### before issuing an eapo , the court may require the provision of a security deposit or an equivalent assurance by the claimant to ensure compensation for any damage suffered by the defendant to the extent the claimant is liable to compensate such damage under national law . ### before issuing an eapo , the court shall require the provision of a security deposit or an equivalent assurance by the claimant to ensure compensation for any damage suffered by the defendant . the claimant shall be liable to compensate such damage should the court which issued the eapo decide , upon review , that the claimant wrongfully applied for an eapo .


### where an application for an eapo is made prior to the initiation of proceedings on the substance , the claimant shall initiate such proceedings within 30 days of the date of issue of the order or within any shorter time period set by the issuing court , failing which the order shall be revocable in accordance with point of article 34 or article 35 . ### where an application for an eapo is made prior to the initiation of proceedings on the substance , the claimant shall initiate such proceedings within 30 calendar days of the date of issue of the order or within any shorter time period set by the issuing court , failing which the order shall be revocable in accordance with point of article 34 or article 35 .


### either ### any of the following :


### the possibility to oblige all banks in their territory to disclose whether the defendant holds an account with them . ### an obligation on all banks in their territory to disclose whether the debtor holds an account with them ;


### where the claimant obtained a judgment , authentic instrument or court settlement on the substance which is enforceable in the member state of origin or in cases referred to in article 5 , until the effect of the eapo is replaced by an equivalent effect of an enforcement measure under national law , provided that in the former case the claimant has launched the enforcement proceedings within 30 days after the judgment , authentic instrument or court settlement has been notified or has become enforceable , whichever is the later . ### where the claimant obtained a judgment , authentic instrument or court settlement on the substance which is enforceable in the member state of origin or in cases referred to in article 5 , until the effect of the eapo is replaced by an equivalent effect of an enforcement measure under national law , provided that in the former case the claimant has launched the enforcement proceedings within 30 calendar days after the judgment , authentic instrument or court settlement has been notified or has become enforceable , whichever is the later .


### an appeal is to be lodged within 30 days of notification of the decision referred to in paragraph 1 . ### an appeal is to be lodged within 30 calendar days of notification of the decision referred to in paragraph 1 .


### an eapo issued in one member state pursuant to article 6 and article 14 shall be recognised and enforceable in other member states without the need for a declaration of enforceability and without any possibility of opposing its recognition . ### an eapo issued in one member state in circumstances as referred to in article 5 and article 14 shall be recognised and enforceable in other member states without the need for a declaration of enforceability and without any possibility of opposing its recognition .


### the defendant shall be served with the eapo and all documents submitted to the court or competent authority with a view to obtaining the order without undue delay after service on the bank has been effected pursuant to article 24 and the bank has issued the declaration pursuant to article 27 . ### no more than one working day after service on the bank has been effected pursuant to article 24 and the bank has issued the declaration pursuant to article 27 , the defendant shall be served with the eapo and with all documents submitted to the court or competent authority with a view to obtaining the eapo .


### where the currency of the funds held in the account is not the same as that in which the eapo was issued , the bank shall convert the amount by reference to the official exchange rate of the day of implementation . ### where the currency of the funds held in the account is not the same as that in which the eapo was issued , the bank shall convert the amount by reference to the official exchange rate applying on the day of implementation in the member state in which the account is located .


### remedies of the defendant in the member state of origin ### right of the defendant to a review of the eapo


### with the exception of a review pursuant to paragraph 1 , the application for a review shall be made promptly , in any event within 45 days from the day the defendant was effectively acquainted with the contents of the order and was able to react . ### with the exception of a review pursuant to paragraph 1 , the application for a review shall be made promptly , and in any event within 45 calendar days from the day the defendant was effectively acquainted with the contents of the order and was able to react thereto .


### the application for a review shall be addressed to the court which issued the order . the application shall be submitted using the form set out in annex iv and by any means of communication , including electronic . ### the application for a review of the eapo as it applies across the union shall be addressed to the court which issued the order . the application shall be submitted using the form set out in annex iv and by any means of communication , including electronic .


### the application shall be served on the claimant in accordance with the applicable rules on the service of documents . ### the application shall be served on the claimant by the court in accordance with the applicable rules on the service of documents .


### the decision will be immediately served on the bank or banks concerned which shall immediately upon receipt implement the decision by unblocking the amount preserved fully or partially . it will also be immediately served to the claimant in accordance with the applicable rules on the service of documents . ### the decision will be immediately served by the court on the bank or banks concerned which shall immediately upon receipt implement the decision by unblocking the amount preserved fully or partially . it will also be immediately served by the court to the claimant in accordance with the applicable rules on the service of documents .


### in the area of information , directive 2001 / 83 / ec lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes : the summary of product characteristics and the package leaflet . on the other hand , as regards the dissemination of information from the marketing authorisation holder to the general public , the directive only provides that certain information activities are not covered by the rules on advertising , without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated . ### in the area of information , directive 2001 / 83 / ec lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes : the summary of product characteristics and the package leaflet . on the other hand , as regards the making available of information from the marketing authorisation holder to patients and the general public , the directive only provides that certain information activities are not covered by the rules on advertising , without providing for a harmonised framework on the contents and the quality of non - promotional information on medicinal products or on the channels through which this information may be made available .


### experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the community . ### experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to make information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the community .


### those disparities in the interpretation of the community rules on advertising , and between national provisions on information have a negative impact on the uniform application of community rules on advertising , and on the effectiveness of the provisions on product information contained in the summary of products characteristics and the package leaflet . although those rules are fully harmonised to ensure the same level of protection of public health across the community , this objective is undermined if widely divergent national rules on the dissemination of such key information are allowed . ### those disparities in the interpretation of the community rules on advertising , and between national provisions on information have a negative impact on the uniform application of community rules on advertising , and on the effectiveness of the provisions on product information contained in the summary of products’ characteristics and the package leaflet . although those rules are fully harmonised to ensure the same level of protection of public health across the community , this objective is undermined if widely divergent national rules on the making available of such key information are allowed .


### in the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the european union have become increasingly active as regards healthcare , it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good - quality , objective , reliable and non promotional information on medicinal products . ### in the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the european union have become increasingly active as regards healthcare , it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good - quality , objective , reliable and non - promotional information on medicinal products by placing emphasis on the interests of patients . they should have the right to easily access certain information such as a summary of product characteristics and the package leaflet in electronic and printed form .


### national competent authorities and health care professionals should remain important sources of information on medicinal products for the general public . member states should facilitate the access of citizens to high - quality information through appropriate channels . marketing authorisation holders may be a valuable source of non promotional information on their medicinal products . this directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisation holders to the general public . the ban on advertising to the general public for prescription - only medicinal products should be maintained . ### national competent authorities and health care professionals should remain the main sources of information on medicinal products for the general public . member states should facilitate the access of citizens to high - quality information through appropriate channels . without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public , marketing authorisation holders may be an additional source of non - promotional information on their medicinal products . this directive should therefore establish a legal framework for the making available of specific information on medicinal products by marketing authorisation holders to the general public . the ban on advertising to the general public for prescription - only medicinal products should be maintained .


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


### information to the general public on prescription - only medicinal products should only be provided through specific channels of communication , including internet and health - related publications , to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public . where information is disseminated via television or radio , patients are not protected against such unsolicited information and such dissemination should therefore not be allowed . ### information to the general public on prescription - only medicinal products should only be provided through specific channels of communication , including the internet and health - related publications , to ensure that the effectiveness of the prohibition on advertising is not undermined by unsolicited provision of information to the public . where information is made available via television or radio , patients are not protected against such unsolicited information and such making available should therefore be prohibited .


### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring . ### monitoring of information on authorised prescription - only medicinal products under this directive should ensure that marketing authorisation holders only disseminate information which is in compliance with directive . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . in cases of non - compliance , procedures should be put into place by means of which marketing authorisation holders can be represented and heard in the course of the consideration of their case . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure adequate , effective and independent monitoring .


### - factual , informative announcements and reference material relating , for example , to pack changes , adverse - reaction warnings as part of general drug precautions , trade catalogues and price lists , provided they include no product claims ; ### - factual , informative announcements and reference material on a medicinal product relating , for example , to pack changes , adverse - reaction warnings as part of general drug precautions , trade catalogues , price lists and reimbursement , provided they include no promotional claims relating to medicinal products ;


### – information by the marketing authorisation holder to the general public on medicinal products subject to medical prescription , which is subject to the provisions of title viiia . ### – information made available by the marketing authorisation holder to the general public on medicinal products subject to medical prescription , which is subject to the provisions of title viiia .


### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . ### without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public on authorised medicinal products subject to medical prescription , member states shall allow the marketing authorisation holder to make available , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii .


### the following types of information on authorised medicinal products subject to medical prescription may be disseminated by the marketing authorisation holder to the general public or members thereof : ### the marketing authorisation holder shall , in respect of authorised medicinal products subject to medical prescription , make available to the general public or members thereof a summary of the product characteristics , labelling and package leaflet of the medicinal product , as approved by the competent authorities , and the publicly accessible version of the assessment report drawn up by the competent authorities . this information should be made available both in electronic and in printed form and in a format accessible to people with disabilities . 2 . in addition , the following types of information may also be made available to the general public or members thereof by the marketing authorisation holder :


### information on the environmental impact of the medicinal product , prices and factual , informative announcements and reference material relating , for example , to pack changes or adverse - reaction warnings ; ### information relating to the disposal of unused medicinal products or waste derived from medicinal products , as well as reference to any collection system in place ; information on prices and factual , informative announcements and reference material on a medicinal product , relating , for example , to pack changes or adverse - reaction warnings ;


### information on the environmental impact of the medicinal product , prices and factual , informative announcements and reference material relating , for example , to pack changes or adverse - reaction warnings ; ### information on the environmental impact of the medicinal product , availability and prices , and factual , informative announcements , provided that no comparison is made to a previous situation or to another medicinal product of the same kind , and reference material on a medicinal product relating , for example , to pack changes , reimbursement , or adverse - reaction warnings ;


### information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio . it shall only be made available through the following channels : ### information on authorised medicinal products subject to medical prescription made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television , radio or in the printed media . it shall only be made available through the following channels :


### internet websites on medicinal products , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; ### marketing authorisation holders’ internet websites on medicinal products , to the exclusion of unsolicited material actively distributed to the general public or members thereof ;


### internet websites on medicinal products , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; ### internet websites and other electronic repositories containing information on medicinal products , to the exclusion of unsolicited distribution to citizens through mass communications such as e - mails and telephone text messages to multiple recipients ;


### the content and presentation of information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall fulfil the following conditions : ### the content and presentation of information on authorised medicinal products subject to medical prescription made available by the marketing authorisation holder to the general public or members thereof shall fulfil the following conditions :


### it must take into account the general needs and expectations of patients ; ### it must be patient - oriented to better meet their needs ;


### a statement indicating that the information is disseminated by a marketing authorisation holder ; ### a statement indicating that the information is made available by or on behalf of a named marketing authorisation holder ;


### comparisons between medicinal products ; ### comparisons between medicinal products regarding their quality , safety and efficiency , if disseminated by marketing authorisation holders except : - where those comparisons are included in officially approved documents , such as the summary of product characteristics ; - where those comparisons are based on comparative scientific studies published by the relevant national authorities or the european medicines agency ;


### the methods may include the voluntary control of information on medicinal products by self - regulatory or co - regulatory bodies and recourse to such bodies , if proceedings before such bodies are possible in addition to the judicial or administrative proceedings available in the member states . ### the methods may include the voluntary control of information on medicinal products by co - regulatory bodies and recourse to such bodies , if proceedings before such bodies are possible in addition to the judicial or administrative proceedings available in the member states .


### after consulting the member states , the commission shall draw up guidelines concerning information allowed under this title and containing a code of conduct for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescription . the commission shall draw up these guidelines on the entry into force of this directive and update them regularly on the basis of the experience gained . ### after consulting the member states and other stakeholders , the commission shall draw up guidelines concerning information allowed under this title and containing a mandatory code of conduct for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescription . the commission shall draw up these guidelines on the entry into force of this directive and update them regularly on the basis of the experience gained .


### member states shall ensure that marketing authorisation holders register internet websites containing information on medicinal products with the national competent authorities of the member state of the country code top level domain used by the website concerned , prior to making it available to the general public . where the website does not use a country code top level domain , the marketing authorisation holder shall select the member state of registration . ### member states shall ensure that marketing authorisation holders register internet websites under their control that are directed specifically at citizens of one or more member states and that contain information on prescription only medicines covered by this title , prior to making it available to the general public . where the website does not use a country code top level domain , the marketing authorisation holder shall select the member state of registration .


### internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holder websites unless they have also been registered in accordance with that paragraph . those websites shall identify the competent authority which granted the marketing authorisation and its website address . internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof . those websites shall not contain web - tv . ### internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holder websites containing information covered by this title unless they have also been registered in accordance with that paragraph . those websites shall identify the competent authority which granted the marketing authorisation and its website address . internet websites registered in accordance with paragraph 1 shall not allow the automatic identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof . those websites shall not contain video broadcast materials .


### the member state where the internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website . ### the member state where the internet website has been registered shall be responsible for the monitoring of the contents relating to medicinal products subject to medical prescription made available on that website .


### member states shall allow marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this directive . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval . ### member states shall require marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the website has been registered and is subject to monitoring in accordance with this directive . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval .


### massive flows of dirty money can damage the stability and reputation of the financial sector and threaten the single market , and terrorism shakes the very foundations of our society . in addition to the criminal law approach , a preventive effort via the financial system can produce results . ### massive flows of illicit money can damage the stability and reputation of the financial sector and threaten the single market , as well as international development , and terrorism shakes the very foundations of our society . crucial facilitators of illicit money flows are secretive corporate structures operating in and through secrecy jurisdiction , often also referred to as tax havens . in addition to the criminal law approach , a preventive effort via the financial system can produce results . however , the preventive approach should be targeted and proportional , and should not amount to an overall controlling system of the whole population .


### money laundering and terrorist financing are frequently carried out in an international context . measures adopted solely at national or even european union level , without taking account of international coordination and cooperation , would have very limited effects . the measures adopted by the european union in this field should therefore be consistent with other action undertaken in other international fora . the european union action should continue to take particular account of the recommendations of the fatf , which constitutes the foremost international body active in the fight against money laundering and terrorist financing . with the view to reinforce the efficacy of the fight against money laundering and terrorist financing , directives 2005 / 60 / ec and 2006 / 70 / ec should be aligned with the new fatf recommendations adopted and expanded in february 2012 . ### money laundering and terrorist financing are frequently carried out in an international context . measures adopted solely at national or even european union level , without taking account of international coordination and cooperation , would have very limited effects . the measures adopted by the european union in this field should therefore be consistent with other action undertaken in other international fora . the european union action should continue to take particular account of the recommendations of the fatf , which constitutes the foremost international body active in the fight against money laundering and terrorist financing . with the view to reinforce the efficacy of the fight against money laundering and terrorist financing , directives 2005 / 60 / ec and 2006 / 70 / ec should be aligned with the new fatf recommendations adopted and expanded in february 2012 . however , such an alignment with the non - binding fatf recommendations has to be carried out in full respect with the union legal order , especially as regards union data protection law and the protection of fundamental rights as enshrined in the charter of fundamental rights of the european union .


### furthermore , the misuse of the financial system to channel criminal or even clean money to terrorist purposes poses a clear risk to the integrity , proper functioning , reputation and stability of the financial system . accordingly , the preventive measures of this directive should cover not only the manipulation of money derived from crime but also the collection of money or property for terrorist purposes . ### furthermore , the misuse of the financial system to channel criminal or even clean money to terrorist purposes poses a clear risk to the integrity , proper functioning , reputation and stability of the financial system . accordingly , the preventive measures of this directive should cover not only the manipulation of money derived from crime but also the collection of money or property for terrorist purposes . it should also address the vulnerabilities of the financial systems in the different eu member states .


### furthermore , the misuse of the financial system to channel criminal or even clean money to terrorist purposes poses a clear risk to the integrity , proper functioning , reputation and stability of the financial system . accordingly , the preventive measures of this directive should cover not only the manipulation of money derived from crime but also the collection of money or property for terrorist purposes . ### furthermore , the misuse of the financial system to channel criminal or even clean money to terrorist purposes poses a clear risk to the integrity , proper functioning , reputation and stability of the financial system . accordingly , the preventive measures of this directive should cover the manipulation of money derived from serious crime and the collection of money or property for terrorist purposes .


### the use of large cash payments is vulnerable to money laundering and terrorist financing . in order to increase vigilance and mitigate the risks posed by cash payments natural or legal persons trading in goods should be covered by this directive to the extent that they make or receive cash payments of eur 7 500 or more . member states may decide to adopt stricter provisions including a lower threshold . ### the use of large cash payments is vulnerable to money laundering and terrorist financing . in order to increase vigilance and mitigate the risks posed by cash payments natural or legal persons trading in goods should be covered by this directive to the extent that they make or receive cash payments of eur 15 000 or more . member states may decide to adopt stricter provisions including a lower threshold .


### the use of large cash payments is vulnerable to money laundering and terrorist financing . in order to increase vigilance and mitigate the risks posed by cash payments natural or legal persons trading in goods should be covered by this directive to the extent that they make or receive cash payments of eur 7 500 or more . member states may decide to adopt stricter provisions including a lower threshold . ### the use of large cash payments is vulnerable to money laundering and terrorist financing . in order to increase vigilance and mitigate the risks posed by cash payments natural or legal persons trading in goods should be covered by this directive to the extent that they make or receive cash payments of eur 7 500 or more .


### the use of large cash payments is vulnerable to money laundering and terrorist financing . in order to increase vigilance and mitigate the risks posed by cash payments natural or legal persons trading in goods should be covered by this directive to the extent that they make or receive cash payments of eur 7 500 or more . member states may decide to adopt stricter provisions including a lower threshold . ### the use of large cash payments is vulnerable to money laundering and terrorist financing . in order to increase vigilance and mitigate the risks posed by cash payments natural or legal persons should be covered by this directive to the extent that they make or receive cash payments of eur 7 500 or more . member states may decide to adopt stricter provisions including a lower threshold .


### it is important to expressly highlight that ‘ tax crimes’ related to direct and indirect taxes are included in the broad definition of ‘ criminal activity’ under this directive in line with the revised fatf recommendations . ### it is important to expressly highlight that ‘ tax crimes’ related to direct and indirect taxes are included in the definition of ‘ criminal activity’ under this directive in line with the revised fatf recommendations .


### the need for accurate and up - to - date information on the beneficial owner is a key factor in tracing criminals who might otherwise hide their identity behind a corporate structure . member states should therefore ensure that companies retain information on their beneficial ownership and make this information available to competent authorities and obliged entities . in addition , trustees should declare their status to obliged entities . ### it is important to ensure and enhance the traceability of payments . the need for accurate and up - to - date information on the beneficial owner is a key factor in tracing criminals who might otherwise hide their identity behind a corporate structure . member states should therefore ensure that companies retain information on their beneficial ownership and make this information available to competent authorities and obliged entities . in addition , trustees should declare their status to obliged entities .


### the use of the gambling sector to launder the proceeds of criminal activity is of concern . in order to mitigate the risks related to the sector and to provide parity amongst the providers of gambling services , an obligation for all providers of gambling services to conduct customer due diligence for single transactions of eur 2 000 or more should be laid down . member states should consider applying this threshold to the collection of winnings as well as wagering a stake . providers of gambling services with physical premises should ensure that customer due diligence , if it is taken at the point of entry to the premises , can be linked to the transactions conducted by the customer on those premises . ### in order to mitigate the risks related to the use of the gambling sector to launder the proceeds of criminal activity and to provide parity amongst the providers of gambling services , an obligation for all providers of gambling services to conduct customer due diligence for single transactions of eur 2000 or more should be laid down . member states should consider applying this threshold to the collection of winnings as well as wagering a stake . providers of gambling services with physical premises subject to state supervision will be deemed in any event to have satisfied the customer due diligence requirements if they register , identify , and verify the identity of , their customers immediately on or before entry , whatever the value of the transactions to be carried out .


### underpinning the risk - based approach is a need for member states to identify , understand and mitigate the money laundering and terrorist financing risks it faces . the importance of a supra - national approach to risk identification has been recognised at international level , and the european supervisory authority , established by regulation no 1093 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 78 / ec29 ; the european supervisory authority , established by regulation no 1094 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 79 / ec30 ; and the european supervisory authority , established by regulation no 1095 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 77 / ec31 , should be tasked with issuing an opinion on the risks affecting the financial sector . __________________ 29 oj l 331 , 15 . 12 . 2010 , p . 12 . 30 oj l 331 , 15 . 12 . 2010 , p . 48 . 31 oj l 331 , 15 . 12 . 2010 , p . 84 . ### underpinning the risk - based approach is a need for member states and the union to identify , understand and mitigate the money laundering and terrorist financing risks it faces . the importance of a supra - national approach to risk identification has been recognised at international level , and the european supervisory authority , established by regulation no 1093 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 78 / ec29 ; the european supervisory authority , established by regulation no 1094 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 79 / ec30 ; and the european supervisory authority , established by regulation no 1095 / 2010 of the european parliament and of the council of 24 november 2010 establishing a european supervisory authority , amending decision no 716 / 2009 / ec and repealing commission decision 2009 / 77 / ec31 , should be tasked with issuing an opinion on the risks affecting the financial sector . __________________ 29 oj l 331 , 15 . 12 . 2010 , p . 12 . 30 oj l 331 , 15 . 12 . 2010 , p . 48 . 31 oj l 331 , 15 . 12 . 2010 , p . 84 .


### the results of risk assessments at member state level should , where appropriate , be made available to obliged entities to enable them to identify , understand and mitigate their own risks . ### the results of risk assessments should , where appropriate , be made available in a timely manner to obliged entities to enable them to identify , understand and mitigate their own risks .


### in order to better understand and mitigate risks at european union level , member states should share the results of their risk assessments with each other , the commission and eba , eiopa and esma , where appropriate . ### in order to better understand and mitigate risks at european union level , the commission should share the results of the risk assessments with member states and eba , eiopa and esma , where appropriate .


### this is particularly true of business relationships with individuals holding , or having held , important public positions , particularly those from countries where corruption is widespread . such relationships may expose the financial sector in particular to significant reputational and legal risks . the international effort to combat corruption also justifies the need to pay special attention to such cases and to apply appropriate enhanced customer due diligence measures in respect of persons who hold or have held prominent functions domestically or abroad and senior figures in international organisations . ### this is particularly true of relationships with individuals holding , or having held , important public positions , particularly those from countries where corruption is widespread . such relationships may expose the financial sector in particular to significant reputational and legal risks . the international effort to combat corruption also justifies the need to pay special attention to such cases and to apply appropriate enhanced customer due diligence measures in respect of persons who hold or have held prominent functions domestically or abroad and senior figures in international organisations .


### all member states have , or should , set up financial intelligence units to collect and analyse the information which they receive with the aim of establishing links between suspicious transactions and underlying criminal activity in order to prevent and combat money laundering and terrorist financing . suspicious transactions should be reported to the fius , which should serve as a national centre for receiving , analysing and disseminating to the competent authorities suspicious transaction reports and other information regarding potential money laundering or terrorist financing . this should not compel member states to change their existing reporting systems where the reporting is done through a public prosecutor or other law enforcement authorities , as long as the information is forwarded promptly and unfiltered to fius , allowing them to perform their tasks properly , including international cooperation with other fius . ### all member states have , or should , set up financial intelligence units to collect and analyse the information which they receive with the aim of establishing links between suspicious transactions and underlying criminal activity in order to prevent and combat money laundering and terrorist financing . suspicious transactions should be reported to the fius , which should serve as a national centre for receiving and analysing suspicious transactions report and other information relevant to money laundering , associated predicate offences and terrorist financing , and for disseminating to the competent authorities the results of these analyses . this should not compel member states to change their existing reporting systems where the reporting is done through a public prosecutor or other law enforcement authorities , as long as the information is forwarded promptly and unfiltered to fius , allowing them to perform their tasks properly , including international cooperation with other fius .


### certain aspects of the implementation of this directive involve the collection , analysis , storage and sharing of data . the processing of personal data should be permitted in order to comply with the obligations laid down in this directive , including carrying out of customer due diligence , ongoing monitoring , investigation and reporting of unusual and suspicious transactions , identification of the beneficial owner of a legal person or legal arrangement , sharing of information by competent authorities and sharing of information by financial institutions . the personal data collected should be limited to what is strictly necessary for the purpose of complying with the requirements of this directive and not further processed in a way inconsistent with directive 95 / 46 / ec . in particular , further processing of personal data for commercial purposes should be strictly prohibited . ### certain aspects of the implementation of this directive involve the collection , analysis , storage and sharing of data . the processing of personal data should be permitted in order to comply with the obligations laid down in this directive , including carrying out of customer due diligence , ongoing monitoring , investigation and reporting of unusual and suspicious transactions , identification of the beneficial owner of a legal person or legal arrangement , identification of a politically exposed person , sharing of information by competent authorities and sharing of information by financial institutions . the personal data collected should be limited to what is strictly necessary for the purpose of complying with the requirements of this directive and not further processed in a way inconsistent with directive 95 / 46 / ec . in particular , further processing of personal data for commercial purposes should be strictly prohibited .


### certain aspects of the implementation of this directive involve the collection , analysis , storage and sharing of data . the processing of personal data should be permitted in order to comply with the obligations laid down in this directive , including carrying out of customer due diligence , ongoing monitoring , investigation and reporting of unusual and suspicious transactions , identification of the beneficial owner of a legal person or legal arrangement , sharing of information by competent authorities and sharing of information by financial institutions . the personal data collected should be limited to what is strictly necessary for the purpose of complying with the requirements of this directive and not further processed in a way inconsistent with directive 95 / 46 / ec . in particular , further processing of personal data for commercial purposes should be strictly prohibited . ### certain aspects of the implementation of this directive involve the collection , analysis , storage and sharing of data . the processing of personal data should be permitted in order to comply with the obligations laid down in this directive , including carrying out of customer due diligence , ongoing monitoring , investigation and reporting of unusual and suspicious transactions , identification of the beneficial owner of a legal person or legal arrangement , sharing of information by competent authorities and sharing of information by financial institutions . the personal data collected should be limited to what is necessary for the purpose of complying with the requirements of this directive and not further processed in a way inconsistent with directive 95 / 46 / ec . in particular , further processing of personal data for commercial purposes should be strictly prohibited .


### the rights of access of the data subject are applicable to the personal data processed for the purpose of this directive . however , access by the data subject to information contained in a suspicious transaction report would seriously undermine the effectiveness of the fight against money laundering and terrorist financing . limitations to this right in accordance with the rules laid down in article 13 of directive 95 / 46 / ec may therefore be justified . ### the rights of access of the data subject are applicable to the personal data processed for the purpose of this directive . however , access by the data subject to information contained in a suspicious transaction report would seriously undermine the effectiveness of the fight against money laundering and terrorist financing . limitations to this right in accordance with the rules laid down in article 13 of directive 95 / 46 / ec may therefore be justified . however , such limitations have to be counterbalanced by by effective powers of data protection authorities , including the indirect access powers , as laid down in directive 95 / 46 / ec to investigate , either ex officio or based on a complaint , any claims as regards problems with personal data processing . this should include particularly access to the data file at the obliged entity .


### the rights of access of the data subject are applicable to the personal data processed for the purpose of this directive . however , access by the data subject to information contained in a suspicious transaction report would seriously undermine the effectiveness of the fight against money laundering and terrorist financing . limitations to this right in accordance with the rules laid down in article 13 of directive 95 / 46 / ec may therefore be justified . ### the rights of access of the data subject are applicable to the personal data processed for the purpose of this directive . however , access by the data subject to information contained in a suspicious transaction report , or obtained in order to examine transactions or patterns of transactions , which have no apparent economic or lawful purpose , would seriously undermine the effectiveness of the fight against money laundering and terrorist financing . limitations to this right in accordance with the rules laid down in article 13 of directive 95 / 46 / ec are therefore justified .


### feedback should , where practicable , be made available to obliged entities on the usefulness and follow - up of the suspicious transactions reports they present . to make this possible , and to be able to review the effectiveness of their systems to combat money laundering and terrorist financing member states should keep and improve the relevant statistics . to further enhance the quality and consistency of the statistical data collected at union level , the commission should keep track of the eu - wide situation with respect to the fight against money laundering and terrorist financing and publish regular overviews . ### feedback should , where practicable , be made available to obliged entities on the usefulness and follow - up of the suspicious transactions reports they present . to make this possible , and to be able to review the effectiveness of their systems to combat money laundering and terrorist financing member states should keep and improve the relevant statistics . to further enhance the quality and consistency of the statistical data collected at union level , the commission should keep track of the eu - wide situation with respect to the fight against money laundering and terrorist financing and publish regular overviews . the commission should also include in its overviews an evaluation of national risk assessments . the first overview by the commission should be carried out within one year from the date of entry into force of this directive .


### improving the exchange of information between fius within the eu is of particular importance to face the transnational character of money laundering and terrorist financing . the use of secure facilities for the exchange of information , especially the decentralised computer network fiu . net and the techniques offered by that network should be encouraged by member states . ### improving the exchange of information between fius within the eu is of particular importance to face the transnational character of money laundering and terrorist financing . the use of secure facilities for the exchange of information and the techniques offered by such a network should be encouraged by member states .


### this directive respects the fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union , in particular , the respect for private and family life , the right to protection of personal data , the freedom to conduct a business , the prohibition of discrimination , the right to an effective remedy and to a fair trial , and the right of defence . ### this directive respects the fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union , in particular , the respect for private and family life , the presumption of innocence , the right to protection of personal data , the freedom to conduct a business , the prohibition of discrimination , the right to an effective remedy and to a fair trial , and the right of defence .


### the conversion or transfer of property , knowing that such property is derived from criminal activity or from an act of participation in such activity , for the purpose of concealing or disguising the illicit origin of the property or of assisting any person who is involved in the commission of such activity to evade the legal consequences of his action ; ### the conversion or transfer of property , knowing , or should have known based on concrete facts and circumstances , that such property is derived from criminal activity or from an act of participation in such activity , for the purpose of concealing or disguising the illicit origin of the property or of avoiding freezing or confiscation orders or of assisting any person who is involved in the commission of such activity to evade the legal consequences of his action ;


### creation , operation or management of trusts , companies or similar structures ; ### creation , operation or management of trusts , foundations , mutuals , companies or similar structures ;


### all offences , including tax crimes related to direct taxes and indirect taxes , which are punishable by deprivation of liberty or a detention order for a maximum of more than one year or , as regards those states which have a minimum threshold for offences in their legal system , all offences punishable by deprivation of liberty or a detention order for a minimum of more than six months ; ### all offences , including tax offences related to direct taxes and indirect taxes , which are punishable by deprivation of liberty or a detention order for a maximum of more than one year or , as regards those states which have a minimum threshold for offences in their legal system , all offences punishable by deprivation of liberty or a detention order for a minimum of more than six months ; this linguistic change is proposed to align in particular the english language version with other language versions making clear that criminal law tax offences are addressed .


### if there is any doubt that the person identified in point are the beneficial owner , the natural person who exercises control over the management of a legal entity through other means ; ### if there is any doubt that the person identified in point are the beneficial owner or if after having taken all the necessary measures no person can be found under point , the natural person who exercises control over the legal entity or its management through other means , which may include senior managing officials ;


### in the case of legal entities , such as foundations , and legal arrangements , such as trusts , which administer and distribute funds : ### in the case of legal entities , such as foundations , and legal arrangements , such as trusts or mutuals , which administer and distribute funds :


### ' domestic politically exposed persons ' means natural persons who are or who have been entrusted by a member state with prominent public functions ; ### ' domestic politically exposed persons ' means natural persons who are or who have been entrusted by the member state with prominent public functions ; linguistic amendment


### members of the administrative , management or supervisory bodies of state owned enterprises . ### senior members of the administrative , management or supervisory bodies of state owned enterprises .


### 1 : the member states may adopt or retain in force stricter provisions in the field covered by this directive to prevent money laundering and terrorist financing . ### 1 : the member states may adopt or retain in force stricter provisions in the field covered by this directive to prevent money laundering and terrorist financing , provided that such provisions are in full compliance with the union legal order , especially as regards union data protection rules and the protection of fundamental rights as enshrined in the charter of fundamental rights of the european union .


### the european banking authority , european insurance and occupational pensions authority and european securities and markets authority shall provide a joint opinion on the money laundering and terrorist financing risks affecting the internal market . ### the commission shall provide an assessment at european level on the identification , understanding and analysis of cross - border phenomena and money laundering and terrorist financing risks affecting the internal market . in order to prepare and carry out the assessment the commission shall be assisted by the expert group on money laundering and terrorist financing and include advice from the european banking authority , the european insurance and occupational pensions authority , the european securities and markets authority , the european data protection supervisor , the committee of european financial intelligence units , the article 29 working party , europol and other relevant authorities .


### the european banking authority , european insurance and occupational pensions authority and european securities and markets authority shall provide a joint opinion on the money laundering and terrorist financing risks affecting the internal market . ### the commission shall produce an assessment on the money laundering and terrorist financing risks affecting the internal market . in order to produce such assessment , the commission will consult the member states , the european banking authority , the european insurance and occupational pensions authority , the european securities and markets authority , the edps , article 29 working party , europol and other relevant authorities .


### the european banking authority , european insurance and occupational pensions authority and european securities and markets authority shall provide a joint opinion on the money laundering and terrorist financing risks affecting the internal market . the opinion shall be provided within 2 years from the date of entry into force of this directive . ### the european commission shall produce an assessment on the money laundering and terrorist financing risks affecting the internal market . in order to produce such assessment , the european commission will consult europol , the european banking authority , the european insurance and occupational pensions authority , the european securities and markets authority , and other authorities , as necessary . the assessment shall be produced within 2 years from the date of entry into force of this directive .


### each member state shall designate an authority to co - ordinate the national response to the risks referred to in paragraph 1 . the identity of that authority shall be notified to the commission , eba , eiopa and esma and other member states . ### each member state shall designate an authority to co - ordinate the national response to the risks referred to in paragraph 1 . the identity of that authority shall be notified to the commission , eba , eiopa , europol and esma and other member states .


### each member state shall take appropriate steps to identify , assess , understand and mitigate the money laundering and terrorist financing risks affecting it , and keep the assessment up - to - date . ### each member state shall take appropriate steps to identify , assess , understand and mitigate the money laundering and terrorist financing risks affecting it , as well as data protection concerns in that regard , and keep the assessment up - to - date .


### make appropriate information available to obliged entities to carry out their own money laundering and terrorist financing risk assessments . ### make appropriate information available to obliged entities in a timely manner to carry out their own money laundering and terrorist financing risk assessments .


### member states shall make the results of their risk assessments available to the other member states , the commission , and eba , eiopa and esma upon request . ### member states shall make the results of their risk assessments available to the other member states , the commission , and eba , eiopa and esma upon request . a summary of the assessment shall be publicly available . that summary shall not contain classified information .


### the assessments referred to in paragraph 1 shall be documented , kept up to date and be made available to competent authorities and self - regulatory bodies . ### the assessments referred to in paragraph 1 shall be documented , kept up to date and be made available to competent authorities and self - regulatory bodies upon request .


### the development of internal policies , procedures and controls , including customer due diligence , reporting , record keeping , internal control , compliance management and employee screening ; ### the development of internal policies , procedures and controls , including model risk management practices , customer due diligence , reporting , record keeping , internal control , compliance management and employee screening ;


### identifying the beneficial owner and taking reasonable measures to verify his identity so that the institution or person covered by this directive is satisfied that it knows who the beneficial owner is , including , as regards legal persons , trusts and similar legal arrangements , taking reasonable measures to understand the ownership and control structure of the customer ; ### further to the identification of the beneficial owner as listed in a register pursuant to article 29 , taking reasonable measures to verify his identity so that the institution or person covered by this directive is satisfied that it knows who the beneficial owner is , including , as regards legal persons , trusts , foundations , mutuals , holdings and all other similar existing or future legal arrangements , taking all necessary measures to understand the ownership and control structure of the customer ;


### by way of derogation from paragraph 1 , member states may allow the verification of the identity of the customer and the beneficial owner to be completed during the establishment of a business relationship if this is necessary not to interrupt the normal conduct of business and where there is little risk of money laundering or terrorist financing occurring . in such situations these procedures shall be completed as soon as practicable after the initial contact . ### by way of derogation from paragraph 1 , member states shall allow the verification of the identity of the customer and the beneficial owner to be completed during the establishment of a business relationship or during the execution of the transaction for entities subject to the obligations referred to in article 2 and , at all events , at the time when any winnings are paid out , if this is necessary not to interrupt the normal conduct of business and where there is little risk of money laundering or terrorist financing occurring . in such situations these procedures shall be completed as soon as practicable after the initial contact .


### when assessing the money laundering and terrorist financing risks relating to types of customers , countries or geographic areas , and particular products , services , transactions or delivery channels , member states and obliged entities shall take into account at least the factors of potentially lower risk situations set out in annex ii . ### when assessing the money laundering and terrorist financing risks relating to types of customers , countries or geographic areas , and particular products , services , transactions or delivery channels , member states and obliged entities shall take into account at least the factors relating to customer and product , service , transaction or delivery channel as potentially lower risk situations set out in annex ii .


### member states shall require obliged entities to examine , as far as reasonably possible , the background and purpose of all complex , unusual large transactions , and all unusual patterns of transactions , which have no apparent economic or lawful purpose . in particular , they shall increase the degree and nature of monitoring of the business relationship , in order to determine whether those transactions or activities appear unusual or suspicious . ### member states shall require obliged entities to examine , the background and purpose of all complex , unusual large transactions , and all unusual patterns of transactions , which have no apparent economic or lawful purpose , or which constitute tax offences within the meaning of article 3 . in particular , they shall increase the degree and nature of monitoring of the business relationship , in order to determine whether those transactions or activities appear unusual or suspicious .


### when assessing the money laundering and terrorist financing risks , member states and obliged entities shall take into account at least the factors of potentially higher - risk situations set out in annex iii . ### when assessing the money laundering and terrorist financing risks , member states and obliged entities shall take into account at least the factors relating to customer and product , service , transaction or delivery channel as potentially higher - risk situations set out in annex iii .


### the measures referred to in articles 18 , 19 and 20 shall also apply to family members or persons known to be close associates of such politically exposed persons . ### the measures referred to in articles 18 , 19 and 20 with the exception of article 19a shall also apply to family members or persons that evidence indicates are close associates of such politically exposed persons .


### where a person referred to in articles 18 , 19 and 20 has ceased to be entrusted with a prominent public function by a member state or a third country or with a prominent function by an international organisation , obliged entities shall be required to consider the continuing risk posed by that person and to apply such appropriate and risk - sensitive measures until such time as that person is deemed to pose no further risk . this period of time shall not be less than 18 months . ### where a person referred to in articles 18 , 19 and 20 has ceased to be entrusted with a prominent public function by a member state or a third country or with a prominent function by an international organisation , obliged entities shall be required to consider the continuing risk posed by that person and to apply such appropriate and risk - sensitive measures until such time as that person is deemed to pose no further risk . this period of time shall not be less than 12 months .


### the effective implementation of requirements referred to in point is supervised at group level by a competent authority . ### the effective implementation of requirements referred to in point is supervised at group level by a home competent authority in cooperation with host competent authorities .


### the fiu shall be established as a central national unit . it shall be responsible for receiving , analysing and disseminating to the competent authorities , disclosures of information which concern potential money laundering or associated predicate offences , potential terrorist financing or are required by national legislation or regulation . the fiu shall be provided with adequate resources in order to fulfil its tasks . ### the fiu shall be established as a central national unit . it shall be responsible for receiving , analysing and disseminating to the competent authorities , disclosures of information which concern potential money laundering or associated predicate offences , potential terrorist financing or are required by national legislation or regulation . the fiu shall be provided with adequate financial , technical and human resources in order to fulfil its tasks . member states shall ensure that the fiu is free from undue interference .


### member states shall ensure that the fiu has access , directly or indirectly , on a timely basis , to the financial , administrative and law enforcement information that it requires to properly fulfil its tasks . in addition , fius shall respond to requests for information by law enforcement authorities in their member state unless there are factual reasons to assume that the provision of such information would have a negative impact on ongoing investigations or analyses , or , in exceptional circumstances , where divulgation of the information would be clearly disproportionate to the legitimate interests of a natural or legal person or irrelevant with regard to the purposes for which it has been requested . ### member states shall ensure that the fiu has access , directly or indirectly , on a timely basis , to the financial , administrative and law enforcement information that it requires to properly fulfil its tasks . in addition , fius shall respond to requests for information by law enforcement authorities in their member state related to investigations of money laundering , associated predicate offences and terrorist financing , unless there are factual reasons to assume that the provision of such information would have a negative impact on ongoing investigations or analyses , or , in exceptional circumstances , where divulgation of the information would be clearly disproportionate to the legitimate interests of a natural or legal person or irrelevant with regard to the purposes for which it has been requested . when the fiu receives such a request , the decision to conduct analysis and / or dissemination of information to the requesting law enforcement authority should remain within the fiu .


### member states shall take all appropriate measures in order to protect employees of the obliged entity who report suspicions of money laundering or terrorist financing either internally or to the fiu from being exposed to threats or hostile action . ### member states shall ensure that individuals , including employees and representatives of the obliged entity who report suspicions of money laundering or terrorist financing either internally or to the fiu are duly protected from being exposed to threats or hostile action , adverse treatment or adverse consequence . member states shall guarantee legal aid free of charge for such persons and shall provide secure communication channels for persons to report suspicions of money laundering or terrorist financing .


### the prohibition laid down in paragraph 1 shall not include disclosure to the competent authorities of member states , including the self - regulatory bodies , or disclosure for law enforcement purposes . ### the prohibition laid down in paragraph 1 shall not include disclosure to the competent authorities of member states , including the self - regulatory bodies , data protection authorities or disclosure for law enforcement purposes .


### for the purposes of the first subparagraph , a ‘ network’ shall mean the larger structure to which the person belongs and which shares common ownership , management or compliance control . ### for the purposes of the first subparagraph , a ' network ' shall mean the larger structure to which the person belongs and which shares common ownership , management , standards , methods or compliance control .


### in the case of the customer due diligence , a copy or the references of the evidence required , for a period of five years after the business relationship with their customer has ended . upon expiration of this period , personal data shall be deleted unless otherwise provided for by national law , which shall determine under which circumstances obliged entities may or shall further retain data . member states may allow or require further retention only if necessary for the prevention , detection or investigation of money laundering and terrorist financing . the maximum retention period after the business relationship has ended shall not exceed ten years ; ### in the case of the customer due diligence , a copy or the references of the evidence required , for a period of five years after the business relationship with their customer has ended or after the date of the occasional transaction . upon expiration of this period , personal data shall be deleted unless otherwise provided for by national law , which shall determine under which circumstances obliged entities may or shall further retain data . member states may allow or require further retention only if necessary for the prevention , detection or investigation of money laundering and terrorist financing . the maximum retention period after the business relationship has ended shall not exceed ten years ;


### in the case of the customer due diligence , a copy or the references of the evidence required , for a period of five years after the business relationship with their customer has ended . upon expiration of this period , personal data shall be deleted unless otherwise provided for by national law , which shall determine under which circumstances obliged entities may or shall further retain data . member states may allow or require further retention only if necessary for the prevention , detection or investigation of money laundering and terrorist financing . the maximum retention period after the business relationship has ended shall not exceed ten years ; ### in the case of the customer due diligence , a copy or the references of the evidence required , for a period of five years after the business relationship with their customer has ended , or after the date of the occasional transaction . upon expiration of this period , personal data shall be deleted unless otherwise provided for by national law , which shall determine under which circumstances obliged entities may or shall further retain data . member states may allow or require further retention only if necessary for the prevention , detection or investigation of money laundering and terrorist financing . the maximum retention period after the business relationship has ended shall not exceed ten years ;


### in respect of the obliged entities referred to in article 2 , , and , member states shall ensure that competent authorities take the necessary measures to prevent criminals or their associates from holding or being the beneficial owner of a significant or controlling interest , or holding a management function in those obliged entities . ### in respect of the obliged entities referred to in article 2 , , and , member states shall ensure that competent authorities and self - regulatory bodies take the necessary measures to prevent criminals or their associates from holding or being the beneficial owner of a significant or controlling interest , or holding a management function in those obliged entities .


### member states shall ensure that policy makers , the fiu , law enforcement authorities , supervisors and other competent authorities involved in anti - money laundering and combating terrorist financing have effective mechanisms to enable them to co - operate and co - ordinate domestically concerning the development and implementation of policies and activities to combat money laundering and terrorist financing . ### member states shall ensure that policy makers , the fiu , law enforcement authorities , supervisors , data protection authorities and other competent authorities involved in anti - money laundering and combating terrorist financing have effective mechanisms to enable them to co - operate and co - ordinate domestically concerning the development and implementation of policies and activities to combat money laundering and terrorist financing .


### the competent authorities shall provide eba , eiopa and esma with all the information necessary to carry out their duties under this directive . ### without prejudice to data protection rules , the competent authorities shall provide eba , eiopa and esma with all the relevant information necessary to carry out their duties under this directive .


### member states shall ensure that their fius co - operate with each other to the greatest extent possible irrespective of whether they are administrative , law enforcement or judicial or hybrid authorities . ### member states shall ensure that their fius co - operate with each other to the greatest extent possible irrespective of whether they are administrative , law enforcement or judicial or hybrid authorities , without prejudice to union data protection rules .


### a public statement which indicates the natural or legal person and the nature of the breach ; ### a public statement which indicates the natural or legal person and the nature of the breach , if necessary and proportionate after a case by case evaluation ;


### for the purpose of point , where the legal person is a subsidiary of a parent undertaking , the relevant total annual turnover shall be the total annual turnover resulting from the consolidated account of the ultimate parent undertaking in the preceding business year . ### for the purpose of point , where the legal person is a subsidiary of a parent undertaking , the relevant total annual turnover shall be the total annual turnover resulting from the account of the subsidiary .


### member states shall ensure that competent authorities publish any sanction or measure imposed for breach of the national provisions adopted in the implementation of this directive without undue delay including information on the type and nature of the breach and the identity of persons responsible for it , unless such publication would seriously jeopardise the stability of financial markets . where publication would cause a disproportionate damage to the parties involved , competent authorities shall publish the sanctions on an anonymous basis . ### member states shall ensure that competent authorities publish any sanction or measure imposed for breach of the national provisions adopted in the implementation of this directive , if necessary and proportionate after a case by case evaluation , without undue delay including information on the type and nature of the breach and the identity of persons responsible for it . where publication would cause a disproportionate damage to the parties involved , competent authorities may publish the sanctions on an anonymous basis .


### eba , eiopa , and esma shall issue guidelines addressed to competent authorities in accordance with article 16 of regulation no 1093 / 2010 , of regulation no 1094 / 2010 and of regulation no 1095 / 2010 on types of administrative measures and sanctions and level of administrative pecuniary sanctions applicable to obliged entities referred to in article 2 and . these guidelines shall be issued within 2 years of the date of entry into force of this directive . ### eba , eiopa , and esma shall issue guidelines addressed to competent authorities in accordance with article 16 of regulation no 1093 / 2010 , of regulation no 1094 / 2010 and of regulation no 1095 / 2010 on types of administrative measures and sanctions and level of administrative pecuniary sanctions applicable to obliged entities referred to in article 2 and . these guidelines shall be issued within one year of the date of entry into force of this directive .


### third countries having effective anti - money laundering / combating terrorist financing systems ; ### third countries identified by credible sources , such fatf public statements , mutual evaluation or detailed assessment reports or published follow - up reports , as having effective anti - money laundering / combating terrorist financing systems ;


### non - face - to - face business relationships or transactions ; ### non - face - to - face business relationships or transactions , without certain safeguards , e . g . electronic signatures ;


### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . ### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , and anti - corruption , bribery , and tax evasion matters . such a statement should include a description of the policies , results , and the risks related to those matters .


### for companies whose average number of employees during the financial year exceeds 500 and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including : ### for companies whose average number of employees during the financial year exceeds 500 and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , and anti - corruption , bribery , and tax evasion matters , including :


### the risks related to these matters and how the company manages those risks . ### the principal risks related to these matters and how the company manages those risks .


### ' 4 . where a company prepares a comprehensive report corresponding to the same financial year relying on national , eu - based or international frameworks and which covers the information provided for in paragraph 1 , it shall be exempt from the obligation to prepare the non - financial statement set out in paragraph 1 , provided that such report is part of the annual report . ' ### ' 4 . where a company prepares a comprehensive report corresponding to the same financial year relying on eu - based or international frameworks and which covers the information provided for in paragraph 1 , it shall be exempt from the obligation to prepare the non - financial statement set out in paragraph 1 , provided that such report is part of the annual report . '


### ' 4 . point of paragraph 1 does not apply to companies within the meaning of article 27 . ' ### ' 4 . point of paragraph 1 does not apply to companies within the meaning of article 27 and to micro , small and medium - sized enterprises as defined in commission recommendation 2003 / 3611 . ' __________________ 1 commission recommendation 2003 / 361 / ec of 6 may 2003 concerning the definition of micro , small and medium - sized enterprises .


### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following : ### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , and anti - corruption , bribery , and tax evasion matters , including the following :


### in providing such information the consolidated annual report may rely on national , eu - based or international frameworks and if so , shall specify which frameworks it has relied upon . ### in providing such information the consolidated annual report may rely on eu - based or international frameworks and if so , shall specify which frameworks it has relied upon .


### ' 4 . where a parent undertaking prepares a comprehensive report corresponding to the same financial year , referring to the whole group of consolidated undertakings , relying on national , eu - based or international frameworks and covering the information provided for in the third subparagraph of paragraph 1 , the parent undertaking shall be exempt from the obligation to prepare the non - financial statement set out in the third subparagraph of paragraph 1 , provided that such comprehensive report is part of the consolidated annual report . ' ### ' 4 . where a parent undertaking prepares a comprehensive report corresponding to the same financial year , referring to the whole group of consolidated undertakings , relying on eu - based or international frameworks and covering the information provided for in the third subparagraph of paragraph 1 , the parent undertaking shall be exempt from the obligation to prepare the non - financial statement set out in the third subparagraph of paragraph 1 , provided that such comprehensive report is part of the consolidated annual report . '


### the european railway agency was originally established by regulation 881 / 2004 of the european parliament and of the council of 29 april 2004 , in order to promote the establishment of a european railway area without borders and to help revitalise the railway sector while reinforcing its essential advantages in terms of safety . regulation 881 / 2004 has to be replaced by a new act due to substantial amount of changes to the tasks of the agency and its internal organisation . ### the european railway agency was originally established by regulation 881 / 2004 of the european parliament and of the council of 29 april 2004 , in order to promote the establishment of a european railway area without borders and to help revitalise the railway sector while reinforcing its essential advantages in terms of safety . regulation 881 / 2004 has to be replaced by a new act due to the substantial changes which should be made to the tasks of the agency and its internal organisation .


### the fourth railway package proposes important changes to improve the functioning of the single european railway area through amendments by way of recast to directive 2004 / 49 / ec and directive 2008 / 57 / ec , both directly linked to the tasks of the agency . those directives , together with this regulation , provide in particular for performing tasks related to issuing vehicle authorisations and safety certificates at the union level . it implies a greater role of the agency . ### the fourth railway package proposes important changes to improve the functioning of the single european railway area through amendments by way of recast to directive 2004 / 49 / ec and directive 2008 / 57 / ec , both directly linked to the tasks of the agency . those directives , together with this regulation , provide in particular for performing tasks related to issuing vehicle authorisations and safety certificates , especially in cross - border traffic at the union level . it implies a greater role of the agency .


### in order to further pursue the development of single european rail area , in particular with relation to providing appropriate information to freight customers and passengers , and taking into account current involvement of the agency , it is necessary to give it a strengthened role in the field of telematics applications . this would ensure their consistent development and swift deployment . ### in order to further pursue the development of single european rail area , in particular with relation to providing appropriate information to freight customers and passengers , and taking into account current involvement of the agency , it is necessary to give it a strengthened role in the field of telematics applications . this would ensure their consistent development and swift deployment , excluding commercial applications , which remain the responsibility of the operators .


### the agency may , if necessary , appoint to the working parties independent experts and representatives of international organisations recognised as competent in the field concerned . staff of the agency may not be appointed to the working parties . ### the agency may , if necessary , appoint to the working parties independent experts and representatives of international organisations recognised as competent in the field concerned . staff of the agency may not be appointed to the working parties , except for the chair of the working parties , who shall be a representative of the agency .


### each representative body referred to in article 34 shall forward to the agency a list of the most qualified experts mandated to represent them in each working party . ### each year , each representative body referred to in article 34 shall forward to the agency a list of the most qualified experts mandated to represent them in each working party .


### these consultations shall be held before the agency submits its recommendations to the commission . the agency shall take due account of these consultations , and shall , at all times , be available to expound on its recommendations . the opinions expressed by the sectoral dialogue committee shall be forwarded by the agency to the commission and by the commission to the committee referred to in article 75 . ### these consultations shall be held before the agency submits its recommendations to the commission . the agency shall take due account of these consultations , and shall , at all times , be available to expound on its recommendations . the opinions expressed by the sectoral dialogue committee shall be forwarded , within two months , by the agency to the commission and by the commission to the committee referred to in article 75 .


### these consultations shall be held before the agency submits its proposals to the commission . the agency shall take due account of these consultations , and shall , at all times , be available to expound on its proposals . the opinions expressed by the organisations concerned shall be forwarded by the agency to the commission and by the commission to the committee referred to in article 75 . ### these consultations shall be held before the agency submits its proposals to the commission . the agency shall take due account of these consultations , and shall , at all times , be available to expound on its proposals . the opinions expressed by the organisations concerned shall be forwarded , within two months , by the agency to the commission and by the commission to the committee referred to in article 75 .


### the agency shall issue single safety certificates in accordance with articles 10 and 11 of directive … [ the safety directive ] . ### in accordance with articles 10 and 11 of directive . . . [ the safety directive ] , the agency shall act as the appeals body in the event of a dispute concerning single safety certificates between the national safety authority of the member state in which the railway undertaking is established and the national safety authority of the member state in which the railway undertaking operates .


### the agency shall issue authorisations for placing in service of the trackside control - command and signalling subsystems located or operated in the entire union in accordance with article 18 of directive … [ the interoperability directive ] . ### the agency is the decision making authority for trackside ertms in accordance with article 18 of directive . . . [ the interoperability directive ] .


### where after the examination referred to paragraph 1 the agency considers that national rules enable the essential requirements for interoperability to be fulfilled , csms to be respected and the csts to be achieved , and that they would not result in arbitrary discrimination or a disguised restriction on rail transport operation between member states , the agency shall inform the commission and the member state concerned about its positive assessment . the commission may validate the rule in the it system referred to in article 23 . ### where after examination and within the deadlines referred to in paragraph 1 the agency considers that national rules enable the essential requirements for interoperability to be fulfilled , csms to be respected and the csts to be achieved , and that they would not result in arbitrary discrimination or a disguised restriction on rail transport operation , the agency shall inform the commission and the member state concerned about its positive assessment . the commission may validate the rule in the it system referred to in article 23 .


### issue a recommendation addressed to the member state concerned stating the reasons why the rule in question should be modified or repealed ; ### issue a recommendation addressed to the member state concerned , that the problematic rule be repealed or modified immediately , and stating the reasons why that rule has to be modified or repealed ;


### if the agency considers that the deficiencies referred to in paragraph 3 prevent the national safety authority concerned from effectively performing its tasks in relation to railway safety and interoperability , the agency shall recommend to the national safety authority to take appropriate steps within a time limit to be defined taking into account the importance of the deficiency . ### if the agency considers that the deficiencies referred to in paragraph 3 prevent the national safety authority concerned from effectively performing its tasks in relation to railway safety and interoperability , the agency shall recommend to the national safety authority to take appropriate steps within a time limit which it defines taking into account the importance of the deficiency .


### the national rules notified to the commission in accordance with article 8 of directive … [ railway safety directive ] and articles 14 of directive … [ interoperability directive ] ; ### the national rules notified to the commission in accordance with article 8 of directive … [ railway safety directive ] and article 14 of directive … [ interoperability directive ] and the agency ' s assessment of them ;


### the term of office of the members shall be four years and may be renewed . ### the term of office of the members shall be five years and may be renewed once .


### the term of office of the chairperson and deputy chairperson shall be four years and may be renewed . if , however , their membership of the management board ends at any time during their term of office , their term of office shall automatically expire on that date also . ### the term of office of the chairperson and deputy chairperson shall be five years and may be renewed once . if , however , their membership of the management board ends at any time during their term of office , their term of office shall automatically expire on that date also .


### the work programme shall be adopted without prejudice to the union’s annual budgetary procedure . if , within 15 days of the date of adoption of the work programme , the commission expresses its disagreement with the programme , the management board shall re - examine the programme and adopt it , as amended if necessary , within a period of two months , in second reading either by a two - thirds majority of its members entitled to vote , including by all commission representatives , or by unanimity of the representatives of the member states . ### the work programme shall be adopted without prejudice to the union’s annual budgetary procedure . if , within 15 days of the date of adoption of the work programme , the commission expresses its disagreement with the programme , the management board shall re - examine the programme and adopt it , as amended if necessary , within a period of two months , in second reading by a two - thirds majority of its members entitled to vote , including all commission representatives .


### the term of office of the members and alternates of a board of appeal shall be four years and may be renewed . ### the term of office of the members and alternates of a board of appeal shall be five years and may be renewed once .


### an appeal may be brought before the board of appeal against decisions taken by the agency pursuant to articles 12 , 16 , 17 and 18 . ### an appeal may be brought before the board of appeal against decisions taken , or not taken within the prescribed time limits , by the agency pursuant to articles 12 , 16 , 17 and 18 .