### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information . with respect to generic medicinal products , that time limit shall be in all events 45 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 90 days of receipt of this additional information . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines and that the generic product is essentially similar to the reference product , within the meaning of directive 2001 / 83 / ec of 6 november 2001 .


### it is important that the penalties for breaches of this regulation are proportionate and dissuasive , and reflect the gravity of the infringements and the potential gains from trading on the basis of inside information and market manipulation . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec . ### it is important that the penalties for breaches of this regulation are proportionate and dissuasive , and reflect the gravity of the infringements and the potential gains from trading on the basis of inside information and market manipulation . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec . in order to achieve the level of dissuasion required , minimum penalties should therefore be set at the volume of at least the double of the direct and indirect potential financial gains and the damage caused to consumers resulting from the actions this regulation seeks to prevent


### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive and reflect the damage caused to consumers . eu wide minimum standards for penalties to be endorsed by 2012 should be set at the level of at least the double of the total of the direct and indirect potential financial gains resulting from the actions this regulation seeks to prevent . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them .


### qualified trust services and qualified certificates provided by qualified trust service providers established in a third country shall be accepted as qualified trust services and qualified certificates provided by a qualified trust service providers established in the territory of the union if the qualified trust services or qualified certificates originating from the third country are recognised under an agreement between the union and third countries or international organisations in accordance with article 218 tfue . ### trust services provided by trust service providers established in a third country shall be recognised as legally equivalent to qualified trust services provided by qualified trust service providers established in the union if the trust services originating from the third country comply with the relevant requirements of this regulation as determined by a supervisory body established in a member state .


### a qualified electronic signature shall have the equivalent legal effect of a handwritten signature . ### an electronic signature shall have the equivalent legal effect of a handwritten signature .


### the cross border use of electronic identification means under a notified scheme requires member states to cooperate in providing technical interoperability . this rules out any specific national technical rules requiring non - national parties for instance to obtain specific hardware or software to verify and validate the notified electronic identification . technical requirements on users , on the other hand , stemming from the inherent specifications of whatever token is used are inevitable . ### the cross border use of electronic identification means under a notified scheme requires member states to cooperate in providing technical interoperability . technical requirements on users stemming from the inherent specifications of whatever token is used are inevitable . member states whose identification mechanisms rely on specific hardware or software to verify and validate the notified electronic identification must provide such certification tokens at no additional cost for union principals who are not their nationals or residents .


### qualified trust services and qualified certificates provided by qualified trust service providers established in a third country shall be accepted as qualified trust services and qualified certificates provided by a qualified trust service providers established in the territory of the union if the qualified trust services or qualified certificates originating from the third country are recognised under an agreement between the union and third countries or international organisations in accordance with article 218 tfue . ### trust services and certificates provided by trust service providers established in a third country shall be accepted as trust services and certificates provided by a qualified trust service providers established in the territory of the union if the trust services or certificates originating from the third country are recognised under an agreement between the union and third countries or international organisations in accordance with article 218 tfeu .


### each supervisory body shall submit a yearly report on the last calendar year ' s supervisory activities to the commission and member states by the end of the first quarter of the following year . it shall include at least : ### each supervisory body shall publish a yearly report on the last calendar year ' s supervisory activities by the end of the first quarter of the following year . it shall include at least :


### the supervisory body concerned may also inform the public or require the trust service provider to do so , where it determines that disclosure of the breach is in the public interest . ### the supervisory body concerned shall also inform the public or require the trust service provider to do so , where it determines that disclosure of the breach is in the public interest .


### with reference to paragraph 1 , such agreements shall ensure that the requirements applicable to qualified trust services and qualified certificates provided by qualified trust service providers established in the territory of the union are met by the trust service providers in the third countries or international organisations , especially with regard to the protection of personal data , security and supervision . ### with reference to paragraph 1 , such agreements shall ensure that the requirements applicable to trust services and certificates provided by trust service providers established in the territory of the union are met by the trust service providers in the third countries or international organisations , especially with regard to the protection of personal data , security and supervision , including the requirement for openness set out in article 8 and the liability requirement set out in article 9 .


### ' electronic identification ' means the process of using person identification data in electronic form unambiguously representing a natural or legal person ; ### ' electronic identification ' means the process of using person identification data in electronic form unambiguously representing an entity , a natural or legal person or a pseudonym thereof ;


### member states which notify an electronic identification scheme shall forward to the commission the following information and without undue delay , any subsequent changes thereof : ### member states which notify an electronic authentication or identification scheme shall forward to the commission the following information and without undue delay , any subsequent changes thereof :


### when an electronic identification using an electronic identification means and authentication is required under national legislation or administrative practice to access a service online , any electronic identification means issued in another member state falling under a scheme included in the list published by the commission pursuant to the procedure referred to in article 7 shall be recognised and accepted for the purposes of accessing this service . ### when an electronic authentication using an electronic authentication means is required under national legislation or administrative practise to access a service online , a notified electronic authentication means of the same or higher assurance level issued in another member state shall be recognised under national legislation or administrative practice to access a service of the same sector online . additionally , any electronic authentication means issued in another member state falling under a scheme included in the list published by the commission pursuant to the procedure referred to in article 7 shall be recognised and accepted for the purposes of accessing this service . 2 . a member state may limit recognition and acceptance of notified electronic authentication means to a specific sector or sectors . 3 . a member state may withdraw recognition and acceptance of electronic authentication means in the event of security compromise , including the issuance of certificates to impostors or a technical vulnerability in the mechanism .


### the supervisory body shall have the power to issue binding instructions to qualified trust service providers to remedy any failure to fulfil the requirements indicated in the security audit report . ### the supervisory body shall have the power to issue binding instructions to trust service providers to remedy any failure to fulfil the requirements indicated in the security audit report . such instructions shall be published .


### this regulation establishes a legal framework for electronic signatures , electronic seals , electronic time stamps , electronic documents , electronic delivery services and website authentication . ### this regulation establishes a legal framework for certain electronic signatures , associated trust services and the authentication of certain aspects of networked services .


### member states shall notify to the commission and other member states the names and the addresses of their respective designated supervisory bodies . ### member states shall publish the names and the addresses of their respective designated supervisory bodies .


### a qualified electronic signature shall have the equivalent legal effect of a handwritten signature . ### an electronic signature shall have the equivalent legal effect of a handwritten signature . in particular , a forged signature shall be null and void . the risk of determining whether a signature is forged shall fall on the relying party .


### the commission shall , by means of implementing acts , establish the necessary modalities to facilitate the cooperation between the member states referred to in paragraph 1 with a view to fostering a high level of trust and security appropriate to the degree of risk . those implementing acts shall concern , in particular , the exchange of information , experiences and good practice on electronic identification schemes , the peer review of notified electronic identification schemes and the examination of relevant developments arising in the electronic identification sector by the competent authorities of the member states . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission shall , by means of implementing acts , establish the necessary modalities to facilitate the cooperation between the member states and the publication and peer - review mechanisms referred to in paragraph 1 with a view to fostering a high level of trust and security appropriate to the degree of risk . those implementing acts shall concern , in particular , the exchange of information , experiences and good practice on electronic identification schemes , the independent , third - party auditing of notified electronic identification schemes and the examination of relevant developments arising in the electronic identification sector by the competent authorities of the member states . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### undertaking supervision of qualified trust service providers established in the territory of the designating member state and of the qualified trust services they provide in order to ensure that they and the qualified trust services provided by them meet the applicable requirements laid down in this regulation ; ### undertaking supervision of trust service providers established in the territory of the designating member state and of the trust services they provide in order to ensure that they and the trust services provided by them meet the applicable requirements laid down in this regulation ;


### building trust in the online environment is key to economic development . lack of trust makes consumers , businesses and administrations hesitate to carry out transactions electronically and to adopt new services . ### building trust in the online environment is key to economic and social development . lack of trust makes consumers , businesses and administrations hesitate to carry out transactions electronically and to adopt new services .


### this regulation lays down the conditions under which member states shall recognise and accept electronic identification means of natural and legal persons falling under a notified electronic identification scheme of another member state . ### this regulation lays down the conditions under which member states shall recognise and accept electronic authentication or identification means for natural and legal persons falling under a notified electronic authentication or identification scheme of another member state .


### ‘ trust service provider’ means a natural or a legal person who provides one or more trust services ; ### ' trust service provider ' means a natural or a legal person who provides one or more trust services as defined in this regulation ;


### without prejudice to article 16 , any trust service provider may submit the report of a security audit carried out by a recognised independent body to the supervisory body to confirm that appropriate security measures have been taken . ### without prejudice to article 16 , any trust service provider shall publish the report of a security audit carried out by an independent body whose competence to carry out the audit has been demonstrated to confirm that appropriate security measures have been taken .


### qualified trust service providers shall be audited by a recognised independent body once a year to confirm that they and the qualified trust services provided by them fulfil the requirements set out in this regulation , and shall submit the resulting security audit report to the supervisory body . ### trust service providers shall be audited once a year by an independent body whose competence to carry out the audit has been demonstrated to confirm that they and the trust services provided by them fulfil the requirements set out in this regulation , and shall make the resulting security audit report public and transmit it to the supervisory body . in the event that the audit may contain confidential business information , the publication of sensitive sections may be delayed by the supervisory body , but for no more than one year .


### qualified trust services and qualified certificates provided by qualified trust service providers established in a third country shall be accepted as qualified trust services and qualified certificates provided by a qualified trust service providers established in the territory of the union if the qualified trust services or qualified certificates originating from the third country are recognised under an agreement between the union and third countries or international organisations in accordance with article 218 tfue . ### qualified trust services and qualified certificates provided by qualified trust service providers established in a third country shall be accepted as qualified trust services and qualified certificates provided by a qualified trust service provider established in the territory of the union if : the qualified trust service provider fulfils the requirements laid down in this regulation and has been accredited under an accreditation scheme established in a member state ; or the qualified trust service provider established within the union which fulfils the requirements laid down in this regulation guarantees the compliance with the requirements laid down in this regulation ; or the qualified trust services or qualified certificates originating from a third country are recognised under an agreement between the union and that third country or international organisation in accordance with article 218 tfeu .


### member states shall cooperate in order to ensure the interoperability of electronic identification means falling under a notified scheme and to enhance their security . ### member states shall cooperate in order to ensure the interoperability of electronic identification means falling under a notified scheme and to enhance their security . interoperability standards shall be public together with the cryptographic algorithms , protocols and key management standards . all audit reports shall be published together with all breach notifications following the responsible disclosure period set out in article 15 .


### qualified trust services and qualified certificates provided by qualified trust service providers established in a third country shall be accepted as qualified trust services and qualified certificates provided by a qualified trust service providers established in the territory of the union if the qualified trust services or qualified certificates originating from the third country are recognised under an agreement between the union and third countries or international organisations in accordance with article 218 tfue . ### trust services provided by trust service providers established in a third country shall be recognised as legally equivalent to qualified trust services provided by qualified trust service providers established in the union if the trust services originating from the third country comply with the relevant requirements of this regulation as determined by a supervisory body established in a member state .


### accelerating the deployment of fast and ultrafast broadband networks networks and their uptake , including by small and medium sized enterprises , to be measured by the level of broadband and ultrafast broadband coverage and the number of households having subscribed for broadband connections for above 100 mbps ; ### accelerating the deployment of fast and ultrafast broadband networks and their uptake , including by small and medium sized enterprises and in the home , to be measured by the level of broadband and ultrafast broadband coverage and the number of households having subscribed for broadband connections for above 100 mbps ;


### accelerating the deployment of fast and ultrafast broadband networks networks and their uptake , including by small and medium sized enterprises , to be measured by the level of broadband and ultrafast broadband coverage and the number of households having subscribed for broadband connections for above 100 mbps ; ### accelerating the deployment of fast and ultrafast broadband networks and their uptake , including by small and medium sized enterprises and in rural areas , to be measured by the level of broadband and ultrafast broadband coverage and the number of households having subscribed for broadband connections for above 100 mbps ;


### the european rail traffic management system : the amount of union financial aid shall not exceed 50% of the eligible cost ; ### the european rail traffic management system and rail freight ' s noise reduction at the source : the amount of union financial aid shall not exceed 50% of the eligible cost ;


### contribute to smart , sustainable and inclusive growth by developing modern and high performing trans - european networks , thus bringing forward benefits for the entire european union in terms of competitiveness and economic , social and territorial cohesion within the single market and creating an environment more conducive to private and public investment through a combination of financial instruments and union direct support and by exploiting synergies across the sectors . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest , and in particular the volume of public and private investments in projects of common interest realised through the financial instruments under this regulation . ### contribute to smart , sustainable and inclusive growth by developing modern and high performing trans - european networks , thus bringing forward benefits for the entire european union in terms of competitiveness and economic , social and territorial cohesion within the single market and creating an environment more conducive to private and public investment through a combination of financial instruments and union direct support and by exploiting synergies across the sectors . the achievement of this objective will be measured by the volume of public and private investment in projects of common interest , and in particular the volume of public and private investments in projects of common interest realised through the financial instruments under this regulation . all eu co - financed transport infrastructure must be earmarked for green and sustainable intermodal infrastructure networks with a strong focus on the european added value of adding trans - border rail missing links and sustainable projects in and between new member states .


### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are vexatious , in particular because of their repetitive character , or the size or volume of the request , the controller may charge a fee for providing the information or taking the action requested , or the controller may not take the action requested . in that case , the controller shall bear the burden of proving the vexatious character of the request . ### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are manifestly excessive , in particular because of their repetitive character , the controller may charge a reasonable fee for providing the information or taking the action requested . in that case , the controller shall bear the burden of proving the excessive character of the request .


### the principle of fair processing requires that the data subjects should be informed in particular of the existence of the processing operation and its purposes , how long the data will be stored , on the existence of the right of access , rectification or erasure and on the right to lodge a complaint . where the data are collected from the data subject , the data subject should also be informed whether they are obliged to provide the data and of the consequences , in cases they do not provide such data . ### the principle of fair and transparent processing requires that the data subjects should be informed in particular of the existence of the processing operation and its purposes , how long the data will be stored , on the existence of the right of access , rectification or erasure and on the right to lodge a complaint . where the data are collected from the data subject , the data subject should also be informed whether they are obliged to provide the data and of the consequences , in cases they do not provide such data .


### the principle of fair processing requires that the data subjects should be informed in particular of the existence of the processing operation and its purposes , how long the data will be stored , on the existence of the right of access , rectification or erasure and on the right to lodge a complaint . where the data are collected from the data subject , the data subject should also be informed whether they are obliged to provide the data and of the consequences , in cases they do not provide such data . ### the principle of fair and transparent processing requires that the data subjects should be informed in particular of the existence of the processing operation , its legal basis and its purposes , how long the data will be stored , on the existence of the right of access , rectification or erasure and on the right to lodge a complaint . furthermore the data subject shall be informed if profiling takes place and its intended consequences . where the data are collected from the data subject , the data subject should also be informed whether they are obliged to provide the data and of the consequences , in cases they do not provide such data .


### member states shall provide that each controller and processor maintains documentation of all processing systems and procedures under their responsibility . ### all competent authorities shall maintain detailed documentation of all processing systems and procedures under their responsibility . 1a . transmissions of personal data are to be logged or documented for the purposes of verification of the lawfulness of the data processing , self - monitoring and ensuring proper data integrity and security . 1b . the logs and documents so produced must be made available to the supervisory authority upon request . the supervisory authority shall use this information only for the purpose of checking the lawfulness of the data processing and ensuring proper data integrity and security .


### member states should be allowed to adopt legislative measures delaying , restricting or omitting the information of data subjects or the access to their personal data to the extent that and as long as such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned , to avoid obstructing official or legal inquiries , investigations or procedures , to avoid prejudicing the prevention , detection , investigation and prosecution of criminal offences or for the execution of criminal penalties , to protect public security or national security , or , to protect the data subject or the rights and freedoms of others . ### member states should be allowed to adopt legislative measures delaying or restricting the information of data subjects or the access to their personal data to the extent that and as long as such partial or complete restriction constitutes a strictly necessary and proportionate measure in a democratic society with due regard for fundamental rights and the legitimate interests of the person concerned , to avoid obstructing official or legal inquiries , investigations or procedures , to avoid prejudicing the prevention , detection , investigation and prosecution of criminal offences or for the execution of criminal penalties , to protect public security or national security , or , to protect the data subject or the rights and freedoms of others .


### member states shall provide that the controller informs the data subject in writing of any refusal of erasure or marking of the processing , the reasons for the refusal and the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy . ### member states shall provide that the controller informs the data subject in writing of any refusal of erasure or restriction of the processing , the reasons for the refusal and the possibilities of lodging a complaint to the supervisory authority and seeking a judicial remedy .


### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned : ### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent and for the period that such partial or complete restriction constitutes a necessary and strictly proportionate measure in a democratic society with due regard for the legitimate interests and fundamental rights of the person concerned , based on a concrete and individual examination of each specific case :


### processed under the responsibility and liability of the controller , who shall ensure compliance with the provisions adopted pursuant to this directive . ### processed under the responsibility and liability of the controller , who shall ensure and be able to demonstrate , for each processing operation , compliance with the provisions adopted pursuant to this directive .


### ensuring a consistent and high level of protection of the personal data of individuals and facilitating the exchange of personal data between competent authorities of members states is crucial in order to ensure effective judicial co - operation in criminal matters and police cooperation . to that aim , the level of protection of the rights and freedoms of individuals with regard to the processing of personal data by competent authorities for the purposes of prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties must be equivalent in all member states . effective protection of personal data throughout the union requires strengthening the rights of data subjects and the obligations of those who process personal data , but also equivalent powers for monitoring and ensuring compliance with the rules for the protection of personal data in the member states . ### ensuring a consistent and high level of protection of the personal data of individuals and facilitating the exchange of personal data between competent authorities of members states is crucial in order to ensure effective judicial co - operation in criminal matters and police cooperation . to that aim , minimum standards must be ensured in all member states with regard to any processing of personal data by competent authorities for the purposes of prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties .


### where requests are vexatious , in particular due to their repetitive character , the supervisory authority may charge a fee or not take the action required by the data subject . the supervisory authority shall bear the burden of proving of the vexatious character of the request . ### where requests are manifestly excessive , in particular due to their repetitive character , the supervisory authority may charge a reasonable fee . the supervisory authority shall bear the burden of proving of the excessive character of the request .


### the recipients or categories of recipients to whom the personal data have been disclosed , in particular the recipients in third countries ; ### the recipients to whom the personal data have been disclosed , including all the recipients in third countries ;


### ' data subject ' means an identified natural person or a natural person who can be identified , directly or indirectly , by means reasonably likely to be used by the controller or by any other natural or legal person , in particular by reference to an identification number , location data , online identifiers or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural or social identity of that person ; ### ' data subject ' means an identified natural person or a natural person who can be identified or singled out , directly or indirectly , alone or in combination with associated data , by means reasonably likely to be used by the controller or by any other natural or legal person , in particular by reference to unique identifier , location data , online or offline identifier or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural , social or gender identity or sexual orientation of that person ;


### member states may adopt legislative measures restricting , wholly or partly , the data subject ' s right of access to the extent that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned : ### member states may adopt legislative measures restricting , wholly or partly , depending on the individual case , the data subject ' s right of access to the extent and for the period that such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned :


### by way of derogation from articles 34 and 35 , member states shall provide that a transfer of personal data to a third country or an international organisation may take place only on condition that : ### where the commission concludes pursuant to article 34 that an adequate level of protection does not exist , personal data may not be transferred to the third country or a territory or a processing sector within that third country , or the international organisation in question , if , in the case in question , the legitimate interests of the data subject in preventing any such transfer outweigh the public interest in transferring such data . by way of derogation from paragraph 1 and article 35 , member states may provide that a transfer of personal data to a third country or an international organisation may take place only on condition that :


### instead of erasure , the controller shall mark the personal data where : ### instead of erasure , the controller shall restrict the processing of the personal data where :


### member states shall provide that each supervisory authority draws up an annual report on its activities . the report shall be made available to the commission and the european data protection board . ### member states shall provide that each supervisory authority draws up a report on its activities at least every two years . the report shall be presented to the national parliament , and be made available to the commission , the european data protection board , and the public . it shall include information on the extent to which competent authorities in their jurisdiction have accessed data held by private parties to investigate or prosecute criminal offences .


### accurate and , where necessary , kept up to date ; every reasonable step must be taken to ensure that personal data that are inaccurate , having regard to the purposes for which they are processed , are erased or rectified without delay ; ### accurate and kept up to date ; every reasonable step must be taken to ensure that personal data that are inaccurate , having regard to the purposes for which they are processed , are erased or rectified without delay ;


### instead of erasure , the controller shall mark the personal data where : ### instead of erasure , the controller shall restrict processing of personal data in such a way that it is not subject to the normal data access and processing operations of the controller and can not be changed anymore , where :


### where requests are vexatious , in particular due to their repetitive character , the supervisory authority may charge a fee or not take the action required by the data subject . the supervisory authority shall bear the burden of proving of the vexatious character of the request . ### where requests are vexatious , in particular due to their repetitive character , the supervisory authority may charge a reasonable fee . the supervisory authority shall bear the burden of proving of the vexatious character of the request .


### automated processing of personal data intended to evaluate certain personal aspects relating to the data subject shall not be based solely on special categories of personal data referred to in article 8 . ### automated processing of personal data intended to single out a data subject without an initial suspicion that the data subject might have committed or will be committing a criminal offence shall only be lawful if and to the extent that it is strictly necessary for the investigation of a serious criminal offence or the prevention of a clear and imminent danger , established on factual indications , to public security , the existence of the state , or the life of persons . it shall not include or generate special categories of personal data referred to in article 8 .


### the transfer is necessary in order to protect the vital interests of the data subject or another person ; or ### the transfer is necessary to safeguard the vital interests of the data subject or another person , particularly in terms of their physical safety and well - being ; or


### in the course of an activity which falls outside the scope of union law , in particular concerning national security ; ### in the course of an activity which falls outside the scope of union law ;


### ' data subject ' means an identified natural person or a natural person who can be identified , directly or indirectly , by means reasonably likely to be used by the controller or by any other natural or legal person , in particular by reference to an identification number , location data , online identifiers or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural or social identity of that person ; ### ' data subject ' means an identified natural person or a natural person who can be identified or singled out , directly or indirectly , alone or in combination with associated data , by means reasonably likely to be used by the controller or by any other natural or legal person , in particular by reference to a unique identifier , location data , online identifiers or to one or more factors specific to the physical , physiological , genetic , mental , economic , cultural , social or gender identity or sexual orientation of that person ;


### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are vexatious , in particular because of their repetitive character , or the size or volume of the request , the controller may charge a fee for providing the information or taking the action requested , or the controller may not take the action requested . in that case , the controller shall bear the burden of proving the vexatious character of the request . ### member states shall provide that the information and any action taken by the controller following a request referred to in paragraphs 3 and 4 are free of charge . where requests are manifestly excessive , in particular because of their repetitive character , the controller may charge a reasonable fee for providing the information or taking the action requested . in that case , the controller shall bear the burden of proving the excessive character of the request .


### member states shall provide that , having regard to the state of the art and the cost of implementation , the controller shall implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject . ### member states shall provide that , having regard to the state of the art and the cost of implementation , the controller shall , both at the time of the determination of the purposes and means for processing and at the time of the processing itself , implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of provisions adopted pursuant to this directive and ensure the protection of the rights of the data subject . where the controller has carried out a data protection impact assessment pursuant to article 25a , the results shall be taken into account when developing those measures and procedures .


### the transfer of the data is essential for the prevention of an immediate and serious threat to public security of a member state or a third country ; or ### the transfer of the data is limited to a specific case and essential for the prevention of an immediate and serious threat to public security of a member state or a third country ; or


### adequate , relevant , and not excessive in relation to the purposes for which they are processed ; ### adequate , relevant , and limited to the minimum necessary in relation to the purposes for which they are processed ; they shall only be processed if , and as long as , the purposes could not be fulfilled by processing information that does not involve personal data ;


### member states shall provide that any information and any communication relating to the processing of personal data are to be provided by the controller to the data subject in an intelligible form , using clear and plain language . ### member states shall provide that any information and any communication relating to the processing of personal data are to be provided by the controller to the data subject in an intelligible form , using clear and plain language , adapted to the data subject , in particular where that information is addressed specifically to a child .


### it is inherent to the processing of personal data in the areas of judicial co - operation in criminal matters and police co - operation that personal data relating to different categories of data subjects are processed . therefore a clear distinction should as far as possible be made between personal data of different categories of data subjects such as suspects , persons convicted of a criminal offence , victims and third parties , such as witnesses , persons possessing relevant information or contacts and associates of suspects and convicted criminals . ### it is inherent to the processing of personal data in the areas of judicial co - operation in criminal matters and police co - operation that personal data relating to different categories of data subjects are processed . therefore a clear distinction should be made between personal data of different categories of data subjects such as suspects , persons convicted of a criminal offence , victims and third parties , such as witnesses , persons possessing relevant information or contacts and associates of suspects and convicted criminals .


### it is inherent to the processing of personal data in the areas of judicial co - operation in criminal matters and police co - operation that personal data relating to different categories of data subjects are processed . therefore a clear distinction should as far as possible be made between personal data of different categories of data subjects such as suspects , persons convicted of a criminal offence , victims and third parties , such as witnesses , persons possessing relevant information or contacts and associates of suspects and convicted criminals . ### it is inherent to the processing of personal data in the areas of judicial co - operation in criminal matters and police co - operation that personal data relating to different categories of data subjects are processed . therefore a clear distinction should be made between personal data of different categories of data subjects such as suspects , persons convicted of a criminal offence , victims and third parties , such as witnesses , persons possessing relevant information or contacts and associates of suspects and convicted criminals . specific rules on the consequences of this categorisation should be provided by the member states , taking into account the different purposes for which data are collected and providing specific safeguards for persons who are not suspect or have not been convicted of a criminal offence .


### the communication to the data subject may be delayed , restricted or omitted on the grounds referred to in article 11 . ### the communication to the data subject may be delayed or restricted on the grounds referred to in article 11 .


### member states may adopt legislative measures delaying , restricting or omitting the provision of the information to the data subject to the extent that , and as long as , such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the legitimate interests of the person concerned : ### member states may adopt legislative measures delaying or restricting the provision of the information to the data subject to the extent that , and as long as , such partial or complete restriction constitutes a necessary and proportionate measure in a democratic society with due regard for the fundamental rights and the legitimate interests of the person concerned :


### the purposes of the processing for which the personal data are intended ; ### the legal basis and the purposes of the processing for which the personal data are intended ;


### member states may determine categories of data processing which may wholly or partly fall under the exemptions of paragraph 4 . ### member states shall provide that the controller shall assess , in each specific case , by means of a concrete and individual examination , whether a partial or complete restriction for one of the reasons referred to in paragraph 4 applies . member state law may also determine categories of data processing which may wholly or partly fall under the exemptions of paragraph 4 , , and .


### any company that issues transferable securities which are admitted to trading on regulated markets shall arrange for such securities to be represented in book - entry form as immobilisation through the issuance of a global note , which represents the whole issue , or subsequent to a direct issuance of the securities into a dematerialised form . ### any legal entity that issues transferable securities which are admitted to trading on regulated markets shall arrange for such securities to be represented in book - entry form as immobilisation through the issuance of a global note , which represents the whole issue , or subsequent to a direct issuance of the securities into a dematerialised form .


### the authorities of the member state where the company that issues securities is established shall be competent for ensuring that article 3 is applied . ### the authorities of the member state where the legal entity that issues securities is established shall be competent for ensuring that article 3 is applied .


### any company that issues transferable securities which are admitted to trading on regulated markets shall arrange for such securities to be represented in book - entry form as immobilisation through the issuance of a global note , which represents the whole issue , or subsequent to a direct issuance of the securities into a dematerialised form . ### any legal entity that issues transferable securities or units in collective investment undertakings as defined in article&#160 ; 2 which are admitted to trading on regulated markets or traded in trading venues shall arrange for such securities to be represented in book - entry form as immobilisation through the issuance of a global note , which represents the whole issue , or subsequent to a direct issuance of the securities into a dematerialised form .


### the delegation of power referred to in articles 2 and 10 of this regulation shall be conferred for an indeterminate period of time from the [ date of entry into force of the basic legislative act or from any other date set by the legislator . ] ### the delegation of power referred to in articles 10 and 11 of this regulation shall be conferred for a period of 5 years from the [ date of entry into force of the basic legislative act or from any other date set by the legislator . ]


### the free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well - being of citizens , and to their social and economic interests . ### that food is safe is an essential prerequisite for its free movement within the internal market in order to ensure the health and well - being of citizens .


### ' if , at the end of the two month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the two month period or after a joint decision has been reached ' . ### ' if , at the end of the initial two month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the competent authorities of the host member state shall await the decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with eu law , and shall take their final decision in conformity with the authority ' s decision . the authority ' s decision shall not replace the prudential judgement of the competent authorities of the member state . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the initial two month period or after a joint decision has been reached ' .


### if , at the end of the two month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the two month period or after a joint decision has been reached . ### if , at the end of the two month period following receipt of a request under the first subparagraph any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the competent authorities of the host member state shall await the decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with union law , and shall take their final decision in conformity with the authority ' s decision . the authority ' s decision shall not replace the prudential judgement of the competent authorities of the member state . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of that two month period or after a joint decision has been reached .


### if , at the end of the six month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the six month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the six month period or after a joint decision has been reached ### if , at the end of the six - month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer its decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation on its decision , and shall take its decision in conformity with the european banking authority ' s decision . the six - month period shall be deemed to be the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the six - month period or after a joint decision has been reached . decisions taken by the european banking authority shall not replace the lawful exercise of judgment by the competent authorities of the consolidating supervisor pursuant to this directive .


### in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . ### in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer its decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with union law , and shall take its final decision in conformity with the authority ' s decision . the authority ' s decision according to the precautionary principle shall not replace the consolidating supervisor ' s additional prudential judgement . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached .


### ' in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . ' ### ' in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer their decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with union law , and shall take its final decision in conformity with the authority ' s decision . the authority ' s decision according to the precautionary principle shall not replace the consolidating supervisor ' s additional prudential judgement . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . '


### if , at the end of the two month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the two month period or after a joint decision has been reached . ### if , at the end of the two month period following receipt of a request under the first subparagraph any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the competent authorities of the host member state shall await the decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with eu law , and shall take their final decision in conformity with the authority ' s decision . the two month period shall be deemed the conciliation period within the meaning of that regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of that two month period or after a joint decision has been reached .


### in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . ### in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer its decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation to settle the matter in order to ensure compliance with union law , and shall take its final decision in conformity with the authority ' s decision . the authority ' s decision according to the precautionary principle shall take into consideration the consolidating supervisor ' s additional prudential judgement . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached .


### member states shall establish a register of all investment firms . the register shall be publicly accessible and shall contain information on the services or activities for which the investment firm is authorised . it shall be updated on a regular basis . the european securities and markets authority established by regulation… / …of the european parliament and of the council shall establish a list of all investment firms in the community . the european securities and markets authority shall publish that list and shall keep it up to date . ### member states shall register all investment firms which provide services or carry out activities within their sphere of authority . a systematically updated list of those firms shall be transferred to the european securities and markets authority established by regulation… / …of the european parliament and of the council . the european supervisory authority shall establish a register of all investment firms in the union . the register shall be publicly accessible and shall contain information on the services or activities for which the investment firm is authorised . it shall be updated on a regular basis . where a competent authority has withdrawn an authorisation in accordance with article 8 to , the withdrawal shall be published in the register for a period of two years .


### ' where an emergency situation , including adverse developments in financial markets , arises , which potentially jeopardises the market liquidity and the stability of the financial system in any of the member state where entities of a group have been authorised or where significant branches referred to in article 42a are established , the consolidating supervisor shall , subject to chapter 1 , section 2 , alert as soon as is practicable , the european banking authority and the authorities referred to in the fourth subparagraph of article 49 and article 50 , and shall communicate all information essential for the pursuance of their tasks . those obligations shall apply to all competent authorities under articles 125 and 126 and to the competent authority identified under article 129 . ### ' where a potential or effective emergency situation , including any potential adverse developments in financial markets or in real economy , arises , which potentially jeopardises the market liquidity and the stability of the financial system in any of the member state where entities of a group have been authorised or where significant branches referred to in article 42a are established , the consolidating supervisor shall , subject to chapter 1 , section 2 , alert as soon as is practicable , the european banking authority and the authorities referred to in the fourth subparagraph of article 49 and article 50 , and shall communicate all information essential for the pursuance of their tasks . those obligations shall apply to all competent authorities under articles 125 and 126 and to the competent authority identified under article 129 .


### in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four month period , a competent authority has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall await any decision that the european banking authority may take in accordance with article 11 of that regulation , and shall act in conformity with that decision . the four month period shall be deemed the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four month period or after a joint decision has been reached . ### in the absence of such a joint decision between the competent authorities within four months , a decision on the application of articles 123 and 124 and article 136 shall be taken on a consolidated basis by the consolidating supervisor after duly considering the risk assessment of subsidiaries performed by relevant competent authorities . if , at the end of the four - month period , any of the competent authorities concerned has referred the matter to the european banking authority in accordance with article 11 of regulation … / … [ eba ] , the consolidating supervisor shall defer its decision and await any decision that the european banking authority may take in accordance with article 11 of that regulation on its decision , and shall take its decision in conformity with the european banking authority ' s decision . the four - month period shall be deemed to be the conciliation period within the meaning of the regulation . the european banking authority shall take its decision within one month . the matter shall not be referred to the authority after the end of the four - month period or after a joint decision has been reached . decisions taken by the european banking authority shall not replace the lawful exercise of judgment by the competent authorities of the consolidating supervisor pursuant to this directive .


### the price increase referred to in paragraph 1 shall not exceed 10% of the price of the package . ### the price increase referred to in paragraph 1 shall not exceed 3% of the price of the package .


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


### in the light of advice from ices and stecf certain technical conservation measures in the west of scotland , celtic sea and irish sea to protect rockall haddock , cod , haddock and whiting stocks should be maintained to contribute to the conservation of fish stocks . ### in the light of advice from ices and stecf certain technical conservation measures in the west of scotland , celtic sea and irish sea , to protect cod , haddock and whiting stocks should be maintained to contribute to the conservation of fish stocks .


### improving market access and developing trade , investment and business opportunities for european companies by means of economic partnerships and business and regulatory cooperation . this objective shall be measured by the union’s share in foreign trade with key partner countries and by trade and investments flows to partner countries specifically targeted by actions , programmes and measures under this regulation ; ### promoting high social and environmental standards for fair and equitable trade and investment relations , by means of economic partnerships and business and regulatory cooperation . this objective shall be measured , inter alia , by the union’s share in foreign trade with key partner countries , by the balance of trade and investment flows with partner countries , and the uptake of trade qualification measures specifically targeted by actions , programmes and measures under this regulation ;


### the union should be able to respond in a flexible and timely manner to evolving and / or unforeseen needs in order to make its commitment to promote its interests in its relations with third countries more effective , by adopting special measures not covered by multi - annual indicative programmes . ### the union should be able to respond in a flexible and timely manner to evolving and / or unforeseen needs in order to make its commitment to promote mutual interests in its relations with third countries more effective , by adopting special measures not covered by multi - annual indicative programmes .


### when setting up the electronic system referred in paragraph 1 , the commission shall ensure that it is interoperable with the eu database for clinical trials on medicinal products for human use set up in accordance with article [ … ] of regulation no [ ref . of future regulation on clinical trials ] . with the exception of the information referred to in article 50 , the information collated and processed in the electronic system shall be accessible only to the member states and to the commission . ### when setting up the electronic system referred in paragraph 1 , the commission shall ensure that it is interoperable with the eu database for clinical trials on medicinal products for human use set up in accordance with article [ … ] of regulation no [ ref . of future regulation on clinical trials ] . the information collated and processed in the electronic system shall be accessible to the member states , to the commission , and the commission shall also ensure that healthcare professionals and patients have access to the electronic system


### it should be the responsibility of the member states to decide on a case - by - case basis whether or not a product falls within the scope of this regulation . if necessary , the commission may decide , on a case - by - case basis , whether or not a product falls within the definition of an in vitro diagnostic medical device or of an accessory to an in vitro diagnostic medical device . ### it should be the responsibility of the commission to decide on a case - by - case basis whether or not a product falls within the scope of this regulation . if necessary , the commission may decide , on a case - by - case basis , whether or not a product falls within the definition of an in vitro diagnostic medical device or of an accessory to an in vitro diagnostic medical device .


### classification and conformity assessment ### classification , marketing authorisation and conformity assessment


### the joint assessment team shall provide its opinion regarding the assessment report and the draft notification within 21 days of receipt of those documents and the commission shall immediately submit this opinion to the mdcg . within 21 days after receipt of the opinion of the joint assessment team , the mdcg shall issue a recommendation with regard to the draft notification which the relevant national authority shall duly take into consideration for its decision on the designation of the notified body . ### the joint assessment team shall provide its opinion regarding the assessment report and the draft notification within 21 days of receipt of those documents and the commission shall immediately submit this opinion to the mdcg . within 21 days after receipt of the opinion of the joint assessment team , the mdcg shall issue a recommendation with regard to the draft notification . the relevant national authority shall base its decision on the designation of the notified body on this recommendation by the mdcg . in case where its decision differs from that recommendation , the national authority shall provide the mdcg with all necessary justifications .


### member states may not maintain or introduce , in their national law , provisions diverging from those laid down in this directive , including more or less stringent provisions to ensure a different level of consumer protection . ### unless indicated differently in this directive , member states may adopt or maintain in force more stringent provisions , compatible with the treaty in the field covered by this directive , to ensure a higher level of consumer protection . 2 . where member states maintain or introduce more stringent provisions to ensure a higher level of consumer protection in the field harmonised by this directive , these provisions must be compatible with the treaty and must be notified to the commission . the commission shall make that information public on a website or in another easily accessible way . 3 . the rights resulting from this directive shall be exercised without prejudice to other rights which the consumer may invoke under the national rules governing contractual or non - contractual liability .


### this directive shall only apply to financial services as regards certain off - premises contracts as provided for by articles 8 to 20 , unfair contract terms as provided for by articles 30 to 39 and general provisions as provided for by articles 40 to 46 , read in conjunction with article 4 on full harmonisation . ### this directive shall only apply to financial services as regards certain off - premises contracts as provided for by articles 8 to 20 , unfair contract terms as provided for by articles 30 to 39 and general provisions as provided for by articles 40 to 46 , read in conjunction with article 4 on minimum harmonisation .


### the risks related to these matters and how the company manages those risks ### the risks related to these matters linked to the company ' s operations which are likely to cause , or have caused , severe adverse social , environmental or human rights impacts , and how the company manages those risks


### in providing this information , companies may rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and international frameworks such as the united nations global compact , the guiding principles on business and human rights implementing the un “protect , respect and remedy” framework , the organisation for economic co - operation and development guidelines for multinational enterprises , the international organisation for standardisation 26000 , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative . ### in providing information on their compliance with rights and values protected by norms of international law , companies shall apply the guiding principles on business and human rights implementing the un “protect , respect and remedy” framework and the oecd guidelines for multinational enterprises , companies may also rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and other international frameworks such as the united nations global compact , the international organisation for standardisation 26000 standard , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative .


### ‘ advice’ means the provision of a recommendation to a customer , either upon their request or at the initiative of the insurance undertaking or the insurance intermediary ; ### ‘ advice’ means the counselling to an actual or potential customer in relation to an insurance product , which is based on a personal recommendation upon their request or at the initiative of the insurance undertaking or the insurance intermediary ;


### such bans should only be introduced where they will result in lower overall greenhouse gas emissions , in particular from both the leakage of any fluorinated greenhouse gases and the co2 emissions resulting from their energy consumption . equipment containing fluorinated greenhouse gases should thus be allowed if their overall greenhouse gas emissions are less than those that would result from an equivalent equipment without fluorinated greenhouse gases , which has the maximum allowed energy consumption set out in relevant implementing measures adopted under directive 2009 / 125 / ec . ### such bans should only be introduced where they will result in lower overall greenhouse gas emissions , in particular from both the leakage of any fluorinated greenhouse gases and the co2 emissions resulting from their energy consumption .


### for that purpose they shall establish one of the following systems , as appropriate : a system whereby a database is kept at national level for the collection of the data recorded in accordance with article 5 ; a system whereby surveys on emissions from a representative sample of operators covered by the provisions of article 5 are carried out , and results are extrapolated from those surveys . ### for that purpose they shall establish a system whereby a database is kept at national level for the collection of the data recorded in accordance with article 5 .


### the commission shall be empowered to adopt delegated acts in accordance with article 20 amending the list set out in annex iii to include other products and equipment that contain fluorinated greenhouse gases with a global warming potential of 150 or more , or that rely on them to work , if it has been established that alternatives to the use of fluorinated greenhouse gases or to the use of specific types of fluorinated greenhouse gases are available , and their use would result in lower overall greenhouse gas emissions and to exclude , where appropriate for a specified period of time , certain categories of products or equipment for which alternative substances which fall below the specified global warming potential limit are not available for technical , economic or safety reasons . ### the commission shall be empowered to adopt delegated acts in accordance with article 20 amending the list set out in annex iii to include other products and equipment that contain fluorinated greenhouse gases , or that rely on them to work , if it has been established that alternatives to the use of fluorinated greenhouse gases or to the use of specific types of fluorinated greenhouse gases are available , and their use would result in lower overall greenhouse gas emissions and to exclude , where appropriate for a specified period of time , certain categories of products or equipment for which alternative substances which fall below the specified global warming potential limit are not available for technical , economic or safety reasons .


### gradually reducing the placing on the market of hydrofluorocarbons has been identified as the most effective , cost - efficient way of reducing emissions of those substances in the long term . ### the regulatory approach used for ozone - depleting substances under regulation no 2037 / 2000 and regulation no 1005 / 2009 of the european parliament and of the council of 16 september 2009 on substances that deplete the ozone layer1 , should also be used to regulate hydrofluorocarbons . in addition to bans on the placing on the market of hydrofluorocarbon - based equipment , containment measures and recovery requirements , the gradual reduction of the placing on the market of hydrofluorocarbons has been identified as the most effective , cost - efficient way of reducing emissions of those substances in the long term . ________________ 1 oj l 286 , 31 . 10 . 2009 , p . 1


### amending the maximum quantities set out in annex v in the light of developments of the market in hydrofluorocarbons and related emissions ; and ### reducing the maximum quantities set out in annex v in the light of developments of the market in hydrofluorocarbons and related emissions ; and


### by 31 march 2014 and every year after that , each undertaking that destroyed more than one metric tonne or 1 000 tonnes of co2 equivalent of fluorinated greenhouse gases and gases listed in annex ii during the preceding calendar year shall report to the commission the data specified in annex vii on each of those substances for that calendar year . ### by 31 march 2014 and every year after that , each undertaking that destroyed more than one metric tonne or 500 tonnes of co2 equivalent of fluorinated greenhouse gases and gases listed in annex ii during the preceding calendar year shall report to the commission the data specified in annex vii on each of those substances for that calendar year .


### stationary air - conditioning equipment ; ### stationary and mobile air - conditioning equipment ;


### the power to adopt delegated acts referred to in articles 3 , 7 , 8 , 9 , 10 , 13 , 14 , 17 , 18 and 19 and shall be conferred on the commission for an indeterminate period of time from [ dd / mm / yyyy ] [ insert date of entry into force of this regulation ] . ### the power to adopt delegated acts referred to in articles 3 , 7 , 8 , 9 , 10 , 13 , 14 , 17 , 18 and 19 and shall be conferred on the commission for a period of five years from . . . 1 . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period . _______________________ 1 please insert the date of entry into force of this regulation .


### to implement the gradual reduction of the placing on the market of hydrofluorocarbons , the commission should allocate quotas to individual producers and importers for placing them on the market in order that the overall quantitative limit for placing hydrofluorocarbons on the market in the union is not exceeded . ### to implement the gradual reduction of the placing on the market of hydrofluorocarbons , the commission should allocate quotas to individual producers and importers for placing them on the market in order that the overall quantitative limit for placing hydrofluorocarbons on the market in the union is not exceeded . from 1 january 2018 the use of quotas should be subject to a fee which should be collected by the commission and redistributed to address regional differences in implementing the regulation within the union .


### stationary refrigeration equipment ; ### stationary and mobile refrigeration equipment ;


### the commission may determine the format of the records referred to in paragraph 1 and specify how they should be established and maintained in an implementing act . that implementing act shall be adopted in accordance with the examination procedure referred to in article 21 . ### the commission shall determine the format of the records referred to in paragraph 1 and specify how they should be established and maintained in an implementing act . that implementing act shall be adopted in accordance with the examination procedure referred to in article 21 .


### if the council addresses to a member state a recommendation in accordance with article 121 of the treaty to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from prudent fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed to be adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council addresses to a member state a recommendation in accordance with article 121 of the treaty to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from sustainable fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , and whenever credits referred to in article 2a reach a negative value the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed to be adopted by the council unless it decides by simple majority to reject the proposal within thirty days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty .


### sanctions for member states whose currency is the euro in the preventive part of the stability and growth pact should provide incentives for prudent fiscal policy - making . such policy - making should ensure that the growth rate of government expenditure does not normally exceed a prudent medium - term growth rate of gross domestic product , unless the excess is matched by increases in government revenues or discretionary revenue reductions are compensated by reductions in expenditure . ### sanctions for member states whose currency is the euro in the preventive part of the stability and growth pact as well as incentives should be foreseen in order to reinforce compliance with the sustainable fiscal policy - making rule . such policy - making should ensure that the growth rate of government expenditure does not normally exceed a sustainable medium - term growth rate of gross domestic product , unless the excess is matched by increases in government revenues or discretionary revenue reductions are compensated by reductions in expenditure .


### if the council decides in accordance with article 126 of the treaty that an excessive deficit exists in a member state , the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council decides in accordance with article 126 of the treaty that an excessive deficit exists in a member state , and whenever credits referred to in article 2a reach a negative value the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed adopted by the council unless it decides by simple majority to reject the proposal within thirty days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty .


### in the preventive part of the stability and growth pact , the incentive for prudent fiscal policy - making should consist of an obligation to lodge an interest - bearing deposit temporarily imposed on a member state whose currency is the euro that is making insufficient progress with budgetary consolidation . this should be the case when , following an initial warning from the commission , a member state persists in conduct which , while not amounting to a violation of the ban on excessive deficits , is imprudent and potentially detrimental to the smooth functioning of economic and monetary union , and the council therefore issues a recommendation in accordance with article 121 of the treaty . ### in the preventive part of the stability and growth pact , the sanction foreseen in case of non compliance with the sustainable fiscal policy - making rule should consist of an obligation to lodge an interest - bearing deposit temporarily imposed on a member state whose currency is the euro that is making insufficient progress with budgetary consolidation . this should be the case when , following an initial warning from the commission , a member state persists in conduct which , while not amounting to a violation of the ban on excessive deficits , is imprudent and potentially detrimental to the smooth functioning of economic and monetary union , and the council therefore issues a recommendation in accordance with article 121 of the treaty .


### the european union is confronted with structural challenges arising from economic globalisation , technological change and an increasingly ageing workforce and growing skills and labour shortages in some sectors and regions . they have been compounded by the recent economic and financial crisis , which has resulted in increased levels of unemployment , hitting in particular young people and other vulnerable groups , such as migrants . the esf should aim to promote employment and support labour mobility , invest in education , skills and life - long learning , promote social inclusion and combat poverty . in promoting the better functioning of labour markets by enhancing the transnational geographical mobility of workers , the esf should , in particular , support european employment services in relation to recruitment and the related information , advice and guidance services at national and cross - border level . ### the european union is confronted with structural challenges arising from economic globalisation , technological change and an increasingly ageing workforce and growing skills and labour shortages in some sectors and regions . they have been compounded by the recent economic and financial crisis , which has resulted in increased levels of unemployment , hitting in particular young people and other vulnerable groups , such as migrants , refugees and asylum seekers . the esf should aim to promote quality employment with particular attention to those who are the furthest from the labour market and support labour mobility , invest in education , skills and life - long learning , promote social inclusion , combat poverty and discrimination . in promoting the better functioning of labour markets by enhancing the transnational geographical mobility of workers , the esf should , in particular , support european employment services and related eures activities especially the eures cross - border partnerships in relation to recruitment and the related information , advice and guidance services at national and cross - border level , taking into account particularly cross border workers .


### pursuant to article 32 of regulation no [ &#8230 ; ] , the esf may support actions and policies falling within its scope through financial instruments , such as risk - sharing schemes , equity and debt , guarantee funds , holding funds , and loan funds . ### pursuant to article 32 of regulation no [ . . . ] , the esf may support actions and policies falling within its scope through financial instruments , such as risk - sharing schemes , equity and debt , guarantee funds , holding funds , loan funds and microcredits and - facilities .


### by way of derogation from article 110 of regulation no [ … ] , the maximum co - financing rate for a priority axis shall be increased by ten percentage points , but not exceeding 100% , where the whole of a priority axis is dedicated to social innovation or to transnational cooperation , or a combination of both . ### by way of derogation from article 110 109 of regulation no [ . . . ] , the maximum co - financing rate for a priority axis shall be increased by ten percentage points , but not exceeding 100% , where the whole of a priority axis is dedicated to social innovation or to transnational cooperation , or a combination of both or refer to article 6 , paragraph .