### for other single - use plastic products , suitable and more sustainable alternatives that are also affordable are readily available . in order to limit the adverse impact of such products on the environment , member states should be required to prohibit their placing on the union market . by doing so , the use of those readily available and more sustainable alternatives as well as innovative solutions towards more sustainable business models , re - use alternatives and substitution of materials would be promoted . ### for other single - use plastic products , suitable and more sustainable alternatives that are also affordable are readily available . in order to limit the adverse impact of such products on the environment , member states should be required to prohibit their placing on the union market . by doing so , the use of those readily available and more sustainable alternatives as well as innovative solutions towards more sustainable business models , re - use alternatives and substitution of materials would be promoted . specific criteria should be laid down to determine whether these alternatives meet the requirements that are currently met by single - use plastic products , comply with eu legislation on waste and provide greater sustainability .


### certain single - use plastic products end up in the environment as a result of inappropriate disposal through sewers or other inappropriate release into the environment . therefore , single - use plastic products that are frequently disposed of through sewers or otherwise inappropriately disposed of should be subject to marking requirements . the marking should inform consumers about appropriate waste disposal options and / or waste disposal options to be avoided and / or about the negative environmental impacts of litter as a result of inappropriate disposal . the commission should be empowered to establish a harmonised format for the marking and when doing so should , where appropriate , test the perception of the proposed marking with representative groups of consumers to ensure that it is effective and clearly understandable . ### certain single - use plastic products end up in the environment as a result of inappropriate disposal through sewers or other inappropriate release into the environment . therefore , single - use plastic products that are frequently disposed of through sewers or otherwise inappropriately disposed of should be subject to marking requirements . the marking should inform consumers about appropriate waste disposal options and / or waste disposal options to be avoided and / or about the negative environmental impacts of litter as a result of inappropriate disposal . the commission should be empowered to establish a harmonised format for the marking and when doing so should , where appropriate , test the perception of the proposed marking with representative groups of consumers to ensure that it is effective and clearly understandable . with regard to fishing gear , the marking requirements adopted pursuant to regulation no 1224 / 2009 shall apply . the member states shall implement the fao voluntary guidelines on marking fishing gear .


### the large portion of plastic stemming from abandoned , lost and discarded fishing gear containing plastic in marine litter indicates that the existing legal requirements46 do not provide sufficient incentives to return such fishing gear to shore for collection and treatment . the indirect fee system envisaged under union law on port reception facilities for the delivery of waste from ships takes away the incentive for ships to discharge their waste at sea , and ensures a right of delivery . that system should , however , be supplemented by further financial incentives for fishermen to bring their fishing gear waste on shore to avoid any potential increase in the indirect waste fee to be paid . as plastic components of fishing gear have a high recycling potential , member states should , in line with the polluter pays principle , introduce extended producer responsibility for fishing gear containing plastic to facilitate separate collection of waste fishing gear and to finance sound waste management of such fishing gear , in particular recycling . _________________ 46 council regulation no 1224 / 2009 , directive 2000 / 59 / ec and directive 2008 / 98 / ec . ### the large portion of plastic stemming from abandoned , lost and discarded fishing gear containing plastic in marine litter indicates that the existing legal requirements46 do not provide sufficient incentives to return such fishing gear to shore for collection and treatment . on the other hand , some measures are already laid down in council regulation no 1224 / 2009 , in particular in a requirement on the master of a union fishing vessel to report within 24 hours to the competent authority of its flag member state any losses of fishing gear that cannot be retrieved . however , regulation no 1224 / 2009 does not monitor such losses of fishing gear in consistent way . furthermore , the indirect fee system envisaged under union law on port reception facilities for the delivery of waste from ships takes away the incentive for ships to discharge their waste at sea , and ensures a right of delivery . that system should , however , be supplemented by further financial incentives for fishermen to bring their fishing gear waste on shore to avoid any potential increase in the indirect waste fee to be paid . as plastic components of fishing gear have a high recycling potential , member states should , in line with the polluter pays principle , introduce extended producer responsibility for fishing gear containing plastic to facilitate separate collection of waste fishing gear and to finance sound waste management of such fishing gear , in particular recycling . such systems should provide for modulated financial contributions for gear designed for reuse and recycling , in line with the requirements of directive 2008 / 98 / ec . _________________ 46 council regulation no 1224 / 2009 , directive 2000 / 59 / ec and directive 2008 / 98 / ec .


### the large portion of plastic stemming from abandoned , lost and discarded fishing gear containing plastic in marine litter indicates that the existing legal requirements46 do not provide sufficient incentives to return such fishing gear to shore for collection and treatment . the indirect fee system envisaged under union law on port reception facilities for the delivery of waste from ships takes away the incentive for ships to discharge their waste at sea , and ensures a right of delivery . that system should , however , be supplemented by further financial incentives for fishermen to bring their fishing gear waste on shore to avoid any potential increase in the indirect waste fee to be paid . as plastic components of fishing gear have a high recycling potential , member states should , in line with the polluter pays principle , introduce extended producer responsibility for fishing gear containing plastic to facilitate separate collection of waste fishing gear and to finance sound waste management of such fishing gear , in particular recycling . _________________ 46 council regulation no 1224 / 2009 , directive 2000 / 59 / ec and directive 2008 / 98 / ec . ### the large portion of plastic stemming from abandoned , lost and discarded fishing gear containing plastic in marine litter and in passively fished waste collected during normal fishing operations indicates that the existing legal requirements46 do not provide sufficient incentives to return such fishing gear or such passively fished waste to shore for collection and treatment . under regulation no 1224 / 2009 , if lost fishing gear cannot be retrieved the master of the vessel must inform the competent authority of its flag member state . in order to ensure harmonised monitoring , the data on lost fishing gear shall be collected and recorded by the member states and forwarded annually to the commission . the indirect fee system envisaged under union law on port reception facilities for the delivery of waste from ships takes away the incentive for ships to discharge their waste at sea , and ensures a right of delivery . that system should , however , be supplemented by further financial incentives for fishermen to bring their fishing gear waste and passively fished waste on shore to avoid any potential increase in the indirect waste fee to be paid . the delivery of passively fished waste should not result in additional costs to be borne by fishermen . as plastic components of fishing gear have a high recycling potential , member states should , in line with the polluter pays principle , introduce extended producer responsibility for fishing gear containing plastic to facilitate separate collection of waste fishing gear and to finance sound waste management of such fishing gear , by laying down incentives for those sending these materials for recycling . _________________ 46 council regulation no 1224 / 2009 , directive 2000 / 59 / ec and directive 2008 / 98 / ec .


### the objective of this directive is to prevent and reduce the impact of certain plastic products on the environment , in particular the aquatic environment , and on human health as well as to promote the transition to a circular economy with innovative business models , products and materials , thus also contributing to the efficient functioning of the internal market . ### the objective of this directive is for the union to play its part in solving the global problem of marine litter due to plastic , by preventing and reducing the impact of certain plastic products on the environment , in particular the aquatic environment , and on human health as well as by promoting the transition to a circular economy with innovative business models , products and materials , thus also contributing to the efficient functioning of the internal market .


### ‘ fishing gear’ means any item or piece of equipment that is used in fishing and aquaculture to target or capture marine biological resources or that is floating on the sea surface and is deployed with the objective of attracting and capturing such marine biological resources ; ### ‘ fishing gear’ means any item or piece of equipment that is used in fishing and aquaculture to target or capture or retain for farming marine biological resources or that is floating on the sea surface and is deployed with the objective of attracting , capturing or retaining such marine biological resources ;


### ‘ producer’ means any natural or legal person that , irrespective of the selling technique used , including distance contracts within the meaning of directive 2011 / 83 / eu of the european parliament and of the council of 25 october 201150 , places on the market single - use plastic products and fishing gear containing plastic except persons carrying out fishing activities as defined in article 4 of regulation no 1380 / 2013 of the european parliament and of the council51 ; _________________ 50 directive 2011 / 83 / eu of the european parliament and of the council of 25 october 2011 on consumer rights , amending council directive 93 / 13 / eec and directive 1999 / 44 / ec of the european parliament and of the council and repealing council directive 85 / 577 / eec and directive 97 / 7 / ec of the european parliament and of the council . 51 regulation no 1380 / 2013 of the european parliament and of the council of 11 december 2013 on the common fisheries policy , amending council regulations no 1954 / 2003 and no 1224 / 2009 and repealing council regulations no 2371 / 2002 and no 639 / 2004 and council decision 2004 / 585 / ec . ### ‘ producer’ means any natural or legal person that , irrespective of the selling technique used , including distance contracts within the meaning of directive 2011 / 83 / eu of the european parliament and of the council of 25 october 201150 , places on the market single - use plastic products and fishing gear containing plastic except persons carrying out fishing activities or aquaculture as defined in article 4 and of regulation no1380 / 2013 of the european parliament and of the council51 ; _________________ 50 directive 2011 / 83 / eu of the european parliament and of the council of 25 october 2011 on consumer rights , amending council directive 93 / 13 / eec and directive 1999 / 44 / ec of the european parliament and of the council and repealing council directive 85 / 577 / eec and directive 97 / 7 / ec of the european parliament and of the council . 51 regulation no 1380 / 2013 of the european parliament and of the council of 11 december 2013 on the common fisheries policy , amending council regulations no 1954 / 2003 and no 1224 / 2009 and repealing council regulations no 2371 / 2002 and no 639 / 2004 and council decision 2004 / 585 / ec .


### information on monitoring of implementation ### information on monitoring of implementation and reporting obligations


### the commission may adopt implementing acts laying down the format for the data set , information and data referred to in paragraph 1 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 16 . ### the commission shall adopt implementing acts laying down the format for the data set , information and data referred to in paragraphs 1 and 3a . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 16 .


### 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 authority should be established in order to help strengthen fairness , trust and providing a level playing field 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 and enforcement of the union law in these areas , and mediate and facilitate a solution in case of cross - border disputes , a persistent lack of cooperation in cross - border enforcement of the rules or labour market disruptions .


### 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 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 cross - border provision of services . it should also oblige 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 authority should support member states in fulfilling their responsibilities and thereby help them to exploit any synergy effects in order to work as efficient as possible .


### in certain instances , sector - specific union law has been adopted in order to respond to specific needs in that sector , such as the area of international transport . the authority should also deal with the cross - border aspects of the application of such sector - specific union law , in particular regulation no 561 / 2006 of the european parliament and the council49 , directive 2006 / 22 / ec of the european parliament and the council50 , regulation no 1071 / 2009 of the european parliament and the council51 and directive 278 ) 52 . _________________ 49 regulation no 561 / 2006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations no 3821 / 85 and no 2135 / 98 and repealing council regulation no 3820 / 85 . 50 directive 2006 / 22 / ec of the european parliament and of the council of 15 march 2006 on minimum conditions for the implementation of council regulations no 3820 / 85 and no 3821 / 85 concerning social legislation relating to road transport activities and repealing council directive 88 / 599 / eec . 51 regulation no 1071 / 2009 of the european parliament and of the council of 21 october 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing council directive 96 / 26 / ec . 52 com278 – proposal for a directive of the european parliament and of the council amending directive 2006 / 22 / ec as regards enforcement requirements and laying down specific rules with respect to directive 96 / 71 / ec and directive 2014 / 67 / eu for posting drivers in the road transport sector . ### in certain instances , sector - specific union law has been adopted in order to respond to specific needs in that sector , such as the area of international transport . the authority should also deal with the cross - border aspects of the application of such sector - specific union law , in particular regulation no 561 / 2006 of the european parliament and the council49 , directive 2006 / 22 / ec of the european parliament and the council50 , regulation no 1072 / 2009 , directive no 2002 / 15 , regulation no 1071 / 2009 of the european parliament and the council51 and directive 278 ) 52 , as well as regulation no 1008 / 2008 . _________________ 49 regulation no 561 / 2006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations no 3821 / 85 and no 2135 / 98 and repealing council regulation no 3820 / 85 . 50 directive 2006 / 22 / ec of the european parliament and of the council of 15 march 2006 on minimum conditions for the implementation of council regulations no 3820 / 85 and no 3821 / 85 concerning social legislation relating to road transport activities and repealing council directive 88 / 599 / eec . 51 regulation no 1071 / 2009 of the european parliament and of the council of 21 october 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing council directive 96 / 26 / ec . 52 com278 – proposal for a directive of the european parliament and of the council amending directive 2006 / 22 / ec as regards enforcement requirements and laying down specific rules with respect to directive 96 / 71 / ec and directive 2014 / 67 / eu for posting drivers in the road transport sector .


### in certain instances , sector - specific union law has been adopted in order to respond to specific needs in that sector , such as the area of international transport . the authority should also deal with the cross - border aspects of the application of such sector - specific union law , in particular regulation no 561 / 2006 of the european parliament and the council49 , directive 2006 / 22 / ec of the european parliament and the council50 , regulation no 1071 / 2009 of the european parliament and the council51 and directive 278 ) 52 . __________________ 49 regulation no 561 / 2006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations no 3821 / 85 and no 2135 / 98 and repealing council regulation no 3820 / 85 . 50 directive 2006 / 22 / ec of the european parliament and of the council of 15 march 2006 on minimum conditions for the implementation of council regulations no 3820 / 85 and no 3821 / 85 concerning social legislation relating to road transport activities and repealing council directive 88 / 599 / eec . 51 regulation no 1071 / 2009 of the european parliament and of the council of 21 october 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing council directive 96 / 26 / ec . 52 com278 – proposal for a directive of the european parliament and of the council amending directive 2006 / 22 / ec as regards enforcement requirements and laying down specific rules with respect to directive 96 / 71 / ec and directive 2014 / 67 / eu for posting drivers in the road transport sector . ### in certain instances , sector - specific union law has been adopted in order to respond to specific needs in that sector , such as the area of international transport . the authority should also deal with the cross - border aspects of the application of such sector - specific union law , in particular regulation no 561 / 2006 of the european parliament and the council49 , directive 2006 / 22 / ec of the european parliament and the council50 , regulation no 1071 / 2009 of the european parliament and the council51 , directive 278 ) 52 and regulation no 1008 / 2008 of the european parliament and the council52a . __________________ 49 regulation no 561 / 2006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations no 3821 / 85 and no 2135 / 98 and repealing council regulation no 3820 / 85 . 50 directive 2006 / 22 / ec of the european parliament and of the council of 15 march 2006 on minimum conditions for the implementation of council regulations no 3820 / 85 and no 3821 / 85 concerning social legislation relating to road transport activities and repealing council directive 88 / 599 / eec . 51 regulation no 1071 / 2009 of the european parliament and of the council of 21 october 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing council directive 96 / 26 / ec . 52 com278 – proposal for a directive of the european parliament and of the council amending directive 2006 / 22 / ec as regards enforcement requirements and laying down specific rules with respect to directive 96 / 71 / ec and directive 2014 / 67 / eu for posting drivers in the road transport sector . 52a regulation no 1008 / 2008 of the european parliament and of the council of 24 september 2008 on common rules for the operation of air services in the community , oj l 293 , 31 . 10 . 2008


### the individuals covered by the activities of the authority should be persons who are subject to the union law within the scope of this regulation , including workers , self - employed persons , jobseekers , and economically non - active persons ; this should cover both union citizens and third - country nationals who are legally resident in the union , such as posted workers , eu blue card holders , intra - corporate transferees or long - term residents , as well as their family members . ### the individuals covered by the activities of the authority should be persons who are subject to the union law within the scope of this regulation , including workers , self - employed persons , jobseekers , and economically non - active persons ; this should cover both union citizens and third - country nationals who are legally resident in the union , such as posted workers , eu blue card holders , intra - corporate transferees or long - term residents , as well as their family members . this shall also apply to workers from third countries who are not legally resident in the union but are subject to postings of any duration to the eu .


### 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 fair , simple and effective application of union law , the authority should improve cooperation and timely exchange of information between member states . together with other staff , national liaison officers working within the authority should help member states to comply with their 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 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 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 . furthermore , the authority should encourage the establishment and use of the following systems for the exchange of information : – the european register of road transport undertakings , with a legal basis in article 16 of regulation no 1071 / 20091a , through which an interconnection is established between the national registers of transport undertakings and activities in each member state , making it possible to exchange information on operators contained in these national databases in an effective and harmonised manner ; – the internal market information system , with a legal basis in regulation no 1024 / 2012 , through which the member states will be able to establish administrative cooperation and exchange data and information with regard to the enforcement of the rules . similarly , with the objective of using imi for the sending and updating of posting declarations between transport operators and the competent authorities of the receiving member states , it will be necessary to develop a parallel public interface within the imi system to which transport operators will have access . with the objective of verifying the correct application of and compliance with union law , inspectors responsible for roadside checks will have direct real - time access , via an electronic application common to all member states , both to the system interconnecting national registers of transport undertakings and activities , erru , and to information on the driver’s posting declaration through the imi . in this context , the authority should promote this electronic application that will provide direct real - time access to the erru and imi during roadside checks . __________________ 1a regulation no 1071 / 2009 of the european parliament and of the council of 21 october 2009 establishing common rules concerning the conditions to be complied with to pursue the occupation of road transport operator and repealing council directive 96 / 26 / ec , oj l 300 , 14 . 11 . 2009


### 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 in relation to union law within its scope , the authority should support the national authorities in carrying out concerted and joint inspections , both at the workplace or roadside and at the premises , 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 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 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 order to ensure proper application of this regulation , all officials participating in concerted or joint inspections should have minimum investigation powers . the results of the joint inspections should have legal effects in the member states concerned .


### to strengthen the capacity of national authorities and improve consistency in the application of union law within its scope , the authority should provide operational assistance to national authorities , including by developing practical guidelines , establishing training and peer learning programmes , promoting mutual assistance projects , facilitating staff exchanges such as those referred to in article 8 of directive 2014 / 67 / eu , and supporting member states in organising awareness - raising campaigns informing individuals and employers of their rights and obligations . the authority should promote the exchange , dissemination and uptake of good practices . ### despite various previous initiatives , administrative cooperation at a national level remains limited and exchanges of information are sporadic and incomplete . to strengthen the capacity of national authorities and improve consistency in the application of union law within its scope , the authority should provide operational assistance to national authorities , including by developing practical guidelines , establishing training and peer learning programmes , promoting mutual assistance projects , facilitating staff exchanges such as those referred to in article 8 of directive 2014 / 67 / eu , and supporting member states in organising awareness - raising campaigns informing individuals and employers of their rights and obligations . the authority should promote the exchange , dissemination and uptake of good practices .


### to strengthen the capacity of national authorities and improve consistency in the application of union law within its scope , the authority should provide operational assistance to national authorities , including by developing practical guidelines , establishing training and peer learning programmes , promoting mutual assistance projects , facilitating staff exchanges such as those referred to in article 8 of directive 2014 / 67 / eu , and supporting member states in organising awareness - raising campaigns informing individuals and employers of their rights and obligations . the authority should promote the exchange , dissemination and uptake of good practices . ### to strengthen the capacity of national authorities and improve consistency in the application and enforcement of union law within its scope , the authority should provide operational and technical assistance to national authorities , including by developing practical guidelines , establishing training and peer learning programmes , promoting mutual assistance projects and regular peer - reviews , facilitating staff exchanges such as those referred to in article 8 of directive 2014 / 67 / eu , and supporting member states in organising awareness - raising campaigns informing individuals and employers of their rights and obligations . the authority should promote the exchange , dissemination and uptake of good practices .


### the member states and the commission should be represented on a management board , in order to ensure the effective functioning of the authority . the composition of the management board , including the selection of its chair and deputy - chair , should respect the principles of gender balance , experience and qualification . in view of the effective and efficient functioning of the authority , the management board , in particular , should adopt an annual work programme , carry out its functions relating to the authority’s budget , adopt the financial rules applicable to the authority , appoint an executive director , and establish procedures for taking decisions relating to the operational tasks of the authority by the executive director . representatives from countries other than union member states , which are applying the union rules within the scope of the authority , may participate in the meetings of the management board as observers . ### the member states and the commission should be represented on a management board , in order to ensure the effective functioning of the authority . the composition of the management board , including the selection of its chair and deputy - chair , should respect the principles of gender balance , experience , qualification and equitable geographical representation . in view of the effective and efficient functioning of the authority , the management board , in particular , should adopt an annual work programme , carry out its functions relating to the authority’s budget , adopt the financial rules applicable to the authority , appoint an executive director , and establish procedures for taking decisions relating to the operational tasks of the authority by the executive director . representatives from countries other than union member states , which are applying the union rules within the scope of the authority , may participate in the meetings of the management board as observers .


### to guarantee its full autonomy and independence , the authority should be granted an autonomous budget , with revenue coming from the general budget of the union , any voluntary financial contribution from the member states and any contribution from third countries participating in the work of the authority . in exceptional and duly justified cases it should also be in the position to receive delegation agreements or ad hoc grants , and to charge for publications and any service provided by the authority . ### to guarantee its full autonomy and independence , the authority should be granted an autonomous budget , with revenue coming from the general budget of the union and any voluntary financial contribution from the member states participating in the work of the authority . in exceptional and duly justified cases it should also be in the position to receive delegation agreements or ad hoc grants , and to charge for publications and certain services provided by the authority at the request of interested parties .


### 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 field of activity of the authority shall comprise ensuring fairness in the field of cross - border labour mobility , fight against social dumping and improving the coordination of social security systems within the union .


### the authority shall encourage the use of innovative approaches to effective and efficient cross - border cooperation , and explore the potential use of electronic exchange mechanisms between the member states to facilitate the detection of fraud , providing reports to the commission with a view to their further development . ### the authority shall encourage the use of digital tools and innovative approaches to effective and efficient cross - border cooperation , and play a central role in developing electronic exchange mechanisms between the member states to facilitate the detection of fraud , in particular by using electronic application that shall provide direct real - time access to the erru , eessi and imi during roadside checks through which national authorities can access relevant data in real time . it shall provide reports to the commission with a view to their further development .


### 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 . these inspections may take place both at the workplace or roadside and at the premises . 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 .


### promote the exchange and dissemination of experiences and good practices , including examples of cooperation between the relevant national authorities ; ### promote the exchange and dissemination of experiences and best practices , including examples of cooperation between the relevant national authorities ;


### the stakeholder group shall be composed of six representatives of union - level social partners equally representing trade unions and employer’s organisations , and two representatives of the commission . ### the stakeholder group shall be composed of six representatives of union - level social partners equally representing trade unions and employer’s organisations , and two representatives of the commission . the members may be accompanied by experts to meetings of the stakeholders group .


### 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 harmonised and allow the competent national authorities , including road inspectors , direct real - time access to provide them with a clear and complete overview of the transport operators being checked or 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 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 vehicles at the disposal of operators , the number of drivers and their risk rating , which 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 means by which road transport operators can prove compliance with the rules for cabotage operations should be clarified . the use and transmission of electronic transport information should be recognised as such means , which should simplify the provision of relevant evidence and its treatment by the competent authorities . the format used for that purpose should ensure reliability and authenticity . considering the increasing use of efficient electronic exchange of information in transport and logistics , it is important to ensure coherence in the regulatory frameworks and provisions addressing the simplification of administrative procedures . ### the means by which road transport operators can prove compliance with the rules for cabotage operations should be clarified . the use and transmission of electronic transport information should be recognised as such means , which should simplify the provision of relevant evidence and its treatment by the competent authorities . the format used for that purpose should ensure reliability and authenticity . to this end , further digitalization of enforcement capacity and documentation is essential and should be further encouraged at national and eu level , beginning with the introduction and use of smart tachographs and with the tools communicating remotely with smart tachographs , which are necessary for the roadside enforcement authorities . considering the increasing use of efficient electronic exchange of information in transport and logistics , it is important to ensure coherence in the regulatory frameworks and provisions addressing the simplification of administrative procedures .


### the means by which road transport operators can prove compliance with the rules for cabotage operations should be clarified . the use and transmission of electronic transport information should be recognised as such means , which should simplify the provision of relevant evidence and its treatment by the competent authorities . the format used for that purpose should ensure reliability and authenticity . considering the increasing use of efficient electronic exchange of information in transport and logistics , it is important to ensure coherence in the regulatory frameworks and provisions addressing the simplification of administrative procedures . ### the means by which road transport operators can prove compliance with the rules for cabotage operations should be clarified . the use and transmission of electronic transport information should be recognised as such means , which should simplify the provision of relevant evidence and its treatment by the competent authorities . the format used for that purpose should ensure reliability and authenticity . considering the increasing use of efficient electronic exchange of information in transport and logistics , it is important to ensure coherence in the regulatory frameworks and provisions addressing the simplification of administrative procedures , while avoiding the creation of a new database in order not to impose an additional burden on international transport operators , in particular smes .


### article 3 and and articles 4 , 6 , 8 , 9 , 14 , 19 and 21 shall not apply to undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or combinations of vehicles with a permissible laden mass not exceeding 3 . 5 tonnes . ### ' 6 . article 3 and and articles 4 , 6 , 8 , 9 , 14 , 19 and 21 shall not apply to undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles or combinations of vehicles with a permissible laden mass not exceeding 2 . 8 tonnes . member states may , however , lower this limit for all or some categories of road transport operations ;


### 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 premises in which it keeps its original business documents , or ensure access to the documents electronically , in particular its transport contracts , accounting documents , personnel management documents , labour contracts , social security documents , documents relating to collective agreements , where appropriate , 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 ;


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


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


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


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


### animals may suffer from a broad range of diseases which can be prevented or treated . the impact of animal diseases and the measures necessary to control them can be devastating for individual animals , animal populations , animal keepers and the economy . animal diseases transmissible to humans may also have a significant impact on public health . therefore sufficient and effective veterinary medicinal products should be available in the union in order to ensure high standards of animal and public health , and for the development of the agriculture and aquaculture sectors . ### animals may suffer from a broad range of diseases which can be prevented or treated . the impact of animal diseases and the measures necessary to control them can be devastating for individual animals , animal populations , animal keepers and the economy . animal diseases transmissible to humans may also have a significant impact on public health . therefore sufficient and effective veterinary medicinal products should be available in the union in order to ensure high standards of animal and public health , and for the development of the agriculture and aquaculture sectors . to this end , good husbandry and management practices have to be put place in order to improve animal welfare , limit the spread of diseases , prevent antimicrobial resistance and ensure proper nutrition of livestock .


### 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 . veterinarians are the only professional authorised to prescribe medicinal products to animals , 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 veterinarians should be restricted to the amount required to continue the treatment until the medicinal product prescribed by the veterinarian is obtained by the farmer or by the owner and only for treatment of the animals under their care .


### 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 . 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 . to this end , it is necessary to develop an international strategy to combat antimicrobial resistance .


### the illegal sale of veterinary medicinal products to the public via the internet may represent a threat to public and animal health , as falsified or substandard medicines may reach the public in this way . it is necessary to address this threat . account should be taken of the fact that specific conditions for supply of medicinal products to the public have not been harmonised at union level and , therefore , member states may impose conditions for supplying medicinal products to the public within the limits of the treaty . ### the illegal sale of veterinary medicinal products to the public via the internet may represent a threat to public and animal health , as falsified or substandard medicines may reach the public in this way . it is necessary to address this threat . account should be taken of the fact that specific conditions for the supply of medicinal products to the public have not been harmonised at union level and , therefore member states may impose conditions for supplying medicinal products to the public within the limits of the treaty . the online sale of antibiotics should be prohibited .


### this regulation lays down rules for the placing on the market , manufacture , import , export , supply , pharmacovigilance , control and use of veterinary medicinal products . ### this regulation lays down rules for the placing on the market , development , manufacture , import , export , wholesale distribution , retail supply , pharmacovigilance , control and use of veterinary medicinal products .


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


### ' antimicrobial resistance ' means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill microorganisms of the same species ; ### ' antimicrobial resistance ' means the ability of bacteria to withstand the effects of antimicrobial agents that are intended to inhibit or kill them ;


### ‘ clinical trial ' means a study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product or both under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof ; ### ‘ clinical trial ' means a scientific study not falling under the scope of directive 2010 / 63 / eu , conducted in a target species in accordance with good clinical practice under field conditions to test at least one hypothesis relevant to efficacy claim or to in - use safety in the target animal for a veterinary medicinal product under investigation for the purpose of obtaining a marketing authorisation for the veterinary medicinal product concerned or variation thereof ; in case of immunological veterinary medicinal product the study is a ' field trial ' ;


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


### ‘ common name ' means the international non - proprietary name recommended by the world health organisation for a veterinary medicinal product , or , if one does not exist , the name generally used ; ### ' common name ' means the international non - proprietary name recommended by the world health organisation , or , if one does not exist , the usual common name ;


### ‘ package leaflet ' means a documentation leaflet on a veterinary medicinal product which contains information to ensure its safe and efficacious use ; ### ' package leaflet ' means an information leaflet which attached to a veterinary medicinal product which is intended for a user of the veterinary medicinal product and which contains information to ensure its safe and efficacious use which are compliant with the information provided for in the summary of product characteristics of the veterinary medicinal product ;


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


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


### ' withdrawal period ' means the minimum period between the last administration of a veterinary medicinal product to an animal and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs do not contain residues in quantities harmful to public health ; ### ' withdrawal period ' means the period between the last administration of a veterinary medicinal product to an animal under normal conditions of use and in accordance with the provisions of this regulation and the production of foodstuffs from that animal which under normal conditions of use is necessary to ensure that such foodstuffs comply with requirements laid down pursuant to regulation 470 / 2009 ;


### ‘ making available on the market ' means any supply of a veterinary medicinal product for distribution , consumption or use on the union market in the course of a commercial activity , whether in return for payment or free of charge ; ### ‘ making available on the market ' means any supply of a veterinary medicinal product for distribution , consumption or use on the market of a member state in the course of a commercial activity , whether in return for payment or free of charge ;


### a veterinary medicinal product shall be placed on the market only when a marketing authorisation has been granted in respect of the product by a competent authority in accordance with articles 44 , 46 or 48 or by the commission in accordance with article 40 . ### without prejudice to other provisions of this regulation , a veterinary medicinal product shall be placed on the market of a member state only when a marketing authorisation has been granted in respect of the product by a the competent authority of that member state or by the commission in accordance this regulation .


### the mutual recognition procedure laid down in articles 47 and 48 . ### the mutual recognition procedure laid down in articles 47 , 48 and 57 .


### 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 or saved in exceptional circumstances and following agreement with a competent authority , or , in case of central application , with the agency . the commission , in collaboration with the member states and with the agency shall adopt detailed guidelines for the format of electronic applications .


### within 15 days of receipt of the application , the competent authority or the agency shall notify the applicant of whether all data required in accordance with article 7 have been presented . ### without prejudice to specific provisions related to mutual recognition procedure and decentralised procedure , the competent authority or the agency shall , within 15 days of receipt of the application , notify the applicant of the formal requirements laid down in this regulation for the application concerned have been met and whether the application can be subject to scientific assessment .


### where the application concerns a veterinary medicinal product intended for food - producing target species and containing pharmacologically active substances that are not listed in table 1 of the annex to regulation no 37 / 2010 for the animal species in question , a document certifying that a valid application for the establishment of maximum residue limits has been submitted to the agency in accordance with regulation no 470 / 2009 of the european parliament and of the council22 shall be submitted in addition to the information listed in paragraph 1 . __________________ 22 regulation no 470 / 2009 of the european parliament and of the council of 6 may 2009 laying down community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin , repealing council regulation no 2377 / 90 and amending directive 2001 / 82 / ec of the european parliament and of the council and regulation no 726 / 2004 of the european parliament and of the council . ### where the application concerns a veterinary medicinal product intended for food - producing target species and containing pharmacologically active substances that are not listed in table 1 of the annex to regulation no 37 / 2010 for the animal species in question , a document shall be submitted in addition to the information listed in paragraph 1 certifying that a valid application for the establishment of maximum residue limits has been submitted to the agency in accordance with regulation no 470 / 2009 of the european parliament and of the council and that at least six months has elapsed from submission of such application __________________ 22 regulation no 470 / 2009 of the european parliament and of the council of 6 may 2009 laying down community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin , repealing council regulation no 2377 / 90 and amending directive 2001 / 82 / ec of the european parliament and of the council and regulation no 726 / 2004 of the european parliament and of the council .


### the information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters , or , where appropriate , abbreviations or pictograms common throughout the union . ### the information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters , or , where appropriate , abbreviations or pictograms common throughout the union . in exceptional cases , the applicant , or the competent authority may request additional text to be included where this is justified to ensure safe and correct administration of the product .


### the information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters , or , where appropriate , abbreviations or pictograms common throughout the union . ### the information listed in paragraph 1 shall appear in easily legible and clearly comprehensible characters , or , where appropriate , abbreviations or pictograms common throughout the union . in exceptional cases , the applicant or the competent authority may request additional text to be included where this is justified to ensure the safe and correct administration of the product .


### the package leaflet shall be available for each veterinary medicinal product and shall contain at least the following information : ### the package leaflet shall be attached to each veterinary medicinal product and shall contain at least the following information :


### target species ; ### target species ; dosage levels for the different target species ;


### by way of derogation from article 7 an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products , but have not hitherto been authorised in that combination shall satisfy the following criteria : ### by way of derogation from article 7 an application for a marketing authorisation for a veterinary medicinal product containing a combination of active substances that have each already been used in authorised veterinary medicinal products shall satisfy the following criteria :


### a requirement to notify the competent authorities of any incident relating to the use of the veterinary medicinal product ; ### a requirement to notify the competent authorities of any adverse event relating to the use of the veterinary medicinal product .


### a competent authority or the commission shall classify the following veterinary medicinal products as subject to veterinary prescription : ### the following veterinary medicinal products shall be subject to veterinary prescription :


### a competent authority or the commission shall classify the following veterinary medicinal products as subject to veterinary prescription : ### a competent authority or the commission shall classify the following veterinary medicinal products as subject to mandatory veterinary prescription :


### a competent authority or the commission may classify a veterinary medicinal product as subject to veterinary prescription where special precautions are contained in the summary of product characteristics referred to in article 30 , and in particular potential risks to : ### a veterinary medicinal product shall be classified as subject to veterinary prescription where special precautions are contained in the summary of product characteristics referred to in article 30 , and in particular potential risks to :


### a competent authority or the commission may classify a veterinary medicinal product as subject to veterinary prescription where special precautions are contained in the summary of product characteristics referred to in article 30 , and in particular potential risks to : ### a competent authority or the commission may classify a veterinary medicinal product as subject to mandatory veterinary prescription where special precautions are contained in the summary of product characteristics referred to in article 30 , and in particular potential risks to :


### by the way of derogation from paragraph 1 , a competent authority or the agency may not classify a veterinary medicinal product as subject to veterinary prescription if all of the following conditions are fulfilled : ### a competent authority or the agency may classify a veterinary medicinal product as not subject to veterinary prescription if paragraphs 1 and 2 do not apply and all of the following conditions are fulfilled :


### by the way of derogation from paragraph 1 , a competent authority or the agency may not classify a veterinary medicinal product as subject to veterinary prescription if all of the following conditions are fulfilled : ### by the way of derogation from paragraph 1 , a competent authority or the agency may not classify a veterinary medicinal product as subject to mandatory veterinary prescription if all of the following conditions are fulfilled :


### the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious side effects deriving from its correct use ; ### the summary of the product characteristics of the veterinary medicinal product does not contain any warnings of potential serious adverse events deriving from its correct use ;


### there is no risk to public or animal health as regards the development of resistance to anthelmintic substances even where the veterinary medicinal products containing those substances are used incorrectly . ### there is no risk to public or animal health as regards the development of antimicrobial or antiparasitic resistance even where the veterinary medicinal products containing those substances are used incorrectly


### qualitative and quantitative composition of the active substances or other constituents stating the common name or the chemical description of the substances or other constituents ; ### qualitative and quantitative composition of the active substances and all the essential constituents , stating the common name or the chemical description of the substances or other constituents ;


### the withdrawal period is not long enough to ensure food safety ; ### the proposed withdrawal period to ensure food safety is not well justified , or the proposed withdrawal period by the agency or by the competent authorities is not taken into account ;


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


### 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 , pigs , chickens , salmons , dogs and cats .


### prolongation of the periods of the protection of technical documentation ### grant of periods of the protection of technical documentation


### 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 granted of the protection provided for in that article shall be prolonged by 1 year for each additional target species .


### applications for decentralised marketing authorisation shall be submitted to the member state chosen by the applicant . ### applications and the dossier for decentralised marketing authorisation shall be submitted to all the member states . the member state chosen by the applicant is the .


### applications for mutual recognition of marketing authorisations shall be submitted to the member state that granted the first national marketing authorisation . ### applications and the dossier for mutual recognition of marketing authorisations shall be submitted to all the member states . the member state that granted the first national marketing authorisation is the .


### applications for mutual recognition of marketing authorisations shall be submitted to the member state that granted the first national marketing authorisation . ### identical applications for mutual recognition of marketing authorisations shall be submitted to the member state that granted the first national marketing authorisation and the member states where the applicant seeks to obtain recognition of the marketing authorisation .


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


### veterinary medicinal products authorised within the union by the commission and by the competent authorities , together with their summaries of product characteristics , package leaflets and lists of sites where each product is manufactured ; ### veterinary medicinal products authorised within the union by the commission and by the competent authorities , together with their summaries of product characteristics , package leaflets , and lists of sites where each product is manufactured and reference numbers to the pharmacovigilance system master file ;


### member states shall send data on the volume of sales and the use of veterinary antimicrobial medicinal products to the agency . the agency shall analyse the data and publish an annual report . ### member states shall send to the agency data on the volume of sales and the use of veterinary antimicrobial medicinal products as well as data on how , when , where and why antimicrobials are being used . the agency shall analyse the data and publish an annual report .


### marketing authorisation holders shall elaborate and maintain a system for collecting information on the risks of veterinary medicinal products as regards animal health , public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed in articles 73 , 76 and 77 . ### marketing authorisation holders shall ensure that benefit - risk balance of the authorised veterinary medicinal products is evaluated on a continuous basis and that appropriate measure are taken by the marketing authorisation holders in order ensure that the benefit - risk balance remains positive for the authorised veterinary medicinal products . to this end , the marketing authorisation holders elaborate and maintain a system for collecting , investigating , assessment and communicating of information on the risks of veterinary medicinal products as regards animal health , public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed in articles 73 , 76 and 77 .


### marketing authorisation holders shall elaborate and maintain a system for collecting information on the risks of veterinary medicinal products as regards animal health , public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed in articles 73 , 76 and 77 . ### marketing authorisation holders shall elaborate and maintain a system for collecting information on the adverse events of veterinary medicinal products as regards animal health , public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed in articles 73 , 76 and 77 .


### competent authorities and the agency shall supervise the pharmacovigilance systems of marketing authorisation holders . ### competent authorities and , where the centrally authorised products are concerned , the committee shall supervise the pharmacovigilance systems of marketing authorisation holders .


### 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 , the agency and marketing authorisation holders shall collaborate in setting up and maintaining a system to monitor , on a continuous basis benefit - risk balance of authorised veterinary medicinal products and enabling them to fulfil their responsibilities as listed in articles 77 and 79 .


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


### any response in an animal to a veterinary or human medicinal product , that is noxious and unintended ; ### any response in an animal to a veterinary medicinal product , that is noxious and unintended ;


### the agency shall , in collaboration with the member states and the commission , draw up the functional specifications for the pharmacovigilance database . ### commission shall , in collaboration with the agency and with the member states and the commission , draw up the functional specifications for the pharmacovigilance database .


### the number of adverse events reported each year , broken down by product , animal species and type of adverse event ; ### the number of adverse events reported each year , broken down by product and active substance , animal species and type of adverse event ;


### the number of adverse events reported each year , broken down by product , animal species and type of adverse event ; ### the number of adverse events reported each year , broken down by type of product , animal species and type of adverse event ;


### competent authorities shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their member state , within 30 days following the receipt of the adverse event report . ### competent authorities shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their member state , within 30 days following the receipt of the adverse event report . serious adverse event in animals , noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported within 15 days following the receipt of such adverse event report .


### competent authorities may , on their own initiative or on request from the agency , request the marketing authorisation holder to collect specific pharmacovigilance data , in particular regarding the use of a veterinary medicinal product in specified animal species , in the context of public and animal health , safety of the persons administering the product , and the protection of the environment . the authority shall state in detail the reasons for the request and inform other competent authorities and the agency thereof . ### competent authorities may , on their own initiative or on a request from the agency , request the marketing authorisation holder to provide specific pharmacovigilance data , in particular regarding the use of a veterinary medicinal product in specified animal species , in the context of public and animal health , safety of the persons administering the product , and the protection of the environment . the authority shall state in detail the reasons for the request and inform other competent authorities and the agency thereof .


### the marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation . ### the marketing authorisation holder shall be responsible for the pharmacovigilance of the products for which he holds a marketing authorisation . to this end , the holder of a marketing authorisation for a veterinary medicinal product shall establish a contact point for adverse events reporting in each member state where the veterinary medicinal product is authorised to facilitate averse events reporting by the animal health professionals and animal owners in the official language in that member state . such contact point shall be a part of the marketing authorisation holder&#180 ; s pharmacovigilance master file and shall be under the supervision of the competent authority in that member state .


### qualified persons responsible for pharmacovigilance as referred to in article 77 shall carry out the following tasks : ### qualified persons responsible for pharmacovigilance as referred to in article 77 shall ensure that the following tasks are carried out :


### preparing the adverse event reports referred to in article 76 ; ### preparing the adverse event reports referred to in article 76 and reports referred to in article 77 ;


### monitoring the pharmacovigilance system and ensuring that if needed , an appropriate corrective action plan is prepared and implemented ; ### carrying out a signal detection of adverse events included in pharmacovigilance database to ensure that if needed , an appropriate corrective action plan is prepared and implemented . the signal detection should be made every six months during the first two years of effective commercialization of the product and afterwards yearly and the analysis and results should be sent to competent authorities .


### competent authorities shall evaluate all adverse events reported to them by healthcare professionals and animal holders , manage risks and take the measures referred to in articles 130 to 135 concerning marketing authorisations where necessary . ### competent authorities shall evaluate all adverse events reported to them by marketing authorisation holders , healthcare professionals and animal holders , manage risks and take the measures referred to in articles 130 to 135 concerning marketing authorisations where necessary .


### competent authorities and the agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit - risk balance of veterinary medicinal products with a view to detecting risks to animal health , public health and protection of the environment . ### marketing authorisation holders , competent authorities and the agency shall cooperate in monitoring the data in the pharmacovigilance database to determine whether there is any change to the benefit - risk balance of veterinary medicinal products with a view to detecting risks to animal health , public health and protection of the environment .


### the results of the signal management process shall be agreed upon by the competent authorities and , where appropriate , the agency . the lead authority shall record the results in the pharmacovigilance database . ### given that the marketing authorisation holder is the primary source of expertise and information concerning the product under his / her responsibility , the lead authority could where necessary consult the marketing authorisation holder during the signal management process . the results of the signal management process shall be agreed upon by the competent authorities and , where appropriate , the agency . the lead authority shall record the results in the pharmacovigilance database .


### supplies of small quantities of veterinary medicinal products from one retailer to another shall not be regarded as wholesale distribution . ### supplies of small quantities of veterinary medicinal products from one retailer to another shall not be regarded as wholesale distribution . the commission shall define the maximum scope of ' small quantities ' of veterinary medicinal products in retail through delegated acts .


### retail of veterinary medicinal products at a distance ### retail of veterinary medicinal products at a distance shall be prohibited .


### members states may impose conditions , justified on grounds of public health protection , for the retail on their territory of medicinal products offered for sale at a distance to the public by means of information society services . ### member states may impose conditions , justified on grounds of public and animal health , animal welfare and environmental protection , for the retail on their territory of medicinal products offered for sale at a distance to the public by means of information society services


### name of the prescribed product ; ### name of the prescribed product and the active substance ;


### quantity ; ### quantity ; in cases where the treatment has to be repeated , it should also contain the number of times it can be repeated ;


### where a veterinary medicinal product is supplied on prescription , the quantity prescribed and supplied shall be restricted to the amount required for the treatment or therapy concerned . ### where a veterinary medicinal product is prescribed on prescription , the quantity prescribed shall be restricted to the amount required for the treatment or therapy concerned . routine prophylactic use of antimicrobials shall not be allowed . prophylactic use of antimicrobials shall be allowed only in exceptional cases , when fully justified by a veterinarian and where said use is expressly specified in the authorised product information of the veterinary medicinal product . antimicrobials shall not be applied to compensate for poor hygiene or for inadequate husbandry conditions .


### date of administering the veterinary medicinal product to the animal ; ### date of administering the veterinary medicinal product to the animal and the disease treated ;


### 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 : ### member states shall take the necessary measures to ensure that , if there is no authorised veterinary medicinal product in a member state for a condition affecting a non - food producing species , by way of exception , the veterinarian responsible may , under his / her direct personal responsibility and in particular to avoid causing unacceptable suffering , treat the animal concerned with :


### a medicinal product : ### a veterinary medicinal product authorised in the member state concerned under this regulation for use with another animal species , or for another condition in the same species ; or


### 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 : ### member states shall take the necessary measures to ensure that , if there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing species , by way of exception , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , treat the animals concerned on a particular holding with :


### 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 in the member state concerned under this regulation for use with another animal species , or for another condition in the same species ; or


### 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 , either : 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 a veterinary medicinal product authorised in another member state in accordance with this regulation for use in the same species or in another food - producing species for the condition in question or for another condition ; or


### 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 veterinary medicinal product authorised under this regulation in the member state concerned for the same or another condition or for another condition in different food - producing species ;


### 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 . ### 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


### the commission may , by means of implementing acts in accordance with the examination procedure referred to in article 145 , and taking into consideration scientific advice of the agency , establish a list of antimicrobial medicinal products that cannot be used in accordance with paragraph 1 , or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions . ### the commission should , by means of implementing acts in accordance with the examination procedure referred to in article 145 , and taking into consideration scientific advice of the agency , establish a list of antimicrobial medicinal products that cannot be used in accordance with paragraph 1 , or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions , or that are of critical importance for human medicine and whose use for veterinary medicine is therefore prohibited .


### the prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to prescribe or supply veterinary medicinal products . ### the prohibition laid down in paragraph 1 shall not apply to advertising to persons permitted to use , prescribe or supply veterinary medicinal products .


### member states shall designate the competent authorities to carry out tasks under this regulation . ### member states shall designate the competent authorities to carry out tasks under this regulation . the competent authorities shall , inter alia , be responsible for providing the scientific expertise for assessment of all applications under this regulation .


### the committee may co - opt a maximum of five additional members chosen on the basis of their specific scientific competence . these members shall be appointed for a term of three years , which may be renewed , and shall not have alternates . ### the committee may co - opt a maximum of five additional members chosen on the basis of their specific scientific competence . these members shall be appointed for a term of three years , which may be renewed , and shall not have alternates . the co - opted members may act as rapporteurs .


### experiments on animals other than clinical trials shall be conducted in accordance with directive 2010 / 63 / eu . ### member states shall ensure that all experiments on animals shall be conducted in accordance with directive 2010 / 63 / eu . as specified in the directive 2010 / 63 / eu , it is necessary to replace , reduce or refine testing on vertebrate animals . these methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved .


### regulation no 1215 / 2009 does not provide any possibility to temporarily suspend the grant of exceptional trade measures in case of serious and systematic violations of the fundamental principles of human rights , democracy and the rule of law by its beneficiaries . it is appropriate to introduce such possibility , so as to ensure that swift action can be taken in case serious and systematic violations of the fundamental principles of human rights , democracy and the rule of law would occur in one of the countries and territories participating in or linked to the european union ' s stabilisation and association process . ### regulation no 1215 / 2009 does not provide any possibility to temporarily suspend the grant of exceptional trade measures in case of serious and systematic violations of the fundamental principles of human and labour rights or those related to the environment , democracy , good governance or the rule of law by its beneficiaries . it is appropriate to introduce such possibility , so as to ensure that swift action can be taken in case serious and systematic violations of the principles laid down in relevant international conventions concerning core human rights and labour rights or those related to the environment , democracy , good governance or the rule of law would occur in one of the countries and territories participating in or linked to the european union ' s stabilisation and association process . respect for democratic principles , the rule of law , human rights and the protection of minorities are required to achieve progress in the accession process .


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