### in order to guarantee its full autonomy and independence , the agency should be granted an autonomous budget with revenue from the general budget of the european union . the union budgetary procedure should be applicable as far as the union contribution and any other subsidies chargeable to the general budget of the european union are concerned . the auditing of accounts should be undertaken by the court of auditors . ### in order to guarantee its full autonomy and independence , the agency should be granted an autonomous budget with revenue from the general budget of the european union . the financing of the agency is subject to an agreement by the budgetary authority as set out in point 47 of the iia of 17 may 2006 . the union budgetary and discharge procedures should be applicable . the auditing of accounts and of the legality and regularity of the underlying transactions should be undertaken by the court of auditors .


### a european agency for the operational management of the second - generation schengen information system , the visa information system , eurodac and for developing and managing other large - scale information technology systems , in application of title v of the treaty on the functioning of the european union is hereby established . ### a european agency for the operational management of the second - generation schengen information system , the visa information system , eurodac and for developing and managing other large - scale information technology systems , in application of title v of the treaty on the functioning of the european union is hereby established , in accordance with article 185 of the financial regulation .


### before 31 march each year , adopt the agency ' s annual activity report for the previous year and transmit it by 15 june at the latest to the european parliament , the council , the commission , the european economic and social committee and the court of auditors ; the annual activity report shall be published ; ### before 31 march each year , adopt the agency ' s annual activity report for the previous year comparing , in particular , the results achieved with the objectives of the annual work programme and transmit it by 15 june at the latest to the european parliament , the council , the commission , the european economic and social committee and the court of auditors ; the annual activity report shall be published ;


### the members of the management board shall be appointed on the basis of their high level relevant experience and expertise in the field of large - scale it systems in the area of freedom , security and justice . ### the members of the management board shall be appointed on the basis of their high level relevant experience and expertise in the field of large - scale it systems in the area of freedom , security and justice . they shall also have the necessary administrative and management skills to fulfil the tasks listed in article 9 .


### establish and implement an effective system enabling regular monitoring and evaluations of the it systems , including statistics , and of the agency ; ### establish and implement an effective system enabling regular monitoring , auditing and evaluations of the it systems , including statistics , and of the agency , also in terms of effective and efficient achievement of agency ' s objectives ;


### the agency ' s annual work programme and its annual activity report , after prior consultation of the advisory groups ; ### the agency ' s annual work programme and its annual activity report , with an indication of the resources allocated to each activity , after prior consultation of the advisory groups ;


### the budget for the coming year ; ### the budget for the coming year , established on the basis of activity - based budgeting ;


### before appointment , the candidate selected by the management board may be invited to make a statement before the competent committee of the european parliament and answer questions from its / their members . ### before appointment , the candidate selected by the management board may be invited to make a statement before the competent committee of the european parliament and answer questions from its / their members . its / their opinion , if any , shall be considered before appointment .


### the management board , acting on a proposal from the commission , taking into account the evaluation report , and only in those cases where it can be justified by the duties and requirement of the agency , may extend the term of office of the executive director once for not more than three years . ### the management board , acting on a proposal from the commission , taking into account the evaluation report , and only in those cases where it can be justified by the duties and requirement of the agency , may extend the term of office of the executive director once for not more than three years . the executive director shall hold office for a period of not exceeding eight years .


### each member state , each country associated with the implementation , application and development of the schengen acquis and the eurodac related measures as well as the commission shall appoint one member to each of the advisory groups for a three - year term , which may be renewed ; ### each member state , each country associated with the implementation , application and development of the schengen acquis and the eurodac related measures as well as the commission shall appoint one member to one of the three advisory groups for a three - year term , which may be renewed , on a rotating basis ;


### the evaluation shall assess the utility , relevance and effectiveness of the agency and its working practices . the evaluation shall take into account the views of stakeholders , at both european and national level . ### the evaluation shall assess the utility , relevance and effectiveness of the agency and its working practices . the evaluation shall take into account the views of stakeholders , at both european and national level . it shall , in particular , address the possible need to modify or extend the agency ' s tasks or to put an end to its activities in the event of its role having become superfluous .


### the expenditure of the agency shall include , inter alia , staff remuneration , administrative and infrastructure expenses , operating costs and expenditure relating to contracts or agreements concluded by the agency . each year the executive director shall draw up a draft statement of estimates of the agency ' s revenue and expenditure for the following financial year , together with the establishment plan , and shall transmit it to the management board . ### the expenditure of the agency shall include , inter alia , staff remuneration , administrative and infrastructure expenses , operating costs and expenditure relating to contracts or agreements concluded by the agency . each year the executive director shall draw up , on the basis of the activities carried out by the agency , a draft statement of estimates of the agency ' s revenue and expenditure for the following financial year , together with the establishment plan , and shall transmit it to the management board .


### its draft work programme ; ### its draft work programme , together with the anticipated human and financial resources associated with each programmed activity ;


### the statement of estimates shall be forwarded by the commission to the european parliament and the council together with the preliminary draft general budget of the european union . ### the statement of estimates shall be forwarded by the commission to the european parliament and the council together with the draft general budget of the european union .


### on the basis of the statement of estimates , the commission shall enter in the preliminary draft general budget of the european union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget , which it shall place before the budgetary authority in accordance with article 314 of the treaty on the functioning of the european union . ### on the basis of the statement of estimates , the commission shall enter in the draft general budget of the european union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget , which it shall place before the budgetary authority in accordance with article 314 of the treaty on the functioning of the european union , together with a description of and justification for any difference between the agency ' s statement of estimates and the subsidy to be charged to the general budget .


### the agency ' s budget shall be adopted by the management board . it shall become final following the final adoption of the general budget of the european union . where appropriate , it shall be adjusted accordingly . ### the agency ' s budget shall be adopted by the management board . it shall become final following the final adoption of the general budget of the european union . where appropriate , it shall be adjusted accordingly , together with the annual work programme .


### the executive director shall forward annually to the budgetary authority any information relevant to the outcome of the evaluation procedures . ### the executive director shall forward annually to the budgetary authority any information regarding the outcome of the evaluation procedures .


### for that purpose , until such time as the executive director takes up his / her duties following his / her appointment by the management board in accordance with article 15 of this regulation , the commission may assign a limited number of officials including one to fulfil the functions of the executive director , on an interim basis . ### for that purpose , until such time as the executive director takes up his / her duties following his / her appointment by the management board in accordance with article 15 of this regulation , the commission shall assign a limited number of officials including one to fulfil the functions of the executive director , on an interim basis .


### the agency shall take up its responsibilities set out in articles 2 to 6 from 1 january 2012 . ### the agency shall take up its responsibilities set out in articles 2 to 6 from 1 january 2012 , provided that the member states have agreed on the location of its seat sufficiently in advance to allow its basic infrastructure and procedures to become operational at that seat .


### provisions should be established to ensure that only high - quality non - promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated . the information should take into account patients needs and expectations in order to empower patients , allow informed choices and enhance the rational use of medicinal products . therefore , any information to the general public on prescription - only medicinal products should comply with a set of quality criteria . ### provisions should be established to ensure that only high - quality non - promotional information about the benefits and the risks of authorised medicinal products subject to medical prescription may be made available . the information should take into account patients needs and expectations in order to empower patients , allow informed choices and enhance the rational use of medicinal products . therefore , any information to the general public on authorised prescription - only medicinal products should comply with a set of quality criteria .


### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . ### member states shall allow the marketing authorisation holder to disseminate information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii .


### information which does not go beyond the elements of the summary of product characteristics , labelling and the package leaflet of the medicinal product , and the publicly accessible version of the assessment report drawn up by the competent authorities , but presents them in a different way ; ### information which does not go beyond the elements of the summary of product characteristics , labelling and the package leaflet of the medicinal product , and the publicly accessible version of the assessment report drawn up by the competent authorities , but presents them in a different way , provided that it clearly contains an accurate representation of the risks and benefits of the medicinal product ;


### it must take into account the general needs and expectations of patients ; ### it must be geared to the patient , to better meet his or her needs ;


### a statement indicating that the information is disseminated by a marketing authorisation holder ; ### a statement indicating that the information is disseminated by a marketing authorisation holder and naming the holder ;


### the member state where the internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website . ### the member state where the internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website in relation to medicinal products subject to medical prescription .


### member states shall allow marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this directive . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval . ### member states shall require that : marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this directive . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval ; registered internet websites include on each of their pages , in a prominent position , a hyperlink to the web page of the eudrapharma database , together with an explanatory note informing users that this is the official database developed by the european medicines agency .


### the animal health strategy for the union proposes that ‘ prevention is better than cure’ and was adopted by the commission in its communication of 19 september 2007 to the european parliament , the council , the european economic and social committee and the committee of the regions11 . it aims to put greater focus on preventive measures , disease surveillance , disease control and research , in order to reduce the incidence of animal diseases and minimise the impact of outbreaks when they do occur . it proposes the adoption of a ‘ single and simplified regulatory framework for animal health’ seeking convergence to international standards while ensuring a firm commitment to high standards of animal health . __________________ 11 com 539 final . ### the animal health strategy for the union proposes that ‘ prevention is better than cure’ and was adopted by the commission in its communication of 19 september 2007 to the european parliament , the council , the european economic and social committee and the committee of the regions11 . it aims to promote animal health through putting greater focus on preventive measures , disease surveillance , disease control and research , in order to reduce the incidence of animal diseases and minimise the impact of outbreaks when they do occur . it proposes the adoption of a ‘ single and simplified regulatory framework for animal health’ seeking convergence to international standards while ensuring a firm commitment to high standards of animal health . __________________ 11 com 539 final .


### in laying down those animal health rules , it is essential that considerations are given to the link between animal health and public health , the environment , food and feed safety , animal welfare , food security , economic , social and cultural aspects . ### in laying down those animal health rules , it is essential that considerations are given to the link between animal health and public health , the environment , food and feed safety , animal welfare , food security , economic , social and cultural aspects . it is also essential that biosecurity rules in the field of animal health are complied with .


### new hazards associated with certain diseases or species may develop in particular due to changes in the environment , the climate , animal husbandry , farming traditions but also through social changes . scientific progress may also lead to new knowledge and increased awareness concerning existing diseases . furthermore , diseases and species that are important today may be marginalised in the future . therefore the scope of this regulation should be broad and the rules laid down should be focused on diseases with high public relevance . the oie has , with the support of the european commission , developed a system of disease prioritisation and categorisation , by producing a study on the ' listing and categorisation of priority animal diseases , including those transmissible to humans ' 23 and a tool for such an exercise . this regulation should introduce such an approach in union legislation . __________________ 23 http : / / www . oie . int / en / support - to - oie - members / global - studies / categorisation - of - animal - diseases / . ### new hazards associated with certain diseases or species may develop in particular due to changes in the environment , the climate , animal husbandry , farming traditions but also through social changes and changes in economic and trade relations inside and outside the union . unless they are totally eradicated , diseases currently confined to limited geographical areas could spread and cause economic damage over wider areas . furthermore , scientific progress may also lead to new knowledge and increased awareness concerning existing diseases . at the same time , diseases and species that are important today may be marginalised in the future . therefore the scope of this regulation should be broad and the rules laid down should be focused on diseases with high public relevance . the oie has , with the support of the european commission , developed a system of disease prioritisation and categorisation , by producing a study on the ' listing and categorisation of priority animal diseases , including those transmissible to humans ' 23 and a tool for such an exercise . this regulation should introduce such an approach in union legislation . __________________ 23 http : / / www . oie . int / en / support - to - oie - members / global - studies / categorisation - of - animal - diseases / .


### the prevention and control rules of this regulation for a specific transmissible animal disease should apply to species of animals which can transmit the disease in question , by being susceptible to it or by acting as its vector . in order to ensure uniform conditions for the implementation of this regulation , it is necessary to establish a harmonised list of species to which the measures for specific listed diseases should apply at union level and thus implementing powers to lay down such a list should be conferred on the commission . ### the prevention and control rules of this regulation for a specific transmissible animal disease should apply to species of animals which can transmit the disease in question , by being susceptible to it or by acting as its vector . in order to ensure uniform conditions for the implementation of this regulation , it is necessary for it to establish a harmonised list of species to which the measures for specific diseases included in the list of listed diseases should apply at union level and to confer on the commission delegated powers to amend it .


### based on the importance and the level of impact of a listed disease , its distribution , prevalence and incidence in the union and the availability of disease prevention and control measures in respect of that listed disease , a different category of specific disease prevention and control rules provided for in this regulation should apply coherently and consistently to each listed disease . ### based on the importance and the level of impact of a listed disease , its distribution , prevalence and incidence in the union , the risk of its spreading and the availability of disease prevention and control measures in respect of that listed disease , a different category of specific disease prevention and control rules provided for in this regulation should apply coherently and consistently to each listed disease .


### the competent authority cannot always perform all the activities required to be carried out by it under this regulation due to the limited resources . for that reason it is necessary to provide a legal basis for the delegation of the performance of those activities to veterinarians . in order to ensure that the necessary conditions are laid down for the general application of disease prevention and control measures across the union , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect to the delegation of the performance of those activities to veterinarians and their appropriate training . ### the competent authority cannot always perform all the activities required to be carried out by it under this regulation due to the limited resources . for that reason it is necessary to provide a legal basis for the delegation of the performance of those activities to veterinarians and professional and trade organisations with the necessary qualifications , as laid down by law . in order to ensure that the necessary conditions are laid down for the general application of disease prevention and control measures across the union , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect to the delegation of the performance of those activities to veterinarians and professional and trade organisations and to training for veterinarians , as well as to the qualifications that professional and trade organisations must have in order to be delegated this responsibility .


### early detection and a clear chain of disease notification and reporting are crucial for effective disease control . in order to achieve an efficient and quick response any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to the competent authority . those notification obligations should be applicable to any natural and legal person in order to ensure that no disease outbreaks remain unnoticed . ### early detection and a clear chain of disease notification and reporting are crucial for effective disease control . in order to achieve an efficient and quick response any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to the competent authority . at the same time , a professional approach to notification and reporting must be ensured , in order avoid unnecessary health scares . those notification obligations should therefore be applicable to all operators , animal professionals and pet keepers .


### criteria for priority access to the union antigen , vaccine and diagnostic reagent banks ' resources should be established in order to ensure their effective distribution in emergencies . ### criteria for priority access to the union antigen , vaccine and diagnostic reagent banks ' resources should be established in order to ensure their effective distribution in emergencies . similarly , for those member states which have not set up national antigen , vaccine and diagnostic reagent banks or which find that stocks are limited in the union banks , criteria for access to the resources of other member states should be established .


### the occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals . special rules should therefore be laid down for disease control and eradication measures in wild animals where needed . ### the occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals . this risk is higher in areas where livestock are allowed to roam free . special rules should therefore be laid down for disease control and eradication measures in wild animals where needed .


### this regulation lays down rules for the prevention and control of animal diseases , which are transmissible to animals or to humans . ### this regulation lays down : rules for the prevention and control of animal diseases , which are transmissible to animals or to humans ; instruments and mechanisms to facilitate progress towards the declaration of disease - free zones and territories ; priority actions ; and the division of responsibilities in the area of animal health .


### ' aquaculture animals ' means aquatic animals subject to aquaculture ; ### ‘ aquaculture animals’ means aquatic animals subject to techniques designed to increase production above the natural capacity of the environment in question ;


### ' risk ' means the likelihood of the occurrence and the likely magnitude of the biological and economic consequences of an adverse effect on animal or public health ; ### ' risk ' means the likelihood of the scientifically demonstrated or demonstrable occurrence and the likely magnitude of the biological and economic consequences of scientifically proven or provable adverse effect on animal or public health ;


### that list shall comprise diseases which meet with the conditions laid down in the following points and of this paragraph , taking into account the criteria for listing diseases laid down in article 6 : ### that list shall comprise diseases which meet with the conditions laid down in the following points and of this paragraph , taking into account the evaluation of the criteria for listing diseases laid down in article 6 :


### the society in member states and where appropriate in third countries or territories ; ### the society in member states and regions , and , where appropriate , in third countries or territories ;


### the commission shall take account of the following criteria in determining whether a disease meets the conditions to be listed in accordance with article 5 : ### when applying article 5 , the commission shall take account of the following criteria in determining whether a disease meets the conditions to be listed in accordance with article 5 :


### that list shall comprise those animal species or groups of animal species , which pose a considerable risk for the spread of specific listed diseases , taking into account the following criteria : ### that list shall comprise those animal species or groups of animal species , which pose a considerable risk for the spread of specific diseases included on the list of listed diseases , taking into account the following criteria :


### the commission shall , by means of implementing acts , determine the application of the disease prevention and control rules referred to in the following points to listed diseases : ### the commission shall , by means of delegated acts , and in accordance with article 252 , determine for each of the diseases listed in the new annex - i the application of the community prevention and control rules referred to in the following paragraphs :


### listed diseases subject to rules on : ### 1 section 1 of new annex - i listed diseases subject to rules on :


### listed diseases subject to the disease prevention and control rules on : ### listed diseases in respect of which it is imperative , in the public interest , to take measures , subject to the disease prevention , surveillance and control rules on :


### listed diseases subject to the disease prevention and control rules on : ### listed diseases in respect of which it may be necessary , in the public interest , to take measures , subject to the disease prevention , surveillance and control rules on :


### listed diseases subject to the disease prevention and control rules on : ### listed diseases that are covered by the provisions of one or more of points , and above , and other diseases in respect of which measures are needed to prevent them spreading in the union , subject to the disease prevention , surveillance and control rules on :


### listed diseases subject to the disease prevention and control rules on : ### 2 section 2 of new annex - i listed diseases subject to the disease prevention and control rules on :


### listed diseases subject to the disease prevention and control rules on : ### listed diseases that are covered by the provisions of one or more of points , , and above , and other diseases which the union wishes to monitor , subject to the disease prevention , surveillance and control rules on :


### operators and animal professionals shall acquire knowledge of : ### operators and animal professionals shall acquire and actively promote spreading the knowledge of :


### the knowledge provided for in paragraph 1 shall be acquired in one of the following ways : ### the knowledge provided for in paragraph 1 may be acquired in one of the following ways :


### member states shall support operators and animal professionals in acquiring , maintaining and developing the basic knowledge of animal health provided for in article 10 through relevant programmes in agricultural or aquaculture sectors or formal education . ### member states shall support operators , animal professionals and pet keepers in acquiring , maintaining and developing the basic knowledge of animal health provided for in article 10 through relevant programmes in agricultural or aquaculture sectors or formal education .


### observe the health and behaviour of animals under their responsibility ; ### observe the health and welfare of animals under their responsibility ;


### operators shall ensure that establishments under their responsibility receive animal health visits from a veterinarian when appropriate due to the risks posed by the establishment , taking into account : ### with the view to ensure the highest possible degree of disease prevention , operators shall ensure that establishments under their responsibility receive animal health visits from a veterinarian when appropriate due to the risks posed by the establishment , taking into account :


### the requirements laid down in article 23 as regards the content and frequency of animal health visits for the different types of establishments , to ensure that the purposes of the animal health visits are achieved ; ### the requirements laid down in article 23 as regards the content and frequency of animal health visits for the different types of risk posed by the different types of establishments , to ensure that the purposes of the animal health visits are achieved ;


### the means of communication chosen must be generally available and not restrict economic operators’ access to the procurement procedure . ### the means of communication chosen must be generally available and accessible also to persons with disabilities and not restrict economic operators’ access to the procurement procedure .


### quality , including technical merit , aesthetic and functional characteristics , accessibility , design for all users , environmental characteristics and innovative character ; ### quality , including technical merit , aesthetic and functional characteristics , accessibility to persons with disbilities , design for all users , environmental characteristics and innovative character ;


### pursuant to resolution 126 on increase in authorised capital stock , issuance of paid - in shares , and payment through reallocation of net income , the authorised capital stock of the ebrd is increased by 100 000 paid - in shares , and each member is issued a number of whole shares , rounded downwards , pro rata to their existing shareholding . the paid - in part of the capital increase will be paid through integration in the capital of part of the ebrd ' s unrestricted general reserves . all ebrd shareholders will automatically receive paid - in shares in proportion of their existing shareholding , without any further procedural steps to be taken by the shareholders themselves . accordingly , the eu is issued 3 031 new shares , each share having a par value of eur 10 000 increasing the number of paid - in shares of the eu to 63 031 . ### pursuant to resolution 126 on increase in authorised capital stock , issuance of paid - in shares , and payment through reallocation of net income , the authorised capital stock of the ebrd is increased by 100 000 paid - in shares , and each member is issued a number of whole shares , rounded downwards , pro rata to their existing shareholding . the paid - in part of the capital increase will be paid through integration in the capital of part of the ebrd ' s unrestricted general reserves . this decision thus has no direct impact on the budget of the union . all ebrd shareholders will automatically receive paid - in shares in proportion of their existing shareholding , without any further procedural steps to be taken by the shareholders themselves . accordingly , the eu is issued 3 031 new shares , each share having a par value of eur 10 000 increasing the number of paid - in shares of the eu to 63 031 .


### it is appropriate for the european union to subscribe to those additional shares in order to achieve the european union ' s objectives in the field of economic external relations and preserve its relative voting power within the ebrd . ### this decision provides the opportunity for the ebrd to increase its activities in its countries of operation , thus providing valuable assistance to the economies of those countries in times of restricted capital availability . it is appropriate for the european union to subscribe to those additional shares in order to achieve the european union ' s objectives in the field of economic external relations and preserve its relative voting power within the ebrd . the governor of the ebrd for the european union should , however , suggest that the board of governors consider the possibility of rebalancing the level of shareholder equity relative to loans and other investments in order to decrease the impact of the equity valuation on the ebrd ' s balance sheet . the governor of the ebrd for the european union should also support the further development of financial instruments , based on co - financing between the eu budget and that of the ebrd , supporting the achievement of the eu objectives , while taking into account that such cooperation should be accompanied by better control and visibility of eu public funds .


### it is appropriate to clarify that staff of the eeas who carry out tasks for the commission as part of their duties should follow instructions given by the commission . likewise , commission officials working in union delegations should follow instructions from the head of delegation , in particular on organisational and administrative matters and on the implementation of the union budget . ### it is appropriate to clarify that staff of the eeas who carry out tasks for the commission as part of their duties should follow instructions given by the commission under the overall responsibility of the head of delegation . likewise , commission officials working in union delegations should follow instructions from the head of delegation , in particular on organisational and administrative matters .


### in order to take account of specific situations in a flexible manner , a transfer of officials in the interests of the service , that is without prior publication of the vacant post , from the council or the commission to the eeas should also be made possible in exceptional cases . similarly , it should be possible to transfer officials in the interest of the service from the eeas to the council or the commission . ### in order to take account of specific situations in a flexible manner , a transfer of officials in the interests of the service , that is without prior publication of the vacant post , from the council or the commission to the eeas should also be made possible in duly justified exceptional cases . similarly , it should be possible to transfer officials in the interest of the service from the eeas to the council or the commission .


### in order to ease the administrative burden of the eeas , the disciplinary board established in the commission should also serve as the disciplinary board for the eeas , unless the high representative of the union for foreign affairs and security policy and vice - president of the commission decides to establish a disciplinary board for the eeas . ### in order to ease the administrative burden of the eeas , the disciplinary board established in the commission should also serve as the disciplinary board for the eeas .


### unless the high representative of the union for foreign affairs and security policy and vice - president of the commission decides to establish a disciplinary board for the eeas , the disciplinary board of the commission shall also serve as the disciplinary board for the eeas . ### the disciplinary board of the commission shall also serve as the disciplinary board for the eeas .


### in order to guarantee the free movement of products within the union , it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , protection of consumers , protection of the environment and public security . robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the union goods market can thrive . rules are therefore necessary on market surveillance and on controls of products entering the union from third countries . ### in order to guarantee and improve the functioning of the single market as well as the free movement of products within the union , it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , protection of consumers , protection of the environment and public security . robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the union goods market can thrive . rules are therefore necessary on market surveillance and on controls of products entering the union from third countries .


### both new and second hand products originating outside the union may be placed on the market only after they have been released for free circulation . effective controls are required at the external borders of the union to suspend the release of products that may present a risk if placed on the market in the union pending evaluation and a final decision by market surveillance authorities . ### both new and second hand products originating outside the union may be placed on the market only after they have been released for free circulation . respecting the principle of uniformity of the common commercial policy , effective controls are required at the external borders of the union to suspend the release of products that may present a risk if placed on the market in the union pending evaluation and a final decision by market surveillance authorities . the commission should assess the effectiveness of these controls , in order to ensure that the same standards are applied at all entry points to the union market so that goods and rogue traders do not divert trade to entry points to the union market with a less stringent implementation of the eu market surveillance regulatory regime .


### there should be effective , speedy and accurate exchange of information among the member states and between the member states and the commission . it is therefore necessary to provide for effective tools for such exchange . the union rapid information system has proved its effectiveness and efficiency . rapex enables measures to be taken across the union in relation to products that present a risk beyond the territory of a single member state . to avoid unnecessary duplication , this system should be used for all alert notifications required by this regulation relating to products presenting a risk . ### there should be effective , speedy and accurate exchange of information among the member states and between the member states and the commission . it is therefore necessary to provide for effective tools for such exchange . the union rapid information system has proved its effectiveness and efficiency . rapex enables measures to be taken across the union in relation to products that present a risk beyond the territory of a single member state . to avoid unnecessary duplication , this system should be used and constantly updated for all alert notifications required by this regulation relating to products presenting a risk .


### given the size of the union market for goods and as there are no internal borders , it is imperative that the market surveillance authorities of the member states are willing and able to cooperate with each other effectively and to coordinate joint support and action . accordingly , mechanisms for mutual assistance should be established . ### given the size of the union market for goods and as there are no internal borders , it is imperative that the market surveillance authorities of the member states are willing and able to cooperate with each other effectively and to coordinate joint support and action . accordingly , mechanisms for mutual assistance should be established and enforced . member states should ensure that these mechanisms are adequately financed .


### member states should lay down rules on penalties applicable to infringements of this regulation and ensure that they are implemented . those penalties must be effective , proportionate and dissuasive . ### member states should lay down rules on penalties applicable to infringements of this regulation and ensure that they are implemented . those penalties must be effective , proportionate and dissuasive , in order to discourage the rogue traders to deliberately introduce dangerous or non - compliant products on the internal market .


### this regulation lays down a framework for verifying that products meet requirements which safeguard , at a high level , the health and safety of persons in general , health and safety in the workplace , consumer protection , the environment , public security and other public interests . ### this regulation lays down a framework for verifying that products placed on the market and entering the eu market for release meet requirements which safeguard , at a high level , the health and safety of persons in general , health and safety in the workplace , consumer protection , the environment , public security .


### the implementation of market surveillance activities and external border controls shall be monitored by the member states which shall report on these activities and controls to the commission every year . the information reported shall include statistics regarding the number of controls carried out and shall be communicated to all member states . member states may make a summary of the results accessible to the public . ### the implementation of market surveillance activities and external border controls shall be monitored by the member states which shall report on these activities and controls to the commission every year . the information reported shall include statistics regarding the number of controls carried out and shall be communicated to all member states . member states shall make a summary of the results accessible to the public . the commission shall assess the consistent implementation as well as the effectiveness of these activities and controls and , if necessary , make recommendations to the market surveillance authorities to ensure consistent and effective implementation across the union .


### each member state shall establish appropriate mechanisms to ensure that the market surveillance authorities that it has established or designated exchange information , cooperate and coordinate their activities both among themselves and with the authorities in charge of controls of products at the external borders of the union . ### each member state shall establish appropriate mechanisms to ensure that the market surveillance authorities that it has established or designated exchange information , cooperate and coordinate their activities both among themselves and with the authorities in charge of controls of products at the external borders of the union . each member state shall ensure that the market surveillance authorities it has designated or established dispose of appropriate resources to carry out this cooperation . each member state shall inform the commission about these information exchange and cooperation mechanisms .


### each member state shall draw up a general market surveillance programme and shall review that programme , and update it if necessary , at least every four years . the programme shall cover market surveillance organisation and related activities and take into account the specific needs of business generally , and smes in particular , when implementing union harmonisation legislation and regulation no [ &#8230 ; / &#8230 ; ] [ on consumer product safety ] , and provide for guidance and assistance . it shall include the following : ### each member state shall draw up a general market surveillance programme and shall review that programme and deletion update it at least every four years . the programme shall cover market surveillance organisation and related activities and take into account the specific needs of business generally , and smes in particular , when implementing union harmonisation legislation and regulation no [ … / … ] [ on consumer product safety ] , and provide for guidance and assistance . it shall include the following :


### each member state shall draw up sector - specific programmes and shall review these programmes , and update them if necessary , every year . these programmes shall cover all sectors in which authorities conduct market surveillance activities . ### each member state shall draw up sector - specific programmes and shall review these programmes , and update them deletion every year , notably taking account of increased entry to the union market of certain goods due to the application of eu trade agreements with third countries . these programmes shall cover all sectors in which authorities conduct market surveillance activities .


### participation in rapex shall be open to applicant countries , third countries or international organisations within the framework of and in accordance with agreements between the union and those countries or organisations . any such agreements shall be based on reciprocity and include provisions on confidentiality corresponding to those applicable in the union . ### participation in rapex shall be open and encouraged to applicant countries , third countries or international organisations within the framework of and in accordance with agreements between the union and those countries or organisations . for third countries the commission is engaging in trade negotiations to provide preferential access for goods to the union ' s market , the commission shall encourage these countries to participate in rapex and take account of the third countries ' capacity to participate , when negotiating provisions on market access . any such agreements shall be based on reciprocity and include provisions on confidentiality corresponding to those applicable in the union .


### the emsf may establish standing or temporary sub - groups which shall include the administrative cooperation groups for market surveillance set up for the implementation of union harmonisation legislation . organisations representing the interests of industry , small and medium - sized enterprises , consumers , laboratories and conformity assessment bodies at union level may be invited to participate in such sub - groups as observers . ### the emsf may establish standing or temporary sub - groups which shall include the administrative cooperation groups for market surveillance set up for the implementation of union harmonisation legislation . organisations representing the interests of industry , small and medium - sized enterprises , consumers , laboratories and conformity assessment bodies at union level should be invited to participate in such sub - groups as observers , their opinions should be taken into consideration as far as possible .


### no later than [ five ] years after the date of application , the commission shall assess the application of this regulation and transmit an evaluation report to the european parliament and the council . that report shall assess if this regulation achieved its objectives , in particular with regard to ensuring more effective and efficient enforcement of product safety rules and union harmonisation legislation , improving cooperation between market surveillance authorities , strengthening the controls of products entering the union and better protecting the health and safety of persons in general , health and safety in the workplace , consumer protection , the environment , public security and other public interests , taking into account its impact on business and in particular on small and medium - sized enterprises . ### no later than [ five ] years after the date of application , the commission shall assess the application of this regulation and transmit an evaluation report to the european parliament and the council . that report shall assess if this regulation achieved its objectives , in particular with regard to ensuring more effective and efficient enforcement of product safety rules and union harmonisation legislation , ensuring that the same standards are applied at all entry points to the union market , improving cooperation between market surveillance authorities among member states as well as with third countries , notably with those , which benefit from preferential access to the union ' s market , strengthening the controls of products entering the union and better protecting the health and safety of persons in general , health and safety in the workplace , consumer protection , the environment , public security and other public interests , taking into account its impact on business and in particular on small and medium - sized enterprises .


### ' rail system ' means the union rail system as defined in article 2 of directive [ xx on interoperability of the rail system ] ; ### ' union rail system ' means the conventional and high - speed union rail system as defined in article&#160 ; 2 of directive [ xx on interoperability of the rail system ] ;


### ' rail system ' means the union rail system as defined in article 2 of directive [ xx on interoperability of the rail system ] ; ### ' rail system ' means the trans - european conventional and high - speed rail systems as defined in article 2 of the directive on interoperability of the rail system ;


### ' safety management system ' means the organisation and arrangements established by an infrastructure manager or a railway undertaking to ensure the safe management of its operations ; ### ' safety management system ' means the organisation and procedures established by an infrastructure manager or a railway undertaking to ensure the safe management of its operations ;


### ‘ accident’ means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences ; accidents are divided into the following categories : collisions , derailments , level - crossing accidents , accidents to persons caused by rolling stock in motion , fires and others ; ### ‘ accident’ means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences ; accidents are divided into the following categories : collisions , derailments , level - crossing accidents caused by failures in the rail system , accidents to persons caused by rolling stock in motion , fires and others ;


### the safety management system of any infrastructure manager shall take into account the effects of operations by different railway undertakings on the network and make provisions to allow all railway undertakings to operate in accordance with tsis and national rules and with the conditions laid down in their safety certificate . the safety management systems shall be developed with the aim of coordinating the emergency procedures of the infrastructure manager with all railway undertakings that operate on its infrastructure . ### the safety management system of any infrastructure manager shall take into account the effects of operations by different railway undertakings on the network and make provisions to allow all railway undertakings to operate in accordance with tsis and national rules and with the conditions laid down in their safety certificate . the safety management systems shall be developed with the aim of coordinating the emergency procedures of the infrastructure manager with all railway undertakings that operate on its infrastructure , with the emergency services , so as to guarantee the rapid intervention of rescue services , and with any other party that could be involved in an emergency situation .


### the single safety certificate shall be granted by the agency on the basis of the evidence that the railway undertaking has established its safety management system in accordance with article 9 and meets the requirements laid down in tsis and in other relevant legislation in order to control risks and provide transport services safely on the network . ### before any new service gets under way , a single safety certificate shall be granted by the agency on the basis of the evidence that the railway undertaking has put in place its safety management system in accordance with article 9 and meets the requirements laid down in tsis , in other relevant legislation and in the rules specific to the system in order to control risks and provide transport services safely on the network .


### authorisation confirming acceptance of the infrastructure manager’s safety management system laid down in article 9 , which shall include the procedures and provisions for meeting the requirements necessary for the safe design , maintenance and operation of the railway infrastructure , including , where appropriate , the maintenance and operation of the traffic control and signalling system . ### authorisation confirming acceptance of the infrastructure manager’s safety management system laid down in article 9 , which shall include the procedures and provisions for meeting the requirements necessary for the safe design , maintenance and operation of the railway infrastructure , including , where appropriate , the maintenance and operation of the traffic control and signalling system , as well as procedures for action in the event of a serious accident in order to guarantee emergency assistance and restore infrastructure safety .


### the power to adopt delegated acts referred to in articles 5 and 7 shall be conferred on the commission for an indeterminate period of time . ### the power to adopt delegated acts referred to in articles 5 and 7 shall be conferred on the commission for a period of five years from [ opoce please insert the date of entry into force of this directive ] . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### on the basis of relevant information provided by the agency , the commission shall submit to the european parliament and to the council before [ specific date to be inserted by opoce - five years after the date of entry into force ] and every five years thereafter a report on the implementation of this directive . ### on the basis of relevant information provided by the agency , the commission shall submit to the european parliament and to the council before [ specific date to be inserted by opoce - three years after the date of entry into force ] and every three years thereafter a report on the implementation of this directive .


### the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation . ### the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation . pharmaceutical excipients , other than active pharmaceutical ingredients , used in drug product manufacturing should be subject to appropriate controls by the manufacturing authorisation holder such that the excipients are checked and verified by the manufacturing authorisation holder to be suitable for use in the production of drug products in accordance with good manufacturing practices and that the verification provides for an adequate level of protection of public health .


### trading of medicinal products : all activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products , or billing or brokering medicinal products , apart from supplying medicinal products to the public , and not falling under the definition of wholesale distribution . ### third party intermediation in the trading and brokering of medicinal products : all activities relating to the buying and selling of medicines , except for the supply of medicinal products to the public and wholesale distribution , as defined in paragraph 17 of this article , which do not include the physical handling of such products and take the form of independent negotiation on behalf of another natural or legal person or of a body provided for in national law .


### ‘ the principles of good manufacturing practice for active substances used as starting materials referred to in point of article 46 and in article 46b shall be adopted in the form of detailed guidelines . ’ ### ‘ the principles of good manufacturing practice for active substances used as starting materials referred to in point of article 46 and in article 46b shall be adopted in the form of detailed guidelines . ’ the principles by which the manufacturing authorisation holder ensures that excipients are suitable for use in manufacturing operations , carried out using risk based analyses under the principles of good manufacturing practices , shall be adopted in the form of guidelines .


### the safety features referred to in point of article 54 shall allow wholesale distributors or pharmacists or persons authorised or entitled to supply medicinal products to the public to perform all of the following : ### the safety features referred to in point of article 54 shall allow wholesale distributors or pharmacists and persons authorised or entitled to supply medicinal products to the public to perform all of the following :


### the regularity of inspections of good manufacturing practices ; ### the regularity of repeated and unannounced inspections of good manufacturing practices ;


### in line with the commission communication ' a budget for europe 2020 ' 4 , which recommends rationalising and simplifying the union ' s funding instruments and sharpening their focus both on union added value and on impacts and results , this regulation establishes a european union programme for social change and innovation to provide for the continuation and development of activities carried out on the basis of decision no 1672 / 2006 / ec of the european parliament and of the council of 24 october 2006 establishing a community programme for employment and social solidarity &#8211 ; progress5 , regulation no 492 / 2011 of the european parliament and of the council of 5&#160 ; april 2011 on freedom of movement for workers within the union6 and commission decision 2003 / 8 / ec of 23 december 2002 implementing regulation no 1612 / 1968 as regards the clearance of vacancies and applications for employment7 and decision no&#160 ; 283 / 2010 / eu of the european parliament and of the council of 25&#160 ; march 2010 establishing a european progress microfinance facility for employment and social inclusion8 . ### in line with the commission communication ' a budget for europe 2020 ' , which recommends rationalising and simplifying the union ' s funding instruments and sharpening their focus both on union added value and on impacts and results , this regulation establishes a european union programme for social progress and employment to provide for the continuation and development of activities carried out on the basis of decision no 1672 / 2006 / ec of the european parliament and of the council of 24 october 2006 establishing a community programme for employment and social solidarity &#8211 ; progress , regulation no 492 / 2011 of the european parliament and of the council of 5&#160 ; april 2011 on freedom of movement for workers within the union and commission decision 2003 / 8 / ec of 23 december 2002 implementing regulation no 1612 / 1968 as regards the clearance of vacancies and applications for employment and decision no&#160 ; 283 / 2010 / eu of the european parliament and of the council of 25&#160 ; march 2010 establishing a european progress microfinance facility for employment and social inclusion .


### in line with the europe 2020 strategy , the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter allia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on large projects with clear eu added value in order to reach critical mass and reduce administrative burden for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro - credit , capacity building and technical assistance . lastly , the programme should provide for budgetary flexibility through the establishment of a reserve to be allocated on an annual basis in order to respond to policy priorities . ### in line with the europe 2020 strategy , the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should focus on large projects with a clear exemplary character and eu added value in order to reach critical mass and reduce administrative burden for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro - credit , capacity building and technical assistance . within its limited scope , the programme should provide for budgetary flexibility through the establishment of a reserve to be allocated on an annual basis in order to respond to policy priorities .


### the union is uniquely placed to provide a union platform for policy exchanges and mutual - learning between the member states in the employment and social areas . knowledge of policies applied in other countries and of their results broadens the range of options available to policy - makers , triggers new policy developments and encourages national reform . ### the union is uniquely placed to provide a union platform for policy exchanges and mutual - learning between the member states in the areas of employment , social protection and social inclusion . knowledge of policies applied in other countries and of their results broadens the range of options available to policy - makers , thereby triggering new policy developments .


### the union is committed to strengthening the social dimension of globalisation by promoting decent work and labour standards internationally , either directly vis - à - vis third countries or indirectly through cooperation with international organisations . accordingly , suitable relations need to be developed with third countries not participating in the programme in order to help achieve its objectives , having regard to any agreements of relevance between such countries and the union . this may involve the attendance of representatives of these third countries at events of mutual interest that take place in countries participating in the programme . in addition , cooperation should be developed with the international organisations concerned , and in particular the international labour organisation , the council of europe and the organisation for economic cooperation and development , with a view to implementing the programme in a way that takes the role of such organisations into account . ### the union is committed to strengthening the social dimension of globalisation by promoting decent work and labour standards not only in its member states but also internationally , either directly vis - à - vis third countries or indirectly through cooperation with international organisations . accordingly , suitable relations need to be developed with third countries not participating in the programme in order to help achieve its objectives , having regard to any agreements of relevance between such countries and the union . this may involve the attendance of representatives of these third countries at events of mutual interest that take place in countries participating in the programme . in addition , cooperation should be developed with the international organisations concerned , in particular the international labour organisation and other relevant united nations bodies , the council of europe , and the organisation for economic cooperation and development , with a view to implementing the programme in a way that takes the role of such organisations into account .


### in accordance with articles 45 and 46 of the treaty , regulation no 492 / 2011 lays down provisions intended to achieve freedom of movement for workers by ensuring close cooperation between the member states and with the commission . eures should promote better functioning of the labour markets by facilitating transnational geographical mobility of workers , providing greater transparency on the labour market , ensuring the clearance of vacancies and applications for employment and supporting activities in the areas of recruitment , advice and guidance services at national and cross - border level , thereby contributing to the objectives of the europe 2020 strategy . ### in accordance with articles 45 and 46 tfeu , regulation no 492 / 2011 lays down provisions intended to achieve freedom of movement for workers by ensuring close cooperation between the member states and with the commission . eures should promote better functioning of the labour markets by facilitating voluntary transnational geographical mobility of workers and supporting advice , guidance and placement services at national and cross - border level for mobile workers and employers , thereby contributing to the objectives of the europe 2020 strategy . however , the commission itself should in no circumstances act as an employment service .


### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility . ### lack of access to credit , equity or quasi equity is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility .


### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility . ### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed , women and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility .


### making microfinance more available on the union’s young microfinance market calls for the institutional capacity of microfinance providers , and in particular non - bank microfinance institutions , to be stepped up in line with the commission communication ' a european initiative for the development of micro - credit ' 10 . ### making microfinance more available on the union’s young microfinance market calls for the institutional capacity of microfinance providers , and in particular non - bank microfinance institutions , to be stepped up in line with the commission communication ' a european initiative for the development of micro - credit ' 10 . care must be taken to ensure that the annual amount of the budget appropriation , increased by the reinvested capital , which is granted to the european progress microfinance facility at least matches the annual amount of the appropriation granted for the period from 1 january 2010 to 31 december 2013 .


### in order to capitalise on the experience of international financial institutions , and in particular the european investment bank group , action involving microfinance and social entrepreneurship should be implemented by the commission indirectly by entrusting budget implementations tasks to financial institutions in accordance with the financial regulation . using union resources concentrates leverage from international financial institutions and other investors , unifies approaches and thus improves access to finance for micro - enterprises , including the self - employed and social enterprises . the union contribution thus assists in the development of the emerging social business sector and the microfinance market in the union and encourages cross - border activities . ### in order to capitalise on the experience of international financial institutions , and in particular the european investment bank group , action involving microfinance and social entrepreneurship should be implemented by the commission indirectly by entrusting budget implementations tasks to financial institutions in accordance with the financial regulation . using union resources concentrates leverage from financial institutions and other investors , unifies approaches and thus improves access to finance for micro - enterprises , including the self - employed and social enterprises . the union contribution thus assists in the development of the emerging social business sector and the microfinance market in the union and encourages cross - border activities . the union ' s actions should be complementary to the member states ' use of financial instruments for microfinance and social entrepreneurship . the entities entrusted with the implementation of the actions should ensure added value and avoid duplication of financing through union resources .


### in order to capitalise on the experience of international financial institutions , and in particular the european investment bank group , action involving microfinance and social entrepreneurship should be implemented by the commission indirectly by entrusting budget implementations tasks to financial institutions in accordance with the financial regulation . using union resources concentrates leverage from international financial institutions and other investors , unifies approaches and thus improves access to finance for micro - enterprises , including the self - employed and social enterprises . the union contribution thus assists in the development of the emerging social business sector and the microfinance market in the union and encourages cross - border activities . ### in order to capitalise on the experience of international financial institutions , and in particular the european investment bank group , action involving microfinance and social entrepreneurship should be implemented by the commission indirectly by entrusting budget implementations tasks to financial institutions in accordance with the financial regulation . using union resources concentrates leverage from international financial institutions and other investors , unifies approaches and thus improves access to finance for micro - enterprises , including the self - employed and social enterprises . the union contribution thus assists in the development of the emerging social business sector and the microfinance market in the union and encourages cross - border activities . the union ' s actions should be complementary to the member states ' use of financial instruments for microfinance and social entrepreneurship . the entities entrusted with the implementation of the actions should ensure added value and avoid duplication of financing through union resources .


### pursuant to articles 8 and 10 of the treaty , the programme should support the mainstreaming of gender equality and anti - discrimination objectives in all its activities . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed in the programme ' s activities . ### pursuant to articles 8 and 10 of the treaty , the programme should support the mainstreaming of gender equality and anti - discrimination objectives in all its activities . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed in the programme ' s activities and gender and anti - discrimination spending should be moved to the rights and citizenship programme .


### pursuant to article 9 of the treaty , the programme should ensure that the requirements linked to the promotion of a high - level of employment , a guarantee of adequate social protection and the fight against social exclusion are taken into account in defining and implementing the union ' s policies and activities . ### pursuant to article 9 tfeu and the objectives of the europe 2020 strategy , the programme should contribute to ensuring a high level of high - quality employment , a guarantee of adequate social protection and the fight against poverty and social exclusion .


### to ensure more efficiency in communication to the public at large and stronger synergies between the communication actions undertaken at the initiative of the commission , the resources allocated to information and communication activities under this regulation shall also contribute to corporate communication of the political priorities of the european union as far as they are related to the general objectives of this regulation . ### to ensure more efficiency in communication to the public at large and stronger synergies between the communication actions undertaken at the initiative of the commission , the resources allocated to information and communication activities under this regulation shall also contribute to providing information on the political priorities of the european union as far as they are related to the general objectives of this regulation .


### the implementing powers relating to actions carried out under the progress axis of the programme should be exercised in accordance with 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 member states of the commission ' s exercise of implementing powers . ### implementing powers should be conferred on the commission with a view to ensuring uniform conditions for the implementation of this regulation . those powers should be exercised in accordance with 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 member states of the commission ' s exercise of implementing powers .


### the progress axis , which shall support the development , implementation , monitoring and evaluation of union employment and social policy and legislation on working conditions and shall promote evidence - based policy - making and innovation , in partnership with the social partners , civil society organisations and other interested parties ; ### the progress axis , which shall support the development , implementation , monitoring and evaluation of union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas and shall promote evidence - based policy - making and social progress , in partnership with the social partners and in cooperation with civil society organisations and public bodies ;


### the eures axis , which shall support activities carried out by the eures network , i . e . the specialist services designated by the eea member states and the swiss confederation , together with other interested parties , to develop information exchanges and dissemination and other forms of cooperation to promote workers ' geographical mobility ; ### the eures axis , which shall support activities carried out by the eures network , together with the social partners and other interested parties , to develop information exchanges and dissemination and other forms of cooperation such as cross - border partnerships , as well as individual counselling and information for jobseekers , mobile workers and employers to promote workers ' voluntary geographical mobility on a fair basis and to contribute to a high level of high - quality employment ;


### the common provisions laid down in articles 1 to 14 shall apply to all three axes set out in points , and of paragraph 1 , to each of which specific provisions shall also apply . ### the common provisions laid down in articles 1 to 14 , and the delegated and implementing powers and final provisions laid down in articles 26a to 29 , as appropriate , shall apply to all three axes set out in points , and of paragraph 1 , to each of which specific provisions shall also apply .


### in pursuing those objectives , the programme shall aim to : ### in pursuing those objectives , the programme shall :


### ensure that the requirements linked to the promotion of a high - level of employment , a guarantee of adequate social protection and the fight against social exclusion are taken into account in defining and implementing of the union ' s policies and activities . ### promote a high level of high - quality employment , guarantee adequate and decent social protection and fight against poverty and social exclusion .


### the following indicative percentages shall be allocated to the axes set out in article 3 as follows : ### over the entire period of the programme , the financial breakdown allocated to the axes set out in article 3 , and shall be as follows :


### the remaining 5% shall be apportioned among the axes on an annual basis in line with policy priorities . ### in order to make effective use of the funds and to enable the shifting of funds between the axes in line with policy priorities , the remaining 5 % shall be apportioned among the axes on an annual basis while fully respecting the prerogatives of the budgetary authority in the annual budget .


### the commission may make use of the appropriations referred to paragraph 1 to finance technical and / or administrative assistance , in particular relating to auditing , outsourcing of translation , meetings of experts , and information and communication activities for the mutual benefit of the commission and the beneficiaries . ### the commission may make use of up to 3 % of the appropriations referred to in paragraph 1 , to finance technical and / or administrative assistance , in particular relating to auditing , outsourcing of translation , meetings of experts , cooperation with third countries and information and communication activities for the mutual benefit of the commission and the beneficiaries .


### the commission may make use of the appropriations referred to paragraph 1 to finance technical and / or administrative assistance , in particular relating to auditing , outsourcing of translation , meetings of experts , and information and communication activities for the mutual benefit of the commission and the beneficiaries . ### a maximum of 2 % of the financial envelope referred to in paragraph 1 shall be attributed to the implementation of the programme to cover , for example , the expenditure related to technical and / or administrative assistance , translation , tenders , expert meetings , communication for the mutual benefit of the commission and the beneficiaries .


### surveys , studies , analyses and reports , including through the funding of networks of experts ; ### surveys , studies , analyses and reports , including through the funding of networks and development of expertise on thematic priorities ;


### preparation and implementation of social experimentation as a method for testing and evaluating innovative solutions with a view to scaling them up ; ### preparation and implementation of social policy experimentation as a method for testing and evaluating innovative solutions with a view to scaling them up ;


### exchanges and dissemination of good practice , innovative approaches and experience , peer reviews , benchmarking and mutual learning at european level ; ### focused and strategic exchanges and dissemination of good practice , innovative approaches and experience , peer reviews , benchmarking and mutual learning at european level amongst policy makers and other stakeholders in order to enhance knowledge and make progress towards the union ' s objectives in terms of promoting a high level of quality employment , guaranteeing adequate and decent social protection , combating social exclusion and poverty and improving working conditions ;


### funding of european - level observatories ; ### funding of european - level , interregional and cross - border observatories , including on key thematic priorities ;


### the commission shall establish any relations needed with committees dealing with policies , instruments and actions of relevance to the programme in order to ensure that they are regularly and appropriately informed of progress in implementing the programme . ### the commission shall establish the necessary links with the employment committee , the social protection committee , the advisory committee on health and safety at work and the advisory committee on freedom of movement of workers in order to ensure that they are regularly and appropriately consulted and informed of progress in implementing the programme . the commission shall also inform other committees dealing with policies , instruments and actions of relevance to the programme . where appropriate , the commission shall establish regular and structured cooperation between the strategic advisory board referred to in article 26d , the committee referred to in article 26f and monitoring committees established for other relevant policies , instruments and actions .


### communication activities shall also contribute to corporate communication of the political priorities of the european union as far as they are related to the general objectives of this regulation . ### communication activities shall also provide information on the political priorities of the european union as far as they are related to the general objectives of this regulation .


### lump - sums and scale of unit costs and flat - rate financing may be used in respect of support awarded to programme participants , in particular in respect of mobility schemes referred to in article 6 . ### the grant agreement shall specify which part of the union financial contribution will be based on the reimbursement of eligible costs , and which part will be based on flat rates or lump - sums in respect of support awarded to programme participants , in particular in respect of mobility schemes referred to in article 6 .


### the commission shall take appropriate preventive measures ensuring that , when actions financed under this regulation are implemented , the financial interests of the union are protected against fraud , corruption and any other illegal activities , by effective checks and , if irregularities are detected , by the recovery of amounts wrongly paid and , where appropriate , by effective , proportional and deterrent penalties , in accordance with article 325 of the treaty , council regulation no 2988 / 95 of 18 december 1995 on the protection of the european communities ' financial interests and the financial regulation . ### the commission shall take appropriate preventive measures and carry out effective checks ensuring that , when actions financed under this regulation are implemented , the financial interests of the union are protected against fraud , corruption and any other illegal activities . 1a . if irregularities are detected , amounts wrongly paid shall be recovered primarily by offsetting and , where appropriate , the protection of the financial interests of the union in accordance with article 325 of the treaty , council regulation no 2988 / 95 of 18 december 1995 on the protection of the european communities’ financial interests and the financial regulation may include effective , proportional and deterrent penalties .


### without prejudice to paragraphs 1 and 2 , decisions , agreements and contracts resulting from the implementation of this regulation shall expressly entitle the commission , including olaf , and the court of auditors to conduct such audits , on - the - spot checks and inspections . ### without prejudice to paragraphs 1 and 2 , decisions , agreements and contracts resulting from the implementation of this regulation shall expressly entitle the commission , including olaf , and the court of auditors to conduct such audits , on - the - spot checks and inspections up to four years after the final payment .


### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up biennial monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities . ### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up qualitative and quantitative annual monitoring reports and send them to the european parliament and the council . the reports shall also be transmitted , for information , to the european economic and social committee and the committee of the regions . the annual monitoring reports shall cover the programme ' s results and contain information on the impact and sustainability of its axes , including where appropriate , the total number of people assisted , placed and / or still employed as well as microenterprises and social enterprises still in business at the end of the period of support , and information on compatibility with other union financial instruments , in particular the esf . the annual monitoring reports shall also cover the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities .


### a mid - term evaluation of the programme shall be carried out by the end of 2017 to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . ### a mid - term evaluation of the programme shall be carried out by mid - 2017 to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . the commission may , on the basis of the evaluation , present a proposal on the transfer of appropriations between the programme ' s axes .


### specific provisions ### provisions specific to programme axes


### provide policy - makers with financial support to test social and labour market policy reforms , build up the main actors ' capacity to design and implement social experimentation , and make the relevant knowledge and expertise accessible ; ### provide policy - makers with financial support to test social and labour market policy reforms , where necessary , in order to ensure adequate and decent social protection , social inclusion , a reduction of poverty , a high level of high - quality employment and better working conditions , build up the main actors ' capacity to design and implement social policy experimentation , and make the relevant knowledge and expertise accessible ;


### the commission may cooperate with international organisations , and in particular the council of europe , the oecd , the ilo and the world bank . ### the commission may cooperate with international organisations , and in particular the council of europe , the oecd , the ilo and other united nations bodies , and the world bank .


### the eures axis shall be open to all public and private bodies , actors and institutions designated by a member state or the commission which fulfil the conditions for participating in the eures network , as set out in commission decision 2003 / 8 / ec19 . such bodies and organisations shall include in particular : ### the eures axis shall be open to all bodies , actors and institutions designated by a member state or the commission which fulfil the conditions for participating in the eures network , as set out in commission decision 2003 / 8 / ec19 . such bodies and organisations shall include in particular :


### persons who have lost or are at risk of losing their jobs , or who have difficulty in entering or re - entering the labour market , persons at risk of social exclusion and vulnerable persons who are in a disadvantaged position with regard to access to the conventional credit market and who wish to start up or develop their own micro - enterprises ; ### persons who have lost or are at risk of losing their jobs , or who have difficulty in entering or re - entering the labour market , persons at risk of social exclusion and vulnerable persons who are in a disadvantaged position with regard to accessing the conventional credit market or holding the necessary equity or semi - equity and who wish to start up or develop their own micro - enterprises ;


### support the development of social enterprises , in particular by facilitating access to finance . ### support the development of the social investment market and facilitate access to finance for social enterprises by making available equity , quasi - equity , loan instruments and grants of up to [ eur 500 000 ] to social enterprises , that have either an annual turnover not exceeding eur 50 million , or an annual balance sheet total not exceeding eur 43 million and which are not a collective investment undertaking .


### microfinance for persons and micro - enterprises ; ### microfinance for persons and micro - enterprises ; and / or


### public and private bodies that carry out activities as referred to in paragraph 1 shall adhere to high standards concerning governance , management and customer protection in line with the principles of the european code of good conduct for microcredit provision and shall seek to prevent persons and undertakings from becoming over - indebted . ### public and private bodies that carry out activities as referred to in paragraph 1 shall adhere to high standards concerning governance , management and customer protection in line with the principles of the european code of good conduct for microcredit provision , and access to equity or quasi equity , and shall seek to prevent persons and undertakings from becoming over - indebted .


### except in the case of joint actions , the financial appropriations allocated to the microfinance and social entrepreneurship axis shall cover the full cost of the actions implemented through financial instruments , including payment obligations towards financial intermediaries , such as losses from guarantees , management fees for the international financial institutions managing the union ' s contribution and any other eligible costs . ### except in the case of joint actions , the financial appropriations allocated to the microfinance and social entrepreneurship axis shall cover the full cost of the actions implemented through financial instruments , including payment obligations towards financial intermediaries , such as losses from guarantees , management fees for the financial institutions managing the union ' s contribution and any other eligible costs .


### agreements as referred to in paragraph 1 of this article shall provide for an obligation on the international financial institutions to re - invest the resources and proceeds , including dividends and reimbursements , in actions as referred to in article 6 for a period of ten years from the starting date of the programme . ### agreements as referred to in paragraph 1 of this article shall provide for an obligation on the financial institutions to re - invest the resources and proceeds , including dividends and reimbursements , in actions as referred to in article 6 for a period of ten years from the starting date of the programme .


### in accordance with article 18 of the financial regulation , revenues and payments generated by one financial instrument shall be assigned to that financial instrument . for financial instruments already set up in the previous multiannual financial framework , revenues and payments generated by operations started in the previous period shall be assigned to the financial instrument in the current period . ### in accordance with the relevant provisions of the financial regulation , revenues and payments generated by one financial instrument shall be assigned to that financial instrument , as long as that financial instrument is in place . for financial instruments already set up in the previous multiannual financial framework , revenues and payments generated by operations started in the previous period shall be assigned to the financial instrument in the current period .


### on the expiry of the agreements concluded with the international financial institutions or after the termination of the investment period of the specialised investment vehicle , the proceeds and balance due to the union shall be paid into the general budget of the union . ### on the expiry of the agreements concluded with the financial institutions or after the termination of the investment period of the specialised investment vehicle , the proceeds and balance due to the union shall be paid into the general budget of the union .