### article 10 single safety certificate access to the railway infrastructure shall be granted only to railway undertakings which hold the single safety certificate . 2 . the single safety certificate shall be granted by the agency on the basis of the evidence that the railway undertaking has established its safety management system in accordance with article 9 and meets the requirements laid down in tsis and in other relevant legislation in order to control risks and provide transport services safely on the network . 3 . the single safety certificate shall specify the type and extent of the railway operations covered . it shall be valid throughout the union for equivalent operations . 4 . 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 railway undertaking will follow the operating rules , including national rules made available to them in accordance with article 8 , and assess the safety of their operation , taking into account the requirements in commission regulation no 352 / 2009 and ensuring that they are managing all risks through their safety management system and that they are making all necessary arrangements to operate safely ; the railway undertaking has made the arrangements necessary for cooperation and coordination with the infrastructure manager of the network where it proposes to operate ; the railway undertaking has taken any action necessary to ensure the safe operation of the service ; the railway undertaking has a licence issued in accordance with council directive 95 / 18 / ec ; the type and extent of its intended operation corresponds to that specified in its single 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 . 5 . the single safety certificate shall be renewed upon application by the railway undertaking at intervals not exceeding five years . it shall be wholly or partly updated whenever the type or extent of the operation is substantially altered . 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 agency may require that the single safety certificate be revised following substantial changes to the safety regulatory framework . 6 . if a national safety authority finds that a holder of a single safety certificate no longer satisfies the conditions for certification , it shall ask the agency to revoke it . the agency may revoke the single safety certificate , giving reasons for its decision . the agency shall immediately inform all the national safety authorities of the networks on which the railway undertaking operates . 7 . the agency shall inform the national safety authorities within one month of the issue , renewal , amendment or revocation of a single safety certificate . it shall state the name and address of the railway undertaking , the issue date , the scope and validity of the certificate and , in the case of revocation , the reasons for its decision . 8 . the agency shall continuously monitor the effectiveness of the measures for the issuing of single safety certificates and supervision by national safety authorities and , where appropriate , shall make recommendations to the commission for improvement . these may include a recommendation for a csm covering a process of the safety management system which needs to be harmonised at union level , as referred to in article 6 . ### article 10 single safety certificate access to the railway infrastructure shall be granted only to railway undertakings which hold the single safety certificate issued by the agency or by a national safety authority . the purpose of the single safety certificate is to provide evidence that the railway undertaking has established its safety management system and is able to operate safely in the intended area of operation . 2 . in its application for a single safety certificate , the applicant shall specify the type and extent of the railway operations covered and the intended area of operation . the application shall be accompanied by a file including the documentary evidence that the railway undertaking has established its safety management system in accordance with article 9 and meets the requirements laid down in the relevant legislation in order to control risks and provide transport services safely on the network . 3 . within one month of the receipt of the request of the applicant , the agency shall inform the applicant that the file is complete or ask for relevant complementary information , setting a reasonable deadline . 4 . the agency or the national safety authority shall issue the safety certificate within four months from receipt of all relevant information . 5 . the agency shall issue a single safety certificate to railway undertakings having an area of operation in one or more member state . in order to issue such certification , the agency shall assess the file accompanying the application and refer the entire applicant ' s file to the national safety authorities concerned by the intended area of operation for assessing the ability to comply with the relevant national rules , including those notified under article 14 of directive . . . / . . . . in its assessment , the agency shall take full account of the assessment of the concerned national safety authorities . the agency shall take full responsibility for the certifications it issues . 6 . when the agency disagrees with an assessment carried out by one or more national safety authorities , they shall cooperate with a view to reaching a mutually acceptable assessment . if no mutually acceptable assessment can be found within one month after the agency has informed the national safety authority or authorities of its disagreement , the agency shall take its final decision unless the national safety authority or authorities have referred the matter for arbitration to the board of appeal established under article 51 of regulation no . . . / . . . . 7 . where the area of operation is limited to one member state , the national safety authority of that member state may , under its own responsibility and when the applicant so requests , issue a single safety certificate after the assessment of the applicant ' s file . the national safety authority shall take full responsibility for the safety certificates it issues . 8 . safety certificates shall specify the type and extent of the railway operations covered and the area of operation . the safety certificate may also cover sidings owned by the railway undertaking if they are included in its safety management system . in this case , no additional safety authorisation shall be necessary for the sidings concerned . 9 . any decision refusing the issuing of a safety certificate shall be duly justified . the applicant may , within a period of one month from receipt of the negative decision , request that the agency or the national safety authority , as appropriate , review the decision . the agency or the national safety authority shall have two months from the date of receipt of the request for review to confirm or reverse its decision . 10 . if the negative decision of the agency is confirmed , the applicant may bring an appeal before the board of appeal designated under article 51 of regulation no . . . / . . . . if the negative decision of a national safety authority is confirmed , the applicant may bring an appeal to the appeal body designated by the competent member state . member states may designate the regulatory body set out in article 56 of directive 2012 / 34 / eu establishing a single european railway area for the purpose of this appeal procedure . 11 . the single safety certificate issued either by the agency or by a national safety authority under this article , shall be renewed upon application by the railway undertaking at intervals not exceeding five years . it shall be fully or partly updated whenever the type or extent of the operation is substantially altered . 12 . where the applicant already has a safety certificate and wishes to extend its area of operations to another member state , it shall complement the file with the relevant documents concerning the additional area of operation . the applicant shall submit the file to the agency , which shall , after the assessment , issue an updated certificate covering the extended area of operation . in this case , only the national safety authority concerned by the extension of operation will be consulted for assessing the file . the agency shall only assess the file concerning the additional area of operation . 13 . the agency and the competent national safety authorities may require the revision of relevant single safety certificates following substantial changes to the safety regulatory framework . 14 . the agency shall inform the relevant national safety authorities without delay , and in any case within one month , of the issue of a single safety certificate . the agency shall inform the relevant national safety authorities immediately in the case of renewal , amendment or revocation of a single safety certificate . it shall state the name and address of the railway undertaking , the issue date , the scope , validity and area of operation of the certificate and , in the case of revocation , the reasons for its decision . in the case of certificates issued by the national safety authorities , the same information shall be provided to the agency .


### 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 four months after all the information required and any supplementary information requested has been submitted . negative decisions shall be duly justified . if the 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 the 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 .


### ‘ 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 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 agency 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 :


### 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 .


### 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 .


### 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 .


### 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 each for their own missions shall ensure that railway safety is 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 .


### 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 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 for the traceability of maintenance activities , traceability of safety critical components , 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 .


### articles 10 and 11 shall apply from [ specific date to be inserted by opoce - two years after the date of entry into force ] . ### articles 10 and 11 shall apply from [ specific date to be inserted by opoce - five years after the date of entry into force ] .


### where rules concerning existing safety methods are not covered by a csm ; ### to maintain the present safety level or where rules concerning existing safety methods are not covered by a csm ;


### ‘ 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 notified by a member state containing railway safety , or technical requirements imposed at member state level and applicable to railway actors , irrespective of the body issuing them ;


### 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 .


### when drafting the recommandations , the agency shall take account of the opinion of the users and of the stakeholders . the recommendations shall enclose a report on the results of this consultation and a report assessing the impact of the new csm to be adopted . ### when drafting the recommendations , the agency shall take account of the opinion of the users , the social partners and of other stakeholders . the recommendations shall enclose a report on the results of this consultation and a report assessing the impact of the new csm to be adopted .


### 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 .


### the single safety certificate shall specify the type and extent of the railway operations covered . it shall be valid throughout the union for equivalent operations . ### the single safety certificate shall specify the type and extent of the railway operations covered . it shall be valid throughout the union for equivalent operations . the safety certificate may also include sidings owned by the railway undertaking if they were included in its safety management system .


### the responsibility of infrastructure managers and railway undertakings for operating the rail system does not preclude other actors such as manufacturers , carriers , consignors , fillers , loaders entities in charge of maintenance , maintenance suppliers , wagon keepers , service providers and procurement entities from assuming responsibility for their products or services . to avoid the risk that the responsibilities are not properly assumed , each relevant actor should be made responsible for its particular process . each actor in the rail system should be responsible in respect to the other actors for complete and truthful communication of all relevant information to check if the vehicles are fit to run . in particular that concerns information on the status and history of the vehicle , maintenance files , traceability of loading operations , and consignment notes . ### the responsibility of infrastructure managers and railway undertakings for operating the rail system does not preclude other actors such as manufacturers , carriers , consignors , fillers , loaders , unloaders , consignee , entities in charge of maintenance , maintenance suppliers , vehicle owner , vehicle keepers , service providers and procurement entities from assuming responsibility for their products or services and for implanting risk control measures . to avoid the risk that the responsibilities are not properly assumed , each relevant actor should be made responsible for its particular process . each actor in the rail system should be responsible in respect to the other actors for complete and truthful communication of all relevant information to check if the vehicles are fit to run . in particular that concerns information on the status and history of the vehicle , maintenance files , traceability of loading operations , and consignment notes .


### 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 .


### 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 :


### the main actors in the rail system , infrastructure managers and railway undertakings , should bear full responsibility for the safety of the system , each for their own part . whenever appropriate , they should cooperate in implementing risk control measures . member states should make a clear distinction between this immediate responsibility for safety and the national safety authorities ' task of providing a national regulatory framework and supervising the performance of all operators . ### all the actors in the rail system should bear full responsibility for the safety of the system , each for their own part . member states should make a clear distinction between this immediate responsibility for safety and the national safety authorities ' task of providing a national regulatory framework and supervising the performance of all operators .


### article 10 single safety certificate access to the railway infrastructure shall be granted only to railway undertakings which hold the single safety certificate . 2 . the single safety certificate shall be granted by the agency on the basis of the evidence that the railway undertaking has established its safety management system in accordance with article 9 and meets the requirements laid down in tsis and in other relevant legislation in order to control risks and provide transport services safely on the network . 3 . the single safety certificate shall specify the type and extent of the railway operations covered . it shall be valid throughout the union for equivalent operations . 4 . 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 railway undertaking will follow the operating rules , including national rules made available to them in accordance with article 8 , and assess the safety of their operation , taking into account the requirements in commission regulation no 352 / 2009 and ensuring that they are managing all risks through their safety management system and that they are making all necessary arrangements to operate safely ; the railway undertaking has made the arrangements necessary for cooperation and coordination with the infrastructure manager of the network where it proposes to operate ; the railway undertaking has taken any action necessary to ensure the safe operation of the service ; the railway undertaking has a licence issued in accordance with council directive 95 / 18 / ec ; the type and extent of its intended operation corresponds to that specified in its single 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 . 5 . the single safety certificate shall be renewed upon application by the railway undertaking at intervals not exceeding five years . it shall be wholly or partly updated whenever the type or extent of the operation is substantially altered . 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 agency may require that the single safety certificate be revised following substantial changes to the safety regulatory framework . 6 . if a national safety authority finds that a holder of a single safety certificate no longer satisfies the conditions for certification , it shall ask the agency to revoke it . the agency may revoke the single safety certificate , giving reasons for its decision . the agency shall immediately inform all the national safety authorities of the networks on which the railway undertaking operates . 7 . the agency shall inform the national safety authorities within one month of the issue , renewal , amendment or revocation of a single safety certificate . it shall state the name and address of the railway undertaking , the issue date , the scope and validity of the certificate and , in the case of revocation , the reasons for its decision . 8 . the agency shall continuously monitor the effectiveness of the measures for the issuing of single safety certificates and supervision by national safety authorities and , where appropriate , shall make recommendations to the commission for improvement . these may include a recommendation for a csm covering a process of the safety management system which needs to be harmonised at union level , as referred to in article 6 . ### article 10 single safety certificate access to the railway infrastructure shall be granted only to railway undertakings which hold the single safety certificate issued by the agency or by a national safety authority . the purpose of the single safety certificate is to provide evidence that the railway undertaking has established its safety management system and is able to operate safely in the intended area of operation . 2 . in its application for a single safety certificate , the applicant shall specify the type and extent of the railway operations covered and the intended area of operation . the application shall be accompanied by a file including the documentary evidence that the railway undertaking has established its safety management system in accordance with article 9 and meets the requirements laid down in the relevant legislation in order to control risks and provide transport services safely on the network . 3 . within one month of the receipt of the request of the applicant , the agency shall inform the applicant that the file is complete or ask for relevant complementary information , setting a reasonable deadline . 4 . the agency or the national safety authority shall issue the safety certificate within four months from receipt of all relevant information . 5 . the agency shall issue a single safety certificate to railway undertakings having an area of operation in one or more member state . in order to issue such certification , the agency shall assess the file accompanying the application and refer the entire applicant ' s file to the national safety authorities concerned by the intended area of operation for assessing the ability to comply with the relevant national rules , including those notified under article 14 of directive . . . / . . . . in its assessment , the agency shall take full account of the assessment of the concerned national safety authorities . the agency shall take full responsibility for the certifications it issues . 6 . when the agency disagrees with an assessment carried out by one or more national safety authorities , they shall cooperate with a view to reaching a mutually acceptable assessment . if no mutually acceptable assessment can be found within one month after the agency has informed the national safety authority or authorities of its disagreement , the agency shall take its final decision unless the national safety authority or authorities have referred the matter for arbitration to the board of appeal established under article 51 of regulation no . . . / . . . . 7 . where the area of operation is limited to one member state , the national safety authority of that member state may , under its own responsibility and when the applicant so requests , issue a single safety certificate after the assessment of the applicant ' s file . the national safety authority shall take full responsibility for the safety certificates it issues . 8 . safety certificates shall specify the type and extent of the railway operations covered and the area of operation . the safety certificate may also cover sidings owned by the railway undertaking if they are included in its safety management system . in this case , no additional safety authorisation shall be necessary for the sidings concerned . 9 . any decision refusing the issuing of a safety certificate shall be duly justified . the applicant may , within a period of one month from receipt of the negative decision , request that the agency or the national safety authority , as appropriate , review the decision . the agency or the national safety authority shall have two months from the date of receipt of the request for review to confirm or reverse its decision . 10 . if the negative decision of the agency is confirmed , the applicant may bring an appeal before the board of appeal designated under article 51 of regulation no . . . / . . . . if the negative decision of a national safety authority is confirmed , the applicant may bring an appeal to the appeal body designated by the competent member state . member states may designate the regulatory body set out in article 56 of directive 2012 / 34 / eu establishing a single european railway area for the purpose of this appeal procedure . 11 . the single safety certificate issued either by the agency or by a national safety authority under this article , shall be renewed upon application by the railway undertaking at intervals not exceeding five years . it shall be fully or partly updated whenever the type or extent of the operation is substantially altered . 12 . where the applicant already has a safety certificate and wishes to extend its area of operations to another member state , it shall complement the file with the relevant documents concerning the additional area of operation . the applicant shall submit the file to the agency , which shall , after the assessment , issue an updated certificate covering the extended area of operation . in this case , only the national safety authority concerned by the extension of operation will be consulted for assessing the file . the agency shall only assess the file concerning the additional area of operation . 13 . the agency and the competent national safety authorities may require the revision of relevant single safety certificates following substantial changes to the safety regulatory framework . 14 . the agency shall inform the relevant national safety authorities without delay , and in any case within one month , of the issue of a single safety certificate . the agency shall inform the relevant national safety authorities immediately in the case of renewal , amendment or revocation of a single safety certificate . it shall state the name and address of the railway undertaking , the issue date , the scope , validity and area of operation of the certificate and , in the case of revocation , the reasons for its decision . in the case of certificates issued by the national safety authorities , the same information shall be provided to the agency .


### 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 .


### access to the railway infrastructure shall be granted only to railway undertakings which hold the single safety certificate . ### access to railway infrastructure across the european union shall be granted only to railway undertakings which hold the single safety certificate .


### 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 . ### for the purpose of implementing the provisions on the single safety certificate , the agency and the national safety authorities shall conclude cooperation agreements with national safety authorities in accordance with article 69 of regulation . . . / . . . [ agency regulation ] . these agreements could be specific or framework agreements , and involve one or more national safety authorities . these agreements shall contain a specified description of tasks and conditions for deliverables , the time - limits applying to their delivery , the apportioning of the fees paid by the applicant . they may also include specific cooperation arrangements in the case of networks requiring specific expertise due to geographical or historical reasons , including networks which are isolated from the rest of the union , with a view to reducing administrative burden and costs to the applicant . these agreements shall be in place before the agency is entitled to receive applications in accordance with this directive , and in any case by three years following the date of entry into force of this directive at the latest .


### any actor of the rail system who identifies a safety risk related to defects and construction non - conformities or malfunctions of technical equipment , including those of structural sub - systems , shall report those risks to the other parties involved to enable them to take any necessary corrective actions to ensure continuous achievement of the safety performance of the rail system . ### any actor of the rail system who identifies a safety risk related to defects and construction non - conformities or malfunctions of technical equipment , including those of structural sub - systems , shall report those risks to the other parties involved to enable them to take any necessary corrective actions to ensure continuous achievement of the safety performance of the rail system . it shall be ensured that safety risks can be reported easily and anonymously . they shall be notified to the agency and the national safety authority .


### the single safety certificate shall specify the type and extent of the railway operations covered . it shall be valid throughout the union for equivalent operations . ### the single safety certificate shall specify the type and extent of the railway operations covered and the member states to which this applies .


### 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 agency 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 specific actors , obliging them :


### each member state shall establish a safety authority . this authority shall be independent in its organisation , legal structure and decision making from any railway undertaking , infrastructure manager , applicant and procurement entity . ### each member state shall establish a safety authority . this authority shall be independent in its organisation , legal structure and decision making from any railway undertaking , infrastructure manager and applicant . provided that this independence is guaranteed , the authority may be a department in the ministry responsible for transport .


### single safety certificate ### does not affect the english version


### 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 .


### 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 .


### access to the railway infrastructure shall be granted only to railway undertakings which hold the single safety certificate . ### does not affect the english version


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


### falsified active pharmaceutical ingredients pose the risk of sub - standard active pharmaceutical ingredients . this risk should be addressed . in particular , manufacturers of medicinal products should ensure either by themselves of through a body accredited for that purpose that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices . ### falsified active pharmaceutical ingredients pose the risk of sub - standard active pharmaceutical ingredients . this risk should be addressed by combining an effective inspection system with a system ensuring the traceability of active pharmaceutical ingredients . in particular , manufacturers of medicinal products should themselves ensure that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices .


### ‘ 17a . trading of medicinal products : all activities consisting of negotiating independently on behalf of another person the sale or the purchase of medicinal products , or billing or brokering medicinal products , apart from supplying medicinal products to the public , and not falling under the definition of wholesale distribution . ’ ### ‘ 17a . trading of medicinal products : all activities consisting of the sale , purchase or billing of medicinal products , apart from the physical handling and supply of medicinal products to the public , and not falling under the definition of wholesale distribution . ’


### they must keep records either in the form of purchase / sales invoices or on computer , or in any other form , giving for any transaction in medicinal products received , dispatched or traded at least the following information : - date , - name of the medicinal product , - quantity received , supplied or traded , - name and address of the supplier or consignee , as appropriate ; ’ ; ### they must keep records either in the form of purchase / sales invoices or on computer , or in any other form , giving for any transaction in medicinal products received , dispatched , traded or brokered at least the following information : - date , - name of the medicinal product , - quantity received , supplied , traded or brokered , - name and address of the supplier or consignee , as appropriate , - national identification number , where appropriate ,


### the safety features referred to in point of article 54 shall not be partly or fully removed or covered - up , unless the following conditions are fulfilled : ### the safety features referred to in point of article 54 shall not be removed or covered - up . if the following conditions are fulfilled and justified for public health reasons , the manufacturing authorisation holder may place the original medicinal product inside another package while preserving intact its original safety feature .


### 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 , subject to medical prescription as defined in title vi , where the commission decides that there is a risk that a medicinal product will be counterfeited due to the price or past incidences .


### for the purpose of point , in the case where the product is obtained from another wholesale distributor , holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor either by themselves or through a body accredited for that purpose by the competent authority of a member state . ### for the purpose of point , in the case where the product is obtained from another wholesale distributor , holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor and check that the latter holds a wholesale distribution authorisation .


### 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 and of the protection of industrial and commercial property rights . it has to be ensured that no collection or commercial processing of data takes place that would enable a link to be made between the medicinal products supplied and the corresponding patients or pharmacies . ’


### ' to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ’ ### ' to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorisation shall ensure that production operations are conducted in accordance with the guidelines and standards of good manufacturing practice in force within the union through the performance of mandatory inspections by the competent union authorities or the authorities of countries with which mutual recognition agreements covering , inter alia , active pharmaceutical ingredients , are in force . '


### identify individual packs ; ### identify individual packs by a single eu - wide standard ;


### the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation . ### in order to ensure sufficient protection of public health the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices and should comply with the information submitted within , or supplied to , the marketing authorisation application , irrespective of whether those ingredients were manufactured in the community or imported . therefore , with regard to the manufacture of active pharmaceutical ingredients in third countries intended for medicinal products marketed in the union , it should be ensured through repeated , mandatory inspections and enforcement by the union’s competent authorities or by authorities with mutual recognition agreements covering active pharmaceutical ingredients in force , that manufacture is taking place in compliance with both of the above - mentioned requirements .


### ‘ they must keep records either in the form of purchase / sales invoices or on computer , or in any other form , giving for any transaction in medicinal products received , dispatched or traded at least the following information : – date , – name of the medicinal product , – quantity received , supplied or traded , – name and address of the supplier or consignee , as appropriate ; ### ‘ they must keep records either in the form of purchase / sales invoices or on computer , or in any other form , giving for any transaction in medicinal products received , dispatched , traded or brokered at least the following information : – date , – name of the medicinal product , – quantity received , supplied , traded or brokered , – name and address of the supplier or consignee , as appropriate , - batch number , - registration number of the marketing authorisation ;


### on the basis of these criteria , the requirements referred to in points and of paragraph of this article may be waived for certain products or product categories . ### on the basis of these criteria , the commission may decide that the security features referred to in point of article 54 and the requirements in points to of paragraph 1 of this article shall be applied to certain medicinal products subject to prescription that pose a high risk of being counterfeited .


### 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 at least all of the following : the cost - effectiveness of the system , in order to guarantee that any measure that is applied is based on a cost - benefit analysis ; the proportional application of costs related to the measures to all participants in the supply chain and the linking of those costs to the price of the medicinal product concerned ; the independence of the system and the legitimate interests to protect information of commercially confidential nature and the protection of industrial and commercial property rights and personal data .


### within 90 days of an inspection as referred to in paragraph 1 , a certificate of good manufacturing practice or good distribution practice shall be issued to the manufacturer , importer , or wholesale distributor if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice or good distribution practice as provided for by community legislation . ### within 90 days of an inspection as referred to in paragraph 1 , a certificate of good manufacturing practice , good distribution practice , good trading practice or good brokering practice shall be issued to the manufacturer , importer , or wholesale distributor if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice , good distribution practice , good trading practice and good brokering practice as provided for by union legislation .


### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , or wholesale distributor complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorization holder , or to the wholesale distributor who has undergone the inspection . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorization holder , or wholesale distributor concerned the opportunity to submit their comments . ### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , wholesale distributor , trader or broker complies with the principles and guidelines of good manufacturing practice and good distribution , trading and brokering practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorisation holder , the wholesale distributor who has undergone the inspection or the trading or brokering authorisation holder . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorisation holder , wholesale distributor , trader or broker concerned the opportunity to submit their comments .


### ‘ o ) 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 . ’ ### ‘ o ) safety features making it possible to ascertain identification , authenticity and traceability of medicinal products , other than radiopharmaceuticals . ’


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


### any actor in the supply chain who packages medicinal products has to be a holder of a manufacturing authorization . in order for the safety features to be effective , the manufacturing authorization holder should only be permitted to remove , replace or cover these features under strict conditions . ### any actor in the supply chain who labels or packages medicinal products or inserts changes to the labelling or packaging of medicinal products has to be a holder of a manufacturing authorization . in order for the safety features to be effective , the manufacturing authorisation holder should only be permitted to remove , replace or cover these features under strict conditions . the strict conditions should provide adequate safeguards against falsified products entering the distribution chain and also reflect a strict duty of care of those manufacturing authorisation holders towards the original manufacturer and the marketing authorisation holder of the products and to consumers of the products .


### when adopting those measures , the commission shall consider the risk related to products or categories of products and at least all of the following : ### when adopting those measures , the commission shall consider the risk related to prescription products and at least all of the following :


### the member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by [ insert concrete date 18 months after publication ] at the latest and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate , dissuasive and equivalent . the member states shall notify those provisions to the commission by [ insert concrete date 6 months after publication ] at the latest and shall notify it without delay of any subsequent amendment affecting them .


### persons trading medicinal products shall ensure that the traded medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . in addition , the requirements set out in article 80 to shall apply . ### persons trading or brokering medicinal products shall ensure that the traded or brokered medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . in addition , the requirements set out in article 80 to shall apply .


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


### the number of incidences of falsifications in third countries and within the community ; ### the number and frequency of past incidences of reported cases of counterfeited medicines within the union and the evolution of those incidences in the past ;


### today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in directive 2001 / 83 / ec . in order to ensure reliability in the distribution chain , pharmaceutical legislation should address all actors in the distribution chain : this includes not only distributors who procure , hold , store and supply products , but also persons who are involved in transactions without handling the products . they should be submitted to proportionate rules in order to exclude , by all practical means , the possibility that medicinal products which are falsified in relation to their identity , history or source to enter the legal supply chain in the community . ### today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in directive 2001 / 83 / ec , such as traders and brokers . in order to ensure reliability in the distribution chain , pharmaceutical legislation should address all actors in the distribution chain : this includes not only distributors who procure , hold , store and supply products , but also persons who are involved in transactions without handling the products , such as traders and brokers . they should be clearly and unambiguously defined , as should their responsibilities , and should be submitted to proportionate rules in order to exclude , by all practical means , the possibility that medicinal products which are falsified in relation to their identity , history or source to enter the legal supply chain in the community . in particular , such persons should have a valid licence for their business activities , which should be conducted in accordance with the good practice laid down by the commission , in cooperation with the agency and the member state authorities , by analogy with that applying to producers and distributors of medicinal products .


### the manufacturing authorisation holder complies with point of article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification , authenticity and uninterrupted traceability of the medicinal product , and without opening the immediate packaging as defined in article 1 ; ### the manufacturing authorisation holder complies with point of article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification , authenticity and uninterrupted traceability of the medicinal product , and without opening the immediate packaging as defined in article 1 ; to this effect , the manufacturing authorisation holder shall produce a new outer carton replicating all relevant product and trademark information and subject to carrying safety features as required by article 54 ; original cartons shall be destroyed ;


### the manufacturing authorisation holder complies with point of article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification , authenticity and uninterrupted traceability of the medicinal product , and without opening the immediate packaging as defined in article 1 ; ### the manufacturing authorisation holder complies with point of article 54 . under no circumstances may he replace the safety feature applied to the original container , which enables the identification , authenticity and uninterrupted traceability of the initial medicinal product to be ascertained ;


### ' to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ’ ### to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall ensure that production operations are conducted in accordance with the guidelines and standards of good manufacturing practice in force within the union through the performance of mandatory inspections by the competent union authorities or the authorities of countries with which mutual recognition agreements covering , inter alia , active pharmaceutical ingredients , are in force .


### 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 .


### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , or wholesale distributor complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorization holder , or to the wholesale distributor who has undergone the inspection . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorization holder , or wholesale distributor concerned the opportunity to submit their comments . ’ ### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , wholesale distributor , trader or broker complies with the principles and guidelines of good manufacturing practice , good distribution practice , good trading practice , or good brokerage practice referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorization holder , wholesale distributor , trading authorisation holder or brokerage authorisation holder who has undergone the inspection . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorization holder , wholesale distributor , trader or broker concerned the opportunity to submit their comments .


### ' to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a member state . ’ ### ' to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances , which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials . to this end , the holder of the manufacturing authorisation shall ensure that production operations are conducted in accordance with the guidelines and standards of good manufacturing practice in force within the union through the performance of mandatory inspections by the competent union authorities or the authorities of countries with which mutual recognition agreements covering , inter alia , active pharmaceutical ingredients , are in force . '


### if the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices as provided for by community legislation , the information shall be entered in the community database referred to in paragraph 6 . ### if the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices , good distribution practices , good trading practices or good brokering practices as provided for by union legislation , the information shall be entered in the union database referred to in paragraph 6 and the manufacturing and distribution processes shall cease forthwith .


### 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 at least all of the following : the cost - effectiveness of the system , in order to guarantee that any measure that is applied is based on a cost - benefit analysis ; the proportional application of costs related to the measures to all participants in the supply chain and the linking of those costs to the price of the medicinal product concerned ; the independence of the system and the legitimate interests to protect information of commercially confidential nature and the protection of industrial and commercial property rights and personal data .


### they must inform the competent authority of products they receive which they identify as infringing , or they suspect of infringing , either of the following : ### they must inform the competent authority of products they receive , trade or broker which they identify as infringing , or they suspect of infringing , either of the following :


### the following point is added : ‘ to inform the competent authority of products he gets knowledge of which are or which are suspected to be falsified in relation to the identity , history or source of products manufactured by him . ’ ### the following point is added : ‘ to inform the competent authority of products he gets knowledge of which are or which are suspected to be falsified in relation to the identity , history or source of products manufactured by him either in the legal supply chain or being sold by means of illegal internet trade .


### the safety features referred to in point of article 54 shall not be partly or fully removed or covered - up , unless the following conditions are fulfilled : ### member states shall ensure that the holder of a manufacturing authorisation does not exchange , partly or fully remove , or cover up the safety features referred to in point of article 54 , unless that holder has a marketing authorisation for the relevant medicinal product in accordance with article 6 or has obtained written authorisation from the marketing authorisation holder .


### the safety features referred to in point of article 54 shall not be partly or fully removed or covered - up , unless the following conditions are fulfilled : ### the safety features referred to in point of article 54 shall not be partly or fully removed or covered - up , unless the identification , authenticity and traceability of the medicinal products are guaranteed and the following conditions are fulfilled :


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


### within 90 days of an inspection as referred to in paragraph 1 , a certificate of good manufacturing practice or good distribution practice shall be issued to the manufacturer , importer , or wholesale distributor if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice or good distribution practice as provided for by community legislation . ### within 90 days of an inspection as referred to in paragraph 1 , a certificate of good manufacturing practice , good distribution practice , good trading practice or good brokering practice shall be issued to the manufacturer , importer , or wholesale distributor if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice , good distribution practice , good trading practice and good brokering practice as provided for by union legislation .


### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , or wholesale distributor complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorization holder , or to the wholesale distributor who has undergone the inspection . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorization holder , or wholesale distributor concerned the opportunity to submit their comments . ### after every inspection as referred to in paragraph 1 , the competent authority shall report on whether the manufacturer , importer , wholesale distributor , trader or broker complies with the principles and guidelines of good manufacturing practice and good distribution , trading and brokering practices referred to in articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in title ix . the competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer , importer , marketing authorisation holder , the wholesale distributor who has undergone the inspection or the trading or brokering authorisation holder . before adopting the report , the competent authority shall give the manufacturer , importer , marketing authorisation holder , wholesale distributor , trader or broker concerned the opportunity to submit their comments .


### the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the community or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that the rules for the manufacture of active pharmaceutical ingredients intended for export to the community , including inspection and enforcement , provide for a level of protection of public health equivalent to that provided for by community legislation . ### in order to ensure sufficient protection of public health the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices and should comply with the information submitted within , or supplied to , the marketing authorisation application , irrespective of whether those ingredients were manufactured in the community or imported . therefore , with regard to the manufacture of active pharmaceutical ingredients in third countries intended for medicinal products marketed in the union , it should be ensured through repeated , mandatory inspections and enforcement by the union’s competent authorities or by authorities with mutual recognition agreements covering active pharmaceutical ingredients in force , that manufacture is taking place in compliance with both of the above - mentioned requirements .


### the competent authorities shall issue the accreditation referred to in articles 46 and 80 if the applicant can demonstrate that he is competent to carry out verification of compliance with good manufacturing practices or , in the case of wholesale distributors , good distribution practices . ### the competent authorities shall issue the accreditation referred to in articles 46 and 80 if the applicant can demonstrate that he is competent to carry out verification of compliance with good manufacturing practices or , in the case of wholesale distributors , good distribution practices or , in the case of traders , good trading practices or , in the case of brokers , good brokering practices .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 18 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 18 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 24 months after publication ] ; the provisions necessary to comply with article 1 , and from [ insert concrete date 48 months after publication ] . when member states adopt those provisions , they shall contain a reference to this directive or be accompanied by such a reference on the occasion of their official publication . member states shall determine how such reference is to be made . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 6 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 6 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 6 months after publication ] ; the provisions necessary to comply with article 1 and from [ insert concrete date 12 months after publication ] ; the provisions necessary to comply with article 1 in so far as it relates to article 54a and articles 54a and 54a to the extent they are referred to 54a of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 6 months after publication ] ; the provisions necessary to comply with article 1 except in so far as it relates to article 54a and articles 54a and 54a to the extent they are referred to 54a of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 48 months after publication ] . when member states adopt those provisions , they shall contain a reference to this directive or be accompanied by such a reference on the occasion of their official publication . member states shall determine how such reference is to be made .


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


### the member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by [ insert concrete date 18 months after publication ] at the latest and shall notify it without delay of any subsequent amendment affecting them . ### without prejudice to the principle of subsidiarity , member states shall lay down the rules on penalties applicable to infringements of provisions of this directive and shall take all measures necessary to ensure that they are implemented . applicable penalties , which may be criminal penalties , shall take into account the threat to public health presented by the falsification of medicinal products . the penalties provided for shall be harmonised , effective , proportionate and dissuasive , and shall cover , inter alia , the following forms of behaviour : manufacturing falsified medicinal products , active substances , excipients , parts , materials and accessories ; supplying or offering to supply , including brokering , trafficking , keeping in stock , importing and exporting falsified medicinal products , active substances , excipients , parts , materials and accessories ; making false documents or tampering with documents ; aiding and abetting any of the above - mentioned infringements ; attempting to commit any of the above - mentioned infringements . the member states shall notify those provisions to the commission by [ 18 months after the publication ] at the latest and shall notify it without delay of any subsequent amendment affecting them .


### they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the community , and that the plant is subject to control and enforcement ensuring that those good manufacturing practices cannot be circumvented . ### they have , in the past three years , successfully passed an inspection specifically covering active pharmaceutical ingredients carried out by a competent community authority or an authority of a country with which a mutual recognition agreement is in force . the passing of the inspection shall be documented by a certificate issued by a competent authority , attesting compliance with good manufacturing practice .


### 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 prescription medicinal products should be established at community level .


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


### the number of incidences of falsifications in third countries and within the community ; ### the number and frequency of past incidences of reported cases of counterfeited medicines within the union and the evolution of those incidences in the past ;


### the safety features referred to in point of article 54 shall not be partly or fully removed or covered - up , unless the following conditions are fulfilled : ### the safety features referred to in point of article 54 shall not be removed or covered - up .


### 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 ; ### promote social governance by targeting greater social convergence , stimulating social innovation and supporting the development of adequate , accessible , equitable and efficient social protection systems and labour markets , and facilitate policy reform , by promoting good governance , mutual learning and social innovation ;


### the commission may make use of the appropriations referred to paragraph 1 to finance technical and / or administrative assistance , in particular relating to auditing , outsourcing of translation , meetings of experts , and information and communication activities for the mutual benefit of the commission and the beneficiaries . ### the commission may make use of the appropriations referred to paragraph 1 to finance technical and / or administrative assistance , in particular relating to auditing , outsourcing of translation , meetings of experts , and information and communication activities for the mutual benefit of the commission and the beneficiaries , and strengthen checks on expenditure . these appropriations shall be limited and capped .


### 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 allia , 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 high - quality 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 focus on projects with clear eu added value . it should provide support to small , medium - sized and large projects alike . in order to reach critical mass and reduce administrative burden , while allowing access to stakeholders such as small non - governmental organisations , the programme should support the creation and development of networks and partnerships . 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 jointly set by the european parliament and the council .


### making microfinance more available on the union’s young microfinance market calls for the institutional capacity of microfinance providers , and in particular non - bank microfinance institutions , to be stepped up in line with the commission communication ' a european initiative for the development of micro - credit ' . ### making microfinance more available on the union’s young microfinance market calls for the institutional capacity of microfinance providers , and in particular non - bank microfinance institutions , to be stepped up in line with the commission communication ‘ a european initiative for the development of micro - credit’ and the commission report on ‘ promotion of women innovators and entrepreneurship’1 . _____________ 1 dg enterprise and industry , european commission of 25 july 2008


### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up biennial monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities . ### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up annual monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities .


### ensure that the requirements linked to the promotion of a high - level of employment , a guarantee of adequate social protection and the fight against social exclusion are taken into account in defining and implementing of the union ' s policies and activities . ### promote a high level of high - quality employment , guarantee adequate and decent social protection and fight against poverty and social exclusion .


### strengthen ownership of the union objectives in the employment , social and working conditions fields among key union and national policy - makers , as well as other interested parties in order to bring about concrete and coordinated actions at both union and member state level ; ### bring about concrete and coordinated actions in the employment , social , social exclusion and working conditions fields , at both union and member state level , by strengthening ownership among key union and national policy - makers , as well as other interested parties , of the union ' s objectives in these fields and promoting close collaboration with the social partners concerned ;


### 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 allia , 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 focus on small , medium and large projects with clear eu added value while maintaining the lowest possible level of 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 enabling the transfer of appropriations between the axes of the programme .


### 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 allia , 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 allia , 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 , while at the same time ensuring transparency of proceedings . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro - credit , capacity building and technical assistance . lastly , the programme should provide for budgetary flexibility through the establishment of a reserve to be allocated on an annual basis in order to respond to policy priorities .


### the results of the actions implemented under the programme shall be suitably communicated and disseminated in order to maximise their impact , sustainability and union added value . ### the results of the actions implemented under the programme shall be regularly and suitably communicated and disseminated to citizens , the eesc , and representatives of smes , the social partners , and the european parliament in order to maximise their impact , sustainability and union added value .