### it is necessary to ensure the effective enforcement of the provisions of the national law adopted pursuant to this directive . collecting societies should offer their members specific procedures for the handling of complaints and the resolution of disputes . these procedures should also be made available to other rightholders represented by the collecting society . it is also appropriate to ensure that member states have independent , impartial and effective dispute resolution bodies capable of settling commercial disputes between collecting societies and users on existing or proposed licensing conditions as well as on situations in which the granting of a licence is refused . furthermore , the effectiveness of the rules on the multi - territorial licensing of online rights in musical works could be undermined if disputes between collecting societies and their counterparts were not solved quickly and efficiently by independent and impartial bodies . as a result , it is appropriate to provide , without prejudice to the right of access to a tribunal , for an easily accessible , efficient and impartial out - of - court procedure for resolving conflicts between collecting societies , on the one hand , and online music service providers , rightholders or other collecting societies , on the other . ### it is necessary to ensure the effective enforcement of the provisions of the national law adopted pursuant to this directive . collecting societies should offer their members specific procedures for the handling of complaints and the resolution of disputes . these procedures should also be made available to other rightholders represented by the collecting society . it is also appropriate to ensure that member states have independent , impartial and effective dispute resolution bodies capable of settling commercial disputes between collecting societies and users on existing or proposed licensing conditions as well as on situations in which the granting of a licence is refused . furthermore , the effectiveness of the rules on the multi - territorial licensing of online rights in musical works could be undermined if disputes between collecting societies and their counterparts were not solved quickly and efficiently by independent and impartial bodies . as a result , it is appropriate to provide , without prejudice to the right of access to a court , for an easily accessible , efficient and impartial out - of - court procedure for resolving conflicts between collecting societies , on the one hand , and online music service providers , rightholders or other collecting societies , on the other .


### this directive respects the fundamental rights and observes the principles enshrined in the charter of fundamental rights of the european union . the requirement in the directive that dispute resolution mechanisms should be made available to members , rightholders , users and collecting societies should not prevent the parties from exercising their right of access to a tribunal as guaranteed in the charter of fundamental rights of the european union . ### this directive respects the fundamental rights and observes the principles enshrined in the charter of fundamental rights of the european union . the requirement in the directive that dispute resolution mechanisms should be made available to members , rightholders , users and collecting societies should not prevent the parties from exercising their right of access to a court as guaranteed in the charter of fundamental rights of the european union .


### member states shall ensure that collecting societies act in the best interest of their members and do not impose on rightholders whose rights they manage any obligations which are not objectively necessary for the protection of the rights and interests of these rightholders . ### member states shall ensure that collective management organisations act in the best interests of the rightholders whose rights they represent and do not impose on them any obligations which are not objectively necessary for the protection of the rights and interests of these rightholders .


### member states shall ensure that the persons who effectively manage the business of a collecting society and its directors , with the exception of the directors exercising supervisory function , design procedures so as to avoid conflicts of interest . the collecting society shall have procedures to identify , manage , monitor and disclose conflicts of interest in order to prevent them from adversely affecting the interests of members of the society . ### member states shall ensure that the persons who effectively manage the business of a collecting society and its directors design procedures so as to avoid conflicts of interest . the collecting society shall have procedures to identify , manage , monitor and disclose conflicts of interest in order to prevent them from adversely affecting the interests of members of the society .


### where , pending the distribution of the amounts due to rightholders , the collecting society invests the rights revenue and any income derived from its investment , it shall do so in accordance with the general investment policy referred to in article 7 and the following rules : ### where , pending the distribution of the amounts due to rightholders , the collecting society invests the rights revenue and any income derived from its investment , it shall do so in the best interests of the rightholders whose rights it represents and in accordance with the general investment policy referred to in article 7 and the following rules :


### member states shall ensure that , where a collecting society provides social , cultural or educational services funded through deductions from rights revenue , rightholders are entitled to the following : ### member states shall ensure that , where a collecting society provides social , cultural or educational services funded through deductions from rights revenue and from any income arising from the investment of rights revenue , rightholders are entitled to the following :


### member states shall ensure that a collecting society does not discriminate between its members and any rightholders whose rights it manages under a representation agreement , in particular with respect to applicable tariffs , management fees , and the conditions for the collection of the rights revenue and distribution of the amounts due to rightholders . ### member states shall ensure that a collecting society does not discriminate against any rightholders whose rights it manages under a representation agreement , in particular with respect to applicable tariffs , management fees , and the conditions for the collection of the rights revenue and distribution of the amounts due to rightholders .


### as recent experiences have demonstrated , transmissible animal diseases may also have a significant impact on public health , as for example in the case of avian influenza and salmonella . ### as recent experiences have demonstrated , transmissible animal diseases may also have a significant impact on public health , as for example in the case of bovine spongiform encephalopathy , avian influenza and salmonella .


### in union legislation adopted prior to this regulation separate animal health rules are laid down for terrestrial and aquatic animals . council directive 2006 / 88 / ec of 24 october 2006 on animal health requirements for aquaculture animals and products thereof , and on the prevention and control of certain diseases in aquatic animals20 lays down specific rules for aquatic animals . yet in most cases , the main principles for good animal health governance are applicable to both groups of animal species . accordingly , the scope of this regulation should cover both terrestrial and aquatic animals and aligns those animal health rules where applicable . however , for certain aspects , in particular the registration and approval of establishments and the traceability and movements of animals within the union , this regulation adheres to the approach adopted in the past , which was to lay down different sets of animal health rules for terrestrial and aquatic animals due to their different environments and accordingly different requirements to safeguard health . ### in union legislation adopted prior to this regulation separate animal health rules are laid down for terrestrial and aquatic animals . council directive 2006 / 88 / ec of 24 october 2006 on animal health requirements for aquaculture animals and products thereof , and on the prevention and control of certain diseases in aquatic animals lays down specific rules for aquatic animals . yet in most cases , the main principles for good animal health governance and good animal husbandry are applicable to both groups of animal species . accordingly , the scope of this regulation should cover both terrestrial and aquatic animals and aligns those animal health rules where applicable . however , for certain aspects , in particular the registration and approval of establishments and the traceability and movements of animals within the union , this regulation adheres to the approach adopted in the past , which was to lay down different sets of animal health rules for terrestrial and aquatic animals due to their different environments and accordingly different requirements to safeguard health .


### in order to ensure uniform conditions for the implementation of this regulation in relation to transmissible animal diseases at union level , it is necessary to establish a harmonised list of transmissible animal diseases . thus implementing powers to lay down such a list should be conferred on the commission . ### it is necessary to establish a harmonised list of transmissible animal diseases , which should be set out in a table in an annex attached to this regulation . the power to adopt acts amending or supplementing such a list should be delegated to the commission in accordance with article 290 of the treaty on the functioning of the european union .


### the prevention and control rules of this regulation for a specific transmissible animal disease should apply to species of animals which can transmit the disease in question , by being susceptible to it or by acting as its vector . in order to ensure uniform conditions for the implementation of this regulation , it is necessary to establish a harmonised list of species to which the measures for specific listed diseases should apply at union level and thus implementing powers to lay down such a list should be conferred on the commission . ### the prevention and control rules of this regulation for a specific transmissible animal disease should apply to species of animals which can transmit the disease in question , by being susceptible to it or by acting as its vector . it is thus necessary to establish a harmonised list of species to which the measures for specific listed diseases should apply at union level and which should be set out in a table in an annex to this regulation . the power to adopt acts amending or supplementing such a list should be delegated to the commission in accordance with article 290 of the treaty on the functioning of the european union .


### in order to ensure uniform conditions for the implementation of this regulation in relation to the disease prevention and control measures applicable to listed diseases , it is necessary to determine the application of the rules , provided for in this regulation , to listed diseases at union level . thus implementing powers to lay down which listed diseases are to be subject to which rules , should be conferred on the commission . ### it is necessary to determine , and lay down in a list , the application of the rules , provided for in this regulation , to listed diseases at union level . such a list should be kept and updated in a table in an annex to this regulation . the power to adopt acts amending or supplementing such a list should be delegated to the commission in accordance with article 290 of the treaty on the functioning of the european union .


### knowledge of animal health , including of disease symptoms , consequences of diseases and possible means of prevention including biosecurity , treatment and control is a prerequisite for efficient animal health management and essential in ensuring the early detection of animal diseases . operators and other animal professionals should therefore acquire such knowledge as appropriate . that knowledge may be acquired by different means , for example formal education , but also through the farm advisory system existing in the agricultural sector or by informal training to which national and european farmer organisations and other organisations may be valuable contributors . those alternative means of acquiring such knowledge should also be recognised by this regulation . ### knowledge of animal health is a prerequisite for efficient animal health management and essential in ensuring the prevention and early detection of animal diseases . operators and other animal professionals should therefore be encouraged to acquire , maintain and develop such knowledge , including of disease symptoms , consequences of diseases , possible means of prevention including biosecurity , treatment and control , the dangers posed by anti - microbial resistance and the link between animal health and animal welfare and animal husbandry practices . that knowledge may be acquired by different means , for example formal education , but also through the farm advisory system existing in the agricultural sector or by informal training to which national and european farmer organisations and other organisations may be valuable contributors . those alternative means of acquiring such knowledge should also be recognised by this regulation . however , with regard to the multi - facetted and international dimension in which operators and other animal professionals operate , sole reliance on professional experience is no longer compatible with an eu animal health strategy that focuses on prevention .


### operators observe their animals on a regular basis and are best positioned to detect abnormal mortalities or other serious disease symptoms . operators are therefore the cornerstone of any surveillance and essential for the surveillance undertaken by the competent authority . ### operators observe their animals on a regular basis and are best positioned to detect abnormal behaviour , mortalities or other serious disease symptoms . operators are therefore the cornerstone of any surveillance and are essential for the surveillance undertaken by the competent authority . despite potential economic risks for operators , it is in their own interest that abnormal mortalities or other serious disease symptoms are reported to the competent authority , as certain disease control measures may have a significant impact on operators and as member states may decide to enforce private law accountability on operators who did not report correctly to the competent authority .


### however , control strategies for some transmissible animal diseases require prohibition or restriction of the use of certain veterinary medicinal products , as their use would hamper the effectiveness of those strategies . for example , hyper immune sera or antimicrobial agents may mask the expression of a disease , make the detection of a disease agent impossible or render a swift and differential diagnosis difficult and thus endanger the correct detection of disease . ### however , control strategies for some transmissible animal diseases require prohibition or restriction of the use of certain veterinary medicinal products , as their use would hamper the effectiveness of those strategies . for example , hyper immune sera or antimicrobial agents may mask the expression of a disease , make the detection of a disease agent impossible or render a swift and differential diagnosis difficult , and thus endanger the correct detection of disease , thereby significantly putting at risk public and animal health .


### the occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals . special rules should therefore be laid down for disease control and eradication measures in wild animals where needed . ### the occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals . special rules should therefore be laid down for disease control and eradication measures in wild animals where needed . such rules should take account of the need to preserve biodiversity and should allow for the mass culling of wild animals only as a last resort .


### for animals that are moved between member states a set of basic animal health requirements apply . in particular , animals may not be moved from establishments with abnormal mortalities or signs of disease of unknown cause . however , mortalities , even if abnormal , which are linked to scientific procedures authorised under 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 and which are not of infectious origin related to listed diseases , should not be a reason to prevent the movements of animals intended for scientific purposes . ### for animals that are moved between member states a set of basic animal health requirements apply . in particular , animals may not be moved from establishments with abnormal mortalities or signs of disease of unknown cause . however , mortalities , even if abnormal , which are linked to scientific procedures authorised under 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 and which are not of infectious origin related to listed diseases , should not be a reason to prevent the movements of animals intended for scientific purposes . nonetheless , these mortalities shall be registered by the competent authority .


### as assembly operations for ungulates and poultry represent a particularly high disease risk , it is appropriate to lay down specific rules in this regulation to protect the health of the animals involved and prevent the spread of transmissible animal diseases . ### as movements and assembly operations for ungulates and poultry represent a particularly high disease risk , it is appropriate to lay down specific rules in this regulation to protect the health of the animals involved and prevent the spread of transmissible animal diseases .


### for scientific purposes , such as research or diagnostic purposes , and in particular those authorised in accordance with directive 2010 / 63 / eu , it may be necessary to move animals which do not comply with the general animal health requirements laid down in this regulation and represent a higher animal health risk . those kinds of movements should not be prohibited or unduly restricted by the provisions of this regulation , as this could impede otherwise authorised research activities and delay scientific progress . nonetheless , it is essential that rules are laid down in this regulation to ensure that movements of those animals take place in a safe manner . ### for scientific purposes , such as research or diagnostic purposes , and in particular those authorised in accordance with directive 2010 / 63 / eu , it may be necessary to move animals which do not comply with the general animal health requirements laid down in this regulation and represent a higher animal health risk . those kinds of movements should not be prohibited or unduly restricted by the provisions of this regulation , as this could impede otherwise authorised research activities and delay scientific progress . nonetheless , it is essential that rules are laid down in this regulation to ensure that movements of those animals take place in a safe manner and are registered by the competent authority .


### the specific nature of movements of pet animals represents an animal health risk which deviates significantly from that of other kept animals . specific rules for such movements should therefore be laid down in this regulation . in order to ensure that pet animals do not pose a significant risk for the spread of transmissible animal diseases , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the detailed rules for movements of those animals . in order to ensure uniform conditions for the implementation of the animal health requirements laid down in this regulation concerning the movements of pet animals , implementing powers should be conferred on the commission to lay down rules concerning the disease prevention and control measures to be taken for such movements . ### the specific nature of movements of pet animals represents an animal health risk which deviates significantly from that of other kept animals . such movements should therefore continue to be governed by the provisions already adopted . this will ensure that pet animals do not pose a significant risk for the spread of transmissible animal diseases . the power to adopt rules concerning the disease prevention and control measures to be taken for such movements should be conferred on the commission .


### it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### it is of particular importance that the commission carry out appropriate consultations with stakeholders during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### this regulation lays down rules for the prevention and control of animal diseases , which are transmissible to animals or to humans . ### this regulation lays down : rules for the prevention and control of animal diseases , which are transmissible to animals or to humans , the instruments and arrangements for moving towards the declaration of disease - free zones , the prioritising of actions and the attribution of responsibilities in the field of animal health and puts into practice the ' one health ' approach establishing a new paradigm for the relationship between animals , humans and the environment .


### ' disease ' means the occurrence of infections and infestations in animals , with or without clinical or pathological manifestations , caused by one or more disease agents transmissible to animals or to humans ; ### ' disease ' means the occurrence of infections and infestations in animals , with or without clinical or pathological manifestations , caused by one or more disease agents transmissible to animals or to humans . for the purposes of this regulation , microorganisms that have developed resistance to antimicrobials should also be considered a ' disease ' ;


### ' risk ' means the likelihood of the occurrence and the likely magnitude of the biological and economic consequences of an adverse effect on animal or public health ; ### ' risk ' means , based on the precautionary principle , the likelihood of the occurrence and the likely magnitude of the biological , health , economic and social consequences of an adverse effect on animal or public health ;


### ' biosecurity ' means the sum of management and physical measures designed to reduce the risk of the introduction , development and spread of diseases to , from and within : ### ' biosecurity ' means the sum of management and physical measures designed to reduce the risk of the introduction , development and spread of diseases or microorganisms that have developed resistance to antimicrobials to , from and within :


### the commission shall , by means of implementing acts , establish a list of species , as referred to in paragraph 1 . ### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning amendments to the list of species , as referred to in paragraph 1 and set out in a table in annex - i , to take account of technical progress , scientific developments and changed circumstances in public and animal health .


### that list shall comprise diseases which meet with the conditions laid down in the following points and of this paragraph , taking in to account the criteria for listing diseases laid down in article 6 : ### that table shall comprise diseases which meet with the conditions laid down in the following points and of this paragraph , taking in to account the criteria for listing diseases laid down in article 6 :


### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of highly significant impact the commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in article 255 . ### where in the case of a disease representing an emerging risk of highly significant impact , imperative grounds of urgency so require , the procedure provided for in article 254 shall apply to delegated acts adopted pursuant to this article . the commission shall no later than six weeks after adoption of these emergency measures present a report to the european parliament and council describing these measures in detail and their impact , where appropriate , on : - the agricultural and / or aquaculture production in the union ; - the functioning of the internal market ; - public health , animal health , animal welfare and the environment .


### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of highly significant impact the commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in article 255 . ### where in the case of a disease representing an emerging risk of highly significant impact , imperative grounds of urgency so require , the procedure provided for in article 254 shall apply to delegated acts adopted pursuant to this article .


### the commission shall by means of implementing acts establish which of the listed diseases referred to in in article 8 shall be subject to immediate notification by the member states in accordance with paragraph 1 of this article . ### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning the listed diseases referred to in in article 8 which shall be subject to immediate notification by the member states in accordance with paragraph 1 of this article .


### implementing powers ### implementing powers and delegation of powers concerning performance indicators


### where a member state has reason to suspect that any of the conditions for maintaining its status as a disease - free member state , or zone or compartment thereof have been breached , it shall immediately : ### where a member state has reason to suspect , or is alerted by a notification from the commission , that any of the conditions for maintaining its status as a disease - free member state , or zone or compartment thereof have been breached , it shall immediately :


### the commission shall , by means of implementing acts , withdraw the approval of the disease - free status of a member state or zone granted in accordance with article 36 or the recognition of the disease - free status of a compartment granted in accordance with article 37 after obtaining the information from the member state referred to in paragraph 3 of this article that the conditions for maintaining the disease - free status are no longer met . ### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning the withdrawal of the approval of the disease - free status of a member state or zone , granted in accordance with article 36 or of the recognition of the disease - free status of a compartment granted in accordance with article 37 after obtaining the information from the member state referred to in paragraph 3 of this article that the conditions for maintaining the disease - free status are no longer met .


### new knowledge of and developments in disease control tools . ### new knowledge of and developments on the listed diseases and in disease control tools .


### restrict the movements of kept animals , products and , if appropriate , people , vehicles and any material or other means by which the disease agent could have spread to or from the establishment , households , food and feed business establishments , animal by - products establishments or any other location where that listed disease is suspected , as far as necessary to prevent its spread of the listed disease ; ### ;


### apply appropriate biosecurity measures to prevent the spreading of that listed disease agent to other animals or to humans ; ### ensure that appropriate biosecurity measures are applied to prevent the spreading of that listed disease agent to other animals or to humans ;


### if the epidemiological enquiry provided for in article 57 shows that the likely origin of the listed disease referred to in article 8 is another member state or it is likely that that listed disease has spread to another member state , the competent authority shall inform that member state . ### if the epidemiological enquiry provided for in article 57 shows that the likely origin of the listed disease referred to in article 8 is another member state or it is likely that that listed disease has spread to another member state , the competent authority shall inform that member state and the commission .


### the designation or where relevant , approval of a food business establishment for the purposes of the slaughtering of animals or the treatment of products of animal origin originating from the restricted zones ; ### the designation or where relevant , approval of a food business establishment for the purposes of the slaughtering , using pre - stunning , of animals or the treatment of products of animal origin originating from the restricted zones ;


### take the necessary disease prevention and control measures to avoid the further spread of that listed disease . ### take the necessary disease prevention and control measures to avoid the further spread of that listed disease . only after a thorough assessment of the economic , social , animal welfare and environmental impact the competent authority shall take a disease control measure which may result in the killing and disposal of animals that may be contaminated and contribute to the spread of the listed disease ;


### the kept animals affected ; ### the kept animals affected , especially when these belong to an endangered race or variety .


### the categories and species of kept terrestrial animals or germinal products in an establishment ; ### the categories and species or breeds of kept terrestrial animals or germinal products collected , produced , stored or processed in an establishment ;


### where that on - site visit shows that clear progress has been made but the establishment still does not meet all of those requirements , the competent authority may prolong the conditional approval . however , conditional approval shall not exceed a total period of six months . ### where that on - site visit shows that clear progress has been made but the establishment still does not meet all of those requirements , the competent authority may prolong the conditional approval and shall provide the necessary effective guidance in order to contribute to the successful resolve of the deficiency . however , conditional approval shall not exceed a total period of six months .


### it shall make that register available to other member states and to the public . ### it shall make that register available on a dedicated website to other member states and to the public .


### establishments which are exempted from the registration requirement in accordance with article 83 may be exempted by the member state from the requirement to keep records of the information listed in paragraph 1 of this article . ### establishments which are exempted from the registration requirement in accordance with article 83 may be exempted by the member state from the requirement to keep records of the information listed in paragraph 1 of this article . member states shall notify the commission of any exemptions made and keep a record of all the exempted establishments on their territory .


### establishments which are exempted from the registration requirement in accordance with article 84 may be exempted by the member state from the requirement to keep records of the information listed in paragraph 1 of this article . ### establishments which are exempted from the registration requirement in accordance with article 84 may be exempted by the member state from the requirement to keep records of the information listed in paragraph 1 of this article . member states shall notify the commission of any exemptions made and keep a record of all the exempted establishments on their territory .


### transporters which are exempted from the registration requirement in accordance with article 86 may be exempted by the member state from the requirement to keep records of the information listed in paragraph 1 of this article . ### transporters which are exempted from the registration requirement in accordance with article 86 may be exempted by the member state from the requirement to keep records of the information listed in paragraph 1 of this article . member states shall notify the commission of any exemptions made and keep a record of all the exempted establishments on their territory .


### information related to kept animals of the porcine species and the establishments keeping them ; ### information related to kept animals of the porcine species , the establishments keeping them and their movements into and from establishments ;


### pet keepers shall ensure that terrestrial pet animals of the species listed in part a of annex i which are moved from one member state to another member state : ### pet keepers shall ensure that terrestrial pet animals of the species listed in part a of annex i which are moved from one member state to another member state meet the requirements laid down in regulation no 576 / 2013 on the non - commercial movement of pet animals1a . __________________ 1a oj l 178 , 28 . 6 . 2013 , p . 1 .


### pet keepers shall ensure that terrestrial pet animals of the species listed in part b of annex i when moved from one member state to another member state , and when required by rules adopted pursuant to articles 114 and 117 , are : ### pet keepers shall ensure that terrestrial pet animals of the species listed in part b of annex i when moved from one member state to another member state comply with the rules laid down in regulation no 576 / 2013 on the non - commercial movement of pet animals1a . __________________ 1a oj l 178 , 28 . 6 . 2013 , p . 1 .


### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning derogations for operators from the identification and registration requirements provided for in articles 106 , 107 and 109 and 110 : ### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning derogations for operators from the identification and registration requirements provided for in articles 106 , 107 and 109 and 110 , provided that full traceability is ensured :


### operators of slaughterhouses receiving kept ungulates and poultry from another member state shall slaughter those animals as soon as possible following their arrival and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to paragraph 2 . ### operators of slaughterhouses receiving kept ungulates and poultry from another member state shall slaughter , using pre - stunning , those animals as soon as possible following their arrival and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to paragraph 2 .


### pet keepers shall only carry out non - commercial movements of terrestrial pet animals of the species listed in annex i from one member state to another member state where : ### pet keepers shall only carry out non - commercial movements of terrestrial pet animals of the species listed in annex i from one member state to another member state in compliance with the rules laid down in regulation no 576 / 20131a on the non - commercial movement of pet animals . __________________ 1a oj l 178 , 28 . 6 . 2013 , p . 1 .


### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning the prevention and disease control measures referred to in paragraph 1 of this article to ensure that the terrestrial pet animals do not pose a significant risk for the spread of diseases referred to in article 8 and emerging diseases to animals during transport and at the place of destination and when relevant taking into account the health status of the place of destination . ### without prejudice to regulation no 576 / 2013 on the non - commercial movement of pet animals1a , the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning the disease prevention and control measures to ensure that the terrestrial pet animals do not pose a significant risk for the spread of diseases referred to in article 8 and emerging diseases to animals during transport and at the place of destination and when relevant taking into account the health status of the place of destination . __________________ 1a oj l 178 , 28 . 6 . 2013 , p . 1 .


### the power to adopt delegated acts referred to in articles 4 , 6 , 9 , 11 , 13 , 15 , 16 , 18 , 24 , 28 , 30 , 31 , 34 , 37 , 39 , 41 , 42 , 44 , 47 , 48 , 53 , 54 , 55 , 58 , 63 , 64 , 67 , 68 , 70 , 72 , 73 , 74 , 76 , 79 , 80 , 85 , 89 , 92 , 96 , 100 , 103 , 114 , 115 , 119 , 122 , 128 , 129 , 132 , 133 , 134 , 135 , 136 , 137 , 141 , 143 , 144 , 146 , 148 , 151 , 152 , 154 , 158 , 159 , 160 , 162 , 163 , 164 , 165 , 166 , 174 , 179 , 184 , 188 , 191 , 196 , 199 , 200 , 201 , 202 , 203 , 204 , 205 , 211 , 213 , 214 , 216 , 218 , 221 , 222 , 223 , 224 , 225 , 229 , 231 , 233 , 235 , 236 , 239 , 240 , 241 , 242 , 243 , 244 , 252 , 259 , 260 and 261 shall be conferred on the commission for an indeterminate period of time from . ### the power to adopt delegated acts referred to in articles 4 , 5 , 6 , 7 , 8 , 9 , 11 , 13 , 15 , 16 , 17 , 18 , 24 , 28 , 30 , 31 , 34 , 35 , 36 , 37 , 39 , 41 , 42 and , 44 , 47 , 48 , 53 , 54 , 55 , 58 , 63 , 64 , 67 , 68 , 70 , 72 , 73 , 74 , 76 , 79 , 80 , 85 , 89 , 92 , 96 , 100 , 103 , 114 , 115 , 119 , 122 , 128 , 129 , 132 , 133 , 134 , 135 , 136 , 137 , 141 , 143 , 144 , 146 , 148 , 151 , 152 , 154 , 158 , 159 , 160 , 162 , 163 , 164 , 165 , 166 , 174 , 179 , 184 , 188 , 191 , 196 , 199 , 200 , 201 , 202 , 203 , 204 , 205 , 211 , 213 , 214 , 216 , 218 , 221 , 222 , 223 , 224 , 225 , 229 , 231 , 233 , 235 , 236 , 239 , 240 , 241 , 242 , 243 , 244 , 252 , 259 , 260 and 261 shall be conferred on the commission for a period of 5 years from . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### transitional measures related to the repeal of regulation no 1760 / 2000 , regulation no 21 / 2004 and directive 2008 / 71 / ec ### transitional measures related to the repeal of regulation no 21 / 2004 and directive 2008 / 71 / ec


### notwithstanding article 258 of this regulation , regulations no 1760 / 2000 , and no 21 / 2004 and directive 2008 / 71 / ec shall continue to apply until the date to be determined in a delegated act adopted in accordance with paragraph 2 of this article . ### notwithstanding article 258 of this regulation , regulation no 21 / 2004 and directive 2008 / 71 / ec shall continue to apply until the date to be determined in a delegated act adopted in accordance with paragraph 2 of this article .


### in order to guarantee the free movement of products within the union , it is necessary to ensure that they fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , protection of consumers , protection of the environment and public security . robust enforcement of these requirements is essential to the proper protection of these interests and to create the conditions in which fair competition in the union goods market can thrive . rules are therefore necessary on market surveillance and on controls of products entering the union from third countries . ### in order to guarantee the rights of workers and consumers in the eu and in third countries trading with the eu , it is necessary to ensure that products entering the eu market fulfil requirements providing a high level of protection of public interests such as health and safety in general , health and safety in the workplace , protection of consumers and workers and their basic rights , protection of the environment and public security . robust enforcement of these requirements is essential to the proper protection of these interests . rules are therefore necessary on market surveillance and on controls of products entering the union from third countries .


### market surveillance should be financed at least in part by fees charged to economic operators where they are required by market surveillance authorities to take corrective action or where those authorities are obliged to take action themselves . ### market surveillance should be financed at least in part by fees charged to economic operators where they are required by market surveillance authorities to take corrective action or where those authorities are obliged to take action themselves . those fees should not be borne by the consumer and therefore should have no bearing on the retail price of a product .


### this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union . in particular this regulation seeks to ensure full respect for obligation to ensure a high level of human health protection and consumer protection as well as full respect of the freedom to conduct a business and the right to property , ### this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union . in particular this regulation seeks to ensure full respect for obligation to ensure a high level of human health protection as well as full respect for consumers ' and workers ' rights ,


### ‘ product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general , health and safety in the workplace , consumer protection , the environment and public security as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned , including the duration of use and , where applicable , its putting into service , installation and maintenance requirements ; ### ‘ product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general , including those involved in the manufacturing process , health and safety in the workplace , workers ' rights through non - compliance with fundamental ilo conventions , consumer protection , the environment and public security , including in the country where the product was produced and / or processed , as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned , including the duration of use and , where applicable , its putting into service , installation and maintenance requirements ;


### they shall cooperate with economic operators to prevent or reduce risks caused by products made available by those operators . for this purpose , they shall encourage and promote voluntary action by economic operators including , where applicable , through the development of and adherence to codes of good practice . ### they shall cooperate with economic operators and trade unions to prevent or reduce risks caused by products made available by those economic operators and develop guidelines of and adherence to codes of good practice .


### provide consumers and other interested parties with the opportunity to submit complaints on issues relating to product safety , market surveillance activities and risks arising in connection with products and follow up those complaints as appropriate ; ### provide consumers and other interested parties , including trade unions , with the opportunity to submit complaints on issues relating to product safety , market surveillance activities and risks arising in connection with products and follow up those complaints as appropriate ;


### a product the release of which has been suspended by the authorities in charge of external border controls pursuant to article 14 shall be released if , within three working days of the suspension of release , those authorities have not been requested by the market surveillance authorities to continue the suspension or they have been informed by the market surveillance authorities that the product does not present a risk , and provided that all the other requirements and formalities pertaining to such release have been fulfilled . ### a product the release of which has been suspended by the authorities in charge of external border controls pursuant to article 14 shall be released if , within five working days of the suspension of release , those authorities have not been requested by the market surveillance authorities to continue the suspension or they have been informed by the market surveillance authorities that the product does not present a risk , and provided that all the other requirements and formalities pertaining to such release have been fulfilled .


### today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in directive 2001 / 83 / ec . in order to ensure reliability in the distribution chain , pharmaceutical legislation should address all actors in the distribution chain : this includes not only distributors who procure , hold , store and supply products , but also persons who are involved in transactions without handling the products . they should be submitted to proportionate rules in order to exclude , by all practical means , the possibility that medicinal products which are falsified in relation to their identity , history or source to enter the legal supply chain in the community . ### today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in directive 2001 / 83 / ec . in order to ensure reliability in the distribution chain , pharmaceutical legislation should address all actors in the distribution chain : this includes not only distributors and transporters who procure , hold , store and supply products , but also persons who are involved in transactions without handling the products , such as traders or brokers . they should be submitted to proportionate rules in order to exclude , by all practical means , the possibility that medicinal products which are falsified in relation to their identity , history or source to enter the legal supply chain in the community .


### the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation . ### the manufacture of active pharmaceutical ingredients or excipients should be subject to good manufacturing practices irrespective of whether those ingredients or excipients were manufactured in the community or imported . with regard to their manufacture in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients or excipients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation .


### in order to facilitate enforcement and control of community rules relating to active substances used as starting material , the manufacturers or importers of those substances should notify their activity . ### in order to facilitate enforcement and control of community rules relating to active substances used as starting material , the manufacturers , importers or distributors of those substances should notify their activity .


### to ensure a similar level of protection of human health throughout the community , and to avoid distortions in the internal market , the harmonised principles and guidelines for inspections of holders of manufacturing and wholesaler authorisations of medicinal products as well as manufacturers of active substances should be strengthened . this should also help to ensure the functioning of existing mutual recognition agreements which rely on efficient and comparable inspection and enforcement throughout the community . ### to ensure a similar level of protection of human health throughout the community , and to avoid distortions in the internal market , the harmonised principles and guidelines for inspections of holders of manufacturing and wholesaler authorisations of medicinal products as well as manufacturers and distributors of active substances should be strengthened . this should also help to ensure the functioning of existing mutual recognition agreements which rely on efficient and comparable inspection and enforcement throughout the community .


### the measures necessary for the implementation of this directive should be adopted in accordance with council decision 1999 / 468 / ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred by the commission . ### in accordance with article 291 tfeu , rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers shall be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure . pending the adoption of that new regulation , given the necessity of adopting and implementing this directive as soon as possible , control by member states should be carried out in accordance with the provisions of council decision 1999 / 468 / ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission , insofar as those provisions remain compatible with the amended treaties . references to those provisions should nevertheless be replaced with references to the rules and principles set out in the new regulation as soon as that regulation enters into force .


### ‘ notwithstanding paragraph 1 and article 3 , title iv of this directive shall apply to medicinal products intended only for export and to intermediate products and active substances used as starting materials . ’ ### ‘ notwithstanding paragraph 1 and article 3 , title iv of this directive shall apply to medicinal products intended only for export and to intermediate products and active substances used as starting materials and excipients . ’


### to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ### to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances and excipients , which have been manufactured and distributed in accordance with the detailed guidelines on good manufacturing and distribution practices for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances and the excipients manufacturer and distributor with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state .


### ‘ to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ’ ### ‘ to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured and distributed in accordance with the detailed guidelines on good manufacturing and distribution practices for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . excipients shall be subject to the same conditions of good manufacturing and distribution practices . '


### member states shall take appropriate measures to ensure that the manufacture on their territory of active substances used as starting material , including active substances that are intended for export , complies with good manufacturing practices for active substances . ### member states shall take appropriate measures to ensure that the manufacture and distribution on their territory of active substances used as starting material , including active substances that are intended for export , complies with good manufacturing practices for active substances .


### the principles of good manufacturing practice for active substances used as starting materials referred to in point of article 46 and in article 46b shall be adopted in the form of detailed guidelines . ’ ### the commission shall adopt , by means of delegated acts in accordance with article 121a and subject to the conditions of articles 121b and 121c , the principles of good manufacturing and distribution practices for active substances used as starting materials and excipients referred to in point of article 46 and in article 46b in the form of detailed criteria .


### ‘ the principles of good manufacturing practice for active substances used as starting materials referred to in point of article 46 and in article 46b shall be adopted in the form of detailed guidelines . ’ ### ‘ the principles of good manufacturing and distribution practices for active substances used as starting materials and excipients referred to in point of article 46 and in article 46b shall be adopted in the form of detailed guidelines . ’


### importers and manufacturers of active substances used as starting materials established in the community shall notify their address to the competent authority of the member state where they are established . ### importers , manufacturers and distributors of active substances used as starting materials and excipients established in the community shall notify their address to the competent authority of the member state where they are established .


### notwithstanding article 2 , and without prejudice to title vii , member states shall ensure that medicinal products not intended to be placed on the market are not introduced into the community if there are reasons to believe that the products claim a falsified identity , history or source . the commission shall adopt the necessary measures for the implementation of paragraph 1 . those measures , designed to amend non - essential elements of this directive by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 121 . ’ ### notwithstanding article 2 , and without prejudice to title vii , member states shall take the necessary measures to prevent medicinal products not intended to be placed on the market from being introduced into the union if there are reasons to believe that these products are falsified . in order to establish the necessary measures referred to in paragraph , the commission shall adopt by means of delegated acts in accordance with article 121a and subject to the conditions of articles 121b and 121c : - the criteria to be considered and the verifications to be made by the national authorities when assessing a medicinal product intended for introduction into the union in terms of identity , history or source . - the documentation that is to accompany the medicinal product in order to facilitate enforcement , without prejudice to the applicable documentation requirements in accordance with customs legislation . - the minimum extent of cooperation and the mechanisms between customs authorities and competent authorities for medicinal products . this shall at least include risk management concepts and triggers for inspections .


### the commission shall adopt the measures necessary for the implementation of point of article 54 and of paragraphs and of this article . ### the commission shall adopt , by means of delegated acts in accordance with article 121a and subject to the conditions of articles 212b and 121c , the measures necessary for the implementation of point of article 54 and of paragraphs and of this article .


### in the case of wholesale distribution to third countries article 76 , article 80 and , and articles 81 and 82 shall not apply . moreover , article 80 shall not apply where a product is directly received from a third country . ### member states shall take all appropriate actions to ensure that no falsified medicinal products are distributed or exported from their territory to third countries . this directive is without prejudice to provisions in the istanbul convention as regards the supply of medicines to third countries in the case of emergency situations . for all supplies of medicinal products to a person authorised or entitled to supply medicinal products to the public in a third country , the authorised wholesaler shall keep records either in the form of purchase / sales invoices , or on computer , or in any other form , giving for any transaction in medicinal products received or dispatched at least the following information : &#8212 ; date , &#8212 ; name of the medicinal product , &#8212 ; quantity received or supplied , &#8212 ; name and address of the supplier or consignee , as appropriate ; t he authorised wholesaler shall keep tho se records available to the competent authorities , for inspection purposes , for a period of five years ;


### the commission , in accordance with the procedure set out in article 121 , shall adopt guidelines defining in detail the requirements set out in points to of paragraph 1 . ### the commission shall , by means of delegated acts in accordance with article 121a and subject to the conditions of articles 121b and 121c , adopt criteria defining in detail the requirements set out in points to of paragraph 1 .


### member states , in applying this directive , shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities . ### member states , in applying this directive , shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities ; member states shall also ensure that customs officers receive proper training for the identification of falsified medicinal products .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 18 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 18 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 24 months after publication ] ; the provisions necessary to comply with article 1 , and from [ insert concrete date 48 months after publication ] . when member states adopt those provisions , they shall contain a reference to this directive or be accompanied by such a reference on the occasion of their official publication . member states shall determine how such reference is to be made . 2 ) member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 12 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 12 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 12 months after publication ] , the provisions necessary to comply with article 1 , and from [ insert concrete date 24 months after publication ] . when member states adopt those provisions , they shall contain a reference to this directive or be accompanied by such a reference on the occasion of their official publication . member states shall determine how such reference is to be made . 2 ) member states shall communicate to the commission the text of the main provisions of national law which they adopt in the field covered by this directive .


### in accordance with article 148 of the treaty on the functioning of the european union , the council adopted guidelines for employment policies on 21 october 2010 , which , together with the broad guidelines for the economic policies of the member states and of the union adopted in accordance with article 121 of the treaty , comprise the europe 2020 integrated guidelines . the programme should contribute to applying the europe 2020 integrated guidelines , and in particular guidelines 7 , 8 and 10 , while supporting implementation of the flagship initiatives , with special regard to the european platform against poverty and social exclusion , an agenda for new skills and jobs , and youth on the move . ### in accordance with article 148 of the treaty on the functioning of the european union , the council adopted guidelines for employment policies on 21 october 2010 , which , together with the broad guidelines for the economic policies of the member states and of the union adopted in accordance with article 121 of the treaty , comprise the europe 2020 integrated guidelines . the programme should contribute to achieving the europe 2020 targets with special regard to poverty reduction and employment objectives .


### in line with the europe 2020 strategy , the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on large projects with clear eu added value in order to reach critical mass and reduce administrative burden for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro - credit , capacity building and technical assistance . lastly , the programme should provide for budgetary flexibility through the establishment of a reserve to be allocated on an annual basis in order to respond to policy priorities . ### the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on large projects with clear eu added value in order to reach critical mass and reduce administrative burden for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , fostering capacity building , technological improvement and modernisation and providing financing for micro - credit and technical assistance . lastly , the programme should provide for budgetary flexibility through the establishment of a reserve to be allocated on an annual basis in order to respond to policy priorities .


### the union should equip itself with a sound analytical basis to support policy - making in the employment and social area . such an evidence base adds value to national action by providing a union dimension and comparison for data - gathering and the development of statistical tools and methods and common indicators with a view to composing a full picture of the situation in the fields of employment , social policy and working conditions across the union and ensuring high - quality evaluation of the efficiency and effectiveness of programmes and policies . ### the union should equip itself with a sound analytical basis , especially focussing on the impact of the crisis , to support policy - making in the employment and social area . such an evidence base adds value to national action by providing a union dimension and comparison for data - gathering and the development of statistical tools and methods and common indicators with a view to composing a full picture of the situation in the fields of employment , social policy and working conditions across the union and ensuring high - quality evaluation of the efficiency and effectiveness of programmes and policies .


### ensuring that minimum standards are in place and that working conditions improve constantly in the union is a central feature of union social policy . the union has an important role to play both in ensuring that the legislative framework is adapted , in line with ‘ smart regulation’ principles , to evolving work patterns and new health and safety risks and in financing measures to improve compliance with union rules on the protection of workers ' rights . ### ensuring that minimum standards are in place and that working conditions improve constantly in the union is a central feature of union social policy . the union has an important role to play both in ensuring that the legislative framework is adapted , in line with ' good work ' principles , to evolving work patterns and new health and safety risks and in financing measures to improve compliance with ilo labour standards , the un and ilo ' decent work ' agenda and union rules on the protection of workers ' rights .


### social enterprises are a cornerstone of europe ' s pluralist social market economy . they can act as drivers of social change by offering innovative solutions , and therefore make a valuable contribution to meeting the objectives of the europe 2020 strategy . the programme should improve social enterprises ' access to finance and thereby contribute to the social business initiative launched by the commission11 . ### the social economy is a cornerstone of europe ' s social models . it can act as a driver of social progress by offering innovative solutions , and therefore make a valuable contribution to promoting inclusive labour markets and social services accessible to all . the programme should improve the social economy organisations ' access to finance .


### in order to capitalise on the experience of international financial institutions , and in particular the european investment bank group , action involving microfinance and social entrepreneurship should be implemented by the commission indirectly by entrusting budget implementations tasks to financial institutions in accordance with the financial regulation . using union resources concentrates leverage from international financial institutions and other investors , unifies approaches and thus improves access to finance for micro - enterprises , including the self - employed and social enterprises . the union contribution thus assists in the development of the emerging social business sector and the microfinance market in the union and encourages cross - border activities . ### in order to capitalise on the experience of international financial institutions , and in particular the european investment bank group , action involving microfinance and the social economy should be implemented by the commission indirectly by entrusting budget implementations tasks to financial institutions in accordance with the financial regulation . using union resources concentrates leverage from financial institutions and other investors , unifies approaches and thus improves access to finance for micro - enterprises , including the self - employed and social economy organisations . the union contribution thus assists in the development of the social economy and the microfinance market in the union and encourages cross - border activities . the union ' s actions should be complementary to the member states ' use of financial instruments for microfinance and the social economy . the entities entrusted with the implementation of the actions should ensure added value and avoid duplication of financing through union resources .


### support the development of adequate , accessible and efficient social protection systems and labour markets and facilitate policy reform , by promoting good governance , mutual learning and social innovation ; ### support the development of adequate , accessible and efficient high quality social protection systems , protecting beneficiaries from poverty , and inclusive labour markets in order to ensure social inclusion and a high level of high - quality employment and facilitate social progress , by promoting participation of all relevant stakeholders , including non - governmental organisations and people experiencing poverty and social exclusion as well as good and decent work , good governance , mutual learning and social innovation ;


### exchanges and dissemination of good practice , innovative approaches and experience , peer reviews , benchmarking and mutual learning at european level ; ### exchanges , identification and dissemination of good practice , innovative approaches and experience , peer reviews , benchmarking and mutual learning at european level ;


### organisation of working groups of national officials to monitor the implementation of union law ; ### organisation of working groups of national officials to monitor the proper implementation of union law ;


### two years after the expiry of the programme at the latest , the commission shall carry out an ex - post evaluation measuring its impact and union added value and shall forward a report on that evaluation to the european parliament , the council , the european economic and social committee and the committee of the regions . ### one year after the expiry of the programme at the latest , the commission shall carry out an independent ex - post evaluation measuring its impact and union added value and shall forward a report on that evaluation to the european parliament , the council , the european economic and social committee and the committee of the regions . following the evaluation , the commission may recommend continuation of the programme , two years after expiry thereof at the latest . the report shall be published and made available to the public in the interests of greater transparency .


### facilitate effective and inclusive information - sharing , mutual learning and dialogue on union employment and social policy and working conditions legislation at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in implementing union law ; ### facilitate effective and inclusive information - sharing , mutual learning and dialogue on union employment and social policy and working conditions legislation at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in properly implementing union law ;


### provide policy - makers with financial support to test social and labour market policy reforms , build up the main actors ' capacity to design and implement social experimentation , and make the relevant knowledge and expertise accessible ; ### provide policy - makers with financial support to anticipate and develop the job creation potential and skills needs for a transition towards a resource - efficient and low carbon economy as well as environmental and social sustainable development , to test social and labour market policies accordingly to deliver on improving the quality of jobs and social protection , build up the main actors ' capacity to design and implement social policy experimentation linked to those objectives and social progress , and make the relevant knowledge and expertise accessible ;


### to reach out to the final beneficiaries and create competitive , viable micro - enterprises , public and private bodies that carry out activities as referred to in paragraph 1 shall cooperate closely with organisations representing the interests of the final beneficiaries of microcredit and with organisations , in particular those supported by the esf , which provide mentoring and training programmes to such final beneficiaries . ### to reach out to the final beneficiaries and create competitive , viable micro - enterprises , public and private bodies that carry out activities as referred to in paragraph 1 shall cooperate closely with organisations representing the interests of the final beneficiaries of microcredit and with organisations , in particular those supported by the esf , which provide mentoring and training programmes to such final beneficiaries . the training programmes should take into account the requirements of the internal market .


### the international financial institutions and , where relevant , the fund managers shall send the commission annual implementation reports setting out the activities granted support and covering their financial implementation and the allocation and accessibility of funding and investment by sector and type of beneficiary , applications accepted or rejected and contracts concluded by the public and private bodies concerned , actions funded and the results , including in terms of social impact , employment creation and sustainability of the businesses support granted . ### the international financial institutions and , where relevant , the fund managers shall send the commission annual implementation reports setting out the activities granted support and covering their financial implementation and the allocation and accessibility of funding and investment by member state , sector and type of beneficiary , applications accepted or rejected and contracts concluded by the public and private bodies concerned , actions funded and the results , including in terms of social impact , employment creation and sustainability of the businesses support granted .


### this directive does not govern member states ' policies with regard to consensual sexual activities in which children may be involved and which can be regarded as the normal discovery of sexuality in the course of human development , taking account of the different cultural and legal traditions and of new forms of establishing and maintaining relations among children and adolescents , including through information and communication technologies . ### unless there is an element of abuse , coercion or exploitation , this directive does not govern member states ' policies with regard to consensual sexual activities in which children may be involved and which can be regarded as the normal discovery of sexuality in the course of human development , taking account of the different cultural and legal traditions and of new forms of establishing and maintaining relations among children and adolescents , including through information and communication technologies .


### where the danger posed by the offenders and the possible risks of repetition of the offences make it appropriate , convicted offenders should be temporarily or permanently prevented from exercising activities involving regular contacts with children , where appropriate . implementation of such prohibitions throughout the eu should be facilitated . ### in cases of recidivism , or attempts thereof , measures can be adopted by a judiciary authority in order to temporarily or permanently prevent any regular professional contacts between the offenders and children . implementation of such prohibitions throughout the eu should be facilitated .


### coercing a child into sexual activities with a third party shall be punishable by a maximum term of imprisonment of at least ten years . ### coercing , forcing or threatening a child into sexual activities with a third party shall be punishable by a maximum term of imprisonment of at least ten years .


### the child has not reached the age of sexual consent under national law ; ### the child has not reached the age of sexual consent under national law , or exhibits signs of slower physical and psychological development ;


### member states shall take the necessary measures to enable investigative units or services to attempt to identify the victims of the offences referred to in articles 3 to 7 , in particular by analysing child pornography material , such as photographs and audiovisual recordings transmitted or made available by means of information and communication technology . ### member states shall take the necessary measures to enable investigative units or services , in accordance with national and eu data protection legislation , to attempt to identify the victims of the offences referred to in articles 3 to 7 , in particular by analysing child pornography material , such as photographs and audiovisual recordings transmitted or made available by means of information and communication technology .


### protection of child victims in criminal investigations and proceedings ### assistance , support and protection of child victims in criminal investigations and proceedings


### member states shall take the necessary measures to ensure that in criminal investigations and proceedings , judicial authorities appoint a special representative for the child victim where , by national law , the holders of parental responsibility are precluded from representing the child as a result of a conflict of interest between them and the child victim , or where the child is unaccompanied or separated from the family . ### member states shall take the necessary measures to ensure the child victim is given an appropriate time period to decide if he or she will cooperate with the competent authorities in the criminal proceedings .


### the procedures to be followed by european political parties and their affiliated european political foundations to obtain a european legal status pursuant to this regulation should be laid down , as should the procedures and criteria to be respected in arriving at a decision on whether to grant such a european legal status . it is also necessary to lay down the procedures for cases where a european political party or a european political foundation may forfeit , lose or give up its european legal status . ### the procedures to be followed by european political parties and their affiliated european political foundations in order to obtain or give up a european legal status pursuant to this regulation by way of formal registration with the european parliament should be laid down , as should the procedures and criteria to be respected on registration by the european parliament itself . it is also necessary to lay down the procedures for cases where a european political party or a european political foundation may forfeit or lose its european legal status .


### the european political parties and the european political foundations should be governed by the substantive rules set out in this regulation , and by national law in the member states , in particular that of the member state where they have their respective seat and for the purposes of which they should identify the appropriate legal form , which must correspond to a form of legal entity recognised in the legal order of that member state . ### the european political parties and the european political foundations should be governed , as regards the substantive rules set out in this regulation , by the same legislation as the other european institutions , regardless of the member state where they have their respective seat .


### european political parties should be able to finance campaigns conducted in the context of elections to the european parliament , while the funding and limitation of election expenses for parties and candidates at such elections should be governed by the rules applicable in each member state . in order to help raise the european political awareness of citizens of the union and to promote the transparency of the european electoral process , european political parties should be encouraged to inform citizens during elections to the european parliament of the ties between them and their affiliated national political parties and candidates . ### european political parties should be able to finance their own campaigns conducted in the context of elections to the european parliament , while the funding and limitation of election expenses for parties and candidates at such elections should be governed by the rules applicable in each member state . in order to help raise the european political awareness of citizens of the union and to promote the transparency of the european electoral process , european political parties should be encouraged to inform citizens during elections to the european parliament of the ties between them and their affiliated national political parties and candidates .


### european political parties should not fund , directly or indirectly , other political parties and in particular national parties or candidates . european political foundations should not fund , directly or indirectly , european or national political parties or candidates . moreover , european political parties and their affiliated european political foundations should not finance national referenda campaigns . these principles reflect declaration no 11 on article 191 of the treaty establishing the european community annexed to the final act of the treaty of nice . ### european political parties may not fund , directly or indirectly , political parties and in particular national parties or candidates . european political foundations may not fund , directly or indirectly , european or national political parties or candidates . moreover , european political parties and their affiliated european political foundations may not finance national or regional referendum campaigns on purely national or regional topics . these principles reflect declaration no 11 on article 191 of the treaty establishing the european community annexed to the final act of the treaty of nice .


### technical assistance to be afforded by the european parliament to european political parties should be guided by the principle of equal treatment , should be supplied against invoice and payment and shall be subject to a regular public report . ### technical assistance to be afforded by european institutions to european political parties should be guided by the principle of equal treatment , should be supplied against invoice and payment and shall be subject to a regular public report by the relevant institution .


### within three months following the reception of the application for registration , the european parliament shall adopt a decision , which it shall publish in the official journal of the european union , together with the party or foundation statutes or , where an application has not been approved , the grounds for rejection . ### if the documents submitted with an application by a political alliance and / or the foundation affiliated to it for registration as a european political party or european political foundation fulfil the criteria in articles 3 , 4 and 5 of this regulation , it shall be formally registered . if the documents do not meet these requirements , the application for registration shall be deemed to have been rejected . the applicant shall be informed accordingly by the european parliament . the applicant may resubmit its application for registration in an appropriately corrected form .


### its governing body decides to wind up the european political party or the european political foundation , ### the governing body of the european political party or the european political foundation decides to halt structured cooperation in the political alliance or to wind up the associated foundation ,


### the funding of european political parties from the general budget of the european union or from any other source may be used to finance campaigns conducted by the european political parties in the context of the elections to the european parliament , in which they participate as required in article 3 . ### the funding of european political parties from the general budget of the european union or from any other source may be used to finance their own campaigns in the context of the elections to the european parliament , in which they participate as required in article 3 .


### at the latest within six months following the end of the financial year , european political parties and european political foundations shall submit to the registry and to the competent national authorities in the member states : ### at the latest within six months following the end of the financial year , european political parties and european political foundations shall submit to the european court of auditors as the inspection authority , the registry and to the competent national authorities in the member states :


### however , where the customs authorities are unable to comply with those time - limits , they shall inform the applicant of that fact before the expiry of those time - limits , stating the reasons and indicating the further period of time which they consider necessary in order to take a decision . ### the time - limit for taking a decision , as laid down in the customs legislation , shall start from the date of acceptance of the application . where the customs authorities are unable to comply with the time - limit for taking a decision , as laid down in the customs legislation , they shall inform the applicant of that fact before the expiry of the time - limit , stating the reasons and indicating the further period of time which they consider necessary to take a decision . this further period shall not exceed 30 days . without prejudice to the third subparagraph , the decision - taking customs authority may extend the time - limit for taking a decision [ as laid down in the customs legislation ] where the applicant requests such an extension to carry out adjustments in order to ensure the fulfilment of the conditions and criteria . those adjustments and the further period of time necessary to carry them out shall be communicated to the decision - taking customs authority , which shall decide about the extension .


### in certain cases the first subparagraph shall not apply . ### the first subparagraph shall not apply in the following cases : when the request for a decision , including the assignment of an economic operators registration and identification number , may not be accepted ; when it concerns a decision referred to in article 32 ; in case of refusal of the benefit of a tariff quota where the specified tariff quota volume is reached as referred to in the first subparagraph of article 49 ; when the nature or the level of the threat to the security and safety of the union and its residents , to human , animal or plant health , to the environment or to consumers so requires ; where the decision aims at securing the implementation of another decision for which this paragraph has been applied , without prejudice to the law of the member state concerned ; in case risk analysis is carried out on the basis of the entry summary declaration or the customs declaration replacing it ; in case it would prejudice investigations initiated for the purpose of combating fraud ; for decisions by the commission on whether repayment or remission is justified .


### in certain cases the customs authorities shall carry out the following : monitor compliance with a decision ; re - assess a decision ; suspend a decision which is not to be annulled , revoked or amended . ### the customs authorities shall monitor compliance with the obligations resulting from the decision and re - assess or suspend a decision in the cases specified by customs legislation .


### the commission shall be empowered to adopt delegated acts in accordance with article 243 , specifying : ### the commission shall be empowered to adopt delegated acts in accordance with article 243 , with a view to establish more detailed rules on the procedure regarding specific use under the temporary admission specifying :


### they fulfil the criteria laid down in article 22 ; ### they fulfil the criteria laid down in article 22 , for as far as relevant to the authorisation ;


### they are regular users of the customs procedures involved or they fulfil the criteria laid down in article 22 . ### they are regular users of the customs procedures involved or they fulfil the criteria laid down in article 22 , for as far as relevant to the authorisation .


### where a comprehensive guarantee is to be provided for customs debts and other charges which may be incurred , an economic operator may be authorised to use a comprehensive guarantee with a reduced amount or to have a guarantee waiver provided that he fulfils the criteria laid down in article 22 and . ### where a comprehensive guarantee is to be provided for customs debts and other charges which may be incurred , an economic operator may be authorised to use a comprehensive guarantee with a reduced amount or to have a guarantee waiver provided that he fulfils the criteria laid down in article 22 and , for as far as relevant to the authorisation .


### in certain cases where the competent authority considers that repayment or remission should be granted , that authority shall transmit the case to the commission for decision . ### where the customs authorities consider that repayment or remission should be granted , that authority shall transmit the case to the commission in the following cases : in case the customs authorities consider that a special situation is either exclusively the result of the commission failing in its obligations or the special situation results from both a failure of the customs authorities and of the commission ; in case the customs authorities consider that the commission has committed an error within the meaning of paragraph 1 ; and in case the circumstances of the case are related to the findings of a union investigation carried out under council regulation no 515 / 97 of 13 march 1997 on mutual assistance between the administrative authorities of the member states and cooperation between the latter and the commission to ensure the correct application of the law on customs and agricultural matters1 , or under any other union legislation or any agreement concluded by the union with countries or groups of countries in which provision is made for carrying out such union investigations ; when the amount for which the person concerned may be liable in respect of one or more import or export operations but in consequence of an error or special circumstances is eur 500 000 or more . ________ 1 oj l 82 , 22 . 3 . 1997 , p . 1 .


### where the competent authority has granted repayment or remission in error , the original customs debt shall be reinstated insofar as it is not time - barred under article 91 . ### where the customs authorities have granted repayment or remission in error , the original customs debt shall be established in accordance with article 91 .


### the rules for the granting of the authorisation referred to in article 196 ; ### the rules for granting of the authorisation for authorised consignor , authorised consignee , the use of special seals and the rules for simplified transit procedures for movements by air and sea referred to in article 196 .


### where the opinion of the committee is to be obtained by written procedure and reference is made to this paragraph , that procedure shall be terminated without result only when , within the time - limit for delivery of the opinion , the chair of the committee so decides . ### the written procedure shall be terminated without result where the chair so decides or a committee member so requests . in such a case , the chair shall convene a committee meeting within a reasonable time .


### when assessing imbalances , account should be taken of their severity , of the degree to which they may be considered unsustainable and of the potential negative economic and financial spillovers to other member states . the economic adjustment capacity and the track record of the member state concerned as regards compliance with earlier recommendations issued under this regulation and other recommendations issued under article 121 of the treaty as part of multilateral surveillance , in particular the broad guidelines for the economic policies of the member states and of the union , should also be considered . ### when assessing imbalances , account should be taken of their severity , of the degree to which they may be considered unsustainable and of the potential negative economic and financial spillovers to other member states . the structural or short - term nature of imbalances as well as the national , union or external character of their causes needs to be understood . inter - linkages between policy options by different member states as well as spill - over effects should be adequately taken into account . the track record of the member state concerned as regards compliance with earlier recommendations issued under this regulation and other recommendations issued under article 121 of the treaty as part of multilateral surveillance , in particular the broad guidelines for the economic policies of the member states and of the union and the consequences of such recommendations , should also be considered .


### ' imbalances ' means macroeconomic developments which are adversely affecting , or have the potential adversely to affect , the proper functioning of the economy of a member state or of economic and monetary union , or of the union as a whole . ### ' imbalances ' mean persistently diverging developments between aggregate demand and aggregate supply leading to a systematic surplus or deficit in the overall savings position of an economy , which is adversely affecting , or has the potential to adversely affect the proper functioning of the economy of a member state or of economic and monetary union , or of the union as a whole .


### ‘ excessive imbalances’ means severe imbalances , including imbalances that jeopardise the proper functioning of economic and monetary union . ### ‘ excessive imbalances’ means macroeconomic imbalances within the area of economic and monetary union which disrupt even and viable economic development in one or more member states participating in economic and monetary union .


### the release of the updated scoreboard shall be accompanied by a commission report containing an economic and financial assessment putting the movement of the indicators into perspective , drawing if necessary on any other economic and financial indicator relevant to detection of imbalances . the report shall also indicate whether the crossing of lower or upper thresholds in one or more member states signifies the possible emergence of imbalances . ### the release of the updated scoreboard shall be accompanied by a commission report containing a sound economic and financial assessment and putting the indicators into perspective . best practices shall be taken into account . the report shall also indicate whether the crossing of lower or upper thresholds in one or more member states signifies the possible emergence of imbalances inside the member state concerned , in another member state or across the union as a whole . all the available information shall be taken into account and conclusions shall not be drawn from the scoreboard based on the indicators alone .