reasonable margin of appreciation of the member states .


### for the purposes of paragraph 2 , the relevant competent authorities shall assess in particular the cumulative effect of imposing any of the following requirements : ### for the purposes of paragraph 2 , member states shall assess all regulation in place and in particular the effect of the new or amended requirement in combination with the following requirements , it being understood that there might be positive as well as negative effects :


### member states should carry out proportionality assessments in an objective and independent manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so . in particular , while the assessment of the local authorities , regulatory bodies or professional organisations , whose greater proximity to local conditions and specialised knowledge could in certain cases make them better placed to identify the best way of meeting the public interest objectives , there is particular reason for concern in cases where the policy choice made by those authorities or bodies provides benefits to established operators at the expense of new market entrants . ### member states should carry out proportionality assessments in an objective and independent manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so . in cases where regulatory provisions restricting the access to or pursuit of the regulated profession are established by professional bodies such as orders or chambers , there is a particular reason for concern given the proximity of such bodies to local conditions and a risk that policy choices made might favour established operators at the expense of new market entrants .


### member states shall take the necessary measures to ensure that the assessment of proportionality referred to in paragraph 1 is carried out in an objective and independent manner including through involvement of independent scrutiny bodies . ### member states shall take the necessary measures to ensure that the assessment referred to in paragraph 1 is carried out in an objective and independent manner .


### where the taking - up and pursuit of certain employed or self - employed activities are conditional on complying with certain provisions relating to specific professional qualifications , laid down directly or indirectly by the member states , it is necessary to ensure that such provisions are justified by public interest objectives , such as those within the meaning of the treaty , namely public policy , public security and public health or by overriding reasons of general interest , recognised as such in the case - law of the court of justice . it is important to ensure that public interest objectives are adequately identified in order to determine the intensity of the regulation . for example , in order to ensure a high level of protection of public health , member states should enjoy a margin of discretion to decide on the degree of protection which they wish to afford to public health and on the way in which that protection is to be achieved . it is also necessary to clarify that among the overriding reasons of general interest , recognised by the court of justice , are preserving the financial equilibrium of the social security system ; the protection of consumers , recipients of services and workers ; the safeguarding of the proper administration of justice ; fairness of trade transactions ; combating fraud and prevention of tax evasion and avoidance ; road safety ; the protection of the environment and the urban environment ; the health of animals ; intellectual property ; the safeguarding and conservation of the national historic and artistic heritage , social policy objectives and cultural policy objectives . according to settled case - law , purely economic reasons , having essentially protectionist aims , as well as purely administrative reasons , such as carrying out controls or gathering statistics cannot constitute an overriding reason of general interest . ### where the taking - up and pursuit of employed or self - employed activities are conditional on complying with certain requirements relating to specific professional qualifications , laid down directly or indirectly by the member states , it is necessary to ensure that such requirements are justified by public interest objectives , such as those within the meaning of the treaty , namely public policy , public security and public health or by overriding reasons of general interest , recognised as such in the case - law of the court of justice . it is also necessary to clarify that the following are among the overriding reasons of general interest , recognised by the court of justice : preserving the financial equilibrium of the social security system ; the protection of consumers , of the recipients of services and of workers ; safeguarding the proper administration of justice ; ensuring the fairness of trade transactions ; combating fraud and prevention of tax evasion and avoidance ; road safety ; guaranteeing the quality of craft work ; research and development ; the protection of the environment and the urban environment ; the health of animals ; intellectual property ; the safeguarding and conservation of the national historic and artistic heritage , social policy objectives and cultural policy objectives . according to settled case law , purely economic reasons , such as promoting the national economy to the detriment of the of the fundamental freedoms , as well as purely administrative reasons , such as carrying out controls or gathering statistics cannot constitute an overriding reason of general interest . it is important to ensure that public interest objectives are adequately identified in order to determine the appropriate level of regulation . for example , where the risks to the public interest objective increase , member states should enjoy a margin of appreciation within which they are able to determine the degree of protection which they wish to afford , and if necessary to strengthen the regulation in place . the fact that one member state imposes less strict rules than another member state does not mean that the latter member state ' s rules are disproportionate and therefore incompatible with union law .


### before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall assess whether those provisions are necessary and suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective . ### before introducing new , or amending existing , legislative , regulatory or administrative provisions restricting access to or pursuit of service activities , including the activities of regulated professions , member states shall assess whether those provisions are necessary and suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective . where those provisions introduce substantive changes to the regulation of a services activity or the profession concerned , member states shall also assess the proportionality of the existing regulation .


### the reasons for considering that provisions , assessed in accordance with this directive , are justified , necessary and proportionate , and which are communicated to the commission pursuant to paragraphs 5 and 6 of article 59 of directive 2005 / 36 / ec , shall be recorded by the relevant competent authorities in the database of regulated professions , referred to in article 59 paragraph 1 of directive 2005 / 36 / ec and thereafter made publicly available by the commission . ### the reasons for considering that provisions , assessed in accordance with this directive , are justified , necessary and proportionate , and which are communicated to the commission pursuant to paragraphs 5 and 6 of article 59 of directive 2005 / 36 / ec , shall be recorded expeditiously by the relevant competent authorities in the database of regulated professions , referred to in article 59 paragraph 1 of directive 2005 / 36 / ec and thereafter made publicly available as soon as possible by the commission .


### the cumulative effect of restrictions to both access to and pursuit of the profession , and in particular how each of those requirements contributes to and whether it is necessary to achieve the same public interest objective . ### the effect of new or amended provisions , when combined with other provisions restricting access to or pursuit of the profession , and in particular how each of those requirements contributes to and whether it is necessary to achieve the same public interest objective .


### member states shall monitor the proportionality of legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions on a regular basis and with a frequency appropriate to the regulation concerned , having due regard to any developments that have occurred since the measure concerned was adopted . ### member states shall monitor the compliance of legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions with the rules laid down in this directive on a regular basis and with a frequency appropriate to the regulation concerned , having due regard to any developments that have occurred since the provision concerned was adopted .


### for the purposes of the efficient application of this directive , before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall encourage the exchange of information with competent authorities of other member states on matters covered by this directive , such as the particular way they regulate a profession or the effects of regulation identified in similar sectors of activities , on a regular basis , or , where appropriate , on an ad hoc basis . ### for the purposes of the efficient application of this directive , when introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall encourage the exchange of information with other member states on matters covered by this directive , such as the particular way they regulate a profession or the effects of regulation identified in similar sectors of activities , on a regular basis , or , where appropriate , on an ad hoc basis .


### the scope of the professional activities reserved to holders of a particular professional qualification , namely whether and why the activities reserved to certain professions can or cannot be shared with other professions ; ### whether and why the activities reserved to certain professions can or cannot be shared with other professions ;


### the economic impact of the measure , including a cost - benefit analysis with particular regard to the degree of competition in the market and the quality of the service provided , as well as the impact on the right to work and on the free movement of persons and services within the union should be duly taken into account by the competent authorities . based on this analysis , member states should ascertain , in particular , whether the extent of the restriction of access to or pursuit of regulated professions within the union is proportionate to the importance of the objectives pursued and the expected gains . ### the balance between , on the one hand , the freedom to choose an occupation , to exercise the right of establishment and to provide services and , on the other hand , the protection of the public interest objectives , paying particular regard to the quality of service provided , should be duly taken into account by the member states . on that basis , member states should ascertain , in particular , whether the extent of the provision restricting access to or pursuit of regulated professions is proportionate to the importance of the objectives pursued and the expected gains .


### member states shall , by appropriate means , inform citizens , service recipients , representative associations and relevant stakeholders other than the members of the profession before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , and give them the opportunity to make known their views . ### in addition to members of the profession , member states shall , by appropriate means , inform all relevant stakeholders including citizens , service recipients and representative associations before proposing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , giving them the opportunity to make known their views , which shall then be given due consideration . that process may take place , for example , by means of a public consultation the results of which shall inform the content of the provisions adopted .


### the activities covered by this directive should concern the regulated professions falling within the scope of directive 2005 / 36 / ec . this directive should apply in addition to directive 2005 / 36 / ec and without prejudice to other provisions laid down in a separate union act concerning access to , and the exercise of a given regulated profession . ### the activities covered by this directive should concern the regulated professions falling within the scope of directive 2005 / 36 / ec . this directive should apply in addition to directive 2005 / 36 / ec and without prejudice to other provisions laid down in a separate union act concerning access to , and the exercise of a given regulated profession . while professional activities in the healthcare services sector are covered by the assessment referred to in article 59 of directive 2005 / 36 / ec and thus are within the scope of this directive , the directive respects member states ' competence to regulate professions in the field of public health based on article 168 tfeu as well as their margin of appreciation to guarantee a high level of health care and patient safety , within the limits of proportionality .


### the link between the scope of activities covered by a profession or reserved to it and the professional qualification required ; ### the appropriate link between the scope of activities covered by a profession or reserved to it and the specific professional qualification required ;


### when assessing the necessity and the proportionality of the provisions , the relevant competent authorities shall consider in particular : ### member states shall consider where relevant :


### the burden of proof of justification and proportionality lies on the member states . the reasons for regulation invoked by a member state by way of justification should thus be accompanied by an analysis of the appropriateness and proportionality of the measure adopted by that state and by specific evidence substantiating its arguments . ### the burden of proof of justification and proportionality lies on the member states . the reasons for regulation invoked by a member state by way of justification should thus be accompanied by an analysis of the proportionality of the measure adopted by that member state and by specific evidence substantiating its arguments . although a member state does not necessarily have to be able to produce a specific study or a specific form of evidence or materials establishing the proportionality of such measure prior to its adoption , it should carry out a review capable of demonstrating that there is a genuine need to achieve public - interest objectives in view of the specific circumstances of that member state .


### continuous professional development requirements ; ### obligation to undergo continuous professional development ;


### in order to increase transparency and promote proportionality assessments based on comparable criteria , it is important that the information submitted by member states be easily accessible in the database of regulated professions to allow all interested parties to submit comments . ### in order to increase transparency and promote proportionality assessments based on comparable criteria , the reasons that member states submit for considering that provisions are non - discriminatory , justified , and proportionate should be easily accessible in the database of regulated professions to allow other member states to submit their observations to the commission .


### the national authorities should carry out a global assessment of the circumstances in which the restrictive measure is adopted and implemented and examine in particular the cumulative effect of imposing several requirements in addition to the specific professional qualification . the taking - up and pursuit of certain activities may be conditional on complying with certain provisions such as rules relating to the organisation of the profession , compulsory membership of a professional body , professional ethics , supervision and liability . therefore , when assessing the cumulative effect of the measures , the competent authorities should also take into account other existing requirements , such as continuous professional development , compulsory chamber membership , registration or authorisation schemes , quantitative restrictions , specific legal form requirements and shareholding requirements , territorial restrictions , multidisciplinary restrictions and incompatibility rules , requirements concerning insurance cover as well as language knowledge requirements , to the extent necessary to practise the profession . a measure introduced by a member state cannot be regarded as necessary to achieve the objective pursued if it essentially duplicates requirements which have already been introduced in the context of other rules or procedures . ### member states should carry out a comprehensive assessment of the circumstances in which the requirement is adopted and implemented and examine in particular the combined effect of imposing several requirements in addition to the specific professional qualification . the taking - up and pursuit of certain activities may be conditional on complying with several requirements such as rules relating to the organisation of the profession , compulsory membership of a professional body , professional ethics , supervision and liability . therefore , when assessing the effect of the measures , member states should take into account all existing requirements , including continuous professional development , compulsory chamber membership , registration or authorisation schemes , quantitative restrictions , specific legal form requirements and shareholding requirements , territorial restrictions , multidisciplinary restrictions and incompatibility rules , requirements concerning insurance cover as well as language knowledge requirements , to the extent necessary to practise the profession .


### member states shall ensure that before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , the relevant competent authorities undertake an assessment of their proportionality in accordance with the rules laid down in this directive . ### member states shall undertake an assessment in accordance with the rules laid down in this directive when introducing new or amending existing legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions . this shall only apply to essential regulatory decisions on regulated professions .


### requirements concerning insurance cover or other means of personal or collective with regard to professional liability ; ### requirements concerning insurance cover or other means of personal or collective protection with regard to professional liability ;


### where the taking - up and pursuit of certain employed or self - employed activities are conditional on complying with certain provisions relating to specific professional qualifications , laid down directly or indirectly by the member states , it is necessary to ensure that such provisions are justified by public interest objectives , such as those within the meaning of the treaty , namely public policy , public security and public health or by overriding reasons of general interest , recognised as such in the case - law of the court of justice . it is important to ensure that public interest objectives are adequately identified in order to determine the intensity of the regulation . for example , in order to ensure a high level of protection of public health , member states should enjoy a margin of discretion to decide on the degree of protection which they wish to afford to public health and on the way in which that protection is to be achieved . it is also necessary to clarify that among the overriding reasons of general interest , recognised by the court of justice , are preserving the financial equilibrium of the social security system ; the protection of consumers , recipients of services and workers ; the safeguarding of the proper administration of justice ; fairness of trade transactions ; combating fraud and prevention of tax evasion and avoidance ; road safety ; the protection of the environment and the urban environment ; the health of animals ; intellectual property ; the safeguarding and conservation of the national historic and artistic heritage , social policy objectives and cultural policy objectives . according to settled case - law , purely economic reasons , having essentially protectionist aims , as well as purely administrative reasons , such as carrying out controls or gathering statistics cannot constitute an overriding reason of general interest . ### where the taking - up and pursuit of employed or self - employed activities are conditional on complying with certain requirements relating to specific professional qualifications , laid down directly or indirectly by the member states , it is necessary to ensure that such requirements are justified by public interest objectives , such as those within the meaning of the treaty , namely public policy , public security and public health or by overriding reasons of general interest , recognised as such in the case - law of the court of justice . it is also necessary to clarify that the following are among the overriding reasons of general interest , recognised by the court of justice : preserving the financial equilibrium of the social security system ; the protection of consumers , of the recipients of services and of workers ; safeguarding the proper administration of justice ; ensuring the fairness of trade transactions ; combating fraud and prevention of tax evasion and avoidance ; road safety ; guaranteeing the quality of craft work ; research and development ; the protection of the environment and the urban environment ; the health of animals ; intellectual property ; the safeguarding and conservation of the national historic and artistic heritage , social policy objectives and cultural policy objectives . according to settled case law , purely economic reasons , such as promoting the national economy to the detriment of the of the fundamental freedoms , as well as purely administrative reasons , such as carrying out controls or gathering statistics cannot constitute an overriding reason of general interest . it is important to ensure that public interest objectives are adequately identified in order to determine the appropriate level of regulation . for example , where the risks to the public interest objective increase , member states should enjoy a margin of appreciation within which they are able to determine the degree of protection which they wish to afford , and if necessary to strengthen the regulation in place . the fact that one member state imposes less strict rules than another member state does not mean that the latter member state ' s rules are disproportionate and therefore incompatible with union law .


### member states should carry out proportionality assessments in an objective and independent manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so . in particular , while the assessment of the local authorities , regulatory bodies or professional organisations , whose greater proximity to local conditions and specialised knowledge could in certain cases make them better placed to identify the best way of meeting the public interest objectives , there is particular reason for concern in cases where the policy choice made by those authorities or bodies provides benefits to established operators at the expense of new market entrants . ### member states should carry out proportionality assessments in an objective and independent manner , including where a profession is regulated indirectly , by giving a particular professional body the power to do so . the member states may obtain comments from any bodies they consider relevant and capable of providing such comments , especially bodies that are part of the national legislative process and have advisory powers , such as professional organisations , for example .


### for the purposes of paragraph 2 , the relevant competent authorities shall assess in particular the cumulative effect of imposing any of the following requirements : ### for the purposes of paragraph 2 , member states shall assess all regulation in place and in particular the effect of the new or amended requirement in combination with the following requirements , it being understood that there might be positive as well as negative effects :


### member states shall , by appropriate means , inform citizens , service recipients , representative associations and relevant stakeholders other than the members of the profession before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , and give them the opportunity to make known their views . ### member states shall , by appropriate means , inform citizens , service recipients , professional organisations and relevant stakeholders when they are introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , and give them the opportunity to make known their views .


### before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall assess whether those provisions are necessary and suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective . ### when introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall ensure that those provisions are suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective . the extent of the assessment shall be proportionate to the nature , the content and the impact of the provision being introduced , in view of all regulation in place , taking into account the reasonable margin of appreciation of the member states .


### it is appropriate to monitor the proportionality of the provisions restricting access to or pursuit of regulated professions on a regular basis and with a frequency appropriate to the regulation concerned . a review of the proportionality of restrictive national legislation in the area of regulated professions should be based not only on the objective of that legislation at the time of its adoption , but also on the effects of the legislation , assessed after its adoption . the assessment of the proportionality of the national legislation should be based on developments found to have occurred in the area since the legislation was adopted . ### it is appropriate to monitor the proportionality of the requirements restricting access to or pursuit of regulated professions with a frequency appropriate to the regulation concerned . a review of the proportionality of restrictive national legislation in the area of regulated professions should be based not only on the objective of that legislation at the time of its adoption , but also on the effects of the legislation , assessed after its adoption . the assessment of the proportionality of the national legislation should be based on developments found to have occurred in the area of regulated professions since the legislation was adopted .


### member states and other interested parties may submit comments to the commission or to the member state which has notified the provisions . ### member states may submit comments to the commission concerning the provisions and the reasons for considering that they are non - discriminatory , justified and proportionate . these observations shall be duly taken into account by the commission in its summary report pursuant to paragraph 8 of article 59 of directive 2005 / 36 / ec .


### the reasons for considering that provisions , assessed in accordance with this directive , are justified , necessary and proportionate , and which are communicated to the commission pursuant to paragraphs 5 and 6 of article 59 of directive 2005 / 36 / ec , shall be recorded by the relevant competent authorities in the database of regulated professions , referred to in article 59 paragraph 1 of directive 2005 / 36 / ec and thereafter made publicly available by the commission . ### the reasons for considering that provisions , assessed in accordance with this directive , are non - discriminatory , justified and proportionate , and which are communicated to the commission pursuant to paragraphs 5 of article 59 of directive 2005 / 36 / ec , shall be recorded by the member states in the database of regulated professions , referred to in article 59 paragraph 1 of directive 2005 / 36 / ec and thereafter , unless the member state concerned objects , made publicly available by the commission .


### grounds of a purely economic nature having essentially protectionist aim or effects or purely administrative reasons shall not constitute overriding reasons in the public interest , justifying a restriction on access to or pursuit of regulated professions . ### grounds of a purely economic nature or purely administrative reasons shall not constitute overriding reasons in the public interest , justifying a restriction on access to or pursuit of regulated professions .


### where a member state intends to regulate a profession or to amend existing rules , account should be taken of the nature of the risks related to the public interest objectives pursued , in particular the risks to consumers , to professionals or third parties . it should also be borne in mind that , in the field of professional services , there is usually an asymmetry of information between consumers and professionals . professionals have a high level of technical knowledge which consumers may not have and consumers therefore find it difficult to judge the quality of the services provided to them . ### where a member state intends to regulate a profession or to amend existing rules , account should be taken of the nature of the risks related to the public interest objectives pursued , in particular the risks to consumers , to professionals or third parties . it should also be borne in mind that , in the field of professional services , there is usually an asymmetry of information between consumers and professionals . professionals display a high level of technical knowledge , which consumers may not have and consumers therefore find it difficult to judge the quality of the services provided to them . member states should apply the proportionality criteria laid down in this directive when introducing new or amending existing legislative , regulatory or administrative provisions to the extent that those criteria are relevant for a given profession . the extent of the assessment should be proportionate to the nature , the content and the impact of the provision being introduced for a given regulated profession .


### to facilitate the exchange of best practices , each member state should encourage the relevant competent authorities to share adequate and regularly updated information with other member states on the regulation of professions . ### for the purposes of exchanging best practices , member state are to be encouraged to share adequate and regularly updated information with other member states on the regulation of professions , including on the effects of such regulation . the commission should facilitate that exchange of best practices among member states .


### member states shall , by appropriate means , inform citizens , service recipients , representative associations and relevant stakeholders other than the members of the profession before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , and give them the opportunity to make known their views . ### in addition to members of the profession , member states shall , by appropriate means , inform all relevant stakeholders including citizens , service recipients and representative associations before proposing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , giving them the opportunity to make known their views , which shall then be given due consideration . that process may take place , for example , by means of a public consultation the results of which shall inform the content of the provisions adopted .


### it is essential for the proper functioning of the internal market to ensure that member states provide information to citizens , representative associations or other relevant stakeholders before introducing new measures restricting access to or pursuit of regulated professions and give them the opportunity to make known their views . ### it is essential for the proper functioning of the internal market to ensure that member states provide information to citizens , professional organisations and representative associations or other relevant stakeholders when introducing new or amending existing requirements restricting access to , or pursuit of , regulated professions , and give them the opportunity to make known their views .


### this directive lays down rules on a common framework for conducting proportionality assessments before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , with a view to ensuring the proper functioning of the internal market . ### this directive lays down rules on a common framework for conducting proportionality assessments when introducing new or amending existing legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , with a view of ensuring the proper functioning of the internal market .


### the scientific and technological developments which may reduce the asymmetry of information between professionals and consumers ; ### the scientific and technological developments which may reduce or increase the asymmetry of information between professionals and consumers ;


### member states shall ensure that before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , the relevant competent authorities undertake an assessment of their proportionality in accordance with the rules laid down in this directive . ### member states shall carry out an assessment of the proportionality of the rules laid down in this directive when introducing new or amending existing legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions in accordance with the rules set out in this directive . member states shall remove disproportionate restrictions on access to or pursuit of regulated professions .


### member states shall ensure that legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions they intend to introduce and amendments they intend to make to existing provisions are justified by public interest objectives . ### member states shall ensure that legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions they introduce and amendments they make to existing provisions are justified by public interest objectives .


### the national authorities should carry out a global assessment of the circumstances in which the restrictive measure is adopted and implemented and examine in particular the cumulative effect of imposing several requirements in addition to the specific professional qualification . the taking - up and pursuit of certain activities may be conditional on complying with certain provisions such as rules relating to the organisation of the profession , compulsory membership of a professional body , professional ethics , supervision and liability . therefore , when assessing the cumulative effect of the measures , the competent authorities should also take into account other existing requirements , such as continuous professional development , compulsory chamber membership , registration or authorisation schemes , quantitative restrictions , specific legal form requirements and shareholding requirements , territorial restrictions , multidisciplinary restrictions and incompatibility rules , requirements concerning insurance cover as well as language knowledge requirements , to the extent necessary to practise the profession . a measure introduced by a member state cannot be regarded as necessary to achieve the objective pursued if it essentially duplicates requirements which have already been introduced in the context of other rules or procedures . ### member states should carry out a comprehensive assessment of the circumstances in which the requirement is adopted and implemented and examine in particular the combined effect of imposing several requirements in addition to the specific professional qualification . the taking - up and pursuit of certain activities may be conditional on complying with several requirements such as rules relating to the organisation of the profession , compulsory membership of a professional body , professional ethics , supervision and liability . therefore , when assessing the effect of the measures , member states should take into account all existing requirements , including continuous professional development , compulsory chamber membership , registration or authorisation schemes , quantitative restrictions , specific legal form requirements and shareholding requirements , territorial restrictions , multidisciplinary restrictions and incompatibility rules , requirements concerning insurance cover as well as language knowledge requirements , to the extent necessary to practise the profession .


### it is essential for the proper functioning of the internal market to ensure that member states provide information to citizens , representative associations or other relevant stakeholders before introducing new measures restricting access to or pursuit of regulated professions and give them the opportunity to make known their views . ### it is essential for the proper functioning of the internal market to ensure that member states provide information to citizens , representative associations or other relevant stakeholders when introducing new or amending existing requirements restricting access to , or pursuit of regulated professions and give them the opportunity to make known their views . where necessary , member states are encouraged to carry out wider public consultation in order to gather adequate evidence necessary for designing reforms of professional services , especially in cases of reforms with a greater impact .


### the burden of proof of justification and proportionality lies on the member states . the reasons for regulation invoked by a member state by way of justification should thus be accompanied by an analysis of the appropriateness and proportionality of the measure adopted by that state and by specific evidence substantiating its arguments . ### the burden of proof as regards justification and proportionality lies with the member states , who must be assisted by professional organisations and other stakeholders . the reasons for regulation invoked by a member state by way of justification should thus be accompanied by an analysis of the appropriateness and proportionality of the measure adopted by that member state and by specific evidence substantiating its arguments .


### the economic impact of the measure , including a cost - benefit analysis with particular regard to the degree of competition in the market and the quality of the service provided , as well as the impact on the right to work and on the free movement of persons and services within the union should be duly taken into account by the competent authorities . based on this analysis , member states should ascertain , in particular , whether the extent of the restriction of access to or pursuit of regulated professions within the union is proportionate to the importance of the objectives pursued and the expected gains . ### the economic impact of the measure , including a cost - benefit analysis with particular regard to the degree of competition in the market and the quality of the service provided , as well as the impact on the right to work and on the free movement of persons and services within the union , having due regard to the specific situation of cross - border regions , should be duly taken into account by the competent authorities . based on this analysis , member states should ascertain , in particular , whether the extent of the restriction of access to or pursuit of regulated professions within the union is proportionate to the importance of the objectives pursued and the expected gains .


### the scope of the professional activities reserved to holders of a particular professional qualification , namely whether and why the activities reserved to certain professions can or cannot be shared with other professions ; ### the scope of the professional activities reserved to holders of a particular professional qualification , namely whether and why the activities reserved to certain professions can or cannot be shared with other professions , provided that the security and the quality of the service can be guaranteed at the same level .


### for the purposes of paragraph 2 , the relevant competent authorities shall assess in particular the cumulative effect of imposing any of the following requirements : ### for the purposes of paragraph 2 , member states shall assess all regulation in place and in particular the effect of the new or amended requirement in combination with the following requirements , it being understood that there might be positive as well as negative effects :


### to meet the requirement of proportionality , the measure should be suitable for securing the attainment of the objective pursued . a measure should only be considered suitable for securing the attainment of the objective pursued , if it genuinely reflects a concern to attain that objective in a consistent and systematic manner , for instance where similar risks related to certain activities are addressed in a comparable way and where any exceptions to the restrictions involved are applied in line with the stated objective . furthermore , the national measure should contribute to achieving the objective pursued and therefore , where it has no effect on the ground for justification , it should not be considered as suitable . ### to meet the requirement of proportionality , the measure should be suitable for securing the attainment of the objective pursued . a measure should only be considered suitable for securing the attainment of the objective pursued , if it genuinely reflects a concern to attain that objective in a consistent and systematic manner , for instance where similar risks related to certain activities are addressed in a comparable way and where any exceptions to the restrictions involved are applied in line with the stated objective . furthermore , the national measure should contribute effectively to achieving the objective pursued and therefore , where it has no effect on the ground for justification , it should not be considered as suitable .


### where the taking - up and pursuit of certain employed or self - employed activities are conditional on complying with certain provisions relating to specific professional qualifications , laid down directly or indirectly by the member states , it is necessary to ensure that such provisions are justified by public interest objectives , such as those within the meaning of the treaty , namely public policy , public security and public health or by overriding reasons of general interest , recognised as such in the case - law of the court of justice . it is important to ensure that public interest objectives are adequately identified in order to determine the intensity of the regulation . for example , in order to ensure a high level of protection of public health , member states should enjoy a margin of discretion to decide on the degree of protection which they wish to afford to public health and on the way in which that protection is to be achieved . it is also necessary to clarify that among the overriding reasons of general interest , recognised by the court of justice , are preserving the financial equilibrium of the social security system ; the protection of consumers , recipients of services and workers ; the safeguarding of the proper administration of justice ; fairness of trade transactions ; combating fraud and prevention of tax evasion and avoidance ; road safety ; the protection of the environment and the urban environment ; the health of animals ; intellectual property ; the safeguarding and conservation of the national historic and artistic heritage , social policy objectives and cultural policy objectives . according to settled case - law , purely economic reasons , having essentially protectionist aims , as well as purely administrative reasons , such as carrying out controls or gathering statistics cannot constitute an overriding reason of general interest . ### where the taking - up and pursuit of employed or self - employed activities are conditional on complying with certain requirements relating to specific professional qualifications , laid down directly or indirectly by the member states , it is necessary to ensure that such requirements are justified by public interest objectives , such as those within the meaning of the treaty , namely public policy , public security and public health or by overriding reasons of general interest , recognised as such in the case - law of the court of justice . it is also necessary to clarify that the following are among the overriding reasons of general interest , recognised by the court of justice : preserving the financial equilibrium of the social security system ; the protection of consumers , of the recipients of services and of workers ; safeguarding the proper administration of justice ; ensuring the fairness of trade transactions ; combating fraud and prevention of tax evasion and avoidance ; road safety ; guaranteeing the quality of craft work ; research and development ; the protection of the environment and the urban environment ; the health of animals ; intellectual property ; the safeguarding and conservation of the national historic and artistic heritage , social policy objectives and cultural policy objectives . according to settled case law , purely economic reasons , such as promoting the national economy to the detriment of the of the fundamental freedoms , as well as purely administrative reasons , such as carrying out controls or gathering statistics cannot constitute an overriding reason of general interest . it is important to ensure that public interest objectives are adequately identified in order to determine the appropriate level of regulation . for example , where the risks to the public interest objective increase , member states should enjoy a margin of appreciation within which they are able to determine the degree of protection which they wish to afford , and if necessary to strengthen the regulation in place . the fact that one member state imposes less strict rules than another member state does not mean that the latter member state ' s rules are disproportionate and therefore incompatible with union law .


### any provision referred to in paragraph 1 shall be accompanied by a detailed statement making it possible to appraise compliance with the principle of proportionality . ### any requirement referred to in paragraph 1 shall be accompanied by a detailed statement making it possible to appraise compliance with the principles of non - discrimination and proportionality .


### where specific arrangements concerning the regulation of a given profession are established in a separate union act , the corresponding provisions of this directive shall not apply . ### where specific requirements concerning the regulation of a given profession are established in a separate union act , the corresponding provisions of this directive shall not apply .


### before introducing new legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions , or amending existing ones , member states shall assess whether those provisions are necessary and suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective . ### the member states shall assess whether the legislative , regulatory or administrative provisions restricting access to or pursuit of regulated professions are necessary and suitable for securing the attainment of the objective pursued and do not go beyond what is necessary to attain that objective .


### the economic impact of the measure , including a cost - benefit analysis with particular regard to the degree of competition in the market and the quality of the service provided , as well as the impact on the right to work and on the free movement of persons and services within the union should be duly taken into account by the competent authorities . based on this analysis , member states should ascertain , in particular , whether the extent of the restriction of access to or pursuit of regulated professions within the union is proportionate to the importance of the objectives pursued and the expected gains . ### the economic impact of the measure , including a cost - benefit analysis with particular regard to the degree of competition in the market and the quality of the service provided , as well as the impact on the right to work and on the free movement of persons and services within the union should be duly taken into account by the competent authorities . based on this analysis , member states should ascertain , in particular , whether the extent of the restriction of access to or pursuit of regulated professions within the union is proportionate to the importance of the objectives pursued and the expected gains . with regard to protection of public health , the member states should be able to decide on the degree of importance of economic considerations in relation to other relevant proportionality criteria .


### four years after the start of operations of each interoperability component and every four years thereafter , eu - lisa shall submit to the european parliament , the council and the commission a report on the technical functioning of the interoperability components , including the security thereof . ### two years after the start of operations of each interoperability component and every two years thereafter , eu - lisa shall submit to the european parliament , the council and the commission a report on the technical functioning of the interoperability components , including their security and costs .


### member states shall ensure that this article applies to trusts and other types of legal arrangements having a structure or functions similar to trusts , such as , inter alia , fiducie , treuhand or fideicomiso . ### member states shall ensure that this article applies to trusts and other types of legal instrument or legal arrangements having a structure or functions similar to trusts , such as , inter alia , fiducie , treuhand , waqf or fideicomiso , and all existing or future legal arrangements , which are similar in terms of structure or function .


### the specific factor determining the member state responsible for the monitoring and registration of beneficial ownership information of trusts and similar legal arrangements should be clarified . in order to avoid that , due to differences in the legal systems of member states , certain trusts are not monitored or registered anywhere in the union , all trusts and similar legal arrangements should be registered where they are administered . in order to ensure the effective monitoring and registration of information on the beneficial ownership of trusts , cooperation among member states is also necessary . ### the specific factor determining the member state responsible for the monitoring and registration of beneficial ownership information of trusts and similar legal arrangements should be clarified . in order to avoid that , due to differences in the legal systems of member states , certain trusts and similar legal arrangements are not monitored or registered anywhere in the union . all trusts and similar legal arrangements including inter alia treuhand , stiftung , privatstiftung , usufruct fiducia , or fideicomiso , which operate in the union should be registered in an eu member state and be obliged to disclose beneficial ownership information to competent and law enforcement authorities in all other member states . in order to ensure the effective monitoring and registration of information on the beneficial ownership of trusts and similar legal arrangements , cooperation among member states is necessary .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions and in particular the methodological guidelines and evidence submission template . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta . the procedural and methodological framework are updated at the frequency deemed necessary by the commission to ensure that they should be adapted to the evolution of science . in developing the methodological framework , the commission should consider the specificity and corresponding challenges of certain types of health technologies , advanced therapies or life - prolonging therapies where innovative clinical study designs may be required . these may result in evidential uncertainty at the time of the marketing authorization . as such innovative clinical study designs are often accepted for the purposes of regulatory assessments , the methodology for joint clinical assessments should not prevent these health technologies from reaching patients . the commission should therefore ensure that the methodology provides for a sufficient level of flexibility to enable an adequate assessment of such health technologies . such flexibility should include the acceptance of the best available scientific evidence at the time of the submission , including , for instance , data from case control studies , real world evidence , as well as the acceptance of indirect treatment comparators . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 _________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### the commission shall adopt implementing acts concerning : ### the commission shall adopt delegated acts concerning :


### on the request of the coordination group , the commission shall invite patients and clinical experts nominated by the stakeholder network to attend meetings of the coordination group as observers . ### on the request of the coordination group , the commission shall invite relevant experts nominated by the stakeholder network to attend meetings of the coordination group as observers .


### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors . ### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors and shall consider the work already undertaken in the eunethta joint actions .


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


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


### five years after the entry into force of this regulation , and every five years thereafter , the commission shall ensure an evaluation of the impact of the multiannual plan on the stocks to which this regulation applies and on the fisheries exploiting those stocks . the commission shall submit the results of this evaluation to the european parliament and to the council . ### three years after the entry into force of this regulation , and every five years thereafter , the commission shall ensure an evaluation of the impact of the multiannual plan on the stocks to which this regulation applies and on the fisheries exploiting those stocks , in particular as regards progress achieved towards restoring and maintaining fish stocks above levels capable of producing maximum sustainable yield . the commission shall submit the results of this evaluation to the european parliament and to the council and may , where appropriate and taking into account the most recent scientific advice , propose adaptations to the multiannual plan or initiate modifications to the delegated acts .


### the common fisheries policy should contribute to the protection of the marine environment , to the sustainable management of all commercially exploited species , and in particular to the achievement of good environmental status in the marine environment by 2020 in accordance with article 1 of directive 2008 / 56 / ec of the european parliament and of the council . 40 __________________ 40 directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy . ### the common fisheries policy should ensure the protection of the marine environment and the sustainable management of all commercially exploited species and should contribute to the achievement of good environmental status in the marine environment by 2020 in accordance with article 1 of directive 2008 / 56 / ec of the european parliament and of the council . 40 __________________ 40 directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy .


### the prior notification obligation shall apply to masters of union fishing vessels retaining on board at least one tonne of anchovy or one tonne of sardine . ### the prior notification obligation shall apply to masters of union fishing vessels retaining on board at least one tonne of anchovy or one tonne of sardine . these quantities shall be calculated after deduction of the catches referred to in paragraph 11 of article 15 of regulation no 1380 / 2013 .


### the commission shall assess intergovernmental agreements notified in accordance with paragraph 1 or 2 . where , following its first assessment , the commission has doubts as to the compatibility of those agreements with union law , in particular with internal energy market legislation , and union competition law in particular with internal energy market legislation and union competition law , the commission shall inform the member states concerned accordingly within nine months of the notification of those agreements . ### the commission shall assess intergovernmental agreements notified in accordance with paragraph 1 or 2 . where , following its first assessment , the commission has doubts as to the compatibility of those agreements with union law , in particular with internal energy market legislation , union competition law and matters falling under union competence in the context of the common commercial policy , the commission shall inform the member states concerned accordingly within nine months of the notification of those agreements .


### if a member state considers an intergovernmental agreement to be confidential , it should provide the commission with a summary of it for the purposes of sharing that summary with the other member states . ### if a member state considers an intergovernmental agreement to be confidential , it should provide the commission with a summary containing its main elements and relevant clauses , including restrictions , for the purposes of sharing that summary with the other member states .


### measures in and in relation to third countries supported through the instrument should be implemented in full synergy and coherence with and should complement other actions outside the union supported through the union ' s external financing instruments . in particular , in implementing such actions , full coherence should be sought with the principles and general objectives of the union’s external action and foreign policy related to the country or region in question . in relation to the external dimension , the instrument should target support to enhance cooperation with third countries and to reinforce key aspects of their border surveillance and border management capabilities in areas of interest to the union’s migration policy and union’s security objectives . ### measures in and in relation to third countries supported through the instrument should be implemented in full synergy and coherence with and should complement other actions outside the union supported through the union ' s external financing instruments as well as any other union financing instrument having an external dimension component , such as for example the asylum and migration fund . in particular , in implementing such actions , full coherence should be sought with the principles and general objectives of the union’s external action and foreign policy related to the country or region in question . in relation to the external dimension , the instrument should target support to enhance cooperation with third countries and to reinforce key aspects of their border surveillance and border management capabilities in areas of interest to the union’s migration policy and union’s security objectives .


### in compliance with its reporting requirements pursuant to article 43 of the financial regulation , the commission shall present to the european parliament and the council information on performance in accordance with annex v . ### in compliance with its reporting requirements pursuant to article 41 and of regulation 2018 / 10461a of the european parliament and of the council , , the commission shall present yearly to the european parliament and the council information on performance in accordance with annex v . ____________________ 1a regulation 2018 / 1046 of the european parliament and of the council of 18 july 2018 on the financial rules applicable to the general budget of the union , amending regulations no 1296 / 2013 , no 1301 / 2013 , no 1303 / 2013 , no 1304 / 2013 , no 1309 / 2013 , no 1316 / 2013 , no 223 / 2014 , no 283 / 2014 , and decision no 541 / 2014 / eu and repealing regulation no 966 / 2012


### that the geographical indication registered in the international register relates to a product in respect of which protection within the eu of geographical indications is currently not provided ; ### that the geographical indication registered in the international register relates to a product in respect of which protection within the eu of geographical indications is not provided at the moment of opposition ;


### in order to ensure that additional geographical indications protected and registered in the union are registered in the international register , it is appropriate to authorise the commission , at a later stage , to file applications for the international registration of such additional geographical indications , on its own initiative or at the request of a member state or of an interested group of producers or , in exceptional cases , at the request of a single producer . ### in order to ensure that additional or future geographical indications protected and registered in the union are registered in the international register , including the possible extension of protection to geographical indications for non - agricultural products , it is appropriate to authorise the commission , at a later stage , to file applications for the international registration of such additional geographical indications , on its own initiative or , in case of non - agricultural geographical indications , at the request of a member state or of an interested group of producers or , in exceptional cases , at the request of a single producer . the accession of the union to the geneva act does not prejudice the current and future protection of geographical indications in bilateral free trade agreements . in this regard , the commission should use a regular mechanism to consult member states , trade associations and european producers in order to establish a fluid dialogue with stakeholders .


### following the accession of the union to the geneva act , the commission should as a first step file with the international bureau of the world intellectual property organization an application for registration of a list of geographical indications originating and protected in the territory of the union in their register . the criteria for the establishment of such a list should , as it is the case for some of the bilateral and regional agreements of the union regarding protection of geographical indications , take into account in particular the production value and export value , protection under other agreements as well as current or potential misuse in the third countries concerned . ### following the accession of the union to the geneva act , the commission should as a first step file with the international bureau of the world intellectual property organization an application for registration of a list of geographical indications originating and protected in the territory of the union in their register , in close cooperation with the member states , trade associations and producers concerned . the criteria for the establishment of such a list should , as is the case for some of the bilateral and regional agreements of the union regarding protection of geographical indications , take into account in particular the production value and export value , protection under other agreements , balance between member states and current or potential misuse in the third countries concerned .


### as the three tripartite agencies - eu - osha , the european centre for development and vocational training , and the european foundation for the improvement of living and working conditions - address issues related to the labour market , working environment and vocational education and training and skills , close coordination among three agencies is required and the ways to enhance efficiency and synergies should be exploited . in addition , whenever relevant , the agency should seek to engage in efficient cooperation with the european commission ' s in - house research capacities . ### as the three tripartite agencies - eu - osha , the european centre for development and vocational training , and the european foundation for the improvement of living and working conditions - address issues related to the labour market , working environment and vocational education and training and skills , close coordination among three agencies is required so that the work of the agencies does not overlap where they have similar fields of interest , while ways to enhance efficiency and synergies should be exploited and any duplication among the agencies , as well as between them and the commission , concerning their mandates , objectives and activities , should be avoided . in addition , whenever relevant , the agency should seek to engage in efficient cooperation with the commission ' s and the european parliament ' s in - house research capacities .


### the executive director may be removed from office only upon a decision of the management board acting on a proposal from the commission . ### in the event of misconduct , unsatisfactory performance or recurring or serious irregularities , the executive director may be removed from office only upon a decision of the management board acting on a proposal , based on a reasoned assessment , from the commission .


### since its establishment in 1994 eu - osha has played an important role in supporting the improvement of health and safety at work throughout the european union . at the same time there have been developments in the area of occupational safety and health . in this light some adjustments are required in describing the objectives and tasks of eu - osha as compared to the provisions in council regulation no . 2062 / 94 . ### since its establishment in 1994 eu - osha has , by virtue of its expertise , played an important role in supporting the improvement of health and safety at work throughout the european union . at the same time there have been developments in the area of occupational safety and health , including technological developments , particularly in the digital area , which add to the challenge of promoting high osh standards . in this light some adjustments are required in describing the objectives and tasks of eu - osha as compared to the provisions in council regulation no . 2062 / 94 .


### the agency may establish local offices in the member states , subject to their consent and in accordance with article 11 . ### the agency may run a liaison office in brussels in accordance with article 11 .


### the term of office of members of the executive board shall be two years . that term shall be extendable . the term of office of members of the executive board shall end when their membership of the management board ends . ### the term of office of members of the executive board shall be two years . that term shall be renewable . the term of office of members of the executive board shall end when their membership of the management board ends .


### in so far as is necessary in order to achieve the objectives set out in this regulation , and without prejudice to the respective competences of the member states and the institutions of the union , the agency may cooperate with the competent authorities of third countries and / or with international organisations . to this end , the agency may , subject to prior approval by the commission , establish working arrangements with the authorities of third countries and international organisations . these arrangements shall not create legal obligations incumbent on the union and its member states ### in so far as is necessary in order to achieve the objectives set out in this regulation , and without prejudice to the respective competences of the member states and the institutions of the union , the agency may cooperate with the competent authorities of third countries and / or with international organisations . to this end , the agency may establish working arrangements with the authorities of third countries and international organisations . these arrangements shall not create legal obligations incumbent on the union and its member states