### the authority shall promote the use of electronic tools and procedures for message exchange between national authorities , including the internal market information system and the electronic exchange of social security information system . ### the agency shall promote the use of electronic tools and procedures for message exchange between member states , including the internal market information system .


### at the request of one or several member states , the authority shall coordinate concerted or joint inspections in the areas under the scope of the authority ' s competences . the request may be submitted by one or several member states . the authority may also suggest to the authorities of the member states concerned that they perform a concerted or joint inspection . ### at the request of one or several member states , the agency shall coordinate concerted or joint inspections in the areas under the scope of the agency ' s competences . the request may be submitted by one or several member states .


### at the request of one or several member states , the authority shall coordinate concerted or joint inspections in the areas under the scope of the authority ' s competences . the request may be submitted by one or several member states . the authority may also suggest to the authorities of the member states concerned that they perform a concerted or joint inspection . ### at the request of one or several member states , the authority shall coordinate and facilitate&#160 ; concerted or joint inspections between member states&#160 ; in the areas under the scope of the authority ' s competences . &#160 ; the authority may also suggest to the authorities of the member states concerned that they perform a concerted or joint inspection .


### an agreement for setting up a joint inspection between the participating member states and the authority shall set out the conditions for carrying out such an exercise . the joint inspection agreement may include provisions which enable joint inspections , once agreed and planned , to take place at short notice . the authority shall establish a model agreement . ### an agreement for setting up each joint inspection or concerted inspection between the participating member states and the agency shall set out the conditions for carrying out such an exercise , such as : place and time of the inspection , detailed purpose of the inspection , number and identification of inspectors and of the staff of the agency , when allowed to participate in the inspection , and expected follow - up of the inspection . the joint inspection agreement and concerted inspection agreement may include provisions which enable joint and concerted inspections , once agreed and planned , to take place at short notice . the agency shall establish a model agreement .


### the authority shall provide logistical and technical support , which may include translation and interpretation services , to member states carrying out concerted or joint inspections . ### the agency shall provide logistical and technical support , which may include translation and interpretation services , to member states carrying out concerted or joint inspections .


### information on concerted and joint inspections shall be included in quarterly reports to be submitted to the management board . a yearly report on the inspections supported by the authority shall be included in the authority ' s annual activity report . ### information on concerted and joint inspections shall be included in quarterly reports to be submitted to the management board . a yearly report on the inspections supported by the agency shall be included in the agency ' s annual activity report .


### the authority shall assess risks and carry out analyses regarding cross - border labour flows , such as labour market imbalances , sector - specific threats and recurring problems encountered by individuals and employers in relation to cross - border mobility . for that purpose , the authority shall ensure complementarity with , and draw on the expertise of , other union agencies or services , including in the areas of skills forecasting and health and safety at work . upon a request by the commission , the authority may carry out focused in - depth analyses and studies to investigate specific labour mobility issues . ### the agency shall assess risks and carry out analyses regarding cross - border labour flows , such as obstacles to the free flow of workers and services , non - proportionate or discriminatory provisions in national laws , labour market imbalances , sector - specific threats and recurring problems encountered by individuals and employers in relation to cross - border mobility . for that purpose , the agency shall ensure complementarity with , and draw on the expertise of , other union agencies or services , including in the areas of skills forecasting and health and safety at work . upon a request by the commission , the agency may carry out focused in - depth analyses and studies to investigate specific labour mobility issues .


### the authority shall assess risks and carry out analyses regarding cross - border labour flows , such as labour market imbalances , sector - specific threats and recurring problems encountered by individuals and employers in relation to cross - border mobility . for that purpose , the authority shall ensure complementarity with , and draw on the expertise of , other union agencies or services , including in the areas of skills forecasting and health and safety at work . upon a request by the commission , the authority may carry out focused in - depth analyses and studies to investigate specific labour mobility issues . ### the agency shall assess risks and carry out analyses regarding cross - border labour flows , such as labour market imbalances , sector - specific threats and recurring problems encountered by individuals and employers in relation to cross - border mobility . for that purpose , the agency shall use statistical data available from existing surveys , ensure complementarity with , and draw on the expertise of , other union agencies or services , including in the areas of skills forecasting and health and safety at work . upon a request by the commission , the agency may carry out focused in - depth analyses and studies based on data available to investigate specific labour mobility issues .


### the authority shall assess risks and carry out analyses regarding cross - border labour flows , such as labour market imbalances , sector - specific threats and recurring problems encountered by individuals and employers in relation to cross - border mobility . for that purpose , the authority shall ensure complementarity with , and draw on the expertise of , other union agencies or services , including in the areas of skills forecasting and health and safety at work . upon a request by the commission , the authority may carry out focused in - depth analyses and studies to investigate specific labour mobility issues . ### the authority shall , in cooperation with member states and social partners , &#160 ; assess risks and carry out analyses regarding cross - border labour flows , such as labour market imbalances , sector - specific threats and recurring problems encountered by individuals and employers in relation to cross - border mobility . for that purpose , the authority shall ensure complementarity with , and draw on the expertise of , other union agencies or services , including in the areas of skills forecasting and health and safety at work . upon a request by the commission , the authority may carry out focused in - depth analyses and studies to investigate specific labour mobility issues .


### the authority shall organise peer reviews amongst national authorities and services in order to : ### the agency shall organise peer reviews amongst national authorities and services of member states which agreed to participate in the review , in order to :


### the authority shall regularly report its findings to the commission , as well as directly to the member states concerned , outlining possible measures to address identified weaknesses . ### the agency shall regularly report its findings to the commission , as well as directly to the member states concerned , outlining possible measures to address identified weaknesses .


### the authority shall collect statistical data compiled and provided by member states in the areas of union law within the scope of the authority’s competences . in doing so , the authority shall seek to streamline current data collection activities in those areas . where relevant , article 16 shall apply . the authority shall liaise with the commission and share the results of its data collection activities , where appropriate . ### the agency shall collect statistical data compiled and provided by member states in the areas of union law within the scope of the agency’s competences . in doing so , the agency shall seek to streamline current data collection activities in those areas . where relevant , article 16 shall apply . the agency shall liaise with the commission and share the results of its data collection activities , where appropriate .


### promote and support mutual assistance , either in the form of peer - to - peer or group activities , as well as staff exchanges and secondment schemes between national authorities ; ### promote and support mutual assistance , either in the form of peer - to - peer or group activities , as well as staff exchanges and secondment schemes between member states ;


### the authority shall establish cooperation arrangements with other decentralised union agencies where appropriate . ### the agency shall establish cooperation arrangements with other decentralised union agencies where appropriate .


### the authority ' s administrative and management structure shall be composed of : ### the agency ' s administrative and management structure shall be composed of :


### the authority may set up working groups or expert panels with representatives from member states and / or from the commission , or external experts following selection procedures , for the fulfilment of its specific tasks or for specific policy areas , including a mediation board in order to fulfil its tasks in accordance with article 13 of this regulation , and a dedicated group for the purpose of handling financial matters related to the application of regulations no 883 / 2004 and no 987 / 2009 , as referred to in article 8 of this regulation . ### the agency may set up working groups or expert panels with representatives from all member states that wish to participate and / or from the commission , or external experts following selection procedures , for the fulfilment of its specific tasks or for specific policy areas .


### the management board shall elect a chairperson and a deputy chairperson from among the members with voting rights , and shall strive for gender balance . the chairperson and the deputy chairperson shall be elected by a majority of two - thirds of the members of the management board with voting rights . ### the management board shall elect a chairperson and a deputy chairperson from among the members with voting rights , and shall strive for geographical and gender balance . the chairperson and the deputy chairperson shall be elected by a majority of two - thirds of the members of the management board with voting rights .


### there are many challenges in setting up all the necessary electronic systems by 2020 both for the commission and for the member states . first , in some cases , harmonising the data elements on the basis of internationally accepted data models as required by the code demands a full reprogramming of existing electronic systems and investments both in financial terms and in terms of time that are greater than foreseen at the time of adoption of the code . second , as the electronic systems are closely interlinked , introducing them in the right order is important . delays in the development of one system will therefore unavoidably lead to delays in the development of others . third , the code was adopted in 2013 while the rules supplementing and implementing it , namely commission delegated regulation 2015 / 244610 , commission implementing regulation 2015 / 244711 and commission delegated regulation 2016 / 34112 , were only adopted in 2015 and 2016 . the discussions on those rules took much longer than expected and this has caused a delay in setting out the functional and technical specifications necessary for the development of the electronic systems . _________________ 10 commission delegated regulation 2015 / 2446 of 28 july 2015 supplementing regulation no 952 / 2013 of the european parliament and of the council as regards detailed rules concerning certain provisions of the union customs code . 11 commission implementing regulation 2015 / 2447 of 24 november 2015 laying down detailed rules for implementing certain provisions of regulation no 952 / 2013 of the european parliament and of the council laying down the union customs code . 12 commission delegated regulation 2016 / 341 of 17 december 2015 supplementing regulation no 952 / 2013 of the european parliament and of the council as regards transitional rules for certain provisions of the union customs code where the relevant electronic systems are not yet operational and amending delegated regulation 2015 / 2446 . ### setting up electronic systems requires the commission and the member states to harmonise the data elements on the basis of internationally accepted data models , as required by the code , in some cases to fully reprogramme existing electronic systems and to make investments both in financial terms and in terms of time . adaptation is prioritised differently by member states , which has led to differences in the timing of implementation of systems in member states . as the electronic systems are closely interlinked , introducing them in the right order is important . delays in the development of one system will therefore unavoidably lead to delays in the development of others . the code was adopted in 2013 while the rules supplementing and implementing it , namely commission delegated regulation 2015 / 244610 , commission implementing regulation 2015 / 244711 and commission delegated regulation 2016 / 34112 , were only adopted in 2015 and 2016 and this has caused a delay in setting out the functional and technical specifications necessary for the development of the electronic systems . _________________ 10 commission delegated regulation 2015 / 2446 of 28 july 2015 supplementing regulation no 952 / 2013 of the european parliament and of the council as regards detailed rules concerning certain provisions of the union customs code . 11 commission implementing regulation 2015 / 2447 of 24 november 2015 laying down detailed rules for implementing certain provisions of regulation no 952 / 2013 of the european parliament and of the council laying down the union customs code . 12 commission delegated regulation 2016 / 341 of 17 december 2015 supplementing regulation no 952 / 2013 of the european parliament and of the council as regards transitional rules for certain provisions of the union customs code where the relevant electronic systems are not yet operational and amending delegated regulation 2015 / 2446 .


### it is necessary to ensure that road transport operators established in a member state have a real and continuous presence in that member state and conduct their business from there . therefore , and in light of experience , it is necessary to clarify the provisions regarding the existence of an effective and stable establishment . ### in order to put an end to so - called letter - box companies and the distortion of competition they cause , it is necessary to ensure that road transport operators established in a member state have a real and continuous presence in that member state and provide most of their transport services in the member state of establishment or from there . therefore , and in light of experience , it is necessary to clarify the provisions regarding the existence of an effective and stable establishment .


### it is necessary to ensure that road transport operators established in a member state have a real and continuous presence in that member state and conduct their business from there . therefore , and in light of experience , it is necessary to clarify the provisions regarding the existence of an effective and stable establishment . ### it is necessary to ensure that road transport operators established in a member state have a real and continuous presence in that member state and conduct their business from there . freedom of establishment is a cornerstone of the internal market . however , the existence of letterbox companies and bogus self - employment within the transport sector have caused a proliferation of illicit practices , which undermine the sector ' s image , since they illegally reduce labour costs and fail to ensure that working standards are maintained . therefore , and in light of experience , it is necessary to clarify , the provisions of regulation no 1071 / 2009 on the conditions relating to the requirement of establishment , regarding the existence of an effective and stable establishment , and to ensure and to monitor their implementation , stepping up checks and so putting an end to the illegal practice of so - called letterbox companies and bogus self - employment . it is also necessary to foster enhanced cooperation , joint controls , the setting of more ambitious targets and the exchange of best practices between member states .


### undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or with combinations of vehicles not exceeding that limit should have a minimum level of financial standing , to ensure that they have the means to carry out operations on a stable and long - lasting basis . however , since the operations concerned are generally of a limited size , the corresponding requirements should be less demanding than those applicable to operators using vehicles or combinations of vehicles above that limit . ### undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or with combinations of vehicles not exceeding that limit involved in international transport should have a sufficient level of financial standing , to ensure that they have the means to carry out operations on a stable and long - lasting basis and should have the means to fulfil their obligations related to their employees’ wages and social contributions . however , since the operations concerned are generally of a limited size , the corresponding requirements should be less demanding than those applicable to operators using vehicles or combinations of vehicles above that limit and they should not represent an unnecessary burden for smaller undertakings or self - employed workers .


### the rules on national transport performed on a temporary basis by non - resident hauliers in a host member state should be clear , simple and easy to enforce , while broadly maintaining the level of liberalisation achieved so far . ### the rules on national transport performed on a temporary basis by non - resident hauliers in a host member state – in order to avoid their having to return empty – should be clear , simple for hauliers to implement and easy to enforce in order to guarantee road transport workers’ rights and promote fair competition between companies without undermining the basic principle of the free movement of services in the internal market .


### the rules on national transport performed on a temporary basis by non - resident hauliers in a host member state should be clear , simple and easy to enforce , while broadly maintaining the level of liberalisation achieved so far . ### the principal aim of cabotage operations is to avoid empty journeys while returning to the country of establishment , which contribute to reduce fuel consumption and emissions , improve the profitability of undertakings and hence the internal market and the labour market . the rules on national transport performed on a temporary basis by non - resident hauliers in a host member state should be clear , simple for hauliers to implement and easy to enforce . those rules should comply with the applicable law while maintaining the level of liberalisation achieved so far , without undermining the basic principle of the freedom to provide services in the internal market and the protection of the posted workers . in order to ensure the temporary character and to avoid any misused or distortion of the market , as well as the danger of systematic cabotage caused by so - called ‘ letter - box’ companies or nomadic drivers , the union rules established in directive 96 / 71 / ec of the european parliament and of the council1a in the road transport sector are applied to cabotage operations from day 1 . _______________


### the means by which road transport operators can prove compliance with the rules for cabotage operations should be clarified . the use and transmission of electronic transport information should be recognised as such means , which should simplify the provision of relevant evidence and its treatment by the competent authorities . the format used for that purpose should ensure reliability and authenticity . considering the increasing use of efficient electronic exchange of information in transport and logistics , it is important to ensure coherence in the regulatory frameworks and provisions addressing the simplification of administrative procedures . ### the means by which road transport operators can prove compliance with the rules for cabotage operations should be clarified . to ensure fair competition in each internal market , the application of eu rules to electronic transport information , the use and transmission of which should simplify the provision of relevant evidence and its treatment by the competent authorities , should be subject to effective control . the format used for that purpose should ensure reliability and authenticity . considering the increasing use of efficient electronic exchange of information in transport and logistics , it is important to ensure coherence in the regulatory frameworks and provisions addressing the simplification of administrative procedures . to do that , it is desirable to continue the process of making transport documents paperless in order to simplify controls and administrative and procedures . thus , in the spirit of the additional protocol of 20 february 2008 to the convention on the contract for the international carriage of goods by road , the use of electronic documents should eventually become the rule , particularly the electronic consignment note .


### article 3 and and articles 4 , 6 , 8 , 9 , 14 , 19 and 21 shall not apply to undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or combinations of vehicles with a permissible laden mass not exceeding 3 . 5 tonnes . ### article 3 and and articles 4 , 6 , 8 , 9 , 14 , 19 and 21 shall not apply to undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or combinations of vehicles with a permissible laden mass not exceeding 3 . 5 tonnes when they operate international carriage as defined in regulation 1072 / 2009 .


### ‘ have premises in which it keeps its core business documents , in particular its commercial contracts , accounting documents , personnel management documents , labour contracts , documents containing data relating to driving time and rest and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this regulation ; ’ ### ‘ have adequate premises , proportionate to the activities of the undertaking , in which it keeps its core business documents , or secures access to them , either in paper or electronic form , in particular its commercial contracts , accounting documents , personnel management documents , labour contracts , documents containing data relating to cabotage , posting of drivers , where needed , and driving time and rest and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this regulation ; ’


### in order to satisfy the requirement laid down in article 3 , an undertaking shall , on a permanent basis , be able to meet its financial obligations in the course of the annual accounting year . the undertaking shall demonstrate , on the basis of annual accounts certified by an auditor or a duly accredited person , that , every year , it has at its disposal equity capital totalling at least eur 9 000 when only one vehicle is used and eur 5 000 for each additional vehicle used . undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or combinations of vehicles with a permissible laden mass not exceeding 3 . 5 tonnes shall demonstrate , on the basis of annual accounts certified by an auditor or a duly accredited person , that , every year , they have at their disposal equity capital totalling at least eur 1 800 when only one vehicle is used and eur 900 for each additional vehicle used . ### in order to satisfy the requirement laid down in article 3 , an undertaking shall at all times be able to meet its financial obligations in the course of the annual accounting year . the undertaking shall demonstrate , on the basis of annual accounts certified by an auditor or a duly accredited person , that , every year , it has at its disposal equity capital totalling at least eur 9 000 when only one vehicle is used and eur 5 000 for each additional vehicle used that exceeds 3 . 5 tonnes . undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles or combinations of vehicles the permissible laden mass of which does not exceed 3 . 5 tonnes shall demonstrate , on the basis of annual accounts certified by an auditor or a duly accredited person , that , every year , it has at its disposal equity capital totalling at least eur 1 800 when only one vehicle is used and eur 900 for each additional vehicle used .


### by way of derogation from paragraph 1 , in the absence of certified annual accounts the competent authority shall agree that an undertaking demonstrate its financial standing by means of a certificate , such as a bank guarantee , a document issued by a financial institution establishing access to credit in the name of the undertaking , or another binding document proving that the undertaking has at its disposal the amounts specified in the first subparagraph of paragraph 1 ; ### by way of derogation from paragraph 1 , in the absence of certified annual accounts the competent authority shall agree that an undertaking demonstrate its financial standing by means of a certificate , such as a bank guarantee , an insurance policy , a document issued by a financial institution establishing access to credit in the name of the undertaking , or another binding document proving that the undertaking has at its disposal the amounts specified in the first subparagraph of paragraph 1 ;


### member states may promote periodic training on the subjects listed in annex i at 10 - year intervals to ensure that transport managers are aware of developments in the sector . ### in article 8 , paragraph 5 is replaced by the following : ' member states may promote periodic training on the subjects listed in annex i at three - year intervals to ensure that the person or persons referred to in paragraph 1 are sufficiently aware of developments in the sector .


### in article 12 , the second subparagraph is deleted ; ### in article 12 , the second subparagraph is replaced by following ; ' member states shall carry out checks at least every three years to verify that undertakings fulfil the requirements laid down in article 3 . '


### the names of the transport managers designated to meet the conditions as to good repute and professional competence or , as appropriate , the name of a legal representative ; ### point c is replaced by the following : the names of the transport managers designated to meet the requirements laid down in article 3 relating to good repute and professional competence or , as appropriate , the name of a legal representative ;


### the number of employees ; ### the number of employees , their identity , their country of residence , the labour law applicable to their employment contract , the country of payment of social contributions and their social security identifier ;


### where it is difficult or impossible to comply with a request for information or to carry out checks , inspections or investigations , the member state in question shall inform the requesting member state accordingly within ten working days , with reasons . the member states concerned shall discuss with each other with a view to finding a solution for any difficulty raised . ### where it is difficult or impossible to comply with a request for information or to carry out checks , inspections or investigations , the member state in question shall inform the requesting member state accordingly within ten working days , with reasons . the member states concerned shall cooperate with each other with a view to finding a solution for any difficulty raised .


### in the event of carriage from a member state to a third country and vice versa , this regulation shall apply to the part of the journey on the territory of any member state crossed in transit . it shall not apply to that part of the journey on the territory of the member state of loading or unloading , as long as the necessary agreement between the community and the third country concerned has not been concluded . ### article 1 is replaced by the following : ‘ 2 . in the event of carriage from a member state to a third country and vice versa , this regulation shall apply to the part of the journey on the territory of any member state crossed in transit . however , this journey in transit shall be excluded from the application of the directive on posted workers . it shall not apply to that part of the journey on the territory of the member state of loading or unloading , as long as the necessary agreement between the community and the third country concerned has not been concluded . ’


### once the goods carried in the course of an incoming international carriage from another member state or from a third country to a host member state have been delivered , hauliers referred to in paragraph 1 shall be allowed to carry out , with the same vehicle or , in the case of a coupled combination , the motor vehicle of that same vehicle , cabotage operations in the host member state or in contiguous member states . the last unloading in the course of a cabotage operation shall take place within 5 days from the last unloading in the host member state in the course of the incoming international carriage . ### once the goods carried in the course of an incoming international carriage from another member state or from a third country to a host member state have been delivered , hauliers referred to in paragraph 1 shall be allowed to carry out , with the same vehicle or , in the case of a coupled combination , the motor vehicle of that same vehicle , cabotage operations in the host member state . the last unloading in the course of a cabotage operation shall take place within 48 hours from the last unloading in the host member state in the course of the incoming international carriage . cabotage operations permitted under the first subparagraph shall have a temporary character and the work of the driver performing those operations shall be organised in such a way which allows the driver to rest at home or at another location chosen by himself / herself in accordance with regulation no 561 / 2006 .


### each member state shall organise checks in such a way that , as from 1 january 2020 , in every calendar year at least 2 % of all cabotage operations performed in their territory are checked . they shall increase the percentage to at least 3 % from 1 january 2022 . the basis for the calculation of that percentage shall be the total cabotage activity in the member state in terms of tonnes - kilometres in year t - 2 , as reported by eurostat . ### each member state shall be responsible for pursuing an effective enforcement policy in its territory . as part of that policy , each member state shall organise checks in such a way that , as from 1 january 2020 , in every calendar year at least 4% of all cabotage operations performed in their territory are checked . they shall increase the percentage to at least 6% from 1 january 2022 . the basis for the calculation of that percentage shall be the total cabotage activity in the member state in terms of tonnes - kilometres in year t - 2 , as reported by eurostat .


### member states shall , at least three times per year , undertake concerted roadside checks on cabotage operations . such checks shall be undertaken at the same time by the national authorities in charge of enforcing the rules in the field of road transport of two or more member states , each operating in its own territory . the national contact points designated in accordance with article 18 of regulation no 1071 / 2009 of the european parliament and of the council**** shall exchange information on the number and type of infringements detected after the concerted roadside checks have taken place . ### member states shall , at least six times per year , undertake concerted roadside checks on cabotage operations . the checksmay coincide with checks performed in accordance with article 5 of directive 2006 / 22 / ec . such checks shall be undertaken at the same time by the national authorities in charge of enforcing the rules in the field of road transport of two or more member states , each operating in its own territory . the national contact points designated in accordance with article 18 of regulation no 1071 / 2009 of the european parliament and of the council**** shall exchange information on the number and type of infringements detected after the concerted roadside checks have taken place .


### member states shall provide for sanctions against consignors , freight forwarders , contractors and subcontractors for non - compliance with chapters ii and iii , where they knowingly commission transport services which involve infringements of this regulation . ### member states shall provide for effective , proportionate and dissuasive sanctions against consignors , freight forwarders , contractors and subcontractors for non - compliance with chapters ii and iii , where they knowingly commission transport services which involve infringements of this regulation .


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


### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide . many of the antimicrobials used in animals are also used in humans . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . it needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials . use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products . ### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide . many of the antimicrobials used in animals are also used in humans . given that the effects on humans are not the same as those on animals , a thorough investigation should be conducted into possible contraindications . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . it needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials . use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be assessed before being allowed , on a restricted basis , in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements must sufficiently address the risks and benefits of antimicrobial veterinary medicinal products .


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


### the development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials . given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible . the use of antimicrobials in veterinary medicinal products may accelerate the emergence and spread of resistant micro - organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections . therefore the misuse of antimicrobials should not be allowed . ### the development of new antimicrobials has not kept pace with the increase of resistance to existing antimicrobials . given the limited innovation in developing new antimicrobials it is essential that the efficacy of existing antimicrobials is maintained for as long as possible . the use of antimicrobials in medicinal products may accelerate the emergence and spread of resistant micro - organisms and may compromise the effective use of the already limited number of existing antimicrobials to treat human infections . therefore the misuse of antimicrobials should not be allowed .


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


### there is still a lack of sufficiently detailed and comparable data at union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced . therefore it is important to collect data on the sales and use of antimicrobials in animals , data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals , humans and food . to ensure that the information collected can be used effectively , appropriate rules should be laid down concerning the collection and the exchange of data . the member states should be responsible for collecting data on the use of antimicrobials under the coordination of the agency . ### there is still a lack of sufficiently detailed and comparable data at union level to determine the trends and identify possible risk factors that could lead to the development of measures to limit the risk from antimicrobial resistance and to monitor the effect of measures already introduced . therefore it is important to collect data on the sales and use of antimicrobials in animals , data on the use of antimicrobials in humans and data on antimicrobial resistant organisms found in animals , humans and food . to ensure that the information collected can be used effectively , appropriate rules should be laid down concerning the collection and the exchange of data . veterinarians are already required to meet comprehensive documentation requirements in connection with the use of antibiotics . in keeping with the ‘ one health’ approach , similar documentation requirements should be introduced in the area of human medicine . the member states should be responsible for collecting data on the use of antimicrobials under the coordination of the agency .


### the illegal sale of veterinary medicinal products to the public via the internet may represent a threat to public and animal health , as falsified or substandard medicines may reach the public in this way . it is necessary to address this threat . account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at union level and , therefore , member states may impose conditions for supplying medicinal products to the public within the limits of the treaty . ### the illegal sale of veterinary medicinal products to the public via the internet may represent a threat to public and animal health , as falsified or substandard medicines may reach the public in this way . a system needs to be introduced that will ensure that such products are properly sold and will place controls on the distribution and falsification of substances that are potentially dangerous for human use . account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at union level and , therefore , member states may impose conditions for supplying medicinal products to the public within the limits of the treaty .


### in order to protect public health , animal health and the environment , the activities and tasks attributed to the agency in this regulation should be adequately funded . those activities , services and tasks should be funded through fees charged to enterprises . those fees , however , should not affect the right of member states to charge fees for activities and tasks at national level . ### in order to protect public health , animal health and the environment , the activities and tasks attributed to the agency in this regulation should be adequately funded . those activities , services and tasks , including the establishment of new it services with the aim of reducing bureaucracy , should be funded through fees charged to enterprises and through an increased financial contribution from the commission . those fees , however , should not affect the right of member states to charge fees for activities and tasks at national level .


### ‘ immunological veterinary medicinal product’ means a veterinary medicinal product consisting of vaccines , toxins , sera or allergen products and intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity ; ### ‘ immunological veterinary medicinal product’ means a veterinary medicinal product such as vaccines , toxins , sera or allergen products intended to be administered to an animal in order to produce active or passive immunity or to diagnose its state of immunity ;


### ‘ benefit - risk balance ' means an evaluation of the positive effects of the veterinary medicinal product in relation to the following risks relating to the use of that product : ### ‘ benefit - risk balance’ means an evaluation of the positive therapeutic effects of the veterinary medicinal product in relation to the following risks relating to the use of that product :


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


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


### ‘ veterinary prescription ‘ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law ; ### ‘ veterinary prescription’ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law , once a veterinary diagnosis has been established following a clinical examination of the animal or in the light of continuous health checks on the animal ;


### ‘ withdrawal period’ means the minimum period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health ; ### ‘ withdrawal period’ means the period necessary between the last administration of a veterinary medicinal product to an animal under normal conditions of use , and the production of foodstuffs from that animal , for the purpose of ensuring that such foodstuffs do not contain residues in quantities greater than the maximum limits established under regulation no 470 / 2009 of the european parliament and of the council1a ; ___________________ 1a regulation no 470 / 2009 of the european parliament and of the council of 6 may 2009 laying down community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin , repealing council regulation no 2377 / 90 and amending directive 2001 / 82 / ec of the european parliament and of the council and regulation no 726 / 2004 of the european parliament and of the council .


### requirement to use take - back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and , if appropriate , additional precautions regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products ; ### the precautions to take concerning the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and , if appropriate , a reference to the take - back schemes for these specific cases


### the commission shall , by means of implementing acts , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans . these implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . ### commission shall , by means of implementing acts and drawing on the scientific recommendations made by the agency , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans , in accordance with the rules under paragraph 3 . these implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 .


### any marketing authorisation or variation to the terms of a marketing authorisation differing from the previously granted marketing authorisation only with regard to strengths , pharmaceutical forms , administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted for the purpose of applying the rules of the protection of technical documentation . ### any marketing authorisation or variation to the terms of a marketing authorisation differing from the previously granted marketing authorisation only with regard to strengths , pharmaceutical forms , administration routes or presentations shall be regarded as the same marketing authorisation as the one previously granted for the purpose of applying the rules of the protection of technical documentation , unless that authorisation was granted for an antimicrobial medicinal product .


### 14 years for antimicrobial veterinary medicinal products for cattle , sheep , pigs , chickens , dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the union on the date of the submission of the application ; ### 18 years for antimicrobial veterinary medicinal products for cattle , sheep reared for meat , pigs , chickens , salmon , dogs and cats containing an antimicrobial active substance which has not been an active substance in a veterinary medicinal product authorised within the union on the date of the submission of the application ;


### centralised marketing authorisations shall be granted by the commission in accordance with this section . they shall be valid throughout the union . ### centralised marketing authorisations shall be granted by the commission in accordance with this section . they shall be valid throughout the union . the commission and the agency shall develop and encourage use of the centralised procedure , particularly by facilitating access for smes .


### for veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may be granted if no other marketing authorisation has been granted for the veterinary medicinal product within the union . ### for veterinary medicinal products other than those listed in paragraph 2 a centralised marketing authorisation may also be granted .


### within 90 days of receipt of a valid application , the reference member state shall prepare an updated assessment report for the veterinary medicinal product . the updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all member states and the applicant , together with the list of member states where the applicant seeks to obtain recognition of the marketing authorisation . ### within 45 days of receipt of a valid application , the reference member state shall prepare an updated assessment report for the veterinary medicinal product . the updated assessment report together with the approved summary of the product characteristics and the text to appear in the labelling and package leaflet shall be forwarded to all member states concerned and the applicant , together with the list of member states where the applicant seeks to obtain recognition of the marketing authorisation .


### the re - examination procedure shall deal only with the points of the assessment report identified by the applicant in the written notice . ### the committee shall define the scope of the examination , taking into account the information supplied by the applicant .


### within 15 days of its adoption , the agency shall forward the opinion of the committee to the coordination group , together with a report describing the assessment of the veterinary medicinal product by the committee and stating the reasons for its conclusions . those documents shall be forwarded to the commission , to member states and to the applicant for information purposes . ### within 15 days of its adoption , the agency shall forward the opinion of the committee to the commission , together with a report describing the assessment of the veterinary medicinal product by the committee and stating the reasons for its conclusions . those documents shall be forwarded to member states and to the applicant for information purposes .


### upon presentation of the agency ' s opinion , the coordination group shall act by the majority of the votes cast by its members represented at the meeting . the reference member state shall record the agreement , close the procedure and inform the applicant . article 49 shall apply accordingly . where the decision is not in accordance with the opinion of the agency , the coordination group shall annex a detailed explanation of the reasons for the differences . ### within 15 days of receipt of the opinion , the commission shall prepare a draft of the decision associated with the procedure . if the draft decision proposes that marketing authorisation be granted , the draft shall include or refer to the documents listed in article 28 . where the draft decision proposes that marketing authorisation be refused , the grounds for refusal shall be stated in accordance with article 32 . where the draft decision does not accord with the committee’s opinion , the commission shall attach detailed explanations of the grounds for these differences . the commission may , by means of implementing acts , take a final decision on the granting of a marketing authorisation under the decentralised or mutual recognition procedure . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . the agency shall forward to the applicant the documents provided for by article 28 . the agency shall make the opinion publicly available , after deleting any commercially confidential information .


### a union database on veterinary medicinal products shall be set up and maintained by the agency . ### a european union wide database on veterinary medicinal products shall be set up and maintained by the agency .


### marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations . ### marketing authorisation holders shall have full access to the information in the product database concerning their own marketing authorisations and limited access to other products .


### if a variation application fulfils the requirements laid down in article 61 , the competent authority or the agency , or a competent authority assigned in accordance with article 63 shall acknowledge receipt of a complete application . ### if a variation application fulfils the requirements laid down in article 61 , the competent authority or the agency , or a competent authority assigned in accordance with article 63 shall acknowledge receipt of a complete application in 15 days .


### marketing authorisation holders shall elaborate and maintain a system for collecting information on the risks of veterinary medicinal products as regards animal health , public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed in articles 73 , 76 and 77 . ### marketing authorisation holders shall carry out regular evaluations of their products and ensure a positive benefit / risk assessment . they shall elaborate and maintain a system for collecting and evaluating information on the risks of veterinary medicinal products as regards animal health , public health and the environment . the system shall serve to coordinate the necessary measures to fulfil the pharmacovigilance responsibilities listed in articles 73 , 76 and 77 e .


### member states , the commission , the agency and marketing authorisation holders shall collaborate in setting up and maintaining a system to monitor the safety of authorised veterinary medicinal products , enabling them to fulfil their responsibilities as listed in articles 77 and 79 . ### member states , the commission and the agency shall collaborate in setting up , interconnecting and further developing their systems to monitor the safety , effectiveness and quality of authorised veterinary medicinal products in order to fulfil their responsibilities as listed in article 79 . marketing authorisation holders shall set up and maintain a system to monitor the safety , effectiveness and quality of their products , enabling them to fulfil their responsibilities as listed in articles 77 and 78 .


### competent authorities , the agency and marketing authorisation holders shall make available to healthcare professionals and animal holders different means of reporting to them the following events whether or not the event is considered to be product - related : ### competent authorities , the agency and marketing authorisation holders shall make available to healthcare professionals and animal holders different means of reporting to them the adverse events listed below . an adverse event is :


### any response in an animal to a veterinary or human medicinal product , that is noxious and unintended ; ### any response in an animal to a veterinary or human medicinal product , that is noxious and unintended , regardless of whether the product can be related to the outcome , which manifests after any use of the product ;


### any observation of a lack of efficacy of a veterinary medicinal product following administration to an animal in accordance with the summary of product characteristics ; ### any observation of a lack of efficacy of a veterinary medicinal product following its use on an animal in accordance with the details of the summary of product characteristics , including in the event of an overdose ;


### any noxious response in humans to a veterinary medicinal product ; ### any noxious reaction in humans to a veterinary medicinal product ;


### any finding of an active substance in a produce of a food - producing animal exceeding the levels of residues established in accordance with regulation no 470 / 2009 . ### any finding , after the stipulated waiting time has been observed , of a substance in edible materials , milk , eggs or honey from food - producing animals exceeding the levels of residues established in accordance with regulation no 470 / 2009 .


### the agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with article 75 . ### the agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with article 75 , and that the marketing authorisation holders forward the information to the responsible authorities of the member states concerned for further evaluation .


### competent authorities shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their member state , within 30 days following the receipt of the adverse event report . ### competent authorities shall record and assess all adverse events of which they learn under article 73 and which occur in the territory of their member state and shall enter them immediately , but no later than 15 days following the receipt of the information , in the eu ' s pharmacovigilance database .


### the marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation . ### the marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation and shall take all appropriate steps to encourage members of the health professions and animal holders to report adverse events .


### where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party , those arrangements shall be set out in details in the pharmacovigilance system master file . ### where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party , the responsibilities of both parties shall be set out explicitly in a contract and in the pharmacovigilance system master file .


### the marketing authorisation holder shall permanently have at his disposal one or more appropriately qualified persons responsible for pharmacovigilance . those persons shall reside and operate in the union . only one qualified person shall be designated by the marketing authorisation holder per pharmacovigilance system master file . ### the marketing authorisation holder shall permanently have at his disposal an appropriately qualified person responsible for pharmacovigilance . that person shall reside and operate in the union . the qualified person responsible for pharmacovigilance may delegate specific areas of work to appropriately trained staff but shall remain responsible for the marketing authorisation holder’s pharmacovigilance system and for the safety profile of his veterinary medicinal products .


### where the tasks of the qualified person responsible for pharmacovigilance listed in article 78 have been contracted out to a third party , those arrangements shall be detailed in the contract . ### where the tasks of the qualified person responsible for pharmacovigilance listed in article 78 have been contracted out to a third party , the relevant arrangements shall be set out explicitly in a contract .


### allocating reference numbers to the pharmacovigilance system master file and communicating the reference number of the pharmacovigilance master file of each product to the product database ; ### allocating reference numbers to the pharmacovigilance system master file and communicating , for each product , the reference number in question of the pharmacovigilance master file of each product to the product database ;


### ensuring that all personnel involved in the performance of pharmacovigilance activities receives continued training ; ### ensuring that all personnel involved in the performance of pharmacovigilance activities receive continued training tailored to their duties , on an ongoing basis ; training courses should be documented and their effectiveness reviewed ;


### competent authorities and the agency shall provide the general public , veterinarians and other healthcare professionals with all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication . ### competent authorities and the agency shall provide the general public , veterinarians and other healthcare professionals with all important information on adverse events relating to the use of a veterinary medicinal product in a timely manner electronically or through other publicly available means of communication . competent authorities and the agency shall ensure that veterinarians receive feedback on adverse events reported and regular feedback on all adverse reactions reported .


### competent authorities shall verify by means of inspections referred to in article 125 that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this section . ### competent authorities shall verify by means of inspections referred to in article 125 or any other way that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this section .


### the results of the signal management process shall be agreed upon by the competent authorities and , where appropriate , the agency . the lead authority shall record the results in the pharmacovigilance database . ### the results of the signal management process , except for nationally authorised products , shall be agreed upon by the competent authorities and , where appropriate , the agency . the lead authority shall record the results in the pharmacovigilance database .


### by way of derogation from article 5 , homeopathic veterinary medicinal products that satisfy the requirements set out in article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with article 90 . ### by way of derogation from article 5 , homeopathic veterinary medicinal products that satisfy the requirements set out in article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with article 90 . veterinary medicinal products registered or approved in accordance with national rules before 31 december 1993 shall not be affected by the provisions of this article .


### a manufacturing authorisation may be granted conditionally , subject to a requirement for the applicant to undertake actions or introduce specific procedures within a given time period . the manufacturing authorisation may be suspended if these requirements are not complied with . ### a manufacturing authorisation may be granted conditionally where minor shortcomings are identified , subject to a requirement for the applicant to rectify the shortcomings within a given time period . the manufacturing authorisation may be suspended if these requirements are not complied with .


### supplies of small quantities of veterinary medicinal products from one retailer to another shall not be regarded as wholesale distribution . ### the purchase , sale , import or export of veterinary medicinal products or any other kind of commercial transaction concerning these medicinal products , whether for profit or not for profit , shall be subject to the possession of a wholesale distribution authorisation for veterinary medicinal products . said authorisation shall not apply to the supply , by a manufacturer , of veterinary medicinal products which it has itself manufactured , nor to the retail sale of veterinary medicinal products by persons entitled to conduct such sales in accordance with article 107 .


### has at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down by the member state concerned as regards the storage and handling of veterinary medicinal products ; ### has at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down by the member state concerned as regards the storage and handling of veterinary medicinal products , and which representatives of the competent authority may enter at any time ;


### retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each purchase and sale of veterinary medicinal products : ### retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each purchase and sale of veterinary medicinal products obtainable only on prescription :


### retail of anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic veterinary medicinal products ### retail of anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal , immunological or psychotropic veterinary medicinal products


### only manufacturers , wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties . ### only manufacturers , wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal , immunological or psychotropic properties or substances which may be used as veterinary medicinal products having those properties .


### only manufacturers , wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties . ### only manufacturers , wholesale distributors and retailers authorised to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties .


### name and address of the supplier in the event of purchase , or of the recipient in the event of sale . ### name and address of the supplier in the event of purchase .


### identification of the animal under treatment ; ### identification of the animal or class of animal under treatment ;


### veterinary prescriptions shall be recognised throughout the union . a veterinary medicinal product prescribed shall be supplied in accordance with applicable national law . ### veterinary prescriptions shall be recognised throughout the union . the removal of regulatory and administrative barriers to such recognition should not affect any professional or ethical duty for dispensing professionals to refuse to dispense the medicine stated in the prescription . a veterinary medicinal product prescribed shall be supplied in accordance with applicable national law .


### owners or , where the animals are not kept by the owners , keepers of food - producing animals shall keep records of the veterinary medicinal products they use and , if applicable , a copy of the veterinary prescription . ### owners or , where the animals are not kept by the owners , keepers of food - producing animals shall keep records of the vet - prescribed veterinary medicinal products and veterinary medicinal products with a withdrawal period higher than nil they use and , if applicable , a copy of the veterinary prescription .


### name and address of the supplier ; ### name and address of the supplier and , if applicable , a copy of the delivery note ;


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a non - food producing animal , the veterinarian responsible may , under his / her direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with the following : a medicinal product : a veterinary medicinal product authorised under this regulation in the member state concerned for use with another animal species , or for another condition in the same species ; a veterinary medicinal product authorised under this regulation in another member state for use in the same species or in another species , for the same condition or for another condition ; a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec of the european parliament and of the council30 or regulation no 726 / 2004 ; if there is no product as referred to in point , a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation . ____________________ 30directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use . ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a non - food producing animal , the veterinarian responsible may , under his / her direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with the following : a medicinal product : a veterinary medicinal product authorised under this regulation in the member state concerned for use with another animal species , or for another condition in the same species ; a veterinary medicinal product authorised under this regulation in another member state for use in the same species or in another species , for the same condition or for another condition ; if there is no product as referred to in point : a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec of the european parliament and of the council30 or regulation no 726 / 2004 ; a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation . ____________________ 30 directive 2001 / 83 / ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use .


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following : ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , or where a veterinary medicinal product is not available on the market for logistical reasons , for example , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following :


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following : a veterinary medicinal product authorised under this regulation in the member state concerned for use with another food - producing animal species , or for another condition in the same species ; a veterinary medicinal product authorised under this regulation in another member state for use in the same species or in another food - producing species for the same condition or for another condition ; a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec or under regulation no 726 / 2004 . or if there is no product as referred to in point , a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription by a person authorised to do so under national legislation . ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following : a veterinary medicinal product authorised under this regulation in the member state concerned for use with another food - producing animal species , or for another condition in the same species ; a veterinary medicinal product authorised under this regulation in another member state for use in the same species or in another food - producing species for the same condition or for another condition ; if there is no product as referred to in point : a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec or under regulation no&#160 ; 726 / 2004 ; or a veterinary medicinal product prepared extemporaneously in accordance with the terms of a veterinary prescription issued by a person authorised to do so under national legislation .


### pharmacologically active substances included in the medicinal product used in accordance with paragraph 1 shall be listed in table 1 of the annex to regulation no 37 / 2010 . the veterinarian shall specify an appropriate withdrawal period in accordance with article 117 . ### pharmacologically active substances included in the medicinal product used in accordance with paragraph 1 and paragraph 3 shall be listed in table 1 of the annex to regulation no 37 / 2010 . the veterinarian shall specify an appropriate withdrawal period in accordance with article 117 .


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


### antimicrobial medicinal products shall only be used in accordance with articles 115 and 116 to treat conditions for which there is no other treatment available , and the use of which would not present a risk to public or animal health . ### antimicrobial medicinal products shall only be used in accordance with articles 115 and 116 to treat conditions for which there is no other treatment available , once the applicable preventative measures listed in annex iiia have been fulfilled , and the proper use of such treatment would not present a risk to public or animal health . it shall not be used for routine prophylactic use or a prophylactic group treatment where there is no diagnosis of disease .


### risks to public health if the antimicrobial product is used in accordance with paragraph 1 ; ### risks to public health if the antibiotic product is used in accordance with paragraph 1 ;


### by way of derogation from article 111 , in the event of an outbreak of a listed disease as referred to in article 5 of regulation no… / … . of the european parliament and the council31 [ office of publications , please insert number and , in a footnote , date , title and the oj reference for the regulation on animal health ] a competent authority may allow , for a limited period of time and under specific restrictions , the use of an immunological veterinary medicinal product authorised in another member state . __________________ 31 regulation of the european parliament and the council of… . . on animal health . ### by way of derogation from article 111 , in the event of an outbreak of a listed disease as referred to in article 5 of regulation no… / … . of the european parliament and the council31 [ office of publications , please insert number and , in a footnote , date , title and the oj reference for the regulation on animal health ] or any critical health situation acknowledged by the chief veterinary officer of the member state a competent authority may allow , for a limited period of time and under specific restrictions , the use of an immunological veterinary medicinal product without a marketing authorization in the member state in question but which is authorised either in another member state or under the legislation of a the third country , in the absence of a suitable medicinal product and after informing the commission of the detailed conditions of use . __________________ 31 regulation of the european parliament and the council of… . . on animal health .


### the prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products . ### the prohibition set out in paragraph 1 shall not apply : to advertising to persons permitted to prescribe or supply veterinary medicinal products ; to advertising concerning immunological veterinary products to the owners of animals for consumption .


### regulation no 1215 / 2009 does not provide any possibility to temporarily suspend the grant of exceptional trade measures in case of serious and systematic violations of the fundamental principles of human rights , democracy and the rule of law by its beneficiaries . it is appropriate to introduce such possibility , so as to ensure that swift action can be taken in case serious and systematic violations of the fundamental principles of human rights , democracy and the rule of law would occur in one of the countries and territories participating in or linked to the european union ' s stabilisation and association process . ### regulation no 1215 / 2009 does not provide any possibility to temporarily suspend the grant of exceptional trade measures in case of violations of the fundamental principles of human rights , democracy and the rule of law by its beneficiaries . it is appropriate to introduce such possibility , so as to ensure that swift action can be taken in case violations of the fundamental principles of human rights , democracy and the rule of law would occur in one of the countries and territories participating in or linked to the european union ' s stabilisation and association process .


### since the launch of the stabilisation and association process , stabilisation and association agreements have been concluded with all concerned western balkan countries , with the exception of bosnia and herzegovina and kosovo3 . in june 2013 , the council authorised the commission to start negotiations for a stabilisation and association agreement with kosovo . ____________________ 3 this designation is without prejudice to positions on status , and is in line with unscr 1244 / 1999 and the icj opinion on the kosovo declaration of independence . ### since the launch of the stabilisation and association process , stabilisation and association agreements have been concluded with all concerned western balkan countries , with the exception of bosnia and herzegovina and kosovo3 . in may 2014 , the negotiations for a stabilisation and association agreement with kosovo were completed and the agreement was initialled in july 2014 . ____________________ 3 this designation is without prejudice to positions on status , and is in line with unscr 1244 / 1999 and the icj opinion on the kosovo declaration of independence .


### in article 2 , the following points 22 , 23 , 24 and 25 are added : ### in article 2 , the following points 22 , 23 , 24 , 25 and 25a are added :


### heads of state and members of their delegation in accordance with point 1 of annex vii ; ### heads of state , heads of government and the members of their delegations in accordance with point 1 of annex vii ;


### the travel document presented for the border crossing shall contain an electronic storage medium and the authenticity of the chip data shall be confirmed using the complete valid certificate chain ; ### the travel document presented for the border crossing shall contain an electronic storage medium and the authenticity and integrity of the chip data shall be confirmed using the complete valid certificate chain ;


### the residence permit presented for the border crossing shall contain an electronic storage medium and the authenticity of the chip data shall be confirmed using the complete valid certificate chain ; ### the residence permit presented for the border crossing shall contain an electronic storage medium and the authenticity and integrity of the chip data shall be confirmed using the complete valid certificate chain ;


### the travel document presented for the border crossing shall contain a facial image recorded in the chip which can be technically accessed by the automated system so as to verify the identity of the holder of the travel document by comparing the facial image recorded in the chip and the live facial image ; ### the travel document presented for the border crossing shall contain a facial image recorded in the chip which can be technically accessed by the automated border control system so as to verify the identity of the holder of the travel document by comparing the facial image recorded in the chip and the live facial image ;


### the travel document presented for the border crossing shall contain a facial image recorded in the chip which can be legally and technically accessed by the automated system so as to verify the identity of the holder of the travel document by comparing the facial image recorded in the chip and his or her live facial image ; ### the travel document presented for the border crossing shall contain a facial image recorded in the chip which can be legally and technically accessed by the automated border control system so as to verify the identity of the holder of the travel document by comparing the facial image recorded in the chip and his or her live facial image ;


### the residence permit presented for the border crossing shall contain a facial image recorded in the chip which can be technically accessed by the automated system so as to verify the identity of the holder of the residence permit , by comparing the facial image recorded in the chip and the live facial image . ### the residence permit presented for the border crossing shall contain a facial image or fingerprints recorded in the chip which can be technically accessed by the automated border control system so as to verify the identity of the holder of the residence permit , by comparing the facial image or fingerprints recorded in the chip and the live facial image or , where applicable , the fingerprints .


### where the conditions laid down in paragraph 1 are met , the checks on entry and exit provided for in articles 8 and 8 and or articles 8 and 8 and may be carried out through a self - service system . when carried out through an automated border control system , the borders check on exit shall include the checks provided for in article 8 . ### where the conditions laid down in paragraph 1 are met , the border checks on entry and exit provided for in articles 8 and 8 and or articles 8 and 8 and may be carried out through a self - service system . when carried out through an automated border control system , the borders check on exit shall include the checks provided for in article 8 .


### each member state may establish a voluntary programme in order to allow third country nationals as defined in article 2 or nationals of a specific third country who do not benefit from the right of free movement to benefit from the facilitations made pursuant to paragraph 2 of this article when crossing the external border of a member state . ### each member state may establish a voluntary programme in order to allow third country nationals as defined in article 2 or nationals of a specific third country who do not enjoy the right of free movement under union law to benefit from the facilitations made pursuant to paragraph 2 of this article when crossing the external border of a member state .


### the applicant proves integrity and reliability , in particular , if applicable , , that previous visas with limited territorial validity have been lawfully used , the applicant ' s economic situation in the country of origin and the genuine intention to leave the territory of the member states in due time . in accordance with article 23 of [ regulation establishing the entry / exit system ] , the authorities referred to in paragraph b ) of this article shall have access to consult the ees to verify that the applicant has not previously exceeded the maximum duration of authorised stay in the territory of the member states ; ### the applicant proves his or her integrity and reliability , in particular , if applicable , the lawful use of previous visas or visas with limited territorial validity , his or her economic situation in the country of origin and his or her genuine intention to leave the territory of the member states before the expiry of the visa , if applicable , or the end of the authorised period of stay . in accordance with article 23 of [ regulation establishing the entry / exit system ] , the authorities referred to in paragraph b ) of this article shall have access to consult the ees to verify that the applicant has not previously exceeded the maximum duration of authorised stay in the territory of the member states ;


### the power to adopt delegated acts referred to in article 13 and article 36 shall be conferred on the commission for an indeterminate period of time . ### the power to adopt delegated acts referred to in article 8aa , article 13 and article 36 shall be conferred on the commission for an indeterminate period of time .


### the delegation of powers referred to in article 13 and article 36 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of powers referred to in article 8aa , article 13 and article 36 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### a delegated act adopted pursuant to article 13 and article 36 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act adopted pursuant to article 8aa , article 13 and article 36 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### heads of state by way of derogation from article 6 and articles 8 to 14 , heads of state and the members of their delegation , whose arrival and departure have been officially announced through diplomatic channels to the border guards , may not be subject to border checks . ### heads of state and heads of government by way of derogation from article 6 and articles 8 to 14 , heads of state , heads of government and the members of their delegations , whose arrival and departure have been officially announced through diplomatic channels to the border guards , may not be subject to border checks .


### the stockholm programme21 put a strong focus on the strengthening of the rights of individuals in criminal proceedings . in its point 2 . 4 , the european council invited the commission to put forward proposals setting out a step by step approach22 to strengthening the rights of suspects or accused persons . __________________ 22 oj c 291 , 4 . 12 . 2009 , p . 1 . ### on 30 november 2009 , the council adopted the roadmap for strengthening the procedural rights of suspected and accused persons in criminal proceedings . taking a step - by - step approach , the roadmap calls for the adoption of measures regarding the right to obtain translation and interpretation , the right to receive information on rights and information about the charges , the right to receive legal advice and legal aid , the right to communicate with relatives , employers and consular authorities , and establishing special safeguards for suspected or accused persons who are vulnerable . the roadmap emphasises that the order of the rights is indicative , implying that it may be changed according to priorities . it is designed to operate as a whole ; only when all its components are implemented will its benefits be felt in full . __________________ 22 oj c 291 , 4 . 12 . 2009 , p . 1 .


### this directive should also apply in respect of offences which have been committed after the age of 18 years by the same suspect or accused person and which are jointly investigated and prosecuted as they are inextricably linked to offences where criminal proceedings started against that person before the age of 18 . ### this directive should also apply in respect of offences which have been allegedly committed after the suspect or accused person had reached the age of 18 years , where such offences are jointly investigated and prosecuted as they are inextricably linked to offences to which this directive is applicable .


### in order to ensure the personal integrity of a child who is arrested or detained , the child should have access to a medical examination . the medical examination should be carried out by a physician . ### in order to ensure the personal integrity of a child who is arrested or detained and to assess his or her physical and mental state , the child should have access to a medical examination . the medical examination should be as non - invasive as possible and carried out by a qualified physician .