### there are many challenges in setting up all the necessary electronic systems by 2020 both for the commission and for the member states . first , in some cases , harmonising the data elements on the basis of internationally accepted data models as required by the code demands a full reprogramming of existing electronic systems and investments both in financial terms and in terms of time that are greater than foreseen at the time of adoption of the code . second , as the electronic systems are closely interlinked , introducing them in the right order is important . delays in the development of one system will therefore unavoidably lead to delays in the development of others . third , the code was adopted in 2013 while the rules supplementing and implementing it , namely commission delegated regulation 2015 / 244610 , commission implementing regulation 2015 / 244711 and commission delegated regulation 2016 / 34112 , were only adopted in 2015 and 2016 . the discussions on those rules took much longer than expected and this has caused a delay in setting out the functional and technical specifications necessary for the development of the electronic systems . _________________ 10 commission delegated regulation 2015 / 2446 of 28 july 2015 supplementing regulation no 952 / 2013 of the european parliament and of the council as regards detailed rules concerning certain provisions of the union customs code . 11 commission implementing regulation 2015 / 2447 of 24 november 2015 laying down detailed rules for implementing certain provisions of regulation no 952 / 2013 of the european parliament and of the council laying down the union customs code . 12 commission delegated regulation 2016 / 341 of 17 december 2015 supplementing regulation no 952 / 2013 of the european parliament and of the council as regards transitional rules for certain provisions of the union customs code where the relevant electronic systems are not yet operational and amending delegated regulation 2015 / 2446 . ### the commission and the member states should have known that this task , the setting up all the necessary electronic systems by 2020 , was a major challenge . harmonising the data elements on the basis of internationally accepted data models as required by the code in some cases demanded not only a full reprogramming of existing electronic systems , but also investments both in financial terms and in terms of time that are greater than foreseen at the time of adoption of the code . another important point is to respect the correct order in introducing the electronic systems as they are closely interlinked . delays in the development of one system will therefore unavoidably lead to delays in the development of others . however , the code was already adopted in 2013 while the rules supplementing and implementing it , namely commission delegated regulation 2015 / 244610 , commission implementing regulation 2015 / 244711 and commission delegated regulation 2016 / 34112 , were only adopted in 2015 and 2016 . the european parliament disapproves of the fact that discussions on those rules took much longer than expected and this in turn has caused a delay in setting out the functional and technical specifications necessary for the development of the electronic systems . all of these delays suggest that the rules on the basis of which the electronic systems were designed , developed and set up , as well as the systems themselves , are now completely obsolete and lag far behind the current state of technical progress and therefore pose an unquantifiable but high risk for data security . _________________ 10 commission delegated regulation 2015 / 2446 of 28 july 2015 supplementing regulation no 952 / 2013 of the european parliament and of the council as regards detailed rules concerning certain provisions of the union customs code . 11 commission implementing regulation 2015 / 2447 of 24 november 2015 laying down detailed rules for implementing certain provisions of regulation no 952 / 2013 of the european parliament and of the council laying down the union customs code . 12 commission delegated regulation 2016 / 341 of 17 december 2015 supplementing regulation no 952 / 2013 of the european parliament and of the council as regards transitional rules for certain provisions of the union customs code where the relevant electronic systems are not yet operational and amending delegated regulation 2015 / 2446 .


### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do not apply to undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or combinations of vehicles not exceeding that limit . the number of such undertakings which are active in both national and international transport operations has been increasing . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass not exceeding 3 . 5 tonnes by way of common rules , and thus to approximate competitive conditions between all operators , this provision should be deleted , whereas the requirements regarding effective and stable establishment and appropriate financial standing should be rendered mandatory . ### so far , and unless otherwise provided for in national law , the rules on access to the occupation of road transport operator do not apply to undertakings engaged in the occupation of road haulage operator solely by means of motor vehicles with a permissible laden mass not exceeding 3 . 5 tonnes or combinations of vehicles not exceeding that limit . the number of such undertakings which are active in both national and international transport operations has been increasing . as a result , several member states have decided to apply the rules on access to the occupation of road transport operator , provided for in regulation no 1071 / 2009 , to those undertakings . to ensure a minimum level of professionalisation of the sector using vehicles with a permissible laden mass not exceeding 3 . 5 tonnes by way of common rules , and thus to approximate competitive conditions between all operators , this provision should be deleted , whereas the requirements regarding effective and stable establishment and appropriate financial standing should be rendered mandatory for undertakings conducting transport operations internationally .


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


### the rules on national transport performed on a temporary basis by non - resident hauliers in a host member state should be clear , simple and easy to enforce , while broadly maintaining the level of liberalisation achieved so far . ### the rules on national transport performed on a temporary basis by non - resident hauliers in a host member state should be clear , simple and easy to enforce .


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


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


### it is necessary to ensure that road transport operators established in a member state have a real and continuous presence in that member state and conduct their business from there . therefore , and in light of experience , it is necessary to clarify the provisions regarding the existence of an effective and stable establishment . ### it is necessary to ensure that road transport operators established in a member state have a real and continuous presence in that member state and conduct their business from there . therefore , and in light of experience , it is necessary to clarify the provisions regarding the existence of an effective and stable establishment , thereby putting an end to so - called letterbox companies .


### 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 medicinal product authorised in the member state concerned for another food - producing species for the same condition ;


### before the expiry of the period of validity of 3 years , marketing authorisations for a limited market granted in accordance with article 21 shall be re - examined on application from the marketing authorisation holder . after the initial re - examination , it shall be re - examined every 5 years . ### each year , marketing authorisations for a limited market granted in accordance with article 21 shall be re - examined . to this end , the holder of marketing authorisation for a limited market shall provide their sales figures for the authorised medicinal product , broken down by member state and by species , and the outlook for the five years to come . after the third re - examination , it shall be re - examined every three years .


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a food - producing animal of a non - aquatic species , the veterinarian responsible may , under his direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with any of the following : ### 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 , in particular to avoid causing unacceptable suffering and on condition that any subsequent use of products from the animal in the food chain is definitively precluded , exceptionally treat the animal concerned with any of the following , which are indicated in order of desirability :


### a veterinary medicinal product authorised under this regulation in the member state concerned for use with another food - producing animal species , or for another condition in the same species ; ### a veterinary medicinal product authorised under this regulation in the member state concerned for use for another condition in the same 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 . ### if there is no product as referred to in point , a veterinary medicinal product prepared extemporaneously in accordance with the terms of a prescription issued by a veterinarian .


### 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 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 , after examination of sick animals and those likely to have been contaminated .


### 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 another member state for use in the same species for the same condition ;


### the applicant provides the evidence that the veterinary medicinal product is intended for a limited market . ### the applicant provides the evidence that the veterinary medicinal product is intended for a limited market , detailing his sales prospects , in units , over the first five years of sale and the development costs .


### the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain documentation has not been provided ; ### the benefit of the immediate availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain information has not been provided ;


### a requirement to introduce conditions or restrictions , in particular concerning the safety of the veterinary medicinal product ; ### a requirement to introduce conditions or restrictions to ensure the safety of the veterinary medicinal product and that it is only prescribed and supplied by veterinarians ;


### the conditions governing the supply of veterinary medicinal products to the public should be harmonised in the union . veterinary medicinal products should only be supplied by persons authorised to do so by the member state where they are established . at the same time , in order to improve access to veterinary medicinal products in the union , retailers that are authorised to supply veterinary medicinal products by the competent authority in the member state where they are established should be allowed to sell prescription and non - prescription veterinary medicinal products via the internet to buyers in other member states . ### the conditions governing the supply of veterinary medicinal products to the public should be harmonised in the union . veterinary medicinal products should only be supplied by persons authorised to do so by the member state where they are established . at the same time , in order to improve access to veterinary medicinal products in the union , retailers that are authorised to supply veterinary medicinal products by the competent authority in the member state where they are established should be allowed to sell non - prescription veterinary medicinal products via the internet , after the destination member state has obtained a licence .


### 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 , as public health should take precedence over any economic consideration , the restrictions applied in the european union must also be applied in the same way to imported products . for the same reasons , and in order to support its animal production sectors , the union must take the necessary measures to promote local consumption and self - sufficiency in the internal market .


### member states shall adopt and publish , by 1 april 2019 at the latest , the laws , regulations and administrative provisions necessary to comply with this directive . they shall forthwith communicate to the commission the text of those provisions . ### member states shall adopt and publish , by 1 april 2020 at the latest , the laws , regulations and administrative provisions necessary to comply with this directive . they shall forthwith communicate to the commission the text of those provisions .


### they shall apply those provisions from 1 april 2019 . ### they shall apply those provisions from 1 april 2020 .


### this directive should apply from 1 april 2019 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 31 march 2019 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 27 october 2019 , so that similar and lasting changes occurring in different member states take place simultaneously . it is desirable that member states take the decisions on the standard time that each of them will apply as from 2019 in a concerted manner . ### this directive should apply from 1 april 2020 , so that the last summer - time period subject to the rules of directive 2000 / 84 / ec should start , in every member state , at 1 . 00 a . m . , coordinated universal time , on 29 march 2020 . member states that , after that summer - time period , intend to adopt a standard time corresponding to the time applied during the winter season in accordance with directive 2000 / 84 / ec should change their standard time at 1 . 00 a . m . , coordinated universal time , on 01 november 2020 , so that similar and lasting changes occurring in different member states take place simultaneously . it is a prerequisite for the implementation of this scheme that member states take the decisions on the standard time that each of them will apply as from 2020 in a concerted and consensual manner , taking account of their need to remain in their current time zone .


### without prejudice to article 1 , if a member state decides to change its standard time or times in any territory under its jurisdiction , it shall notify the commission at least 6 months before the change takes effect . where a member state has made such a notification and has not withdrawn it at least 6 months before the date of the envisaged change , the member state shall apply this change . ### if a member state decides to change its standard time or times in any territory under its jurisdiction , it shall notify the commission at least&#160 ; 18 months before the change takes effect . where a member state has made such a notification and has not withdrawn it at least 18 months before the date of the envisaged change , the member state shall apply this change .


### a lively public debate is taking place on summer - time arrangements and some member states have already expressed their preference to discontinue the application of such arrangements . in the light of these developments , it is necessary to continue safeguarding the proper functioning of the internal market and to avoid any significant disruptions thereto caused by divergences between member states in this area . therefore , it is appropriate to put an end in a coordinated way to summer - time arrangements . ### a lively public debate is taking place on summer - time arrangements , and , in the light of these developments , it is necessary to continue safeguarding the proper functioning of the internal market and to avoid any significant disruptions thereto caused by divergences between member states in this area .


### market surveillance authorities shall take appropriate measures to alert users within their territories within an adequate timeframe of hazards they have identified relating to any vehicle , system , component and separate technical unit so as to prevent or reduce the risk of injury or other damage . ### market surveillance authorities shall take appropriate measures to alert users within their territories as quickly as possible of hazards they have identified relating to any vehicle , system , component and separate technical unit so as to prevent or reduce the risk of injury or other damage .


### where the scientific advice shows that the spawning biomass of any of the stocks concerned is below the precautionary reference point , remedial measures shall be adopted to ensure the rapid return of the stocks concerned to levels above those capable of producing msy . in particular , by way of derogation from article 4 and , fishing opportunities shall be set at levels consistent with a fishing mortality that is reduced within the range of fmsy for the most vulnerable stock , taking into account the decrease in biomass . ### where the scientific advice shows that the spawning biomass of any of the stocks concerned is below the precautionary reference point , remedial measures shall be adopted to ensure the rapid return of the stocks concerned to levels above those capable of producing msy . in particular , by way of derogation from article&#160 ; 4 and&#160 ; , fishing opportunities shall be set at levels consistent with a fishing mortality that is reduced within the range of fmsy for the most vulnerable stock , taking into account the decrease in biomass , provided that fishers affected by those closures are given fair compensation .


### five years after the date of entry into force of this regulation and every five years thereafter , the commission shall report to the european parliament and to the council on the results and the impact of the plan on the stocks to which this regulation applies and on the fisheries exploiting those stocks , in particular as regards the achievement of the objectives set out in article 3 . ### two years after the date of entry into force of this regulation and every two years thereafter , the commission shall report to the european parliament and to the council on the results and the impact of the plan on the stocks to which this regulation applies and on the fisheries exploiting those stocks , in particular as regards the achievement of the objectives set out in article 3 .


### the certificate referred to in paragraph 1 shall not confer protection against a particular act against which the basic patent conferred protection if , with respect to that particular act , the following conditions are met : ### the certificate referred to in paragraph 1 shall not confer protection against particular acts against which the basic patent conferred protection if , with respect to those particular acts , the following conditions are met :


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state for the exclusive purpose of export to third countries or countries and / or day - 1 entry on the union’s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export or for the actual export itself or for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , or temporary storage of the product or medicinal product or other activities necessary for the purpose of export to third country destinations or day - 1 entry .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purpose of export or day - 1 entry on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting , i . e . their re - export from third countries to the union .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in these specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . the exception should apply to products to be placed on the market as medicinal products , as well as to products which are active ingredients of a medicinal product or combinations thereof , protected by the relevant supplementary protection certificate .


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired , and to ensure the entry of generics and biosimilar medicines onto the union market from day - 1 after the expiry of the relevant supplementary protection certificate , thus fostering access to medicines . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate , namely the day - 1 entry . it would also help to serve the aim of fostering access to medicines in the union and thereby help to prevent shortages of certain medicines , by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries , and / or day - 1 entry , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself or for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , or temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . ### by limiting the scope of the exception to making for day - 1 entry in the union ' s market and for the purpose of export outside the union , and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in these specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to eliminate the unintentional effects of a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . entry onto the union market immediately after expiry of the relevant supplementary protection certificate , and any related acts strictly necessary for making or for the actual export itself or entry onto the union market .


### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , even for the exclusive purpose of exporting to third country markets in which such protection does not exist or has expired . a further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the union market immediately after expiry of the certificate , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired . ### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established within the union from manufacturing , with a view to enter the union market immediately after expiry of the certificate and / or export to countries outside the union in which protection does not exist or has expired , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purpose of export and day - 1 entry on the market in a member state where a supplementary protection certificate is in force , nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting .


### adopt non - binding guidelines for inspectors , handbooks of good practice and common principles of inspections to tackle undeclared work , ### adopt non - binding guidelines for inspectors , handbooks of good practice and common principles of inspections to tackle undeclared work and work done by illegal immigrants without legal status ,


### a wide range of policy approaches and measures to tackle undeclared work have been introduced across the member states . member states have also concluded bilateral agreements and carried out multilateral projects on certain aspects of undeclared work . the platform will not prevent the application of bilateral agreements or arrangements concerning administrative cooperation . ### a wide range of policy approaches and measures to tackle undeclared work have been introduced across the member states . member states have also concluded bilateral agreements and carried out multilateral projects on certain aspects of undeclared work . the platform will not prevent the application of bilateral agreements or arrangements concerning administrative cooperation . measures should also be taken to tackle effectively the exploitation of illegal immigrants working without legal status .


### the platform should involve the social partners at eu level , both cross - industry and in those sectors more severely affected by undeclared work , and cooperate with relevant international organisations , such as the international labour organisation , and union decentralised agencies , in particular eurofound and european agency for safety and health at work . the involvement of eurofound and european agency for safety and health at work in the work of the platform as observers will not extend their existing mandates . ### the platform should involve the social partners at eu level , both cross - industry and in those sectors more severely affected by undeclared and hidden work , and cooperate with relevant international organisations , such as the international labour organisation , and union decentralised agencies , in particular eurofound and the european agency for safety and health at work . the involvement of eurofound and the european agency for safety and health at work in the work of the platform as observers will not extend their existing mandates .


### the platform should make use of all relevant sources of information , in particular studies , bilateral agreements concluded between member states and multilateral cooperation projects and create synergies between existing eu level instruments and structures to maximise the deterrent or preventive effect of these measures . the operational coordination of actions of the member states could take the form of joint trainings , peer reviews and solutions for data sharing . european campaigns or common strategies could increase the awareness of undeclared work . ### the platform should make use of all relevant sources of information , in particular studies , bilateral agreements concluded between member states and multilateral cooperation projects and create synergies between existing eu level instruments and structures to maximise the deterrent or preventive effect of these measures . the operational coordination of actions of the member states could take the form of joint trainings , peer reviews and solutions for data sharing . european campaigns or common strategies could increase the awareness of undeclared or hidden work .


### eu level cooperation remains far from comprehensive , both in terms of the member states involved and the issues covered . there is a no formal mechanism in place for cross - border cooperation between member states’ relevant authorities to address issues related to undeclared work . ### eu level cooperation remains far from comprehensive , both in terms of the member states involved and the issues covered . there is a no formal mechanism in place for cross - border cooperation between member states’ relevant authorities to address issues related to undeclared work , or any mechanism to prohibit the movement of illegal immigrants without legal status .


### develop forms of cooperation increasing the technical capacity to tackle cross - border aspects of undeclared work by adopting a common framework for joint operations for inspections and exchange of staff , ### develop forms of cooperation increasing the technical capacity to tackle cross - border aspects of undeclared work and work done by illegal immigrants without legal status by adopting a common framework for joint operations for inspections and exchange of staff ,


### organise peer reviews to follow member states progress when fighting undeclared work , including support for the implementation of country - specific recommendations related to fight or prevent undeclared work issued by the council . ### organise peer reviews to follow member states’ progress when fighting undeclared work , including support for the implementation of country - specific recommendations issued by the council to fight or prevent undeclared work and work done by illegal immigrants without legal status .


### examine ways to improve data sharing in compliance with the union data protection rules , including exploring possibilities to use of the internal market information system and the electronic exchange of social security information . ### examine ways to improve data sharing , including exploring possibilities to use the internal market information system and the electronic exchange of social security information .


### eu level cooperation remains far from comprehensive , both in terms of the member states involved and the issues covered . there is a no formal mechanism in place for cross - border cooperation between member states’ relevant authorities to address issues related to undeclared work . ### eu level cooperation remains far from comprehensive , both in terms of the member states involved and the issues covered . there is a no formal mechanism in place for cross - border cooperation between member states’ relevant authorities to address issues related to undeclared or hidden work .


### the programme ' s general objective is to deliver scientific , economic and societal impact from the union ' s investments in research and innovation so as to strengthen the scientific and technological bases of the union and foster its competitiveness , including in its industry , deliver on the union strategic priorities , and contribute to tackling global challenges , including the sustainable development goals . ### the programme ' s general objective is to deliver scientific , economic and societal impact from the union ' s investments in research and innovation so as to strengthen the scientific and technological bases of the european research area and foster its competitiveness , including in its research excellence , fundamental research and industry , deliver on the union strategic priorities , and contribute to tackling global challenges , including the sustainable development goals .


### an initiative shall be prepared and managed by a group of at least seven natural persons . members of the european parliament shall not be counted for the purpose of that minimum number . ### an initiative shall be prepared and managed by a group of at least five natural persons . members of the european parliament shall not be counted for the purpose of that minimum number .


### the members of the group of organisers shall be citizens of the union , of the age to be entitled to vote in elections to the european parliament and residents of at least seven different member states . ### the members of the group of organisers shall be citizens of the union , of the age to be entitled to vote in elections to the european parliament and residents of at least five different member states .


### within five months after the publication of the initiative in accordance with article 14 , and after the public hearing referred to in article 14 , the commission shall set out in a communication its legal and political conclusions on the initiative , the action it intends to take , if any , and its reasons for taking or not taking action . ### within five months after the publication of the initiative in accordance with article 14 , and after the public hearing referred to in article 14 , the commission shall set out in a communication its legal and political conclusions on the initiative , the action it intends to take , if any , and its reasons for taking or not taking action . these conclusions must be clearly presented and duly justified .


### where a ce marked fertilising product contains a substance or mixture within the meaning of regulation no 1907 / 2006 , the safety of its constituent substances for the intended use should be established through registration pursuant to that regulation . the information requirements should ensure that the safety of the intended use of the ce marked fertilising product is demonstrated in a manner comparable to that achieved through other regulatory regimes for products intended for use on arable soil or crops , notably member states’ national fertiliser legislation and regulation no 1107 / 2009 . therefore , where the actual quantities placed on the market are lower than 10 tonnes per company per year , the information requirements determined by regulation no 1907 / 2006 for the registration of substances in quantities of 10 to 100 tonnes should exceptionally apply as a condition for making available pursuant to this regulation . ### where a ce marked fertilising product contains a substance or mixture within the meaning of regulation no 1907 / 2006 , the safety of its constituent substances for the intended use should be established through registration pursuant to that regulation .


### the commission shall adopt a decision by means of an implementing act approving the partnership agreement no later than four months after the date of submission of that partnership agreement by the member state concerned . the partnership agreement shall not be amended . ### the commission shall adopt a decision by means of an implementing act approving the partnership agreement no later than three months after the date of submission of that partnership agreement by the member state concerned . the partnership agreement may be amended where appropriate and at least following the mid - term review .


### the co - financing rate for the cohesion fund at the level of each priority shall not be higher than 70 % . ### the co - financing rate for the cohesion fund at the level of each priority shall not be higher than 85 % .


### 40 % for the more developed regions . ### 50 % for the more developed regions .


### 55 % for the transition regions ; ### 65 % for the transition regions ;


### 70 % for the less developed regions ; ### 85 % for the less developed regions ;


### the commission shall decommit any amount in a programme which has not been used for pre - financing in accordance with article 84 or for which a payment application has not been submitted in accordance with articles 85 and 86 by 26 december of the second calendar year following the year of the budget commitments for the years 2021 to 2026 . ### the commission shall decommit any amount in a programme which has not been used for pre - financing in accordance with article 84 or for which a payment application has not been submitted in accordance with articles 85 and 86 by 31 december of the third calendar year following the year of the budget commitments for the years 2021 to 2026 .


### the commission shall decommit any amount in a programme which has not been used for pre - financing in accordance with article 84 or for which a payment application has not been submitted in accordance with articles 85 and 86 by 26 december of the second calendar year following the year of the budget commitments for the years 2021 to 2026 . ### the commission shall decommit any amount in a programme which has not been used for pre - financing in accordance with article 84 or for which a payment application has not been submitted in accordance with articles 85 and 86 by 26 december of the third calendar year following the year of the budget commitments for the years 2021 to 2026 .


### the co - financing rate for interreg programmes shall be no higher than 70 % . ### the co - financing rate for interreg programmes shall be no higher than 85 % .


### each member state shall organise a partnership with the competent regional and local authorities . that partnership shall include at least the following partners : ### each member state shall organise a partnership with the competent national , regional and local authorities . that partnership shall include at least the following partners :


### there is evidence to suggest a serious deficiency and for which corrective measures have not been taken ; ### there is a serious deficiency and for which corrective measures have not been taken ;


### where the commission disagrees with the assessment of the member state , it shall inform the member state accordingly and give it the opportunity to present its observations within one month . ### where the commission disagrees with the assessment of the member state , it shall inform the member state accordingly and give it the opportunity to present its observations within one month . the deadline may be extended if the member state presents an appropriate justification to the commission .


### rules applicable for the transport sector under regulation [ new cef regulation ] shall apply to the specific calls referred to in the first subparagraph . until 31 december 2023 , the selection of projects eligible for financing shall respect the national allocations under the cohesion fund with regard to 70% of the resources transferred to the cef . ### rules applicable for the transport sector under regulation [ new cef regulation ] shall apply to the specific calls referred to in the first subparagraph . until 31 december 2025 , the selection of projects eligible for financing shall respect the national allocations under the cohesion fund with regard to 70% of the resources transferred to the cef .


### commission audits shall be carried out up to three calendar years following the acceptance of the accounts in which the expenditure concerned was included . this period shall not apply to operations where there is a suspicion of fraud . ### commission audits shall be carried out up to two calendar years after the final payment to the beneficiary was included . this period shall not apply to operations where there is a suspicion of fraud .


### commission audits shall be carried out up to three calendar years following the acceptance of the accounts in which the expenditure concerned was included . this period shall not apply to operations where there is a suspicion of fraud . ### commission audits shall be carried out up to two calendar years after the final payment to the beneficiary . this period shall not apply to operations where there is a suspicion of fraud .


### it is within member states ' competence to set rules on remuneration in accordance with their law and practice . however , national rules on remuneration applied to posted workers must be justified by the need to protect posted workers and must not disproportionately restrict the cross - border provision of services . ### it is within member states ' exclusive competence to set rules on remuneration in accordance with their law and practice .


### in order to maintain the efficient exchange of supplementary information concerning the action to be taken specified in the alerts , it is appropriate to reinforce the functioning of the sirene bureaux by specifying the requirements concerning available resources , user training and the response time to the inquiries received from other sirene bureaux . ### in order to provide an efficient exchange of supplementary information concerning the action to be taken specified in the alerts , it is appropriate to reinforce the functioning of the sirene bureaux by specifying the requirements concerning available resources , user training and the response time to the inquiries received from other sirene bureaux .


### decision no&#160 ; 445 / 2014 / eu of the european parliament and of the council5 aims to safeguard and promote the diversity of cultures in europe and to highlight the common features they share while increasing citizens ' sense of belonging to a common cultural area . that decision also aims to foster the contribution of culture to the long - term development of cities in accordance with their respective strategies and priorities . _________________ 5 decision no 445 / 2014 / eu of the european parliament and of the council of 16 april 2014 establishing a union action for the european capitals of culture for the years 2020 to 2033 and repealing decision no 1622 / 2006 / ec . ### decision no 445 / 2014 / eu of the european parliament and of the council5 aims to safeguard and promote the diversity of cultures in europe and to highlight the common features they share while increasing citizens ' sense of belonging to a common civilisation . that decision also aims to foster the contribution of culture to the sustainable environmental , economic and social development of cities in accordance with their respective strategies and priorities . _________________ 5 decision no 445 / 2014 / eu of the european parliament and of the council of 16 april 2014 establishing a union action for the european capitals of culture for the years 2020 to 2033 and repealing decision no 1622 / 2006 / ec .


### cities in efta / eea countries and in candidate countries and potential candidates which participate in the creative europe programme or in the subsequent union programmes supporting culture at the date of publication of the call for submission of applications referred to in article 10 may apply for the title for one year in the framework of an open competition organised every third year in accordance with the calendar . ### cities in efta / eea countries which participate in the creative europe programme or in the subsequent union programmes supporting culture at the date of publication of the call for submission of applications referred to in article 10 may apply for the title for one year in the framework of an open competition organised every third year in accordance with the calendar .


### ' class formation ' means the grouping of affected creditors and equity holders in a restructuring plan in such a way as to reflect the rights and seniority of the affected claims and interests , taking into account possible pre - existing entitlements , liens or inter - creditor agreements , and their treatment under the restructuring plan ; ### ' class formation ' means the grouping of affected creditors and equity holders in a restructuring plan in such a way as to reflect the rights and seniority of the affected claims and interests , taking into account possible pre - existing entitlements , liens or inter - creditor agreements , and their treatment under the restructuring plan . workers shall be a class of preferential creditors . in order to prevent chain bankruptcies , suppliers / clients with fewer than 50 employees shall be treated as a preferential class of creditors when activities essential to their survival are at stake . a creditor who is a dominant bank or dominant client whose deliberate actions have been shown to have given rise to the probability of insolvency shall be placed by the member state in a separate , less preferential class .


### member states may stipulate that a vote on the adoption of a restructuring plan takes the form of a consultation and agreement of a requisite majority of affected parties in each class . ### member states may stipulate that a vote on the adoption of a restructuring plan takes the form of a consultation and agreement of a requisite majority of affected parties in each class . in the workers’ class this vote shall be held in compliance with national laws .


### where a restructuring plan entails a transfer of part of undertaking or business , workers ' rights arising from a contract of employment or from an employment relationship , notably including the right to wages , should be safeguarded in accordance with articles 3 and 4 of directive 2001 / 23 / ec , without prejudice to the specific rules applying in the event of insolvency proceedings under article 5 of that directive and in particular the possibilities allowed by article 5 of that directive . furthermore , in addition and without prejudice to the rights to information and consultation , including on decisions likely to lead to substantial changes in work organisation or in contractual relations with a view to reaching an agreement on such decisions , which are guaranteed by directive 2002 / 14 / ec , under this directive workers who are affected by the restructuring plan should have the right to vote on the plan . for the purposes of voting on the restructuring plan , member states may decide to place workers in a class separate from other classes of creditors . ### where a restructuring plan entails a transfer of part of undertaking or business , workers ' rights arising from a contract of employment or from an employment relationship , notably including the right to wages , should be safeguarded in accordance with articles 3 and 4 of directive 2001 / 23 / ec , without prejudice to the specific rules applying in the event of insolvency proceedings under article 5 of that directive and in particular the possibilities allowed by article 5 of that directive . furthermore , in addition and without prejudice to the rights to information and consultation , including on decisions likely to lead to substantial changes in work organisation or in contractual relations with a view to reaching an agreement on such decisions , which are guaranteed by directive 2002 / 14 / ec , under this directive workers who are affected by the restructuring plan should have the right to vote on the plan . for the purposes of voting on the restructuring plan , member states shall place workers in a class separate from other classes of creditors .


### in many member states it takes more than three years for bankrupt , but honest entrepreneurs to discharge their debts and make a fresh start . inefficient second chance frameworks result in entrepreneurs having to relocate in other jurisdictions in order to benefit from a fresh start in a reasonable period of time , at considerable additional costs to both their creditors and the debtors themselves . long disqualification orders which often accompany a procedure leading to discharge create obstacles to the freedom to take up and pursue a self - employed , entrepreneurial activity . ### in many member states it takes more than three years for bankrupt , but honest entrepreneurs to discharge their debts and make a fresh start . long disqualification orders which often accompany a procedure leading to discharge create obstacles to the freedom to take up and pursue a self - employed , entrepreneurial activity .


### restructuring should enable enterprises in financial difficulties to continue business in whole or in part , by changing the composition , conditions or structure of assets and liabilities or of their capital structure , including by sales of assets or parts of the business . preventive restructuring frameworks should above all enable the enterprises to restructure at an early stage and to avoid their insolvency . those frameworks should maximise the total value to creditors , owners and the economy as a whole and should prevent unnecessary job losses and losses of knowledge and skills . they should also prevent the build - up of non - performing loans . in the restructuring process the rights of all parties involved should be protected . at the same time , non - viable businesses with no prospect of survival should be liquidated as quickly as possible . ### restructuring should enable enterprises in financial difficulties for which they are not responsible to continue business in whole or in part , by changing the composition , conditions or structure of assets and liabilities or of their capital structure , including by sales of assets or parts of the business . preventive restructuring frameworks should above all enable the enterprises to restructure at an early stage . those frameworks should maximise the total value to owners and the economy as a whole and should prevent unnecessary job losses and losses of knowledge and skills . in the restructuring process the rights of all parties involved should be protected .


### those differences lead to uneven conditions for access to credit and to uneven recovery rates in the member states . a higher degree of harmonisation in the field of restructuring , insolvency and second chance is thus indispensable for a well - functioning single market in general and for a working capital markets union in particular . ### those differences damage conditions for access to credit for honest entrepreneurs because certain dishonest entrepreneurs , some of them from other countries , abuse insolvency rules or commit fraud against them . it is therefore important that the directive should treat honest entrepreneurs as a separate category in order to facilitate a second chance for them .


### in view of the specificities of the sector , in practice no collaborative project between undertakings will be launched if the member states have not first agreed to support such projects . after having defined common defence capability priorities at union - level and also taking into account where appropriate collaborative initiatives on a regional basis , member states identify and consolidate military requirements and define the technical specifications of the project . they may also appoint a project manager in charge of leading the work related to the development of a collaborative project . ### in view of the specificities of the sector , in practice no collaborative project between european undertakings will be launched if the member states have not first agreed to support such projects . after having defined collaborative initiatives , member states specify the technical specifications of the project . they may also appoint a project manager in charge of leading the work related to the development of a collaborative project .


### as the objective of the programme is to support the competitiveness of the union defence industry by de - risking the development phase of cooperative projects , actions related to the development of a defence product or technology , namely definition of common technical specifications , design , prototyping , testing , qualification , certification as well feasibility studies and other supporting measures , should be eligible to benefit from it . this will also apply to the upgrade of existing defence products and technologies . ### as the objective of the programme is to support the competitiveness of the defence industry in the union by de - risking the development phase of cooperative projects , actions related to the development of a defence product or technology , namely definition of common technical specifications , design , prototyping , testing , qualification , certification as well feasibility studies and other supporting measures , should be eligible to benefit from it . this will also apply to the upgrade of existing defence products and technologies .


### several member states have been undergoing and continue to undergo adjustment processes to correct macroeconomic imbalances accumulated in the past and many are facing the challenge of low potential growth . the union has identified the implementation of structural reforms among its policy priorities to set the recovery on a sustainable path , unlock the growth potential to strengthen the adjustment capacity , and support the process of convergence . ### the only way for jobs to be created and unemployment to be properly addressed in each member state is for national measures tailored specifically to the needs of each country to be implemented .


### ' the eafrd may also finance actions implemented by the european solidarity corps with an amount of eur 1 800 000 in current prices in accordance with regulation 2017 / xxx , which contribute to one or more of the union priorities for rural development . the allocation shall be implemented solely in accordance with the regulation 2017 / xxx , to the exclusion of the specific requirements of regulation no 1305 / 2013 . ' ### the eafrd may also finance actions implemented by the european solidarity corps with an amount of eur 1 800 000 in current prices in accordance with regulation 2017 / xxx , which contribute to one or more of the union priorities for rural development in order to help boost young people’s interest in agriculture . the allocation shall be implemented solely in accordance with the regulation 2017 / xxx , to the exclusion of the specific requirements of regulation no 1305 / 2013 .


### special attention should be paid to ensuring that the activities supported by the european solidarity corps are accessible to all young people , notably the most disadvantaged ones . special measures should therefore be put in place to promote social inclusion , the participation of disadvantaged young people , as well as to take into account the constraints imposed by the remoteness of the outermost regions of the union and the overseas countries and territories24 . similarly , the participating countries should endeavour to adopt all appropriate measures to remove legal and administrative obstacles to the proper functioning of the european solidarity corps . this includes resolving , where possible , and without prejudice to the schengen acquis and union law on the entry and residence of third - country nationals , administrative issues that create difficulties in obtaining visas and residence permits . _________________ 24 individuals from an overseas country or territory and competent public and / or private bodies and institutions from an oct may participate in the programmes in accordance with council decision 2001 / 822 / ec of 27 november 2001 on the association of the overseas countries and territories with the european community , oj l314 , 30 . 11 . 2001 , p . 1 . ### special attention should be paid to ensuring that the activities supported by the european solidarity corps are accessible to all young people , notably the most disadvantaged ones and those from rural areas . special measures should therefore be put in place to promote social inclusion , the participation of disadvantaged young people , as well as to take into account the constraints imposed by the remoteness of the outermost regions of the union and the overseas countries and territories24 . similarly , the participating countries should endeavour to adopt all appropriate measures to remove legal and administrative obstacles to the proper functioning of the european solidarity corps . this includes resolving , where possible , and without prejudice to the schengen acquis and union law on the entry and residence of third - country nationals , administrative issues that create difficulties in obtaining visas and residence permits . _________________ 24 individuals from an overseas country or territory and competent public and / or private bodies and institutions from an oct may participate in the programmes in accordance with council decision 2001 / 822 / ec of 27 november 2001 on the association of the overseas countries and territories with the european community , oj l314 , 30 . 11 . 2001 , p . 1 .


### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth and sport , in europe and beyond , thereby contributing to sustainable growth , jobs and social cohesion and to strengthening european identity . as such , the programme shall be a key instrument for building a european education area , supporting the implementation of the european strategic cooperation in the field of education and training , with its underlying sectoral agendas , advancing youth policy cooperation under the union youth strategy 2019 - 2027 and developing the european dimension in sport . ### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth and sport , in europe and beyond , thereby contributing to sustainable growth , jobs and social cohesion . as such , the programme shall be a key instrument for building an accessible and inclusive european education area , supporting the implementation of the european strategic cooperation in the field of education and training , with its underlying sectoral agendas , advancing youth policy cooperation under the union youth strategy 2019 - 2027 and developing the european dimension in sport .


### as a way to ensure cooperation with other union instruments and support to other policies of the union , mobility opportunities should be offered to people in various sectors of activity , such as the public sector , agriculture and enterprise , to have a learning experience abroad allowing them , at any stage of their life , to grow and develop professionally but also personally , in particular by developing an awareness of their european identity and an understanding of european cultural diversity . the programme should offer an entry point for union transnational mobility schemes with a strong learning dimension , simplifying the offer of such schemes for beneficiaries and those taking part in these activities . the scaling - up of erasmus projects should be facilitated ; specific measures should be put in place to help promoters of erasmus projects to apply for grants or develop synergies through the support of the european structural and investment funds and the programmes relating to migration , security , justice and citizenship , health and culture . ### as a way to ensure cooperation with other union instruments and support to other policies of the union , mobility opportunities should be offered to people in various sectors of activity , such as the public sector , agriculture and enterprise , to have a learning experience abroad allowing them , at any stage of their life , to grow and develop professionally but also personally . the programme should offer an entry point for union transnational mobility schemes with a strong learning dimension , simplifying the offer of such schemes for beneficiaries and those taking part in these activities . the scaling - up of erasmus projects should be facilitated ; specific measures should be put in place to help promoters of erasmus projects to apply for grants or develop synergies through the support of the european structural and investment funds and the programmes relating to migration , security , justice and citizenship , health and culture .


### the programme should reinforce existing learning mobility opportunities , notably in those sectors where the programme could have the biggest efficiency gains , to broaden its reach and meet the high unmet demand . this should be done notably by increasing and facilitating mobility activities for higher education students , school pupils and learners in vocational education and training . mobility of low - skilled adult learners should be embedded in partnerships for cooperation . mobility opportunities for youth participating in non - formal learning activities should also be extended to reach more young people . mobility of staff in education , training , youth and sport should also be reinforced , considering its leverage effect . in line with the vision of a true european education area , the programme should also boost mobility and exchanges and promote student participation in educational and cultural activities by supporting digitalisation of processes , such as the european student card . this initiative can be an important step in making mobility for all a reality first by enabling higher education institutions to send and receive more exchange students while still enhancing quality in student mobility and also by facilitating students ' access to various services before arriving at the institution abroad . ### the programme should reinforce existing learning mobility opportunities , notably in those sectors where the programme could have the biggest efficiency gains , to broaden its reach and meet the high unmet demand . this should be done notably by increasing and facilitating mobility activities for higher education students , school pupils and learners in vocational education and training . mobility of low - skilled adult learners should be embedded in partnerships for cooperation . mobility of staff in education , training , youth and sport should also be reinforced , considering its leverage effect . in line with the vision of a true european education area , the programme should also boost mobility and exchanges and promote student participation in educational and cultural activities by supporting digitalisation of processes , such as the european student card . this initiative can be an important step in making mobility for all a reality first by enabling higher education institutions to send and receive more exchange students while still enhancing quality in student mobility and also by facilitating students ' access to various services before arriving at the institution abroad .


### the programme is a key component of building a european education area . it should be equipped to contribute to the successor of the strategic framework for cooperation in education and training and the skills agenda for europe28with a shared commitment to the strategic importance of skills and competences for sustaining jobs , growth and competitiveness . it should support member states in reaching the goals of the paris declaration on promoting citizenship and the common values of freedom , tolerance and non - discrimination through education29 . _________________ 28 com 381 final . 29 [ reference ] . ### the programme is a key component in terms of skills for europe28 with a shared commitment to the strategic importance of skills and competences for sustaining jobs , growth and competitiveness . it should support member states in reaching the goals of the paris declaration on promoting citizenship and the common values of freedom , tolerance and non - discrimination through education29 . _________________ 28 com 381 final . 29 [ reference ] .


### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible learning mobility formats , and by fostering participation of small organisations , in particular newcomers and community - based grassroots organisations that work directly with disadvantaged learners of all ages . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted to reach more participants , in particular those with fewer opportunities and those for whom moving physically to a country other than their country of residence would be an obstacle . ### the programme should be more inclusive by improving its outreach to those with fewer opportunities , including through more flexible learning mobility formats , and by fostering participation of small organisations , in particular newcomers and community - based grassroots organisations that work directly with disadvantaged learners of all ages who have the nationality of a member state . virtual formats , such as virtual cooperation , blended and virtual mobility , should be promoted to reach more participants , in particular those with fewer opportunities and those for whom moving physically to a country other than their country of residence would be an obstacle .


### the declarations shall be accurate and complete , made in writing and updated whenever necessary . the declarations of interests made by the members of the management board and the executive director shall be made public . ### the declarations shall be accurate and complete , made in writing and updated whenever necessary . the declarations of interests made by the members of the management board and the secretary - general shall be made public .


### members of the management board , the executive director , members of the board of appeal , seconded national experts , other staff not employed by berec and experts participating in working groups shall comply with the confidentiality requirements under article 339 of the treaty , even after their duties have ceased . ### members of the management board , the director , seconded national experts , other staff not employed by the berec office and experts participating in working groups shall comply with the confidentiality requirements under article 339 of the treaty , even after their duties have ceased .


### assist , advise and cooperate with the commission as well as nras , on request or on its own initiative , on any technical matter within its mandate , and assist and advise the european parliament and the council on request ; ### assist , advise and cooperate with the nras , on request or on its own initiative , on any technical matter within its mandate , and assist and advise the commission , the european parliament and the council on request ;


### the role of the executive director , who would be the legal representative of berec , is crucial for the adequate functioning of the new agency and the implementation of the tasks assigned to it . the management board should appoint him / her on the basis of a list drawn up by the commission following an open and transparent selection procedure in order to guarantee a rigourous evaluation of the candidates and a high level of independence . moreover , in the past the term of office of the administrative manager of the berec office was three years . it is necessary that the executive director has a sufficiently long mandate in order to ensure stability and delivery of a long - term strategy for the agency . ### the role of the executive director , who would be the legal representative of berec , is crucial for the adequate functioning of the new agency and the implementation of the tasks assigned to it . the management board should appoint him / her on the basis of a list drawn up by the commission following an open and transparent selection procedure in order to guarantee a rigorous evaluation of the candidates and a high level of independence . before appointment , the candidate selected by the management board should be invited to appear before the competent committees of the european parliament so that they may give their consent . moreover , in the past the term of office of the administrative manager of the berec office was three years . it is necessary that the executive director has a sufficiently long mandate in order to ensure stability and delivery of a long - term strategy for the agency .


### berec and the berec office have made a positive contribution towards a consistent implementation of the regulatory framework for electronic communications . notwithstanding , there are still significant disparities between member states as regards regulatory practice . moreover , the governance structure of berec and the berec office is cumbersome and gives rise to unnecessary administrative burden . in order to ensure efficiency gains and synergies and to further contribute to the development of the internal market for electronic communications throughout the union as well as to the promotion of access to , and take - up of , very high capacity data connectivity , competition in the provision of electronic communications networks , services and associated facilities and the interests of the citizens of the union , this regulation aims to strengthen the role of berec and enhance its governance structure by establishing berec as a union decentralised agency . this also corresponds to the need to reflect the significantly enhanced role played by berec following regulation no 531 / 2012 which establishes tasks for berec in relation to union - wide roaming , regulation no 2015 / 2120 which establishes tasks for berec in relation to open internet access and union - wide roaming , and the directive which establishes a significant number of new tasks for berec such as issuing decisions and guidelines on several topics , reporting on technical matters , keeping registers and delivering opinions on internal market procedures for draft national measures on market regulation as well as on assignments of rights of use for radio spectrum . ### berec and the berec office have made a positive contribution towards a consistent implementation of the regulatory framework for electronic communications . notwithstanding , there are still significant disparities between member states as regards regulatory practice . in order to ensure efficiency gains and synergies and to further contribute to the development of the internal market for electronic communications throughout the union as well as to the promotion of access to , and take - up of , very high capacity data connectivity , competition in the provision of electronic communications networks , services and associated facilities and the interests of the citizens of the union , this regulation aims to strengthen the roles of berec and the berec office and enhance their governance structure . this also corresponds to the need to reflect the significantly enhanced role played by berec following regulation no 531 / 2012 which establishes tasks for berec in relation to union - wide roaming , regulation no 2015 / 2120 which establishes tasks for berec in relation to open internet access and union - wide roaming , and the directive which establishes a significant number of new tasks for berec such as issuing decisions and guidelines on several topics , reporting on technical matters , keeping registers and delivering opinions on internal market procedures for draft national measures on market regulation as well as on assignments of rights of use for radio spectrum .


### the role of the executive director , who would be the legal representative of berec , is crucial for the adequate functioning of the new agency and the implementation of the tasks assigned to it . the management board should appoint him / her on the basis of a list drawn up by the commission following an open and transparent selection procedure in order to guarantee a rigourous evaluation of the candidates and a high level of independence . it is necessary that the executive director has a sufficiently long mandate in order to ensure stability and delivery of a long - term strategy for the agency . ### the role of the secretary - general , who would be the legal representative of berec , is crucial for the adequate functioning of the new agency and the implementation of the tasks assigned to it . the management board should appoint him / her on the basis of a list drawn up by the council in order to confer specific legitimacy on him / her resting on the member states . it is necessary that the secretary - general has a sufficiently long mandate in order to ensure stability and delivery of a long - term strategy for the agency .


### the management board shall be composed of one representative from each member state and two representatives of the commission , all with voting rights . each nra shall be responsible for nominating its respective representative amongst the head or members of the collegiate body of the nra . ### the management board shall be composed of one representative from each member state , all with voting rights . each nra shall be responsible for nominating its respective representative amongst the head or members of the collegiate body of the nra . the representatives of the commission shall take part in the deliberations , with the right to vote on administrative matters and without the right to vote on regulatory matters as referred to in article 2 .


### the body of european regulators for electronic communications is hereby established . ### the body of european regulators for electronic communications and the ' berec office ' are hereby established .


### the prescribed medicated feed may be used only for animals examined by the person who issued the prescription and only for a diagnosed disease . the person who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds . furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra - indication or interaction where several medicinal products are used . ### the prescribed medicated feed may be used only for animals examined by the veterinarian who issued the prescription and only for a diagnosed disease . the veterinarian who issued the prescription shall verify that this medication is justified for the target animals on veterinary grounds . furthermore he shall ensure that the administration of the veterinary medicinal product concerned is not incompatible with another treatment or use and that there is no contra - indication or interaction where several medicinal products are used .


### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antimicrobials for food - producing animals . preventive use or use to enhance the performance of food - producing animals should in particular not be allowed . ### taking into account the serious public health risk posed by resistance to antimicrobials , it is appropriate to limit the use of medicated feed containing antimicrobials for food - producing animals . in particular , preventive use or use to enhance the performance of food - producing animals should not be allowed and the necessary measures should be taken to prevent the import of any live animals , carcases , meat , and prepared meals and dishes based on meat which have been treated for such purposes .


### the prescription shall contain the information set out in annex v . the original prescription shall be kept by the manufacturer or , where appropriate , the distributor . the person issuing the prescription and the animal holder shall keep a copy of the prescription . the original and copies shall be kept for three years from the date of issuance . ### the prescription shall contain the information set out in annex v . the original prescription shall be kept by the manufacturer or , where appropriate , the distributor . the veterinarian issuing the prescription and the animal holder shall keep a copy of the prescription . the original and copies shall be kept for three years from the date of issuance .


### there is a need to ensure greater parity of treatment for frontier and cross - border workers by ensuring frontier workers receive unemployment benefits from the member state of last activity provided that they have worked in that member state for at least the past twelve months . ### there is a need to ensure greater parity of treatment for frontier and cross - border workers by ensuring frontier workers receive the applicable unemployment benefits from the member state of last activity provided that they have worked in that member state for at least three months in the past twelve months .


### the commission ' s communication on the interim evaluation of horizon 2020 2 final ) has provided a set of recommendations for this programme , including its rules for participation and dissemination , building on the lessons learnt from the previous programme as well as input from eu institutions and stakeholders . those recommendations include to invest more ambitiously in order to reach critical mass and maximise impact ; to support breakthrough innovation ; to prioritise union research and innovation investments in areas of high added value , notably through mission - orientation , citizen involvement and wide communication ; to rationalise the union funding landscape , including by streamlining the range of partnership initiatives and co - funding schemes ; the development of more and concrete synergies between different union funding instruments , notably with the aim of helping to mobilise under - exploited r&i potential across the union ; to strengthen international cooperation and reinforce openness to third countries ' participation ; and to continue simplification based on implementation experiences from horizon 2020 . ### the commission ' s communication on the interim evaluation of horizon 2020 2 final ) has provided a set of recommendations for this programme , including its rules for participation and dissemination , building on the lessons learnt from the previous programme as well as input from eu institutions and stakeholders . those recommendations include to invest more effectively ambitiously in order to reach critical mass and maximise impact ; to support breakthrough innovation ; to prioritise union research and innovation investments in areas of high added value , notably through mission - orientation , citizen involvement and wide communication ; to rationalise the union funding landscape , including by streamlining the range of partnership initiatives and co - funding schemes ; the development of more and concrete synergies between different union funding instruments , notably with the aim of helping to mobilise under - exploited r&i potential across the union ; to ensure closer interaction between union funding instruments with a view to achieving objectives such as mobilising under - utilised r&i in the eu , to strengthen international cooperation and reinforce openness to third countries ' participation ; and to continue simplification based on implementation experiences from horizon 2020 .


### that information shall be collected before departure and recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu upon the passenger ship ' s departure but in no case later than thirty minutes after its departure . ### that information shall be collected before departure and recorded in the single window established pursuant to article 5 of directive 2010 / 65 / eu upon the passenger ship’s departure but in no case later than 15 minutes after it has cast off .


### although emissions of methane are not known to have a direct harmful effect on human health , methane is a strong greenhouse gas . therefore , in line with the communication of the commission on the application and future development of community legislation concerning vehicle emissions from light - duty vehicles and access to repair and maintenance information 2 and with article 14 of regulation 715 / 2007 of the european parliament and of the council3 , the commission should consider including methane emissions in the calculation of co2 emissions . __________________ 2 oj c 182 , 19 . 7 . 2008 , p . 17 . 3 regulation 715 / 2007 of the european parliament and of the council of 20 june 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles and on access to vehicle repair and maintenance information . ### methane is well - known as a strong green - house gas , as in atmosphere , methane disintegrates into carbon monoxide subsequently oxidizing to carbon dioxide . in higher concentrations , methane has anaesthetic and asphyxiant effects on human health . therefore , in line with the commission communication of the 2008 / c 182 / 08 on the application and future development of community legislation concerning vehicle emissions from light - duty vehicles and access to repair and maintenance information 2 and with article 14 of regulation 715 / 2007 of the european parliament and of the council3 , the commission should consider including methane emissions in the calculation of co2 emissions . __________________ 2 oj c 182 , 19 . 7 . 2008 , p . 17 . 3 regulation 715 / 2007 of the european parliament and of the council of 20 june 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles and on access to vehicle repair and maintenance information .


### in order to facilitate the introduction of natural gas vehicles the current total hydrocarbons emission limit should be increased and the effect of methane emissions should be taken into account and expressed as a co2 equivalent for regulatory and consumer information purposes . ### in order to facilitate the introduction of natural gas vehicles on equal standards , the current limit for total hydrocarbons , especially methane should be fully taken into account in expressing emissions as a co2 equivalent calculated on the stoichiometrics of methane dissociation thus boosting environmental protection as well as allowing to choose on a transparent and comparable co2 emissions basis , for regulatory and consumer information purposes .


### the current emission limits for co and total hydrocarbons after a cold start at low temperature have been carried over from euro 3 requirements set out in directive 98 / 69 / ec of the european parliament and of the council4 , which appear to be outdated in the light of existing vehicle technology and air quality needs . in addition , air quality problems and results of vehicle emission measurements suggest the need to introduce an appropriate limit for nox / no2 emissions . therefore , revised emission limits should be introduced pursuant to article 14 of regulation no 715 / 2007 . __________________ 4 directive 98 / 69 / ec of the european parliament and of the council of 13 october 1998 relating to measures to be taken against air pollution by emissions from motor vehicles and amending council directive 70 / 220 / eec . ### the current emission limits for co and total hydrocarbons after a cold start at low temperature have been carried over from euro 3 requirements set out in directive 98 / 69 / ec of the european parliament and of the council4 , which appear to be outdated in the light of existing vehicle technology and air quality needs . in addition , air quality problems and results of vehicle emission measurements suggest the need to introduce an appropriate limit for nox / no2 emissions . causing 41% of nox emissions , traffic is by far the main source of those emissions . in particular , the high efficiency of state - of - the - art motors is due to higher combustion temperatures which , in turn , produce higher amounts of nox . no2 , on the other hand , is responsible for ozone formation , acid rain and irritation of the human respiratory system . consequently , revised emission limits should be introduced pursuant to article 14 of regulation no 715 / 2007 . __________________ 4 directive 98 / 69 / ec of the european parliament and of the council of 13 october 1998 relating to measures to be taken against air pollution by emissions from motor vehicles and amending council directive 70 / 220 / eec .