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


### a competent authority or the agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 july 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product . ### the applicant shall submit to the competent authority or the agency safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment if a potential environmental risk has been identified for that product .


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


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


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


### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a non - food producing animal , the veterinarian responsible may , under his / her direct personal responsibility and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with the following : ### by way of derogation from article 111 , where there is no authorised veterinary medicinal product in a member state for a condition affecting a non - food producing animal , the veterinarian responsible may , under his / her direct personal responsibility and in the interest of animal health and welfare , exceptionally treat the animal concerned with the following , with the exception of anticrobial products used as routine prophylactic measure , unless specifically authorised by the committee for medicinal products for veterinary use :


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


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


### ‘ veterinary prescription ‘ means any prescription for a veterinary medicinal product issued by a professional person qualified to do so in accordance with applicable national law ; ### ‘ veterinary prescription ‘ means any prescription for a veterinary medicinal product issued by a veterinarian or another professional person qualified to do so in accordance with applicable national law ;


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


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


### the scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells . at the same time , in order to ensure the widest possible availability of veterinary medicinal products in the union , the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product , including for generics of nationally authorised veterinary medicinal products . ### the scope of the mandatory use of a centralised authorisation procedure under which the authorisations are valid throughout the union should cover inter alia products containing new active substances and products which contain or consist of engineered tissues or cells . at the same time , in order to ensure the widest possible availability of veterinary medicinal products in the union , the centralised authorisation procedure should be extended to allow for applications for authorisations under that procedure to be submitted for any veterinary medicinal product , including for generics of nationally authorised veterinary medicinal products . the use of the centralised procedure should be encouraged in every way , in particular by facilitating access for smes .


### a marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans . ### a marketing authorisation for an antimicrobial veterinary medicinal product shall be refused if the antimicrobial is reserved for treatment of certain infections in humans within the meaning of paragraph 4 .


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


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


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


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


### competent authorities and the agency shall supervise the pharmacovigilance systems of marketing authorisation holders . ### competent authorities and the agency shall supervise the pharmacovigilance systems of marketing authorisation holders and authorise them .


### it is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment . therefore , where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment , it is appropriate to require data on the potential effect on the environment in order to safeguard the environment . in such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals . ### it is recognised that the potential effect of a product on the environment may depend on the volume used and the resulting amount of the pharmaceutical substance that may reach the environment . therefore , where there is evidence that a constituent of a medicinal product for which a generic application for a marketing authorisation is submitted is a hazard for the environment , it is appropriate to require data on the potential effect on the environment in order to safeguard the environment . in such cases applicants should endeavour to join efforts in generating such data in order to reduce costs and to reduce testing on vertebrate animals . the current impact assessment system results in repetitive and potentially divergent assessments of substances ' environmental properties . this can lead to divergent decisions being taken on products with similar effects on the environment , especially in the case of products authorised before the environmental impact assessment was carried out . the establishment of a single centralised assessment of the environmental properties of active substances for veterinary use by means of a monograph system could be a potential alternative . the commission should therefore submit a report to parliament and the council examining the feasibility of monographs and potential alternative options as soon as possible .


### a competent authority or the agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment in case the marketing authorisation for the reference veterinary medicinal product was granted before 20 july 2000 or in case the second phase environmental risk assessment was required for the reference veterinary medicinal product . ### a competent authority or the agency may require the applicant to provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment where there are serious and established reasons to believe that the authorisation of the generic product may pose greater risks to the environment than does the original product .


### veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation . ### veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation . nevertheless , the veterinarian should be able , in justified circumstances , to prescribe veterinary medicinal products in different terms to the ones authorised for the product .


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


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


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


### marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the union or in a third country with regard to their authorised veterinary medicinal products , within 30 days following the receipt of the adverse event report . ### marketing authorisation holders shall notify electronically all serious adverse events and human events relating to the use of veterinary medicinal products that are brought to their attention or which they can reasonably be expected to have knowledge of to the competent authority of the member state on whose territory the incident occurred and no later than 15 days following receipt of the information . the remaining adverse events relating to the use of veterinary medicinal products that are brought to the attention of the marketing authorisation holders or of which they can reasonably be expected to have knowledge , shall be notified electronically to the pharmacovigilance database no later than 30 days following receipt of the information . different requirements shall apply for adverse events observed in clinical trials .


### within 15 days after receipt of the assessment report referred to in article 46 or in article 48 the applicant may provide written notice to the agency requesting a re - examination of the assessment report . in that case the applicant shall forward to the agency detailed grounds for the request within 60 days of receipt of the assessment report . the application shall be accompanied by proof of payment of the fee payable to the agency for the re - examination . ### within 15 days after receipt of the assessment report referred to in article 46 or in article 48 the applicant may provide written notice to the coordination group requesting a re - examination of the assessment report . in that case the applicant shall forward to the agency detailed grounds for the request within 60 days of receipt of the assessment report . the application shall be accompanied by proof of payment of the fee payable to the agency for the re - examination


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


### those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction : ### those manufacturers and suppliers shall keep detailed records of the following information in respect of each purchase and sale transaction pertaining to prescription veterinary medicinal products :


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


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


### marketing authorisation holders shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the union or in a third country with regard to their authorised veterinary medicinal products , within 30 days following the receipt of the adverse event report . ### marketing authorisation holders shall record and evaluate all adverse events which were reported to them by healthcare professionals and animal holders and that occurred within the union or in a third country with regard to their authorised veterinary medicinal products . serious adverse events should be reported without delay , and at the latest within 15 days of their coming to light ; less serious adverse events should be reported within 90 days . competent authorities may , on their own initiative or on request from the agency , request the marketing authorisation holder to collect specific pharmacovigilance data and to notify other competent authorities and the agency accordingly . marketing authorisation holders shall be required to comply with such a request within an appropriate deadline set by the competent authority .


### 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 , under his direct personal responsibility in the interest of animal health and welfare , exceptionally treat the animal concerned with any of the following :


### the commission may , by means of implementing acts in accordance with the examination procedure referred to in article 145 , and taking into consideration scientific advice of the agency , establish a list of antimicrobial medicinal products that cannot be used in accordance with paragraph 1 , or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions . ### the commission may , by means of implementing acts in accordance with the examination procedure referred to in article 145 , and taking into consideration scientific advice of the agency , establish a list of antimicrobial substances or groups of substances that cannot be used in accordance with paragraph 1 , or which can only be used for treatment in accordance with paragraph 1 subject to certain conditions .


### the marketing authorisation holder shall not communicate information regarding adverse events to the general public in relation to the veterinary medicinal product without giving prior notification of his intention to the competent authority or authorities having granted the marketing authorisation or to the agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure . ### the marketing authorisation holder shall not communicate information regarding adverse events and potential pharmacovigilance concerns to the general public in relation to the veterinary medicinal product without sending in advance a copy of that communication to the competent authority or authorities having granted the marketing authorisation or to the agency where the marketing authorisation was granted in accordance with the centralised authorisation procedure .


### communicating any regulatory measure that is taken in a third country and is based on pharmacovigilance data to the competent authorities and the agency within 15 days of receipt of such information . ### communicating any regulatory measure that is taken in a member state or a third country and is based on pharmacovigilance data to the competent authorities and the agency within 15 days of receipt of such information .


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


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


### frequency and seriousness of adverse events , ### frequency and seriousness of adverse reactions ,


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


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


### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide . many of the antimicrobials used in animals are also used in humans . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . it needs to be ensured that appropriate warnings and guidance are included on the labels of veterinary antimicrobials . use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products . ### antimicrobial resistance to human and veterinary medicinal products is a growing health problem in the union and worldwide , thus involving a common responsibility of member states and all relevant actors . many of the antimicrobials used in animals are also used in humans . some of those antimicrobials are critical for preventing or treating life - threatening infections in humans . in order to fight antimicrobial resistance a number of measures should be taken . better information is necessary regarding the utilisation and effects of antimicrobial medicines . it needs to be ensured that measures are proportionally applied in both the human and animal sector and that appropriate warnings and guidance are included on the labels of antimicrobials . use not covered by the terms of the marketing authorisation of certain new or critically important antimicrobials for humans should be restricted in the veterinary sector . the rules for advertising veterinary antimicrobials should be tightened , and the authorisation requirements should sufficiently address the risks and benefits of antimicrobial veterinary medicinal products .


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


### any observation of a lack of efficacy of a veterinary medicinal product following administration to an animal in accordance with the summary of product characteristics ; ### any observation of a lack of efficacy of a veterinary medicinal product , including signs of antimicrobial resistance , following administration to an animal in accordance with the summary of product characteristics ;


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


### within 120 days of his appointment , the rapporteur shall present the coordination group a report regarding possible harmonisation of summaries of product characteristics for the similar veterinary medicinal products in the group and propose a harmonised summary of products characteristics . ### within 120 days of his appointment , the rapporteur shall present the coordination group a report proposing harmonisation of the conditions governing the use of the group of similar veterinary medicinal products .


### within 120 days of his appointment , the rapporteur shall present the coordination group a report regarding possible harmonisation of summaries of product characteristics for the similar veterinary medicinal products in the group and propose a harmonised summary of products characteristics . ### within 120 days of his appointment , the rapporteur shall present to the coordination group a report with a proposal for harmonisation of the conditions for use of the group of essentially similar veterinary medicinal products or for marketing authorisation for same veterinary medicinal products .


### all therapeutic indications mentioned in the marketing authorisations granted by member states in respect of the similar products in the group ; ### all therapeutic indications and dosages mentioned in the marketing authorisations granted by member states in respect of the essentially similar products in the group ,


### all species mentioned in the marketing authorisations granted by member states in respect of the similar products in the group ; ### all species mentioned in the marketing authorisations granted by member states in respect of the essentially similar products in the group ;


### harmonised summaries of product characteristics for veterinary medicinal products shall contain all of the following information : ### harmonised conditions of use shall contain at least the following information :


### the shortest withdrawal period of those stated in the summaries of the product characteristics . ### a withdrawal period which ensures that consumers are adequately protected .


### ' the abstention of the countries and territories referred to in article 1 from engaging in serious and systematic violations of human rights , including core labour rights , fundamental principles of democracy and the rule of law . ' ### ' respect for democratic principles , human rights and fundamental freedoms and respect for the principle of rule of law by the countries and territories referred to in article 1 . '


### except for third country nationals whose entry is subject to a registration in the ees , if the travel document contains a facial image recorded in the electronic storage medium and if the facial image recorded in the chip can be legally and technically accessed , this verification shall include the verification of the facial image recorded in the chip , by comparing electronically this image with the live facial image of the concerned third country national . ### except for third country nationals whose entry is subject to a registration in the ees , if the travel document contains a facial image recorded in the electronic storage medium and if the facial image recorded in the chip can be legally and technically accessed , this verification shall include , whenever necessary , the verification of the facial image recorded in the chip , by comparing electronically this image with the live facial image of the concerned third country national .


### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . in exceptional cases the court may decide that a hearing should be held publicly after it has taken due account of the best interests of the child . ### children should be judged in the absence of the public in order to protect their privacy and to facilitate their re - integration into society . only in exceptional cases should the court be allowed , taking into account the best interests of the child , to hold a hearing in public . member states should seek to protect the privacy of children in connection with criminal proceedings and their outcome , having regard also to breaches that might be committed through the media , including the internet , and to facilitate the re - integration into society of children involved in criminal proceedings , to that end taking steps to prevent discrimination and marginalisation .


### in case of deprivation of liberty of a child , member states shall ensure that the child has access to a medical examination with a view , in particular , to assessing the general mental and physical condition of the child with the aim to determine the capacity of the child to face questioning or other investigative or evidence gathering acts or any measures taken or envisaged against the child . ### member states shall ensure , when a child has been deprived of liberty or when the proceedings so require , that the child has access without delay to a medical examination with a view , in particular , to assessing the general mental and physical condition of the child with the aim of determining the capacity of the child to face questioning or other investigative or evidence gathering acts or any measures taken or envisaged against the child .


### member states shall ensure that children are detained separately from adults , unless it is considered in the child ' s best interest not to do so . when a detained child reaches the age of 18 years , member states shall provide the possibility to continue the separate detention where warranted , taking into account the individual circumstances of the detained person . ### member states shall ensure that children are detained separately from adults and may , when they reach the age of 18 years , continue to be detained separately unless it is considered to be in their best interests or in the best interests of other detained persons not to do so .


### in case of deprivation of liberty of a child , member states shall ensure that the child has access to a medical examination with a view , in particular , to assessing the general mental and physical condition of the child with the aim to determine the capacity of the child to face questioning or other investigative or evidence gathering acts or any measures taken or envisaged against the child . ### member states shall ensure , when a child has been deprived of liberty or when the proceedings or the best interest of the child&#160 ; so require , that the child has access without delay to a medical examination with a view , in particular , to assessing the general mental and physical condition of the child with the aim of determining any medical needs and the capacity of the child to face questioning or other investigative or evidence gathering acts or any measures taken or envisaged against the child .


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


### member states shall ensure that children are detained separately from adults , unless it is considered in the child ' s best interest not to do so . when a detained child reaches the age of 18 years , member states shall provide the possibility to continue the separate detention where warranted , taking into account the individual circumstances of the detained person . ### member states shall ensure that children are detained separately from adults and may , when they reach the age of 18 years , continue to be detained separately unless it is considered to be in their best interests not to do so .


### in order to ensure the personal integrity of a child who is arrested or detained , the child should have access to a medical examination . the medical examination should be carried out by a physician . ### in order to ensure the personal integrity of a child who is deprived of liberty , including being arrested , detained or imprisoned , to assess his or her general physical and mental state , and any medical needs , and to determine whether he or she should be subjected to questioning , investigative or evidence - taking measures , or any special measures taken or envisaged concerning him or her , that child should have access to a medical examination . the medical examination should be carried out by a physician .


### for that purpose children shall be individually assessed . the assessment shall take particular account of the personality and maturity of the child and their economic and social background . ### for that purpose children shall be individually assessed . the assessment shall take particular account of the personality and maturity of the child and their family , economic , and social background and their living environment . more vulnerable children shall receive particular attention .


### member states shall ensure that children are assisted by a lawyer throughout the criminal proceedings in accordance with directive 2013 / 48 / eu . the right to access to a lawyer cannot be waived . ### member states shall ensure that children are assisted by a lawyer at every stage of the criminal proceedings in accordance with directive 2013 / 48 / eu . the right to access to a lawyer cannot be waived . however , in minor cases this assistance might be provided by a pedagogical authority where such pedagogical solution prevails over a conviction .


### member states shall ensure that children are present at the trial . ### member states shall ensure that children have the right to appear in person and to participate in the trial and shall take all necessary steps to enable them to participate fully , including by giving them the opportunity to be heard .


### for that purpose children shall be individually assessed . the assessment shall take particular account of the personality and maturity of the child and their economic and social background . ### for that purpose children shall be individually assessed . the assessment shall take particular account of the personality and maturity of the child and their family , economic , and social background , their living environment and any specific vulnerabilities .


### member states shall ensure that children are informed promptly about their rights in accordance with directive 2012 / 13 / eu . they shall also be informed about the following rights within the same scope as directive 2012 / 13 / eu : ### member states shall ensure that children are informed promptly &#8211 ; in writing and orally , by procedures appropriate to their age , understanding , and intellectual ability &#8211 ; about the conduct of the proceedings and their rights in accordance with directive 2012 / 13 / eu , including the following rights :


### in order to ensure sufficient protection of children who are not always able to understand the content of interviews to which they are subject , to avoid any challenge of the content of an interview and thereby undue repetition of questioning , questioning of children should be audio - visually recorded . this does not include questioning necessary to identify the child . ### bearing in mind that children are particularly vulnerable , questioning may be perceived to be traumatic , and it is essential that it take place in the presence of the lawyer and , where appropriate , the holder of parental responsibility or another appropriate adult and / or specialist professionals . audio - visual recording of interviews is a vital safeguard serving both to guarantee that interviews will be conducted properly and to ensure sufficient protection of children who are not always able to understand the content of interviews to which they are subject . in order to avoid any challenge of the content of an interview and thereby undue repetition of questioning , questioning of children should therefore be audio - visually recorded . this does not include questioning necessary to identify the child .


### member states shall ensure that children are deprived of liberty before their conviction only as a measure of last resort and for the shortest appropriate period of time . due account shall be taken of the age and individual situation of the child . ### member states shall ensure that children are deprived of liberty before their conviction only as a measure of last resort , &#160 ; a specific and detailed justification for this being given , and for the shortest appropriate period of time , ensuring in every case respect for the human dignity and the rights of the child in custody . due account shall be taken of the age , individual situation and personality of the child and the particular circumstances under which the offence was committed .


### children are in a particularly vulnerable position in relation to detention . special efforts should be undertaken to avoid deprivation of liberty of children given the inherent risks for their physical , mental and social development . the competent authorities should consider alternative measures and impose such measures whenever this is in the best interests of the child . this may include the obligation to report to a competent authority , a restriction on contact with specific persons , a requirement to undergo therapeutic treatment or treatment for addiction and participation in educational measures . ### children are in a particularly vulnerable position in relation to detention . special efforts should be undertaken to avoid deprivation of liberty of children given the inherent risks for their physical , mental and social development and given that it seriously hampers their reintegration in society . therefore , deprivation of liberty should be used only as a measure of last resort and for the shortest appropriate period of time . the competent authorities should consider alternative measures and impose such measures whenever this is in the best interests of the child . this may include the obligation to report to a competent authority , a restriction on contact with specific persons , a requirement to undergo therapeutic treatment or treatment for addiction and participation in educational measures .


### member states shall ensure that judicial and law enforcement authorities and prison staff who deal with cases involving children are professionals specialising in the field of criminal proceedings involving children . they shall receive particular training with regard to children ' s legal rights , appropriate interviewing techniques , child psychology , communication in a language adapted to the child and pedagogical skills . ### member states shall ensure that law enforcement authorities , staff of detention facilities , and other relevant professionals who deal with cases involving children receive adequate training at a level appropriate to their contact with children with regard to children ' s needs and legal rights , appropriate interviewing techniques , child psychology , communication in a language adapted to the child and pedagogical skills , as well as on rules of confidentiality .


### in order to ensure sufficient protection of children who are not always able to understand the content of interviews to which they are subject , to avoid any challenge of the content of an interview and thereby undue repetition of questioning , questioning of children should be audio - visually recorded . this does not include questioning necessary to identify the child . ### bearing in mind that children are particularly vulnerable , questioning may be perceived to be traumatic , therefore it is essential that questioning be carried out by trained professionals taking into consideration the children’s age , maturity , level of understanding and any communication difficulties they may have . questioning should take place in the presence of a lawyer and , where so requested by the child and / or where that is in the best interest of the child , the holder of parental responsibility and , where necessary , specialist professionals . thorough documentation and audio - visual recording of interviews are a vital safeguard serving both to guarantee that interviews will be conducted properly and to ensure sufficient protection of children who are not always able to understand the content of interviews to which they are subject . in order to avoid any challenge of the content of an interview and thereby undue repetition of questioning , questioning of children should therefore be audio - visually recorded .


### member states shall ensure that judicial and law enforcement authorities and prison staff who deal with cases involving children are professionals specialising in the field of criminal proceedings involving children . they shall receive particular training with regard to children ' s legal rights , appropriate interviewing techniques , child psychology , communication in a language adapted to the child and pedagogical skills . ### member states shall ensure that judicial and law enforcement authorities and&#160 ; staff of detention facilities&#160 ; who deal with cases involving children receive appropriate training with regard to children ' s legal rights , interviewing techniques , child psychology , communication in a language adapted to the child and pedagogical skills .


### this directive applies to suspects or accused persons subject to criminal proceedings referred to in paragraph 1 , and to persons subject to european arrest warrant proceedings referred to in paragraph 2 , who are no longer children in the course of those proceedings , which started when they were children . ### this directive applies to suspects or accused persons subject to criminal proceedings referred to in paragraph 1 , and to persons subject to european arrest warrant proceedings referred to in paragraph 2 , who are no longer children in the course of those proceedings , which relate to offences allegedly committed before those persons had reached the age of 18 .


### provisional prohibition ### prohibition


### taking into account the objectives of the union ' s agricultural policy , the results of the recent scientific assessments of efsa and the animal welfare requirement provided in article 13 of the treaty , it is prudent to provisionally prohibit the use of cloning in animal production for farm purposes of certain species . ### taking into account the objectives of the union ' s common agricultural policy , the results of the recent assessments of efsa , based on all available scientific studies , and the animal welfare requirement provided in article 13 tfeu , it is prudent to prohibit the use of cloning in animal production for farming purposes .


### member states shall provisionally prohibit : ### the following shall be prohibited :


### this directive respects the fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union , and notably the freedom to conduct a business and the freedom of the sciences . this directive has to be implemented in accordance with these rights and principles . ### this regulation respects the fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union , and in particular the freedom to conduct a business and the freedom of the sciences . this regulation has to be applied in accordance with these rights and principles .


### council directive 98 / 58 / ec20 lays down general minimum welfare standards for animals bred or kept for farming purposes . it calls on member states to avoid unnecessary pain , suffering or injury of farm animals . if cloning causes unnecessary pain , suffering or injury , member states have to act at national level to avoid it . different national approaches to animal cloning could lead to market distortion . it is thus necessary to ensure that the same conditions apply to all involved in the production and distribution of live animals throughout the union . __________________ 20 council directive 98 / 58 / ec of 20 july 1998 concerning the protection of animals kept for farming purposes . ### council directive 98 / 58 / ec20 lays down general minimum welfare standards for animals bred or kept for farming purposes . it calls on member states to avoid unnecessary pain , suffering or injury of farm animals . if cloning causes unnecessary pain , suffering or injury , member states have to act at national level to avoid it . moreover , a large majority of european consumers have no desire to eat food derived from animal clones . different national approaches to animal cloning could lead to market distortion . it is thus necessary to ensure that the same conditions apply to all involved in the production and distribution of live animals throughout the union . __________________ 20 council directive 98 / 58 / ec of 20 july 1998 concerning the protection of animals kept for farming purposes .


### animals &#8220 ; kept and reproduced for farming purposes&#8221 ; means animals kept and reproduced for the production of food , wool , skin or fur or for other farming purposes . it shall not include animals kept and reproduced exclusively for other purposes such as research , the production of medicinal products and medical devices , the preservation of rare breeds or endangered species , sporting and cultural events ; ### animals &#8220 ; kept and reproduced for farming purposes&#8221 ; means animals kept and reproduced for the production of food , wool , skin or fur or for other farming purposes . it shall not include animals kept and reproduced exclusively for other purposes such as research or the production of medicinal products and medical devices ;


### it is expected that the knowledge on the impact of the cloning technique on the welfare of the animals used will increase . the cloning technique is likely to improve over time . consequently prohibitions should only apply provisionally . this directive should therefore be reviewed within a reasonable time taking into account the experience gained by the member states in its implementation , scientific and technical progress and international developments . ### this regulation should be reviewed within a reasonable time , taking into account the experience gained by the member states in its application , scientific and technical progress , the evolution of consumer perceptions , and international developments .


### “cloning” means asexual reproduction of animals with a technique whereby the nucleus of a cell of an individual animal is transferred into an oocyte from which the nucleus has been removed to create genetically identical individual embryos , that can subsequently be implanted into surrogate mothers in order to produce populations of genetically identical animals ; ### “cloning” means asexual reproduction of animals using a process by which the nucleus of a cell of an individual animal is transferred into an oocyte from which the nucleus has been extracted to create genetically identical individual embryos , that can subsequently be implanted into surrogate mothers in order to produce populations of genetically identical animals ;


### the placing on the market of animal clones and embryo clones . ### the placing on the market and import into the european union of animal clones , embryo clones , descendants of animal clones , germinal products of animal clones and of their descendants , and food or feed from animal clones and their descendants .


### the placing on the market of embryo clones and animal clones . ### the placing on the market and import of animal clones , embryo clones , descendants of animal clones , germinal products of animal clones and of their descendants , and food from animal clones and their descendants .


### proposal for a directive of the european parliament and the council on the cloning of animals of the bovine , porcine , ovine , caprine and equine species kept and reproduced for farming purposes ### proposal for a regulation of the european parliament and the council on the cloning of animals kept and reproduced for farming purposes


### member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . member states shall notify those provisions to the commission by [ date for transposition of the directive ] at the latest and shall notify it without delay of any subsequent amendment affecting them . ’ ### member states shall lay down the rules on penalties applicable to infringements of this regulation and shall take all measures necessary to ensure that they are applied . the penalties provided for shall be effective , proportionate , dissuasive and shall ensure a level playing field . member states shall notify those provisions to the commission by [ date : 1 year from the entry into force of the regulation ] and shall notify it without delay of any subsequent amendment thereto .


### –technologies and solutions to reduce greenhouse gas emissions from fossil fuel - based power generation via co2 capture , utilisation and storage . ### –technologies and solutions to reduce greenhouse gas emissions from fossil fuel - based power generation via co2 capture , utilisation and storage , as well as solutions to support storing excess wind and solar electricity in the form of gas ;


### –next generation internet applications and services for consumers , industry and society building on trust , interoperability , better user control of data , transparent language access , new multi modal interaction concepts , inclusive and highly personalised access to objects , information and content , including immersive and trustworthy media , social media and social networking ; ### –next generation internet applications and services for consumers , industry and society building on trust , interoperability , better user control of data , transparent language access , new multi modal interaction concepts , inclusive and highly personalised access to objects , information and content , including immersive and trustworthy media , social media and social networking , e - commerce ;


### reflecting the importance of tackling climate change in line with the union ' s commitments to implement the paris agreement and the united nations sustainable development goals , this specific programme will contribute to mainstream climate actions and to the achievement of an overall target of 25 % of the eu budget expenditures supporting climate objectives . actions under this specific programme are expected to contribute 35% of the overall financial envelope of the specific programme to climate objectives . relevant actions will be identified during the specific programme ' s preparation and implementation , and reassessed in the context of the relevant evaluations and review processes . ### reflecting the importance of tackling climate change in line with the union ' s commitments to implement the paris agreement and the united nations sustainable development goals , this specific programme will contribute to mainstream climate actions and to the achievement of an overall target of 25 % of the eu budget expenditures supporting climate objectives . actions under this specific programme are expected to contribute at least 35% of the overall financial envelope of the specific programme to climate objectives . relevant actions will be identified during the specific programme ' s preparation and implementation , and reassessed in the context of the relevant evaluations and review processes .


### –blue innovation including in the blue and digital economies , across coastline areas , coastal cities and ports in order to strengthen resilience of coastal areas and increase citizens ' benefits . ### –blue innovation including in the blue and digital economies , across coastline areas , coastal cities , ports and island regions in order to strengthen resilience of coastal areas and increase citizens ' benefits .


### –connect cultural heritage with emerging creative sectors ; ### –connect cultural heritage with emerging creative sectors and tourism ;


### for the eu to reach its air quality , climate , and energy goals , including a 60% reduction in green - house gas emissions by 2050 as well as noise reduction , will require rethinking the whole mobility system including users , vehicles , fuels and infrastructures . it will also require the deployment of low - emission alternative energies and market uptake of zero - emission vehicles / vessels / aircrafts . in addition to the harmful effects of greenhouse gas emissions , transport contributes significantly to poor air quality and noise in europe with negative consequences for the health of citizens18 . building on progress with electrification and the use of fuel cells for cars , buses and light duty vehicles it is essential to accelerate research and innovation solutions for other sectors such as aviation , maritime and inland navigation and lorries . _________________ 18 around one - third of eu citizens live in urban areas with concentration levels of pollutants above legal thresholds ### for the eu to reach its air quality , climate , and energy goals , including a 60% reduction in green - house gas emissions by 2050 as well as noise reduction , will require rethinking the whole mobility system including users , vehicles , fuels and infrastructures . it will also require the deployment of low - emission alternative energies and market uptake of zero - emission vehicles / vessels / aircrafts . in addition to the harmful effects of greenhouse gas emissions , transport contributes significantly to poor air quality and noise in europe with negative consequences for the health of citizens18 . building on progress with electrification and the use of fuel cells for cars , buses and light duty vehicles it is essential to accelerate research and innovation solutions for other sectors such as aviation , maritime and inland navigation , road transport and tourism . _________________ 18 around one - third of eu citizens live in urban areas with concentration levels of pollutants above legal thresholds


### cultural heritage is the fabric of our lives , meaningful to communities , groups and societies , giving a sense of belonging . it is the bridge between the past and the future of our societies . it is a driving force of local economies and a powerful source of inspiration for creative and cultural industries . accessing , conserving , safeguarding and restoring , interpreting and harnessing the full potential of our cultural heritage are crucial challenges now and for future generations . cultural heritage is the major input and inspiration for the arts , traditional craftsmanship , the cultural , entrepreneurial and creative sectors that are drivers of sustainable economic growth , new job creation and external trade . ### cultural heritage is the fabric of our lives , meaningful to communities , groups and societies , giving a sense of belonging . it is the bridge between the past and the future of our societies . it is a driving force of local economies and a powerful source of inspiration for creative and cultural industries as well as the tourism sector . accessing , conserving , safeguarding and restoring , interpreting and harnessing the full potential of our cultural heritage are crucial challenges now and for future generations . cultural heritage is the major input and inspiration for the arts , traditional craftsmanship , the cultural , entrepreneurial and creative sectors such as tourism that are drivers of sustainable economic growth , new job creation and external trade .


### cultural heritage is the fabric of our lives , meaningful to communities , groups and societies , giving a sense of belonging . it is the bridge between the past and the future of our societies . it is a driving force of local economies and a powerful source of inspiration for creative and cultural industries . accessing , conserving , safeguarding and restoring , interpreting and harnessing the full potential of our cultural heritage are crucial challenges now and for future generations . cultural heritage is the major input and inspiration for the arts , traditional craftsmanship , the cultural , entrepreneurial and creative sectors that are drivers of sustainable economic growth , new job creation and external trade . ### cultural heritage the fabric of our lives , meaningful to communities , groups and societies , giving a sense of belonging . it is the bridge between the past and the future of our societies . it is a driving force of local economies and a powerful source of inspiration for creative and cultural industries and the tourism sector . accessing , conserving , safeguarding and restoring , interpreting and harnessing the full potential of our cultural heritage are crucial challenges now and for future generations . cultural heritage is the major input and inspiration for the arts , traditional craftsmanship , the cultural , entrepreneurial , creative and tourism sectors that are drivers of sustainable economic growth , new job creation and external trade .


### 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 .


### directive 2000 / 84 / ec is repealed with effect from 1 april 2019 . ### directive 2000 / 84 / ec is repealed with effect from 1 april 2020 .


### notwithstanding paragraph 1 , member states may still apply a seasonal change of their standard time or times in 2019 , provided that they do so at 1 . 00 a . m . , coordinated universal time , on 27 october 2019 . the member states shall notify this decision in accordance with article 2 . ### notwithstanding paragraph 1 , member states may still apply a seasonal change of their standard time or times in 2020 , provided that they do so at 1 . 00 a . m . , coordinated universal time , on 01 november 2020 . the member states shall notify this decision in accordance with article 2 .


### member states shall provide the commission with the relevant information by 30 april 2024 at the latest . ### member states shall provide the commission with the relevant information by 30 april 2025 at the latest .


### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , communications and other concerned sectors , they should notify the commission in due time of their intention to change their standard time and subsequently apply the notified changes . the commission should , on the basis of that notification , inform all other member states so that they can take all necessary measures . it should also inform the general public and stakeholders by publishing this information . ### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , communications and other concerned sectors , they shall conduct an impact assessment on changing their standard time at national level . the commission should , on the basis of those impact assessments , inform all other member states about the cross - border impact caused by differences between neighbouring countries on , inter alia , transport , communication and commerce as well as the attractiveness of the eu for foreign investments . it should also inform the general public and stakeholders by publishing this information .


### 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 . ### 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 12 months before the change takes effect . where a member state has made such a notification and has not withdrawn it at least 12 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 which has thus far not been accompanied by an impact assessment founded on science and existing analyses upstream of this legislative proposal . 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 .


### the commission shall report to the european parliament and to the council on the implementation of this directive by 31 december 2024 at the latest . ### the commission shall report to the european parliament and to the council on the implementation of this directive by 31 december 2025 at the latest .


### 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&#160 ; intends to change its standard time or times in any territory under its jurisdiction , it shall&#160 ; inform the commission .


### 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 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 essential , in the context of the codecision procedure for this directive , that summer - time arrangements should only be brought to an end if the member states have first reached agreement on a coordination mechanism . this mechanism should take account of the three existing time zones in the eu when the standard time is set . the relevant council presidency will have a leading role to play in establishing this coordination mechanism .


### 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 .


### implementation of this directive should be monitored . the results of this monitoring should be presented by the commission in a report to the european parliament and to the council . that report should be based on the information that is made available to the commission by the member states in a timely fashion to allow for the report to be presented at the specified time . ### implementation of this directive must be monitored and shall be covered by the coordination mechanism agreed in advance among the member states as part of this codecision procedure . the results of this monitoring should be presented by the commission in a report to the european parliament and to the council . that report should be based on the information that is made available to the commission by the member states in a timely fashion to allow for the report to be presented at the specified time .


### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , communications and other concerned sectors , they should notify the commission in due time of their intention to change their standard time and subsequently apply the notified changes . the commission should , on the basis of that notification , inform all other member states so that they can take all necessary measures . it should also inform the general public and stakeholders by publishing this information . ### this directive should not prejudice the right of each member state to decide on the standard time or times for the territories under its jurisdiction and falling under the territorial scope of the treaties , and on further changes thereto . however , in order to ensure that the application of summer - time arrangements by some member states only does not disrupt the functioning of the internal market , member states should refrain from changing the standard time in any given territory under their jurisdiction for reasons related to seasonal changes , be such change presented as a change of time zone . moreover , in order to minimise disruptions , inter alia , to transport , and in particular aviation , with its established slot system for take - offs and landings , communications and other concerned sectors , they should notify the commission in due time of their intention to change their standard time and subsequently apply the notified changes . the decision to abolish the clock change should not serve to jeopardise the competitiveness of european airlines and airports with those in third countries . the commission should , on the basis of that notification , inform all other member states so that they can take all necessary measures . it should also inform the general public and stakeholders by publishing this information .


### 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 .


### member states shall provide the commission with the relevant information by 30 april 2024 at the latest . ### the member states shall provide the commission with the relevant information by 30 april 2026 at the latest .


### obligations of manufacturers concerning their vehicles , systems , components , separate technical units or parts and equipment that are not in conformity or that present a serious risk ### obligations of manufacturers concerning their vehicles , systems , components , separate technical units or parts and equipment that are not in conformity or that present a serious risk to safety , the environment and health


### type - approvals for vehicles , systems , components and separate technical units shall be issued for a limited period of 5 years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it may be renewed upon application by the manufacturer and only where the approval authority has verified that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type . ### type - approvals for vehicles , systems , components and separate technical units shall be issued for a limited period of eight years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it shall be reissued unchecked , upon application by the manufacturer , only where the approval authority has verified that there have been no changes to the type of vehicle , system , component and separate technical unit concerned and that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type .


### type - approvals for vehicles , systems , components and separate technical units shall be issued for a limited period of 5 years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it may be renewed upon application by the manufacturer and only where the approval authority has verified that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type . ### type - approvals for vehicles , systems , components and separate technical units shall be issued for a limited period of eight years without the possibility of prolongation . the expiry date shall be indicated in the type - approval certificate . after the expiry of the type - approval certificate , it shall be reissued unchecked , upon application by the manufacturer , only where the approval authority has verified that there has been no change to the type of vehicle , system , component and separate technical unit concerned and that the type of vehicle , system , component and separate technical unit complies with all the requirements of the relevant regulatory acts for new vehicles , systems , components and separate technical units of that type .


### those national fees shall be levied on the manufacturers who have applied for type - approval in the member state concerned . fees shall not be levied directly by technical services . ### those national fees shall be levied on the manufacturers who have applied for type - approval in the member state concerned .


### the member states shall periodically review and assess the functioning of their type - approval activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public , in particular the number of type - approval granted and the identity of the corresponding manufacturers . ### the member states shall periodically review and assess the functioning of their type - approval activities and the quality of the type - approvals issued . such reviews and assessments shall be carried out at least every three years and the results thereof shall be communicated to the other member states , the commission and third parties upon request . the member state concerned shall make a summary of the results accessible to the general public , in particular the number of type - approval granted or rejected and the identity of the corresponding manufacturers and vehicle types .


### the power to adopt delegated acts referred to in article 4 , article 5 , article 10 , article 22 , article 24 , article 25 , article 26 , article 28 , article 29 , article 34 , article 55 and , article 56 , article 60 , article 65 , article 76 and article 90 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation . ### the power to adopt delegated acts referred to in article 4 , article 5 , article 8 , article 10 , article 22 , article 24 , article 25 , article 26 , article 28 , article 29 , article 34 , article 55 and , article 56 , article 60 , article 65 , article 76 and article 90 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation .


### a delegated act adopted pursuant to article 4 , article 5 , article 10 , article 22 , article 24 , article 25 , article 26 , article 28 , article 29 , article 34 , article 55 and , article 56 , article 60 , article 65 , article 76 and article 90 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act adopted pursuant to article 4 , article 5 , article 8 , article 10 , article 22 , article 24 , article 25 , article 26 , article 28 , article 29 , article 34 , article 55 and , article 56 , article 60 , article 65 , article 76 and article 90 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### the member states shall periodically review and assess the functioning of their type - approval activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public , in particular the number of type - approval granted and the identity of the corresponding manufacturers . ### the member states shall periodically review and assess the functioning of their type - approval activities and the quality of the type - approvals issued . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . third parties will have access to the results upon request . the member state concerned shall make a summary of the results accessible to the general public , in particular the number of type - approvals granted or rejected and the identity of the corresponding manufacturers and vehicle types .


### where an approval authority is informed in accordance with articles 8 , 9 , 52 or 54 , it shall take all necessary measures to review the approval granted and , where appropriate , correct or withdraw the approval depending on the reasons and the seriousness of the deviations demonstrated . ### where an approval authority is informed in accordance with articles 8 , 9 , 52 or 54 , it shall take all necessary measures to review the approval granted , correct or withdraw the approval , where appropriate , depending on the reasons and the seriousness of the deviations demonstrated , and notify the commission without delay about the action taken .


### this forum shall be composed of members appointed by the member states . ### this forum shall be composed of members appointed by the member states and representatives of the commission . representatives of the european parliament , representatives of technical services , third - party testing organisations , safety and environment ngos and consumer groups shall be included as observers .


### market surveillance authorities shall perform regular checks to verify compliance of vehicles , systems , components and separate technical units with the requirements set out in this regulation as well as with the correctness of the type approvals . those checks shall be performed on an adequate scale , by means of documentary checks and real - drive and laboratory tests on the basis of statistically relevant samples . when doing so , market surveillance authorities shall take account of established principles of risk assessment , complaints and other information . ### market surveillance authorities shall perform regular checks to verify compliance of vehicles , systems , components and separate technical units with the requirements set out in this regulation as well as with the correctness of the type approvals . those checks shall be performed on an adequate scale , by means of documentary checks and real - drive and laboratory tests on the basis of statistically relevant samples that are representative of the number of vehicles in that member state . when doing so , market surveillance authorities shall take account of established principles of risk assessment , including complaints , popularity of vehicles models and their parts , third - party testing results , new technologies on the market , reports from periodic technical inspections and other information .


### the member states shall draw up the annual plan for the peer - review , ensuring an appropriate rotation in respect of reviewing and reviewed type - approval authorities , and submit it to the commission . ### the forum established in article 10 shall draw up a working plan for the peer - review , ensuring an appropriate rotation in respect of reviewing and reviewed type - approval authorities .


### the manufacturer shall provide the approval authority with the vehicles , systems , components or separate technical units that are required under the relevant acts listed in annex iv for the performance of the required tests . ### the manufacturer shall provide the technical service with the vehicles , systems , components or separate technical units that are required under the relevant acts listed in annex iv for the performance of the required tests .


### the delegation of power referred to in article 4 , article 5 , article 10 , article 22 , article 24 , article 25 , article 26 , article 28 , article 29 , article 34 , article 55 and , article 56 , article 60 , article 65 , article 76 and article 90 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of power referred to in article 4 , article 5 , article 8 , article 10 , article 22 , article 24 , article 25 , article 26 , article 28 , article 29 , article 34 , article 55 and , article 56 , article 60 , article 65 , article 76 and article 90 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .