### the general meeting shall control the activities of the collecting society by , at least , deciding on the appointment and removal of the auditor and approving the annual transparency report and the auditor ' s report . ### the general meeting shall control the activities of the collecting society by , at least , deciding on the appointment and removal of the auditor and approving the annual transparency report and the auditor ' s report . if there are duly substantiated doubts concerning the financial conduct of the society , the members shall have the right to appoint an internal or external auditor to carry out checks . the results of that audit must be forwarded to the competent national authority , so that appropriate procedures can be initiated .


### in order to ensure that holders of copyright and related rights can fully benefit from the internal market when their rights are being managed collectively and that their freedom to exercise their rights is not unduly affected , it is necessary to provide for the inclusion of appropriate safeguards in the constituting documents of collecting societies . moreover , in accordance with directive 2006 / 123 / ec collecting societies should not discriminate , directly or indirectly , between rightholders on the basis of their nationality , place of residence or place of establishment when providing their management services . ### in order to ensure that holders of copyright and related rights can fully benefit from the internal market when their rights are being managed collectively and that their freedom to exercise their rights is not under any circumstances affected , it is necessary to provide for the inclusion of appropriate safeguards in the constituting documents of collecting societies . moreover , in accordance with directive 2006 / 123 / ec collecting societies should not discriminate , directly or indirectly , between rightholders on the basis of their nationality , place of residence or place of establishment when providing their management services . any direct or indirect discrimination on the basis of existing licences , extent of repertoire or expected sales should be avoided .


### the necessary arrangements concerning the accommodation to be provided for the agency in the host member state and the facilities to be made available by that state , as well as the specific rules applicable in the agency ' s host member state to the executive director , the members of the management board , staff of the agency and members of their families shall be laid down in a headquarters agreement between the agency and the host member state concluded after obtaining the approval of the management board . the agency ' s host member state should provide the best possible conditions to ensure proper functioning of the agency , including multilingual , european - oriented schooling and appropriate transport connections . ### the necessary arrangements concerning the accommodation to be provided for the agency in the host member state and the facilities to be made available by that state , as well as specific rules aiming at ensuring the agency ' s attractiveness to staff , applicable in the agency ' s host member state to the executive director , the members of the management board , staff of the agency and members of their families shall be laid down in a headquarters agreement between the agency and the host member state concluded after obtaining the approval of the management board . the agency ' s host member state should provide the best possible conditions to ensure proper functioning of the agency , including multilingual , european - oriented schooling and appropriate transport connections .


### information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio . it shall only be made available through the following channels : ### information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio , or in general newspapers and magazines or in the form of inserts or supplements to them . it shall only be made available through the following channels :


### health - related publications as defined by the member state of publication , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; ### technical and scientific magazines in the field of health , or magazines addressed to the general public whose main content is in the field of health , brochures , leaflets and other categories of printed information , to the exclusion of unsolicited material actively distributed to the general public or members thereof ;


### knowledge of animal health , including of disease symptoms , consequences of diseases and possible means of prevention including biosecurity , treatment and control is a prerequisite for efficient animal health management and essential in ensuring the early detection of animal diseases . operators and other animal professionals should therefore acquire such knowledge as appropriate . that knowledge may be acquired by different means , for example formal education , but also through the farm advisory system existing in the agricultural sector or by informal training to which national and european farmer organisations and other organisations may be valuable contributors . those alternative means of acquiring such knowledge should also be recognised by this regulation . ### knowledge of animal health , including of disease symptoms , consequences of diseases and possible means of prevention including biosecurity , treatment and control is a prerequisite for efficient animal health management and essential in ensuring the early detection of animal diseases . operators and other animal professionals should therefore acquire such knowledge as appropriate . that knowledge may be acquired by different means , for example formal education , but also through the farm advisory system existing in the agricultural sector or by informal training to which national and european farmer organisations and other organisations may be valuable contributors . those alternative means of acquiring such knowledge should also be recognised by this regulation . the same may also be said of pet keepers , while bearing in mind their different position and level of responsibility .


### take appropriate biosecurity measures , taking into account the risks involved , to ensure the health of those kept animals and products and to prevent the introduction into , development and multiplication within and spread between and from such kept animals and products under their responsibility of diseases , except where that is specifically authorised for scientific purposes , as appropriate for : ### take appropriate biosecurity measures , taking into account the risks involved , to ensure the health and welfare of those kept animals and products and to prevent the introduction into , development and multiplication within and spread between and from such kept animals and products under their responsibility of diseases and microorganisms that have developed resistance to antimicrobials , except where that is specifically authorised for scientific purposes , as appropriate for :


### ' outbreak ' means one or more cases in an establishment , household or other place where animals are kept or located ; ### ‘ outbreak’ means one or more cases in an epidemiological unit ;


### 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 .


### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of highly significant impact the commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in article 255 . ### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of significant impact the commission shall adopt immediately applicable delegated acts in accordance with the procedure referred to in article 254 .


### the competent authority may delegate one or more of the following activities to veterinarians : ### the competent authority may delegate one or more of the following activities to natural or legal persons who have the relevant technical capacity :


### the detection of any signs indicative of the occurrence of listed diseases or emerging diseases ; ### the prevention and detection of any signs indicative of the occurrence of listed diseases or emerging diseases ;


### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the date on which regulations no 1760 / 2000 , no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply . ### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the date on which regulations no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply .


### 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 : ### operators shall ensure that establishments under their responsibility receive animal health visits from a veterinarian , as provided for in article 22 , when appropriate due to the risks posed by the establishment , taking into account :


### 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 to establish a harmonised list of species to which the measures for specific listed diseases should apply at union level . the commission shall be empowered to adopt delegated acts to amend or adjust the list as appropriate .


### 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 :


### in order to ensure uniform conditions for the implementation of this regulation in relation to transmissible animal diseases at union level , it is necessary to establish a harmonised list of transmissible animal diseases . thus implementing powers to lay down such a list should be conferred on the commission . ### in order to ensure uniform conditions for the implementation of this regulation in relation to transmissible animal diseases at union level , it is necessary to establish a harmonised list of transmissible animal diseases . this regulation should thus lay down such a list and empower the commission to adopt delegated acts amending that list .


### raising animal health awareness ; ### raising animal health and animal welfare awareness ;


### the commission shall take into account the following criteria when adopting implementing acts provided for in paragraph 1 : ### the commission shall take into account the following criteria when adopting delegated acts provided for in paragraph 1 :


### where there are reasonable grounds to suspect that animals or products may present a risk , the competent authority shall take appropriate steps to inform the general public of the nature of the risk and the measures which are taken or about to be taken to prevent or control that risk , taking into account the nature , seriousness and extent of that risk and the public interest in being informed . ### where there are reasonable grounds to suspect that animals or products may present a significant public health risk , the competent authority shall take appropriate steps to inform the general public of the nature of the risk and the measures which are taken or about to be taken to prevent or control that risk , taking into account the nature , seriousness and extent of that risk , the need to avoid spreading panic unnecessarily and the public interest in being informed .


### the commission shall , by means of implementing acts , establish a list of species , as referred to in paragraph 1 . ### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning amendments to the list of species set out in annex ib to this regulation .


### the disease specific rules for listed diseases provided for in this regulation and the rules adopted pursuant to this regulation shall apply to listed species . ### the disease specific rules for listed diseases and the rules adopted pursuant to this regulation shall apply to the species listed in annex ib to this regulation .


### operators and animal professionals shall acquire knowledge of : ### operators , animal professionals and pet keepers shall acquire knowledge of :


### the commission shall , by means of implementing acts , establish a list of listed diseases , as referred to in paragraph 1 . ### the listed diseases , as referred to in paragraph 1 , are set out in the new annex - i .


### 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 .


### 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 , the instruments and arrangements for moving towards the declaration of disease - free zones , the prioritising of actions and the attribution of responsibilities in the field of animal health and puts into practice the ' one health ' approach establishing a new paradigm for the relationship between animals , humans and the environment .


### the commission shall be empowered to adopt delegated acts in accordance with article 253 , concerning : ### the member states shall inform the commission of the activities they have delegated and the conditions and requirements governing the type of delegation concerned .


### member states that are not free or are not known to be free from listed diseases which are subject to eradication measures as provided for in this regulation , should be required to establish compulsory eradication programmes to eradicate those diseases where the eradication is compulsory in the union , or have the possibility to establish voluntary eradication programmes , to eradicate those diseases where the eradication is envisaged in the union , but is not compulsory . to ensure uniform conditions of general application throughout the union , it is necessary to lay down harmonised requirements for such compulsory or voluntary eradication programmes . in order to ensure effective disease eradication , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the objectives of disease control strategies , disease control measures under the compulsory or voluntary eradication programmes and requirements of such programmes . ### member states that are not free or are not known to be free from listed diseases which are subject to eradication measures as provided for in this regulation , should be required to establish compulsory eradication programmes to eradicate those diseases where the eradication is compulsory in the union , or have the possibility to establish voluntary eradication programmes , to eradicate those diseases where the eradication is envisaged in the union , but is not compulsory . to ensure uniform conditions of general application throughout the union , it is necessary to lay down harmonised requirements for such compulsory or voluntary eradication programmes . in order to ensure effective disease eradication , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the objectives of disease control strategies , disease control measures under the compulsory or voluntary eradication programmes and requirements of such programmes . the commission should launch negotiated procedures with the countries neighbouring the eu aimed at establishing harmonised requirements for those compulsory and voluntary eradication programmes .


### listed diseases ; ### the listed diseases set out in annex ia to this regulation ;


### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of highly significant impact the commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in article 255 . ### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of significant impact the commission shall adopt immediately applicable delegated acts in accordance with the procedure referred to in article 254 .


### in order to ensure uniform conditions for the implementation of this regulation in relation to transmissible animal diseases at union level , it is necessary to establish a harmonised list of transmissible animal diseases . thus implementing powers to lay down such a list should be conferred on the commission . ### in order to ensure uniform conditions for the implementation of this regulation in relation to transmissible animal diseases at union level , it is necessary to establish a harmonised list of transmissible animal diseases , which shall be provided in an annex to this regulation . the commission shall be empowered to adopt delegated acts to amend or adjust the list as appropriate .


### 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 and ensure that operators and animal professionals are acquiring , maintaining and developing the basic and specialist knowledge of animal health provided for in article 10 , as well as in the exchange of best practices through relevant programmes in agricultural or aquaculture sectors or formal education .


### ' 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 occurrence and the likely magnitude of the biological , health , social and economic consequences of an adverse effect on animal or public health ;


### natural and legal persons shall immediately notify : ### operators , animal professionals and pet keepers shall immediately notify :


### operators , animal professionals and pet keepers working with animals are in the best position to observe and ensure the health of the animals and products under their responsibility . they should therefore hold primary responsibility for carrying out measures for the prevention and control of the spread of diseases among animals and products under their responsibility . ### operators , animal professionals and pet keepers working with animals are in the best position to observe and ensure the health of the animals and products under their responsibility . they should therefore hold primary responsibility for carrying out measures for the prevention and control of the spread of diseases among animals and products under their responsibility , and should work individually and collectively to improve animal health practices .


### operators observe their animals on a regular basis and are best positioned to detect abnormal mortalities or other serious disease symptoms . operators are therefore the cornerstone of any surveillance and essential for the surveillance undertaken by the competent authority . ### operators observe their animals on a regular basis and are best positioned to detect abnormal mortalities or other serious disease symptoms . operators are therefore the cornerstone of any surveillance and essential for the surveillance undertaken by the competent authority . the same may be said of hunters , hunting associations and owners of hunting land , with respect to wild animals .


### market surveillance authorities may cooperate with the competent authorities of third countries with a view to exchanging information and technical support , promoting and facilitating access to union information exchange systems including the rapex system in accordance with article 19 , and promoting activities relating to conformity assessment and market surveillance . ### market surveillance authorities shall be encouraged to cooperate with the competent authorities of third countries with a view to exchanging information and technical support , promoting and facilitating access to union information exchange systems including the rapex system in accordance with article 19 , and promoting activities relating to conformity assessment and market surveillance .


### 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 .


### obliging the authorities responsible for the control of products entering the union market to carry out checks on an adequate scale therefore contributes to a safer union market for products . in order to increase the effectiveness of such checks , cooperation and exchange of information between those authorities and market surveillance authorities concerning products presenting a risk should be enhanced . ### obliging the authorities responsible for the control of products entering the union market to carry out checks on an adequate scale therefore contributes to a safer union market for products . in order to increase the effectiveness of such checks , cooperation and exchange of information between those authorities and market surveillance authorities concerning products presenting a risk should be enhanced significantly . the commission should monitor the cooperation between these market surveillance authorities and make recommendations to further improve their cooperation .


### 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 .


### ‘ national rules’ means all binding rules containing railway safety or technical requirements imposed at member state level and applicable to railway undertakings , irrespective of the body issuing them ; ### ‘ national rules’ means all binding rules that have been notified by a member state and that contain railway safety , operational or technical requirements imposed at member state level and applicable to railway actors , irrespective of the body issuing them ;


### metros , trams and light rail systems ; ### does not affect english version


### ' 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 ] ;


### member states and the agency shall ensure that railway safety is generally maintained and , where reasonably practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents . ### member states and the agency each for their own missions shall ensure that railway safety is maintained and , where reasonably practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents .


### this directive lays down provisions to ensure the development and improvement of safety of the union ' s railways and improved access to the market for rail transport services by : ### this directive lays down provisions to ensure the development and improvement of safety of the union ' s railways by :


### ‘ keeper’ means the person or entity that , being the owner of a vehicle or having the right to use it , exploits the vehicle as a means of transport and is registered as such in the national vehicle register referred to in article 43 of directive xx on the interoperability of the rail system ; ### ' owner ' means the person or entity that , being the owner of a vehicle , is registered as such in the national vehicle register referred to in article 43 of directive xx on the interoperability of the rail system ;


### the type and extent of its intended operation corresponds to that specified in its single safety certificate . ### the type , extent and scope of its intended operation correspond to those specified in its single safety certificate .


### the responsibility of infrastructure managers and railway undertakings for operating the rail system does not preclude other actors such as manufacturers , carriers , consignors , fillers , loaders entities in charge of maintenance , maintenance suppliers , wagon keepers , service providers and procurement entities from assuming responsibility for their products or services . to avoid the risk that the responsibilities are not properly assumed , each relevant actor should be made responsible for its particular process . each actor in the rail system should be responsible in respect to the other actors for complete and truthful communication of all relevant information to check if the vehicles are fit to run . in particular that concerns information on the status and history of the vehicle , maintenance files , traceability of loading operations , and consignment notes . ### the responsibility of infrastructure managers and railway undertakings for operating the rail system does not preclude other actors such as manufacturers , carriers , consignors , fillers , loaders , unloaders , consignee , entities in charge of maintenance , maintenance suppliers , vehicle owner , vehicle keepers , service providers and procurement entities from assuming responsibility for their products or services and for implanting risk control measures . to avoid the risk that the responsibilities are not properly assumed , each relevant actor should be made responsible for its particular process . each actor in the rail system should be responsible in respect to the other actors for complete and truthful communication of all relevant information to check if the vehicles are fit to run . in particular that concerns information on the status and history of the vehicle , maintenance files , traceability of loading operations , and consignment notes .


### the single safety certificate shall specify the type and extent of the railway operations covered . it shall be valid throughout the union for equivalent operations . ### the single safety certificate shall specify the type and extent of the railway operations covered . it shall be recognised throughout the union for equivalent operations .


### 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 article 5 and 7 shall be conferred on the commission for a period of five years from [ the date of entry into force of this regulation ] . 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 .


### 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 start of operation of a new service , a 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 and system specific rules in order to control risks and provide transport services safely in the intended area of operation . the single safety certificate shall also be valid without extension of the area of operations for vehicles travelling to the stations of neighbouring member states with similar network characteristics , when those stations are close to the border , following consultation of the relevant national safety authorities . this consultation may be on a case - by - case basis or set out in a cross border agreement between national safety authorities .


### the main actors in the rail system , infrastructure managers and railway undertakings , should bear full responsibility for the safety of the system , each for their own part . whenever appropriate , they should cooperate in implementing risk control measures . member states should make a clear distinction between this immediate responsibility for safety and the national safety authorities ' task of providing a national regulatory framework and supervising the performance of all operators . ### all the actors in the rail system should bear full responsibility for the safety of the system , each for their own part . member states should make a clear distinction between this immediate responsibility for safety and the national safety authorities ' task of providing a national regulatory framework and supervising the performance of all operators .


### the agency shall inform the national safety authorities within one month of the issue , renewal , amendment or revocation of a single safety certificate . it shall state the name and address of the railway undertaking , the issue date , the scope and validity of the certificate and , in the case of revocation , the reasons for its decision . ### the agency shall inform the national safety authorities , without delay , of the issue , renewal , amendment or revocation of a single safety certificate . it shall state the name and address of the railway undertaking , the issue date , the scope and validity of the certificate and , in the case of revocation , the reasons for its decision . the agency shall , without delay , update the relevant register and its database .


### to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ### to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices . the commission shall draw up a list of certain categories of excipients on the basis of risk criteria , taking into account their origin and intended use . those acts , designed to amend non - essential elements of this directive by supplementing it , shall be adopted in accordance with the procedure referred to in article 290 of the treaty on the functioning of the european union . the manufacturer shall apply , for those categories of excipient , the relevant good manufacturing practices on the basis of a risk analysis conducted in accordance with the directives referred to in article 47 , taking into account other quality system requirements that may be applicable ; they shall properly document this .


### moreover , in cases where these infringements or suspected infringements relate to a falsified medicinal product , the holder of the marketing authorisation or of the trademark that has been falsified shall be informed . ’ ### moreover , in cases where these infringements or suspected infringements relate to a falsified medicinal product , the holder of the marketing authorisation or of the trademark that has been falsified shall be informed and shall inform the appropriate bodies if he becomes aware or suspects that counterfeit products have infiltrated the supply chain . '


### 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 .


### safety features making it possible to ascertain identification authenticity of medicinal products , other than radiopharmaceuticals , subject to medical prescription as defined in title vi . ### safety features making it possible to ascertain identification authenticity of medicinal products , other than radiopharmaceuticals .


### the manufacturing authorisation holder complies with point of article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification , authenticity and uninterrupted traceability of the medicinal product , and without opening the immediate packaging as defined in article 1 ; ### the manufacturing authorisation holder complies with point of article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification , authenticity and inviolability of the external packaging of the medicinal product , and without opening the immediate packaging as defined in article 1 ;


### ‘ safety features making is possible to ascertain identification , authenticity and traceability of medicinal products other than radiopharmaceuticals , subject to medical prescription as defined in title vi’ . ### ‘ safety features making is possible to ascertain identification and authenticity and make it possible to detect any tampering with the packaging of medicinal products other than radiopharmaceuticals which are at risk of being falsified or tampered with . . the decision to require these safety features for medicinal products or categories thereof shall be based on a risk assessment carried out under the provisions of paragraph of article 54a’ .


### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of prescription medicinal products should be established at community level . when introducing obligatory safety features for prescription medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated . ### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of medicinal products should be established at community level . when introducing obligatory safety features for medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines , over - the - counter medicines and medicines sold directly by producers , without any brokering , to establishments at which they are provided to patients . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated .


### to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ### to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . excipients which comply with equivalent good manufacturing practice and good distribution practice , such as ipec - pqg , effci , haccp and / or iso9001 / iso22000 , are exempted from further requirements .


### the manufacturing authorisation holder complies with point of article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification , authenticity and uninterrupted traceability of the medicinal product , and without opening the immediate packaging as defined in article 1 ; ### the manufacturing authorisation holder complies with point of article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification , authenticity and uninterrupted traceability of the medicinal product , and without any changes to the immediate packaging as defined in article 1 other than for the purposes set out in article 55 ;


### verify authenticity by assessing overt , covert or forensic devices ; ### verify authenticity ;


### provide union and national organisations with financial support to step up their capacity to develop , promote and support the implementation of union employment and social policy and working conditions legislation . ### provide union , national and regional organisations with financial support to step up their capacity to develop , promote and support the implementation of union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas .


### the european platform against poverty and social exclusion and the innovation union flagship initiatives identify social innovation as a powerful tool for addressing the social challenges arising from population ageing , poverty , unemployment , new work patterns and life styles , and citizens ' expectations regarding social justice , education and health care . the programme should support action to step up social innovation in policy areas falling within its scope in the public , private and third sectors , taking due account of the role of regional and local authorities . in particular , it should help identify , evaluate and scale up innovative solutions and practice through social experimentation to assist the member states more effectively in reforming their labour markets and social protection policies . it should also act as a catalyst for transnational partnerships and networking between public , private and third - sector actors as well as supporting their involvement in designing and implementing new approaches to tackling pressing social needs and challenges . ### the european platform against poverty and social exclusion and the innovation union flagship initiatives identify social innovation as a powerful tool for addressing the social challenges arising from population ageing , poverty , unemployment , new work patterns and life styles , and citizens ' expectations regarding social justice , education and health care . the programme should support action to step up social innovation in response to social needs that are not met or insufficiently met , in terms of combating poverty and social exclusion , promoting a high level of quality employment and decent work , guaranteeing adequate and poverty preventing social protection , and improving working conditions , taking due account of the role of regional and local authorities . it should also act as a catalyst for transnational partnerships and networking between public , private and third - sector actors as well as supporting their involvement in designing and implementing new approaches to tackling pressing social needs and challenges .


### ensure that job vacancies and applications , and any related information are transparent for the potential applicants and the employers ; this shall be achieved through their exchange and dissemination at transnational , interregional and cross - border level using standard interoperability forms ; ### ensure that information and advice on job vacancies and applications , and any related information such as living and working conditions including social legislation , labour law and collective agreements in force , as well as opportunities to acquire new skills are transparent for the potential applicants and the employers ; this shall be achieved through their exchange and dissemination at transnational , interregional and cross - border level , as well as by individual counselling ;


### 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 high - quality 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 projects with clear eu added value . it should provide support to small , medium - sized and large projects alike . in order to reach critical mass and reduce administrative burden , while allowing access to stakeholders such as small non - governmental organisations , the programme should support the creation and development of networks and partnerships . 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 jointly set by the european parliament and the council .


### 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 annual 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 .


### 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 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 microfinance and social entrepreneurship axis , which shall facilitate access to finance for entrepreneurs , especially those furthest from the labour market , and social enterprises . ### the microfinance and social entrepreneurship axis , which shall facilitate access to , and increase the availability of , finance for potential entrepreneurs , especially unemployed , socially excluded and vulnerable people , as well as existing micro - enterprises and social enterprises .


### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union employment and social policy and working conditions legislation are based on sound evidence and are relevant to needs , challenges and conditions in the individual member states and the other participating countries ; ### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas are based on sound evidence and are relevant to people ' s needs , social challenges and social conditions in the individual member states and the other participating countries ;


### civil society organisations active at various levels can play an important role in meeting the objectives of the programme , by participating in the policy - making process and contributing to social innovation . ### social partners and civil society organisations play a key role in promoting quality employment and combating social exclusion and poverty as well as in fighting the crisis , and should be closely associated in all actions designed to meet the objectives of the programme . therefore , social partners and civil society organisations should participate in the development , evaluation , field testing and dissemination of new policies . high - quality partnerships should be forged at all political levels . the partnership principle should be strengthened and extended as the guiding principle to all sections of the programme .


### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . ### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund , especially in order to provide assistance to the beneficiaries of the microfinance facility . consistency and complementarity shall also be ensured in such areas as social dialogue , justice and fundamental rights , notably through the&#160 ; multi annual programme 2014 - 2020 ' rights and citizenship ' , in education , vocational training and youth policy , notably through the&#160 ; multi annual programme 2014 - 2020 ' erasmus for all ' , and in research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy .


### 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 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 also focus on small , medium and large projects alike with clear eu added value and equally support projects which would not be financed otherwise . it should aim to ensure that the administrative burden is at the lowest possible level 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 , while fully respecting the prerogatives of the budgetary authority in the annual budget , in order to respond to policy priorities and shift funds between the axes of the programme , if deemed to be appropriate .


### strengthen ownership of the union objectives in the employment , social and working conditions fields among key union and national policy - makers , as well as other interested parties in order to bring about concrete and coordinated actions at both union and member state level ; ### strengthen ownership of the union objectives in the fields of employment , social protection and inclusion , combating poverty and improving working conditions among key union and national policy - makers , social partners as well as civil society organisations and public bodies in order to meet the social objectives of the europe 2020 strategy and bring about concrete and coordinated actions at both union and member state level ;


### 60% to the progress axis , of which at least 17% shall be allocated to promoting social experimentation as a method for testing and evaluating innovative solutions with a view to scaling them up ; ### 60% to the progress axis ;


### 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 .


### 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 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 .


### strengthen ownership of the union objectives in the employment , social and working conditions fields among key union and national policy - makers , as well as other interested parties in order to bring about concrete and coordinated actions at both union and member state level ; ### strengthen ownership of the union objectives in the fields of employment , social protection and inclusion , combating poverty and improving working conditions among policy - makers at all levels , social partners as well as civil society organisations and public bodies in order to meet the social objectives of the europe 2020 strategy and bring about concrete and coordinated actions at both union and member state level ;


### in order to implement the instruments and grants referred to in article 6 , the commission may conclude agreements with the entities listed in article 55 and of regulation xxx / 2012 [ new financial regulation 2012 ] on the financial rules applicable to the annual budget of the union , and in particular with the european investment bank and the european investment fund . such agreements shall set out detailed provisions on implementing the tasks entrusted to those financial institutions , including provisions specifying the need to ensure additionality and coordination with existing union and national financial instruments and to apportion the resources in a balanced way among the member states and the other participating countries . financial instruments , such as risk - sharing instruments , equity instruments and debt instruments , may be delivered through investment in a dedicated investment vehicle . ### in order to implement the instruments and grants referred to in article 6 , the commission may conclude agreements with the entities listed in article 55 and of regulation xxx / 2012 [ new financial regulation 2012 ] on the financial rules applicable to the annual budget of the union , and in particular with the european investment bank and the european investment fund . such agreements shall set out detailed provisions on implementing the tasks entrusted to those financial institutions , including provisions specifying the need to ensure additionality and coordination with existing union and national financial instruments and to apportion the resources in a balanced way among the member states and the other participating countries . financial instruments , such as guarantees and counter - guarantees , equity instruments and debt instruments , may be delivered by a fund , which can be co - financed by financial institutions , or by direct conversion of the programme funds into financial instruments such as guarantees .


### ensure that job vacancies and applications , and any related information are transparent for the potential applicants and the employers ; this shall be achieved through their exchange and dissemination at transnational , interregional and cross - border level using standard interoperability forms ; ### ensure that information and advice on job vacancies and applications , and any related information such as living and working conditions including social legislation , labour law and collective agreements in force , as well as opportunities to acquire new skills are transparent for the potential applicants and the employers ; this shall be achieved through their exchange and dissemination at transnational , interregional and cross - border level , as well as by individual counselling ;


### promote employment and social inclusion by increasing the availability and accessibility of microfinance for vulnerable groups and micro - enterprises , and by increasing access to finance for social enterprises . ### promote employment and social inclusion by increasing the availability and accessibility of microfinance for unemployed , socially excluded and vulnerable people who wish to start up a micro - enterprise as well as existing micro - enterprises , and by increasing access to finance for social enterprises ;


### 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 .


### 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 article 3 teu and article 8 tfeu , the programme should promote equality between women and men in all its activities through gender mainstreaming and , where relevant , specific action to promote women ' s employment and social inclusion . pursuant to article 10 tfeu , the programme should support the mainstreaming of 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 .


### facilitate effective and inclusive information - sharing , mutual learning and dialogue on union employment and social policy and working conditions legislation at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in implementing union law ; ### facilitate effective and inclusive information - sharing , mutual learning and dialogue , within the framework of the european employment strategy and the open method of coordination in the field of social protection and inclusion and by networking amongst specialised bodies , including the social partners and civil society organisations , on union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in implementing union law ;


### 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 .


### social enterprises are a cornerstone of europe ' s pluralist social market economy . they can act as drivers of social change by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises ' access to finance and thereby contribute to the social business initiative launched by the commission11 . ### social enterprises are a cornerstone of europe ' s pluralist social market economy . they can act as drivers of social progress by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises ' access to finance and thereby contribute to the social business initiative launched by the commission11 .


### micro - enterprises , especially those which employ persons as referred to in point ; ### micro - enterprises , especially in the social economy , as well as those which employ vulnerable persons who are in a disadvantaged labour market position ;


### support the development of adequate , accessible and efficient social protection systems and labour markets and facilitate policy reform , by promoting good governance , mutual learning and social innovation ; ### support the development of adequate , decent , accessible and efficient social protection systems and labour markets in order to ensure social inclusion and a high level of high - quality employment and facilitate policy reform where necessary , by promoting participation of all relevant stakeholders , including non - governmental organisations and people experiencing poverty and social exclusion as well as good governance , mutual learning and social innovation ;


### facilitate effective and inclusive information - sharing , mutual learning and dialogue on union employment and social policy and working conditions legislation at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in implementing union law ; ### facilitate effective and inclusive information - sharing , mutual learning and dialogue , within the framework of the european employment strategy and the open method of coordination in the field of social protection and inclusion and by networking amongst specialised bodies , including the social partners , on union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in implementing union law ;


### this regulation establishes a european union programme for social change and innovation which aims to contribute to the implementation of the europe 2020 strategy , its headline targets and integrated guidelines by providing financial support for the european union ' s objectives in terms of promoting a high level of employment , guaranteeing adequate social protection , combating social exclusion and poverty and improving working conditions . ### this regulation establishes a european union programme for social progress and employment which aims to contribute to the implementation of the europe 2020 strategy , its headline targets , flagship initiatives and integrated guidelines by providing financial support for the european union ' s objectives in terms of promoting a high level of high - quality employment , guaranteeing adequate and decent social protection , combating social exclusion and poverty and improving working conditions .


### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union employment and social policy and working conditions legislation are based on sound evidence and are relevant to needs , challenges and conditions in the individual member states and the other participating countries ; ### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas are based on sound evidence and are relevant to people ' s needs , social challenges and social conditions in the individual member states and the other participating countries ;


### 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 ;


### 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 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 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 .


### civil society organisations active at various levels can play an important role in meeting the objectives of the programme , by participating in the policy - making process and contributing to social innovation . ### social partners and civil society organisations play a key role in promoting quality employment and combating social exclusion and poverty as well as in fighting the crisis , and should be closely associated in all actions designed to meet the objectives of the programme . therefore , social partners and civil society organisations should participate in the development , evaluation , field testing and dissemination of new policies . high - quality partnerships should be forged at all political levels . the partnership principle should be strengthened and extended as the guiding principle to all sections of the programme .


### ' social enterprise ' means an enterprise whose primary objective is to achieve social impact rather than generate profit for owners and stakeholders . it operates in the market through the production of goods and services in an entrepreneurial and innovative way , and uses surpluses mainly to achieve social goals . it is managed in an accountable and transparent way , in particular by involving workers , customers and stakeholders affected by its business activity . ### ' social enterprise ' means an undertaking that is not listed on a regulated market as defined in point of article 4 of directive 2004 / 39 / ec , which either has an annual turnover not exceeding eur 50 million , or an annual balance sheet total not exceeding eur 43 million , which is not itself a collective investment undertaking and which : in accordance with its articles of association , statutes or any other statutory document establishing the business , has the achievement of measurable , positive social impacts as a primary objective rather then generating profit for its owners , members and stakeholders , where : – the undertaking provides innovative services or goods with a high social return and / or – the undertaking employs an innovative method of production of goods or services that embodies its social objective ; reinvests its profits in the first place to achieve its primary objective and has in place predefined procedures and rules for any circumstances in which profits are distributed to shareholders and owners , in order to ensure that any distribution of profits does not undermine the primary objective ; is managed in an accountable , transparent and democratic way , in particular by involving workers , customers and / or stakeholders affected by its business activities .


### ' social enterprise ' means an enterprise whose primary objective is to achieve social impact rather than generate profit for owners and stakeholders . it operates in the market through the production of goods and services in an entrepreneurial and innovative way , and uses surpluses mainly to achieve social goals . it is managed in an accountable and transparent way , in particular by involving workers , customers and stakeholders affected by its business activity . ### ' social enterprise ' means an enterprise whose primary goal is to achieve social objectives rather than generating profit for its owners , members and stakeholders . it operates in the market through the production of goods and services in an entrepreneurial and innovative way , and mainly reinvests surpluses to further promote its social objectives . it is managed in an accountable and transparent way , in particular by involving workers , customers and stakeholders affected by its business activity .


### 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 the social economy 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 economy organisations . the union contribution thus assists in the development of the social economy 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 the social economy . the entities entrusted with the implementation of the actions should ensure added value and avoid duplication of financing through union resources .


### actions to promote mobility of individuals in the union , in particular the development of a multilingual digital platform for the clearance of job vacancies and applications , and targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or to help specific groups of workers such as young people . ### actions to promote mobility of individuals in the union on a fair basis : information and counselling of jobseekers , mobile workers and employers ; advancement of the multilingual digital platform for the clearance of job vacancies and applications , and targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or to help specific groups of workers such as young people .


### support to microfinance and social enterprises in particular through the financial instruments provided for under title viii of part one of regulation xxx / 2012 [ new financial regulation ] on the financial rules applicable to the annual budget of the union , and grants . ### support to microfinance and social enterprises in particular through the financial instruments provided for under regulation xxx / 2012 [ new financial regulation ] on the financial rules applicable to the annual budget of the union , and grants .


### 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 ;


### promote workers ' geographical mobility and boost employment opportunities by developing union labour markets that are open and accessible to all ; ### promote workers ' voluntary geographical mobility on a fair basis and boost employment opportunities by developing high - quality union labour markets that are open and accessible to all ;


### proposal for a regulation of the european parliament and of the council on a european union programme for social change and innovation ### proposal for a regulation of the european parliament and of the council on a european union programme for social progress and employment and amending decision no 283 / 2010 / eu


### gathering of data and statistics , as well as development of common methodologies , classifications , indicators and benchmarks ; ### gathering of data and statistics , taking account of both qualitative and quantitative criteria , as well as development of common methodologies , classifications , indicators and benchmarks ;


### capacity - building of national administrations and specialist services responsible for promoting geographical mobility designated by the member states and microcredit providers , ### capacity - building of administrations and specialist services responsible for promoting geographical mobility designated by the member states as well as capacity - building of microcredit providers and providers of financing for social enterprises ;


### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . ### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund , the european regional development fund , the horizon 2020 programme for research and innovation , the programme for the competitiveness of enterprises and small and medium - sized enterprises , as well as with regard to the application of the partnership principle and the involvement of the social partners .


### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union employment and social policy and working conditions legislation are based on sound evidence and are relevant to needs , challenges and conditions in the individual member states and the other participating countries ; ### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas are based on sound evidence and are relevant to people ' s needs , social challenges and social conditions in the individual member states and the other participating countries ;


### 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 high - quality 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 projects with clear eu added value . it should provide support to small , medium - sized and large projects alike . in order to reach critical mass and reduce administrative burden , while allowing access to stakeholders such as small non - governmental organisations , the programme should support the creation and development of networks and partnerships . 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 jointly set by the european parliament and the council .


### promote employment and social inclusion by increasing the availability and accessibility of microfinance for vulnerable groups and micro - enterprises , and by increasing access to finance for social enterprises . ### promote employment and social inclusion by increasing the availability and accessibility of microfinance for unemployed , socially excluded and vulnerable people who wish to start up a micro - enterprise as well as existing micro - enterprises , and by increasing access to finance for social enterprises ;


### 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 .


### social enterprises are a cornerstone of europe’s pluralist social market economy . they can act as drivers of social change by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises’ access to finance and thereby contribute to the social business initiative launched by the commission . ### social enterprises are a cornerstone of europe’s pluralist social market economy . they can act as drivers of social change by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . within a limited budgetary framework , the programme should improve social enterprises’ access to finance and thereby contribute to the social business initiative launched by the commission .


### 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 .


### ensure that job vacancies and applications , and any related information are transparent for the potential applicants and the employers ; this shall be achieved through their exchange and dissemination at transnational , interregional and cross - border level using standard interoperability forms ; ### ensure that information and advice on job vacancies and applications , and any related information such as living and working conditions including social legislation , labour law and collective agreements in force , as well as opportunities to acquire new skills are transparent for the potential applicants and the employers ; this shall be achieved through their exchange and dissemination at transnational , interregional and cross - border level using standard interoperability forms , as well as by individual counselling ;


### eures’ scope should be widened to develop and support targeted mobility schemes at union level with a view to filling vacancies where labour market shortcomings have been identified . in accordance with article 47 of the treaty , the scheme should facilitate mobility among young workers . ### eures’ scope should be widened to develop and support targeted mobility schemes at union level with a view to filling vacancies where labour market shortcomings have been identified . in accordance with article 47 of the treaty , the scheme should facilitate mobility among young workers . to enable eures to achieve its objectives , it would be advisable for the three axes that make up the programme to retain a degree of financial independence .


### non - governmental organisations , and in particular those organised at union level ; ### non - governmental organisations at all political levels ;


### actions to promote mobility of individuals in the union , in particular the development of a multilingual digital platform for the clearance of job vacancies and applications , and targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or to help specific groups of workers such as young people . ### financially feasible actions to promote mobility of individuals in the union , in particular the development of a multilingual digital platform for the clearance of job vacancies and applications , and targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or to help specific groups of workers such as young people .


### 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 .


### 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 article 3 teu and article 8 tfeu , the programme should promote equality between women and men in all its activities through gender mainstreaming and , where relevant , specific action to promote women ' s employment and social inclusion . pursuant to article 10 tfeu , the programme should support the mainstreaming of 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 .


### micro - enterprises , especially those which employ persons as referred to in point ; ### micro - enterprises , especially in the social economy , as well as those which employ vulnerable persons who are in a disadvantaged labour market position ;


### the commission shall be empowered to adopt a delegated act in accordance with article 142 on the common strategic framework within 3 months of the adoption of this regulation . where there are major changes in the union strategy for smart , sustainable and inclusive growth , the commission shall review and , where appropriate , adopt , by delegated act in accordance with article 142 , a revised common strategic framework . within 6 months of adoption of a revised common strategic framework , member states shall propose amendments , where necessary , to their partnership contract and programmes to ensure their consistency with the revised common strategic framework . ### the common strategic framework is laid down in annex ia . where there are major changes in the union strategy for smart , sustainable and inclusive growth , the commission shall review and , where appropriate , amend , by delegated act in accordance with article 142 , the common strategic framework laid down in annex ia . within 6 months of adoption of a revised common strategic framework , member states shall propose amendments , where necessary , to their partnership contract and programmes to ensure their consistency with the revised common strategic framework .


### in order to promote the harmonious , balanced and sustainable development of the union , a common strategic framework shall translate the objectives and targets of the union strategy for smart , sustainable and inclusive growth into key actions for the csf funds . ### in order to promote the harmonious , balanced and sustainable development of the union , the common strategic framework as laid down in annex ia shall provide coordination of the csf funds in order to achieve the objectives and targets of the union strategy for smart , sustainable and inclusive growth .


### the commission should adopt by delegated act a common strategic framework which translates the objectives of the union into key actions for the csf funds , in order to provide clearer strategic direction to the programming process at the level of member states and regions . the common strategic framework should facilitate sectoral and territorial coordination of union intervention under the csf funds and with other relevant union policies and instruments . ### the common strategic framework as laid down in annex ia of this regulation should facilitate sectoral and territorial coordination of union intervention under the csf funds and with other relevant union policies and instruments .


### grossly unfair contractual clauses member states shall provide that a clause in a contract relating to the date for payment , the rate of interest for late payment or recovery costs shall either be unenforceable or shall give rise to a claim for damages if it is grossly unfair to the creditor . in determining whether a clause is grossly unfair to the creditor , all circumstances of the case shall be considered , including good commercial practice and the nature of the product or the service . account shall also be taken of whether the debtor has any objective reason to deviate from the statutory rate of interest or from article 3 , article 4 or article 5 . ### unfair contractual clauses and commercial practices member states shall provide that a clause in a contract or commercial practice relating to the date or deadline for payment , the rate of interest for late payment or compensation for recovery costs shall be unenforceable and shall give rise to a claim for damages if it is unfair to the creditor . if such a clause is held to be unfair , the statutory terms shall apply and the national courts shall enjoy the power to rule on the rights and obligations of the parties and the consequences of its ineffectiveness . 1a . in determining whether a clause or a commercial practice is unfair to the creditor within the meaning of the first paragraph , all circumstances of the case shall be considered , including : any serious departure from good commercial practice that is contrary to good faith and fair dealing , the nature of the product or the service , whether the debtor has any objective reason to deviate from the statutory rate of interest or from article 3 , article 4 or article 5 , and whether the clause or commercial practice serves mainly to furnish the debtor with additional income at the expense of the creditor , whether the principal contractor imposes on suppliers and subcontractors terms of payment that cannot be justified on the grounds of the terms from which it benefits itself , or of any other objective reason .