### the authority should provide a platform for resolving disputes between member states in relation to the application of union law that falls within its scope . it should build on dialogue and conciliation mechanisms that are currently in place in the area of social security coordination , which are valued by member states60 and their importance is recognised by the court of justice61 . member states should be able to refer cases to the authority for mediation according to standard procedures put in place for this purpose . the authority should only deal with disputes between member states , while individuals and employers facing difficulties with exercising their union rights should continue to have at their disposal the national and union services dedicated to dealing with such cases , such as the solvit network to which the authority should refer such cases . the solvit network should also be able to refer to the authority for its consideration cases in which the problem cannot be solved due to differences between national administrations . _________________ 60 council , partial general approach of 26 october 2017 on the proposal for a regulation amending regulation no 883 / 2004 on the coordination of social security systems and regulation no 987 / 2009 laying down the procedure for implementing regulation no 883 / 2004 13645 / 1 / 17 . 61 case c - 236 / 88 eu : c : 1990 : 303 , paragraph 17 ; case c - 202 / 97 eu : c : 2000 : 75 , paragraphs 57 - 58 ; case c - 178 / 97 eu : c : 2000 : 169 , paragraphs 44 - 45 ; case c - 2 / 05 eu : c : 2006 : 69 , paragraphs 28 - 29 ; case c - 12 / 14 eu : c : 2016 : 135 , paragraphs 39 - 41 ; case c - 359 / 16 eu : c : 2018 : 63 , paragraphs 44 - 45 . ### individuals and employers facing difficulties with exercising their union rights should continue to have at their disposal the national and union services dedicated to dealing with such cases , such as the solvit network to which the authority should refer such cases . the solvit network should also be able to refer to the authority for its consideration cases in which the problem cannot be solved due to differences between national administrations .


### to increase member states ' capacity to tackle irregularities with a cross - border dimension in relation to union law within its scope , the authority should support the national authorities in carrying out concerted and joint inspections , including by facilitating the implementation of the inspections in accordance with article 10 of directive 2014 / 67 / eu . these should take place at the request of member states or upon their agreement to the authority ' s suggestion . the authority should provide strategic , logistical , and technical support to member states participating in the concerted or joint inspections in full respect of confidentiality requirements . inspections should be carried out in agreement with the member states concerned and take place fully within the legal framework of national law of member states concerned , which should follow up on the outcomes of the concerted and joint inspections according to national law . ### to increase member states ' capacity to tackle irregularities with a cross - border dimension in relation to union law within its scope , the agency should support the national authorities in carrying out concerted and joint inspections , including by facilitating the implementation of the inspections in accordance with article 10 of directive 2014 / 67 / eu . these should take place at the request of member states or upon their agreement to the agency ' s suggestion . the agency should provide strategic , logistical , and technical support to member states participating in the concerted or joint inspections in full respect of confidentiality requirements . inspections should be carried out in agreement with the member state concerned and take place fully within the legal framework of national law applicable on the territory of the member state in which the inspection is being carried out , which should follow up on the outcomes of the concerted and joint inspections according to this national law .


### the objective of the authority shall be to contribute to ensuring fair labour mobility in the internal market . to this end , the authority shall : ### the objective of the agency shall be to promote freedom of movement of workers and services , and to ensure fair labour mobility in the internal market . to this end , the agency shall :


### proposal for a regulation of the european parliament and of the council establishing a european labour authority ### proposal for a regulation of the european parliament and of the council establishing a european labour agency


### provide relevant information on the rights and obligations of individuals in cross - border labour mobility situations ; ### provide relevant information on the rights and obligations of workers and employers in cross - border labour mobility situations in all official eu languages by means of comprehensive reference to the national sources of relevant information of all member states ;


### the authority should perform its activities in the areas of cross - border labour mobility and social security coordination , including free movement of workers , posting of workers and highly mobile services . it should also enhance cooperation between member states in tackling undeclared work . in cases where the authority , in the course of the performance of its activities , becomes aware of suspected irregularities , including in areas of union law beyond its scope , such as violations of working conditions , health and safety rules , or the employment of illegally staying third - country nationals , it should be able to report them and cooperate on these matters with the commission , competent union bodies , and national authorities where appropriate . ### the agency should perform its activities in the areas of cross - border labour mobility and social security coordination , including free movement of workers , posting of workers and highly mobile services . it should also enhance cooperation between member states in tackling undeclared work . in cases where the agency , in the course of the performance of its activities , becomes aware of suspected irregularities , it should be able to report them to the commission , competent union bodies , and national authorities .


### this regulation establishes the european labour authority . ### this regulation establishes the european labour agency .


### where the authority of a member state decides not to participate in or carry out the concerted or joint inspection referred to paragraph 1 , it shall inform the authority in writing of the reasons for its decision duly in advance . in such cases , the authority shall inform the other national authorities concerned . ### the participation of the national authority of the member state in the concerted or joint inspection is voluntary . if the authority of a member state decides not to participate in or carry out the concerted or joint inspection referred to paragraph 1 , it shall inform the agency in writing of the reasons for its decision in advance . in such cases , the agency shall inform the other national authorities concerned .


### in the event that the authority , in the course of concerted or joint inspections , or in the course of any of its activities , becomes aware of suspected irregularities in the application of union law , including beyond the scope of its competences , it shall report those suspected irregularities to the commission and authorities in the member state concerned , where appropriate . ### in the event that the agency , in the course of concerted or joint inspections , or in the course of any of its activities , becomes aware of suspected irregularities in the application of union law , within the scope of its competences , it shall report those suspected irregularities to the commission and authorities in the member state concerned . it can report suspected irregularities to the commission only with the assessment and opinion provided by the member state concerned .


### 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 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 .


### a european labour authority should be established in order to help strengthen fairness and trust in the single market . to that effect , the authority should support the member states and the commission in strengthening access to information for individuals and employers about their rights and obligations in cross - border labour mobility situations as well as access to relevant services , support compliance and cooperation between the member states to ensure the effective application of the union law in these areas , and mediate and facilitate a solution in case of cross - border disputes or labour market disruptions . ### a european labour agency should be established in order to help strengthen fairness and trust in and promote free movement of workers and services within the single market . to that effect , the agency should support the member states and the commission in strengthening access to relevant and up - to - date information for workers and employers about their rights and obligations in cross - border labour mobility situations within all member states through an ela web portal , as well as access to relevant services , and promote cooperation between the member states to ensure the effective application of the union law in these areas , and mediate and facilitate a solution in case of cross - border disputes or labour market disruptions .


### provide relevant information to employers on labour rules , and the living and working conditions applicable to workers in cross - border labour mobility situations , including posted workers ; ### provide workers and employers with relevant information on labour rules and working conditions applicable to workers in cross - border labour mobility situations . the information shall be provided in all official languages of the eu through the ela web portal with references to all national web portals which contain relevant information ;


### the authority shall assist member states and the commission in matters relating to cross - border labour mobility and the coordination of social security systems within the union . ### the agency shall assist member states and the commission in matters relating to cross - border labour mobility .


### in view of the fair , simple and effective application of union law , the authority should support cooperation and timely exchange of information between member states . together with other staff , national liaison officers working within the authority should support member states’ compliance with cooperation obligations , speed up exchanges between them through procedures dedicated to reducing delays , and ensure links with other national liaison offices , bodies , and contact points established under union law . the authority should encourage the use of innovative approaches to effective and efficient cross - border cooperation , including electronic data exchange tools such as the electronic exchange of social security information system and the internal market information system , and should contribute to further digitalising procedures and improving it tools used for message exchange between national authorities . ### in view of the proper application of union law , the agency should support cooperation and timely exchange of information between member states , as provided by other relevant union acts . together with other staff , national liaison officers working within the authority should support member states’ compliance with cooperation obligations , speed up exchanges between them through procedures dedicated to reducing delays , and ensure links with other national liaison offices , bodies , and contact points established under union law . the authority should encourage the use of innovative approaches to effective and efficient cross - border cooperation , including electronic data exchange tools such as the electronic exchange of social security information system and the internal market information system , and should contribute to further digitalising procedures and improving it tools used for message exchange between national authorities .


### the authority shall provide services to individuals and employers to facilitate labour mobility across the union . to that end , the authority shall : ### the agency shall provide services to individuals and employers to facilitate labour mobility across the union , including advisory services and organizing trainings . to that end , the agency shall :


### where the authority of a member state decides not to participate in or carry out the concerted or joint inspection referred to paragraph 1 , it shall inform the authority in writing of the reasons for its decision duly in advance . in such cases , the authority shall inform the other national authorities concerned . ### where the authority of a member state decides not to participate in or carry out the concerted or joint inspection referred to paragraph 1 , it shall inform the agency in writing of the reasons for its decision duly in advance . in such cases , the authority shall inform the other national authorities concerned .


### to increase member states ' capacity to tackle irregularities with a cross - border dimension in relation to union law within its scope , the authority should support the national authorities in carrying out concerted and joint inspections , including by facilitating the implementation of the inspections in accordance with article 10 of directive 2014 / 67 / eu . these should take place at the request of member states or upon their agreement to the authority ' s suggestion . the authority should provide strategic , logistical , and technical support to member states participating in the concerted or joint inspections in full respect of confidentiality requirements . inspections should be carried out in agreement with the member states concerned and take place fully within the legal framework of national law of member states concerned , which should follow up on the outcomes of the concerted and joint inspections according to national law . ### to increase member states ' capacity to tackle irregularities with a cross - border dimension in relation to union law within its scope , the agency should support the national authorities in carrying out concerted and joint inspections , including by facilitating the implementation of the inspections in accordance with article 10 of directive 2014 / 67 / eu . these should take place at the request of member states or upon their agreement to the agency ' s suggestion and always upon the agreement of the member state concerned . the agency should provide strategic , logistical , and technical support to member states participating in the concerted or joint inspections in full respect of confidentiality requirements . inspections should be carried out in agreement with the member states concerned and take place fully within the legal framework of national law of member states concerned , which should follow up on the outcomes of the concerted and joint inspections according to national law .


### in the event that the authority , in the course of concerted or joint inspections , or in the course of any of its activities , becomes aware of suspected irregularities in the application of union law , including beyond the scope of its competences , it shall report those suspected irregularities to the commission and authorities in the member state concerned , where appropriate . ### in the event that the agency , in the course of concerted or joint inspections , or in the course of any of its activities , becomes aware of suspected irregularities in the application of union law , within the scope of its competences , it shall report those suspected irregularities to the commission and authorities in the member state concerned .


### develop common guidelines for use by member states , including guidance for inspections in cases with a cross - border dimension , as well as shared definitions and common concepts , building on relevant work at the union level ; ### develop non - binding common guidelines for use by member states , including guidance for inspections in cases with a cross - border dimension , as well as shared definitions and common concepts , building on relevant work at the union level ;


### the authority shall assist member states and the commission in matters relating to cross - border labour mobility and the coordination of social security systems within the union . ### the authority shall assist member states and the commission in matters relating to enforcement of the union law in the area of cross - border labour mobility and the coordination of social security systems within the union .


### facilitate access to information by individuals and employers on rights and obligations in cross - border situations as well as access to cross - border labour mobility services , in accordance with articles 6 and 7 ; ### provide&#160 ; information to workers and employers on their rights and obligations in cross - border situations , on labour laws and conditions in all eu member states through accessible ela web portal available in all official eu languages , as well as provide cross - border labour mobility services , including advisory services for workers and employers , in accordance with articles 6 and 7 ;


### 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 .


### organisation of the authority ### organisation of the agency


### 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 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 .


### a european labour authority should be established in order to help strengthen fairness and trust in the single market . to that effect , the authority should support the member states and the commission in strengthening access to information for individuals and employers about their rights and obligations in cross - border labour mobility situations as well as access to relevant services , support compliance and cooperation between the member states to ensure the effective application of the union law in these areas , and mediate and facilitate a solution in case of cross - border disputes or labour market disruptions . ### a european labour agency should be established in order to help strengthen fairness and trust in the single market . to that effect , the agency should support the member states and the commission in strengthening access to information for individuals and employers about their rights and obligations in cross - border labour mobility situations as well as access to relevant services , support compliance and cooperation between the member states to ensure the effective application of the union law in these areas , and mediate and facilitate a solution in case of cross - border disputes or labour market disruptions .


### provide relevant information to employers on labour rules , and the living and working conditions applicable to workers in cross - border labour mobility situations , including posted workers ; ### provide workers and employers with relevant information on labour rules and working conditions , applicable in cross - border labour mobility situations , including posted workers , as well as to provide relevant information on labour laws and conditions in all of the eu member states . the information shall be provided in all official languages of the eu through an up - to - date and accessible ela web portal ;


### a european labour authority should be established in order to help strengthen fairness and trust in the single market . to that effect , the authority should support the member states and the commission in strengthening access to information for individuals and employers about their rights and obligations in cross - border labour mobility situations as well as access to relevant services , support compliance and cooperation between the member states to ensure the effective application of the union law in these areas , and mediate and facilitate a solution in case of cross - border disputes or labour market disruptions . ### a european labour agency should be established in order to promote the free movement of workers and services within the single market . to that effect , the authority should support the member states and the commission in strengthening access to information for individuals and employers about their rights and obligations in cross - border labour mobility situations as well as access to relevant services , support compliance and cooperation between the member states to ensure the effective application of the union law in these areas , and mediate and facilitate a solution in case of cross - border disputes or labour market disruptions .


### 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 , upon the agreement of the member states concerned , coordinate concerted or joint inspections in the areas under the scope of the agency ' s competences . for the purpose of this regulation &#8220 ; concerted or joint inspection&#8221 ; means inspections performed in the territory of a member state by its inspection authorities with the participation of the inspection personnel in a capacity of observers of one or more other member states or the agency . concerted or joint on - site inspections can be performed only at workplaces within the remit of the domestic labour inspection services . for the purpose of this regulation , the &#8220 ; inspection&#8221 ; means inquiry on proper application by the employers , settled in the territory of the european union , of the union law on free movement of workers&#160 ; and the&#160 ; cross border provision of services , &#160 ; on intra eu mobility of legally employed third country nationals and on coordination of social security systems


### 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 .


### where the authority of a member state decides not to participate in or carry out the concerted or joint inspection referred to paragraph 1 , it shall inform the authority in writing of the reasons for its decision duly in advance . in such cases , the authority shall inform the other national authorities concerned . ### the participation of the national authority of the member state in the concerted or joint inspection is voluntary . if the authority of a member state decides not to participate in or carry out the concerted or joint inspection referred to paragraph 1 , it shall inform the agency in writing of the reasons for its decision in advance . in such cases , the agency shall inform the other national authorities concerned .


### mediate and facilitate a solution in cases of cross - border disputes between national authorities or labour market disruptions . ### mediate in cases of cross - border disputes between national authorities .


### the objective of the authority shall be to contribute to ensuring fair labour mobility in the internal market . to this end , the authority shall : ### the objective of the agency shall be to promote freedom of movement of workers and services , and to ensure that labour mobility in the internal market fully respects relevant union legislation . it shall also contribute to tackling the complex problem of undeclared work , while fully respecting national competences and procedures . . to this end , the agency shall :


### mediate and facilitate a solution in cases of cross - border disputes between national authorities or labour market disruptions . ### at the request of the member state concerned , mediate and facilitate a solution in cases of cross - border disputes between national authorities or labour market disruptions .


### promote opportunities to support the labour mobility of individuals , including through guidance on access to learning and language training ; ### promote opportunities to support the labour mobility of individuals , including through preparing and organizing relevant trainings and workshops for workers and employers ;


### in the event that the authority , in the course of concerted or joint inspections , or in the course of any of its activities , becomes aware of suspected irregularities in the application of union law , including beyond the scope of its competences , it shall report those suspected irregularities to the commission and authorities in the member state concerned , where appropriate . ### in the event that the agency , in the course of concerted or joint inspections , or in the course of any of its activities , becomes aware of suspected irregularities in the application of union law , within the scope of its competences , it shall report those suspected irregularities to the commission and authorities in the member state concerned .


### 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 .


### to increase member states ' capacity to tackle irregularities with a cross - border dimension in relation to union law within its scope , the authority should support the national authorities in carrying out concerted and joint inspections , including by facilitating the implementation of the inspections in accordance with article 10 of directive 2014 / 67 / eu . these should take place at the request of member states or upon their agreement to the authority ' s suggestion . the authority should provide strategic , logistical , and technical support to member states participating in the concerted or joint inspections in full respect of confidentiality requirements . inspections should be carried out in agreement with the member states concerned and take place fully within the legal framework of national law of member states concerned , which should follow up on the outcomes of the concerted and joint inspections according to national law . ### to increase member states ' capacity to tackle irregularities with a cross - border dimension in relation to union law within its scope , the agency should support the national authorities in carrying out concerted and joint inspections , including by facilitating the implementation of the inspections in accordance with article 10 of directive 2014 / 67 / eu . these should take place at the request of member states or upon their agreement to the agency ' s suggestion and always upon the agreement of the member state concerned . the agency should provide strategic , logistical , and technical support to member states participating in the concerted or joint inspections in full respect of confidentiality requirements . inspections should be carried out in agreement with the member states concerned and take place fully within the legal framework of national law of member states concerned , which should follow up on the outcomes of the concerted and joint inspections according to national law .


### facilitate access for individuals and employers to information on their rights and obligations as well as to relevant services ; ### provide relevant&#160 ; information to workers and employers on their rights and obligations , labour laws and conditions in all of the eu member states through accessible ela web portal available in all eu official languages , as well as provide relevant services related to cross - border mobility , including free of charge advisory services to workers and employers ;


### the objective of the authority shall be to contribute to ensuring fair labour mobility in the internal market . to this end , the authority shall : ### the objective of the agency shall be to promote freedom of movement of workers and services , and to ensure fair labour mobility in the internal market . to this end , the agency shall :


### 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 .


### define the degree of seriousness of infringements according to their potential to create a risk of fatalities or serious injuries and to distort competition in the road transport market , including by undermining the working conditions of transport workers ; ### define the degree of seriousness of infringements according to their potential to create a risk of fatalities or serious injuries , to distort competition in the road transport market , and the failure to comply with , or the poor application of , the relevant union labour legislation ;


### point is deleted ; ### point is replaced by the following ; 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 is lower than 2 , 4 tonnes ;


### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do 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 not exceeding that limit . the number of such undertakings which are active in both national and international transport operations has been increasing . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass not exceeding 3 . 5 tonnes by way of common rules , and thus to approximate competitive conditions between all operators , this provision should be deleted , whereas the requirements regarding effective and stable establishment and appropriate financial standing should be rendered mandatory . ### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do 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 not exceeding that limit . the number of such undertakings has been increasing particularly on the national transport market , because of the use of light commercial vehicles in towns and on shorter routes . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector , prevent the use of loopholes and create fairer competition on the internal market without imposing unnecessary administrative and financial burdens on transport undertakings , particularly smes , the requirements for engagement in the occupation of road transport operator should apply equally for undertakings using vehicles or combinations of vehicles with a permissible laden mass not exceeding 3 . 5 tonnes involved in international transport and cabotage operations .


### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do 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 not exceeding that limit . the number of such undertakings which are active in both national and international transport operations has been increasing . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass not exceeding 3 . 5 tonnes by way of common rules , and thus to approximate competitive conditions between all operators , this provision should be deleted , whereas the requirements regarding effective and stable establishment and appropriate financial standing should be rendered mandatory . ### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do 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 not exceeding that limit . the number of such undertakings which are active in both national and international transport operations has been increasing even if they currently account for only 0 . 11 % of international traffic within the eu in terms of tonnes - kilometres . . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass of 2 . 4 to 3 . 5 tonnes for international transport by way of common rules , and thus to approximate competitive conditions between all operators , the requirements for engagement in the occupation of road transport operator should apply equally .


### manage the transport operations carried out with the vehicles referred to in point with the appropriate technical equiment situated in that member state ; ; ### manage effectively and continuously the transport operations carried out with the vehicles referred to in point with the appropriate technical equipment situated in that member state ;


### the information about transport operators contained in the national electronic registers should be as complete as possible to allow national authorities in charge of enforcing the relevant rules to have a sufficient overview of the operators being investigated . in particular , information regarding the registration number of the vehicles at the disposal of operators , the number of employees they hire , their risk rating and their basic financial information should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . the rules on the national electronic register should therefore be amended accordingly . ### the information about transport operators contained in the national electronic registers should be as complete as possible to allow national authorities in charge of enforcing the relevant rules and inspectors carrying out roadside checks to have a sufficient overview of the operators being investigated . in particular , information regarding the registration number of the vehicles at the disposal of operators , the number of employees they hire , their risk rating and their basic financial information should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . the rules on the national electronic register should therefore be amended accordingly .


### 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 or combinations of vehicles with a permissible laden mass exceeding 2 . 5 tonnes and less than 3 . 5 tonnes 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 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 by means of motor vehicles intended exclusively for the carriage of goods , involved in international transport and which have a permissible laden mass between 2 . 4 and 3 . 5 tonnes or with combinations of vehicles not exceeding that limit should have a minimum financial standing , to ensure that they have the means to carry out operations on a stable and long - lasting basis . however , since the operations conducted with these vehicles are generally of a limited size , the corresponding requirements should be less demanding than those applicable to operators using vehicles or combinations above that limit .


### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do 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 not exceeding that limit . the number of such undertakings which are active in both national and international transport operations has been increasing . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass not exceeding 3 . 5 tonnes by way of common rules , and thus to approximate competitive conditions between all operators , this provision should be deleted , whereas the requirements regarding effective and stable establishment and appropriate financial standing should be rendered mandatory . ### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do 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 not exceeding that limit . several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass of 2 , 8 to 3 . 5 tonnes for international transport by way of common rules , and thus to approximate competitive conditions between all operators , the requirements for engagement in the occupation of road transport operator should apply equally . the exemption should be made , however , as regards transport operations carried out with vehicles with a permissible laden mass not exceeding 3 . 5 tonnes in cross - border regions , carried out by transport operators from these regions , within 100 km radius from the border .


### ‘ 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 ; ’


### 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 . therefore , and in light of experience , it is necessary to clarify and strengthen the provisions set out in article 5 of regulation no 1071 / 2009 regarding the existence of an effective and stable establishment in order to combat the establishment of so - called letterbox companies .


### conduct effectively and continuously its administrative and commercial activities with the appropriate administrative equipment and facilities at premises situated in that member state ; ; ### conduct effectively and continuously its administrative and commercial activities with the appropriate administrative equipment and facilities at premises referred to in point situated in that member state ;


### 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 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 . the rules applicable to access to the occupation of road haulage operator using 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 are those set out in regulation no 1071 / 2009 .


### in view of their potential to considerably affect the road haulage market , as well as the social protection of workers , serious infringements of union rules on the posting of workers and the law applicable to contractual obligations should be added to the items relevant to the assessment of good repute . ### in view of their potential to considerably affect the road haulage market , as well as the social protection of workers , serious infringements of union rules on the posting of workers , cabotage and the law applicable to contractual obligations should be added to the items relevant to the assessment of good repute .


### conduct effectively and continuously its administrative and commercial activities with the appropriate administrative equipment and facilities at premises situated in that member state ; ; ### conduct effectively and continuously its administrative and commercial activities at premises situated in that member state and carry out its transport operations with the vehicles referred to in point with the appropriate technical equipment situated in that member state ;


### 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 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 . _______________


### define the degree of seriousness of infringements according to their potential to create a risk of fatalities or serious injuries and to distort competition in the road transport market , including by undermining the working conditions of transport workers ; ### define the degree of seriousness of infringements according to their potential to create a risk of fatalities or serious injuries , to distort competition in the road transport market , including by undermining the working conditions of transport workers , as well as the non - compliance with relevant union labour law ;


### 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 an establishment situated in that member state with premises in which it keeps its core business documents , in particular its contracts , accounting documents , personnel management documents , pay slips , documents containing data relating to cabotage 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 .


### 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 .


### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do 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 not exceeding that limit . the number of such undertakings which are active in both national and international transport operations has been increasing . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass not exceeding 3 . 5 tonnes by way of common rules , and thus to approximate competitive conditions between all operators , this provision should be deleted , whereas the requirements regarding effective and stable establishment and appropriate financial standing should be rendered mandatory . ### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do 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 not exceeding that limit . the number of such undertakings has been increasing particularly on the national transport market , because of the use of light commercial vehicles in towns and on shorter routes . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector , prevent the use of loopholes and create fairer competition on the internal market without imposing unnecessary administrative and financial burdens on transport undertakings , particularly smes , the requirements for engagement in the occupation of road transport operator should apply equally for undertakings using vehicles or combinations of vehicles with a permissible laden mass not exceeding 3 . 5 tonnes involved in international transport and cabotage operations .


### the information about transport operators contained in the national electronic registers should be as complete as possible to allow national authorities in charge of enforcing the relevant rules to have a sufficient overview of the operators being investigated . in particular , information regarding the registration number of the vehicles at the disposal of operators , the number of employees they hire , their risk rating and their basic financial information should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . the rules on the national electronic register should therefore be amended accordingly . ### the information about transport operators contained in the national electronic registers should be as complete as possible to allow national authorities in charge of enforcing the relevant rules to have a sufficient overview of the operators being investigated . in particular , information regarding the number of the vehicles at the disposal of operators , the number of drivers they hire , their risk rating and their basic financial information should allow a better national and cross - border enforcement of the provisions of regulations no 1071 / 2009 and no 1072 / 2009 . the rules on the national electronic register should therefore be amended accordingly .


### use of antimicrobial veterinary medicinal products for species or indications outside the terms of the marketing authorisation ### use of antimicrobial substances for species or indications outside the terms of the marketing authorisation


### veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the union at the date of the submission of the application ; ### veterinary medicinal products containing an active substance which has not been authorised as a veterinary medicinal product within the union at the date of the submission of the application , with the exception of veterinary medicinal products subject to authorisation under articles 21 and 22 ;


### 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 .


### 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 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 , and only once a veterinary diagnosis has been established following a clinical examination of the animal , or , in exceptional cases , in the light of continuous health checks on the animal .


### 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 .


### applications shall be submitted electronically . for applications submitted in accordance with the centralised marketing authorisation procedure , the formats made available by the agency shall be used . ### applications shall be submitted electronically using a single digital portal . for all applications submitted under this regulation , the formats made available by the agency shall be used .


### any necessary warnings ; ### any necessary warnings and restrictions ;


### by way of derogation from article 5 , a marketing authorisation for a limited market shall be granted for a period of 3 years . ### by way of derogation from article 5 , a marketing authorisation for a limited market shall be granted for a period of 5 years .


### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different member states before 1 january 2004 . ### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for groups of similar veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and have been shown to be bio - equivalents , for which national marketing authorisations have been granted in different member states before the entry into force of this new regulation and for which summaries of product characteristics approved at national level demonstrate a proven difference .


### where a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in that article shall be prolonged by 1 year for each additional target species , provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in article 34 . ### where a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in that article shall be prolonged by two years for each additional target species , provided that the variation has been submitted at least 34 years before the expiration of the protection period laid down in article 1 .


### 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 .


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


### retail of anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic veterinary medicinal products ### retail of prescription only veterinary medicinal products or active substances , with anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic properties


### it is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit - risk balance of certain veterinary antimicrobials in the union . any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the union . moreover , antimicrobial resistant organisms can spread to humans and animals in the union through consumption of products of animal origin imported from third countries , from direct contact with animals or humans in third countries or by other means . therefore , measures restricting the use of veterinary antimicrobials in the union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies . ### it is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit - risk balance of certain veterinary antimicrobials in the union . antimicrobial resistant organisms can spread to humans and animals in the union through consumption of products of animal origin imported from third countries , from direct contact with animals or humans in third countries or by other means . therefore , the eu should be active advocating the creation of an international strategy to combat antimicrobial resistance , in line with the recent global action plan adopted by the world health organisation .


### a marketing authorisation for a veterinary medicinal product shall be valid for an unlimited period of time . ### a marketing authorisation for a veterinary medicinal product shall be valid for five years . the authorisation may be renewed after five years on the basis of a re - evaluation of the risk - benefit balance . once renewed , the marketing authorisation shall be valid for an unlimited period , unless the competent authority decides , on justified grounds relating to pharmacovigilance , to proceed with one additional five - year renewal .


### in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans , it may be necessary to reserve those antimicrobials for humans only . therefore it should be possible to decide that certain antimicrobials , following the scientific recommendations of the agency , should not be available on the market in the veterinary sector . ### in order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans , it may be necessary to reserve those antimicrobials for humans only . therefore it should be possible to decide that certain antimicrobials , following the scientific recommendations of the agency , should not be available on the market in the veterinary sector ; the decisive criteria should be that the antibiotic is used in human medicine when other antibiotic therapies are no longer effective and that there is evidence that resistance in human beings cannot be excluded by use in animals .


### 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 .


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


### the agency shall establish and maintain a union database on pharmacovigilance of veterinary medicinal products . ### the agency shall establish and maintain a union database on pharmacovigilance of veterinary medicinal products . maintaining the database shall include electronic archiving of the original reports , related subsequent reports and continuous quality control of the data .


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


### where a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in that article shall be prolonged by 1 year for each additional target species , provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in article 34 . ### where the first marketing authorisation is granted for more than one species or a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in article 34 shall be prolonged by two years for each additional target species , provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in article 34 .


### by way of derogation from paragraph 2 , and until an implementing act referred to in paragraph 4 is established , if there is no product as referred to in subparagraphs and of paragraph 2 , a veterinarian may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat food - producing animals of an aquatic species on a particular holding with : a veterinary medicinal product authorised under this regulation in the member state concerned or in another member state for use with a food - producing non - aquatic species ; 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 . ### by way of derogation from paragraph 2 , and until an implementing act referred to in paragraph 4 is established , if there is no product as referred to in subparagraphs and of paragraph 2 , a veterinarian may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat food - producing animals of an aquatic species on a particular holding with : a veterinary medicinal product authorised under this regulation in the member state concerned or in another member state for use with a food - producing non - aquatic species ; or 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 726 / 2004 .


### 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 .


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


### approvals of clinical trials shall be granted on condition that food - producing animals used in the clinical trials or their produce do not enter the human food chain unless : the tested product is a veterinary medicinal product authorised for the food - producing species used in the clinical trial , and the withdrawal period set out in the summary of the product characteristics is respected , or the tested product is an authorised veterinary medicinal product for target species other than the food - producing species used in the clinical trial and the withdrawal period set out in accordance with article 117 is respected . ### member states shall not permit test animals to be used as a source of foodstuffs for human consumption unless the competent authorities have established an appropriate withdrawal period . such period shall either : be at least as long as the withdrawal period laid down in article 117 , including , where appropriate , a safety factor reflecting the nature of the substance being tested ; or if maximum residue limits have been established by the union in accordance with regulation no 470 / 2009 , the period shall be such as to ensure that those residue limits will not be exceeded in foodstuffs .


### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different member states before 1 january 2004 . ### harmonised conditions of use and quality parts shall be prepared in accordance with the procedure laid down in article 69 for groups of essentially similar veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different member states before 1 january 2004 .


### the immediate packaging of a veterinary medicinal product shall contain only the following information : ### the immediate packaging of a veterinary medicinal product shall contain only the information listed below . the applicant may include additional information in accordance with article 30 , if the packaging so permits :


### where a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in that article shall be prolonged by 1 year for each additional target species , provided that the variation has been submitted at least 3 years before the expiration of the protection period laid down in article 34 . ### where a variation is approved in accordance with article 65 extending the marketing authorisation to another species listed in article 34 , the period of the protection provided for in that article shall be prolonged by two years for each additional target species , provided that the variation has been submitted at least 34 years before the expiration of the protection period laid down in article 1 .


### veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation . ### veterinary medicinal products shall be used in accordance with the terms of marketing authorisation or registration .


### ‘ homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the european pharmacopoeia or , in the absence thereof , by the pharmacopoeias used officially in member states ; ### ‘ homeopathic veterinary medicinal product’ means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the european pharmacopoeia or , in the absence thereof , by the pharmacopoeias used officially in member states ; a homeopathic veterinary medicinal product may contain a number of active ingredients .


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


### any infringements of withdrawal period following administration to an animal of a veterinary or human medicinal product ; ### any infringements of withdrawal period following administration to an animal of a veterinary medicinal product ;


### upon request from the coordination group or the agency , holders of the marketing authorisations for products included in a group of similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their products . ### upon request from the coordination group or the agency , holders of the marketing authorisations for products included in a group of essentially similar products identified for a harmonisation of the summaries of the product characteristics , or individual holders of marketing authorisations for the same product identified for harmonisation of marketing authorisations shall submit information concerning their products , including a proposal for the harmonisation of the summaries of the product characteristics for their medicines belonging to that group .


### 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 points and , 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


### it is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit - risk balance of certain veterinary antimicrobials in the union . any measure restricting the use of those products may affect the trade of products of animal origin or the competitiveness of certain animal production sectors in the union . moreover , antimicrobial resistant organisms can spread to humans and animals in the union through consumption of products of animal origin imported from third countries , from direct contact with animals or humans in third countries or by other means . therefore , measures restricting the use of veterinary antimicrobials in the union should be based on scientific advice and should be considered in the context of cooperation with third countries and international organisations addressing antimicrobial resistance in order the ensure consistency with their activities and policies . ### it is important to consider the international dimension of the development of antimicrobial resistance when assessing the benefit - risk balance of certain veterinary antimicrobials in the union . antimicrobial resistant organisms can spread to humans and animals in the union through consumption of products of animal origin imported from third countries , from direct contact with animals or humans in third countries or by other means . therefore , the eu should be active advocating the creation of an international strategy to combat antimicrobial resistance , in line with the recent global action plan adopted by the world health organisation .


### before the expiry of the period of validity of 3 years , marketing authorisations for a limited market granted in accordance with article 21 shall be re - examined on application from the marketing authorisation holder . after the initial re - examination , it shall be re - examined every 5 years . ### before the expiry of the period of validity of 5 years , marketing authorisations for a limited market granted in accordance with article 21 shall be re - examined on application from the marketing authorisation holder . after the initial re - examination , it shall be re - examined , if necessary , every 5 years .


### 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 .


### retail of anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic veterinary medicinal products ### retail only of medicinal products which are subject to prescription , or active substances , with anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic properties


### the period of the protection of the first marketing authorisation prolonged by any additional periods of protection due to any variations or new authorisations belonging to the same marketing authorisation shall not exceed 18 years . ### the period of the protection of the first marketing authorisation shall not be prolonged by any additional periods due to any variations or new authorisations belonging to the same marketing authorisation . the variations or new authorisation should have their own period of protection . this protection shall be three years for each variation or new authorisation .


### upon request from the coordination group or the agency , holders of the marketing authorisations for products included in a group of similar products identified for a harmonisation of the summaries of the product characteristics shall submit information concerning their products . ### upon request from the coordination group or the agency , holders of marketing authorisations shall submit information concerning their products , including a proposal for harmonisation of the quality part and summaries of product characteristics for their medicines which belong to the group .


### veterinary medicinal products for animal species other than cattle , sheep , pigs , chickens , dogs and cats ; ### veterinary medicinal products for animal species other than cattle , pigs , chickens , dogs , cats , salmon and sheep reared for their meat ;


### 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 .


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


### 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 .


### by way of derogation from article 5 , a marketing authorisation in exceptional circumstances shall be granted for a period of 1 year . ### renewal of a marketing authorisation granted pursuant to paragraph 1 shall be tied to an annual review of the conditions set out in that paragraph , until the conditions are fulfilled .


### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different member states before 1 january 2004 . ### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for groups of similar veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and have been shown to be bio - equivalents , for which national marketing authorisations have been granted in different member states before the entry into force of this new regulation and for which summaries of product characteristics approved at national level demonstrate a proven difference .