### ‘ internet access service’ means a publicly available electronic communications service that provides connectivity to the internet , and thereby connectivity between virtually all end points connected to the internet , irrespective of the network technology used ; ### ' internet access service ' means a publicly available electronic communications service that provides connectivity to the internet , and thereby connectivity between virtually all end points connected to the internet , irrespective of the network technology used ; the member states shall impose reasonable minimum requirements in respect of internet access service quality , which must be constantly adapted to technological progress ; an internet access service enables end - users to use any internet - based application in accordance with the best effort principle ; the only permissible derogation from this principle is proportional and justified traffic management where the conditions for its use are clearly defined ;


### national regulatory authorities shall closely monitor and ensure the effective ability of end - users to benefit from the freedoms provided for in article 23 and , compliance with article 23 , and the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring and findings . ### national regulatory authorities shall closely ensure the effective ability of end - users to benefit from the freedoms provided for in article 23 and , compliance with article 23 , and the continued availability of non - discriminatory internet access services at levels of quality that reflect advances in technology and that are not impaired by specialised services . they shall , in cooperation with other competent national authorities , also monitor the effects of specialised services on cultural diversity and innovation . national regulatory authorities shall report on an annual basis to the commission and berec on their monitoring and findings . to that purpose , the competent national regulatory authority shall : be mandated to regularly monitor and report on internet traffic management practices and usage polices , in order to ensure network neutrality , evaluate the potential impact of the aforementioned practices and policies on fundamental rights , ensure the provision of a sufficient quality of service and the allocation of a satisfactory level of network capacity to the internet . reporting should be done in an open and transparent fashion and reports shall be made freely available to the public ; put in place appropriate , clear , open and efficient procedures aimed at addressing network neutrality complaints . to this end , all internet users shall be entitled to make use of such complaint procedures in front of the relevant authority ; respond to the complaints within a reasonable time and be able to use necessary measures in order to sanction the breach of the network neutrality principle . this authority must have the necessary resources to undertake the aforementioned duties in a timely and effective manner . they shall , in cooperation with other competent national authorities and the european data protection supervisor , also monitor the effects of specialised services on cultural diversity , competition and innovation . national regulatory authorities shall report on an annual basis to the public , the commission and berec on their monitoring and findings .


### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public is necessary for the provision of specialised services and is expected to play an important role in the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such agreements do not substantially impair the general quality of internet access services . ### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public could be used for the provision of specialised services and is expected to play an important role in the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such quality characteristics are technically necessary for the functionality of the service and agreements do not impair the quality of internet access services .


### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public is necessary for the provision of specialised services and is expected to play an important role in the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such agreements do not substantially impair the general quality of internet access services . ### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on quality parameters . for the provision of specialised services in closed networks , it is necessary that content , applications and service providers have the opportunity to negotiate such a specific quality of service levels with providers of electronic communications to the public for a limited group of users . this is expected to play an important role in the development of new services such as machine - to - machine communications . special services must neither impair open internet access service quality nor be marketed or used as an internet substitute . they are admissible only if there is a manifest technical and de facto need , over and above economic self - interest , to be able to supply real - time critical applications of a particular quality . if special services are offered or marketed by access network providers , they are also under the obligation to provide an open internet access service as referred to in recital . all open internet services are subject to the best - effort principle .


### implement a legislative provision or a court order , or prevent or impede serious crimes ; ### implement a legislative provision or a court order ;


### end - users shall be free to access and distribute information and content , run applications and use services of their choice via their internet access service . ### users shall have the right to access and distribute information and content , run and provide applications and services and use devices of their choice via an internet access . internet service providers shall not discriminate , restrict or interfere with the transmission of internet traffic .


### the freedom of end - users to access and distribute information and lawful content , run applications and use services of their choice is subject to the respect of union and compatible national law . this regulation defines the limits for any restrictions to this freedom by providers of electronic communications to the public but is without prejudice to other union legislation , including copyright rules and directive 2000 / 31 / ec . ### the right of end - users to access and distribute information and content , run applications and use services of their choice is subject to the respect of union and compatible national law .


### harmonised rights of end - users ### users ' rights to open internet access


### the three categories of regions are determined on the basis of how their gdp per capita , measured in purchasing power parities and calculated on the basis of union figures for the period 2006 to 2008 , relates to the average gdp of the eu - 27 for the same reference period . ### the three categories of regions are determined on the basis of how their gdp per capita , measured in purchasing power parities and calculated on the basis the latest available three - year period of union figures , relates to the average gdp of the eu - 27 for the same reference period .


### the commission shall be empowered to adopt a delegated act in accordance with article 142 on the common strategic framework within 3 months of the adoption of this regulation . ### the common strategic framework is annexed to this regulation .


### the commission should adopt by delegated act a common strategic framework which translates the objectives of the union into key actions for the csf funds , in order to provide clearer strategic direction to the programming process at the level of member states and regions . the common strategic framework should facilitate sectoral and territorial coordination of union intervention under the csf funds and with other relevant union policies and instruments ### the common strategic framework in annex x of this regulation translates the objectives of the union into key actions for the csf funds , in order to provide clearer strategic direction to the programming process at the level of member states and regions . the common strategic framework should facilitate sectoral and territorial coordination of union intervention under the csf funds and with other relevant union policies and instruments


### the cohesion fund shall support those member states whose gross national income per capita , measured in purchasing power parities and calculated on the basis of union figures for the period 2007 to 2009 , is less than 90 % of the average gni per capita of the eu - 27 for the same reference period . ### the cohesion fund shall support those member states whose gross national income per capita , measured in purchasing power parities and calculated on the basis of the latest three - year period union figures , is less than 90 % of the average gni per capita of the eu - 27 for the same reference period .


### agreements providing for investment protection typically include an investor - to - state dispute settlement mechanism , which allows an investor from a third country to bring a claim against a state in which it has made an investment . investor - to - state dispute settlement can result in awards for monetary compensation . furthermore , significant costs for administering the arbitration as well as costs relating to the defence of a case will inevitably be incurred in any such case . ### in the cases where it is justifiable , future investment protection agreements concluded by the union can include an investor - to - state dispute settlement mechanism , which allows an investor from a third country to bring a claim against a state in which it has made an investment . investor - to - state dispute settlement can result in awards for monetary compensation . furthermore , significant costs for administering the arbitration as well as costs relating to the defence of a case will inevitably be incurred in any such case .


### by &#8230 ; [ 4 years after the date of application of this regulation ] , member states shall provide the commission with information relating to the application of this regulation , in particular on the level of acceptance of the common european sales law , the extent to which its provisions have given rise to litigation and on the state of play concerning differences in the level of consumer protection between the common european sales law and national law . that information shall include a comprehensive overview of the case law of the national courts interpreting the provisions of the common european sales law . ### by &#8230 ; [ 4 years after the date of application of this regulation ] , member states shall provide the commission with information relating to the application of this regulation , in particular on the level of acceptance of the common european sales law by sme and non - sme traders , the extent to which its provisions have given rise to litigation and on the state of play concerning differences in the level of consumer protection between the common european sales law and national law . that information shall include a comprehensive overview of the case law of the national courts interpreting the provisions of the common european sales law .


### ' collecting society ' means any organisation which is authorised by law or by way of assignment , licence or any other contractual arrangement , by more than one rightholder , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or controlled by its members ; ### ' collective management organisation ' means any organisation authorised by law or by way of assignment , licence or any other contractual arrangement to manage copyright or rights related to copyright on behalf of more than one rightholder , for the collective benefit of those rightholders as its sole or one of its main purposes , and which is : owned or controlled by its members , or organised as a not for profit organisation , or owned or controlled by one or more collective management organisations ;


### ' collecting society ' means any organisation which is authorised by law or by way of assignment , licence or any other contractual arrangement , by more than one rightholder , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or controlled by its members ; ### ' collective management organisation ' means any organisation which is authorised by law or by way of assignment , licence or any other contractual arrangement , by a substantial number of rightholders , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or controlled by its members ;


### rightholders shall have the right to authorise a collecting society of their choice to manage the rights , categories of rights or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collecting society or the rightholder . ### according to the rules collectively decided at the general assembly , rightholders shall have the right to authorise a collective management organisation of their choice to manage the rights , categories of rights or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collecting society or the rightholder .


### member states shall ensure that the collecting society establishes a supervisory function responsible for continuously monitoring the activities and the performance of the duties of the persons entrusted with managerial responsibilities in the collecting society . there shall be fair and balanced representation of the members of the collecting society in the body exercising this function in order to ensure their effective participation . ### member states shall ensure that the collective management organisation establishes a supervisory function responsible for continuously monitoring the activities and the performance of the duties of the persons entrusted with managerial responsibilities in that organisation . there shall be fair and balanced representation of the different categories of members of the collective management organisation in the body exercising this function in order to ensure their effective participation


### rightholders shall have the right to authorise a collecting society of their choice to manage the rights , categories of rights or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collecting society or the rightholder . ### rightholders shall have the right to authorise a collective management organisation of their choice to manage the rights , categories of rights or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collective management organisation or the rightholder . collective management organisation shall have the right to require the exclusive assignment of the rights in all works of their members .


### rightholders shall have the right to terminate the authorisation to manage rights , categories of rights or types of works and other subject matter granted to a collecting society or to withdraw from a collecting society any of the rights or categories of rights or types of works and other subject matter of their choice , for the member states of their choice , upon serving reasonable notice not exceeding six months . the collecting society may decide that such termination or withdrawal will take effect only at the middle and at the end of the financial year , whichever is sooner after the expiry of the notice period . ### rightholders shall have the right to terminate the authorisation to manage rights , categories of rights , works or types of works and other subject matter granted to a collective management organisation or to withdraw from a collective management organisation any of the rights or categories of rights , works or types of works and other subject matter of their choice , at any time during the term of the authorisation , for the member states of their choice , upon serving reasonable notice not exceeding six months . the collective management organisation may decide that such termination or withdrawal will take effect only at the middle and at the end of the financial year , whichever is sooner after the expiry of the notice period .


### ' collecting society ' means any organisation which is authorised by law or by way of assignment , licence or any other contractual arrangement , by more than one rightholder , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or controlled by its members ; ### ' collective management organisation ' means any profit or nonprofit organisation authorised by law or by way of assignment , licence or any other contractual arrangement to manage copyright or rights related to copyright on behalf of more than one rightholder , for the collective benefit of those rightholders as its sole or one of its main purposes ;


### ‘ rights revenue’ means income collected by a collecting society on behalf of rightholders , whether from an exclusive right , a right to remuneration or a right to compensation ; ### ' rights revenue ' means income collected by a collective management organisation on behalf of rightholders , whether from an exclusive right , a right to remuneration or a right to compensation , and including any income derived from the investments of rights revenue ;


### rightholders shall have the right to authorise a collecting society of their choice to manage the rights , categories of rights or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collecting society or the rightholder . ### rightholders shall have the right to authorise a collective management organisation of their choice to manage the rights , categories of rights , works or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collective management organisation or the rightholder .


### surveillance following the use of vaccines and other veterinary medicinal products for specific listed diseases . ### surveillance following the use of vaccines and other veterinary medicinal products for specific diseases .


### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , 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 date on which regulations no 1760 / 2000 , no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply . ### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , 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 date on which regulations no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply .


### member states shall take the following criteria into consideration when determining whether or not to use and how to use veterinary medicinal products as disease prevention and control measures for a specific listed disease : ### member states shall take the following criteria into consideration when determining whether or not to use and how to use veterinary medicinal products as disease prevention and control measures for a specific disease :


### the member states may take measures concerning the use of veterinary medicinal products for listed diseases , to ensure the most efficient disease prevention or control for those diseases , provided that such measures comply with the rules on the use of veterinary medicinal products laid down in delegated acts adopted pursuant to article 47 . ### the member states shall take measures concerning the responsible use of veterinary medicinal products for infectious diseases , to ensure the most efficient disease prevention or control for those diseases , provided that such measures comply with the rules on the use of veterinary medicinal products laid down in delegated acts adopted pursuant to article 47 .


### take appropriate biosecurity measures , taking into account the risks involved , to ensure the health of those kept animals and products and to prevent the introduction into , development and multiplication within and spread between and from such kept animals and products under their responsibility of diseases , except where that is specifically authorised for scientific purposes , as appropriate for : ### take appropriate biosecurity measures , taking into account the risks involved , to ensure the health of those kept animals and products and to prevent the introduction into , development and multiplication within and spread between and from such kept animals and products under their responsibility , or from such kept animals and wild animals , of diseases , except where that is specifically authorised for scientific purposes , as appropriate for :


### specific conditions for the use veterinary medicinal products for a specific listed disease ; ### specific conditions for the use veterinary medicinal products for a specific disease ;


### risk mitigating measures to prevent the spread of listed diseases through animals treated with the veterinary medicinal products or products from such animals ; ### risk mitigating measures to prevent the spread of diseases through animals treated with the veterinary medicinal products or products from such animals ;


### where tenders appear to be abnormally low for other reasons , contracting authorities may also request such explanations . ### where tenders appear to be abnormally low , contracting authorities shall request additional explanations before rejecting a tender .


### for service contracts and contracts involving the design of works , the organisation , qualification and experience of the staff assigned to performing the contract in question may be taken into consideration , with the consequence that , following the award of the contract , such staff may only be replaced with the consent of the contracting authority , which must verify that replacements ensure equivalent organisation and quality ; ### for service contracts and contracts involving the design of works , the organisation , qualification and experience of the staff assigned to performing the contract in question may be taken into consideration ;


### contracting authorities shall require economic operators to explain the price or costs charged , where all of the following conditions are fulfilled : ### contracting authorities shall require economic operators to explain in a detailed manner the price or costs charged for their tender .


### member states and the agency shall ensure that railway safety is generally maintained and , where reasonably practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents . ### member states and the agency shall ensure , each within their respective fields of responsibility , that railway safety is maintained and , where practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents . the commission may request the agency to deliver ad hoc technical opinions .


### metros , trams and light rail systems ; ### metros , trams , tram - trains and light rail systems ;


### ‘ national rules’ means all binding rules containing railway safety or technical requirements imposed at member state level and applicable to railway undertakings , irrespective of the body issuing them ; ### ‘ national rules’ means all binding rules that have been notified by a member state and that contain railway safety , operational or technical requirements imposed at member state level and applicable to railway actors , irrespective of the body issuing them ;


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with articles 2 , 3 , 4 , 8 , 10 , 16 , 18 , 20 and annex i by [ specific date to be inserted by opoce - two years after the date of entry into force ] at the latest . they shall forthwith communicate to the commission the text of those provisions . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with articles 2 , 3 , 4 , 8 , 10 , 16 , 18 , 20 and annex i by [ specific date to be inserted by opoce - one year after the date of entry into force ] at the latest . they shall forthwith communicate to the commission the text of those provisions .


### member states may lay down new national rules only in the following cases : ### member states may draft new national rules after the entry into force of this directive only in the following cases :


### the national safety authority shall take a decision on an application for safety authorisation without delay and in any event not more than four months after all the information required and any supplementary information requested has been submitted . ### the agency shall take a decision on an application for safety authorisation without delay and in any event not more than three months after receipt of the application . negative decisions shall be duly justified . if the agency has doubts concerning the fulfilment of one or more conditions , it shall request further information from the railway undertaking within one month after receipt of the application for a safety authorisation . information requested shall be supplied within a reasonable period set by the national safety authority .


### three months before the start of operation of any new service , the railway undertaking shall notify to the relevant national safety authority the documentation confirming that : ### the application for a single safety certificate shall contain documentation confirming that :


### three months before the start of operation of any new service , the railway undertaking shall notify to the relevant national safety authority the documentation confirming that : ### three months before the start of operation of any new service , the railway undertaking shall notify to the agency , providing a copy to the relevant national safety authority , the documentation confirming that :


### the national safety authority shall take a decision on an application for safety authorisation without delay and in any event not more than four months after all the information required and any supplementary information requested has been submitted . ### the national safety authority shall take a decision on an application for safety authorisation without delay and in any event not more than three months after receipt of the application . negative decisions shall be duly justified . if the national safety authority has doubts concerning the fulfilment of one or more conditions , it shall request further information from the railway undertaking within one month after receipt of the application for a single safety certificate . information requested shall be supplied within a reasonable period set by the national safety authority that shall not exceed one month unless , in exceptional circumstances , the national safety authority agrees to , and authorises , a time - limited extension , which shall not exceed two additional weeks .


### until [ specific date to be inserted by opoce - two years after the date of entry into force ] , the national safety authorities shall continue to grant safety certificates in accordance with the provisions of directive 2004 / 49 / ec . such safety certificates shall be valid until their date of expiry . ### until [ specific date to be inserted by opoce - one year after the date of entry into force ] , the national safety authorities shall continue to grant safety certificates in accordance with the provisions of directive 2004 / 49 / ec . such safety certificates shall be valid until their date of expiry .


### directive 2004 / 49 / ec , as amended by the directives listed in annex ii , part a , is repealed with effect from [ specific date to be inserted by opoce –two years after the date of entry into force ] , without prejudice to the obligations of the member states concerning the time limits for transposition into national law and application of the directives set out in annex ii , part b . ### directive 2004 / 49 / ec , as amended by the directives listed in annex ii , part a , is repealed with effect from [ specific date to be inserted by opoce – one year after the date of entry into force ] , without prejudice to the obligations of the member states concerning the time limits for transposition into national law and application of the directives set out in annex ii , part b .


### applications for single safety certificates shall be submitted to the agency . the agency shall take a decision on an application without delay and in any event not more than four months after all required information and any supplementary information requested by the agency has been submitted . if the applicant is requested to submit supplementary information , such information shall be submitted promptly . ### applications for single safety certificates shall be submitted exclusively to the agency . the agency shall take a decision on an application without delay and in any event not more than three months after receipt of the application . if the applicant is requested to submit supplementary information , such information shall be supplied within a reasonable period set by the agency that shall not exceed one month unless , in exceptional circumstances , the agency agrees to , and authorises , a time - limited extension , which shall not exceed two additional weeks . negative decisions shall be duly justified .


### to ensure a high level of railway safety and equal conditions for all railway undertakings , the latter should be subject to the same safety requirements . a licensed railway undertaking should hold a safety certificate in order to obtain access to the railway infrastructure . the safety certificate should provide evidence that the railway undertaking has established its safety management system and is able to comply with the relevant safety standards and rules . for international transport services , it should be enough to approve the safety management system only once at union level . ### to ensure a high level of railway safety and equal conditions for all railway undertakings , the latter should be subject to the same safety requirements . a licensed railway undertaking should hold a safety certificate in order to obtain access to the railway infrastructure . the safety certificate should provide evidence that the railway undertaking has established its safety management system and is able to comply with the relevant safety standards and rules in all member states in which the undertaking operates . for international transport services , it should be enough to approve the safety management system only once at union level .


### annexes iii and v to directive 2004 / 49 / ec shall apply until the date of application of the implementing acts referred to in articles 6 and , 9 , 14 and 23 of this directive . ### annexes iii and v to directive 2004 / 49 / ec shall apply until the date of application of the delegated or implementing acts respectively referred to in articles 6 and , 9 , 14 and 23 of this directive .


### on request of the agency , supporting it in the issue , renewal , amendment and revocation of single safety certificates granted in accordance with article 10 and checking that the conditions and requirements laid down in them are met and that railway undertakings are operating in accordance with the requirements of union or national law ; ### on request of the agency and on the basis of contractual agreements referred to in regulation [ regulation on the european railway agency ] , supporting it in the issue , renewal , amendment and revocation of single safety certificates granted in accordance with article 10 and checking that the conditions and requirements laid down in them are met and that railway undertakings are operating in accordance with the requirements of union or national law ;


### in order to supplement and amend certain non - essential elements of this directive , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of common safety methods and their revision , and revision of common safety indicators and common safety targets . 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 . ### in order to supplement and amend certain non - essential elements of this directive , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of common safety methods and their revision , and revision of common safety indicators and common safety targets . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level and with social partners . 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 .


### in case of exchange of vehicles between railways undertakings , all actors shall exchange all information relevant to safe operation . such information shall include information on the status and history of the vehicle , elements of the maintenance files , traceability of loading operations , and consignment notes . it shall be sufficiently detailed to allow an assessment of the risks of operating the vehicle by the railway undertaking . ### in the case of exchange of vehicles between railway undertakings , all actors shall exchange all information relevant to safe operation , using inter alia the relevant registers as specified in directive . . . [ interoperability directive ] . such information include information on the status and history of the vehicle , elements of the maintenance files , traceability of loading operations , and consignment notes . it shall be sufficiently detailed to allow an assessment of the risks of operating the vehicle by the railway undertaking .


### common safety targets and csms have been gradually introduced to ensure that safety is maintained at a high level and , when necessary and where reasonably practicable , improved . they should provide tools for assessment of the safety and performance of operators at union level as well as in the member states . common safety indicators have been established in order to assess whether systems comply with the csts and to facilitate the monitoring of railway safety performance . ### common safety targets and csms have been gradually introduced to ensure that safety is maintained at a high level and improved . they should provide tools for assessment of the safety and performance of operators at union level as well as in the member states . common safety indicators have been established in order to assess whether systems comply with the csts and to facilitate the monitoring of railway safety performance .


### the power to adopt delegated acts referred to in articles 5 and 7 shall be conferred on the commission for an indeterminate period of time . ### the power to adopt delegated acts referred to in article 5 and 7 shall be conferred on the commission for a period of five years from [ the date of entry into force of this regulation ] . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . 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 .


### if a member state intends to introduce a new national rule , it shall notify the draft of that rule to the agency and the commission using the appropriate it system in accordance with article 23 of regulation no … / … [ agency regulation ] . ### if a member state intends to introduce a new national rule , it shall notify the draft of that rule to the agency and the commission using the appropriate it system in accordance with article 23 of regulation no . . . / . . . [ agency regulation ] and shall enclose a report assessing the impact of the new rules to be adopted .


### if a member state intends to introduce a new national rule , it shall notify the draft of that rule to the agency and the commission using the appropriate it system in accordance with article 23 of regulation no … / … [ agency regulation ] . ### if a member state intends to introduce a new national rule , it shall notify the draft of that rule to the agency and the commission , using the appropriate it system in accordance with article 23 of regulation no . . . / . . . [ agency regulation ] . after receipt of the draft national rule , the agency shall initiate a coordination process involving all national safety authorities in order to ensure the highest possible degree of harmonisation across the union . in any case , the new national rule may not enter into force before being approved by the agency . if the agency objects to the draft rule , it shall provide a justification of this objection .


### member states and the agency shall ensure that railway safety is generally maintained and , where reasonably practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents . ### member states and the agency shall ensure , each within their respective fields of responsibility , that railway safety is maintained and , where practicable , continuously improved , taking into consideration the development of union legislation and technical and scientific progress and giving priority to the prevention of serious accidents . the commission may request the agency to deliver ad hoc technical opinions .


### the commission shall , by means of implementing acts , adopt common conditions for certification of the entity in charge of maintenance for all vehicles by 24 december 2016 . ### on the basis of the agency ' s recommendation , the commission shall , by means of delegated acts in accordance with article 26 , adopt common conditions for certification of the entity in charge of maintenance for all vehicles by 24 december 2016 .


### if a member state intends to introduce a new national rule , it shall notify the draft of that rule to the agency and the commission using the appropriate it system in accordance with article 23 of regulation no … / … [ agency regulation ] . ### if a member state intends to introduce a new national rule , it shall notify the draft of that rule to the agency and the commission at least three months before its adoption , save in the cases described in point of the first subparagraph of paragraph 1 , using the appropriate it system in accordance with article 23 of regulation no … / … [ agency regulation ] . the new national rule may not enter into force if the agency objects to it , providing a justification of this objection .


### national rules ### national safety rules


### the holder of the single safety certificate shall inform the agency without delay of any major changes in the conditions of the single safety certificate . it shall furthermore notify the agency whenever new categories of staff or new types of rolling stock are introduced . ### the holder of the single safety certificate shall inform the agency without delay of any major changes in the conditions of the single safety certificate . it shall furthermore notify the agency whenever new categories of safety - critical staff or new types of rolling stock are introduced . the time limits laid down in paragraph 4 shall equally apply in this case .


### in order to be allowed to manage and operate a rail infrastructure , the infrastructure manager shall obtain a safety authorisation from the national safety authority in the member state where it is established . ### in order to be allowed to manage and operate a rail infrastructure , the infrastructure manager shall obtain a safety authorisation from the national safety authority in the member state where it is established . if an infrastructure manager manages a bi - national infrastructure or operates trains for inspecting or maintaining infrastructures in several member states , it shall seek additional authorisation from the relevant authorities , without prejudice to existing agreements between member states . where a railway undertaking is to undertake the management of a limited number of the functions usually assigned to an infrastructure manager , the agency shall process the application as part of the railway undertaking ' s application for a safety certificate .


### if the national safety authority has doubts concerning the fulfilment of one or more conditions it shall request more information from the railway undertaking . however , this exchange may not have any suspensive or delaying effect on the start of operation . if the national safety authority finds evidence that one or more conditions are not met , it shall refer the matter to the agency , which shall take the appropriate measures , including revocation of the certificate . ### if the agency or the competent national safety authority has doubts concerning the fulfilment of one or more conditions it shall request more information from the railway undertaking within one month after receipt of the application for a single safety certificate . information requested shall be supplied within a reasonable period set by the agency that shall not exceed one month unless , in exceptional circumstances , the agency agrees to , and authorises , a time - limited extension , which shall not exceed two additional weeks . the agency shall in any case take a decision within three months after receipt of the application . negative decisions shall be duly justified . if the agency finds evidence that one or more conditions are not met , it shall take the appropriate measures , including revocation of the certificate .


### where the product is obtained from the manufacturer or importer , holders of the wholesale distribution authorisation must verify that the manufacturer or importer holds a manufacturing authorization . ### where the product is obtained through trading or brokering , holders of the wholesale distribution , trading or brokering authorisation must verify that the persons or entities involved hold the necessary authorizations through the community database , as referred to in article 111 .


### the measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights . ### the measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature .


### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of prescription medicinal products should be established at community level . when introducing obligatory safety features for prescription medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated . ### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of medicinal products should be established at community level . when introducing obligatory safety features for medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines , over - the - counter medicines and medicines sold directly by producers , without any brokering , to establishments at which they are provided to patients . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated .


### member states shall enter the certificates of good manufacturing practice and good distribution practice which they issue in a community database managed by the agency on behalf of the community . ### member states shall enter the certificates of good manufacturing practice , good distribution practice , good trading practice and good brokering practice which they issue in a union database managed by the agency on behalf of the union .


### safety features making it possible to ascertain identification , authenticity and traceability of medicinal products , other than radiopharmaceuticals , subject to medical prescription as defined in title vi . ### safety features making it possible to ascertain identification , authenticity and traceability of medicinal products , other than radiopharmaceuticals , as defined in title vi .


### wholesale distribution and trading of medicinal products’ ; ### wholesale distribution , trading and brokering of medicinal products’ ; )


### pursuant to articles 8 and 10 of the treaty , the programme should support the mainstreaming of gender equality and anti - discrimination objectives in all its activities . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed in the programme ' s activities . ### pursuant to article 8 of the treaty , the programme ensures that the implementation of its priorities contributes to the promotion of equality between women and men . evaluations have shown the importance of taking the gender aspect into account in all dimensions of the programme , while ensuring that specific actions are taken to promote gender equality . regular monitoring and evaluation should be carried out to assess the way in which gender equality issues are addressed in the programme ' s activities .


### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union employment and social policy and working conditions legislation are based on sound evidence and are relevant to needs , challenges and conditions in the individual member states and the other participating countries ; ### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas are based on sound evidence and are relevant to people ' s needs , social challenges and social conditions in the individual member states and the other participating countries ;


### this regulation establishes a european union programme for social change and innovation which aims to contribute to the implementation of the europe 2020 strategy , its headline targets and integrated guidelines by providing financial support for the european union ' s objectives in terms of promoting a high level of employment , guaranteeing adequate social protection , combating social exclusion and poverty and improving working conditions . ### this regulation establishes a european union programme for social progress , solidarity , employment and innovation which aims to contribute to the implementation of the europe 2020 strategy , its headline targets , flagship initiatives , integrated guidelines and the youth opportunities initiative by providing financial support for the european union ' s objectives in terms of promoting a high level of high - quality employment , guaranteeing adequate and decent social protection , combating social exclusion and poverty , improving working conditions and improving the employment and educational situation of young people .


### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . ### the commission , in cooperation with the member states , in line with the partnership principle , shall ensure that activities carried out under the programme are consistent with and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , equal opportunities , education , vocational training , children ' s rights and well - being , and youth policy , migration policy , research and innovation , entrepreneurship , health , working conditions , enlargement and external relations , and general economic policy .


### 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 . ### 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 reduce administrative burden for the beneficiaries . 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 .


### networking and cooperation among specialist bodies , national , regional and local authorities , and employment services at european level ; ### networking and cooperation among specialist bodies , national , regional and local authorities , civil society and social partner organisations and employment services at european level ;


### the microfinance and social entrepreneurship axis , which shall facilitate access to finance for entrepreneurs , especially those furthest from the labour market , and social enterprises . ### the microfinance and social entrepreneurship axis , which shall help increase access to , and availability of , microfinance for persons who have lost or are at risk of losing their job , or who have difficulties entering or re - entering the labour market , as well as persons who are facing the threat of social exclusion or vulnerable persons who are in a disadvantaged position with regard to access to the conventional credit market , and for micro - enterprises which employ those persons , as well as enterprises in the social economy .


### the progress axis , which shall support the development , implementation , monitoring and evaluation of union employment and social policy and legislation on working conditions and shall promote evidence - based policy - making and innovation , in partnership with the social partners , civil society organisations and other interested parties ; ### the progress axis , which shall support the development , implementation , monitoring and evaluation of union policy in the fields of employment , social protection , social inclusion , combating poverty and working conditions legislation and shall promote evidence - based policy - making and social progress , in partnership with the social partners , civil society organisations and other interested parties ;


### 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 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 , as well as the youth opportunities initiative .


### 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 , within the framework of the european employment strategy and the open method of coordination in the field of social protection and inclusion and by networking amongst specialised bodies , including the social partners and civil society organisations , on union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas 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 ;


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


### promote equality between women and men and combat discrimination based on sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation ; ### promote equality between women and men by gender mainstreaming , implementing positive action to promote gender equality , combat discrimination based on sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation and fulfil the obligation under the un convention on the rights of persons with disabilities with regard inter alia to education , work and employment and accessibility ;


### this regulation establishes a european union programme for social change and innovation which aims to contribute to the implementation of the europe 2020 strategy , its headline targets and integrated guidelines by providing financial support for the european union ' s objectives in terms of promoting a high level of employment , guaranteeing adequate social protection , combating social exclusion and poverty and improving working conditions . ### this regulation establishes a european union programme for social progress and employment which aims to contribute to the implementation of the europe 2020 strategy , its headline targets , flagship initiatives and integrated guidelines by providing financial support for the european union ' s objectives in terms of promoting a high level of high - quality employment , guaranteeing adequate and decent social protection , combating social exclusion and poverty and improving working conditions .


### the progress axis , which shall support the development , implementation , monitoring and evaluation of union employment and social policy and legislation on working conditions and shall promote evidence - based policy - making and innovation , in partnership with the social partners , civil society organisations and other interested parties ; ### the progress axis , which shall support the development , implementation , monitoring and evaluation of union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas and shall promote evidence - based policy - making and social progress , in partnership with the social partners and in cooperation with civil society organisations and public bodies ;


### ' social enterprise ' means an enterprise whose primary objective is to achieve social impact rather than generate profit for owners and stakeholders . it operates in the market through the production of goods and services in an entrepreneurial and innovative way , and uses surpluses mainly to achieve social goals . it is managed in an accountable and transparent way , in particular by involving workers , customers and stakeholders affected by its business activity . ### ' social enterprise ' means an enterprise whose primary goal is to achieve social objectives rather than generating profit for its owners , members and stakeholders . it operates in the market through the production of goods and services in an entrepreneurial and innovative way , and mainly reinvests surpluses to further promote its social objectives . it is managed in an accountable and transparent way , in particular by involving workers , customers and stakeholders affected by its business activity .


### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . ### the commission , in cooperation with the member states , in accordance with the partnership principle , shall ensure that activities carried out under the programme are consistent with and complementary to other union action , in particular under the cohesion policy funds , with special reference to the european social fund and the european fund for regional development and such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy .


### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union employment and social policy and working conditions legislation are based on sound evidence and are relevant to needs , challenges and conditions in the individual member states and the other participating countries ; ### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union policy in the fields of employment , working conditions , social protection , social inclusion and combating discrimination and multiple discrimination , combating poverty and housing exclusion , combating youth unemployment and youth poverty , poverty amongst migrants and ethnic minorities , child poverty , energy poverty as well as legislation in those areas are based on sound evidence and are relevant to people ' s needs , social challenges and social conditions in the individual member states and the other participating countries ;


### the activities supported by the programme shall comply with union and national law , including state aid rules . ### the activities supported by the programme shall comply with union and national law , including state aid rules , and ilo conventions .


### a mid - term evaluation of the programme shall be carried out by the end of 2017 to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . ### a mid - term evaluation of the programme in cooperation with the strategic advisory board referred to in article 26d shall be carried out by the end of 2017 to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . the strategic advisory board referred to in article 26d shall be involved in the whole evaluation process .


### civil society organisations active at various levels can play an important role in meeting the objectives of the programme , by participating in the policy - making process and contributing to social innovation . ### civil society organisations including social partners play a key role in promoting quality employment and combating social exclusion and poverty as well as in fighting unemployment , and should be closely associated in all actions designed to meet the objectives of the programme . civil society organisations active at various levels should be fully involved in order to reach the objectives of the programme . therefore , they shall participate in the development , monitoring , evaluation , field testing , dissemination and mutual learning of new policies . high - quality partnerships should be forged at all levels . the partnership principle should be strengthened and extended as the guiding principle to all sections of the programme .


### 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 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 and the outreach of microfinance to particular at - risk groups and young people . it further supports the development of entrepreneurship , the social economy and micro - enterprises which have no or insufficient credit standing and have no or insufficient capital resources and therefore no access to credits . 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 .


### pursuant to articles 8 and 10 of the treaty , the programme should support the mainstreaming of gender equality and anti - discrimination objectives in all its activities . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed in the programme ' s activities . ### pursuant to article 8 of the treaty , the programme ensures that the implementation of its priorities contributes to the promotion of equality between women and men . evaluations have shown the importance of taking the gender aspect into account in all dimensions of the programme , while ensuring that specific actions are taken to promote gender equality . regular monitoring and evaluation should be carried out to assess the way in which gender equality issues are addressed in the programme ' s activities .


### this regulation establishes a european union programme for social change and innovation which aims to contribute to the implementation of the europe 2020 strategy , its headline targets and integrated guidelines by providing financial support for the european union ' s objectives in terms of promoting a high level of employment , guaranteeing adequate social protection , combating social exclusion and poverty and improving working conditions . ### this regulation establishes a european union programme for social change and innovation which aims to contribute to the implementation of the europe 2020 strategy , its headline targets and integrated guidelines by providing financial support for the european union ' s objectives in terms of promoting a high level of employment , guaranteeing adequate social protection , combating social exclusion and poverty , improving working conditions and promoting a better balance between professional and private life , while always keeping sight of the objective of gender equality and gender mainstreaming .


### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . ### the commission , in cooperation with the member states , in line with the partnership principle , shall ensure that activities carried out under the programme are consistent with and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , equal opportunities , education , vocational training , children ' s rights and well - being , and youth policy , migration policy , research and innovation , entrepreneurship , health , working conditions , enlargement and external relations , and general economic policy .


### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union employment and social policy and working conditions legislation are based on sound evidence and are relevant to needs , challenges and conditions in the individual member states and the other participating countries ; ### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union policy in the fields of employment , working conditions , social protection , social inclusion and combating poverty as well as legislation in those areas are based on sound evidence and are relevant to people ' s needs , social challenges and social conditions in the individual member states and the other participating countries ;


### modernise union law in line with the smart regulation principles and ensure that union law on matters relating to working conditions is effectively applied ; ### monitor the progress on the social objectives of the europe 2020 strategy and the eu policies as well as the union law on matters relating to working conditions ;


### 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 . ### 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 reduce administrative burden for the beneficiaries . 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 .


### training of legal and policy practitioners , and eures advisers ; ### training of legal and policy practitioners , and eures advisers and actors of the eures cross - border partnerships ;


### not later than six years from the date on which the first european patent with unitary effect takes effect in the territories of the participating member states , the commission shall present to the council a report on the operation of this regulation and , where necessary , make appropriate proposals for amending it . subsequent reports on the operation of this regulation shall be presented by the commission every six years . ### not later than six years from the date on which the first european patent with unitary effect takes effect in the territories of the participating member states , the commission shall present to the european parliament and the council a report on the operation of this regulation and , where necessary , make appropriate proposals for amending it . subsequent reports on the operation of this regulation shall be presented by the commission every six years .


### child pornography , which constitutes sex abuse images , is a specific type of content which cannot be construed as the expression of an opinion . to combat it , it is necessary to reduce the circulation of child abuse material by making it more difficult for offenders to upload such content onto the publicly accessible web . action is therefore necessary to remove the content at source and apprehend those guilty of making distributing or downloading child abuse images . the eu , in particular through increased cooperation with third countries and international organisations , should seek to facilitate the effective removal by third country authorities of websites containing child pornography , which are hosted in their territory . however as , despite such efforts , the removal of child pornography content at its source proves to be difficult where the original materials are not located within the eu , mechanisms should also be put in place to block access from the union ' s territory to internet pages identified as containing or disseminating child pornography . for that purpose , different mechanisms can be used as appropriate , including facilitating the competent judicial or police authorities to order such blocking , or supporting and stimulating internet service providers on a voluntary basis to develop codes of conduct and guidelines for blocking access to such internet pages . both with a view to the removal and the blocking of child abuse content , cooperation between public authorities should be established and strengthened , particularly in the interest of ensuring that national lists of websites containing child pornography material are as complete as possible and of avoiding duplication of work . any such developments must take account of the rights of the end users , adhere to existing legal and judicial procedures and comply with the european convention on human rights and the charter of fundamental rights of the european union . the safer internet programme has set up a network of hotlines whose goal is to collect information and to ensure coverage and exchange of reports on the major types of illegal content online . ### child pornography , which constitutes sex abuse images , is a specific type of content which cannot be construed as the expression of an opinion . to combat it , it is necessary to reduce the circulation of child abuse material . action is therefore necessary to remove the content at source and apprehend those guilty of making distributing or downloading child abuse images . the eu , in particular through increased cooperation with third countries and international organisations , should seek to facilitate the effective removal by third country authorities of websites containing child pornography , which are hosted in their territory . for that purpose , mechanisms should be put in place to strengthen international cooperation between states , judicial and police authorities , and reporting points for child pornography in order to ensure the safe and fast removal such websites .


### the proposal , by means of information and communication technology , by an adult to meet a child who has not reached the age of sexual consent under national law , for the purpose of committing any of the offences referred to in articles 3 and article 5 , where this proposal has been followed by material acts leading to such a meeting , shall be punishable by a maximum term of imprisonment of at least two years . ### to influence , as an adult , a child who has not reached the age of sexual consent under national law , by means of written or spoken word or by the showing of pornographic material , in order to commit any of the offences referred to in article 3 , article 4 , and article 5 , shall be punishable by a maximum term of imprisonment of at least two years .


### the proposal , by means of information and communication technology , by an adult to meet a child who has not reached the age of sexual consent under national law , for the purpose of committing any of the offences referred to in articles 3 and article 5 , where this proposal has been followed by material acts leading to such a meeting , shall be punishable by a maximum term of imprisonment of at least two years . ### the proposal , by any means including information and communication technology , by an adult to meet or otherwise solicit a child for the purpose of committing any of the offences referred to in articles 3 and article 5 , where this proposal has been followed by material acts leading to such a meeting or contact , shall be punishable by a maximum term of imprisonment of at least two years .


### the provisions of article 3 , with regard to witnessing sexual activities , and ; article 4 and and article 5 do not govern consensual sexual activities between children or involving persons who are close in age and degree of psychological and physical development or maturity , insofar as the acts did not involve any abuse . ### at the discretion of the courts on a case by case basis and in accordance with national provisions for the implementation of the law concerning the age of sexual consent , the provisions of article 3 , with regard to witnessing sexual activities , and , article 4 and and article 5 may be waived for consensual sexual activities between children or involving persons who are close in age and degree of psychological and physical development or maturity , insofar as the acts did not involve any abuse , including that defined in article 3 and .


### child pornography , which constitutes sex abuse images , is a specific type of content which cannot be construed as the expression of an opinion . to combat it , it is necessary to reduce the circulation of child abuse material by making it more difficult for offenders to upload such content onto the publicly accessible web . action is therefore necessary to remove the content at source and apprehend those guilty of making , distributing or downloading child abuse images . the eu , in particular through increased cooperation with third countries and international organisations , should seek to facilitate the effective removal by third country authorities of websites containing child pornography , which are hosted in their territory . however as , despite such efforts , the removal of child pornography content at its source proves to be difficult where the original materials are not located within the eu , mechanisms should also be put in place to block access from the union ' s territory to internet pages identified as containing or disseminating child pornography . for that purpose , different mechanisms can be used as appropriate , including facilitating the competent judicial or police authorities to order such blocking , or supporting and stimulating internet service providers on a voluntary basis to develop codes of conduct and guidelines for blocking access to such internet pages . both with a view to the removal and the blocking of child abuse content , cooperation between public authorities should be established and strengthened , particularly in the interest of ensuring that national lists of websites containing child pornography material are as complete as possible and of avoiding duplication of work . any such developments must take account of the rights of the end users , adhere to existing legal and judicial procedures and comply with the european convention on human rights and the charter of fundamental rights of the european union . the safer internet programme has set up a network of hotlines whose goal is to collect information and to ensure coverage and exchange of reports on the major types of illegal content online . ### child pornography , which constitutes sex abuse images , is a specific type of content which cannot be construed as the expression of an opinion . to combat it , it is necessary to reduce the circulation of child abuse material by making it more difficult for offenders to upload such content onto the publicly accessible web and to ensure that investigation and prosecution of such crimes is prioritized . action is therefore necessary to remove the content at source and apprehend those guilty of making , distributing or downloading child abuse images . the eu , in particular through increased cooperation with third countries and international organisations , should seek to facilitate the effective removal and prosecution by third country authorities of websites containing child pornography , which are hosted in their territory . cooperation between public authorities should be established and strengthened , particularly in the interest of avoiding duplication of work . any such developments must take account of the rights of the end users , adhere to existing legal and judicial procedures and comply with the european convention on human rights and the charter of fundamental rights of the european union . only in the case of difficulties in cooperation with third countries on removal and prosecution , member states may take up legal measures for restricting access to internet pages containing or disseminating child abuse images . the safer internet programme has set up a network of hotlines whose goal is to collect information and to ensure coverage and exchange of reports on the major types of illegal content online .


### 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 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 . for that purpose , mechanisms shall be put in place to ensure the efficient cooperation and knowledge transfer between law enforcement authorities , judicial authorities , social welfare authorities , the information and communication technology industry and civil society organisations . police forces and social services should work together on these cases so that children receive an adequate response and treatment when they are identified .


### 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 . ### within three months following the reception of the application for registration , the european parliament shall adopt a decision based on the recommendations of the advisory committee on european party regulation , 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 .


### it must be represented , in at least one quarter of the member states , by members of the european parliament or in the national parliaments , regional parliaments or regional assemblies , or ### it must consist of member organisations that are legally recognised as parties or allowed to participate in elections as parties at national or regional level in at least one quarter of 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 registry and to the competent national authorities in the member states : ### at the latest within four 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 :


### it supplies exclusively small , as appropriate to the plants , plant products and other objects concerned , quantities of plants , plant products and other objects to final users , by other means than sales through distance contracts ; ### it supplies exclusively small quantities of plants , plant products and other objects to final users ;


### where the presence of a union quarantine pest is officially confirmed , the competent authority shall immediately take all necessary measures to eliminate that pest in the area concerned and to prevent its spread out of that area . those measures shall be adopted in accordance with annex iv on measures and principles for the management of the risks of pests . ### where the presence of a union quarantine pest is officially confirmed , the competent authority shall immediately take all necessary measures in line with regulation no 1107 / 2009 and directive 128 / 2009 / ec , to eliminate that pest in the area concerned and to prevent its spread out of that area . those measures shall be adopted in accordance with annex iv on measures and principles for the management of the risks of pests .


### the scoreboard shall be made up of an array of macroeconomic and macrofinancial indicators for member states . the commission may set indicative lower or upper thresholds for these indicators to serve as alert levels . the thresholds applicable to member states whose currency is the euro may be different from those applicable to the other member states . ### the scoreboard shall be made up of an array of indicators relevant for detecting the risk of potential macroeconomic and macrofinancial imbalances at the union and member states level . the commission may set indicative lower or upper thresholds for these indicators to serve as alert levels . thresholds for external imbalances will highlight symmetrically excessive deficits as well as excessive surpluses . the thresholds applicable to member states whose currency is the euro may be different from those applicable to the other member states .


### the commission shall , after consultation with member states , establish an indicative scoreboard as a tool to facilitate early identification and monitoring of imbalances . ### the commission shall , after consultation with member states and the european parliament , establish an indicative scoreboard as a tool to facilitate early identification and monitoring of imbalances .


### the commission shall , after consultation with member states , establish an indicative scoreboard as a tool to facilitate early identification and monitoring of imbalances . ### the commission shall , after consultation with member states and the european parliament , establish an indicative scoreboard as a tool to facilitate early identification and monitoring of imbalances following procedures and conditions laid down in paragraphs 2 to 4 of this article .


### the head of the safety investigation authority is authorised to inform victims and their families or their associations or , make public any information on the factual observations and the proceedings of the safety investigation and possibly preliminary conclusions and / or recommendations , provided that it does not compromise the objectives of the investigation . ### the head of the safety investigation authority is authorised to inform victimes and their families or their associations or , make public any information on issues of immediate concern , such as the release of human remains and personal effects held as a part of the investigation , information on the factual observations and the proceedings of the safety investigation , preliminary reports and safety recommendations , provided that it does not compromise the objectives of the investigation .


### de - identified ; or ### de - identified ; and


### safety investigations referred to in paragraph 1 and 3 shall in no case be concerned with apportioning blame or liability . they shall be separate from and without prejudice to any judicial or administrative proceedings to apportion blame or liability . ### safety investigations referred to in paragraph 1 and 3 shall in no case be concerned with apportioning blame or liability . they shall be independent , separate from and without prejudice to any judicial or administrative proceedings or financial interests to apportion blame or liability .


### the flight data recorder recordings shall not be made available or used for purposes other than safety investigation , except when such records are : used for airworthiness or maintenance purposes only ; or de - identified ; or disclosed under secure procedures . ### the flight data recordings shall not be made available or used for purposes other than safety investigation , except when such records are : used for airworthiness or maintenance purposes only ; and de - identified ; and disclosed under secure procedures .


### ' causes ' means actions , omissions , events , conditions , or a combination thereof , which led to the accident or incident ; the identification of causes does not imply the assignment of fault or the determination of administrative , civil or criminal liability ; ### ‘ factors ' means actions , omissions , events , conditions , or a combination thereof , which led to the accident or incident ; the identification of factors does not imply the assignment of fault or the determination of administrative , civil or criminal liability ;


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : ### providers of internet access services shall not restrict the rights provided for in paragraph 1 by blocking , slowing down , degrading , altering or discriminating against specific content , applications or services , or specific classes thereof , except in certain special cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , and strictly proportionate and necessary to


### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public is necessary for the provision of specialised services and is expected to play an important role in the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such agreements do not substantially impair the general quality of internet access services . ### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public could foster the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such defined levels of quality are technically necessary for the functionality of the service and these agreements do not impair the quality of internet access services , in accordance with the principle of net neutrality .


### end - users shall be free to enter into agreements on data volumes and speeds with providers of internet access services and , in accordance with any such agreements relative to data volumes , to avail of any offers by providers of internet content , applications and services . ### users shall have the right to enter into agreements that differentiate on data volumes and speeds with providers of internet access services provided that these agreements do not contain any clauses that discriminate access to any specific content , application or service or classes thereof available to the user .