### names , titles and functions of public office holders , civil servants and interest representatives in relation with their professional activities shall be disclosed unless , given the particular circumstances , disclosure would adversely affect the persons concerned . other personal data shall be disclosed in accordance with the conditions regarding lawful processing of such data laid down in ec legislation on the protection of individuals with regard to the processing of personal data . ### personal data shall not be disclosed if such disclosure would harm the privacy or the integrity of the person concerned . such harm does not arise : – if the data relate solely to the professional activities of the person concerned unless , given the particular circumstances , there is reason to assume that disclosure would adversely affect that person ; – if the data relate solely to a public person unless , given the particular circumstances , there is reason to assume that disclosure would adversely affect that person or other persons related to him or her ; – if the data have already been published with the consent of the person concerned . personal data shall nevertheless be disclosed if an overriding public interest requires disclosure . in such cases , the institution , body , office or agency shall be required to specify the public interest . it shall give reasons why , in the specific case , the public interest outweighs the interests of the person concerned . where an institution , body , office or agency refuses access to a document on the basis of paragraph 1 , it shall consider whether partial access to that document is possible .


### the exceptions as laid down in this article shall only apply for the period during which protection is justified on the basis of the content of the document . the exceptions may apply for a maximum period of 30 years . in the case of documents covered by the exceptions relating to the protection of personal data or commercial interests and in the case of sensitive documents , the exceptions may , if necessary , continue to apply after this period . ### the exceptions as laid down in this article shall not apply to documents transmitted in the framework of procedures leading to a legislative act or a non - legislative act of general application . the exceptions shall only apply for the period during which protection is justified on the basis of the content of the document . the exceptions may apply for a maximum period of 30 years .


### this regulation aims to lay down harmonised rules for the approval of l - category vehicles , with a view to ensuring the functioning of the internal market . l - category vehicles are two - , three - or four - wheel vehicles such as powered two - wheel vehicles , tricycles , on - road quads and mini - cars . in addition , the objectives are to simplify the current legal framework , to contribute to a lower , more proportionate share in overall road transport emissions , to increase the overall level of safety , to adapt to technical progress and to strengthen the rules on market surveillance . ### this regulation aims to lay down harmonised rules for the approval of l - category vehicles , with a view to ensuring the functioning of the internal market . l - category vehicles are two - , three - or four - wheel vehicles such as powered two - wheel vehicles , tricycles , all - terrain vehicles , off - road quads , on - road quads and mini - cars . in addition , the objectives are to simplify the current legal framework , to contribute to a lower , more proportionate share in overall road transport emissions , to increase the overall level of safety , to adapt to technical progress and to strengthen the rules on market surveillance .


### importers shall sell or register only compliant vehicles , systems , components or separate technical units on the union market . ### importers shall sell or register only compliant and safe vehicles , systems , components or separate technical units on the union market .


### if the draft measures are not in accordance with the opinion of the committee , the commission shall not adopt those measures . the chairperson may submit to the committee the draft measures for further deliberation or submit an amended version of the draft measures . ### if the draft measures are not in accordance with the opinion of the committee or if no opinion is delivered by the committee , the commission shall not adopt those measures and shall submit to the council without delay the proposal concerning the measures to be taken or an amended version of the draft measures for further deliberation and shall inform the european parliament of this .


### in such a case the commission shall immediately inform the committee of its reasons for adopting the measures and may submit them to a second deliberation of the committee . if the measures adopted are not in accordance with the second opinion of the committee , or if the measures have not been submitted to a second deliberation within a month after their adoption , the commission shall repeal the measures forthwith . if the measures are in accordance with the second opinion of the committee , or if no opinion is delivered , those measures shall remain in force . ### in such a case the commission shall immediately inform the committee , the european parliament and the council of its reasons for adopting the measures and may submit them to a second deliberation of the committee . if the measures adopted are not in accordance with the second opinion of the committee , or if the measures have not been submitted to a second deliberation within a month after their adoption , the commission shall repeal the measures forthwith . if the measures are in accordance with the second opinion of the committee , or if no opinion is delivered , those measures shall remain in force .


### with regard to digital service infrastructures , building blocks shall take priority over other digital service infrastructures , since the former are a pre - condition for the later . digital service infrastructures should , inter alia , create european added value and meet proven needs . they should be sufficiently mature for deployment , technically as well as operationally as proven in particular through successful piloting . they should be based on a concrete sustainability plan to ensure the long - term operation of core service platforms beyond the cef . financial assistance under this regulation should therefore wherever possible be phased out over time and funding from sources other than the cef should be mobilised . ### with regard to digital service infrastructures , building blocks and digital services infrastructures with elements that can be used by other service providers shall take priority over other digital service infrastructures , since the former provides a basis for the later to build on . digital service infrastructures should , inter alia , create european added value and meet proven needs . they should be sufficiently mature for deployment , technically as well as operationally as proven in particular through successful piloting . they should be based on a concrete sustainability plan to ensure the long - term operation of core service platforms beyond the cef . financial assistance under this regulation should therefore wherever possible be phased out over time and funding from sources other than the cef should be mobilised .


### ' broadband networks ' means wired and wireless access networks , ancillary infrastructure and core networks capable of delivering very high speed connectivity , thereby contributing to the broadband targets of the digital agenda for europe . ### ' broadband networks ' means wired , wireless or satellite - based access networks , ancillary infrastructure and core networks capable of delivering very high speed connectivity , thereby contributing to the broadband targets of the digital agenda for europe .


### building blocks essential for , and with demonstrable prospects of being used in , the development , deployment and operation of other digital service infrastructures as listed in the annex shall be given first priority for funding . ### building blocks and mature digital service infrastructures containing technical models with demonstrable prospects of being used in the development , deployment and operation of other digital service infrastructures listed in the annex shall be given first priority for funding .


### on the basis of the objectives provided for in article 3 and in function of the available budget , the work programmes may establish further eligibility and priority criteria in the field of digital service infrastructures . ### on the basis of the objectives provided for in article 3 and in the annex to this regulation and in function of the available budget , the work programmes may establish further eligibility and priority criteria in the field of digital service infrastructures .


### the core service platforms and their common building blocks address interoperability and security needs of projects of common interest . they are intended to enable digital interactions between public authorities and citizens , public authorities and businesses and organisations , or among public authorities of different member states through standardised , cross - border , and user - friendly interaction platforms . building block digital service infrastructures shall take priority over other digital service infrastructures , since the former are a pre - condition for the latter . the generic services provide the connection to the core service platforms and enable the national added value services to use the core service platforms . they provide gateways between national services and core service platforms and allow national public authorities and organisations , businesses and / or citizens to access the core service platform for their cross - border transactions . the quality of the services and the support for stakeholders involved in cross - border transactions shall be assured . they shall support and stimulate take - up of core service platforms . ### the core service platforms address interoperability and security needs of projects of common interest . they are intended to enable digital interactions between public authorities and citizens , public authorities and businesses and organisations , or among public authorities of different member states through standardised , cross - border , and user - friendly interaction platforms . digital service infrastructures that provide an integral part of other digital service infrastructures , or that can serve as a model for new platforms , shall take priority over other digital service infrastructures . the generic services provide the connection to the core service platforms and enable the national added value services to use the core service platforms . they provide gateways between national services and core service platforms and allow national public authorities and organisations , businesses and / or citizens to access the core service platform for their cross - border transactions . the quality of the services and the support for stakeholders involved in cross - border transactions shall be assured . they shall support and stimulate take - up of core service platforms .


### other digital service infrastructures a priori identified as eligible in accordance with article 6 . 1 : ### core service platforms a priori identified as eligible in accordance with article 6 . 1 :


### access to digital resources of european heritage : this refers to the core service platform based on the current europeana portal . the platform will provide a single access point to europeana cultural heritage content at item level , a set of interface specifications to interact with the infrastructure , support for the metadata adaptation and ingestion of new content , as well as information on conditions for reuse of the content accessible through the infrastructure . ### access to digital resources of european heritage : this refers to the core service platform based on the current europeana portal . the platform provides the central access point to europeana cultural heritage content at item level , a set of interface specifications to interact with the infrastructure , support for the metadata adaptation and ingestion of new content , as well as information on conditions for reuse of the content accessible through the infrastructure .


### all projects financially supported under this regulation shall significantly contribute to the achievement of the targets of the digital agenda for europe . ### all projects financially supported under this section shall significantly contribute to the achievement of the targets of the digital agenda for europe .


### actions : funded from additional ring - fenced contributions provided in accordance with article 15 . 2 of regulation no xxxx / 2012 [ cef regulation ] shall bring significant new capabilities to the market in terms of broadband service availability , speeds and capacity . projects which provide speeds of data transmission of less than 30 mbps should ensure the increase of speeds to at least 30 mbps over time . ### actions funded from additional ring - fenced contributions provided in accordance with article 15 . 2 of regulation no xxxx / 2012 [ cef regulation ] shall bring significant new capabilities to the market in terms of broadband service availability , speeds and capacity . projects shall ensure the increase of speeds to the digital agenda targets over time .


### ‘ member of a collecting society’ means a rightholder or an entity directly representing rightholders , including other collecting societies and associations of rightholders , fulfilling the membership requirements of the collecting society ; ### ' member ' means a rightholder or an entity directly representing rightholders , including other collective management organisations and associations of rightholders , fulfilling the membership requirements of the collective management organisation , regardless of its legal form ;


### ‘ rights revenue’ means income collected by a collecting society on behalf of rightholders , whether from an exclusive right , a right to remuneration or a right to compensation ; ### ‘ rights revenue’ means income collected by a collective management organisation on behalf of rightholders , whether from an exclusive right , a right to remuneration or a right to compensation , and including any income derived from the investments of rights revenue ;


### rightholders shall have the right to authorise a collecting society of their choice to manage the rights , categories of rights or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collecting society or the rightholder . ### rightholders shall have the right to authorise a collective management organisation of their choice to manage the rights , categories of rights , works or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collective management organisation or the rightholder .


### member states shall ensure that the rightholder gives express consent specifically for each right or category of rights or type of works and other subject matter which that rightholder authorises the collecting society to manage and that any such consent is evidenced in documentary form . ### member states shall ensure that the rightholder gives express consent specifically for each right or category of rights or type of works and other subject matter which that rightholder authorises the collecting society to manage and that any such consent is evidenced in documentary form ; this paragraph does not apply to the arrangements in the member states concerning the administration of rights through extended collective licenses , legal presumptions of representation or transfer , mandatory collective management or similar arrangements or a combination of them .


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


### for the purposes of paragraph 2 , measures to identify and locate rightholders shall include verifying membership records and making available to the members of the collecting society as well as to the public a list of works and other subject matter for which one or more rightholders have not been identified or located . ### for the purposes of paragraph 2 , the collective management organisation shall put in place effective measures to identify and locate rightholders while ensuring appropriate safeguards to deter fraud . such measures shall include verifying membership records and making available regularly and at least annually to the members of the collective management organisation as well as to the public a list of works and other subject matter for which one or more rightholders have not been identified or located .


### member states shall ensure that a collecting society makes public the following information : ### member states shall ensure that a collective management organisation makes public the following information preferably through publicly accessible and searchable interfaces :


### member states should have the possibility to apply a test demonstrating that a post cannot be filled from within the domestic labour market . ### member states should require employers of seasonal workers to apply , in a timely and transparent manner , a test demonstrating that a post cannot be filled from within the domestic or the union ' s labour market .


### ‘ seasonal worker’ means a third - country national who retains a legal domicile in a third country but resides temporarily for the purposes of employment in the territory of a member state in a sector of activity dependent on the passing of the seasons , under one or more fixed - term work contracts concluded directly between the third - country national and the employer established in a member state ; ### ‘ seasonal worker’ means a third - country national who retains a legal domicile in a third country but resides temporarily for the purposes of employment in the territory of the european union in a sector of activity dependent on the passing of the seasons , under one or more fixed - term work contracts concluded directly between the third - country national and the employer established in a member state ;


### this directive shall not affect the right of member states to adopt or retain more favourable provisions for persons to whom it applies in respect of articles 13 to 17 of this directive . ### this directive shall not affect the right of member states to adopt or retain more favourable provisions for persons to whom it applies in respect of articles 11 to 17 of this directive .


### the union ecall system is expected to reduce the number of fatalities in the union as well as the severity of injuries caused by road accidents . the mandatory introduction of the ecall system would make the service available to all citizens and thus contribute to reduce human suffering and healthcare and other costs . ### the union ecall system is expected to reduce the number of fatalities in the union as well as the severity of injuries caused by road accidents , thanks to the optimum speed of the emergency services in rescuing victims . the mandatory introduction of the ecall system would make the service available to all citizens and thus contribute to reduce human suffering and costs relating to healthcare , congestion caused by accidents and the installation of emergency roadside telephones .


### the provision of accurate and reliable positioning information is an essential element of the effective operation of the ecall in - vehicle system . therefore , it is appropriate to require its compatibility with the services provided by satellite navigation programmes , including the systems established under the galileo and egnos programmes set out in regulation no 683 / 2008 of the european parliament and of the council of 9 july 2008 on the further implementation of the european satellite navigation programmes 8 . __________________ 8 oj l 196 , 24 . 7 . 2008 , p . 1 . ### the provision of accurate and reliable positioning information is an essential element of the effective operation of the ecall in - vehicle system . therefore , it is appropriate to require its compatibility with the services provided by operational satellite navigation programmes , including the systems established under the galileo and egnos programmes set out in regulation no 683 / 2008 of the european parliament and of the council of 9 july 2008 on the further implementation of the european satellite navigation programmes 8 . __________________ 8 oj l 196 , 24 . 7 . 2008 , p . 1 .


### the mandatory equipping of vehicles with the ecall in - vehicle system should be without prejudice to the right of all stakeholders such as car manufacturers and independent operators to offer additional emergency and / or added value services , in parallel with or building on the 112 - based ecall in - vehicle system . however , these additional services should be designed not to increase driver distraction . ### the mandatory equipping of vehicles with the ecall in - vehicle system should be without prejudice to the right of all stakeholders such as car manufacturers and independent operators to offer additional third - party emergency and / or added value services , in parallel with or building on the 112 - based ecall in - vehicle system . however , these additional services should be designed not to increase driver distraction .


### vehicle manufacturers should be allowed sufficient time to adapt to the technical requirements of this regulation . ### vehicle manufacturers should be allowed sufficient time to adapt to the technical requirements of this regulation , for example in order to carry out the necessary tests under various conditions as required . the deadline for vehicle compliance with the requirements of this directive should be after the deadline for deployment of infrastructures ensuring satisfactory ecall reception .


### ‘ in - vehicle system’ means the in - vehicle equipment together with the means to trigger , manage and effect the ecall transmission via a public mobile wireless communications network providing a link between the vehicle and a means of enacting the ecall service via a public mobile wireless communications network . ### ‘ embedded in - vehicle appliance’ means the in - vehicle equipment together with the means to trigger , manage and effect the ecall transmission via a public mobile wireless communications network providing a link between the vehicle and a means of enacting the ecall service via a public mobile wireless communications network .


### manufacturers shall ensure that the receivers in the in - vehicle systems are compatible with the positioning services provided by satellite navigation systems including the galileo and the egnos systems . ### manufacturers shall ensure that the receivers in the embedded in - vehicle appliance are compatible with the operational positioning services provided by satellite navigation systems including the galileo and the egnos systems .


### the ecall in - vehicle system shall be accessible to all independent operators free of charge and without discrimination at least for repair and maintenance purposes . ### the ecall in - vehicle system shall be accessible to all independent operators free of charge and without discrimination for repair and maintenance purposes .


### privacy enhancing technologies shall be embedded in the in - vehicle ecall system in order to provide ecall users with the desired level of privacy protection , as well as the necessary safeguards to prevent surveillance and misuse . ### privacy enhancing technologies shall be embedded in the in - vehicle ecall system in order to provide ecall users with the desired level of privacy protection , as well as the necessary safeguards to prevent surveillance and misuse . car manufacturers shall duly inform their clients about the possible location tracking as a result of the use of third party services and about the impact it might have for their privacy .


### the time limit for the retention of data in the in - vehicle system ; ### the time limit for the retention of data in the embedded in - vehicle appliance ;


### member states shall lay down the rules on penalties applicable to non - compliance by manufacturers with the provisions of this regulation and shall take all measures to ensure that they are implemented . the penalties provided for shall be effective , proportionate and dissuasive . members states shall notify those provisions to the commission , and shall notify it without delay of any subsequent amendment affecting them . ### member states shall lay down the rules on penalties applicable to non - compliance by manufacturers with the provisions of this regulation and the corresponding delegated acts and shall take all measures to ensure that they are implemented . the penalties provided for shall be effective , proportionate and dissuasive . members states shall notify those provisions to the commission , and shall notify it without delay of any subsequent amendment affecting them .


### the area where the product was caught or farmed ; ### specific fish stock and the area from which the product was caught or area where the product was farmed ;


### the area where the product was caught or farmed ; ### the original point where the product was caught or farmed ;


### make market information available to the adequate level to stakeholders . ### make adequate market information available to all stakeholders . this should include making such information available to consumers in an accessible and understandable manner .


### the main motive for cross - border organised crime is financial gain . in order to be effective , law enforcement and judicial authorities should be given the means to trace , freeze , manage and confiscate the proceeds of crime . ### the main motive for most crime , and particularly cross - border organised crime , including mafia - type criminal organization , is financial gain . in order to be effective , appropriate competent authorities should be given the means to trace , freeze , manage and confiscate the proceeds of crime . however , effective prevention of and fight against organized crime should not be limited to the neutralization of the proceeds of crime but should be extended , in some cases , even to property in any way related to such criminal associations . it is not enough , therefore , merely to ensure mutual recognition in the eu of seizure and confiscation of proceeds of crime . an effective fight against economic crime would also require the mutual recognition of measures taken in a different field from that of criminal law or otherwise adopted in the absence of a criminal conviction and that they have as their object , more broadly , any possible asset or income attributable to a criminal organization or to a person with a criminal conduct or suspected to belong to a criminal organization .


### confiscation of instrumentalities and proceeds following a final decision of a court and of property of equivalent value to those proceeds should therefore refer to this broadened concept for the criminal offences covered by this directive . framework decision 2001 / 500 / jha required member states to enable the confiscation of instrumentalities and proceeds of crime following a final conviction and to enable the confiscation of property of equivalent value to the proceeds of crime . such obligations should be maintained for the criminal offences not covered by this directive . ### confiscation of instrumentalities and proceeds following a final decision of a court and of property of equivalent value to those proceeds should therefore refer to this broadened concept for the criminal offences covered by this directive . framework decision 2001 / 500 / jha required member states to enable the confiscation of instrumentalities and proceeds of crime following a final conviction and to enable the confiscation of property of equivalent value to the proceeds of crime . such obligations should be maintained for the criminal offences not covered by this directive and the concept of proceeds as defined in this directive should be extended also for the criminal offences not covered by this directive .


### the practice by a suspected or accused person of transferring property to a knowing third party with a view to avoiding confiscation is common and increasingly widespread . the current union legal framework does not contain binding rules on the confiscation of property transferred to third parties . therefore it is becoming increasingly necessary to allow for confiscation of property transferred to third parties , which should normally take place when an accused person does not have property that can be confiscated . it is appropriate to provide for third party confiscation , under certain conditions , following an assessment , based on specific facts , that the confiscation of property of the convicted , suspected or accused person is unlikely to succeed , or in situations where unique objects must be restored to their rightful owner . furthermore , to protect the interests of bona fide third parties , such confiscation should only be possible if the third party knew or should have known that property was the proceeds of crime or was transferred in order to avoid confiscation and was given for free or transferred in exchange for an amount lower than its market value . ### the practice by a suspected or accused person of transferring property to a knowing third party with a view to avoiding confiscation is common and increasingly widespread . the current union legal framework does not contain binding rules on the confiscation of property transferred to third parties . therefore it is becoming increasingly necessary to allow for confiscation of property transferred to or acquired by third parties . to protect the interests of bona fide third parties , such confiscation should only be possible if the third party knew or should have been known that property was the instrumentalities or the proceeds of crime or was transferred in order to avoid confiscation or if it was given for free or transferred in exchange for an amount significantly lower than its market value .


### suspected or accused persons often hide property throughout the entire duration of criminal proceedings . as a result confiscation orders cannot be executed , leaving those subject to confiscations orders to benefit from their property once they have served their sentence . it is accordingly necessary to enable the determination of the precise extent of the property to be confiscated even after a final conviction for a criminal offence , in order to permit the full execution of confiscation orders when no property or insufficient property was initially discovered and the confiscation order remains unexecuted . given the limitation of the right to property by freezing orders , such provisional measures should not be maintained longer than necessary to preserve the availability of the property with a view of possible future confiscation . this may require a regular review by the court in order to ensure that their purpose of preventing the dissipation of property remains valid . ### suspected or accused persons often hide property throughout the entire duration of criminal proceedings . as a result confiscation orders cannot be executed , leaving those subject to confiscations orders to benefit from their property once they have served their sentence . it is accordingly necessary to enable the determination of the precise extent of the property to be confiscated even after a final conviction for a criminal offence , in order to permit the full execution of confiscation orders when no property or insufficient property was initially discovered and the confiscation order remains unexecuted . given the limitation of the right to property by freezing orders , such provisional measures should not be maintained longer than necessary to preserve the availability of the property with a view of possible future confiscation . this may require , where necessary , a review by the court in order to ensure that their purpose of preventing the dissipation of property remains valid .


### reliable data sources on the freezing and confiscation of the proceeds of crime are scarce . in order to allow for the evaluation of this directive , it is necessary to collect a comparable minimum set of appropriate statistical data on asset tracing , judicial and asset disposal activities . ### reliable data sources on the freezing and confiscation of the proceeds of crime are scarce . in order to allow for the evaluation of this directive , it is necessary to collect a comparable minimum set of appropriate statistical data on asset tracing , judicial and asset management and disposal activities .


### since the objective of this directive , namely facilitating confiscation of property in criminal matters , cannot be sufficiently achieved by the member states and can be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective . ### since the objective of this directive , namely facilitating confiscation of property , cannot be sufficiently achieved by the member states and can be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective .


### this directive establishes minimum rules on the freezing of property with a view to possible later confiscation and on the confiscation of property in criminal matters . ### this directive establishes minimum rules on the seizure or freezing of property with a view to possible later confiscation , on the confiscation of property in criminal matters and without a criminal conviction and on the management and disposal of confiscated property .


### each member state shall take the necessary measures to enable it to confiscate , either wholly or in part , instrumentalities and proceeds following a final conviction for a criminal offence . ### each member state shall take the necessary measures to enable judicial authorities to confiscate , either wholly or in part , instrumentalities and proceeds or property the value of which corresponds to such instrumentalities and proceeds , subject to a final conviction for a criminal offence .


### each member state shall adopt the necessary measures to enable it to confiscate , either wholly or in part , property belonging to a person convicted of a criminal offence where , based on specific facts , a court finds it substantially more probable that the property in question has been derived by the convicted person from similar criminal activities than from other activities . ### each member state shall adopt the necessary measures to enable competent authorities to confiscate , either wholly or in part , property belonging to a person convicted of a criminal offence where , based on specific facts such as that the value of property is disproportionate to the lawful income of the convicted person , a court finds it on the balance of probabilities that the property in question has been acquired unlawfully .


### other property of the convicted person , which was transferred to third parties in order to avoid confiscation of property the value of which corresponds to the proceeds . ### other property which was transferred to or acquired by third parties in order to avoid confiscation of property the value of which corresponds to the proceeds .


### the proceeds or property were transferred for free or in exchange for an amount lower than their market value when the third party : ### the proceeds or property were transferred for free or in exchange for an amount significantly lower than their market value ;


### each member state shall ensure that the measures referred to in paragraph 1 optimise the economic value of such property , and shall include the sale or transfer of property which is liable to decline in value . ### each member state shall ensure that the measures referred to in paragraph 1 to frozen property optimise the economic value of such property , and shall include , only if necessary , the sale or transfer of property which is liable to decline in value . each member state shall take all the necessary measures to prevent any criminal infiltration in this phase .


### the funding will be made available through 2 multiannual allocations only covering the first 4 years and the remaining 3 years respectively . this funding will be reflected in the multiannual indicative programming of these instruments , in line with the identified needs and priorities of the countries concerned . the allocations can be revised in case of major unforeseen circumstances or important political changes in line with the eu external priorities . ### the funding will be made available through 2 multiannual allocations only covering the first 4 years and the remaining 3 years respectively . this funding will be reflected in the multiannual indicative programming of these instruments , in line with the identified needs and priorities of the countries concerned , and it will only be allocated for purposes for which development aid may be granted . the allocations can be revised in case of major unforeseen circumstances or important political changes in line with the eu external priorities .


### commission proposal directive of the european parliament and of the council on credit agreements relating to residential immovable property ### directive of the european parliament and of the council on credit agreements relating to residential immovable property for consumers


### commission proposal in accordance with the treaty , the internal market comprises an area without internal frontiers in which the free movement of goods and services and the freedom of establishment are ensured . the development of a more transparent and efficient credit market within that area is vital to promote the development of cross - border activity and create an internal market in credit agreements relating to residential immovable property . there are substantial differences in the laws of the various member states with regard to conduct of business in the granting of credit agreements relating to residential immovable property and in the regulation and supervision of credit intermediaries and non - credit institutions providing credit agreements relating to residential immovable property . such differences create obstacles that restrict the level of cross - border activity on the supply and demand sides , thus reducing competition and choice in the market , raising the cost of lending for providers and even preventing them from doing business . ### in accordance with the treaty , the internal market comprises an area without internal frontiers in which the free movement of goods and services and the freedom of establishment are ensured . the development of a more transparent and efficient credit market within the area without internal frontiers is vital to promote the development of cross - border activity . there are substantial differences in the laws of the various member states with regard to conduct of business in the granting of credit agreements relating to residential immovable property and in the regulation and supervision of credit intermediaries and non - credit institutions providing credit agreements relating to residential immovable property . such differences create obstacles that restrict the level of cross - border activity on the supply and demand sides , thus reducing competition and choice in the market .


### commission proposal a series of problems in eu mortgage markets associated with irresponsible lending and borrowing at the pre - contractual stage and the potential scope for irresponsible behaviour by credit intermediaries and non - credit institutions have been identified . some problems concerned loans denominated in a foreign currency which consumers had taken out in that currency to take advantage of the interest rate offered but without having an adequate understanding of the currency risk involved . these problems are driven by market and regulatory failures as well as other factors such as the general economic climate and low levels of financial literacy . other problems include ineffective , inconsistent , or non - existent registration , authorisation and supervision regimes for credit intermediaries and non - credit institutions providing credit for residential immovable property . the problems identified have potentially significant macroeconomic spill - over effects , can lead to consumer detriment , act as economic or legal barriers to cross - border activity and create an unlevel playing field between actors . ### the commission has identified a series of problems in eu mortgage markets associated with irresponsible lending and borrowing at the pre - contractual stage and the potential scope for irresponsible behaviour by credit intermediaries and non - credit institutions . some problems concerned loans denominated in a foreign currency which consumers had taken out in that currency to take advantage of the interest rate offered but without having an adequate understanding of the currency risk involved . these problems are driven by market and regulatory failures as well as other factors such as the general economic climate and low levels of financial literacy . the commission has identified as other problems ineffective , inconsistent , or non - existent registration , authorisation and supervision regimes for credit intermediaries and non - credit institutions providing credit for residential immovable property .


### commission proposal in order to facilitate the emergence of a smoothly functioning internal market with a high level of consumer protection in the area of credit agreements relating to residential immovable property , a harmonised union framework needs to be established in a number of areas . it is further necessary to establish harmonised standards in order to ensure that consumers looking for credit agreements relating to residential immovable property are able to do so confident in the knowledge that the institutions they interact with act in a professional and responsible manner . ### in order to determine the scope for the emergence of a smoothly functioning internal market with a high level of consumer protection in the area of credit agreements relating to residential immovable property , a harmonised union framework could prove useful in a number of areas . at the same time , harmonised standards could be established in order to ensure that consumers looking for credit agreements relating to residential immovable property are able to do so confident in the knowledge that the institutions they interact with act in a professional and responsible manner . in that connection , due account should be taken of the highly local nature of the market in credit agreements relating to residential immovable property . in this area in particular , consumers are very much in need of local advice .


### commission proposal the objective of this directive is to ensure that all credits provided to consumers benefit from a high level of protection . it should therefore apply to credits secured by real estate , or credits which are used to purchase a property in some member states and to credits for the renovation of residential property that are not covered by directive 2008 / 48 / ec of the european parliament and of the council of 23 april 2008 on credit agreements for consumers and repealing council directive 87 / 102 / eec which lays down rules at union level concerning consumer credit agreements . furthermore , this directive should not be applied to certain types of credit agreements where the credit is granted by an employer to his employees under certain circumstances , as already provided in directive 2008 / 48 / ec . ### the objective of this directive is to ensure that all credits provided to consumers benefit from a high level of protection . it should therefore apply to credits secured by real estate , or credits which are used to purchase a property in some member states and to credits for the renovation of residential property that are not covered by directive 2008 / 48 / ec of the european parliament and of the council of 23 april 2008 on credit agreements for consumers and repealing council directive 87 / 102 / eec which lays down rules at union level concerning consumer credit agreements . furthermore , this directive should not be applied to certain types of credit agreements where the credit is granted by an employer to his employees under certain circumstances , as already provided in directive 2008 / 48 / ec . like directive 2008 / 48 / ec , it should also not apply to start - up loans .


### commission proposal ### with a view to guaranteeing a high level of comprehensive consumer protection , when granting , intermediating or advising on credit and , where appropriate , ancillary services to consumers , creditors or credit intermediaries should act honestly , fairly and professionally in accordance with the best interests of the consumer .


### commission proposal in order to take account of developments in the markets for credit relating to residential immovable property , including the range of products available , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union to amend the content of the standard information items to be included in advertising , the content and format of the european standardised information sheet , the content of the information disclosures by credit intermediaries , the formula and the assumptions used to calculate the annual percentage rate of charge and the criteria to be taken into account for the assessment of the consumer’s creditworthiness . ### in order to take account of developments in the markets for credit relating to residential immovable property , including the range of products available , the commission should be empowered to adopt legal acts in accordance with article 290 of the treaty on the functioning of the european union to amend the formula and the assumptions used to calculate the annual percentage rate of charge . it is of particular importance that the commission should carry out appropriate consultations during its preparatory work , including at expert level , and give the experts sufficient time to deliver opinions . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of the relevant documents to the european parliament and the council . in addition it is essential that the commission should always set a sufficiently long deadline for the entry into force of delegated acts .


### commission proposal credit agreements the purpose of which is to acquire or retain property rights in land or in an existing or projected residential building . ### credit agreements the purpose of which at the time they are concluded is to acquire or retain property rights in land or in an existing or projected residential building .


### commission proposal ### credit agreements which relate to loans granted to a restricted public under a statutory provision with a general interest purpose , and at lower interest rates than those prevailing on the market or free of interest or on other terms which are more favourable to the consumer than those prevailing on the market and at interest rates not higher than those prevailing on the market .


### commission proposal ### ‘ residential immovable property’ means an item of immovable property intended primarily for residential purposes ;


### commission proposal member states shall designate the competent authorities empowered to ensure implementation of this directive and shall ensure that they are granted all the powers necessary for the performance of their duties . ### member states shall designate the competent authorities empowered to ensure implementation of this directive and shall ensure that they are granted all the powers necessary for the performance of their duties . if member states implement provisions of this directive by means of statutory provisions which , under their national law , are not subject to regulatory supervision , they shall not be required to designate a competent authority and / or grant powers to the authority so designated .


### commission proposal member states shall ensure that the authorities designated as competent for ensuring the implementation of articles 18 , 19 , 20 and 21 of this directive are one of those competent authorities included in article 4 of regulation no 1093 / 2010 establishing a european supervisory authority . ### if authorities are to be designated and have powers conferred on them , member states shall ensure that the authorities designated as competent for ensuring the implementation of articles 18 , 19 , 20 and 21 of this directive are one of those competent authorities included in article 4 of regulation no 1093 / 2010 establishing a european supervisory authority . by way of derogation , member states may also designate authorities which are not yet among the competent authorities included in article 4 of the regulation referred to above , provided that they ensure that the relevant provisions of that regulation implementing articles 18 , 19 , 20 and 21 of this directive apply mutatis mutandis .


### commission proposal 2 . where there is more than one competent authority on its territory , a member state shall ensure that those authorities collaborate closely so that they can discharge their respective duties effectively . ### where there is more than one competent authority on its territory , a member state shall ensure that those authorities collaborate .


### commission proposal ### this obligation shall not apply where national legislation requires the indication of the annual percentage rate of charge in advertising concerning credit agreements which does not indicate an interest rate or any figures relating to any cost of credit to the consumer within the meaning of the first subparagraph .


### commission proposal 2 . the standard information shall specify the following in a clear , concise and prominent way by means of a representative example : ### the standard information shall specify in a clear , concise and prominent way by means of a representative example :


### commission proposal the duration of the credit agreement ; ### if applicable , the duration of the credit agreement ;


### commission proposal the amount of the instalments ; ### if applicable , the amount of the instalments ;


### commission proposal the total amount payable by the consumer ; ### if applicable , the total amount payable by the consumer ;


### commission proposal pre - contractual information ### general and pre - contractual information


### commission proposal an indicative example of the total cost of credit for the consumer and annual percentage rate of charge ; ### an indicative representative example of the total cost of credit for the consumer and annual percentage rate of charge ;


### commission proposal member states shall ensure that when an offer binding on the creditor is provided to the consumer , it shall be accompanied by an esis . in such circumstances , member states shall ensure that the credit agreement cannot be concluded until the consumer has had sufficient time to compare the offers , assess their implications and take an informed decision on whether to accept an offer , regardless of the means of conclusion of the contract . ### member states shall ensure that when an offer binding on the creditor is provided to the consumer , it shall be accompanied by an esis . in such circumstances , member states shall ensure that the consumer has sufficient time to compare the offers , assess their implications and take an informed decision on whether to accept an offer , regardless of the means of conclusion of the contract . if the consumer has a right of withdrawal in respect of the credit agreement , this shall in itself be regarded as providing him with sufficient time to take a decision .


### commission proposal ### in the case of a credit agreement under which payments made by the consumer do not give rise to an immediate corresponding amortisation of the total amount of credit , but are used to constitute capital during periods and under conditions laid down in the credit agreement or in an ancillary agreement , the creditor shall make additional pre - contractual information available which makes it clear that such credit agreements do not provide for a guarantee of repayment of the total amount of credit drawn down under the credit agreement , unless such a guarantee is given .


### commission proposal ### member states shall ensure that the fee , if any , payable by the consumer to the credit intermediary for his services is communicated to the creditor by the credit intermediary , for the purpose of calculation of the annual percentage rate of charge .


### commission proposal member states shall ensure that creditors and , where applicable , credit intermediaries provide adequate explanations to the consumer on the proposed credit agreement and any ancillary service , in order to place the consumer in a position enabling him to assess whether the proposed credit agreements are adapted to his needs and financial situation . an adequate explanation shall include the provision of personalised information on the characteristics of the credits on offer , without however formulating any recommendation . creditors and , where applicable , credit intermediaries shall accurately assess the level of knowledge and experience with credit of the consumer by any means necessary so as to enable the creditor or the intermediary to determine the level of explanations to be given to the consumer and adjust such explanations accordingly . ### member states shall ensure that creditors and , where applicable , credit intermediaries provide adequate explanations to the consumer , in order to put the consumer in a position to assess whether the proposed credit agreement is suited to his needs and to his financial situation , where appropriate by explaining the pre - contractual information to be provided in accordance with article 9 , the essential characteristics of the products proposed and the specific effects they may have on the consumer , including the consequences of default in payment by the consumer .


### commission proposal ### member states may adapt the manner by which and the extent to which such assistance is given , as well as by whom it is given , to the particular circumstances of the situation in which the credit agreement is offered , the person to whom it is offered and the type of credit offered .


### commission proposal where the opening of an account is obligatory in order to obtain the credit , the costs of maintaining such an account , the costs of using a means of payment for both payment transactions and drawdowns on that account , and other costs relating to payment transactions shall be included in the total cost of credit to the consumer , unless the costs have been clearly and separately shown in the credit agreement or in any other agreement concluded with the consumer . ### the costs of maintaining an account recording both payment transactions and drawdowns , the costs of using a means of payment for both payment transactions and drawdowns , and other costs relating to payment transactions shall be included in the total cost of credit to the consumer unless the opening of the account is optional and the costs of the account have been clearly and separately shown in the credit agreement or in any other agreement concluded with the consumer .


### commission proposal 5 . powers are delegated to the commission in accordance with article 26 and subject to the conditions of articles 27 and 28 , to amend the formula and the assumptions used to calculate the annual percentage rate of charge as set out in annex i . ### powers are delegated to the commission in accordance with article 26 to adopt delegated acts concerning the amendment of the formula and the assumptions used to calculate the annual percentage rate of charge as set out in annex i .


### commission proposal member&#160 ; states shall ensure that , before the conclusion of the credit agreement , a&#160 ; thorough assessment of the consumer ' s creditworthiness is conducted by the creditor , based on criteria including the consumer ' s income , savings , debts and other financial commitments . that assessment shall be carried out on the basis of the necessary information , obtained by the creditor or , where applicable , credit intermediary from the consumer and from relevant internal or external sources and shall respect the requirements with regard to necessity and proportionality set out in article 6 of directive 95 / 46 / ec . member&#160 ; states shall ensure that creditors establish appropriate processes to assess the creditworthiness of the consumer . these processes shall be reviewed at regular intervals and up - to - date records of those processes shall be maintained . ### member&#160 ; states shall ensure that , before the conclusion of the credit agreement , a&#160 ; thorough assessment of the consumer ' s creditworthiness is conducted by the creditor , based on criteria including the consumer ' s income , assets , debts and other financial commitments . that assessment shall be carried out on the basis of the necessary information , obtained by the creditor or , where applicable , credit intermediary from the consumer and from relevant internal or , where appropriate , external sources and shall respect the requirements with regard to necessity and proportionality set out in article 6 of directive 95 / 46 / ec .


### commission proposal where the assessment of the consumer ' s creditworthiness results in a negative prospect for his ability to repay the credit over the lifetime of the credit agreement , the creditor refuses credit . ### where the assessment of the consumer ' s creditworthiness results in a negative prospect for his ability to meet his debt obligations , the creditor refuses credit .


### commission proposal where the credit application is rejected , the creditor informs the consumer immediately and without charge of the reasons for rejection . ### where the granting of credit is denied , because the assessment of the consumer’s creditworthiness has resulted in a negative prospect for his ability to meet his debt obligations , the creditor informs the consumer immediately and without charge of the reasons .


### commission proposal 2 . member states may provide that the exercise of the right referred to in paragraph 1 is subject to certain conditions . such conditions may include time limitations on the exercise of the right , different treatment depending on the type of the borrowing rate , or restrictions with regard to the circumstances under which the right may be exercised . member states may also provide that the creditor should be entitled to fair and objectively justified compensation for potential costs directly linked to early repayment of the credit . in any event , if the early repayment falls within a period for which the borrowing rate is fixed , exercise of the right may be made subject to the existence of a special interest on the part of the consumer . where a member state lays down such conditions , these shall not make the exercise of the right referred to in paragraph 1 excessively difficult or onerous for the consumer . ### member states may provide that the exercise of the right referred to in paragraph 1 is subject to certain conditions . such conditions may include time limitations on the exercise of the right , different treatment depending on the type of the borrowing rate , or restrictions with regard to the circumstances under which the right may be exercised . where a member state lays down such conditions , these shall not make the exercise of the right referred to in paragraph 1 excessively difficult or onerous for the consumer . member states may also provide that the creditor should be entitled to fair and objectively justified compensation for potential costs directly linked to early repayment of the credit . in any event , if the early repayment falls within a period for which the borrowing rate is fixed , exercise of the right may be made subject to the existence of a special interest on the part of the consumer .


### commission proposal without prejudice to procedures for the withdrawal of authorisation or to the right of member&#160 ; states to impose criminal sanctions , member&#160 ; states shall ensure , in conformity with their national law , that appropriate administrative measures can be taken or administrative sanctions imposed against persons responsible where the provisions adopted in the implementation of this directive have not been complied with . member&#160 ; states shall ensure that these measures are effective , proportionate and dissuasive . ### member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are implemented . those sanctions shall be effective , proportionate and dissuasive .


### commission proposal member states shall ensure that appropriate and effective complaints and redress procedures are established for the out - of - court settlement of disputes concerning rights and obligations established under this directive between creditors and consumers and between credit intermediaries and consumers , using existing bodies where appropriate . member states shall further ensure that all creditors and credit intermediaries adhere to one or more such bodies implementing such complaint and redress procedures . ### member states shall ensure that adequate and effective out - of - court dispute resolution procedures for the settlement of consumer disputes concerning credit agreements are put in place , using existing bodies where appropriate .


### commission proposal 2 . member states shall ensure that these bodies actively cooperate in the resolution of cross - border disputes . ### member states shall encourage those bodies to cooperate in order to also resolve cross - border disputes concerning credit agreements .


### commission proposal the powers to adopt delegated acts referred to in articles 6 , 8 , 9 , 10 , 14 and 16 shall be conferred on the commission for an indeterminate period of time following the entry into force of this directive . 2 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 3 . the power to adopt delegated acts is conferred on the commission subject to the conditions laid down in articles 27 and 28 . ### the power to adopt delegated acts referred to in article 12 shall be conferred on the commission subject to the conditions laid down in this article . 2 . the power referred to in article 12 shall be conferred on the commission for an indeterminate period of time following the entry into force of this directive . 3 . the delegation of power referred to in article 12 may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following its publication in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . 4 . as soon as it adopts a delegated act , the commission shall notify it simultaneously to the european parliament and to the council . 5 . a delegated act adopted pursuant to article 12 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of three months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . at the initiative of the european parliament or the council that period shall be extended by two months .


### commission proposal ### article 30a transitional measures this directive shall not apply to credit agreements existing on the date when the national implementing measures enter into force .


### the timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file , while ensuring quick access to new , innovative treatments and ensuring that the union remains an attractive place for conducting clinical trials . against this background , directive 2001 / 20 / ec introduced the concept of tacit authorisation . this concept should be maintained in order to ensure that timelines are adhered to . in the event of a public health crisis , member states should have the possibility to assess and authorise a clinical trial application swiftly . no minimal timelines for approval should therefore be established . ### the timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file , while ensuring quick access to new , innovative as well as , existing treatments and ensuring that the union remains an attractive place for conducting clinical trials . against this background , directive 2001 / 20 / ec introduced the concept of tacit authorisation . this concept should be maintained in order to ensure that timelines are adhered to . in the event of a public health crisis , member states should have the possibility to assess and authorise a clinical trial application swiftly . no minimal timelines for approval should therefore be established .


### the assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits and the risk and inconveniences for the subject . regarding the relevance , numerous aspects should be taken into account , including whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products . ### the assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits , and the risk and inconveniences for the subject . regarding the relevance , numerous aspects should be taken into account ; in later trial phases this should include whether the trial subjects are representative of the population for whom the medicinal product is targeted , and whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products .


### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . this decision is a matter of internal organisation of each member state . member states , when determining the appropriate body or bodies , should ensure the involvement of lay persons and patients . they should also ensure that the necessary expertise is available . in any case , however , and in accordance with international guidelines , the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . the persons assessing the application should be independent from the sponsor , the institution of the trial site , and the investigators involved , as well as free of any other undue influence . ### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . this decision is a matter of internal organisation of each member state . member states , when determining the appropriate body or bodies , should ensure the involvement of lay persons and patients . they should also ensure that the necessary expertise is available . in any case , however , and in accordance with international guidelines , the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . the persons assessing the application should be independent from the sponsor , the institution of the trial site , and the investigators involved , as well as free of any other undue influence . names , qualifications and declarations of interest of the persons assessing the application should be made publicly available .


### the sponsor should assess the information received from the investigator , and report safety information on serious adverse events which are suspected unexpected serious adverse reactions to the agency . ### the sponsor should assess the information received from the investigator , and immediately report safety information on serious adverse events which are suspected unexpected serious adverse reactions to the agency via the electronic database referred to in article 36 .


### in clinical trials with non - authorised investigational medicinal products , or where the intervention poses more than an insignificant risk to subject safety , compensation should be ensured for damages successfully claimed in accordance with the applicable laws . ### in clinical trials with non - authorised investigational medicinal products , or where the intervention poses more than an insignificant risk to subject safety , compensation should be ensured for damages successfully claimed in accordance with the applicable laws . the legal certainty of the subject should , however , always be guaranteed and the change under the regulation in the requirement to provide damage compensation must not lead to a reduction in legal certainty .


### in clinical trials with non - authorised investigational medicinal products , or where the intervention poses more than an insignificant risk to subject safety , compensation should be ensured for damages successfully claimed in accordance with the applicable laws . ### in clinical trials with non - authorised investigational medicinal products , or with authorised investigational medicinal products used outside the terms of the marketing authorisation in a treatment regimen distinct from the standard of care , or where the diagnostic procedure poses more than an insignificant risk to subject safety , compensation should be ensured for damages successfully claimed in accordance with the applicable laws .


### ‘ serious adverse event’ : any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation , results in persistent or significant disability or incapacity , or is a congenital anomaly or birth defect , is life - threatening or results in death ; ### ‘ serious adverse event’ : any untoward medical occurrence , or other event deemed serious by the investigator in the context of the trial , that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation , results in persistent or significant disability or incapacity , or is a congenital anomaly or birth defect , is life - threatening or results in death ;


### – the relevance of the clinical trial , taking account of the current state of scientific knowledge , and of whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products ; ### – the relevance of the clinical trial , ensuring that the trial participants are representative of the target population for the medicinal product , taking account of the current state of scientific knowledge , and of whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products ;


### where , regarding part i of the assessment report , the clinical trial is acceptable or acceptable subject to conditions , the member state concerned shall include in its decision its conclusion on part ii of the assessment report . ### where , regarding part i of the assessment report , the clinical trial is acceptable or acceptable subject to conditions , the member state concerned shall include in its decision its conclusion on part ii of the assessment report . the member state concerned shall submit both part i and part ii of the assessment report , including their conclusions , to the sponsor .


### a reference to the clinical trial or clinical trials which are substantially modified ; ### a reference to the clinical trial or clinical trials which are substantially modified by using their universal trial registration number or the registration number in the eu portal ;


### the clinical trial poses a minimal risk to , and imposes a minimal burden on , the subject . ### the clinical trial poses a minimal risk to , and imposes a minimal burden on , the subject , although this should be judged in proportion to the underlying medical condition .


### the european medicines agency established by regulation no 726 / 2004 shall set up and maintain an electronic database for the reporting provided for in articles 38 and 39 . ### the european medicines agency established by regulation no 726 / 2004 shall set up and maintain an electronic database for the reporting provided for in articles 38 and 39 . that electronic database shall be a module of the database referred to in article 25 of regulation no 726 / 2004 .


### regarding authorised medicinal products which , according to the protocol , are used in accordance with the terms of the marketing authorisation , the sponsor shall inform annually the marketing authorisation holder of all suspected serious adverse reactions . ### regarding authorised medicinal products which , according to the protocol , are used in accordance with the terms of the marketing authorisation , the sponsor shall inform at least annually the marketing authorisation holder of all suspected serious adverse reactions , in addition to safety reporting obligations for authorised medicinal products as per directive 2001 / 83 / ec and regulation no 726 / 2004 .


### safety reporting with regard to auxiliary medicinal products shall be made in accordance with chapter 3 of directive 2001 / 83 / ec . ### safety reporting with regard to auxiliary medicinal products shall be made by the investigator in accordance with directive 2001 / 83 / ec .


### the commission shall set up and maintain a portal at union level as a single entry point for the submission of data and information relating to clinical trials in accordance with this regulation . ### the commission shall set up and maintain a portal at union level as a single entry point for the submission of data and information relating to clinical trials in accordance with this regulation . the portal shall be technically advanced and user - friendly so as to avoid unnecessary work .


### data and information submitted through the eu portal shall be stored in the eu database referred to in article 78 . ### data and information submitted through the eu portal shall be stored in the eu database referred to in article 78 . it shall also be possible to use the portal in just one national language in cases of research which does not extend to more than one member state .


### the sponsor shall , where appropriate , refer to previous applications . if these applications have been submitted by another sponsor , a written agreement from that sponsor shall be submitted . ### the sponsor shall , where appropriate , refer to previous applications using its universal trial registration number or registration number in the eu portal . if these applications have been submitted by another sponsor , a written agreement from that sponsor shall be submitted .


### specific features of the trial population , such as subjects not able to give informed consent or minors ; ### specific features of the trial population , such as subjects not able to give informed consent or minors , or other vulnerable populations ;


### the number of persons suffering from material or even severe material deprivation in the union is increasing and those persons are often too excluded to benefit from the activation measures of regulation no [ …cpr ] , and , in particular of regulation no [ …esf ] . ### the number of persons suffering from material or even severe material deprivation in the union is increasing and those persons are often too excluded to benefit from the activation measures of regulation no [ …cpr ] , and , in particular of regulation no [ …esf ] . the criteria for determining such persons should correspond to the changing economic and social conditions .


### under article 317 of the treaty , and in the context of shared management , the conditions allowing the commission to exercise its responsibilities for implementation of the general budget of the union should be specified and the responsibilities in terms of cooperation by the member states clarified . those conditions should enable the commission to obtain assurance that member states are using the fund in a legal and regular manner and in accordance with the principle of sound financial management within the meaning of council regulation no [ … ] on the financial regulation applicable to the general budget of the european communities 1 . _____________ 1 oj l , , p . . . ### under article 317 of the treaty , and in the context of shared management , the conditions allowing the commission to exercise its responsibilities for implementation of the general budget of the union should be specified and the responsibilities in terms of cooperation by the member states clarified . those conditions should enable the commission to obtain assurance that member states are using the fund in a legal and regular manner and in accordance with the principle of sound financial management within the meaning of regulation no 966 / 2012 of the european parliament and of the council of 25 october 2012 on the financial rules applicable to the general budget of the union1 . in exercising its responsibilities for implementation of the budget , the commission should make increased use of , and promote , performance audits . ____________ 1oj l 298 , 26 . 10 . 2012 , p . 1 .


### those provisions also ensure that the operations supported shall comply with applicable union and national laws , notably in regard to the safety of the goods that are distributed to the most deprived persons . ### those provisions should be consistent with the provisions of the financial regulation and also ensure that the operations supported shall comply with other applicable union and national laws , notably in regard to the safety of the goods that are distributed to the most deprived persons .


### a description of the mechanism setting the eligibility criteria for the most deprived persons , differentiated if necessary by type of material deprivation addressed ; ### a description of the mechanism setting the eligibility criteria for the most deprived persons , differentiated if necessary by type of material deprivation addressed ; the description shall take into consideration newly deprived people with negative income and homeowners in negative equity ;


### during the implementation of an operation , the beneficiaries and partner organisations shall inform the public about the support obtained from the fund by placing at least one poster with information about the operation , including about the financial support from the union , at a location readily visible to the public , at each place of provision of the food , goods and any accompanying measure , except if this is not possible due to the circumstances of the distribution . ### during the implementation of an operation , the beneficiaries and partner organisations shall inform the public about the support obtained from the fund by placing at least one poster with information about the operation , including about the financial support from the union , at a location readily accessible and visible to the public , at each place of provision of the food , goods and any accompanying measure , except if this is not possible due to the circumstances of the distribution . the beneficiaries and partner organisations shall ensure that the elderly and people with disabilities have access to this information .


### all official exchanges of information between the member state and the commission shall be carried out using an electronic data exchange system established in compliance with the terms and conditions laid down by the commission by means of implementing acts . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 60 . ### all official exchanges of information between the member state and the commission shall be carried out using an electronic data exchange system established in compliance with the terms and conditions laid down by the commission by means of a delegated act , in accordance with article 59 .


### the commission shall adopt , by means of implementing acts , models for the audit strategy , the audit opinion and the annual control report , as well as the methodology for the sampling method referred to in paragraph 4 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 60 . ### the commission shall adopt , by means of delegated acts , models for the audit strategy , the audit opinion and the annual control report , as well as the methodology for the sampling method referred to in paragraph 4 . those delegated acts shall be adopted in accordance with the procedure referred to in article 59 .


### the commission may require a member state to take the actions necessary to ensure the effective functioning of their management and control systems or the correctness of expenditure in accordance with this regulation . ### the commission shall require a member state to take the actions necessary to ensure the effective functioning of their management and control systems or the correctness of expenditure in accordance with this regulation .


### for each year from 2015 until and including 2022 , by 15 february of the year following the end of the accounting period , the designated bodies shall submit to the commission the following documents and information in accordance with article 56 of the financial regulation : the certified annual accounts of the relevant bodies designated pursuant to article 32 as referred to in article 56 of the financial regulation ; the management declaration as referred to in article 56 of the financial regulation ; an annual summary of the final audit reports and of controls carried out , including an analysis of the nature and extent of errors and of weaknesses , as well as corrective actions taken or planned ; an audit opinion by the designated independent audit body as referred in article 56 of the financial regulation , accompanied by a control report setting out the findings of the audits carried out relating to the accounting year covered by the opinion . ### for each year from 2015 until and including 2022 , by 15 february of the year following the end of the accounting period , the designated bodies shall submit to the commission the following documents and information in accordance with article 59 of the financial regulation : the certified annual accounts of the relevant bodies designated pursuant to article 32 as referred to in article 59 of the financial regulation ; the management declaration as referred to in article 59 of the financial regulation ; an annual summary of the final audit reports and of controls carried out , including an analysis of the nature and extent of errors and of weaknesses , as well as corrective actions taken or planned ; an audit opinion by the designated independent audit body as referred in article 59 of the financial regulation , accompanied by a control report setting out the findings of the audits carried out relating to the accounting year covered by the opinion ;


### the managing authority shall ensure that all supporting documents on operations are made available to the commission and the european court of auditors upon request for a period of three years . this three year period shall run from 31 december of the year of the decision on acceptance of accounts by the commission pursuant to article 47 or , at the latest , from the date of payment of the final balance . this three year period shall be interrupted either in the case of legal or administrative proceedings or by a duly justified request of the commission . ### the managing authority shall ensure that all supporting documents on operations are made available to the commission and the european court of auditors upon request for a period of five years . this five year period shall run from the date of payment of the final balance . this five year period shall be interrupted either in the case of legal or administrative proceedings or by a duly justified request of the commission .


### the community financial contribution for the implementation phase shall be provided under the following conditions : ### the commission shall before the end of the strategic phase assess the following :


### developing a financing structure of funding bonus - 169 project , based on a pool of funds consisting of cash contributions of the participating states and of the community ; ### developing a financing structure of funding bonus projects ;


### provided that the results of the evaluation and the ex - ante audit of bonus eeig are positive , the commission and the bonus eeig shall conclude the implementation agreement . ### the commission and the bonus eeig shall conclude the implementation agreement as described in article 3 .


### the community financial contribution and the cash contribution of the participating states to bonus - 169 shall be pooled and administered centrally by the bonus eeig . ### as a general rule , the community financial contribution and the cash contribution of the participating states to bonus shall be pooled and administered centrally by the bonus eeig . however , in justified cases , a participating state may devote its cash contribution exclusively to domestic research .


### the concept of a network manager entity is central to improving the performance of air traffic management at network level , by centralising the provision of certain services , which are best performed at network level . in order to facilitate dealing with an aviation crisis , a coordination of such a crisis should be ensured by the network manager . ### the concept of a network manager entity is central to improving the performance of air traffic management at network level , by centralising the provision of certain services , which are best performed at network level . in order to facilitate dealing with an aviation crisis , coordination of the measures to be adopted to prevent and respond to such a crisis should be ensured by the network manager .


### in choosing the provider of support services , in particular cost efficiency , overall service quality and safety of services shall be taken into account by the entity procuring those services . ### in choosing the provider of support services , in particular cost efficiency , overall service quality , safety of services and transparency shall be binding selection criteria for the entity procuring those services . in particular , the awarding entity shall define quality targets related to the reliability and safety of the services , rewards and penalties applicable , parameters of financial compensations to be reflected into charging scheme and conditions related to the essential assets required for the provision of the services .


### the commission shall designate an independent , impartial and competent body to act as a ‘ performance review body’ . the role of the performance review body shall be to assist the commission , in coordination with the national supervisory authorities , and to assist the national supervisory authorities on request in the implementation of the performance scheme referred to in paragraph 1 . technical assistance to the performance review body may be provided by eaa and eurocontrol or another competent entity . ### the commission shall designate an independent , impartial and competent body to act as a ‘ performance review body’ . the role of the performance review body shall be to serve as a european - wide independent economic regulator assisting the commission , in coordination with the national supervisory authorities , and monitoring the national supervisory authorities on request in the implementation of the performance scheme referred to in paragraph 1 . the performance review body shall be established as an independent eu body under the supervision of the commission . technical assistance to the performance review body may be provided by eaa and eurocontrol or another competent entity .


### establishment and revision of union - wide and associated local performance targets that shall be defined taking into consideration inputs identified at national level or at the level of functional airspace blocks ; ### establishment and revision of union - wide and associated local performance targets that shall be defined taking into consideration inputs identified at national level or at the level of functional airspace blocks ; union - wide performance targets shall be set with a view of ensuring each functional airspace block retains enough flexibility to achieve the best results .


### the commission may , and in conformity with the implementing rules referred to in paragraph 4 , appoint eurocontrol , or another impartial and competent body , to carry out the tasks of the network manager . these tasks shall be executed in an impartial and cost - effective manner and performed on behalf of member states and stakeholders . they shall be subject to appropriate governance , which recognises the separate accountabilities for service provision and regulation , taking into consideration the needs of the whole atm network and with the full involvement of the airspace users and air navigation service providers . by 1 january 2020 , the commission shall designate the network manager as a self - standing service provider where possible set up as an industrial partnership . ### the commission may , and in conformity with the implementing rules referred to in paragraph 4 , appoint eurocontrol , or another impartial and competent body , to carry out the tasks of the network manager . these tasks shall be executed in an impartial and cost - effective manner and performed on behalf of member states and stakeholders . they shall be subject to appropriate governance , which recognises the separate accountabilities for service provision and regulation , taking into consideration the needs of the whole atm network and with the full involvement of the airspace users and air navigation service providers . by 1 january 2020 , the commission shall designate the network manager as a self - standing service provider where possible set up as an industrial partnership , similar to the development of centralised services by eurocontrol .


### member states shall lay down rules on penalties applicable to infringements of this regulation , in particular by airspace users and service providers , and shall take all measures necessary to ensure that they are implemented . the penalties provided for shall be effective , proportionate and dissuasive . ### member states shall lay down rules on penalties and compensation mechanisms applicable to infringements of this regulation , in particular by airspace users and service providers , and shall take all measures necessary to ensure that they are implemented . the penalties provided for shall be effective , proportionate and dissuasive .


### the commission has committed to mainstream climate change into union spending programmes and to direct at least 20% of the union budget to climate - related objectives . it is important to ensure that climate change mitigation and adaptation as well as risk prevention and management are promoted in the preparation , design and implementation of projects of common interest . infrastructure investments covered by this regulation should contribute to promoting the transition to a low - carbon and climate - and disaster - resilient economy and society . ### the commission has committed to mainstream climate change into union spending programmes and to direct at least 20% of the union budget to climate - related objectives . it is important to ensure that climate change mitigation and adaptation as well as risk prevention and management are promoted in the preparation , design and implementation of projects of common interest . infrastructure investments covered by this regulation should contribute to promoting the transition to a low - carbon and climate - and disaster - resilient economy and society . the commission should ensure that international agreements and standards applicable within the internal market are applied even - handedly to the member states , without causing distortions of competition , in order to ensure the success of european undertakings in the face of global competition .


### the commission has committed to mainstream climate change into union spending programmes and to direct at least 20% of the union budget to climate - related objectives . it is important to ensure that climate change mitigation and adaptation as well as risk prevention and management are promoted in the preparation , design and implementation of projects of common interest . infrastructure investments covered by this regulation should contribute to promoting the transition to a low - carbon and climate - and disaster - resilient economy and society . ### the commission has committed to mainstream climate change into union spending programmes and to direct at least 20% of the union budget to climate - related objectives . it is important to ensure that climate change mitigation and adaptation as well as risk prevention and management are promoted in the preparation , design and implementation of projects of common interest and that priority is therefore given to electricity interconnection investments . infrastructure investments covered by this regulation should contribute to promoting the transition to a low - carbon and climate - and disaster - resilient economy and society and minimise support for long - term high - carbon projects which lock in fossil fuels into our energy system for several decades and undermine the eu ' s 2020 and 2050 climate targets .


### on 28 march 2011 , the commission adopted the white paper ' ' a roadmap to a single transport area ― towards a competitive and resource - efficient transport system ' ' . the white paper aims at reducting by at least 60% the greeenhouse gas emissions of the transport sector by 2050 with respect to 1990 . as far as infrastructure is concerned , the white paper aims at establishing a fully functional and union - wide multimodal ten - t ‘ core network’ by 2030 . the white paper also aims at optimising the performance of multimodal logistic chains , including by making greater use of more energy - efficient modes . therefore , it sets the following relevant targets for ten - t policy : 30% of road freight over 300 km should shift to other modes by 2030 , and more than 50% by 2050 ; the length of the existing high - speed rail network should triple by 2030 and by 2050 the majority of medium - distance passenger transport should go by rail ; by 2050 , all core network airports should be connected to the rail network ; all seaports to the rail freight and , where possible , to the inland waterway system . ### on 28 march 2011 , the commission adopted the white paper ' ' a roadmap to a single transport area ― towards a competitive and resource - efficient transport system ' ' . the white paper aims at reducing by at least 60% the greenhouse gas emissions of the transport sector by 2050 with respect to 1990 . as far as infrastructure is concerned , the white paper aims at establishing a fully functional and interoperable union - wide multimodal ten - t ‘ core network’ by 2030 . the white paper also aims at optimising the performance of multimodal logistic chains , including by making greater use of more energy - efficient modes . therefore , it sets the following relevant targets for ten - t policy : 30% of road freight over 300 km should shift to other modes by 2030 , and more than 50% by 2050 ; the length of the existing high - speed rail network should triple by 2030 and by 2050 the majority of medium - distance passenger transport should go by rail ; by 2050 , all core network airports should be connected to the rail network ; all seaports to the rail freight and , where possible , to the inland waterway system .