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


### 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 ;


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


### a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec or under regulation no 726 / 2004 , or ### a veterinary medicinal product authorised 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 ;


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


### 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 veterinary medicinal product authorised under this regulation in another member state for use in the same species or in another food - producing species for the same condition or for another condition ; ### if there is no product as referred to in point , either : a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec or under regulation no 726 / 2004 , or a veterinary medicinal product authorised in another member state in accordance with this regulation for use in the same species or in another food - producing species for the condition in question or for another condition ; or


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


### 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 ;


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


### warning that the veterinary medicinal product is for animal treatment only ; ### a common pictogram warning that the veterinary medicinal product is for animal treatment only ;


### 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 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 . serious adverse event in animals , noxious response in humans to a veterinary medicinal product and environmental incidents observed following administration of a veterinary medicinal product to an animal shall be reported within 15 days following the receipt of such adverse event report .


### the commission shall , by means of implementing acts , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . ### the commission shall , by means of implementing acts and taking into consideration the scientific advice of the agency , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . the commission , when establishing these rules , shall make decisions on appropriate risk management measures at the class , substance or even the indication level and shall consider also the route of administration .


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


### for the purpose of this section , where the active substance consists of salts , esters , ethers , isomers and mixtures of isomers , complexes or derivatives differing from the active substance used in the reference veterinary medicinal product , it shall be considered to be the same active substance as that used in the reference veterinary medicinal product , unless it differs significantly in respect of properties with regard to safety or efficacy . where it differs significantly in respect of those properties , the applicant shall submit additional information in order to prove the safety and / or efficacy of the various salts , esters or derivatives of the authorised active substance of the reference veterinary medicinal product . ### for the purpose of this section , where the active substance consists of salts , esters , ethers , isomers and mixtures of isomers , complexes or derivatives differing from the active substance used in the reference veterinary medicinal product , it shall be considered to be the same active substance as that used in the reference veterinary medicinal product , unless it differs significantly in respect of properties with regard to safety , efficacy and behaviour of residues . where it differs significantly in respect of those properties , the applicant shall submit additional information in order to prove the safety and / or efficacy of the various salts , esters or derivatives of the authorised active substance of the reference veterinary medicinal product .


### a veterinary prescription shall only be issued by a person qualified to do so in accordance with applicable national law . ### a veterinary prescription shall only be issued by a veterinarian .


### by way of derogation from article 7 , a marketing authorisation for a veterinary medicinal product intended for a limited market shall be granted although the quality and / or efficacy documentation required in accordance with annex ii has not been provided , if all the following conditions are met : ### by way of derogation from article 7 , in exceptional circumstances related to animal or public health , including unmet needs with respect to animal health , where the applicant has demonstrated that for objective , verifiable reasons he is unable to provide the quality , safety and / or efficacy documentation required in accordance with part 1 , part 2 and part 3 of annex ii , a marketing authorisation may be granted subject to any of the following :


### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care , and only in the amount required for the treatment concerned . ### veterinarians qualified to prescribe veterinary medicinal products in accordance with applicable national law shall not retail antimicrobial products and shall only be allowed to provide an emergency doses after a proper diagnosis for the treatment of animals only for animals under their immediate care , and only in the amount required for the treatment concerned .


### the outer packaging of a veterinary medicinal product shall contain only the following information : ### the outer packaging of a veterinary medicinal product shall contain only the information below . in exceptional cases the applicant , or the competent authority , may request additional text to be included where this is justified to ensure the safe and correct administration of the product .


### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which national marketing authorisations have been granted in different member states before 1 january 2004 . ### a harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in article 69 for veterinary medicinal products , other than homeopathic veterinary medicinal products , which have the same qualitative and quantitative composition of their active substances , the same pharmaceutical form , and have been shown to be bioequivalent and for which national marketing authorisations have been granted in different member states and for which nationally approved summaries of product characteristics show an unacceptable divergence .


### a medicinal product for human use authorised in the member state concerned in accordance with directive 2001 / 83 / ec or under regulation no 726 / 2004 , or ### a veterinary medicinal product authorised 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 ;


### ‘ 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 :


### the general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products , their summaries of product characteristics and package leaflets . ### the general public shall have access to information in the product database as regards the list of the authorised veterinary medicinal products , their summaries of product characteristics , package leaflets and their environmental data .


### 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 .


### the outer packaging of a veterinary medicinal product shall contain only the following information : ### the outer packaging of a veterinary medicinal product shall contain at least the following information :


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


### 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 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 and in particular to avoid causing unacceptable suffering , exceptionally treat the animal concerned with the following :


### the commission shall , by means of implementing acts , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . ### the commission shall , by means of implementing acts and taking into consideration the scientific advice of the agency , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . the commission , when establishing these rules , will make decisions on appropriate risk management measures at the class , substance or even the indication level and will consider also the route of administration .


### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care , and only in the amount required for the treatment concerned . ### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall be prohibited from trading in veterinary medicinal products and from any commercial participation in companies which trade in , manufacture or import veterinary medicinal products .


### only manufacturers , wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties . ### only manufacturers , wholesale distributors and retailers authorised specifically to do so in accordance with applicable national law shall be allowed to supply and purchase veterinary medicinal products which have anabolic , anti - infectious , anti - parasitic , anti - inflammatory , hormonal or psychotropic properties or substances which may be used as veterinary medicinal products having those properties . in the case of non - food producing animals all retailers &#8211 ; ranging from supermarkets , pet stores , to traditional and online pharmacies &#8211 ; should be allowed to sell anti - parasitic and anti - inflammatory products , without the need to be specifically authorised to do so .


### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care , and only in the amount required for the treatment concerned . ### persons qualified to prescribe veterinary medicinal products in accordance with applicable national law shall retail antimicrobial products only for animals which are under their care , subject to a veterinary diagnosis based on clinical examination of the animal concerned and only in the amount required for the treatment concerned . such retain shall only be made at cost price .


### member states shall collect relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products . ### member states shall collect relevant and comparable data on the volume of sales in terms of weight and cost for each antimicrobial type and the use of veterinary antimicrobial medicinal products , broken down by species , condition and method of treatment , as geographically narrowed down as feasible .


### 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 . ### 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 must provide safety data concerning the potential risks posed by the generic veterinary medicinal product to the environment .


### the package leaflet shall be written and designed to be clear and understandable , in terms that are comprehensible to the general public . ### the package leaflet shall be written and designed to be clear , readable and understandable , in terms that are comprehensible to the general public .


### 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 ;


### ‘ antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to inhibit or kill microorganisms of the same species ; ### ‘ antimicrobial resistance’ means the ability of microorganisms to survive or to grow in the presence of a concentration of an antimicrobial agent which is usually sufficient to halt the growth of or kill microorganisms of the same species ;


### signature or an equivalent electronic form of identification of the person writing the prescription ; ### signature or an equivalent electronic form of identification of the person issuing the prescription ;


### 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 .


### in the event of an opinion in favour of adopting a harmonised summary of the product characteristics , each member state shall vary a marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur . ### in the event of an opinion in favour of adopting a harmonisation of the conditions of use and of harmonising a marketing authorisation , each member state shall vary the marketing authorisation or authorisations of the products in their territory so that the elements listed in paragraph 4 , where they are already included in the summaries of characteristics for a product belonging to that group , are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur . those marketing authorisations for the same product shall , henceforth be considered to be mutual recognition marketing authorisations granted under this regulation .


### in the event of an opinion in favour of adopting a harmonised summary of the product characteristics , each member state shall vary a marketing authorisation in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur . ### in the event of an opinion in favour of adopting a harmonisation of conditions of use or of harmonising a marketing authorisation , each member state shall vary the marketing authorisation or authorisations of the products in their territory so that the elements listed in paragraph 4 , where they are already included in the summaries of characteristics for a product belonging to that group , are in conformity with the agreement within 30 days of receipt of the information regarding the agreement from the rapporteur . those marketing authorisations for the same product shall , be eligible to be considered to be mutual recognition marketing authorisations granted under this regulation .


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


### by [ 12 months after the date of application of this regulation for op to insert the actual date ] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted before 1 january 2004 . ### by [ 12 months after the date of application of this regulation for op to insert the actual date ] competent authorities shall provide the coordination group with lists of all products for which national marketing authorisations have been granted .


### this regulation guarantees the right to respect for private and family life and to the protection of personal data , as set out in articles 7 and 8 of the charter of fundamental rights of the european union . ### this regulation guarantees the right to respect for private and family life , to the protection of personal data , non - discrimination and gender equality as set out in articles 7 , 8 , 21 and 23 of the charter of fundamental rights of the european union .


### 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 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 :


### 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 arrested or detained , assess his or her general physical and mental state , and 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 , together , where the proceedings so require , with any other child under investigation or accused , should have access to a medical examination . the medical examination should be carried out by a physician .


### 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 but are still under the age of 21 in the course of those proceedings , which relate to offences allegedly committed before those persons had reached the age of 18 .


### 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 proceedings . the right to be assisted by a lawyer cannot be waived .


### member states should determine the age of children on the basis of the children’s own statements , checks of their civil status , documentary research , other evidence and , if such evidence is unavailable or inconclusive , on the basis of a medical examination . ### member states should determine the age of children on the basis of the children’s own statements , checks of their civil status , documentary research , other evidence and , if such evidence is unavailable or inconclusive , on the basis of a medical examination . where a person’s age is still in doubt , that person should , for all purposes , be presumed to be the age of a child .


### 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 the holder of parental responsibility or another appropriate adult as referred to in article 5 have access to the court hearings involving the child . ### except in cases where this would not be in the best interests of the child , member states shall ensure that the holder of parental responsibility or another appropriate adult as referred to in article 5 have access to the court hearings involving the child and can , where appropriate , be present during other stages in the proceedings at which the child is present .


### member states shall ensure that children are present at the trial . ### member states shall ensure that children can 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 and to express their views .


### 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 may derogate from the obligation in paragraph 1 when it is not proportionate to carry out an individual assessment taking into account the circumstances of the case and whether or not the child has previously come to the attention of member state authorities in the context of criminal proceedings . ### member states may derogate from the obligation to carry out an individual assessment or to provide in so doing for the close involvement of the child if the derogation is warranted by the circumstances of the case or is in the best interests of the child .


### member states shall ensure that any questioning of children by police or other law enforcement or judicial authority carried out prior to the indictment is audio - visually recorded , unless it is not proportionate taking into account the complexity of the case , the seriousness of the alleged offence and the potential penalty that can be incurred . ### member states shall ensure that any questioning of children by police or other law enforcement or judicial authority carried out is audio - visually recorded , unless this is not in the best interests of the child .


### the individual assessment shall take place at an appropriate stage of the proceedings and in any event before indictment . ### the individual assessment shall take place at the earliest appropriate stage of the proceedings and in any event before indictment or the imposition of measures involving deprivation of liberty , except where this is impossible .


### when , at the time a person becomes a suspect or accused person in criminal proceedings , that person is above the age of 18 , member states are encouraged to apply the procedural safeguards foreseen by this directive until this person reaches the age of 21 . ### when , at the time a person becomes a suspect or accused person in criminal proceedings , that person is above the age of 18 , member states should , especially if the offence was committed before the child in question had reached the age of 18 , apply the procedural safeguards provided for by this directive at least until this person reaches the age of 21 .


### 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 .


### however , it would be disproportionate to require the competent authorities to ensure audio - visual recording in all circumstances . due account should be taken of the complexity of the case , the seriousness of the alleged offence and the potential penalty that can be incurred . if a child is deprived of liberty before conviction , any questioning of the child should be audio - visually recorded . ### however , it would be unreasonable to require the competent authorities to ensure audio - visual recording even when this was not in the best interests of the child . if a child is deprived of liberty before conviction , any questioning of the child should be audio - visually recorded .


### provisional prohibition ### prohibition


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


### 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 . ### it is expected that knowledge of 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 could be reviewed and / or updated in the event of evident improvements in the said cloning technique . this regulation should therefore be reviewed within a reasonable time , taking into account the experience gained by the member states in its application , scientific and technical progress , changes in consumer perceptions , and international developments , in particular trade flows and the union ' s trade relations .


### 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 .


### 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 .


### 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


### 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 scientific assessments of efsa , the animal welfare requirement provided in article 13 tfeu , and the fact that the majority of union citizens disapprove of cloning for food production due to animal welfare and general ethical concerns , it is prudent to fully prohibit the use of cloning in animal production for farming purposes or for sporting or cultural events .


### –quality of life for the citizens , safe mobility , urban social innovation , cities ' circular and regenerative capacity , reduced environmental footprint and pollution ; ### –quality of life for the citizens and visitors , safe mobility , urban social innovation , cities ' circular and regenerative capacity , reduced environmental footprint and pollution , smart destinations ;


### –renovation processes of existing buildings towards ' nearly zero energy buildings ' ; ### –renovation processes of existing buildings towards ' nearly zero energy buildings ' , including the tourism accommodation .


### in accordance with article 9of regulation &#8230 ; fp / rfp regulation , the financial envelope for the implementation of the specific programme for the period 2021 to 2027 shall be eur 94 100 000 000 in current prices . ### in accordance with article 9of regulation &#8230 ; fp / rfp regulation , the financial envelope for the implementation of the specific programme for the period 2021 to 2027 shall be eur 120 000 000 000 in current prices .


### the specific programme ' s actions should be used to address market failures or sub - optimal investment situations , in a proportionate manner , without duplicating or crowding out private financing and have a clear european added value . ### the specific programme ' s actions should be used to address market failures , in particular through r&i addressing neglected societal challenges that suffer from sub - optimal investment situations , in a proportionate manner , without duplicating or crowding out private financing and have a clear european added value .


### –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 ;


### finding new ways to accelerate the deployment of clean technologies and solutions for the decarbonisation of the european economy requires also increased demand for innovation . this can be stimulated through the empowerment of citizens as well as socio - economic and public sector innovation and will lead to approaches broader than technology - driven innovation . socio - economic research covering inter alia user needs and patterns , foresight activities , environmental , economic , social and behavioural aspects , business cases and models and pre - normative research for standard setting , will also facilitate actions fostering regulatory , financing and social innovation , skills , as well as engagement and empowerment of market players and consumers . ### finding new ways to accelerate the deployment of clean technologies and solutions for the decarbonisation of the european economy also requires increased demand for innovation . this can be stimulated through the empowerment of citizens as well as socio - economic and public sector innovation and will lead to approaches broader than technology - driven innovation . socio - economic research covering , inter alia , the needs and patterns of all users , foresight activities , environmental , economic , social and behavioural aspects , geographical localisation , business cases and models and pre - normative research for standard - setting , will also facilitate actions fostering regulatory , financing and social innovation , skills , as well as engagement and empowerment of market players and consumers .


### connecting and developing research infrastructures across the european research area ; ### connecting and developing research infrastructures across the european research area , boosting europe ' s competitiveness and making it a global frontrunner in the field of research and innovation ;


### –the capacities of society to better manage and reduce disaster risk , including through nature - based solutions , by enhancing prevention , preparedness and response to existing and new risks ### –the capacities of society and businesses highly sensitive to force majeur events , as is the case of the travel and tourism industry , to better manage and reduce disaster risk , including through nature - based solutions , by enhancing prevention , preparedness and response to existing and new risks ;


### –innovation and food systems for place - based innovation and empowerment of communities , fostering fair trade and pricing , inclusiveness and sustainability through partnerships between industry , local authorities , researchers and society . ### –innovation and food systems for place - based innovation and empowerment of communities , fostering fair trade and pricing , inclusiveness and sustainability through partnerships between industries that can strongly contribute to a significant change on the ways of producing and consuming , as is the case of tourism , local authorities , researchers and society .


### –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 and ports and coastal and maritime tourism in order to strengthen resilience of coastal areas and increase citizens ' and visitor benefits .


### 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 are drivers of sustainable economic growth , new job creation and external trade .


### –consumers ' behaviour , lifestyle and motivations , promoting social innovation and societal engagement for better health and environmental sustainability throughout the entire food value chain ; ### –consumers ' behaviour , lifestyle and motivations , promoting social innovation and societal engagement for better health and environmental sustainability throughout the entire food value chain ; in cooperation with other industries from travel and tourism .


### –energy performance of buildings monitoring and optimisation ; ### –energy performance of buildings including the tourism accommodation monitoring and optimisation ;


### 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 35% of the overall financial envelope of the specific programme to climate objectives . relevant actions will be identified , in consultation with relevant stakeholders and civil society , during the specific programme ' s preparation and implementation , and reassessed in the context of the relevant evaluations and review processes .


### 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 .


### –adaptable and multi - functional nature - based solutions , addressing challenges in cities , rural and coastal areas related to climate change , natural disasters , biodiversity loss , ecosystem degradation , pollution , and citizens’ health and well - being ; ### –adaptable and multi - functional nature - based solutions , addressing challenges in cities , rural and coastal areas related to climate change , natural disasters , biodiversity loss , ecosystem degradation , pollution , and citizens’ and visitors ' health and well - being ;


### 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 .


### 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 the internal market , the energy sector , transport , communications and other concerned sectors , they should notify the commission and all other member states in due time of their intention to change their standard time and subsequently apply the notified changes . the commission should inform the general public and stakeholders by publishing this information .


### 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 .


### the commission has examined available evidence , which points to the importance of having harmonised union rules in this area to ensure the proper functioning of the internal market and avoid , inter alia , disruptions to the scheduling of transport operations and the functioning of information and communication systems , higher costs to cross - border trade , or lower productivity for goods and services . evidence is not conclusive as to whether the benefits of summer - time arrangements outweigh the inconveniences linked to a biannual change of time . ### the commission has examined available evidence , which points to the importance of having harmonised union rules in this area to ensure the proper functioning of the internal market , create predictability and long - term certainty and avoid , inter alia , disruptions to the scheduling of transport operations , the energy sector and the functioning of information and communication systems , higher costs to cross - border trade , or lower productivity for goods and services . furthermore , while scientific evidence is not yet fully conclusive , recent scientific studies have pointed out the possible negative effects on human health linked to a biannual change of time .


### 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 .


### the commission has examined available evidence , which points to the importance of having harmonised union rules in this area to ensure the proper functioning of the internal market and avoid , inter alia , disruptions to the scheduling of transport operations and the functioning of information and communication systems , higher costs to cross - border trade , or lower productivity for goods and services . evidence is not conclusive as to whether the benefits of summer - time arrangements outweigh the inconveniences linked to a biannual change of time . ### the commission has examined available evidence , which points to the importance of having harmonised union rules in this area to ensure the proper functioning of the internal market and avoid , inter alia , disruptions to the scheduling of transport operations and the functioning of information and communication systems , higher costs to cross - border trade , or lower productivity for goods and services . the transition towards a new hour system should be facilitated through ict testing for an effective implementation , without additional costs for businesses and citizens . evidence is not conclusive as to whether the benefits of summer - time arrangements outweigh the inconveniences linked to a biannual change of time . accordingly to the recent studies on human health : it has been also pointed out that biannual time change has several negative effects and adapting is not as easy as thought .


### 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 , as is shown in the 4 , 6 million replies from citizens in the public consultation held by the commission where a majority is against the current system with the seasonal time change . some member states have also 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 .


### 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 .


### the member states shall periodically review and assess the functioning of their surveillance 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 . ### the member states shall periodically review and assess the functioning of their surveillance 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 , the commission and the joint research centre . the member state concerned shall make a summary of the results accessible to the public .


### vehicle manufacturers shall make public data which are needed for the purpose of compliance verification testing by third parties . the commission shall adopt implementing acts in order to define the data to be made public and the conditions for such publication , subject to the protection of commercial secrets and the preservation of personal data pursuant to union and national legislation . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 87 . ### vehicle manufacturers shall provide all data which are needed for the purpose of compliance verification testing by national surveillance authorities and the commission . the commission shall adopt implementing acts in order to define the data to be provided and the conditions for doing so , subject to the protection of commercial secrets and the preservation of personal data pursuant to union and national legislation . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 87 .


### the approval authority shall , within one month of issuing or amending the eu type - approval certificate , send to the approval authorities of the other member states and the commission a copy of the eu type - approval certificate , together with the attachments , including the test reports referred to in article 23 , for each type of vehicle , system , component and technical unit that it has approved . that copy shall be sent by means of a common secure electronic exchange system or in the form of a secure electronic file . ### the approval authority shall , within one month of issuing or amending the eu type - approval certificate , send to the approval authorities of the other member states and the european authority a copy of the eu type - approval certificate , together with the attachments , including the test reports referred to in article 23 , for each type of vehicle , system , component and technical unit that it has approved . that copy shall be sent by means of a common secure electronic exchange system or in the form of a secure electronic file .


### market surveillance authorities shall require economic operators to make the documentation and information available as they consider necessary for the purpose of carrying out their activities . ### market surveillance authorities shall require economic operators to make the documentation and information available as they consider necessary for the purpose of carrying out their activities . when a market surveillance authority requires more information on a manufacturer that has not obtained type - approval for a vehicle in that member state , it shall apply to the surveillance authority , which shall be responsible for centralising all requests and shall act as a point of contact with the manufacturer .


### 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 five years with the possibility of a two - year extension where no substantial change has been made to the relevant regulatory acts . the expiry date shall be indicated in the type - approval certificate . before final 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 . it shall not be necessary to repeat the tests required under article&#160 ; 28 in order to renew the certificate if the legislation which must be complied with is the same as it was on the date on which the vehicle was type - approved .


### those tests and inspections may take place on new vehicles supplied by manufacturers or the economic operator as provided in paragraph 2 below . ### those tests and inspections may take place on new vehicles , components and separate technical units supplied by manufacturers or the economic operator as provided in paragraph 2 below .


### manufacturers holding type - approvals or the economic operators shall , upon request , supply to the commission a statistically relevant number of production vehicles , systems , components and separate technical units selected by the commission that are representative for the vehicles , systems , components and separate technical units available for placing on the market under that type - approval . those vehicles , systems , components and separate technical units shall be supplied for testing at the time and place and for the period the commission may require . ### manufacturers holding type - approvals or the economic operators shall , upon request , supply to the european authority a statistically relevant number of production vehicles , systems , components and separate technical units selected by the european authority that are representative for the vehicles , systems , components and separate technical units available for placing on the market under that type - approval . those vehicles , systems , components and separate technical units shall be supplied for testing at the time and place and for the period the european authority may require .


### the commission shall consult the type - approval authority of the member state where the technical service is established as part of the investigation referred to in paragraph 1 . the type - approval authority of that member state shall provide the commission , upon request , with all relevant information relating to the performance and the compliance with the requirements concerning independence and competence of the technical service concerned . ### the european authority shall consult the type - approval authority of the member state where the technical service is established as part of the investigation referred to in paragraph 1 . the type - approval authority of that member state shall provide the european authority , upon request , with all relevant information relating to the performance and the compliance with the requirements concerning independence and competence of the technical service concerned .


### member states shall facilitate , where appropriate , the cooperation between the information society service providers and rightholders through stakeholder dialogues to define best practices , such as appropriate and proportionate content recognition technologies , taking into account , among others , the nature of the services , the availability of the technologies and their effectiveness in light of technological developments . ### information society service providers that store and provide to the public access to significant amounts of copyright protected works or other subject - matter uploaded by their users , as well as the services referred to in paragraphs 1 and 2 , shall , if requested by and in cooperation with rightholders , take measures to ensure the functioning of agreements concluded with rightholders for the use of their works or other subject - matter or to prevent the availability on their services of works or other subject - matter , if no agreements for use are concluded . for proper functioning of such arrangements , relevant information on the works and other subject matter that need to be identified through the required technical measures shall be provided by rightholders through the cooperation with the service providers . those measures , such as the use of effective technologies for content identification , shall be appropriate and proportionate and compliant with the relevant industry standards . the service providers shall provide rightholders with adequate information on the functioning and the deployment of the measures , as well as , when relevant , adequate and timely reporting on the recognition and use of the works and other subject - matter .


### in order to ensure compliance with union law , member states should notify the draft intergovernmental agreement to the commission before it becomes legally binding for the parties . in a spirit of cooperation , the commission should support the member state in identifying compliance issues of the draft intergovernmental agreement or amendment . the respective member state would then be better prepared to conclude a union law compliant agreement . the commission should have sufficient time for such an assessment in order to provide for as much legal certainty as possible while avoiding undue delays . in order to fully benefit from the commission ' s support member states should refrain from concluding an intergovernmental agreement until the commission has informed the member state of its assessment . the member states should take all necessary steps to find a suitable solution to eliminate the incompatibility identified . ### in order to ensure compliance with union law and provisions on energy security of the eu , member states should notify the draft intergovernmental agreement to the commission before it becomes legally binding for the parties . in a spirit of cooperation , the commission should support the member state in identifying compliance issues of the draft intergovernmental agreement or amendment . the respective member state would then be better prepared to conclude a union law compliant agreement . the commission should have sufficient time for such an assessment in order to provide for as much legal certainty . the commission should avoid undue delays that can have a negative effect on the negotiating position of the member state . in order to fully benefit from the commission ' s support member states should refrain from concluding an intergovernmental agreement until the commission has informed the member state of its assessment . the member states should take all necessary steps to find a suitable solution to eliminate the incompatibility identified .


### in order to avoid any incompliance with union law and enhance transparency , member states should inform the commission of their intent to enter into negotiations with regard to new intergovernmental agreements or amendments to existing intergovernmental agreements as soon as possible . the commission should be kept informed regularly of the progress of the negotiations . member states should have the possibility to invite the commission to participate in the negotiations as an observer . ### in order to avoid any incompliance with union law and provisions on energy security of the eu , and to enhance transparency , member states should inform the commission of their intent to enter into negotiations with regard to new intergovernmental agreements or amendments to existing intergovernmental agreements as soon as possible . the commission should be kept informed regularly and adequately of the progress of the negotiations . member states should have the possibility to invite the commission to participate in the negotiations as an observer .


### during the negotiations the commission should have the possibility to advice on how to avoid incompatibility with union law . in particular , the commission could develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions . ### during the negotiations the commission should have the possibility to advice on how to avoid incompatibility with union law . in particular , the commission should develop , together with member states , optional model clauses and guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions .


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


### by providing for a period of supplementary protection of up to five years , regulation no 469 / 2009 seeks to promote , within the union , the research and innovation that is necessary to develop medicinal products , and to contribute to preventing the relocation of pharmaceutical research outside the union to countries that may offer greater protection . ### by providing for a period of supplementary protection of up to five years , regulation no 469 / 2009 seeks to promote , within the union , the research and innovation that is necessary to develop medicinal products , and to contribute to preventing the relocation of pharmaceutical research outside the union to countries that may offer greater protection , while at the same time ensuring access to medicines within the union .


### the address , or addresses , of the premises where the making is to take place in the relevant member state ; ### the address , or addresses , of the premises where the making and other related acts for that making are to take place in the relevant member state ;


### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the making is intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the once - off duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention . ### to this end , this regulation should impose a duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where each making is to take place . the information should be provided before the making or before other acts that are related for that making are intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention .


### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the making is intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the once - off duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention . ### to this end , this regulation should impose a duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . a standard form should be used for the purpose of communicating such information . the information should be provided before the making is intended to start for the first time in that member state , and before any related act prior to that making , and should be updated as appropriate . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making and has informed the holder of the supplementary protection certificate granted in that member state as regards the making . only the making should be notified , not the related acts . should making take place in more than one member state , a notification should be required in each of those member states . the authority should be required to publish certain elements of that information , in the interests of transparency . certain confidential or commercially sensitive information notified to the authority should not be published . only a court or other competent authority should be able to request such information .


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


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the authority referred to in article 9 of the member state where that making is to take place notified by the person doing the making of the information listed in paragraph 3 no later than 60 days before the intended start date of making in that member state ;


### in addition , this regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate . the maker should be required to inform persons within its supply chain , through appropriate means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate ### in addition , this regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate . the maker should be required to inform persons within its supply chain , through appropriate and documented means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purposes of export and / or day - 1 entry . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate .


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


### the commission should carry out an evaluation of this regulation . pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201643 , that evaluation should be based on the five criteria of effectiveness , efficiency , relevance , coherence and added value and should provide the basis for impact assessments of possible further measures . the evaluation should take into account exports to outside the union and the ability of generics and especially biosimilars to enter markets in the union as soon as possible after a certificate lapses . in particular , this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses . it should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the union and consider the balance between the different interests at stake , including those of public health . _________________ 43 oj l 123 , 12 . 5 . 2016 , p . 1 . ### the commission should carry out an evaluation of this regulation . pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201643 , that evaluation should be based on the five criteria of effectiveness , efficiency , relevance , coherence and added value and should provide the basis for impact assessments of possible further measures . the evaluation should take into account exports to outside the union and the ability of generics and especially biosimilars to enter markets in the union as soon as possible after a certificate lapses . in particular , this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses . it should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the union and consider the balance between the different interests at stake , including access to medicines within the union and those of public health . _________________ 43 oj l 123 , 12 . 5 . 2016 , p . 1 .


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those country markets where supplementary protection does not exist or has expired , and to ensure day - 1 entry of generic and biosimilar medicines onto the union market after the expiry of the relevant supplementary protection certificate and this fostering access to medicines . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate , namely the eu - day1 entry . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in these specific and limited circumstances , it is appropriate to eliminate the aforementioned , unintended side effects of the supplementary protection certificate so as to enable a level - playing field between union - based manufacturers and those in third countries . this would enable manufacturing exclusively for export to country markets where the supplementary protection has expired , as well as for any other acts that are strictly necessary for this manufacturing and entry onto the union market as soon as the supplementary protection certificate expires .


### in addition , this regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate . the maker should be required to inform persons within its supply chain , through appropriate means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate . ### in addition , this regulation should impose certain due diligence requirements on a maker as a condition for the exception to operate . each maker should be required to inform persons within its supply chain , through appropriate and documented means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate .


### this regulation respects fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union . in particular , this regulation seeks to ensure full respect for the right to property in article 17 of the charter by maintaining the core rights of the supplementary protection certificate , by confining the exception to certificates granted on or after a specified date after entry into force of this regulation and by imposing certain conditions on the application of the exception , ### this regulation respects fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union . in particular , this regulation seeks to ensure full respect for the right to property laid down in article 17 of the charter by maintaining the core rights of the supplementary protection certificate , by confining the exception to certificates granted after the date of entry into force of this regulation . , as well as the right to health care provided for in article 35 of the charter by making medicines more accessible to eu patients , the principle of proportionality set out in article 52 of the charter and the right to health protection for european citizens sert out in point of article 6 tfeu .


### the information for the purposes of paragraph 2 shall be as follows : the name and address of the maker ; the address , or addresses , of the premises where the making is to take place in the relevant member state ; the number of the certificate granted in the relevant member state , and identification of the product , by reference to the proprietary name used by the holder of that certificate ; the number of the authorisation granted in accordance with article 40 of directive 2001 / 83 / ec or article 44 of directive 2001 / 82 / ec for the manufacture of the corresponding medicinal product or , in the absence of such authorisation , a valid certificate of good manufacturing practice as referred to in article 111 of directive 2001 / 83 / ec or article 80 of directive 2001 / 82 / ec covering the premises where the making is to take place ; the intended start date of making in the relevant member state ; an indicative list of the intended third country or third countries to which the product is to be exported . ### the information for the purposes of paragraph 2 shall be treated as strictly confidential and be as follows : the name and address of the maker ; the relevant member state where the making is to take place ; the number of the certificate granted in the relevant member state , and identification of the product , by reference to the proprietary name used by the holder of that certificate ; the start date of making in the relevant member state ;