### freedom of contract should be the guiding principle underlying the common european sales law . party autonomy should be restricted only where and to the extent that this is indispensable , in particular for reasons of consumer protection . where such a necessity exists , the mandatory nature of the rules in question should be clearly indicated . ### freedom of contract should be the guiding principle underlying the common european sales law . party autonomy should be restricted only where and to the extent that this is indispensable , in particular for reasons of consumer protection and the protection of smes . where such a necessity exists , the mandatory nature of the rules in question should be clearly indicated .


### it is also appropriate to review the functioning of the common european sales law or any other provision of this regulation after five years of operation . the review should take into account , amongst other things , the need to extend further the scope in relation to business - to - business contracts , market and technological developments in respect of digital content and future developments of the union acquis . ### it is also appropriate to review the functioning of the common european sales law or any other provision of this regulation after five years of operation . the review should take into account , amongst other things , the need to extend further the scope in relation to business - to - business contracts , the need for the common european sales law to include provisions regulating those aspects of the contractual relationship which are currently not dealt with by the common european sales law , particularly transfer of ownership , market and technological developments in respect of digital content and future developments of the union acquis .


### financial services , including online banking services ; ### financial services , including online banking services , payment services and the issue of electronic money ;


### financial services ; ### financial services , including payment services and the issue of electronic money ;


### by … [ 5 years after the date of application of this regulation ] , the commission shall present to the european parliament , the council and the economic and social committee a detailed report reviewing the operation of this regulation , and taking account of , amongst others , the need to extend the scope in relation to business - to - business contracts , market and technological developments in respect of digital content and future developments of the union acquis . ### by … [ 5 years after the date of application of this regulation ] , the commission shall present to the european parliament , the council and the economic and social committee a detailed report reviewing the operation of this regulation , and taking account of , amongst others , the need to extend the scope in relation to business - to - business contracts , the need for the common european sales law to include provisions regulating those aspects of the contractual relationship which are currently not dealt with by the common european sales law , particularly transfer of ownership , market and technological developments in respect of digital content and future developments of the union acquis . as regards matters of a contractual and non - contractual nature which fall outside the scope of the common european sales law but nonetheless concern aspects of the contractual relationship , the commission shall discuss the following subjects : transfer of ownership , legal personality , the invalidity of a contract arising from lack of capacity , illegality or immorality , the determination of the language of the contract , matters of non - discrimination , representation , plurality of debtors and creditors , change of parties including assignment , set - off and merger , property law including the transfer of ownership , intellectual property law and the law of torts , and concurrent contractual and non - contractual liability claims outside the scope of the common european sales law .


### the commission ' s powers , as laid down by the treaty , concerning the implementation of the competition rules , are not affected by this regulation , ### the commission ' s powers , as laid down by the treaty , concerning the implementation of the competition rules , as well as the specific procedures created for the implementation of the common commercial policy which are not currently based upon decision 1999 / 468 / ec , are not affected by this regulation . arrangements for those aspects of the common commercial policy shall be determined by the council and the parliament on a case - by - case basis , on the basis of each legislative proposal from the commission , and with a view to determining the appropriate decision - making arrangements ,


### 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 council . ### 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 . the commission should provide full information and documentation on its meetings with national experts within the framework of its work on the preparation and implementation of delegated acts . in this respect , the commission should ensure that the european parliament is duly involved , drawing on best practices from previous experience in other policy areas in order to create the best possible conditions for future scrutiny of delegated acts by the european parliament .


### the commission shall be empowered to adopt delegated acts in accordance with article 23a concerning updating the list of dual - use items set out in annex i . the updating of annex i shall be performed within the scope set out in paragraph 1 . ### the commission shall be empowered to adopt delegated acts in accordance with article 23a concerning updating the list of dual - use items set out in annex i . the updating of annex i shall be performed within the scope set out in paragraph 1 . where the updating of annex i concerns dual - use items which are also listed in annexes iia - g or iv , those annexes shall be amended accordingly .


### the delegation of power referred to in articles 9 and 15 shall be conferred for an indeterminate period of time from the entry into force of this regulation . ### the delegation of power referred to in articles 9 and 15 shall be conferred on the commission for a period of five years from . . . * . 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 . __________ * oj : please insert the date of entry into force of this regulation .


### the aim of this regulation is to implement the commitments and visions provided for in that animal health strategy , including the ' one health ' principle , and to consolidate the legal framework for a common union animal health policy through a single , simplified , and flexible regulatory framework for animal health . ### the aim of this regulation is to implement the commitments and visions provided for in that animal health strategy , including the ' one health ' principle , as advocated in particular by the world organisation for animal health , and to consolidate the legal framework for a common union animal health policy through a single , simplified , and flexible regulatory framework for animal health .


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


### the rules laid down in the legislative acts referred to in recital 154 are to be replaced by this regulation and by subsequent commission acts to be adopted pursuant to this regulation . accordingly , those legislative acts should be repealed . however , to ensure legal clarity and avoid a legal vacuum , the repeal should only take effect when the relevant delegated and implementing acts are adopted pursuant to this regulation . it is therefore necessary to provide the commission with the empowerment to determine the dates when the repeal of those legislative acts should take effect . ### the rules laid down in the legislative acts referred to in recital 154 are to be replaced by this regulation and by subsequent commission acts to be adopted pursuant to this regulation . accordingly , those legislative acts should be repealed , except very recent and still under negotiation ones . in order to ensure legal clarity and avoid a legal vacuum , the repeal should only take effect when the relevant delegated and implementing acts are adopted pursuant to this regulation . it is therefore necessary to provide the commission with the empowerment to determine the dates when the repeal of those legislative acts should take effect .


### 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 .


### this regulation lays down rules for the prevention and control of animal diseases , which are transmissible to animals or to humans . ### this regulation lays down : rules for the prevention and control of animal diseases , which are transmissible to animals or to humans , the instruments and arrangements for moving towards the declaration of disease - free zones , the prioritising of actions and the attribution of responsibilities in the field of animal health .


### the purposes of breeding of birds used for the types of production referred to in point ; ### the purposes of breeding of birds used for the types of production referred to in points and ;


### ' disease profile ' means the criteria of a disease referred to in article 6 ; ### ‘ disease profile’ means assessment of the criteria of a disease referred to in article 6 ;


### ' compartment ' means an animal subpopulation contained in one or more establishments and in the case of aquatic animals in one or more aquaculture establishments , under a common biosecurity management system with a distinct health status with respect to a specific disease or specific diseases subject to appropriate surveillance , disease control and biosecurity measures ; ### ‘ compartment’ means


### emerging diseases . ### emerging diseases which fulfil similar criteria to those for the diseases under point of this subparagraph .


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


### calculating the likely length of time that the listed disease has been present ; ### calculating the likely length of time since the listed disease was introduced ;


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


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


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


### it shall make that register available to other member states and to the public . ### it shall make that register available to other member states .


### the format of records provided for in articles 97 , 98 and 99 and rules adopted pursuant to article 100 ; ### rules adopted pursuant to article 100 ;


### their individual identification as provided for in articles 106 and 107 ; ### their individual identification , where appropriate , as provided for in articles 106 and 107 ;


### information related to kept animals of the porcine species and the establishments keeping them ; ### the following information on captive animals of the porcine species : the establishments where the animals are housed their movements into and out of the establishments ;


### the establishments where those animals are habitually kept ; ### the establishments where those animals are kept ;


### pet keepers shall ensure that terrestrial pet animals of the species listed in part a of annex i which are moved from one member state to another member state : ### pet keepers shall ensure that terrestrial pet animals of the species listed in part b of annex i when moved from one member state to another member state meet the requirements laid down in regulation no 576 / 2013 on the non - commercial movement of pet animals71c . __________________ 71coj l 178 , 28 . 6 . 2013 , p . 1 .


### pet keepers shall ensure that terrestrial pet animals of the species listed in part b of annex i when moved from one member state to another member state , and when required by rules adopted pursuant to articles 114 and 117 , are : ### pet keepers shall ensure that terrestrial pet animals of the species listed in part b of annex i when moved from one member state to another member state comply with the rules laid down in regulation no 576 / 2013 on the non - commercial movement of pet animals71d . __________________ 71doj l 178 , 28 . 6 . 2013 , p . 1 .


### are accompanied by a correctly completed and updated identification document issued by the competent authority in accordance with article 104 . ### deleted


### identified , either individually or in groups ; ### deleted


### accompanied by correctly completed and updated identification documents , movement documents or other documents for identifying and tracing animals , as appropriate for the animal species concerned . ### deleted


### the designation of other authorities , the authorisation of bodies or natural persons , as provided for in article&#160 ; 102 ; ### deleted


### the species of kept terrestrial animals from which the germinal products originate ; ### the species or breeds of kept terrestrial animals from which the germinal products originate ;


### pet keepers shall only carry out non - commercial movements of terrestrial pet animals of the species listed in annex i from one member state to another member state where : ### pet keepers shall only carry out non - commercial movements of terrestrial pet animals of the species listed in annex i from one member state to another member state in compliance with the rules laid down in regulation no 576 / 201371e on the non - commercial movement of pet animals . __________________ 71eoj l 178 , 28 . 6 . 2013 , p . 1 .


### those terrestrial pet animals are identified and accompanied with an identification document when required in accordance with article 112 or rules adopted pursuant to article 114 and article 117 ; ### deleted


### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning the prevention and disease control measures referred to in paragraph 1 of this article to ensure that the terrestrial pet animals do not pose a significant risk for the spread of diseases referred to in article 8 and emerging diseases to animals during transport and at the place of destination and when relevant taking into account the health status of the place of destination . ### without prejudice to regulation no 576 / 2013 on the non - commercial movement of pet animals71f , the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning the disease prevention and control measures to ensure that the aquatic pet animals do not pose a significant risk for the spread of diseases referred to in article 8 and emerging diseases to animals during transport and at the place of destination , when relevant taking into account the health status of the place of destination . __________________ 71foj l 178 , 28 . 6 . 2013 , p . 1 .


### the nature of the germinal products or the species of animal that those products come from ; ### the nature of the germinal products or the species or breed of animal that those products come from ;


### germinal products intended for scientific purposes and delegated acts ### germinal products intended for scientific purposes or for the establishment of gene banks of endangered breeds and delegated acts ;


### by way of derogation from sections 1 to 4 , the competent authority of the place of destination may authorise movements of germinal products for scientific purposes , which do not comply with the requirements of those sections , with the exception of article 155 , article 155 , article 155 and article156 , subject to compliance with the following conditions : ### . by way of derogation from sections 1 to 4 , the competent authority of the place of destination may authorise movements of germinal products for scientific purposes , or for the establishment of gene banks of endangered breeds , which do not comply with the requirements of those sections , with the exception of article 155 , article 155 , article 155 and article156 , subject to compliance with the following conditions : :


### aquatic animals moved for human consumption , aquaculture , release into the wild or any other specific purpose , shall not be used for any purpose other than the intended one . ### 2aquatic animals moved for human consumption , aquaculture , release into the wild or any other specific purpose , shall not be used for any purpose other than the intended one , except in the situations referred to in article 214 , in which case they should provide additional confirmation that this change of use does not endanger health status at destination .


### by way of derogation from paragraph 1 , the competent authority may authorise such movement or release of aquatic animals , based on an evaluation of risks , provided that the aquatic animals originate from a part of the aquaculture establishment or from the wild that is independent of the epidemiological unit where the abnormal mortalities or other disease symptoms have occurred . ### by way of derogation , movements may be made where the results of laboratory analysis makes it possible to rule out the presence of a disease listed in annex ia section 2 .


### electronic animal health certificates , produced , handled and transmitted by means of imsoc , may replace accompanying animal health certificates provided for in article 208 where such electronic animal health certificates : ### electronic animal health certificates , handled and transmitted by means of imsoc and , if appropriate , produced using the same system , may replace accompanying animal health certificates provided for in article 208 where such electronic animal health certificates :


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


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


### members should be allowed to take part in monitoring the management of collecting societies . to this end , collecting societies should establish a supervisory function appropriate to their organisational structure and allow members to be represented in the body that exercises this function . to avoid imposing excessive burden on smaller collecting societies and to make the obligations arising from this directive proportionate , member states should be able to , if they consider this to be necessary , exclude the smallest collecting societies from having to organise such a supervisory function . ### members should be allowed to take part in monitoring the management of collective management organisations . to this end , collective management organisations should establish a supervisory function appropriate to their organisational structure and allow the different categories of members to be represented in equal manner in the body that exercises this function . to avoid imposing excessive burden on smaller collecting societies and to make the obligations arising from this directive proportionate , member states should be able to , if they consider this to be necessary , exclude the smallest collecting societies from having to organise such a supervisory function .


### while the internet knows no borders , the online market for music services in the eu is still fragmented , and a single market has still not been fully achieved . the complexity and difficulty associated with the collective management of rights in europe has , in a number of instances , exacerbated the fragmentation of the european digital market for online music services . this situation comes in stark contrast to the fast growing demand of consumers for access to digital content and associated innovative services , including across national borders . ### while the internet knows no borders , the online market for music services in the eu is still fragmented , and a single market has still not been fully achieved . the complexity and difficulty associated with the collective management of rights in europe has , in a number of instances , exacerbated the fragmentation of the european digital market for online music services . this situation comes in stark contrast to the fast growing demand of consumers for access to digital content and associated innovative services , including across national borders . as a result , the potential of information technology remains untapped and consumers are deprived of a truly borderless digital single market for music . it is therefore important to move forward in order to ensure equal status for free movement of goods and services both physically and digitally .


### broadcasting organisations generally rely on a licence from a local collecting society , for their own broadcasts of television and radio programmes which include musical works . this licence is often limited to broadcasting activities . a licence for online rights in musical works would be required in order to allow such television or radio broadcasts to be also available online . to facilitate the licensing of online music rights for the purposes of simultaneous and delayed transmission online of television and radio broadcasts , it is necessary to provide for a derogation from the rules that would otherwise apply to the multi - territorial licensing of musical works for online uses . such derogation should be limited to what is necessary to allow access to television or radio programmes online and to material having a clear and subordinate relationship to the original broadcast produced for purposes such as supplementing , previewing or reviewing that television or radio programme . that derogation should not operate so as to distort competition with other services which give consumers access to individual musical or audiovisual works online , or lead to restrictive practices , such as market or customer sharing , in breach of articles 101 or 102 of the treaty on the functioning of the european union . ### broadcasting organisations generally rely on a licence from a local collecting society , for their own broadcasts of television and radio programmes which include musical works . a licence for online rights in musical works would be required in order to allow such television or radio broadcasts to be also available online . to facilitate the licensing of online music rights in the interest of online accessibility , it is necessary to provide for a derogation from the rules that would otherwise apply to the multi - territorial licensing of musical works for online uses . such derogation should be limited to what is necessary to allow access to television or radio programmes online and make possible online offers connected to linear broadcasting . that derogation should not operate so as to distort competition with other services which give consumers access to individual musical or audiovisual works online , or lead to restrictive practices , such as market or customer sharing , in breach of articles 101 or 102 of the treaty on the functioning of the european union .


### member states shall ensure that collecting societies act in the best interest of their members and do not impose on rightholders whose rights they manage any obligations which are not objectively necessary for the protection of the rights and interests of these rightholders . ### member states shall ensure that collecting societies act in the collective best interest of their members and do not impose on rightholders whose rights they manage as trustees any obligations which are not objectively necessary for the protection of the rights and interests of these rightholders provided they allow the collecting societies sufficient discretion to negotiate with rights users .


### 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 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 .


### every member of a collecting society shall have the right to appoint any other natural or legal person as a proxy holder to attend and vote at the general meeting in his name . ### every member of a collecting society shall have the right to appoint any other member or a legal person in the same category as a proxy holder to attend and vote at the general meeting in his name .


### member states shall ensure that the collecting society regularly and diligently distributes and pays amounts due to all rightholders it represents . the collecting society shall carry out such distribution and payments no later than 12 months from the end of the financial year in which the rights revenue was collected , unless objective reasons related in particular to reporting by users , the identification of rights , rightholders or to the matching of information on works and other subject matter with rightholders prevent the collecting society from respecting this deadline . the collecting society shall carry out such distribution and payments accurately , ensuring equal treatment of all categories of rightholders . ### member states shall ensure that the collecting society regularly and diligently distributes and pays amounts due to all rightholders it represents and this on the basis of the information provided by users within 6 months after the use of the content . the collecting society shall carry out such distribution and payments no later than 12 months from the end of the financial year in which the rights revenue was collected , unless objective reasons related in particular to reporting by users , the identification of rights , rightholders or to the matching of information on works and other subject matter with rightholders prevent the collecting society from respecting this deadline . the collecting society shall carry out such distribution and payments accurately , ensuring equal treatment of all categories of rightholders .


### in addition , a collecting society shall make available at the request of any rightholder or any collecting society , any information on works for which one or more rightholders have not been identified including , where available , the title of the work , the name of the author , the name of the publisher and any other relevant information available which could be necessary to identify the rightholders . ### a collecting society shall make available at the request of any rightholder or any collecting society , any information on works for which one or more rightholders have not been identified including , where available , the title of the work , the name of the author , the name of the publisher and any other relevant information available which could be necessary to identify the rightholders .


### member states shall ensure that a collecting society makes public the following information : ### member states shall ensure that a collective management organisation makes available through a publicly accessible website at least the following information :


### any representation agreement between collecting societies whereby a collecting society mandates another collecting society to grant multi - territorial licences for the online rights in musical works in its own music repertoire shall be of a non - exclusive nature . the mandated collecting society shall manage those online rights on non - discriminatory terms . ### in order to allow the aggregation of a multiplicity of repertoires and to be able to grant multi - repertoire and multi - territorial licences , collective management societies shall have the possibility to conclude representation agreements with other collective management societies for the coordination and efficiency of such licenses under equal and non - discriminatory terms . any representation agreement between collective management societies whereby a collective management society mandates another collective management society to grant multi - territorial licences for the online rights in musical works in its own music repertoire should preserve the ability for the mandating society to mandate another society .


### dispute resolution for users ### dispute resolution with users


### in order to further ensure that marketing authorisation holders disseminate only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be disseminated should be defined . it is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements , and other well - defined medicinal product - related information . ### in order to further ensure that marketing authorisation holders disseminate only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be disseminated should be defined . it is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements .


### “4 . the prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the member states . ' ; ### “4 . the prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the member states , which shall ensure that such campaigns are not intended to serve as advertising . ' ;


### the prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the member states . ' ; ### the prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the member states , provided that these campaigns are carried out exclusively for medically necessary purposes . ' ;


### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . ### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title and provided that the medicinal products meet the conditions under which they may be marketed . such information shall not be considered advertising for the purposes of the application of title viii .


### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . ### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii but it shall require prior authorisation by the member state , after having checked that such information complies with the requirements for marketing authorisation for the medicinal product . the information concerned may not contain any data on development studies for medicinal products , new prospects for their use or properties under investigation , or any other information which may create distortions or endow the medicinal product with properties or uses other than those contained in the current marketing authorisation for the medicinal product in question .


### information relating to human health or diseases , provided that there is no reference , even indirect , to medicinal products ; ### information relating to human health or diseases , provided that it is based on objective , realistic data supplied by the competent bodies and there is no reference , even indirect , to medicinal products ;


### material provided by the marketing authorisation holder to healthcare professionals for distribution to patients . ### material provided by the marketing authorisation holder to healthcare professionals for distribution to patients , which must be explicitly authorised by the member states , taking account of what was authorised in the technical summary .


### the summary of product characteristics , labelling and package leaflet of the medicinal product , as approved by the competent authorities , and the publicly accessible version of the assessment report drawn up by the competent authorities ; ### the summary of product characteristics , labelling and package leaflet of the medicinal product , as approved by the competent authorities , and the publicly accessible version of the assessment report drawn up by the competent authorities ; these versions and summaries shall require prior authorisation by the member state before they are disseminated to the public ;


### information which does not go beyond the elements of the summary of product characteristics , labelling and the package leaflet of the medicinal product , and the publicly accessible version of the assessment report drawn up by the competent authorities , but presents them in a different way ; ### information which does not go beyond the elements of the summary of product characteristics , labelling and the package leaflet of the medicinal product , and the publicly accessible version of the assessment report drawn up by the competent authorities , but presents them in a different way ; this publicly accessible version may not constitute a substantial change in the characteristics , properties , effects and reactions that the medicinal product might have ;


### medicinal product - related information about non - interventional scientific studies , or accompanying measures to prevention and medical treatment , or information which presents the medicinal product in the context of the condition to be prevented or treated . ### medicinal product - related information about non - interventional scientific studies , or accompanying measures to prevention and medical treatment , or information which presents the medicinal product in the context of the condition to be prevented or treated . this information must have been evaluated in advance by the member state , and such studies must be included in the registration dossier for the medicinal product . scientific studies may not be submitted if they were carried out without complying with the legal requirements in force for clinical trials . scientific studies may also not be submitted if they relate to properties of the medicinal product or a use of that product other than those for which it is currently authorised in the member state .


### internet websites on medicinal products , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; ### internet websites on medicinal products , explicitly authorised and regarded as such by the member state , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; for this purpose , the member states shall establish a system for authorising , supervising and monitoring internet sites which may present the information referred to in this article . furthermore , an early warning system shall be set up among the member states to combat internet sites which violate the provisions of this directive ;


### internet websites on medicinal products , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; ### internet websites on medicinal products that have been identified and approved by the member state as a source of information on medicinal products , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; an additional authorisation and monitoring system shall be established for the distribution of unsolicited material ;


### written answers to requests for information of a member of the general public . ### written and oral answers , provided that the latter are duly recorded , to requests for information from a member of the general public . these answers shall in all cases correspond to the package leaflet or technical summary for the authorised medicinal product and shall refer the requestor to the member state ' s health authority and to medical or pharmaceutical healthcare staff , giving an explicit indication in the answer that it is no substitute for mandatory intervention by the above healthcare professionals . furthermore , all these written and oral answers shall also be forwarded to the competent health authorities in the member state for periodic supervision .


### it must be understandable for the general public or members thereof ; ### it must be understandable for the general public or members thereof ; in addition , particular attention must be paid to the needs of elderly people ;


### it must be understandable for the general public or members thereof ; ### it must be understandable and perfectly legible for the general public and members thereof , paying particular attention to elderly people ;


### a mail address or e - mail address allowing members of the general public to send comments to the marketing authorisation holder . ### a mail address or e - mail address allowing members of the general public to send comments to the marketing authorisation holder . comments sent by private individuals and the replies from marketing authorisation holders shall be duly recorded and monitored .


### member states shall ensure that marketing authorisation holders register internet websites containing information on medicinal products with the national competent authorities of the member state of the country code top level domain used by the website concerned , prior to making it available to the general public . where the website does not use a country code top level domain , the marketing authorisation holder shall select the member state of registration . ### member states shall ensure that marketing authorisation holders register internet websites containing information on medicinal products with the national competent authorities of the member state of the country code top level domain used by the website concerned , prior to making it available to the general public . where the website does not use a country code top level domain , the marketing authorisation holder shall select the member state of registration . this information shall comply with the requirements laid down in this directive and shall be in accordance with the registration dossier for the medicinal product .


### information on homeopathic medicinal products referred to in article 14 that have been classified as prescription - only shall be subject to the provisions of this title . ### information on homeopathic medicinal products referred to in article 14 that have been classified as prescription - only shall be subject to the provisions of this title . the same shall apply to information on herbal medicinal products or any other compounds or therapies that have been classified as prescription - only .


### the occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals . special rules should therefore be laid down for disease control and eradication measures in wild animals where needed . ### the occurrence of a listed disease in wild animals may pose a risk to public health and the health of kept animals , or vice versa . special rules should therefore be laid down for disease control and eradication measures in wild animals , or , where needed , in kept animals .


### this regulation lays down rules for the prevention and control of animal diseases , which are transmissible to animals or to humans . ### this regulation lays down rules for the prevention and control of animal diseases , which are transmissible to animals or to humans , instruments and mechanisms to facilitate progress towards the declaration of disease - free zones and territories , priority actions , and the division of responsibilities in the area of animal health .


### ' non - commercial movement ' means any movement of pet animals which does not involve or aim , directly or indirectly , at a financial gain or a transfer of ownership ; ### ' non - commercial movement ' means movement for non - commercial purposes in keeping with the definition set out in article 3a of regulation no 576 / 2013 ;


### the capacity to develop resistance to treatments ; ### the capacity of animal pathogens to develop resistance to treatments ;


### the knowledge provided for in paragraph 1 shall be acquired in one of the following ways : ### the knowledge provided for in paragraph 1 shall be acquired in accordance with education and training requirements in the respective member state .


### member states shall support operators and animal professionals in acquiring , maintaining and developing the basic knowledge of animal health provided for in article 10 through relevant programmes in agricultural or aquaculture sectors or formal education . ### where necessary , member states shall assist operators and animal professionals in acquiring , maintaining and developing the basic knowledge of animal health provided for in article 10 , as required by the activities they are performing .


### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning amending and supplementing the requirements of paragraph 2 of this article and reporting on other matters where necessary to ensure an efficient application of the disease prevention and control rules of this regulation . ### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning supplementing the requirements of paragraph 2 of this article and reporting on other matters where necessary to ensure an efficient application of the disease prevention and control rules of this regulation .


### look for abnormal mortalities and other serious disease signs in animals under their responsibility . ### look for abnormal mortalities and other serious transmissible disease signs in animals under their responsibility .


### the submission of surveillance programmes for information to the commission and other member states ; ### the submission of surveillance programmes to the commission and other member states ;


### member states which are not free or not known to be free from one or more of the listed diseases referred to in article 8 and which decide to establish a programme for the eradication of that listed disease to be carried out in the animal populations concerned by it and covering the relevant parts of their territory or zones or compartments thereof shall submit it to the commission for approval . ### member states which are not free or not known to be free from one or more of the listed diseases that do not come under article 8 and which decide to establish a programme for the eradication of that listed disease to be carried out in the animal populations concerned by it and covering the relevant parts of their territory or zones or compartments thereof shall submit it to the commission for information purposes and shall compile a report pursuant to article 33 on the progress and completion of the programme .


### effective cooperation is necessary to ensure consistent advice and practice within each member state and across the union . bodies designated for monitoring , implementation , control and technical assistance should be able to share information and cooperate ; in the same context , the national authority designated by each member state should act as the preferred contact point with the commission services for the purpose of collecting data , exchanging information and monitoring the implementation of union public procurement law . ### effective cooperation and transparency is necessary to ensure consistent advice and practice within each member state and across the union . bodies designated for monitoring , implementation , control and technical assistance should be able to share information and cooperate ; in the same context , the national authority designated by each member state should act as the preferred contact point with the commission services for the purpose of collecting data , exchanging information and monitoring the implementation of union public procurement law .


### where no tenders or no suitable tenders or no requests to participate have been submitted in response to an open procedure or a restricted procedure , provided that the initial conditions of the contract are not substantially altered and that a report is sent to the commission or the national oversight body designated according to article 84 where they so request . ### where no tenders or no suitable tenders or no requests to participate have been submitted in response to an open procedure or a restricted procedure , provided that the initial conditions of the contract are not substantially altered and that a report is sent to the commission .


### quality , including technical merit , aesthetic and functional characteristics , accessibility , design for all users , environmental characteristics and innovative character ; ### quality , including technical merit , aesthetic and functional characteristics , accessibility , design for all users , environmental characteristics and innovative aspects , after - sales service and technical assistance , delivery conditions ;


### 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 ; ### wherever the quality of the staff is of crucial importance for the performance of the contract , 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 ;


### contracting authorities shall reject the tender , where they have established that the tender is abnormally low because it does not comply with obligations established by union legislation in the field of social and labour law or environmental law or by the international social and environmental law provisions listed in annex xi . ### contracting authorities shall reject the tender , where they have established that the tender is abnormally low because the price or costs indicated in a tender does not cover costs of manufacturing a product , providing services or carrying out works which are the subject matter of the public contract , taking into consideration economic conditions , and in particular if it does not comply with obligations established by union legislation in the field of social and labour law or environmental law or by the international social and environmental law provisions listed in annex xi .


### member states may provide that at the request of the subcontractor and where the nature of the contract so allows , the contracting authority shall transfer due payments directly to the subcontractor for services , supplies or works provided to the main contractor . in such case , member states shall put in place appropriate mechanisms permitting the main contractor to object to undue payments . the arrangements concerning that mode of payment shall be set out in the procurement documents . ### member states may provide that at the request of the subcontractor and where the nature of the contract so allows , the contracting authority shall transfer due payments directly to the subcontractor for services , supplies or works provided , as well as any remaining costs , to the main contractor . in such case , member states shall put in place appropriate mechanisms permitting the main contractor to object to undue payments . the arrangements concerning that mode of payment shall be set out in the procurement documents .


### the bodies established or appointed in accordance with article 84 shall forward to the commission an implementation and statistical report on each year , based on a standard form , not later than 31 october of the following year . ### the competent bodies of member states shall forward to the commission an implementation and statistical report on each year , based on a standard form , not later than 31 october of the following year .


### this regulation lays down a framework for verifying that products meet requirements which safeguard , at a high level , the health and safety of persons in general , health and safety in the workplace , consumer protection , the environment , public security and other public interests . ### this regulation lays down a framework for verifying that products meet requirements which safeguard , at a high level , the health and safety of persons in general , health and safety in the workplace , consumer protection , protection of intellectual property rights , the environment , public security and other public interests .


### chapters i , ii , iii , v and vi of this regulation shall apply to all products that are subject to regulation no [ &#8230 ; on consumer product safety ] or union harmonisation legislation , including to products assembled or manufactured for the manufacturer ' s own use , and to the extent that union harmonisation legislation does not contain a specific provision with the same objective . ### chapters i , ii , iii , v and vi of this regulation shall apply to all products that are subject to regulation no [ &#8230 ; on consumer product safety ] or union harmonisation legislation , including to products assembled or manufactured for the manufacturer ' s own exclusive use , and to the extent that union harmonisation legislation does not contain a specific provision with the same objective .


### ‘ product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general , health and safety in the workplace , consumer protection , the environment and public security as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned , including the duration of use and , where applicable , its putting into service , installation and maintenance requirements ; ### ‘ product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general , health and safety in the workplace , consumer protection , the environment , protection of intellectual property rights and public security as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned , including the duration of use and , where applicable , its putting into service , installation and maintenance requirements ;


### market surveillance shall be organised and carried out in accordance with this regulation with a view to ensuring that products presenting a risk are not made available on the union market and , where such products have been made available , effective measures are taken to remove the risk presented by the product . ### market surveillance shall be organised and carried out in accordance with this regulation with a view to ensuring that products presenting a risk are not placed or made available on the union market and , where such products have been made available , effective measures are taken to remove the risk presented by the product .


### there shall be efficient cooperation and exchange of information among the market surveillance authorities of the member states , among the different authorities within each member state and between market surveillance authorities and the commission and the relevant union agencies regarding market surveillance programmes and all issues relating to products presenting a risk . ### there shall be efficient cooperation and exchange of information among the market surveillance authorities of the member states , among the different authorities within each member states and between market surveillance authorities and the commission and the relevant union agencies regarding market surveillance programmes and all issues relating to products presenting a risk , also in view of ensuring a full consistency in the management of the eu external borders .


### market surveillance authorities may cooperate with the competent authorities of third countries with a view to exchanging information and technical support , promoting and facilitating access to union information exchange systems including the rapex system in accordance with article 19 , and promoting activities relating to conformity assessment and market surveillance . ### when appropriate market surveillance authorities must cooperate with the competent authorities of third countries with a view to exchanging information and technical support , promoting and facilitating access to union information exchange systems including the rapex system in accordance with article 19 and promoting activities relating to conformity assessment and market surveillance


### ‘ export authorisation’ means an authorisation granted to one specific exporter for one end user or consignee in a third country and covering one or more firearms , their parts and components and ammunition ; ### ‘ export authorisation’ means an authorisation granted to one specific exporter for one end user or consignee in a third country and covering one or more firearms , their parts and essential components and ammunition ;


### ‘ multiple export authorisation’ means an authorisation granted to one specific exporter for multiple shipments to the same end user or consignee in a third country and covering one or more firearms , their parts and components and ammunition ; ### ‘ multiple export authorisation’ means an authorisation granted on request to one specific exporter for multiple shipments to one or more end users or consignees and / or in one or more specific third countries and covering one or more firearms , their essential parts and ammunition ;


### shipments by sea and through ports of third countries , provided that there is no transhipment or change of means of transport . ### shipments by air or sea and through airports or ports of third countries , provided that there is no transhipment or change of means of transport , and only in the cases of transit referred to in article 5 .


### before issuing an export authorisation or a multiple export authorisation for firearms , their parts and components and ammunition , the member state concerned shall verify that : the importing third country has issued the relevant import authorisation and , the third countries of transit , if any , have given notice in writing — and at the latest prior to shipment — that they have no objection to the transit . ### before issuing an export authorisation or a multiple export authorisation for firearms , their parts and essential components and ammunition , the member state concerned shall verify that : the importing third country has issued the relevant import authorisation and , the third countries of transit , if any , have given notice in writing — and at the latest prior to shipment — that they have no objection to the transit .


### the importing third country has issued the relevant import authorisation and , ### the importing third country has issued the relevant import authorisation where national legislation so provides ; and


### if no objections to the transit are received within twenty working days from the day of the written request for no objection to the transit submitted by the exporter , the consulted third country of transit shall be regarded as having no objection and as having given its tacit consent to the transit ### if no objections to the transit are received within 20 calendar days from the day of the written request for no objection to the transit submitted by the exporter , the consulted third country of transit shall be regarded as having no objection and as having given its tacit consent to the transit .


### the member states shall process requests for exports authorization or multiple export authorization within a period of time to be determined by national law or practice , which in all cases shall not exceed ninety working days . ### the member states shall complete procedures for issuing export or multiple export authorisation within a period of time which shall not exceed 60 calendar days .


### the period of validity of an export or a multiple export authorisation shall be decided by the member states , but shall not be less than twelve months . ### the period of validity of an export authorisation shall be decided by the member states . the period of validity shall not be less than twelve months and , in the case of multiple shipments , shall not be less than eighteen months .


### the period of validity of an export or a multiple export authorisation shall be decided by the member states , but shall not be less than twelve months . ### the period of validity of an export authorisation decided by the member states shall not be less than 12 months and the period of validity of a multiple export authorisation shall not be less than 24 months .


### a description and the quantity of the firearms , their parts and components and ammunition , including the marking applied to the firearms . ### a description and the quantity of the firearms , their essential parts and ammunition .


### the information referred to in paragraph 1 , if contained in the import authorisation , shall be provided by the exporter in advance to the third countries of transit , at the latest prior to the shipment . ### the information referred to in paragraph 1 , if contained in the import authorisation , shall be provided by the exporter to the third countries of transit prior to the shipment .


### the simplified procedures set out in paragraphs 2 , 3 and 4 shall apply for the temporary export of firearms for verifiable lawful purposes , which include hunting , sport shooting , evaluation , exhibitions and repair . ### the simplified procedures set out in paragraphs 2 , 3 and 4 shall apply for the temporary export of firearms for verifiable lawful purposes .


### the simplified procedures set out in paragraphs 2 , 3 and 4 shall apply for the temporary export of firearms for verifiable lawful purposes , which include hunting , sport shooting , evaluation , exhibitions and repair . ### the simplified procedures set out in paragraphs 2 , 3 and 4 shall apply for the temporary export of firearms , their essential parts or ammunition for verifiable lawful purposes , which include hunting , sport shooting , evaluation , exhibitions and repair .


### when leaving the customs territory of the union through a point of crossing of the external border of the member state of their residence , for the temporary export of one or more firearms during a journey to a third country , hunters and sport shooters may produce the european firearms pass pursuant to articles 1 and 12 of directive 91 / 477 / eec , a national firearms licence , a national hunting permit , or other valid national document issued by the competent authority of the member state of their residence . ### when leaving the customs territory of the union through a point of crossing of the external border of the member state of their residence , for the temporary export of one or more firearms during a journey to a third country , hunters and sport shooters using the simplified procedure must produce the european firearms pass pursuant to articles 1 and 12 of directive 91 / 477 / eec or a national firearms licence , a national hunting permit , or other valid national document issued by the competent authority of the member state of their residence .


### when leaving the customs territory of the union through a point of crossing of the external border of the member state of their residence , for the temporary export of one or more firearms during a journey to a third country , hunters and sport shooters may produce the european firearms pass pursuant to articles 1 and 12 of directive 91 / 477 / eec , a national firearms licence , a national hunting permit , or other valid national document issued by the competent authority of the member state of their residence . ### when leaving or re - entering the customs territory of the union through a point of crossing of the external border of the member state of their residence , for the temporary export of one or more firearms , their essential parts or ammunition during a journey to a third country , hunters and sport shooters may produce the european firearms pass pursuant to articles 1 and 12 of directive 91 / 477 / eec , a national firearms licence , a national hunting permit , or other valid national document issued by the competent authority of the member state of their residence .


### when leaving the customs territory of the union through a point of crossing of the external border of a member state other than that of their residence , for the temporary export of one or more firearms during a journey to a third country , hunters and sport shooters may produce a valid european firearms pass issued pursuant to articles 1 and 12 of directive 91 / 477 / eec by the competent authority of the member state of their residence . ### when leaving or re - entering the customs territory of the union through a point of crossing of the external border of a member state other than that of their residence , for the temporary export of one or more firearms , their essential parts or ammunition during a journey to a third country , hunters and sport shooters may produce a valid european firearms pass issued pursuant to articles 1 and 12 of directive 91 / 477 / eec by the competent authority of the member state of their residence .


### refuse to grant an export or a multiple export authorisation if the natural or legal person applying for such authorisation has any previous criminal records concerning illicit trafficking in firearms , their parts and essential components or ammunition , or to other serious crimes ; ### refuse to grant an export or a multiple export authorisation if the natural or legal person applying for such authorisation has any previous criminal records concerning illicit trafficking in firearms , their essential parts or ammunition , or for other violent intentional crimes ;


### member states may request the importing third country to confirm receipt of the dispatched shipment of firearms , their parts and essential components or ammunition . ### member states shall request the importing third country to confirm receipt of the dispatched shipment of firearms , their parts and essential components or ammunition .


### member states shall - to the extent possible - take such measures as may be necessary to ensure that the authorisation procedures are secure and that the authenticity of authorisation documents can be verified or validated . ### member states shall take such measures as may be necessary to ensure that the authorisation procedures are secure and that the authenticity of authorisation documents can be verified or validated .


### every five years the commission shall review the implementation of this regulation and present a report to the european parliament and the council on its application , which may include proposals for its amendment . member states shall provide the commission with all appropriate information for the preparation of the report . ### every 10 years the commission shall review the implementation of this regulation and present a report to the european parliament and the council on its application , which may include proposals for its amendment . member states shall provide the commission with all appropriate information for the preparation of the report .


### directive 2004 / 49 established a common regulatory framework for railway safety , through harmonisation of the content of safety rules , the safety certification of railway undertakings , the tasks and roles of the national safety authorities and the investigation of accidents . nevertheless , to pursue efforts to establish a single market for rail transport services , that directive needs thorough revision . ### directive 2004 / 49 established a common regulatory framework for railway safety , through harmonisation of the content of safety rules , the safety certification of railway undertakings , the tasks and roles of the national safety authorities and the investigation of accidents . the ongoing establishment of a single market for rail transport services has as a consequence a multiplication of different actors and communication interfaces . in order to guarantee railway safety within this environment , this directive needs thorough revision .


### national rules , which are often based on national technical standards , have been gradually replaced by rules based on common standards , established by csts , csms and technical specifications for interoperability . in order to eliminate the obstacles to interoperability , the amount of national rules should be reduced as a consequence of extending the scope of the tsis to the whole union’s rail system and of closing open points in the tsis . for this purpose the member states should keep their system of national rules updated , delete obsolete rules and thereof inform the commission and the the agency . ### national rules , which are often based on national technical standards , have been gradually replaced by rules based on common standards , established by csts , csms and technical specifications for interoperability . in order to eliminate the obstacles to interoperability , the amount of national rules should be reduced as a consequence of extending the scope of the tsis to the whole union’s rail system and of closing open points in the tsis . for this purpose the member states must keep their system of national rules updated , delete obsolete rules and inform the commission and the agency thereof without delay .


### in view of the gradual approach to eliminating obstacles to the interoperability of the rail system and of the time consequently required for the adoption of tsis , steps should be taken to avoid a situation where member states adopt new national rules or undertake projects that increase the diversity of the present system . the safety management system is the recognised tool for preventing accidents and railway undertakings are responsible for taking immediate corrective action to prevent re - occurrence of accidents . member states should not decrease the responsibility of the railway undertakings by establishing new national rules immediately after an accident . ### in view of the gradual approach to eliminating obstacles to the interoperability of the rail system while maintaining a high level of railway safety and of the time consequently required for the adoption of tsis , steps should be taken to avoid a situation where member states adopt new national rules or undertake projects that increase the diversity of the present system . the safety management system is a recognised tool for preventing accidents . member states , the european railway agency and railway undertakings are responsible for taking immediate corrective action to prevent re - occurrence of accidents . member states should not decrease the responsibility of the railway undertakings by establishing new national rules immediately after an accident .


### the certification of train staff is often an insurmountable barrier to new entrants . member states should ensure that facilities for the training and certification of train staff necessary to meet requirements under national rules are available to railway undertakings intending to operate on the relevant network . ### railway undertakings have to ensure that train staff is properly qualified and certified . they have to ensure the relevant training and qualification level when their staff is operating on the network of another member state . safety authorities shall have the responsibility to control and enforce that requirement . the certification of train staff can be a barrier to new entrants . member states should ensure that facilities for the training and certification of train staff necessary to meet requirements under national rules are available to railway undertakings intending to operate on the relevant network .


### the national safety authorities should be fully independent in their organisation , legal structure and decision making from any railway undertaking , infrastructure manager , applicant and procurement entity . they should carry out their tasks in an open and non - discriminatory way and cooperate with the agency to create a single rail area and coordinate their decision - making criteria . to increase efficiency , two or more member states may decide to merge the staff and resources of the respective national safety authorities . ### the national safety authorities should be fully independent in their organisation , legal structure and decision making from any railway undertaking , infrastructure manager , applicant and procurement entity . they should carry out their tasks in an open and non - discriminatory way and cooperate with the agency to create a single rail area with a high level of railway safety and coordinate their decision - making criteria . in order to fulfil their tasks , the national safety authorities must have sufficient budgetary resources and a sufficient number of well trained staff . to increase efficiency , two or more member states may decide to merge the staff and resources of the respective national safety authorities .


### serious accidents on the railways are rare . however , they can have disastrous consequences and raise concern among the public about the safety performance of the rail system . all such accidents should , therefore , be investigated from a safety perspective to avoid recurrence and the results of the investigations should be made public . other accidents and incidents should also be subject to safety investigations when they could be significant precursors to serious accidents . ### serious accidents on the railways are rare . however , they can have disastrous consequences and raise concern among the public about the safety performance of the rail system . all such accidents should , therefore , be investigated from a safety perspective to avoid recurrence and the results of the investigations should be made public . other accidents and incidents should also be subject to safety investigations when they could be significant precursors to serious accidents . in order to identify such precursors , railway undertakings and infrastructure managers shall establish a ' fair culture ' as defined in article 3 .


### ‘ infrastructure manager’ means infrastructure manager as defined in article 2 of directive 2001 / 14 / ec14 ; ### ' infrastructure manager ' means infrastructure manager as defined in article 3 of directive 2012 / 34 / eu ;


### ‘ railway undertaking’ means railway undertaking as defined in article 2 of directive 2001 / 14 / ec , and any other public or private undertaking , the activity of which is to provide transport of goods and / or passengers by rail on the basis that the undertaking must ensure traction , including undertakings which provide traction only ; ### ' railway undertaking ' means railway undertaking as defined in article 3 of directive 2012 / 34 / eu , and any other public or private undertaking , the activity of which is to provide transport of goods and / or passengers by rail on the basis that the undertaking must ensure traction , including undertakings which provide traction only ;


### ‘ accident’ means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences ; accidents are divided into the following categories : collisions , derailments , level - crossing accidents , accidents to persons caused by rolling stock in motion , fires and others ; ### ‘ accident’ means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences ; accidents are divided into the following categories : collisions , derailments , level - crossing accidents , accidents to persons caused by rolling stock in motion , including in shunting yards and during track maintenance works , fires and others ;


### ‘ manufacturer’ means any natural or legal person who manufactures an interoperability constituent or subsystem or has it designed or manufactured , and markets it under his name or trademark ; ### ‘ manufacturer’ means any natural or legal person who manufactures an interoperability constituent , components or subsystem or has it designed or manufactured , and markets it under his name or trademark ;


### 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 that railway safety is maintained and continuously improved , taking into consideration the development of union legislation and technical and scientific progress as well as the role of the human factor for the safety of railway system and giving priority to the prevention of accidents . member states shall make sure that measures for developing and improving railway safety take account of the need for a system based approach . the actors of the railway system , each for their own duty , should be responsible for the safety of the system , without prejudice to civil liability in accordance with the legal requirements of the member states .


### member states shall ensure that the responsibility for the safe operation of the rail system and the control of risks associated with it is laid upon the infrastructure managers and railway undertakings , obliging them : ### each member state and the agency , according to the era regulation , each for their own missions shall ensure that the safe operation of the rail system and the control of risks associated with it is laid upon the railway actors , obliging them :


### member states shall ensure that the responsibility for the safe operation of the rail system and the control of risks associated with it is laid upon the infrastructure managers and railway undertakings , obliging them : ### member states and the european union agency for railways shall ensure , on the basis of their respective competences , that the responsibility for the safe operation of the rail system and the control of risks associated with it is laid upon the entities operating within the rail system , obliging them :


### to establish safety management systems in accordance with this directive . ### for infrastructure managers , railway undertakings and ecms to establish safety management systems or maintenance system in accordance with this directive .


### to establish safety management systems in accordance with this directive . ### to establish practical implementation and application of safety management systems in accordance with this directive .


### to establish safety management systems in accordance with this directive . ### to establish safety or maintenance management systems in accordance with this directive .


### without prejudice to civil liability in accordance with the legal requirements of the member states , each infrastructure manager and railway undertaking shall be made responsible for its part of the system and its safe operation , including supply of material and contracting of services , vis - à - vis users , customers , the workers concerned and third parties . the risks associated with the activities of third parties shall also be taken into account in the safety management systems of infrastructure managers and railway undertakings . ### member states , without prejudice to civil liability in accordance with their legal requirements , shall ensure that all entities operating within the rail system bear responsibility for their parts of the system and its safe operation and that liability in that connection lies with them .


### all actors having a relevant role in safety operations shall implement the necessary risk control measures , where appropriate in cooperation with the others . in addition to railway undertakings and infrastructure managers those actors include : ### all actors as defined in article 3 shall implement the necessary risk control measures . in addition to railway undertakings and infrastructure managers those actors include in particular :


### all actors having a relevant role in safety operations shall implement the necessary risk control measures , where appropriate in cooperation with the others . in addition to railway undertakings and infrastructure managers those actors include : ### all actors having a relevant role in safety operations shall implement the necessary risk control measures . in addition to the actors defined in article 3 those actors include the manufacturers , which are responsible for the design and manufacturing of safe railway vehicles , parts , components or sub - assemblies of vehicle , railway infrastructure , energy and track side control command , as well as issuing of the preliminary maintenance documentation associated to the vehicle .


### the commission shall issue mandates to the agency to draft the new csms referred in point 1 , to review and update all csms to take account of developments in technology or social requirements and to make the relevant recommendations to the commission . ### the commission shall issue mandates to the agency to draft the new csms referred to in point 1 , to review and update all csms to take account of developments in technology or social requirements and to make the relevant recommendations to the commission as quickly as possible .


### the csms shall be revised at regular intervals , taking into account the experience gained from their application and the global development of railway safety and in view of generally maintaining and where reasonably practicable , continuously improving safety . ### the csms shall be revised annually , taking into account the experience gained from their application and the global development of railway safety and with a view to generally maintaining and , where reasonably practicable , continuously improving safety .


### member states shall make any necessary amendments to their national rules in the light of the adoption of csms and revisions to them . ### member states shall promptly make any necessary amendments to their national rules in the light of the adoption of csms and revisions to them .


### the commission shall issue a mandate to the agency to draft revised csts and to make the relevant recommendations to the commission . ### the commission shall issue a mandate to the agency to draft revised csts as soon as possible and to make the relevant recommendations to the commission .


### 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 promptly 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 ] . ### 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 .


### member states shall ensure that national rules are made available free of charge and in a language that can be understood by all parties concerned . ### national rules , shall be provided by member states free of charge and in a language that can be understood by all parties concerned .


### the safety management system shall meet the requirements , adapted to the character , extent and other conditions of the activity pursued . it shall ensure the control of all risks associated with the activity of the infrastructure manager or railway undertaking , including the supply of maintenance and material and the use of contractors . without prejudice to existing national and international liability rules , the safety management system shall also take into account , where appropriate and reasonable , the risks arising as a result of activities by other parties . ### the safety management system shall meet the requirements adapted to the character , extent and other conditions of the activity pursued . it shall ensure the control of all risks associated with the activity of the infrastructure manager or railway undertaking , including the supply of maintenance and material and the use of contractors . without prejudice to existing national and international liability rules , the safety management system shall also take into account , where appropriate and reasonable , the risks arising as a result of activities by other parties . this means that infrastructure managers and railway undertakings have procedures to identify those potential risks which arise from external activities at the interfaces with the rail system and which have a direct impact on operations .