### 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 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 . ### before any new service gets under way , a 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 , in other relevant legislation and in rules specific to the system in order to control risks and provide transport services safely on the network .


### 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 . ### before any start of operation of a new service , the single safety certificate shall be granted by the agency on the basis of the evidence that the railway undertaking has created its safety management system in accordance with article 9 and meets the requirements laid down in tsis , and in other relevant legislation and specific operational rules in order to control risks and provide transport services safely on the network


### 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 recommandation 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 . ### the agency shall ensure the effectiveness of the measures for the issuing of single safety certificates and , in cooperation with the national safety authorities , monitor supervisory measures 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 .


### the certificates granted in accordance with paragraph 4 shall be valid throughout the union . ### the certificates granted in accordance with paragraph 4 shall be valid throughout the union . the agency shall set up and make public , then update without delay a register of certified entities in charge of maintenance . it shall be linked with the national vehicle registers or the european vehicle register in accordance with article 43 §1 and §4 of the interoperability directive . the commission shall adopt common specifications for this register relating to content , data format , functional and technical architecture , operating mode and rules for data input and consultation by means of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 27 .


### by 31 may 2014 , the agency shall evaluate the system of certification of the entity in charge of maintenance for freight wagons and shall consider the opportunity for an extension of that system to all vehicles and shall submit a report to the commission . ### by 31 may 2014 , the agency shall evaluate the system of certification of the entity in charge of maintenance for freight wagons and shall extent that system to all other types of vehicles if deemed necessary by that evaluation . the agency shall submit a report and a recommendation to the commission about this extension .


### in the process of developing the national regulatory framework , the national safety authority shall consult all persons involved and interested parties , including infrastructure managers , railway undertakings , manufacturers and maintenance providers , users and staff representatives . ### in the process of developing the national regulatory framework , the national safety authority shall consult and consider all persons involved and interested parties , including infrastructure managers , railway undertakings , manufacturers and maintenance providers , users and staff representatives .


### the agency and the national safety authorities shall be free to carry out all inspections and investigations that are needed for accomplishment of their tasks and they shall be granted access to all relevant documents and to premises , installations and equipment of infrastructure managers and railway undertakings . ### the agency and the national safety authorities shall be free to carry out all inspections , audits and investigations that are needed for accomplishment of their tasks and they shall be granted access to all relevant documents and to premises , installations and equipment of infrastructure managers and railway undertakings .


### the scope of cooperation between the agency and the national safety authorities in all matters relating to inspections on site related to issuing the single safety certificate and supervision of the railway undertakings after issuing the single safety certificate shall be set out in contractual or other arrangements between the agency and the national safety authorities . ### the scope of cooperation between the agency and the national safety authorities in all matters relating to inspections on site related to issuing the single safety certificate and supervision of the railway undertakings after issuing the single safety certificate shall be set out in contractual or other arrangements between the agency and the national safety authorities . a national safety authority shall have the status of a specialised supporting agency .


### the investigating body shall perform its tasks independently of the organisations referred to in paragraph 1 and shall be able to obtain sufficient resources to do so . its investigators shall be afforded status giving them the necessary guarantees of independence . ### the investigating body shall perform its tasks independently of the organisations referred to in paragraph 1 , without discriminating against any party , and shall be able to obtain sufficient resources to do so . its investigators shall be afforded status giving them the necessary guarantees of independence .


### for each accident or incident the body responsible for the investigation shall arrange for the appropriate means , comprising the necessary operational and technical expertise to carry out the investigation . the expertise may be obtained from inside or outside the body , depending on the character of the accident or incident to be investigated . ### for each accident or incident the body responsible for the investigation shall arrange for the appropriate means , comprising the necessary operational and technical expertise and sufficient resources to carry out the investigation . the expertise may be obtained from inside or outside the body , depending on the character of the accident or incident to be investigated .


### until [ specific date to be inserted by opoce - two years after the date of entry into force ] , the national safety authorities shall continue to grant safety certificates in accordance with the provisions of directive 2004 / 49 / ec . such safety certificates shall be valid until their date of expiry . ### until [ specific date to be inserted by opoce - two years after the date of entry into force ] , the national safety authorities shall continue to grant safety certificates in accordance with the provisions of directive 2004 / 49 / ec . such safety certificates shall be valid until their date of expiry . subject to the maturity of the operational and national safety rules , the arrangements mentioned in article 11 between national safety authorities and the agency may contain transitional provisions to allow national safety authorities to continue to be fully responsible of this particular part of the safety certificate .


### 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 ] at the latest .


### 9 . ‘ accidents to persons involving rolling stock in motion’ means accidents to one or more persons who are either hit by a railway vehicle or by an object attached to , or that has become detached from , the vehicle . persons who fall from railway vehicles are included , as well as persons who fall or are hit by loose objects when travelling on board vehicles . ### 9 . ' accidents to persons caused by rolling stock in motion ' means accidents to one or more persons who are either hit by a railway vehicle or by an object attached to , or that has become detached from , the vehicle . persons who fall from railway vehicles are included , as well as persons who fall or are hit by loose objects when travelling on board vehicles .


### 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 .


### 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 .


### 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 unique 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 . 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 and authentication 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 .


### 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 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 not be permitted to remove , replace or cover these features . except in exceptional cases governed by strict conditions as stipulated in paragraph of article 54a , the manufacturing authorisation holder may only place the original medicinal product container inside another package if this makes it possible to preserve intact the original container and the integrity and effectiveness of the initial safety arrangements throughout the entire distribution chain .


### 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 .


### these manufacturing authorisation holders should be held strictly liable for damages to patients caused by products placed by them on the market which are falsified in relation to their identity . ### these manufacturing authorisation holders must be held strictly liable for damages to patients caused by products placed by them on the market which are falsified in relation to their identity .


### 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 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 . ### with a view to ensuring a high level of protection for public health , the manufacture of active pharmaceutical ingredients or excipients should be subject to the relevant good manufacturing practices in force within the union irrespective of whether those ingredients were manufactured in the union or imported . with regard to the manufacture of active pharmaceutical ingredients in third countries , it should be ensured that good manufacturing practice is complied with , by means of repeated mandatory inspections carried out by the competent union authorities or the authorities of countries with which mutual recognition agreements covering , inter alia , active pharmaceutical ingredients , are in force .


### . ### - 1 ) in article 1 , the following point 5a is inserted after point 5 : ' 5a . falsified medicinal product : any medicinal product that has been intentionally or deliberately falsified in relation to its : identity , including its packaging , labelling , name and composition in terms of both ingredients , including excipients and active ingredients , and the dosage thereof ; and / or source , including the manufacturer , the country of manufacture , the country of origin and the marketing authorisation holder ; and / or history , including the registers and documents enabling the distribution chain to be identified . infringements or disputes concerning patents must be distinguished from counterfeiting or falsification of medicinal products . medicinal products that are not authorised for marketing in a given country but are authorised elsewhere shall not be considered falsified . sub - standard batches or quality defects or non - compliance with good manufacturing practices / good distribution practices in legitimate medicinal products shall not be considered falsified . the commission shall be empowered to adopt delegated acts updating this definition on the basis of technical and scientific progress and / or international agreements . those acts , designed to amend non - essential elements of this directive by supplementing it , shall be adopted in accordance with the procedure referred to in article 290 of the treaty on the functioning of the european union . '


### ' 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 .


### ' 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 . ' ### ' to inform the competent authority of products he gets knowledge of which are or which are reliably suspected to be falsified in relation to the identity , history or source of products manufactured by him . '


### 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 .


### notwithstanding article 2 , and without prejudice to title vii , member states shall ensure that medicinal products not intended to be placed on the market are not introduced into the community if there are reasons to believe that the products claim a falsified identity , history or source . ### notwithstanding article 2 , and without prejudice to title vii , member states shall ensure that medicinal products not intended to be placed on the market are not introduced into and do not transit through the community if there are reasons to believe that the products claim a falsified identity , history or source .


### 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 unique identification , authenticity and traceability of medicinal products , other than radiopharmaceuticals , subject to medical prescription as defined in title vi .


### 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 following : the cost - effectiveness of the system , in order to guarantee that any measure that is applied is based on a cost - benefit analysis ; member states shall ensure that the ownership and confidentiality of the data generated by the use the safety feature to identify , to authenticate and to trace medical products ; the legitimate interests to protect information of a commercially confidential nature and personal data .


### moreover , in cases where these infringements or suspected infringements relate to a falsified medicinal product , the holder of the marketing authorisation or of the trademark that has been falsified shall be informed . ’ ### moreover , in cases where these falsified representations or suspected falsified representations relate to a falsified medicinal product , the holders of both the manufacturing authorisation and the marketing authorisation shall be informed . in the same way , the holder of a marketing or manufacturing authorisation shall inform both the competent authorities as well as other supply chain operators in cases where falsified products are suspected of having infiltrated the legal supply chain .


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


### 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 . they shall notify their activity to the competent authority of the member state where they are established . ### persons trading or brokering medicinal products shall ensure that the traded or brokered medicinal products are covered by a marketing authorisation granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . they shall notify their activity to the competent authority of the member state where they are established , which shall inform the agency .


### 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 .


### 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 .


### 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 practices , or good brokerage practice shall be issued to the manufacturer , importer , wholesale distributor , trader or broker 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 practices , or good brokering practice as provided for by union legislation .


### 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 .


### 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 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 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 or good distribution practices as provided for by community legislation , the information shall be entered in the community database referred to in paragraph 6 . such information shall specify the principles , guidelines and rules not complied with . cases where falsified medicines have been discovered on the union market shall also be reported to this database .


### 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 commission shall adopt detailed guidelines laying down the principles for inspections referred to in article 111 . ### the commission shall adopt detailed guidelines laying down the principles for inspections referred to in article 111 and , in particular , the union or national bodies responsible for carrying out inspections .


### the commission shall adopt detailed guidelines laying down the principles for inspections referred to in article 111 . ### the commission shall adopt detailed guidelines laying down the principles for inspections referred to in article 111 and , in particular , the union and / or national bodies responsible for carrying out inspections .


### the commission , in accordance with the procedure set out in article 121 , shall adopt guidelines defining in detail the requirements set out in points to of paragraph 1 . ### the commission , in accordance with the procedure set out in article 121 , shall adopt guidelines defining in detail the requirements set out in points to of paragraph 1 , performing by means of the appropriate instruments , and possibly also by means of extraordinary measures , the verification and subsequent monitoring of the quality of the principles and safety .


### 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 .


### member states , in applying this directive , shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities . ’ ### member states , in applying this directive , shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities . in that connection , member states , working in coordination with healthcare professionals , including the pharmaceuticals industry , shall take the necessary measures to encourage training for customs officers to help them deal with the phenomenon of falsified medicinal products . that coordination shall be strengthened by international cooperation programmes conducted by the commission . 2 . member states shall take the necessary measures to ensure that customs officers are provided with the resources they need and shall supply , in particular , the technology essential to the work of detecting falsified medicinal products . 3 . the commission shall draw up a report on the relevant action taken 36 months after the publication of this directive .


### 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 .


### 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 , innovative and adaptable approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on large projects with clear eu added value in order to reach critical mass , reduce the administrative burden and make matters simpler and more comprehensible for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of targeted mobility schemes . the programme should be a one - stop shop for microfinance providers and ‘ social enterprises’ , providing a suitable level of financing for micro - credit , and financing for social entrepreneurship , facilitating access to borrowing , building their capacity and providing technical assistance . lastly , the programme should provide for budgetary flexibility through the establishment of a reserve , of a maximum amount to be defined , and to be allocated on an annual basis in order to respond to policy priorities set by the commission after consulting the member states and parliament .


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


### the union should equip itself with a sound analytical basis to support policy - making in the employment and social area . such an evidence base adds value to national action by providing a union dimension and comparison for data - gathering and the development of statistical tools and methods and common indicators with a view to composing a full picture of the situation in the fields of employment , social policy and working conditions across the union and ensuring high - quality evaluation of the efficiency and effectiveness of programmes and policies . ### the union should equip itself with a sound analytical basis to support policy - making in the employment and social area . such an evidence base adds value to national action by providing a union dimension and comparison for data - gathering and the development of statistical tools and methods and common indicators with a view to composing a full picture of the situation in the fields of employment , social policy and working conditions across the union and ensuring high - quality evaluation of the efficiency and effectiveness of programmes and policies with a view to achieving the europe 2020 strategy objectives .


### the union is uniquely placed to provide a union platform for policy exchanges and mutual - learning between the member states in the employment and social areas . knowledge of the policies carried out in other countries increases the range of options available to policy - makers , triggers innovative policy developments and encourages national reform . ### the union is uniquely placed to provide a union platform for policy exchanges and mutual - learning between the member states via social experimentation at local , regional or national level in the employment and social areas . knowledge of the policies carried out in other countries increases the range of options available to policy - makers , paves the way for innovative policy developments and national reform .


### ensuring that minimum standards are in place and that working conditions improve constantly in the union is a central feature of union social policy . the union has an important role to play both in ensuring that the legislative framework is adapted , in line with ‘ smart regulation’ principles , to evolving work patterns and new health and safety risks and in financing measures to improve compliance with union rules on the protection of workers ' rights . ### ensuring that minimum standards , as defined by the oecd and the ilo , and as enshrined in the charter of human rights , are in place and that working conditions improve constantly in the union is a central feature of union social policy . the union must also ensure that all companies active on its territory apply these standards . the union has an important role to play both in ensuring that the legislative framework is adapted , in line with ‘ smart regulation’ principles , to evolving work patterns and new health and safety risks and in financing measures to improve compliance with union rules on the protection of workers ' rights .


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


### ensuring that minimum standards are in place and that working conditions improve constantly in the union is a central feature of union social policy . the union has an important role to play both in ensuring that the legislative framework is adapted , in line with ‘ smart regulation’ principles , to evolving work patterns and new health and safety risks and in financing measures to improve compliance with union rules on the protection of workers ' rights . ### ensuring that minimum standards are in place and that working conditions improve constantly in the union is a central feature of union social policy . the union has an important role to play both in ensuring that the legislative framework is adapted , in line with ‘ smart regulation’ principles , to evolving work patterns and new health and safety risks and in financing measures to improve compliance with union rules on the protection of workers’ rights , without forgetting the need for both men and women to reconcile their professional life and family life .


### the union is committed to strengthening the social dimension of globalisation by promoting decent work and labour standards internationally , either directly vis - à - vis third countries or indirectly through cooperation with international organisations . accordingly , suitable relations need to be developed with third countries not participating in the programme in order to help achieve its objectives , having regard to any agreements of relevance between such countries and the union . this may involve the attendance of representatives of these third countries at events of mutual interest that take place in countries participating in the programme . in addition , cooperation should be developed with the international organisations concerned , and in particular the international labour organisation , the council of europe and the organisation for economic cooperation and development , with a view to implementing the programme in a way that takes the role of such organisations into account . ### the union is committed to combating social dumping and strengthening the social dimension of globalisation by promoting decent work and labour standards internationally , either directly vis - à - vis third countries or indirectly through cooperation with international organisations . accordingly , suitable relations need to be developed with third countries not participating in the programme in order to help achieve its objectives , having regard to any agreements of relevance between such countries and the union . this may involve the attendance of representatives of these third countries at events of mutual interest that take place in countries participating in the programme . in addition , cooperation should be developed with the international organisations concerned , and in particular the international labour organisation , the council of europe and the organisation for economic cooperation and development , with a view to implementing the programme in a way that takes the role of such organisations into account .


### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility . ### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance , facilitate access to borrowing and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility .


### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility . ### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and socially disadvantaged people who wish to start up or develop a micro - enterprise , in particular in the ' white economy ' , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility .


### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit . as a first step , in 2010 the european parliament and the council set up the facility . ### lack of access to credit is one of the main obstacles to business creation , especially among people furthest from the labour market . union and national efforts in this area need to be stepped up in order to increase the supply of microfinance and meet demand from those who need it most , and in particular unemployed and vulnerable people who wish to start up or develop a micro - enterprise , including on a self - employed basis , but do not have access to credit with particular attention being given to boosting entrepreneurship among women , noting that in the union only 1 in 10 women are entrepreneurs as opposed to 1 in 4 men . in this context , female entrepreneurship , made possible through easier access to microcredit via funding opportunities , such as the european progress microfinance facility , could make a significant contribution towards achieving the target of 75% female employment , as defined by the europe 2020 strategy . as a first step , in 2010 the european parliament and the council set up the facility .


### 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 ' 10 . ### 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 that are officially accredited lenders , 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 ' . ### 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


### pursuant to articles 8 and 10 of the treaty , the programme should support the mainstreaming of gender equality and anti - discrimination objectives in all its activities . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed in the programme ' s activities . ### pursuant to articles 8 and 10 of the treaty , the programme should support the mainstreaming of gender equality and anti - discrimination objectives in all its activities . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed by the commission , either directly or indirectly , in the programme ' s activities .


### pursuant to articles 8 and 10 of the treaty , the programme should support the mainstreaming of gender equality and anti - discrimination objectives in all its activities . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed in the programme ' s activities . ### pursuant to articles 8 and 10 of the treaty on the functioning of the european union , the commission and the member states should ensure that the mainstreaming of gender equality and anti - discrimination objectives help to promote equality between men and women in all the programme’s axes and activities , and that the european pact for gender equality is also taken into consideration . regular monitoring and evaluation should be carried out to assess the way in which gender equality and anti - discrimination issues are addressed in the programme ' s activities . effective application of the principle of gender equality should include gender - aggregated data and indicator , s and objectives and criteria focused on gender equality .


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


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


### the eures axis , which shall support activities carried out by the eures network , i . e . the specialist services designated by the eea member states and the swiss confederation , together with other interested parties , to develop information exchanges and dissemination and other forms of cooperation to promote workers’ geographical mobility ; ### the eures axis , which shall support activities carried out by the eures network , i . e . the specialist services designated by the eea member states and the swiss confederation , together with other interested parties , to develop information exchanges and dissemination and other forms of cooperation , such as cross - border partnerships , as well as individual counselling and information for jobseekers , mobile workers and employers to promote workers ' voluntary geographical mobility on a fair basis and to contribute to a high level of high - quality employment ;


### the eures axis , which shall support activities carried out by the eures network , i . e . the specialist services designated by the eea member states and the swiss confederation , together with other interested parties , to develop information exchanges and dissemination and other forms of cooperation to promote workers’ geographical mobility ; ### the eures axis , which shall support activities carried out by the eures network , i . e . the specialist services designated by the eea member states and the swiss confederation , together with other interested parties , to develop information exchanges and dissemination and other forms of cooperation , such as cross - border partnerships , to promote targeted geographical mobility for workers ;


### 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 ; ### 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 ; promote the recognition and appreciation of the social added value offered by social enterprises as part of the social market economy in europe ;


### 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 ;


### promote equality between women and men and combat discrimination based on sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation ; ### promote equality between women and men . to this end , the objectives outlined in the european strategy for gender equality 2010 - 2015 shall be applied , particularly with regard to promoting women ' s economic independence by encouraging self - employment and the creation by women of businesses ; possibilities for reconciliation shall be encouraged and particular emphasis placed on equality in decision making on political and business - related economic issues . these are useful and specific ways in which to counter gender discrimination and should be accompanied by measures to combat discrimination based on racial or ethnic origin , religion or belief , disability , age or sexual orientation . in order to efficiently tackle poverty within the union and specifically among the most vulnerable , such as women , and particularly specific categories of women , integrated actions should be promoted . to this end , the phenomenon of poverty should be challenged by promoting inventive measures at all levels , investment in social infrastructures and enhanced exchange of good practices


### 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 . ### ensure that the requirements linked to the promotion of a high - level of employment , measures to prevent and combat long - term unemployment , 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 .


### gathering of data and statistics , as well as development of common methodologies , classifications , indicators and benchmarks ; ### gathering of data and statistics , as well as development of common methodologies , classifications , indicators and benchmarks , where appropriate broken down by gender and age group ;


### drafting and publication of guides , reports and educational material ; ### drafting and publication of guides , reports and educational materials and measures relating to information , communication , and media coverage of initiatives supported by progress ;


### support to microfinance and social enterprises in particular through the financial instruments provided for under title viii of part one of regulation xxx / 2012 [ new financial regulation ] on the financial rules applicable to the annual budget of the union , and grants . ### the following types of actions may be financed under the heading of ‘ microfinance and social enterprises’ :


### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . ### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to , other union action , in particular within the structural funds , under the european social fund , under the erdf and specific sme programmes , and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy .


### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . ### the commission , in cooperation with the member states , shall ensure that activities carried out under the programme are consistent with , and complementary to other union action , in particular under the european social fund and in such areas as social dialogue , justice and fundamental rights , education , vocational training and youth policy , research and innovation , entrepreneurship , health , enlargement and external relations , and general economic policy . bearing in mind the important role of social and employment policies in promoting gender equality , the commission and the member states should also ensure that the programme ' s activities conform to the union ' s gender equality policies .


### 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 and to the cor and the eesc for information . such reports shall cover the programme’s qualitative and quantified results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities . the reports shall be published and made publicly accessible in order to enhance transparency .


### 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 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 the principles of gender equality and gender mainstreaming have been respected and anti - discrimination considerations , including accessibility issues , have been addressed in all the programme’s axes and activities . wherever possible , data shall be gender - aggregated .


### a mid - term evaluation of the programme shall be carried out by the end of 2017 to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . ### a mid - term evaluation of the programme shall be carried out by the end of 2017 at the latest to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . the commission may , on the basis of the review , propose the transfer of appropriations between the programme ' s axes .


### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union employment and social policy and working conditions legislation are based on sound evidence and are relevant to needs , challenges and conditions in the individual member states and other participating countries ; ### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union social policy , to combat exclusion and as regards both access to health care for the most deprived and employment , and working conditions legislation are based on local , regional , or national evidence and are fully suited to the needs of job - seekers and / or employees and to the needs , challenges and conditions affecting citizens of the individual member states and other participating countries ;


### develop and disseminate high - quality comparative analytical knowledge in order to ensure that union employment and social policy and working conditions legislation are based on sound evidence and are relevant to needs , challenges and conditions in the individual member states and the other participating countries ; ### develop and disseminate high - quality comparative analytical knowledge which is properly designed to also measure the impact of horizontal policies , such as the promotion of gender equality , in order to ensure that union employment and social policy and working conditions legislation are based on sound evidence and are relevant to needs , challenges and conditions in the individual member states and the other participating countries ;


### facilitate effective and inclusive information - sharing , mutual learning and dialogue on union employment and social policy and working conditions legislation at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in implementing union law ; ### facilitate effective and inclusive information - sharing , focusing on innovative actions to promote access to employment and to a first job in particular , mutual learning and dialogue on union social policy , measures to combat exclusion , and information campaigns on the usefulness of a label for the socially most virtuous enterprises in europe and on working conditions legislation at union , national and international level in order to assist the member states and the other participating countries in developing their policies and in implementing union law ;


### provide policy - makers with financial support to test social and labour market policy reforms , build up the main actors’ capacity to design and implement social experimentation , and make the relevant knowledge and expertise accessible ; ### provide national , regional , or local actors with financial support to test social and labour market policy reforms , build up the main actors’ capacity to design and implement social experimentation , and make the relevant knowledge and expertise accessible ;


### provide union and national organisations with financial support to step up their capacity to develop , promote and support the implementation of union employment and social policy and working conditions legislation . ### provide union organisations and national , regional , or local organisations with financial support to step up their capacity to develop innovative social experimentation and promote and support the implementation of social policy , of policy to combat exclusion , of employment policy , and of union working conditions legislation .


### develop services for the recruitment and placing of workers in employment through the clearance of job vacancies and applications at european level ; this shall cover all phases of placement , ranging from pre - recruitment preparation to post - placement assistance with a view to the applicant’s successful integration into the labour market ; such services shall include targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or help particular groups of workers such as young people . ### develop recruitment services , including ‘ one - stop shop’ guidance and training , and services for the placing of workers in employment in order to meet the specific needs of job - seekers , in particular to facilitate administrative formalities and enable skills to be matched with job vacancies and applications at european level ; this shall cover all phases of placement , ranging from pre - recruitment preparation to post - placement assistance with a view to the applicant’s successful integration into the labour market ; such services shall include targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or help particular groups of workers such as young people . it shall be ensured in particular that these recruitment and placement services do not encourage the ‘ brain drain’ .


### develop services for the recruitment and placing of workers in employment through the clearance of job vacancies and applications at european level ; this shall cover all phases of placement , ranging from pre - recruitment preparation to post - placement assistance with a view to the applicant ' s successful integration into the labour market ; such services shall include targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or help particular groups of workers such as young people . ### develop services for the recruitment and placing of workers in employment through the clearance of job vacancies and applications at european level ; this shall cover all phases of placement , ranging from pre - recruitment preparation to post - placement assistance with a view to the applicant ' s successful integration into the labour market ; such services shall include targeted mobility schemes to fill vacancies where labour market shortcomings have been identified and / or help particular groups of workers such as young people , single parents and women and men doing part - time work due to care responsibilities .


### social partner organisations and other interested parties . ### regional and local authorities , social partner organisations and other regional and local organisations and interested parties involved in cross - border partnerships .


### persons who have lost or are at risk of losing their jobs , or who have difficulty in entering or re - entering the labour market , persons at risk of social exclusion and vulnerable persons who are in a disadvantaged position with regard to access to the conventional credit market and who wish to start up or develop their own micro - enterprises ; ### persons who have lost or are at risk of losing their jobs , or who have difficulty in entering or re - entering the labour market , persons at risk of social exclusion and disadvantaged persons who are in a disadvantaged position with regard to access to the conventional credit market and who wish to start up or develop their own micro - enterprises and are thus reliant on start - up capital ;


### persons who have lost or are at risk of losing their jobs , or who have difficulty in entering or re - entering the labour market , persons at risk of social exclusion and vulnerable persons who are in a disadvantaged position with regard to access to the conventional credit market and who wish to start up or develop their own microenterprises ; ### persons who have lost or are at risk of losing their jobs , or who have difficulty in entering or re - entering the labour market , persons at risk of social exclusion and vulnerable persons who are in a disadvantaged position with regard to access to the conventional credit market and who wish to start up or develop their own microenterprises with particular attention being given to boosting entrepreneurship among women ;


### support the development of social enterprises , in particular by facilitating access to finance . ### support the development of social enterprises and of enterprises awarded a label in recognition of their consistent efforts to fulfil a given number of predetermined ambitious social criteria , in particular by facilitating access to finance .


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


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


### on the basis of the common strategic framework adopted by the commission , each member state should prepare , in cooperation with its partners and in dialogue with the commission , a partnership contract . the partnership contract should translate the elements set out in the common strategic framework into the national context and set out firm commitments to the achievement of union objectives through the programming of the csf funds . ### on the basis of the common strategic framework , each member state should prepare , in cooperation with its partners , and in dialogue with the commission , a partnership contract . the partnership contract should translate the elements set out in the common strategic framework into the national context and set out firm commitments to the achievement of union objectives through the programming of the csf funds .


### member states should concentrate support to ensure a significant contribution to the achievement of union objectives in line with their specific national and regional development needs . ex ante conditionalities should be defined to ensure that the necessary framework conditions for the effective use of union support are in place . the fulfilment of those ex ante conditionalities should be assessed by the commission in the framework of its assessment of the partnership contract and programmes . in cases where there is a failure to fulfil an ex ante conditionality , the commission should have the power to suspend payments to the programme . ### member states should concentrate support to ensure a significant contribution to the achievement of union objectives in line with their specific national and regional development needs . ex ante conditionalities should be defined which have a close substantive relationship with , and a direct impact on , the efficient use of the csf funds , in order to ensure that the necessary framework conditions for the effective use of union support are in place . the fulfilment of those ex ante conditionalities should be assessed by the commission in the framework of its assessment of the partnership contract and programmes . in cases where there is a failure to fulfil an ex ante conditionality , the commission should have the power to suspend payments to the programme .


### in order to improve the quality and design of each programme , and verify that objectives and targets can be reached , an ex ante evaluation of each programme should be carried out . ### in order to improve the quality and design of each programme , and verify that objectives and targets can be reached and are consistent in terms of programme aims and financial allocations , an ex ante evaluation of each programme should be carried out that draws on prior experiences .


### as regards the funds and with a view to ensuring an appropriate allocation to each category of regions , resources should not be transferred between less developed , transition and more developed regions except in duly justified circumstances linked to the delivery of one or more thematic objectives and for no more than 2 % of the total appropriation for that category of region . ### as regards the funds and with a view to ensuring an appropriate allocation to each category of regions , resources should as a rule be transferred between different regions except in duly justified circumstances linked to the delivery of one or more thematic objectives and for no more than 30 % of the total appropriation for that category of region .


### the frequency of audits on operations should be proportionate to the extent of the union ' s support from the funds . in particular , the number of audits s carried out should be reduced where the total eligible expenditure for an operation does not exceed eur 100 000 . nevertheless , it should be possible to carry out audits at any time where there is evidence of an irregularity or fraud , or , following closure of a completed operation , as part of an audit sample . in order that the level of auditing by the commission is proportionate to the risk , the commission should be able to reduce its audit work in relation to operational programmes where there are no significant deficiencies or where the audit authority can be relied on . ### the frequency of audits on operations should be proportionate to the extent of the union ' s support from the funds . in particular , a single audit should be carried out where the total eligible expenditure for an operation does not exceed eur 200 000 . nevertheless , it should be possible to carry out audits at any time where there is evidence of an irregularity or fraud , or , following closure of a completed operation , as part of an audit sample . in order that the level of auditing by the commission is proportionate to the risk , the commission should be able to reduce its audit work in relation to operational programmes where there are no significant deficiencies or where the audit authority can be relied on .