### ' lifelong learning ' means learning in all its forms taking place at all stages in life , including early childhood education and care , general education , vocational education and training , higher education , and adult education , and resulting in an improvement in knowledge , skills and attitudes or participation in society in a personal , civic , cultural , social and / or employment - related perspective , including the provision of counselling and guidance services ; ### ' lifelong learning ' means learning in all its forms taking place at all stages in life , including early childhood education and care , general education , vocational education and training , higher education , and adult education , and resulting in an improvement or update in knowledge , skills , competences and attitudes or participation in society in a personal , civic , cultural , social and / or employment - related perspective , including the provision of counselling and guidance services ;


### ' learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training or non - formal or informal learning ; it may be accompanied by measures such as language support and training and / or be complemented by online learning and virtual cooperation . in some specific cases , it may take the form of learning through the use of information technology and communications tools ; ### ' learning mobility ' means moving physically to a country other than the country of residence , in order to undertake study , training , including upskilling or reskilling , teaching or non - formal or informal learning ; it may be accompanied by measures such as language support and training and / or be complemented by online learning and virtual cooperation . in some exceptional cases , it may take the form of learning through the use of information technology and communications tools ;


### ‘ staff’ means any person who , on either a professional or a voluntary basis , is involved in education , training or non - formal learning , and may include professors , teachers , trainers , school leaders , youth workers , sport coaches , non - educational staff and other practitioners involved in promoting learning ; ### ‘ staff’ means any person who , on either a professional or a voluntary basis , is involved in education , training or non - formal learning , and may include professors , teachers , trainers , researchers , school leaders , youth workers , sport coaches , non - educational staff and other practitioners involved in promoting learning ;


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


### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth and sport , in europe and beyond , thereby contributing to sustainable growth , jobs and social cohesion and to strengthening european identity . as such , the programme shall be a key instrument for building a european education area , supporting the implementation of the european strategic cooperation in the field of education and training , with its underlying sectoral agendas , advancing youth policy cooperation under the union youth strategy 2019 - 2027 and developing the european dimension in sport . ### the general objective of the programme is to support the educational , professional and personal development of people in education , training , youth and sport , in europe and beyond , thereby contributing to sustainable development and growth , jobs and social cohesion , to the enhancement of integration policies within a pluralist society , and to strengthening european identity , as well as dialogue and better reciprocal understanding between different cultures . as such , the programme shall be a key instrument for building a european education area , promoting common standards and supporting the implementation of the european strategic cooperation in the field of education and training , with its underlying sectoral agendas , advancing youth policy cooperation under the union youth strategy 2019 - 2027 and developing the european dimension in sport . the programme includes an international dimension , to be incorporated into the framework of the union’s external action , including its development objectives , through cooperation between the union and third countries .


### partnerships for cooperation and exchanges of practices , including small - scale partnerships to foster a wider and more inclusive access to the programme ; ### partnerships for cooperation , peer learning&#160 ; and exchanges of practices , including small - scale partnerships to foster a wider and more inclusive access to the programme ;


### online platforms and tools for virtual cooperation , including the support services for etwinning and for the electronic platform for adult learning in europe . ### accessible and user - friendly online platforms and tools for virtual cooperation , including the support services for etwinning and for the electronic platform for adult learning in europe .


### the support to union tools and measures that foster the quality , transparency and recognition of competences , skills and qualifications45 ; _________________ 45 in particular the single union framework for the transparency of qualifications and competences ; the european qualifications framework ; the european quality assurance reference framework for vocational education and training ; the european credit system for vocational education and training ; the european credit transfer and accumulation system ; the european quality assurance register for higher education ; the european association for quality assurance in higher education ; the european network of information centres in the european region and national academic recognition information centres in the european union ; and the euroguidance networks . ### the support to union tools and measures that foster the quality , transparency , update and recognition of competences , skills and qualifications45 ; _________________ 45 in particular the single union framework for the transparency of qualifications and competences ; the european qualifications framework ; the european quality assurance reference framework for vocational education and training ; the european credit system for vocational education and training ; the european credit transfer and accumulation system ; the european quality assurance register for higher education ; the european association for quality assurance in higher education ; the european network of information centres in the european region and national academic recognition information centres in the european union ; and the euroguidance networks .


### measures that contribute to the qualitative and inclusive implementation of the programme ; ### targeted measures that contribute to the qualitative and inclusive implementation of the programme ;


### the programme shall support teaching , learning , research and debates on european integration matters through the following actions : ### the programme shall support teaching , learning , research and debates on european integration matters and on the union’s future challenges through the following actions :


### online platforms and tools for virtual cooperation . ### accessible and user - friendly online platforms and tools for virtual cooperation .


### not for profit sport events aiming at further developing the european dimension of sport . ### not for profit sport events aiming at promoting social inclusion and the importance of health - enhancing physical activity , as well as further developing the european dimension of sport .


### the programme shall be implemented by work programmes referred to in article [ 108 ] of the financial regulation . in addition , the work programme shall give an indication of the amount allocated to each action and of the distribution of funds between the member states and third countries associated to the programme for the actions to be managed through the national agency . the work programme shall be adopted by the commission by means of an implementing act . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 31 . ### the secondary policy choices and priorities , including details of specific initiatives outlined in articles 4 to 13 , shall be determined by means of a work programme as referred to in article 110 of the financial regulation . the work programme shall also set out how the programme is to be implemented . in addition , the work programme shall give an indication of the amount allocated to each action and of the distribution of funds between the member states and third countries associated to the programme for the actions to be managed through the national agency . the commission is empowered to adopt delegated acts in accordance with article 30 in order to supplement this regulation by adopting the work programme .


### the programme shall be implemented by work programmes referred to in article [ 108 ] of the financial regulation . in addition , the work programme shall give an indication of the amount allocated to each action and of the distribution of funds between the member states and third countries associated to the programme for the actions to be managed through the national agency . the work programme shall be adopted by the commission by means of an implementing act . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 31 . ### the programme shall be implemented by work programmes referred to in article [ 108 ] of the financial regulation . in addition , the work programme shall give an indication of the amount allocated to each action and of the distribution of funds between the member states and third countries associated to the programme for the actions to be managed through the national agency . it shall give a specific indication of the distribution of funds allocated to developing countries . the work programme shall be adopted by the commission by means of an implementing act . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 31 .


### 21evaluation ### 21evaluations , mid - term review and revision


### without prejudice to the requirements set out in chapter ix and the obligations of national agencies as referred to in article 24 , member states shall submit to the commission , by 30 april 2024 , a report on the implementation and the impact of the programme in their respective territories . ### without prejudice to the requirements set out in chapter ix and the obligations of national agencies as referred to in article 24 , member states shall submit to the commission , by 31 december 2023 , a report on the implementation and the impact of the programme in their respective territories .


### without prejudice to the requirements set out in chapter ix and the obligations of national agencies as referred to in article 24 , member states shall submit to the commission , by 30 april 2024 , a report on the implementation and the impact of the programme in their respective territories . ### without prejudice to the requirements set out in chapter ix and the obligations of national agencies as referred to in article 24 , member states shall submit to the commission , by 30 april 2024 , a report on the implementation and the impact of the programme in their respective territories . the eeas shall submit a similar report on the implementation and the impact of the programme in participating developing countries .


### at the end of the implementation period , but no later than four years after the end of the period specified in article 1 , a final evaluation of the programme shall be carried out by the commission . ### at the end of the implementation period , but no later than four years after the end of the period specified in article 1 , a final evaluation of the programme shall be carried out by the commission . the evaluation shall include a specific focus on the achievements in the field of development cooperation .


### the commission shall communicate the conclusions of the evaluations accompanied by its observations to the european parliament , the council , the european economic and social committee and the committee of the regions . ### the commission shall transmit any evaluations and the mid - term review , accompanied by its observations , to the european parliament , the council , the european economic and social committee and to the committee of the regions .


### based on the national agency’s yearly management declaration , the independent audit opinion thereon and the commission’s analysis of the national agency’s compliance and performance , the national authority shall , each year , provide the commission , with information concerning its monitoring and supervision activities in relation to the programme . ### based on the national agency’s yearly management declaration , the independent audit opinion thereon and the commission’s analysis of the national agency’s compliance and performance , the national authority shall , each year , provide the commission , with information concerning its monitoring and supervision activities in relation to the programme . such information shall be made easily accessible to the public .


### if relevant , additional funds for measures under point of article 6 and point of article 10 . ### if relevant , additional funds for measures under point of article 6 , point of article 10 and point of article 13 .


### the power to adopt delegated acts referred to in article 20 shall be conferred on the commission until 31 december 2028 . ### the power to adopt delegated acts referred to in articles 19 and 20 shall be conferred on the commission until 31 december 2028 .


### the delegation of power referred to in article 20 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of power referred to in articles 19 and 20 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### most member states already combine mandatory surveys for the safe operation of regular ro - ro ferries with other types of surveys and inspections where possible , namely flag state surveys and port state control inspections . to further reduce the inspection effort and to maximise the time in which the ship can be commercially exploited , vessels subject to port state control inspections should be therefore transferred to directive 2009 / 16 / ec and the scope of this directive should be confined to ships providing regular ro - ro ferry and high - speed passenger craft services between ports within a member state or between a port in a member state and a port in a third state where the flag of the vessel is the same as the member state in question . ### most member states already combine mandatory surveys for the safe operation of regular ro - ro ferries with other types of surveys and inspections where possible , namely flag state surveys and port state control inspections . to further reduce the inspection effort and to maximise the time in which the ship can be commercially exploited , while continuing to ensure high safety standards that are not watered down , vessels subject to port state control inspections should be therefore transferred to directive 2009 / 16 / ec and the scope of this directive should be confined to ships providing regular ro - ro ferry and high - speed passenger craft services between ports within a member state or between a port in a member state and a port in a third state where the flag of the vessel is the same as the member state in question .


### member states shall carry out an inspection in accordance with annex ii each time the ro - ro ferry or high - speed passenger craft undergoes repairs , alterations and modifications of a major character , or when there is a change in management , or a transfer of class . however , in case of change in management , or transfer of class , the member state may , after taking account of inspections previously carried out for the ro - ro ferry or high - speed passenger craft , and provided that the safe operation of the ferry or craft is not affected by this change or transfer , dispense the ferry or craft from the inspection required by this paragraph . ### member states shall carry out an inspection in accordance with annex ii each time the ro - ro ferry or high - speed passenger craft in regular service on domestic voyages within the meaning of article 1 undergoes repairs , alterations and modifications of a major character , or when there is a change in management , or a transfer of class . however , in case of change in management , or transfer of class , the member state may , after taking account of inspections previously carried out for the ro - ro ferry or high - speed passenger craft , and provided that the safe operation of the ferry or craft is not affected by this change or transfer , dispense the ferry or craft from the inspection required by this paragraph .


### information on concerted and joint inspections shall be included in quarterly reports to be submitted to the management board . a yearly report on the inspections supported by the authority shall be included in the authority ' s annual activity report . ### information on concerted and joint inspections shall be included in quarterly reports to be submitted to the management board . those reports shall be made public and shall contain information about those cases where the authority of a member state does not participate in or conduct the concerted or joint inspection referred to in paragraph 1 . a yearly report on the inspections supported by the authority shall be included in the authority ' s annual activity report .


### means other than the electronic data - processing techniques referred to in article 6 may be used on a transitional basis , until 31 december 2025 at the latest , where the electronic systems which are necessary for the application of the following provisions of the code are not yet operational : ### means other than the electronic data - processing techniques referred to in article 6 may be used on a transitional basis , until 31 december 2022 at the latest , where the electronic systems which are necessary for the application of the following provisions of the code are not yet operational :


### have premises in which it keeps its core business documents , in particular its commercial contracts , accounting documents , personnel management documents , labour contracts , documents containing data relating to driving time and rest and any other document to which the competent authority must have access in order to verify compliance with the conditions laid down in this regulation ; ; ### have premises suitable for carrying out the undertaking ' s activities , in which it keeps its core business documents in paper and / or electronic format , in particular its commercial contracts , accounting documents , personnel management documents , labour contracts , documents containing data relating to postings , driving time and rest and any other document to which the competent authority must have access at any time in order to verify compliance with the conditions laid down in this regulation ;


### without prejudice to paragraphs 1 and 2 , member states shall take all necessary measures to ensure that the national electronic registers are interconnected and accessible throughout the community through the national contact points defined in article 18 . accessibility through national contact points and interconnection shall be implemented by 31 december 2012 in such a way that a competent authority of any member state is able to consult the national electronic register of any member state . ### paragraph 5 is replaced by the following : “5 . member states shall take all necessary measures to ensure that the national electronic registers are interconnected and interoperable throughout the union and are connected to the portal referred to in regulation no 165 / 2014 in such a way that the data referred to in paragraph 2 are directly accessible to all the competent authorities and control bodies of all the member states . ”


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


### member states shall provide for sanctions against consignors , freight forwarders , contractors and subcontractors for non - compliance with chapters ii and iii , where they knowingly commission transport services which involve infringements of this regulation . ### member states shall provide for effective , proportionate and dissuasive sanctions against consignors , freight forwarders , contractors and subcontractors for non - compliance with chapters ii and iii , where they knowingly commission transport services which involve infringements of this regulation .


### directive 2010 / 63 / eu of the european parliament and of the council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement , reduction and refinement . clinical trials for veterinary medicinal products are exempted from that directive . the design and performance of clinical trials , which provide essential information on the safety and efficacy of a veterinary medicinal product , should be such as to provide the most satisfactory results whilst using the minimum number of animals , the procedures should be the least likely to cause pain , suffering or distress to animals and should take into account the principles established by directive 2010 / 63 / eu . __________________ 15 directive 2010 / 63 / eu of the european parliament and of the council of 22 september 2010 on the protection of animals used for scientific purposes . ### directive 2010 / 63 / eu of the european parliament and of the council15 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement , reduction and refinement . clinical trials for veterinary medicinal products are exempted from that directive . the design and performance of clinical trials , which provide essential information on the safety and efficacy of a veterinary medicinal product , should be such as to provide the most satisfactory results whilst using the minimum number of animals , the procedures should be designed to avoid causing pain , suffering or distress to animals and should take into account the principles established by directive 2010 / 63 / eu . __________________ 15 directive 2010 / 63 / eu of the european parliament and of the council of 22 september 2010 on the protection of animals used for scientific purposes .


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


### if an antimicrobial is administered and used incorrectly , this presents a risk to public or animal health . therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription . persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced , directly or indirectly , by economic incentives when prescribing those products . therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care . ### if an antimicrobial is administered and used incorrectly , this presents a risk to public or animal health . therefore antimicrobial veterinary medicinal products should only be available on veterinary prescription . persons having the right to prescribe have a key role in ensuring prudent use of antimicrobials and consequently they should not be influenced , directly or indirectly , by economic incentives when prescribing those products . therefore the supply of veterinary antimicrobials by those health professionals should be restricted to the amount required for treatment of the animals under their care . veterinarians should not be allowed to sell antimicrobial veterinary medicinal products , as this could result in conflicts of interest that give rise to over - prescription of such products .


### 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 via the internet to buyers in other member states . in order to minimise the risk to animal and human health , online sales of antimicrobials should be prohibited .


### having regard to the special characteristics of homeopathic veterinary medicinal products , especially the constituents of these products , it is desirable to establish a special , simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications . immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate . the quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules . ### having regard to the special characteristics of homeopathic veterinary medicinal products , especially the constituents of these products , it is desirable to establish a special , simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications . the quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules .


### ‘ substance ' means any matter of the following origin : ### substances : any matter irrespective of origin which may be :


### human , ### human , e . g . human blood and human blood products ;


### animal , ### animal , e . g . micro - organisms , whole animals , parts of organs , animal secretions , toxins , extracts , blood products ;


### vegetable , ### vegetable , e . g . micro - organisms , plants , parts of plants , vegetable secretions , extracts ;


### chemical ; ### chemical , e . g . elements , naturally occurring chemical materials and chemical products obtained by chemical change or synthesis


### ‘ homeopathic veterinary medicinal product ' means a veterinary medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the european pharmacopoeia or , in the absence thereof , by the pharmacopoeias used officially in member states ; ### ‘ homeopathic veterinary medicinal product ' means a veterinary medicinal product prepared in accordance with a homeopathic manufacturing procedure described by the european pharmacopoeia or , in the absence thereof , by the pharmacopoeias used officially in member states ;


### requirement to use take - back schemes for veterinary medicinal products for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and , if appropriate , additional precautions as regarding hazardous waste disposal of unused veterinary medicinal products or waste materials derived from the use of such products ; ### specific precautions relating to the disposal of unused veterinary medicinal products or waste materials derived from the use of such products and , if appropriate , a reference to any appropriate collection systems already in place ;


### the scientific name of the stock or stocks followed by the degree of dilution , using the symbols of the european pharmacopoeia or , in the absence thereof , of the pharmacopoeias currently used officially in member states ; ### the scientific name of the stock or stocks followed by the degree of dilution , using the symbols of the european pharmacopoeia or , in the absence thereof , of the pharmacopoeias currently used officially in member states ; if the homeopathic veterinary medicinal product is composed of more than one stock , the scientific names of the stocks can be supplemented by a brand name in the labelling ;


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


### 14 years for veterinary medicinal products for animal species other than listed in paragraph 1 and . ### 16 years for veterinary medicinal products for animal species other than listed in paragraph 1 and .


### the agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with article 75 . ### the agency shall ensure that information reported to the pharmacovigilance database is uploaded and made publicly accessible in accordance with article 75 .


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


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


### by way of derogation from article 5 , homeopathic veterinary medicinal products that satisfy the requirements set out in article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with article 90 . ### by way of derogation from article 5 , homeopathic veterinary medicinal products that satisfy the requirements set out in article 89 shall be registered in accordance with article 90 .


### by way of derogation from article 5 , homeopathic veterinary medicinal products that satisfy the requirements set out in article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with article 90 . ### by way of derogation from article 5 paragraph 1 , homeopathic veterinary medicinal products that satisfy the requirements set out in article 89 and are not immunological homeopathic veterinary medicinal products shall be registered in accordance with article 90 .


### there is a sufficient degree of dilution to guarantee the safety of the medicinal product ; in particular , the medicinal product shall not contain more than one part per 10 000 of the mother tincture ; ### there is a sufficient degree of dilution to guarantee the safety of the medicinal product ; in particular the ingredients of the medicinal product must be included in tab . 1 of the regulation no . 37 / 2010 with the comment ' no maximum residue level required ' .


### the agency shall set up a website providing information on the common logo . the agency’s website shall explicitly mention that the websites of member states contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the member state concerned . ### the agency shall set up a website providing information on the common logo . the agency’s website shall explicitly mention that the websites of member states contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the member state concerned . the agency’s website shall be linked to the web pages of the appropriate member state bodies listing authorised retailers in member states .


### veterinary medicinal products shall be used in accordance with the terms of the marketing authorisation . ### notwithstanding art . 115 and 116 , veterinary medicinal products shall be used in accordance with the terms of marketing authorisation or registration within the right of the veterinarian for free choice of therapeutic method ;


### with regard to homeopathic veterinary medicinal products the withdrawal period shall be established at zero days . ### the withdrawal period shall be established at zero days for homeopathic veterinary medicinal products containing solely active substances listed in table 1 of regulation no . 37 / 2010 with the classification ' no maximum residue level required '


### inspection reports shall be uploaded to the appropriate database , with continuous access for all competent authorities . ### final inspection reports shall be uploaded to the appropriate database , with continuous access for all competent authorities , and made public .


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


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


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


### entering into force ### entry into force


### 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 . ### acknowledging climate change as one of the biggest and most important global and societal challenges , and 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 30% of the eu budget expenditures supporting climate objectives . actions under the specific programme should contribute at least 50% of the overall financial envelope of the specific programme to the climate objective , in order to support actions or parts of actions that will help to deliver a net - zero greenhouse gas emission economy by 2050 at the latest . relevant actions will be identified ex - ante and fully reflected during the specific programme ' s preparation and implementation in form of the strategic plan and work programmes , and reassessed in the context of the relevant evaluations and review processes , thereby ensuring that the objective of investing at least 50% of the programme’s overall financial envelope to climate - related research and innovations achieved efficiently and in a timely manner .


### the msca contribute to making the era more effective , competitive and attractive on a global scale . this can be achieved by focusing on a new generation of highly - skilled researchers and providing support for emerging talent from across the eu and beyond ; by fostering the diffusion and application of new knowledge and ideas to european policies , the economy and society , inter alia through improved science communication and public outreach measures ; by facilitating cooperation between research - performing organisations ; and by having a pronounced structuring impact on the era , advocating an open labour market and setting standards for quality training , attractive employment conditions and open recruitment for all researchers . ### the msca contribute to making the era more effective , competitive and attractive on a global scale . this is achieved by focusing on a new generation of highly - skilled researchers and providing support for emerging talent from across the eu and beyond ; by fostering the diffusion and application of new knowledge and ideas to european policies , the economy and society , inter alia through improved science communication and public outreach measures ; by facilitating cooperation between research - performing organisations ; and by having a pronounced structuring impact on the era , advocating an open labour market and setting standards for quality training , attractive employment conditions and open transparent and merit - based recruitment for all researchers .


### –copernicus : innovative applications , global uptake and international partners , robustness and evolution of services , sustainability of supply chains , sensors , systems and mission concepts ; calibration and validation ; sustained exploitation of services and impact on societal challenges ; earth observation data techniques , big data , computing resources and algorithmic tools . next generation systems development for new challenges such as climate change , and security ; ### –copernicus : innovative applications , global uptake and international partners , robustness and evolution of services , sustainability of supply chains , sensors , systems and mission concepts ; calibration and validation ; sustained exploitation of services and impact on societal challenges ; earth observation data techniques , big data , computing resources and algorithmic tools . next generation systems development for new challenges such as disaster risk reduction , climate change , and security ;


### 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 transition to a fully renewable based energy system and a net - zero ghg emission economy by 2050 at the latest , 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 , consumers and communities .


### –renewable energy technologies and solutions for power generation , heating and cooling , sustainable transport fuels and intermediate carriers , at various scales and development stages , adapted to geographic conditions and markets , both within the eu and worldwide ; ### –renewable energy technologies and solutions for power generation , renewable transport fuels and intermediate carriers , at various scales and development stages , adapted to geographic conditions and markets , both within the eu and worldwide ;


### –technologies and solutions to reduce greenhouse gas emissions from fossil fuel - based power generation via co2 capture , utilisation and storage . ### –renewable energy technologies and solution for shifting away rapidly from fossil fuels in the supply of energy in the transport sector ;


### –rail technologies and operations for a high - capacity , silent , interoperable , and automated railway system ; ### –rail technologies and operations for a high - capacity , fully connected , silent , interoperable , and automated railway system ;


### –blue value - chains , the multiple - use of marine space and growth of the renewable energy sector from seas and oceans , including sustainable micro - and macro - algae ; ### –blue value - chains including coastal and maritime tourism , the multiple - use of marine space and growth of the renewable energy sector from seas and oceans , including sustainable micro - and macro - algae ;


### –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 cooperation with other industries from travel and tourism ;


### 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 . ### lively public discussions are 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 jointly agreed and 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 31 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 27 october 2020 , 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 2020 in a concerted manner .


### the treaty on european union reinforces citizenship of the union and enhances further the democratic functioning of the union by providing , inter alia , that every citizen of the union has the right to participate in the democratic life of the union . the european citizens ' initiative is a union instrument of participatory democracy which affords citizens of the union the possibility of directly approaching the commission with a request inviting it to submit a proposal for a legal act of the union for the purpose of implementing the treaties , similar to the right conferred on the european parliament under article 225 of the treaty on the functioning of the european union and on the council under article 241 tfeu . ### the treaty on european union reinforces citizenship of the union and enhances further the democratic functioning of the union by providing , inter alia , that every citizen of the union has the right to participate in the democratic life of the union . the european citizens ' initiative is a union instrument of direct participatory democracy which affords citizens of the union the possibility of directly approaching the commission with a request inviting it to submit a proposal for a legal act of the union for the purpose of implementing the treaties , similar to the right conferred on the european parliament under article 225 of the treaty on the functioning of the european union and on the council under article 241 tfeu .


### to achieve those objectives , the procedures and conditions required for the european citizens’ initiative should be clear , simple , user - friendly and proportionate to the nature of this instrument . they should strike a judicious balance between rights and obligations . ### to achieve those objectives , the procedures and conditions required for the european citizens’ initiative should be effective , clear , simple , user - friendly and proportionate to the nature of this instrument . they should strike a judicious balance between rights and obligations .


### in order to make the european citizens’ initiative more accessible and to provide support to citizens and organisers , the commission should provide information and assistance to organisers and make available an online collaborative platform to provide a dedicated discussion forum and information and advice about the european citizens’ initiative . to ensure proximity to citizens , member states should establish one or more contact points in their respective territories to provide citizens with information and assistance regarding the european citizens’ initiative . ### in order to make the european citizens’ initiative more accessible and to provide support to citizens and organisers , the commission should provide clear , accurate and comprehensive information as well legal and practical assistance to organisers and make publicly available an online collaborative platform to provide a dedicated discussion forum and information and advice about the european citizens’ initiative . to ensure proximity to citizens , member states should establish one or more contact points in their respective territories , accessible to people with disabilities , to provide citizens with information as well as legal and practical assistance regarding the european citizens’ initiative .


### in order to make the european citizens’ initiative more accessible , and taking into account that the procedures and conditions required for the european citizens’ initiative should be clear , simple , user - friendly and proportionate , it is appropriate to partially register an initiative in cases where only part or parts of the initiative meet the requirements for registration under this regulation . initiatives should be partially registered where a substantial part of the initiative , including its main objectives , does not manifestly fall outside the framework of the commission’s powers to submit a proposal for a legal act of the union for the purpose of implementing the treaties and all the other registration requirements are met . clarity and transparency should be ensured as regards the scope of the partial registration and potential signatories should be informed of the scope of the registration and of the fact that statements of support are collected only in relation to the scope of the registration of the initiative . ### in order to make the european citizens’ initiative effective and more accessible , and taking into account that the procedures and conditions required for the european citizens’ initiative should be clear , simple , user - friendly and proportionate , it is appropriate to partially register an initiative in cases where only part or parts of the initiative meet the requirements for registration under this regulation . initiatives should be partially registered where a substantial part of the initiative , including its main objectives , does not manifestly fall outside the framework of the commission’s powers to submit a proposal for a legal act of the union for the purpose of implementing the treaties and all the other registration requirements are met . clarity and transparency should be ensured as regards the scope of the partial registration and potential signatories should be informed of the scope of the registration and of the fact that statements of support are collected only in relation to the scope of the registration of the initiative .


### the commission shall , upon request , provide information and assistance about the european citizens ' initiative to citizens and groups of organisers . ### the commission shall , upon request , provide clear , accurate and comprehensive information and assistance about the european citizens ' initiative to citizens and groups of organisers .


### the commission shall make available an online register allowing groups of organisers to manage their initiative throughout the procedure . the register shall comprise a public website providing information on the european citizens’ initiative in general as well as on specific initiatives and their respective status . ### the commission shall make publicly available an online register allowing groups of organisers to manage their initiative throughout the procedure . the register shall comprise an easily and effectively accessible public website providing clear , accurate and comprehensive information on the european citizens’ initiative in general as well as on specific initiatives and their respective status .


### each member state shall establish one or more contact points to provide information and assistance to groups of organisers in setting up a european citizens’ initiative . ### each member state shall establish one or more contact points , accessible to people with disabilities , to provide information as well legal and practical assistance to groups of organisers in setting up a european citizens’ initiative .


### the commission shall inform the european parliament , the council , the european economic and social committee and the committee of the regions of the registration of an initiative . ### the commission shall inform in a clear , thorough and detailed manner the european parliament , the council , the european economic and social committee , the committee of the regions and the national parliaments of the registration of an initiative .


### the central online collection system shall be accessible for persons with disabilities . ### the central online collection system shall be user - friendly and accessible for persons with disabilities .


### when the commission receives a valid initiative in respect of which the statements of support have been collected and certified in accordance with articles 8 to 12 , it shall publish without delay a notice to that effect in the register and transmit the initiative to the european parliament , the council , the european economic and social committee and the committee of the regions . ### when the commission receives a valid initiative in respect of which the statements of support have been collected and certified in accordance with articles 8 to 12 , it shall publish without delay a notice to that effect in the register and transmit the initiative to the european parliament , the council , the european economic and social committee , the committee of the regions and the national parliaments .


### the group of organisers shall provide , for the publication in the register , and as the case may be on their campaign website , information on the sources of support and funding for the initiative exceeding 500 euros per sponsor . ### the group of organisers shall provide , for the publication in the register , and as the case may be on their campaign website , clear , accurate and comprehensive information on the sources of support and funding for the initiative exceeding 500 euros per sponsor .


### contaminants in ce marked fertilising products , such as cadmium , can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain . their content should therefore be limited in such products . furthermore , impurities in ce marked fertilising products derived from bio - waste , in particular polymers but also metal and glass , should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio - waste before processing . ### contaminants in ce marked fertilising products , such as cadmium , can likely pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain . their content should therefore be limited in such products . furthermore , impurities in ce marked fertilising products derived from bio - waste , in particular polymers but also metal and glass , should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio - waste before processing .


### proposal for a regulation of the european parliament and of the council laying down common provisions on the european regional development fund , the european social fund plus , the cohesion fund , and the european maritime and fisheries fund and financial rules for those and for the asylum and migration fund , the internal security fund and the border management and visa instrument ### proposal for a regulation of the european parliament and of the council laying down common provisions on the european regional development fund , the european social fund plus , the cohesion fund , the european agricultural fund for rural development , the european maritime and fisheries fund and financial rules for those and for the asylum and migration fund , the internal security fund and the border management and visa instrument


### in order to further develop a coordinated and harmonised implementation of union funds implemented under shared management namely the european regional development fund , the european social fund plus , the cohesion fund , measures financed under shared management in the european maritime and fisheries fund , the asylum and migration fund , internal security fund and integrated border management fund , financial rules based on article 322 of the tfeu should be established for all these funds , clearly specifying the scope of application of the relevant provisions . in addition , common provisions based on article 177 of the tfeu should be established to cover policy specific rules for the erdf , the esf + , the cohesion fund and the emff . ### in order to further develop a coordinated , coherent and harmonised implementation of union funds implemented under shared management namely the european regional development fund , the european social fund plus , the cohesion fund , the european agricultural fund for rural development , measures financed under shared management in the european maritime and fisheries fund , the asylum and migration fund , internal security fund and integrated border management fund , financial rules based on article 322 of the tfeu should be established for all these funds , clearly specifying the scope of application of the relevant provisions . in addition , common provisions based on article 177 of the tfeu should be established to cover policy specific rules for the erdf , the esf + , the cohesion fund and the emff .


### horizontal principles as set out in article 3 of the treaty on the european union and in article 10 of the tfeu , including principles of subsidiarity and proportionality as set out in article 5 of the teu should be respected in the implementation of the funds , taking into account the charter of fundamental rights of the european union . member states should also respect the obligations of the un convention on the rights of persons with disabilities and ensure accessibility in line with its article 9 and in accordance with the union law harmonising accessibility requirements for products and services . member states and the commission should aim at eliminating inequalities and at promoting equality between men and women and integrating the gender perspective , as well as at combating discrimination based on sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation . the funds should not support actions that contribute to any form of segregation . the objectives of the funds should be pursued in the framework of sustainable development and the union ' s promotion of the aim of preserving , protecting and improving the quality of the environment as set out in article 11 and article 191 of the tfeu , taking into account the polluter pays principle . in order to protect the integrity of the internal market , operations benefitting undertakings shall comply with union state aid rules as set out in articles 107 and 108 of the tfeu . ### horizontal principles as set out in article 3 of the treaty on the european union and in article 10 of the tfeu , including principles of subsidiarity and proportionality as set out in article 5 of the teu should be respected in the implementation of the funds , taking into account the charter of fundamental rights of the european union . member states should also respect the obligations of the un convention on the rights of persons with disabilities and ensure accessibility in line with its article 9 and in accordance with the union law harmonising accessibility requirements for products and services . member states and the commission should aim at eliminating inequalities and at promoting equality between men and women and integrating the gender perspective , as well as at combating discrimination based on sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation . the funds should not support actions that contribute to any form of segregation , or social exclusion . the objectives of the funds should be pursued in the framework of sustainable development and the union ' s promotion of the aim of preserving , protecting and improving the quality of the environment as set out in article 11 and article 191 of the tfeu , taking into account the polluter pays principle , the fight against climate change and the fulfilment of the objectives of the paris agreement . . in order to protect the integrity of the internal market , operations benefitting undertakings shall comply with union state aid rules as set out in articles 107 and 108 of the tfeu .


### to ensure the effectiveness , fairness and sustainable impact of the funds , there should be provisions guaranteeing that investments in infrastructure or productive investment are long - lasting and prevent the funds from being used to undue advantage . managing authorities should pay particular attention not to support relocation when selecting operations and to treat sums unduly paid to operations not complying with the requirement of durability as irregularities . ### to ensure the effectiveness , fairness and sustainable impact of the funds , there should be provisions guaranteeing that investments in infrastructure or productive investment are long - lasting and prevent the funds from being used to undue advantage . managing authorities should not support relocation when selecting operations and should treat sums unduly paid to operations not complying with the requirement of durability as irregularities .


### a certain amount of the resources from erdf , the esf + and the cohesion fund should be allocated to the european urban initiative which should be implemented through direct or indirect management by the commission . ### a certain amount of the resources from erdf , the esf + and the cohesion fund should be allocated to the european urban initiative to contribute to the further development of the urban agenda for the eu , which should be implemented through direct or indirect management by the commission .


### however , the commission shall implement the amount of support from the cohesion fund transferred to the connecting europe facility , the european urban initiative , interregional innovative investments , the amount of support transferred from the esf + to transnational cooperation , the amounts contributed to investeu37 and technical assistance at the initiative of the commission under direct or indirect management in accordance with [ points and of article 62 ] of the financial regulation . _________________ 37 [ regulation no [ … ] on [ … ] ] . ### without prejudice to article 1 , paragraph 2 , the commission shall implement the amount of support from the cohesion fund transferred to the connecting europe facility , the european urban initiative , interregional innovative investments , the amount of support transferred from the esf + to transnational cooperation , the amounts contributed to investeu37 and technical assistance at the initiative of the commission under direct or indirect management in accordance with [ points and of article 62 ] of the financial regulation . _________________ 37 [ regulation no [ … ] on [ … ] ] .


### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programmes . ### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programme , and shall report to the european parliament and the council on the outcome .


### coordination , demarcation and complementarities between the funds and , where appropriate , coordination between national and regional programmes ; ### coordination , demarcation and complementarities between the funds , where appropriate , coordination between national and regional programmes and coordination mechanisms for the mid term review phase ;


### complementarities between the funds and other union instruments , including life strategic integrated projects and strategic nature projects ; ### complementarities and synergies between the funds , including eafrd and interreg programmes , and other union instruments , including life strategic integrated projects and strategic nature projects ;


### where a guarantee agreement , as set out in article [ 9 ] of the [ investeu regulation ] , has not been concluded within nine months from the approval of the contribution agreement , the respective amounts paid into the common provisioning fund as a provisioning shall be transferred back to a programme or programmes and the member state shall submit a corresponding request for a programme amendment . ### where a guarantee agreement , as set out in article [ 9 ] of the [ investeu regulation ] , has not been concluded within nine months from the approval of the contribution agreement , the respective amounts paid into the common provisioning fund as a provisioning shall be transferred back to the original programme or programmes and the member state shall submit a corresponding request for a programme amendment .


### a programme shall consist of priorities . each priority shall correspond to a single policy objective or to technical assistance . a priority corresponding to a policy objective shall consist of one or more specific objectives . more than one priority may correspond to the same policy objective . ### a programme shall consist of priorities . each priority shall correspond to a single policy objective or to technical assistance . more than one priority may correspond to the same policy objective . a priority corresponding to a policy objective shall consist of one or more specific objectives .


### market failures , investment needs and complementarity with other forms of support ; ### market failures or inefficiencies , investment needs and complementarity with other forms of support ;


### the approval of the commission shall not be required for corrections of a purely clerical or editorial nature that do not affect the implementation of the programme . member states shall inform the commission of such corrections . ### the approval of the commission shall not be required for corrections of a purely clerical or editorial nature that do not affect the implementation of the programme and for the update of information defined as indicative in the provisions regarding the programme content . any specific amendment to the programme should ensure coherent corrections to the resulting programme documents , where appropriate .


### territorial strategies shall be drawn up under the responsibility of the relevant urban , local or other territorial authorities or bodies . ### territorial strategies shall be adopted under the responsibility of the relevant urban , local or other territorial authorities or bodies . pre - existing strategic documents concerning the same territories can be updated and used as territorial strategies . the relevant managing authorities shall approve and fund the first round of strategies within 12 months of the date of the approval of the relevant programme or , in the case of strategies supported by more than one fund , within 12 months of the date of the approval of the last programme concerned .


### support for such actions shall be implemented by financing not linked to costs in accordance with article 89 . ### support for such actions may be implemented by financing not linked to costs in accordance with article 89 .


### financial instruments shall provide support to final recipients only for new investments expected to be financially viable , such as generating revenues or savings , and which do not find sufficient funding from market sources . ### financial instruments shall provide support to final recipients only for new investments expected to be financially viable , without an excessive risk profile , such as generating revenues or savings , and which do not find sufficient funding from market sources .


### the proposed amount of programme contribution to a financial instrument and the expected leverage effect ; ### the proposed amount of programme contribution to a financial instrument and the genuine expected leverage effect ;


### 2021 : 0 . 5 % ; ### 2021 : 2 % ;


### 035adaption to climate change measures and prevention and management of climate related risks : floods ### 035adaption to climate change measures and prevention and management of climate related risks : floods and landslides


### 128protection , development and promotion of public tourism assets and related tourism services ### 128protection , development and promotion of public tourism assets and tourism services


### 130protection , development and promotion of natural heritage and eco - tourism ### 130protection , development and promotion of natural heritage and eco - tourism other than natura 2000 sites


### 17accommodation and food service activities ### 17tourism , accommodation and food service activities


### the advanced digital technologies supported by this programme , such as high performance computing , cybersecurity and artificial intelligence are now sufficiently mature to move beyond the research arena and be deployed , implemented and scaled - up at union level . just as the deployment of these technologies require a union response so does the skills dimension . training opportunities in advanced digital skills need to be scaled up , increased and made accessible throughout the eu . failing this could impede the smooth deployment of advanced digital technologies and hamper the overall competitiveness of union ' s economy . the actions supported by this programme are complementary to those supported by the esf , erdf and horizon europe programmes . ### the advanced digital technologies supported by this programme , such as high performance computing , cybersecurity and artificial intelligence are now sufficiently mature to move beyond the research arena and be deployed , implemented and scaled - up at union level . just as the deployment of these technologies require a union response so does the skills dimension . learning and training opportunities , including on - the - job training , blended and distance learning in advanced digital skills need to be scaled up , increased and made accessible throughout the union . particular attention should be paid to providing workers , especially in the context of an ageing workforce , the means and tools to benefit from the opportunities offered by new digital infrastructures . failing this could impede the smooth deployment of advanced digital technologies and hamper the participation of citizens to the public life and the job market , as well as the overall competitiveness of union ' s economy . the actions supported by this programme are complementary to those supported by the esf , erdf and horizon europe and erasmus programmes .


### the advanced digital technologies supported by this programme , such as high performance computing , cybersecurity and artificial intelligence are now sufficiently mature to move beyond the research arena and be deployed , implemented and scaled - up at union level . just as the deployment of these technologies require a union response so does the skills dimension . training opportunities in advanced digital skills need to be scaled up , increased and made accessible throughout the eu . failing this could impede the smooth deployment of advanced digital technologies and hamper the overall competitiveness of union ' s economy . the actions supported by this programme are complementary to those supported by the esf , erdf and horizon europe programmes . ### the advanced digital technologies supported by this programme , such as high performance computing , cybersecurity and artificial intelligence are now sufficiently mature to move beyond the research arena and be deployed , implemented and scaled - up at union level . just as the deployment of these technologies require a union response so does the skills dimension . training opportunities in advanced digital skills need to be scaled up , increased and made accessible throughout the eu . special attention should be awarded to providing workers , and particularly older workers , with continuous training as well as the means and tools to harness new digital infrastructure . failing this could impede the smooth deployment of advanced digital technologies and hamper the overall competitiveness of union ' s economy . the actions supported by this programme are complementary to those supported by the esf , erdf and horizon europe programmes .


### modernising public administrations and services through digital means is crucial to reducing administrative burden on industry and on citizens in general by making their interactions with public authorities faster , more convenient and less costly , as well as by increasing the efficiency and the quality of the services provided to citizens and businesses . since a number of services of public interest already have a union dimension , the support to their implementation and deployment at union level should ensure that citizens and businesses will benefit from the access to high quality digital services across europe . ### modernising public administrations and services through digital means is crucial to upholding basic rights such as discrimination - free access to health services , sustainable mobility , citizens’ involvement and transparency , and to reducing the administrative burden on industry and on citizens in general by making their interactions with public authorities faster , more convenient and less costly , as well as by increasing the efficiency and the quality of the services provided to citizens and businesses . since a number of services of public interest already have a union dimension , the support to their implementation and deployment at union level should ensure that citizens and businesses will benefit from the access to high quality digital services across europe .


### the programme has the following general objective : to support the digital transformation of the european economy and society and bring its benefits to european citizens and businesses . the programme will : ### the programme has the following general objective : to support the digital transformation of the european economy and society and bring its benefits to the public sector , european citizens and businesses . the programme will :


### widen their diffusion and uptake in areas of public interest and the private sector . ### widen their diffusion and uptake in areas of public interest , supporting their digital transformation and the adoption of cutting - edge technologies , as well as in the private sector ;


### for the purpose of the establishment of the network mentioned in paragraph 1 , each member state shall designate candidate entities through an open and competitive process , on the basis of the following criteria : ### for the purpose of the establishment of the network mentioned in paragraph 1 , it should preferably consist of at least one hub in each member state , which shall designate candidate entities through an open and competitive process , on the basis of the following criteria :


### additional digital innovation hubs shall be selected on the basis of an open and competitive process , in such a way to ensure the widest geographical coverage across europe . the number of entities of the network shall be proportional to the population of a given member states and there shall be at least one digital innovation hub per member state . to address the specific constraints faced by the eu outermost regions , specific entities may be nominated to cover their needs . ### additional digital innovation hubs shall be selected on the basis of an open , transparent and competitive process , in such a way to ensure the widest geographical coverage across europe . the number of entities of the network shall be proportional to the population of a given member states and there shall be at least one digital innovation hub per member state . to address the specific constraints faced by the eu outermost regions and the need to develop the less - favoured areas within the member states , specific entities may be nominated to cover their needs .


### transfer expertise and know - how between regions , in particular by networking smes and midcaps established in one region with digital innovation hubs established in other regions which are best suited to provide relevant services ; ### transfer expertise and know - how between regions , in particular by networking start - ups , smes and midcaps established in one region with digital innovation hubs established in other regions which are best suited to provide relevant services ;


### provide thematic services , including services related to artificial intelligence , high performance computing and cybersecurity and trust to the administrations , public sector organisations , smes and midcaps . individual digital innovation hubs may specialise in specific thematic services and do not need to provide all thematic services mentioned in this paragraph ; ### provide thematic services , including services related to artificial intelligence , high performance computing and cybersecurity and trust to the administrations , public sector organisations , start - ups , smes and midcaps . individual digital innovation hubs may specialise in specific thematic services and do not need to provide all thematic services mentioned in this paragraph ;


### the programme shall support easy access to advanced digital skills , notably in hpc , ai , distributed ledgers and cybersecurity for the current and future labour force by offering students , recent graduates , and existing workers , wherever they are situated , with the means to acquire and develop these skills . ### the programme shall support easy access to advanced digital skills , notably in hpc , ai , distributed ledgers and cybersecurity for the current and future labour force by offering students , recent graduates , and existing and future workers , wherever they are situated , with the means to acquire and develop these skills .


### all interventions will be designed and implemented primarily through the digital innovation hubs , as defined in article 15 . ### interventions will be designed and implemented preferably through the digital innovation hubs , as defined in article 15 .


### transport , energy and environment : deploy decentralised solutions and infrastructures required for large - scale digital applications such as smart cities or smart rural areas in support of transport , energy and environmental policies . ### transport , energy and environment : deploy decentralised solutions and infrastructures required , including distributed register technologies for large - scale digital applications such as smart cities or smart rural areas in support of transport , energy and environmental policies .


### berec shall pursue the same objectives as those of national regulatory authorities referred to in article 3 of the directive . in particular , berec shall ensure a consistent implementation of the regulatory framework for electronic communications within the scope referred to in paragraph 2 and thereby contribute to the development of the internal market . it shall also promote access to , and take - up of , very high capacity data connectivity ; competition in the provision of electronic communications networks , services and associated facilities ; and the interests of the citizens of the union . ### berec shall contribute to the achievement of the objectives of national regulatory authorities and other competent authorities referred to in article 3 of the directive . in particular , berec shall cooperate with the nras to ensure a consistent regulatory approach for the implementation of the regulatory framework for electronic communications within the scope referred to in paragraph 2 and thereby contribute to the development of the internal market . it shall also promote access to , investment in , and take - up of , very high capacity data connectivity ; competition in the provision of electronic communications networks , services and associated facilities ; and the interests of the citizens of the union , including the long - term interests of consumers and businesses


### the union ' s macro - financial assistance should be managed by the commission . in order to ensure that the european parliament and the council are able to follow the implementation of this decision , the commission should regularly inform them of developments relating to the assistance and provide them with relevant documents . ### the union ' s macro - financial assistance should be managed by the commission . in order to ensure that the european parliament and the council are able to follow the implementation of this decision , the commission should inform them at the right time of developments relating to the assistance and provide them with relevant documents .


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


### in paragraph 1 the word &#8220 ; three&#8221 ; shall be replaced by &#8220 ; six&#8221 ; and the words &#8220 ; of three months up to a maximum of six months&#8221 ; shall be replaced by the words &#8220 ; of six months up to the end of the period of that person ' s entitlement to benefits&#8221 ; ; ### paragraph 1 is amended as follows : “ unemployment benefits are extended to the entire period of entitlement ; ”


### when a person ' s rights or obligations to which the basic and implementing regulations apply have been established or determined , the competent institution may request the institution in the member state of residence or stay to provide personal data about that person . the request and any response shall concern information which enables the competent member state to identify any inaccuracy in the facts on which a document or a decision determining the rights and obligations of a person under the basic or implementing regulation is based . the request can also be made where there is no existing doubt about the validity or accuracy of the information contained in the document or on which the decision is based in a particular case . the request for information and any response must be necessary and proportionate . ### when a person ' s rights or obligations to which the basic and implementing regulations apply have been established or determined , the competent institution may request the institution in the member state of residence or stay to provide personal data about that person , while fully respecting privacy requirements . the request and any response shall be limited to information which enables the competent member state to identify any inaccuracy in the facts on which a document or a decision determining the rights and obligations of a person under the basic or implementing regulation is based . the request can also be made where there is no existing doubt about the validity or accuracy of the information contained in the document or on which the decision is based in a particular case . the request for information and any response must be justifiable , necessary and proportionate .


### when a person’s rights or obligations to which the basic and implementing regulations apply have been established or determined , the competent institution may request the institution in the member state of residence or stay to provide personal data about that person . the request and any response shall concern information which enables the competent member state to identify any inaccuracy in the facts on which a document or a decision determining the rights and obligations of a person under the basic or implementing regulation is based . the request can also be made where there is no existing doubt about the validity or accuracy of the information contained in the document or on which the decision is based in a particular case . the request for information and any response must be necessary and proportionate . ### when a person’s rights or obligations to which the basic and implementing regulations apply have been established or determined , the competent institution may request the institution in the member state of residence or stay to provide personal data about that person , while fully complying with privacy requirements . the request and any response shall be confined to information which enables the competent member state to identify any inaccuracy in the facts on which a document or a decision determining the rights and obligations of a person under the basic or implementing regulation is based . the request can also be made where there is no existing doubt about the validity or accuracy of the information contained in the document or on which the decision is based in a particular case . the request for information and any response must be substantiated , necessary , and proportionate .


### in addition to the products referred to in paragraph 1 , chapter vi shall also apply to active substances , intermediate products and excipients used as starting materials in veterinary medicinal products . ### in addition to the products referred to in paragraph 1 , chapter vi shall also apply to intermediate products and active substances used as starting materials in veterinary medicinal products .


### the summary of the product characteristics of the generic veterinary medicinal product shall be identical to that of the reference veterinary medicinal product . however , that requirement shall not apply to those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law at the time when the generic veterinary medicinal product is authorised . ### the clinical information of the summary of the product characteristics , excluding point ) of the generic veterinary medicinal product shall be identical to that of the reference veterinary medicinal product . however , this requirement shall not apply to : those parts of the summary of the product characteristics of the reference veterinary medicinal product that refer to indications or pharmaceutical forms which are still covered by patent law or protection of technical documentation at the time when the generic veterinary medicinal product is authorised or a subsequent amendment of the reference medicinal product .


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


### the applicant can demonstrate that the veterinary medicinal product is a combination of reference veterinary medicinal products as referred to in article 16 ; ### the applicant can demonstrate that the veterinary medicinal product contains a combination with at least one reference veterinary medicinal products as referred to in article 16 ;


### documentation on the safety of that combination is provided . ### where needed , appropriate documentation on the safety of that combination is provided .


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


### interaction with other medicinal products and other forms of interaction , ### known interaction with other medicinal products and other known forms of interaction .


### the agency shall establish and maintain a union database on pharmacovigilance of veterinary medicinal products . ### the agency shall establish and maintain a union database on pharmacovigilance of veterinary medicinal products , linked with the product database . the union database shall be the sole point of receipt for adverse events submitted by the mahs .


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


### the agency shall ensure that information reported to the pharmacovigilance database is uploaded and made accessible in accordance with article 75 . ### the agency shall ensure that information reported to the pharmacovigilance database is uploaded and made publicly accessible in accordance with article 75 .


### 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 . different requirements shall apply for adverse events observed in clinical trials .