### the provision of services other than statutory audit to audited entities by statutory auditors , audit firms or members of their networks may compromise their independence . therefore , it is appropriate to require the statutory auditor , the audit firm and the members of their network not to provide non - audit services to their audited entities . the provision of non - audit services by an audit firm to a company would prevent that audit firm from carrying out statutory audit of that company , thus resulting in a reduction of the audit firms available to provide statutory audit , in particular with regard to the audit of large public - interest entities where the market is concentrated . as a result , in order to secure that a minimum number of audit firms is able to provide audit services to large public - interest entities , it is appropriate to request that audit firms of significant dimension focus their professional activity on the carrying out of statutory audit and are not allowed to undertake other services unconnected to their statutory audit function such as consultancy or advisory services . ### the provision of services other than statutory audit to audited entities by statutory auditors , audit firms or members of their networks may compromise their independence . therefore , it is appropriate to require safeguards to reduce threats to independence to be taken and to require prior approval by the audit committee of the audited entity for any such services as well as prohibit the provision of non - audit services . the provision of non - audit services by an audit firm to a company would prevent that audit firm from carrying out statutory audit of that company , thus resulting in a reduction of the audit firms available to provide statutory audit , in particular with regard to the audit of large public - interest entities where the market is concentrated . as a result , in order to secure that a minimum number of audit firms is able to provide audit services to large public - interest entities , it is appropriate to request that audit firms of significant dimension focus their professional activity on the carrying out of statutory audit and are not allowed to undertake other services unconnected to their statutory audit function such as consultancy or advisory services .


### the statutory audit results in an opinion on the truth and fairness of the financial statements of the audited entities . stakeholders , however , might to be unaware of the limitations of an audit , which can lead to an expectation gap . in order to reduce such gap , it is important to provide more clarity on what the scope of the statutory audit is . ### the statutory audit results in an opinion on the truth and fairness of the financial statements of the audited entities . stakeholders , however , might to be unaware of the limitations of an audit , which can lead to an expectation gap . in order to reduce such gap , it is important to provide more clarity on what the scope of the statutory audit is , without drawing the attention of stakeholders from the actual content of the audit opinion .


### whilst the primary responsibility for delivering financial information should rest with the management of the audited entities , auditors play a role by actively challenging management from a user ' s perspective . in order to improve audit quality , it is therefore important that the professional scepticism exercised by auditors vis - à - vis the audited entity is reinforced . auditors should recognise the possibility that a material misstatment due to fraud or error could exist , notwithstanding the auditor ' s past experience of the honesty and integrity of the audited entity ' s management . securing audit quality should be the main criterion to organise the audit work and to allocate the necessary resources to the tasks . the integrity of the statutory auditor , audit firm and their staff is essential to ensure the public confidence in statutory audits and financial markets . therefore , any incident that may have serious consequences for the integrity of the statutory audit activities should be appropriately managed . the statutory auditor or the audit firm should appropriately document the audit work . ### whilst the primary responsibility for delivering financial information rests with the management of the audited entities , auditors play a role by actively challenging management from a user ' s perspective . in order to improve audit quality , it is therefore important that the professional scepticism exercised by auditors vis - à - vis the audited entity is reinforced . auditors should recognise the possibility that a material misstatment due to fraud or error could exist , notwithstanding the auditor ' s past experience of the honesty and integrity of the audited entity ' s management . securing audit quality should be the main criterion to organise the audit work and to allocate the necessary resources to the tasks . the integrity of the statutory auditor , audit firm and their staff is essential to ensure the public confidence in statutory audits and financial markets . therefore , any incident that may have serious consequences for the integrity of the statutory audit activities should be appropriately managed . the statutory auditor or the audit firm should appropriately document the audit work .


### the results of the statutory audit should be presented to the stakeholders in the audit report . in order to increase the confidence of stakeholders in the financial statements of the audited entity , it is particularly important that the audit report is well - founded and solidly substantiated and its content expanded to include additional information specific to the audit carried out . the audit report should in particular include sufficient information on the methodology used in the audit , especially how much of the balance sheet has been directly verified and how much has been based on system and compliance testing , on the levels of materiality applied to perform the audit , on the key areas of risk of material misstatements of the annual and consolidated financial statements , on whether the statutory audit was designed to detect fraud and , in the event of a qualified or adverse opinion or a disclaimer of opinion , on the reasons for such decision . ### the results of the statutory audit should be presented to the stakeholders in the audit report . in order to increase the confidence of stakeholders in the financial statements of the audited entity , it is particularly important that the audit report is well - founded and solidly substantiated and its content expanded to include additional information specific to the audit carried out . the audit report should in particular include information on the methodology used in the audit , on matters in the financial statements that are fundamental to the users ' understanding , on whether the statutory audit was designed to detect fraud and , in the event of a qualified or adverse opinion or a disclaimer of opinion , on the reasons for such decision .


### audit committees , or bodies performing an equivalent function within the audited entity , have a decisive role in contributing to high - quality statutory audit . it is particularly important to reinforce the independence and technical competence of the audit committee by requiring that a majority of its members is independent and that at least one member of the committee has competence in auditing and another one in auditing and / or accounting . the commission recommendation of 15 february 2005 on the role of non - executive or supervisory directors of listed companies and on the committees of the board sets out how audit committees should be established and function . considering , however , the dimension of boards in companies with reduced market capitalisation and in small and medium - sized public - interest entities , it would be appropriate that the functions assigned to the audit committee for those entities , or to a body performing equivalent functions within the audited entity , may be performed by the administrative or supervisory body as a whole . public - interest entities which are ucits or alternative investment funds should also be exempted from the obligation to have an audit committee . this exemption takes into account the fact that where those funds function merely for the purpose of pooling assets , the employment of an audit committee is not appropriate . ucits and alternative investments funds , as well as their management companies , operate in a strictly defined regulatory environment and are subject to specific governance mechanisms such as controls exercised by their depositary . ### audit committees , or bodies performing an equivalent function within the audited entity , have a decisive role in contributing to high - quality statutory audit . it is particularly important to reinforce the independence and technical competence of the audit committee by requiring that a majority of its members is independent and that at least one member of the committee has competence in auditing and another one in auditing and / or accounting . members of the audit committee should take part in skill enhancement programmes to ensure an appropriate level of technical knowledge to fulfil their roles . the commission recommendation of 15 february 2005 on the role of non - executive or supervisory directors of listed companies and on the committees of the boardsets out how audit committees should be established and function . considering , however , the dimension of boards in companies with reduced market capitalisation and in small and medium - sized public - interest entities , it would be appropriate that the functions assigned to the audit committee for those entities , or to a body performing equivalent functions within the audited entity , may be performed by the administrative or supervisory body as a whole . public - interest entities which are ucits or alternative investment funds should also be exempted from the obligation to have an audit committee . this exemption takes into account the fact that where those funds function merely for the purpose of pooling assets , the employment of an audit committee is not appropriate . ucits and alternative investments funds , as well as their management companies , operate in a strictly defined regulatory environment and are subject to specific governance mechanisms such as controls exercised by their depositary .


### it is also important that the role of the audit committee in the selection of a new statutory auditor or audit firm be reinforced , for the benefit of a more informed decision of the general meeting of shareholders or members of the audited entity . hence , when making a proposal to the general meeting , the board should explain whether it follows the recommendation of the audit committee and , if not , why . the recommendation of the audit committee should include at least two possible choices for the audit engagement and a duly justified preference for one of them , so that the general meeting can make a real choice . in order to provide a fair and proper justification in its recommendation , the audit committee should use the results of a mandatory selection procedure organised by the audited entity , under the responsibility of the audit committee . in such selection procedure , the audited entity should invite statutory auditors or audit firms , including smaller ones , to present proposals for the audit engagement . tender documents should contain transparent and non - discriminatory selection criteria to be used for the evaluation of proposals . considering , however , that this selection procedure could entail disproportionate costs for companies with reduced market capitalisation or small and medium - sized public - interest entities having regard to their dimension , it is appropriate to relieve such entities from this obligation . ### it is also important that the role of the audit committee in the selection of a new statutory auditor or audit firm be reinforced , for the benefit of a more informed decision of the general meeting of shareholders or members of the audited entity . hence , when making a proposal to the general meeting , the board should explain whether it follows the recommendation of the audit committee and , if not , why . it should equally provide reasons if it proposes to renew an audit engagement following a tender procedure . the recommendation of the audit committee should include at least two possible choices for the audit engagement , a comprehensive assessment of both proposals , and a duly justified preference for one of them , so that the general meeting can make a real choice . in order to provide a fair and proper justification in its recommendation , the audit committee should use the results of a mandatory tender procedure organised by the audited entity , under the responsibility of the audit committee . in such tender procedure , the audited entity should publish a call to auditors or audit firms to present proposals for the audit engagement . tender documents should contain transparent and non - discriminatory selection criteria to be used for the evaluation of proposals . considering , however , that this tender procedure could entail disproportionate costs for companies with reduced market capitalisation or small and medium - sized public - interest entities having regard to their dimension , it is appropriate to relieve such entities from this obligation .


### the market for the provision of statutory audit services to public - interest entities evolves over time . it is therefore necessary that competent authorities monitor the developments in the market , particularly as regards possible limited choice of auditor and the risks that arise from high market concentration . ### the market for the provision of statutory audit services to public - interest entities evolves over time . it is therefore necessary that member states monitor the developments in the market , particularly as regards possible limited choice of auditor and the risks that arise from high market concentration .


### in order to take account of developments in auditing and the audit market , the commission should be empowered to specify technical requirements on the content of the handover file that the new statutory auditor or audit firm should receive and on the establishment of a european quality certificate for statutory auditors and audit firms carrying out statutory audits of public - interest entities . ### in order to take account of developments in auditing and the audit market , the commission should be empowered to specify technical requirements on the establishment of a european quality certificate for statutory auditors and audit firms carrying out statutory audits of public - interest entities .


### a statutory auditor or audit firm shall take all necessary steps to ensure that the carrying out of a statutory audit of a public - interest entity is not affected by any existing or potential conflict of interest or business or other relationship involving the statutory auditor or audit firm carrying out the statutory audit and , where appropriate , its network , managers , auditors , employees , any other natural persons whose services are placed at the disposal or under the control of the statutory auditor or audit firm , or any person directly or indirectly linked to the statutory auditor or audit firm by control . ### a statutory auditor or audit firm shall take all necessary steps to ensure that the independence of the statutory auditor or audit firm carrying out the statutory audit is not compromised by financial , personal , business , employment or other relationships involving the statutory auditor , the audit firm , its affiliate firms and network , and any natural person in a position to influence the outcome of the statutory audit .


### a statutory auditor or an audit firm shall establish appropriate and effective organisational and administrative arrangements to prevent , identify , eliminate or manage and disclose any threats to independence referred to in article 11 ; ### a statutory auditor or an audit firm shall establish appropriate and effective organisational and administrative arrangements to prevent , identify , eliminate or manage and disclose to the audit committee of the audited entity any threats to independence referred to in article 11 ;


### persons or firms referred to in paragraph 2 shall not solicit or accept money , gifts or favours from anyone with whom the statutory audit or audit firm has a contractual relationship . ### persons or firms referred to in paragraph 2 shall not solicit or accept gifts or favours from the audited entity unless a reasonable and informed third party would consider the value insignificant .


### for the purposes of this article , related financial audit services shall mean : ### for the purposes of this article , audit - related and other assurance services shall mean in particular :


### providing certification on compliance with tax requirements where such attestation is required by national law ; ### providing certification on compliance with tax requirements , preparation of tax declarations , advice on indirect taxes , payroll tax , transfer prices , customs duties and public support measures , support regarding tax inspections and tax authority enquiries ;


### any other statutory duty related to audit work imposed by union legislation to the statutory auditor or audit firm . ### any other statutory duty related to audit work imposed by union and / or national legislation to the statutory auditor or audit firm ;


### for the purposes of this article , non - audit services shall mean : ### for the purposes of this article , non - audit services shall mean in particular :


### designing and implementing internal control or risk management procedure related to the preparation and / or control of financing information included in the financial statements and advice on risk ; ### designing or implementing technology systems , internal control or risk management procedure related to the preparation and / or control of financing information included in the financial statements and advice on risk ;


### valuation services , providing fairness opinions or contribution - in - kind reports ; ### valuation services ;


### designing and implementing financial information technology systems for public - interest entities as referred to in article 2 to of directive 2006 / 43 / ec ; ### designing or implementing financial information technology systems ;


### where an audit firm generates more than one third of its annual audit revenues from large public - interest entities and belongs to a network whose members have combined annual audit revenues which exceed eur 1 500 million within the european union , it shall comply with the following conditions : ### where an audit firm generates more than one third of its annual audit revenues from large public - interest entities and belongs to a network whose members have combined annual audit revenues which exceed eur 1 500 million within the european union , whereas revenues from audits for which more than one audit firm has been appointed shall not be factored in the calculation of these thresholds , it shall comply with the following conditions :


### – without prejudice to directive 2005 / 60 / / ec , the integrity of the public - interest entity . ### – without prejudice to directive 2005 / 60 / / ec , the integrity of the members of the administrative , management or supervisory body of the public - interest entity .


### when carrying out the statutory audit of a public - interest entity , the statutory auditor or audit firm shall maintain professional scepticism throughout the audit , recognizing the possibility that a material misstatement due to facts or behaviour indicating irregularities , including fraud or error could exist , notwithstanding the auditor ' s or firm ' s past experience of the honesty and integrity of the audited entity ' s management and of the persons charged with its governance . ### when carrying out the statutory audit of a public - interest entity , the statutory auditor or audit firm shall maintain professional scepticism throughout the audit , recognizing the possibility that a material misstatement due to facts or behaviour indicating irregularities , including fraud or error could exist , notwithstanding the auditor ' s or firm ' s past experience of the honesty and integrity of the audited entity ' s management and of the persons charged with its governance , as required by international auditing standards referred to in article 26 of directive 2006 / 43 / ec .


### the correspondence with the audited entity related to the statutory audit ; ### the significant correspondence with the audited entity related to the statutory audit ;


### the starting and ending dates of the phases of audit procedures set out in the audit plan ; ### the starting and ending dates of the statutory audits ;


### the opinion of the statutory auditor or the key audit partner as evidenced by the drafts of the reports referred to in articles 22 and 23 ; ### the opinion of the statutory auditor or the key audit partner as evidenced by the reports referred to in articles 22 and 23 ;


### describe the used methodology , including how much of the balance sheet has been directly verified and how much has been based on system and compliance testing ; ### describe the used methodology ;


### identify key areas of risk of material misstatement of the annual or consolidated financial statements , including critical accounting estimates or areas of measurement uncertainty ; ### draw attention , where appropriate , to matters disclosed in the financial statements that in the auditor ' s judgment are fundamental to the users ' understanding of the financial statements ;


### provide a statement on the the situation of the audited entity or , in case of the statutory audit of consolidated financial statements , of the parent undertaking and the group , especially an assessment of the entity ' s or the parent undertaking ' s and group ' s ability to meet its / their obligation in the forseeable future and therefore continue as a going concern ; ### provide a conclusion on the assessment by the statutory auditor or audit firm on the appropriateness of the management ' s use of the going concern assumption in preparing the financial statements and whether material uncertainties in relation to the going concern assumption have been identified ;


### declare that the non - audit services referred to in article 10 were not provided and that the statutory auditor or the audit firm remained completely independent in conducting the audit . where the statutory audit was carried out by an audit firm , the report shall identify each member of the audit engagement team and shall state that all members remained completely independent and had no direct or indirect interest in the audited entity ; ### declare that the statutory auditor or the audit firm remained completely independent in conducting the audit . where the statutory audit was carried out by an audit firm , the report shall identify each member of the audit engagement team and shall state that all members remained completely independent and had no direct or indirect interest in the audited entity ;


### indicate the non - audit services referred to in article 10 and that the audit committee allowed the statutory auditor or the audit firm to provide to the audited entity ; ### indicate the audit - related and other assurance services referred to in article 10 that the audit committee allowed the statutory auditor or the audit firm to provide to the audited entity ;


### the statutory auditor or the audit firm carrying out statutory audit of public - interest entities shall submit an additional report to the audit committee of the audited entity . ### the statutory auditor or the audit firm carrying out statutory audit of public - interest entities shall submit an additional report to the audit committee and the management , administrative and supervisory board of the audited entity .


### describe the distribution of tasks among the statutory auditors and / or the audit firm ; ### describe the distribution of tasks among the statutory auditors and / or the audit firm and include a description of the scope and timing of the audit and significant findings from the statutory audit conducted , including significant deficiencies in the internal control system of the audited entity ; address significant difficulties encountered during the audit and other matters arising from the statutory audit that in the statutory auditor ' s or audit firm ' s professional judgement are significant to the oversight of the financial reporting process ;


### indicate and explain judgments about material uncertainty that may cast doubt about the entity ' s ability to continue as a going concern ; ### indicate and explain how events or conditions that have been identified in the course of the statutory audit may cast significant doubt about on the audited entity ' s ability to continue as a going concern and whether they give rise to a material uncertainty ;


### determine in detail whether the bookkeeping , the accounting , all audited documents , the annual or consolidated financial statements and possible additional reports show appropriateness ; ### provide details concerning material errors and omissions in the bookkeeping , the accounting , the annual or consolidated financial statements and other reports identified in the course of the statutory audit ;


### indicate and explain in detail all instances of non - compliance , including non - material instances as far as it is considered to be important to the audit committee in order to fulfil its tasks ; ### indicate and explain instances of non - compliance , including non - material instances , identified in the course of the statutory audit as far as it is considered to be important to the audit committee in order to fulfil its task ;


### assess the valuation methods applied to the various items in the annual or consolidated financial statements including any impact of changes of such ; ### assess significant qualitative aspects of the audited entity ' s accounting practices , including accounting policies , accounting estimates , valuations and financial statement disclosures and any material impact of changes of such ;


### without prejudice to article 55 of directive 2004 / 39 / ec , article 53 of directive 2006 / 48 / ec of the european parliament and of the council , article 15 of directive 2007 / 64 / ec , article 106 of directive 2009 / 65 / ec , the first paragraph of article 3 of directive 2009 / 110 / ec and article 72 of directive 2009 / 138 / ec of the european parliament and of the council35 , the statutory auditor or audit firm carrying out the statutory audit of a public - interest entity shall have a duty to report promptly to the competent authorities supervising public - interest entities any fact or decision concerning that public - interest entity of which he , she or it has become aware while carrying out that statutory audit and which is liable to bring about any of the following : ### the statutory auditor or audit firm carrying out the statutory audit of a public - interest entity shall report promptly to the audit committee , the administrative and supervisory body any fact or decision concerning that public - interest entity of which he , she or it has become aware while carrying out that statutory audit . the reporting is to bring about any of the following :


### a refusal to certify the financial statements or the expression of reservations . ### a refusal to issue an audit report or the issuance of an adverse or a qualified audit opinion .


### the statutory auditor or the audit firm shall also have a duty to report any facts and decisions of which he , she or it becomes aware in the course of carrying out the statutory audit of an undertaking having close links with the public - interest entity for which he , she or it is also carrying out the statutory audit . ### the statutory auditor or the audit firm shall also have a duty to report any facts and decisions according to paragraph 1 , or of which he , she or it becomes aware in the course of carrying out a statutory audit of an undertaking controlled by the public - interest entity for which he , she or it is also carrying out the statutory audit . the audit committee , administrative and supervisory body will undertake appropriate steps to immediately inform the competent authorities supervising public interest entities about these reported facts and decisions .


### the disclosure in good faith to the competent authorities , by the statutory auditor or audit firm , of any fact or decision referred to in paragraph 1 or of any fact during the dialogue foreseen in paragraph 2 shall not constitute a breach of any contractual or legal restriction on disclosure of information and shall not involve such persons in liability of any kind . ### the disclosure in good faith to the competent authorities , by the statutory auditor or audit firm , of any fact during the dialogue foreseen in paragraph 2 shall not constitute a breach of any contractual or legal restriction on disclosure of information and shall not involve such persons in liability of any kind .


### the annual financial report and the annual income statement shall show the total turnover divided into fees from the statutory audit of annual and consolidated financial statements of public - interest entities and entities belonging to a group of undertakings whose parent undertaking is a public - interest entity , fees from the statutory audit of annual and consolidated financial statements of other entities and fees charged for related financial audit services as defined in article 10 . ### the annual financial report and the annual income statement shall show the total turnover divided into fees from the statutory audit of annual and consolidated financial statements of public - interest entities and entities belonging to a group of undertakings whose parent undertaking is a public - interest entity , fees from the statutory audit of annual and consolidated financial statements of other entities and fees charged for audit - related and other assurance services as defined in article 10 .


### when it concerns the renewal of an audit engagement in accordance with the second subparagraph of article 33 , the audit committee shall , for the preparation of its recommendation , take into consideration any findings and conclusions on the recommended statutory auditor or audit firm referred to in article 40 and published by the competent authority pursuant to article 44 . ### when it concerns the renewal of an audit engagement in accordance with the second subparagraph of article 33 , the audit committee shall base its recommendation on a comprehensive assessment of the audit quality of the statutory auditor or audit firm after a period of three consecutive years . the competent authority referred to in article 35 may adjust the timing in accordance with the national appointment period .


### the audited entity shall be free to choose the method to contact the invited statutory auditor or audit firm and shall not be required to publish a call for tenders in the official journal of the european union and / or in national gazettes or newspapers ; ### the audited entity shall publish a call for tenders in the official journal of the european union and / or in national gazettes or newspapers ;


### the audited entity shall prepare tender documents to the intention of the invited statutory auditor or audit firm . those tender documents shall allow them to understand the business of the audited entity and the type of statutory audit that is to be carried out . the tender documents shall contain transparent and non - discriminatory selection criteria that shall be used by the audited entity to evaluate the proposals made by statutory auditors or audit firms ; ### the audit committee shall prepare tender documents to the intention of the invited statutory auditor or audit firm . those tender documents shall allow them to understand the business of the audited entity and the type of statutory audit that is to be carried out . the tender documents shall contain transparent and non - discriminatory selection criteria that shall be used by the audited entity to evaluate the proposals made by statutory auditors or audit firms ;


### the audited entity shall be free to define the selection procedure and may conduct direct negotiations with interested tenderers in the course of the procedure ; ### the audit committee shall be free to define the selection procedure and may conduct direct negotiations with interested tenderers in the course of the procedure ;


### the audited entity shall evaluate the proposals made by the statutory auditors or audit firms in accordance with the selection criteria predefined in the tender documents . the audited entity shall prepare a report on the conclusions of the selection procedure , which shall be validated by the audit committee . the audited entity and the audit committee shall take into consideration any inspection report on the applicant statutory auditor or audit firm referred to in article 40 and published by the competent authority pursuant to article 44 ; ### the audit committee shall perform a comprehensive assessment of the proposals made by the statutory auditors or audit firms in a transparent and systematic approach that shall include the consideration of professional competencies of the auditor or audit firm which are necessary to perform the statutory audit in compliance with relevant ethical requirements and international standards on auditing referred to in article 20 . the audited entity and the audit committee shall take into consideration any inspection report on the applicant statutory auditor or audit firm referred to in article 40 and published by the competent authority pursuant to article 44 ;


### the audited entity shall be able to demonstrate to the competent authority referred to in article 35 that the selection procedure was conducted in a fair manner . ### the audit committee shall be able to demonstrate to the competent authority referred to in article 35 that the selection procedure was conducted in a fair manner .


### in the case of a credit institution or insurance undertaking , the administrative or supervisory board shall submit its draft proposal to the competent authority referred to in article 35 . the competent authority referred to in article 35 shall have the right to veto the choice proposed in the recommendation . any such opposition shall be duly justified . ### the administrative or supervisory board shall submit its draft proposal to the competent authority referred to in article 35 . the draft proposal shall be accompanied by the results of the comprehensive assessment referred to in article 32 and . the competent authority referred to in article 35 shall have the right to veto the choice proposed in the recommendation . any such opposition shall be duly justified .


### in the case of a credit institution or insurance undertaking , the administrative or supervisory board shall submit its draft proposal to the competent authority referred to in article 35 . the competent authority referred to in article 35 shall have the right to veto the choice proposed in the recommendation . any such opposition shall be duly justified . ### the administrative or supervisory board shall submit its draft proposal to the competent authority referred to in article 35 . the draft proposal to the competent authority referred to in article 35 shall be accompanied by the results of the comprehensive assessment referred to in article 32 and and have the right to veto the choice proposed in the recommendation . any such opposition shall be duly justified .


### the former statutory auditor or audit firm shall also grant access to the incoming statutory auditor or audit firm to the additional reports to the audit committee referred to in article 23 of previous years and to any information transmitted to competent authorities pursuant to articles 25 and 27 . ### the former statutory auditor or audit firm shall also grant access to the incoming statutory auditors or audit firms to the additional reports to the audit committee referred to in article 23 for the previous three years and to any information transmitted to competent authorities pursuant to articles 25 and 27 .


### the competent authorities referred to in article 35 shall regularly monitor the developments in the market for providing statutory audit services to public - interest entities . ### member states shall regularly monitor the developments in the market for providing statutory audit services to public - interest entities .


### the competent authorities shall in particular assess the following : ### member states shall in particular assess the following :


### regulated markets and investment firms and market operators operating an mtf or an otf based on the trading system operated shall make public prices and the depth of trading interests at those prices for orders or quotes advertised through their systems for bonds and structured finance products admitted to trading on a regulated market or for which a prospectus has been published , emission allowances and for derivatives admitted to trading or which are traded on an mtf or an otf . this requirement shall also apply to actionable indications of interests . regulated markets and investment firms and market operators operating an mtf or an otf shall make this information available to the public on a continuous basis during normal trading hours . ### regulated markets and investment firms and market operators operating an mtf or an otf based on the trading system operated shall make public prices and the depth of trading interests at those prices for orders or quotes advertised through their systems for bonds and structured finance products admitted to trading on a regulated market or for which a prospectus has been published , emission allowances and for derivatives which are subject to the trading obligations as referred to in article 24 . this requirement shall also apply to actionable indications of interests . regulated markets and investment firms and market operators operating an mtf or an otf shall make this information available to the public on a continuous basis during normal trading hours . this publication obligation does not apply to derivative transactions of non - financial counterparties which reduce the objectively measurable risks that are directly related to the business activity or the business financing of this counterparty .


### regulated markets and investment firms and market operators operating an mtf or an otf shall make public the price , volume and time of the transactions executed in respect of bonds and structured finance products admitted to trading on a regulated market or for which a prospectus has been published , emission allowances and for derivatives admitted to trading or which are traded on an mtf or an otf . regulated markets and investment firms and market operators operating an mtf or an otf shall make details of all such transactions public as close to real - time as is technically possible . ### regulated markets and investment firms and market operators operating an mtf or an otf shall make public the price , volume and time of the transactions executed in respect of bonds and structured finance products admitted to trading on a regulated market or for which a prospectus has been published , emission allowances and for derivatives which are subject to the trading obligations as referred to in article 24 . regulated markets and investment firms and market operators operating an mtf or an otf shall make details of all such transactions public as close to real - time as is technically possible . this publication obligation does not apply to derivative transactions of non - financial counterparties which reduce the objectively measurable risks that are directly related to the business activity or the business financing of this counterparty .


### systematic internalisers shall provide firm quotes in bonds and structured finance products admitted to trading on a regulated market or for which a prospectus has been published , emission allowances and derivatives which are clearing - eligible or are admitted to trading on a regulated market or are traded on an mtf or an otf when the following conditions are fulfilled : ### systematic internalisers shall provide firm quotes in bonds and structured finance products admitted to trading on a regulated market or for which a prospectus has been published , emission allowances and derivatives which are subject to the trading obligations as referred to in article 24 when the following conditions are fulfilled :


### investment firms which , either on own account or on behalf of clients , conclude transactions in bonds and structured finance products admitted to trading on a regulated market or for which a prospectus has been published , emission allowances and derivatives which are clearing - eligible or are reported to trade repositories in accordance with article [ 6 ] of regulation [ emir ] or are admitted to trading on a regulated market or are traded on an mtf or an otf shall make public the volume and price of those transactions and the time at which they were concluded . this information shall be made public through an apa . ### investment firms which , either on own account or on behalf of clients , conclude transactions in bonds and structured finance products admitted to trading on a regulated market or for which a prospectus has been published , emission allowances and derivatives which are subject to the trading obligations as referred to in article 24 shall make public the volume and price of those transactions and the time at which they were concluded . this information shall be made public through an apa . this publication obligation does not apply to such derivative transactions of non - financial counterparties which reduce the objectively measurable risks that are directly related to the business activity or the business financing of this counterparty .


### however , member states shall not limit this number to fewer than two suppliers for each category of groundhandling services or , for airports whose annual traffic has been not less than 5 million passengers or 100 000 tonnes of freight for at least the previous three years , to fewer than three suppliers for each category of groundhandling services . ### however , member states shall not limit this number to fewer than two suppliers , provided they are chosen on the basis of relevant , objective , transparent and non - discriminatory criteria , for each category of groundhandling services or , for airports whose annual traffic has been not less than 5 million passengers or 100 000 tonnes of freight for at least the previous three years , to fewer than three suppliers for each category of groundhandling services .


### level of quality of operations as assessed on the basis of a representative flight schedule including , where relevant , efficient use of staff and equipment , last acceptance of baggage and cargo , delivery times for baggage and cargo and maximum turnaround times ; ### level of quality of operations as assessed on the basis of a representative flight schedule including , where relevant , efficient use of staff and equipment , last acceptance of baggage and cargo , delivery times for baggage and cargo , ability to ensure secure and responsible handling of luggage and equipment and maximum turnaround times ;


### adequateness of human resources in terms of workers ' experience and adequateness of training / qualification programme ; ### adequateness of human resources in terms of workers ' experience and reliability and adequateness of training / qualification programme ;


### where a supplier of groundhandling services ceases its activity before the end of the period for which it was authorised , the supplier shall be replaced on the basis of the selection procedure described in articles 7 , 8 , 9 and this article . any supplier ceasing its activity shall inform the relevant tendering authority of its intention to cease activity sufficiently in advance and at least six months in advance before it leaves the airport . financial penalties may be imposed on the supplier if it does not inform the tendering authority sufficiently in advance unless the supplier can demonstrate force majeure . ### where a supplier of groundhandling services ceases its activity before the end of the period for which it was authorised , the supplier shall be replaced on the basis of the selection procedure described in articles 7 , 8 , 9 and this article . any supplier ceasing its activity shall inform the relevant tendering authority of its intention to cease activity sufficiently in advance and at least six months in advance before it leaves the airport . financial penalties may be imposed on the supplier if it does not inform the tendering authority at least six months in advance unless the supplier can demonstrate force majeure .


### for the purposes of the assessment referred to in paragraph , each applicant shall submit its audited accounts for the two previous financial years . ### for the purposes of the assessment referred to in paragraph , each applicant shall submit its audited accounts for the two previous financial years . the approving authority shall lay down the format of the documentation to be submitted .


### passenger handling comprises any kind of information and assistance - including those provided in the framework of the relevant eu legislation on passenger rights - to arriving , departing , transfer or transit passengers , including checking tickets and travel documents , registering baggage and carrying it to the sorting area . ### passenger handling comprises any kind of information and assistance - including those provided in the framework of the relevant eu legislation on passenger rights - to arriving , departing , transfer or transit passengers , including checking tickets and travel documents , registering baggage , establishing that the baggage belongs to the passenger concerned , for example by means of electronic verification , and carrying it to the sorting area .


### in a context of progressive migration to ‘ all ip networks’ , the lack of availability of connectivity products based on the ip protocol for different classes of services with assured service quality that enable communication paths across network domains and across network borders , both within and between member states , hinders the development of applications that rely on access to other networks , thus limiting technological innovation . moreover , this situation prevents the diffusion on a wider scale of efficiencies which are associated with the management and provision of ip - based networks and connectivity products with an assured service quality level , in particular enhanced security , reliability and flexibility , cost - effectiveness and faster provisioning , which benefit network operators , service providers and end users . a harmonised approach to the design and availability of these products is therefore necessary , on reasonable terms including , where requested , the possibility of cross - supply by the electronic communications undertakings concerned . ### in a context of progressive migration to ' all ip networks ' , the lack of availability of connectivity products based on the ip protocol for different classes of services with a defined quality of service within closed communications networks using the internet protocol with strict admission control could hinder the development of services that rely on this defined quality in order to function adequately . a harmonised approach to the design and availability of these services is therefore necessary , including safeguards to guarantee that the enhanced quality is not functionally identical or to the detriment of the performance , affordability or quality of internet access services or undermines competition , innovation or net neutrality .


### this article shall not apply to roaming providers that provide regulated retail roaming services in accordance with article 4a . ### this article shall apply until 30 june 2016 .


### in calculating the average specific emissions of co2 , each new passenger car with specific emissions of co2 of less than 35 g co2 / km shall be counted as 1 . 3 passenger cars in the period from 2020 to 2023 and as 1 passenger car from 2024 onwards . ### in calculating the average specific emissions of co2 , each new passenger car with specific emissions of less than 50 g co2 / km shall be counted as 2 passenger cars from 2016 onwards .


### member states shall ensure that when carrying out a statutory audit , the statutory auditor and / or the audit firm and any holder of voting rights in the audit firm is independent of the audited entity and is not involved in the decision - taking of the audited entity . ### member states shall ensure that when carrying out a statutory audit , the statutory auditor and / or the audit firm takes all necessary steps to ensure that the independence is not compromised by financial , personal , business , employment or other relationships involving the statutory auditor , the audit firm , its affiliate firms and network , and any natural person in a position to influence the outcome of the statutory audit .


### inform the commission of all significant procedural steps , and enter into consultations regularly and , in any event , when requested by the commission ; and , ### inform the commission of all significant procedural steps without delay , and enter into consultations regularly and , in any event , when requested by the commission ; and ,


### the commission shall provide the member state with all documents relating to the proceeding , so as to ensure as effective defence as possible ; and , ### the commission shall keep the member state informed of all significant procedural steps without delay and enter into consultations with the member state regularly , so as to ensure as effective defence as possible ; and ,


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


### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the date on which regulations no 1760 / 2000 , no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply . ### in order to ensure legal certainty as regards the application of rules for identification and registration of animals , disease control measures for certain zoonoses and non - commercial movements of pet animals , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the date on which regulations no xxx / xxx [ ex - 998 / 2003 ] and no 21 / 2004 and directives 92 / 66 / eec , 2000 / 75 / ec , 2001 / 89 / ec , 2002 / 60 / ec , 2003 / 85 / ec , 2005 / 94 / ec and 2008 / 71 / ec cease to apply .


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


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


### collecting societies are expected to act in the best interests of their members . it is therefore important to provide for systems which enable members of collecting societies to exercise their membership rights by participating in the societies ' decision - making process . the representation of the different categories of members in the decision - making process should be fair and balanced . the effectiveness of the rules on the general meeting of members of collecting societies may be undermined if there were no provisions on how the general meeting should be run . thus , it is necessary to ensure that the general meeting is convened regularly , and at least annually , and that the most important decisions in the collecting society are taken by the general meeting . ### collecting societies are expected to act in the best interests of their rightholders and members . it is therefore important to provide for systems which enable members of collecting societies , therefore rightholders and entities directly representing their interests , to exercise their membership rights by participating in the societies ' decision - making process . the representation of the different categories of members in the decision - making process should be fair and balanced . the effectiveness of the rules on the general meeting of members of collecting societies may be undermined if there were no provisions on how the general meeting should be run . thus , it is necessary to ensure that the general meeting is convened regularly , and at least annually , and that the most important decisions in the collecting society are taken by the general meeting .


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


### collecting societies collect , manage and distribute revenue from the exploitation of the rights entrusted to them by rightholders . this revenue is ultimately due to rightholders who may be members of that society , or another society . it is therefore important that collecting societies exercise the utmost diligence in collecting , managing and distributing that revenue . accurate distribution is only possible where collecting societies maintain proper records of membership , licences and use of works and other subject matter . where appropriate , data should also be provided by rightholders and users and verified by the collecting societies . amounts collected and due to rightholders should be managed separately from any own assets of the collecting society and , if they are invested , pending their distribution to rightholders , this should be carried out in accordance with the investment policy decided by the collecting societies ' general meeting . in order to maintain a high level of protection for the rights of rightholders and to ensure that any income which may be derived from exploitation of their rights accrues for the benefit of rightholders , the investments made and held by the collecting society should be managed in accordance with criteria which would oblige the collecting society to act prudently , while allowing the collecting society to decide on the most secure and efficient investment policy . this should allow the colleting society to opt for an asset allocation that suits the precise nature and duration of any exposure to risk of any rights revenue invested and which does not unduly prejudice any rights revenue owed to rightholders . moreover , in order to ensure that the amounts due to rightholders are appropriately and effectively distributed , it is necessary to require collecting societies to undertake diligent and good faith reasonable measures to identify and locate the relevant rightholders . it is also appropriate to provide for the approval by members of collecting societies of the rules governing any situation where , due to the lack of identified or located rightholders , amounts collected cannot be distributed . ### collecting societies collect , manage and distribute revenue from the exploitation of the rights entrusted to them by rightholders . this revenue is ultimately due to rightholders who may be members of that society , or another society . it is therefore important that collecting societies exercise the utmost diligence in collecting , managing and distributing that revenue . accurate distribution is only possible where collecting societies maintain proper records of membership , licences and use of works and other subject matter . where appropriate , data should also be provided by rightholders and users and verified by the collecting societies . amounts collected and due to rightholders should be managed separately from any own assets of the collecting society and , if they are invested , pending their distribution to rightholders , this should be carried out in accordance with the investment policy decided by the collecting societies ' general meeting . in order to maintain a high level of protection for the rights of rightholders and to ensure that any income which may be derived from exploitation of their rights accrues for the benefit of rightholders , the investments made and held by the collecting society should be managed in accordance with criteria which would oblige the collecting society to act prudently , while allowing the collecting society to decide on the most secure and efficient investment policy . this should allow the colleting society to opt for a secure and profitable asset allocation that prevents exposure to risk of any rights revenue invested and which does not prejudice any rights revenue owed to rightholders . moreover , in order to ensure that the amounts due to rightholders are appropriately , timely and effectively distributed , it is necessary to require collecting societies to undertake diligent and good faith reasonable measures to identify and locate the relevant rightholders . it is also appropriate to provide for the approval by members of collecting societies of the rules governing any situation where , due to the lack of identified or located rightholders , amounts collected cannot be distributed .


### fair commercial terms in licensing are particularly important to ensure that users can license the works and other protected subject - matter for which a collecting society represents rights and to ensure the remuneration of rightholders . collecting societies and users should therefore conduct licensing negotiations in good faith and apply tariffs determined on the basis of objective criteria . ### fair commercial terms in licensing are particularly important to ensure that users can license the works and other protected subject - matter for which a collecting society represents rights and to ensure the remuneration of rightholders . collecting societies and users should therefore conduct licensing negotiations in good faith and apply tariffs determined on the basis of objective and non - discriminatory criteria .


### in the online music sector , where collective management of authors ' rights on a territorial basis remains the norm , it is essential to create conditions conducive to the most effective licensing practices by collecting societies , in an increasingly cross - border context . it is therefore appropriate to provide for a set of rules coordinating basic conditions for the provision by collecting societies of multi - territorial collective licensing of authors ' online rights in musical works . these provisions should ensure the necessary minimum quality of the cross - border services provided by collecting societies , notably in terms of transparency of repertoire represented and accuracy of financial flows related to the use of the rights . they should also set out a framework for facilitating the voluntary aggregation of music repertoire and thus reducing the number of licences a user needs to operate a multi - territorial service . these provisions should enable a collecting society to request another collecting society to represent its repertoire on a multi - territorial basis where it cannot fulfil the requirements itself . there should be an obligation on the requested society , provided that it aggregates repertoire and offers or grants multi - territorial licences , to accept the mandate of the requesting society . the development of legal online music services across the union should also contribute to the fight against piracy . ### in the online music sector , where collective management of authors ' rights on a territorial basis remains the norm , it is essential to create conditions conducive to the most effective licensing practices by collecting societies , in an increasingly cross - border context . it is therefore appropriate to provide for a set of rules coordinating basic conditions for the provision by collecting societies of multi - territorial collective licensing of authors ' online rights in musical works . these provisions should ensure the necessary minimum quality of the cross - border services provided by collecting societies , notably in terms of transparency of repertoire represented and accuracy of financial flows related to the use of the rights . they should also set out a framework for facilitating the voluntary aggregation of music repertoire and thus reducing the number of licences a user needs to operate a multi - territorial service . these provisions should enable a collecting society to request another collecting society to represent its repertoire on a multi - territorial basis where it cannot fulfil the requirements itself . there should be an obligation on the requested society , provided that it aggregates repertoire and offers or grants multi - territorial licences , to accept the mandate of the requesting society , without abusing its market power . the development of legal online music services across the union should also contribute to the fight against piracy .


### ‘ online rights in musical works’ means any of the rights in a musical work provided under articles 2 and 3 of directive 2001 / 29 / ec which are required for the provision of an online music service ; ### ‘ online rights in musical works’ means any of the author’s rights in a musical work provided under articles 2 and 3 of directive 2001 / 29 / ec which are required for the provision of an online music service ;


### the general meeting shall have the power to decide on the appointment or dismissal of the directors and approve their remuneration and other benefits such as non - monetary benefits , pension awards , right to other awards and rights to severance pay . ### the general meeting shall have the power to decide on the appointment or dismissal of the directors , monitor their general performance and approve their remuneration and other benefits such as non - monetary benefits , pension awards , right to other awards and rights to severance pay .


### the collecting society shall not be allowed to use rights revenue and any income derived from its investment for its own account , save that it may deduct its management fees . ### the collecting society shall not be allowed to use rights revenue and any income derived from its investment for its own account , save that it may deduct its management fees according to the rules referred to in article 7 .


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


### for the purposes of paragraph 2 , measures to identify and locate rightholders shall include verifying membership records and making available to the members of the collecting society as well as to the public a list of works and other subject matter for which one or more rightholders have not been identified or located . ### for the purposes of paragraph 2 , the collecting society shall put in place effective measures to identify and locate rightholders while ensuring appropriate safeguards to deter fraud . such measures shall include verifying membership records and making available to the members of the collecting society as well as to the public a list of works and other subject matter for which one or more rightholders have not been identified or located including , where available , the title of the work , the name of the author , the name of the publisher and any other relevant information available which could be necessary to identify the rightholders .


### the collecting society shall regularly , diligently and accurately distribute and pay amounts due to other collecting societies . ### the collecting society shall regularly , in a timely manner , diligently and accurately distribute and pay amounts due to other collecting societies . the collecting society shall carry out such distribution and payments to other collecting societies at least on a quarterly basis and no later than 12 months after the rights revenue was collected .


### licensing terms shall be based on objective criteria , in particular in relation to tariffs . ### licensing terms shall be based on objective and non - discriminatory criteria , in particular in relation to tariffs .


### tariffs for exclusive rights shall reflect the economic value of the rights in trade and of the service provided by the collecting society . ### tariffs for exclusive rights and rights to remuneration shall reflect the economic value of the use of the rights in trade and the nature and scope of use of the works and other protected subject - matter and the economic value of the service provided by the collecting society .


### tariffs for exclusive rights shall reflect the economic value of the rights in trade and of the service provided by the collecting society . ### in the absence of any national law or administrative provision laying down tariffs on a statutory basis , the tariffs shall reflect the economic value of the rights in trade and the nature and scope of use of the works and other protected subject - matter and of the service provided by the collecting society .


### member states shall ensure that a collecting society makes available at least once a year , by electronic means , the following information to each rightholder it represents : ### member states shall ensure that a collecting society makes available at least once a year , by electronic means and where appropriate on a more regular basis through individual on - line accounts , the following information to each rightholder it represents directly :


### the collecting society shall offer online music service providers the possibility of reporting the actual use of online rights in musical works by electronic means . the collecting society shall offer the use of a least one method of reporting which takes into account voluntary industry standards or practices developed at international or union level for the electronic exchange of such data . the collecting society may refuse to accept reporting by the user in a proprietary format if the society allows for reporting using an industry standard for the electronic exchange of data . ### the collecting society shall offer online music service providers the possibility of reporting the actual use of online rights in musical works , in accordance with article 15a , by electronic means . the collecting society shall offer the use of a least one method of reporting which takes into account voluntary industry standards or practices developed at international or union level for the electronic exchange of such data . the collecting society may refuse to accept reporting by the user in a proprietary format if the society allows for reporting using an industry standard for the electronic exchange of data .


### the requested collecting society shall accept such a request if it is already granting or offering to grant multi - territorial licences for the same category of online rights in musical works in the repertoire of one or more other collecting societies . ### the requested collecting society shall accept such a request within a reasonable time if it is already granting or offering to grant multi - territorial licences for the same category of online rights in musical works in the repertoire of one or more other collecting societies .


### member states shall ensure that disputes between collecting societies and users concerning existing and proposed licensing conditions , tariffs , and any refusal to grant a licence can be submitted to a court , and if appropriate , to an independent and impartial dispute resolution body . ### member states shall ensure that disputes between collecting societies and users concerning existing and proposed licensing conditions , tariffs , the calculation of tariffs , and any refusal to grant a licence can be submitted to a specialised , independent and impartial dispute resolution body , or if appropriate , to a court .


### disputes with another collecting society on the application of articles 24 , 25 , 26 , 28 and 29 . ### disputes with another collecting society on the application of articles 22 , 23 , 24 , 25 , 26 , 28 and 29 .


### negotiate and , after approval by the management board , sign a headquarters agreement with the government of the host member state . ### negotiate and , after approval by the management board , sign a headquarters agreement with the government of the host member state , having taken into account the cost / benefit assessment as specified in the second subparagraph of article 7 .


### the necessary arrangements concerning the accommodation to be provided for the agency in the host member state and the facilities to be made available by that state , as well as the specific rules applicable in the agency ' s host member state to the executive director , the members of the management board , staff of the agency and members of their families shall be laid down in a headquarters agreement between the agency and the host member state concluded after obtaining the approval of the management board . the agency ' s host member state should provide the best possible conditions to ensure proper functioning of the agency , including multilingual , european - oriented schooling and appropriate transport connections . ### the necessary arrangements concerning the accommodation to be provided for the agency in the host member state and the facilities to be made available by that state , as well as the specific rules applicable in the agency ' s host member state to the executive director , the members of the management board , staff of the agency and members of their families shall be laid down in a headquarters agreement between the agency and the host member state concluded after obtaining the approval of the management board . the agency ' s host member state should provide the best possible conditions to ensure proper functioning of the agency , including multilingual , european - oriented schooling and appropriate transport connections . those conditions shall be examined in the cost / benefit assessment prior to the signing of the headquarters agreement , in accordance with the second subparagraph of article 7 , taking into account the member state’s willingness to provide resources of its own for hosting the agency , and its ability to do so .


### 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 provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the community . as a result citizens in certain member states may be denied the right to have access , in their own language , to high - quality , non - promotional information on medicines .


### national competent authorities and health care professionals should remain important sources of information on medicinal product 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 important sources of information on medicinal product 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 . establishing the necessary legal framework for marketing authorisation holders will enhance legal certainty for the pharmaceutical industry in relation to the provision to the general public of specific types of information on their medicines . the ban on advertising to the general public for prescription - only medicinal products should be maintained .


### in accordance with the principle of proportionality , it is appropriate to limit the scope of this directive to prescription - only medicinal products , as current community rules allow the advertising to the general public of medicinal products not subject to prescription , under certain conditions . ### in accordance with the principle of proportionality , it is appropriate to limit the scope of this directive to prescription - only medicinal products , as current community rules allow the advertising to the general public of medicinal products not subject to prescription , under certain conditions . this directive requires member states to permit , through certain channels and subject to appropriate monitoring , the provision by a marketing authorisation holder or a third party acting on its behalf of certain information on authorised medicines subject to prescription to the public . communications that do not fall within title viiia should be permitted , provided that they do not constitute advertising .


### provisions should be established to ensure that only high - quality non - promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated . the information should take into account patients needs and expectations in order to empower patients , allow informed choices and enhance the rational use of medicinal products . therefore , any information to the general public on prescription - only medicinal products should comply with a set of quality criteria . ### provisions should be established to ensure that only high - quality non - promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated . the information should take into account patients needs and expectations in order to empower patients , allow informed choices and enhance the rational use of medicinal products . providing eu citizens with more high quality information on medicines will enable them to make more rational and appropriate use of medicines , which will lead not only to better informed citizens but also to healthier societies . to achieve this , information to the general public on prescription - only medicinal products should comply with a set of quality criteria .


### the internet is of major importance with regard to the provision of information to patients and its importance is increasing . the internet allows almost unlimited access to information disregarding national boundaries . specific rules on the monitoring of websites should be established to take account of the cross - border nature of information provided over the internet and to allow cooperation between the member states . ### the internet is of major importance with regard to the provision of information to patients and its importance is increasing . the internet allows almost unlimited access to information disregarding national boundaries . specific rules on the monitoring of websites that are directed specifically at eu citizens should be established to take account of the cross - border nature of information provided over the internet and to allow cooperation between the member states .


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


### the summary of product characteristics , labelling and package leaflet of the medicinal product , as approved by the competent authorities , and the publicly accessible version of the assessment report drawn up by the competent authorities ; ### the summary of product characteristics , labelling and package leaflet of the medicinal product , as approved by the competent authorities , the publicly accessible version of the assessment report drawn up by the competent authorities and other available statements and documents published by the competent authorities ;


### 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 , prices and factual , informative announcements and reference material relating , for example , to pack changes , reimbursement , or adverse - reaction warnings ;


### a statement indicating that the information is intended to support , not to replace , the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification on the information provided ; ### a statement indicating that the information is intended to support , not to replace , the relationship between patient and health professionals and that a health professional should be contacted if the patient requires clarification or further information on the information provided ;


### comparisons between medicinal products ; ### comparisons between medicinal products , except where such comparisons are included in officially approved documents , such as the summary of product characteristics ;


### member states shall ensure that marketing authorisation holders ' internet websites for the dissemination of information on medicinal products subject to medical prescription reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official languages of the member states where they are authorised . ### member states shall ensure that marketing authorisation holders ' internet websites for the dissemination of information on medicinal products subject to medical prescription reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official language of the member state , where they are authorised and for which the website is intended .


### 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 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 .


### proposal for a regulation of the european parliament and of the council on animal health ### proposal for a regulation of the european parliament and of the council on the prevention and control of animal diseases which are transmissible among animals or to humans


### furthermore , the preventive and control measures for each transmissible animal disease should be ' tailor - made ' in order to address its unique epidemiological profile and its consequences . the preventive and control rules applying to each of them should therefore be disease specific . ### furthermore , the preventive and control measures for each transmissible animal disease should be ' tailor - made ' in order to address its unique epidemiological profile and its consequences . the preventive and control rules applying to each of them should therefore be disease specific , and strict attention should be paid to different regional conditions .


### early detection and a clear chain of disease notification and reporting are crucial for effective disease control . in order to achieve an efficient and quick response any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to the competent authority . those notification obligations should be applicable to any natural and legal person in order to ensure that no disease outbreaks remain unnoticed . ### early detection and a clear chain of disease notification and reporting are crucial for effective disease control . in order to achieve an efficient and quick response any suspicion or confirmation of an outbreak of certain listed diseases should be immediately notified to veterinarians or aquatic animal health professionals . those notification obligations should be applicable to any natural and legal person in order to ensure that no disease outbreaks remain unnoticed .


### however , those control strategies may substantially vary between different listed diseases . thus this regulation should provide for rules on the use of veterinary medicinal products for the prevention and control of listed diseases and for harmonised criteria for consideration when determining whether or not to use and how to use vaccines , hyper - immune sera and antimicrobials . in order to ensure a flexible approach and to address the specificities of different listed diseases and the availability of the effective treatments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the restrictions , prohibitions or obligations to use certain veterinary medicinal products in the framework of the control of certain listed diseases . in the case of urgency and in order to address emerging risks with possible devastating implications for animal or public health , economy , society or environment , it should be possible for these measures to be adopted by the urgency procedure . ### however , those control strategies may substantially vary between different listed diseases . thus this regulation should provide for rules on the use of veterinary medicinal products for the prevention and control of certain diseases and for harmonised criteria for consideration when determining whether or not to use and how to use vaccines , hyper - immune sera and antimicrobials . in order to ensure a flexible approach and to address the specificities of different listed diseases and the availability of the effective treatments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the restrictions , prohibitions or obligations to use certain veterinary medicinal products in the framework of the control of certain diseases . in the case of urgency and in order to address emerging risks with possible devastating implications for animal or public health , economy , society or environment , it should be possible for these measures to be adopted by the urgency procedure .


### for listed diseases , which are not highly contagious , and which are subject to compulsory eradication , the disease control measures should be implemented to prevent the spread of those listed diseases , in particular to non - infected areas . however , those measures may be more limited or different comparing to those applicable for the most dangerous listed diseases . this regulation should therefore provide for special rules for those diseases . member states that have a voluntary eradication programme in place , should also implement such disease control measures . however , the level and intensity of disease control measures should be proportionate and take into account the characteristics of the listed disease in question , its distribution and its significance for the member state concerned by it and the union as a whole . ### for listed diseases , which are not highly contagious , and which are subject to compulsory eradication , the disease control measures should be implemented to prevent the spread of those listed diseases , in particular to non - infected areas . however , those measures may be more limited or different comparing to those applicable for the most dangerous listed diseases . this regulation should therefore provide for special rules for those diseases . member states that have a voluntary eradication programme in place , should also implement such disease control measures . however , the level and intensity of disease control measures should be proportionate and take into account the characteristics of the listed disease in question , its distribution and its significance for the member state or region concerned by it and the union as a whole .


### when member states take national measures concerning movements of animals and germinal products or decide to take national measures to limit the impact of transmissible animal diseases other than listed diseases within their territory , those national measures should not interfere with the rules on the internal market laid down in union legislation . therefore , it is appropriate to set the framework for such national measures and ensure that they remain within the limits permitted under union law . ### when member states take national measures concerning movements of animals and germinal products or decide to take national measures to limit the impact of transmissible animal diseases other than listed diseases within their territory , those national measures may only interfere with the rules on the internal market laid down in union legislation when this is scientifically justified on the grounds of controlling infectious disease and is proportionate in relation to the risk . therefore , it is appropriate to set the framework for such national measures and ensure that they remain within the limits permitted under union law .


### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of highly significant impact the commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in article 255 . ### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of significant impact the commission shall adopt immediately applicable delegated acts in accordance with the procedure referred to in article 254 .


### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of highly significant impact the commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in article 255 . 3 . ### on duly justified imperative grounds of urgency relating to a disease representing an emerging risk of significant impact the commission shall adopt immediately applicable delegated acts in accordance with the procedure referred to in article 254 .


### the commission shall be empowered to adopt delegated acts in accordance with article 253 concerning amendments to the criteria provided for in paragraph 1 of this article to take account of technical and scientific progress and the developments of relevant international standards . ### the commission shall be empowered , after due public consultation with stakeholders and experts , to adopt delegated acts in accordance with article 253 concerning amendments to the criteria provided for in paragraph 1 of this article to take account of technical and scientific progress and the developments of relevant international standards .


### the availability , feasibility and effectiveness of the different sets of disease prevention and control measures provided for in this regulation with respect to the disease . ### the availability , feasibility and effectiveness of the different sets of disease prevention and control measures provided for in this regulation with respect to the disease , paying strict attention to the prevailing regional conditions .


### biosecurity principles ; ### biosecurity principles , good animal husbandry and responsible use of veterinary medicines ,


### take the necessary disease prevention and control measures to avoid the further spread of that listed disease . ### take the necessary disease prevention and control measures to avoid the further spread of that listed disease , provided that this is done in such a way as to spare the animals any avoidable pain , distress or suffering .


### by way of derogation from article 123 , operators may subject kept ungulates and poultry to a maximum of : one assembly operation in the member state of origin ; one assembly operation in the member state of passage ; one assembly operation in the member state of destination . ### by way of derogation from article 123 , operators may subject kept ungulates and poultry to a maximum of three assembly operations .


### the kept ungulates and poultry are assembled and moved to their final place of destination in another member state as soon as possible after leaving their establishment of origin , and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to article 132 ; ### the kept ungulates and poultry are assembled and moved to their final place of destination as soon as possible after leaving their establishment of origin , and at the latest within a timeframe to be laid down in delegated acts adopted pursuant to article 132 ;


### the timeframe between the time of departure of the kept ungulates or poultry from their establishment of origin and their departure from the assembly operation to their final destination in another member state as referred to in article 131 ; ### the timeframe between the time of departure of the kept ungulates or poultry from their establishment of origin and their departure from the assembly operation to their final destination as referred to in article 131 ;


### where a disease other than listed diseases constitutes a significant risk for the animal health situation of kept terrestrial animals in a member state , the member state concerned may take national measures to control that disease , provided those measures do not : hinder the movement of animals and products between member states ; exceed the limits of what is appropriate and necessary to control that disease . ### where a disease other than listed diseases constitutes a significant risk for the animal health situation of kept terrestrial animals in a member state , the member state concerned may take national measures to prevent the introduction or spread of that disease , provided those measures : only hinder the movement of animals and products between member states when this is scientifically justified on the grounds of controlling infectious disease ; are proportionate in relation to the risk and do not exceed the limits of what is appropriate and necessary to control that disease .


### the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article . ### the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in this article and the requirement for coherent legislation that is easy to understand and apply .


### the national measures referred to in paragraph 1 shall be in accordance with the rules laid down in this regulation and shall not : hinder the movement of animals and products between member states ; be in contradiction with the rules referred to in paragraph 1 . ### the national measures referred to in paragraph 1 shall be in accordance with the rules laid down in this regulation and shall : only hinder the movement of animals and products between member states when this is scientifically justified on the grounds of controlling infectious disease ; be in contradiction with the rules referred to in paragraph 1 .


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