### the commission should be empowered to adopt delegated acts in accordance with article 290 tfeu in respect of functional safety and environmental performance , testing , access to repair and maintenance information and appointment of technical services and their specific authorised tasks , in order to supplement or amend certain non - essential elements of legislative acts through provisions of general application . such empowerment should not allow for amendment of the enforcement dates set out in annex iv or emission limit values set out in annex vi . amendments to those dates or values should be established by the ordinary legislative procedure set out in article 114 tfeu . ### the commission should be empowered to adopt delegated acts in accordance with article 290 tfeu in respect of functional safety and environmental performance , testing , access to repair and maintenance information and appointment of technical services and their specific authorised tasks , in order to supplement or amend certain non - essential elements of legislative acts through provisions of general application . such empowerment should not allow for amendment of the enforcement dates set out in annex iv or emission limit values set out in annex vi or the enhanced functional safety requirements set out in annex viii . amendments to those dates , general requirements or values should be established by the ordinary legislative procedure set out in article 114 tfeu .


### vehicles primarily intended for off - road use and designed to travel on unpaved surfaces ; ### vehicles primarily intended for off - road use and designed to travel on unpaved surfaces with the exception of vehicles for special use as defined in article 4 and annex i ;


### l - category vehicles comprise powered two - , three - and four - wheel vehicles as categorised in the following paragraphs and annex i , including powered cycles , two - and three - wheel mopeds , two - and three - wheel motorcycles , motorcycles with side - cars , light and heavy on - road quads , and light and heavy mini - cars . ### l - category vehicles comprise powered two - , three - and four - wheel vehicles as categorised in the following paragraphs and annex i , including powered cycles , two - and three - wheel mopeds , two - and three - wheel motorcycles , motorcycles with side - cars , light and heavy on - road quads , atvs and light and heavy mini - cars .


### four years after the date referred to in the second subparagraph of article 82 , all new vehicles in subcategories l1be , l3e , l5e , l6ae and l7ae shall be equipped with the first stage of an on - board diagnostic system which monitors and reports on electric circuit continuity , shorted and open electric circuits and circuit rationality of the engine and vehicle management systems . ### four years after the date referred to in the second subparagraph of article 82 , all new vehicles in subcategories l1be , l3e , l5e , l6ae and l7ae shall be equipped with an on - board diagnostic system which monitors and reports on electric circuit continuity , shorted and open electric circuits and circuit rationality of the engine and vehicle management systems .


### six years after the date referred to in the second subparagraph of article 82 , all new vehicles in subcategories l6be and l7be shall be equipped with obd i . ### six years after the date referred to in the second subparagraph of article 82 , all new vehicles in subcategories l6be and l7be shall be equipped with obd .


### eight years after the date referred to in the second subparagraph of article 82 , all new vehicles shall be equipped with obd i . ### eight years after the date referred to in the second subparagraph of article 82 , all new vehicles shall be equipped with obd .


### four years after the date referred to in the second subparagraph of article 82 , all new vehicles in subcategories l1be , l3e , l5e , l6ae and l7ae shall be equipped with the first stage of an on - board diagnostic system which monitors and reports on electric circuit continuity , shorted and open electric circuits and circuit rationality of the engine and vehicle management systems . ### four years after the date referred to in the second subparagraph of article 82 , all new vehicles in subcategories l1be , l3e , l5e , l6ae , l7ae and l7ce shall be equipped with the first stage of an on - board diagnostic system which monitors and reports on electric circuit continuity , shorted and open electric circuits and circuit rationality of the engine and vehicle management systems .


### the amount of end - of - series vehicle shall not exceed 10 % of the number of vehicles registered in the two preceding years or 10 vehicles per member state , whatever is the highest . ### the maximum number of end - of series vehicles put into service in each member state shall be restricted in one of the following ways to be chosen by the member state : the amount of end - of - series vehicle shall not exceed 10 % of the number of vehicles registered in the two preceding years or 10 vehicles per member state , whatever is the highest ; or vehicles shall be restricted to those for which a valid certificate of conformity was issued on or after the date of manufacture and which remained valid for at least three months after its date of issue but subsequently lost its validity because of the entry into force of a regulatory act .


### maximum design speed ≤ 25 km / h and ### maximum design speed ≤ 45 km / h and


### regulation of the european parliament and of the council on guidelines for trans - european telecommunications networks and repealing decision no 1336 / 97 / ec ### regulation of the european parliament and of the council on guidelines for trans - european digital networks and repealing decision no 1336 / 97 / ec


### the digital agenda for europe stipulates that by 2020 all europeans should have access to internet speeds of above 30 mbps and 50% or more of european households should subscribe to internet connections above 100 mbps . ### the digital agenda for europe stipulates that by 2020 all europeans should have access to internet speeds of above 30 mbps and 50% or more of european households should subscribe to internet connections above 100 mbps . however , given the rapid evolution of technologies that lead to ever faster internet connexions , it is appropriate today , for all union households , to target internet connections above 100 mbps with 50% of the households having access to 1 gbps .


### this regulation lays down guidelines for the timely deployment and interoperability of projects of common interest in the field of trans - european telecommunications networks . ### this regulation lays down guidelines for the timely deployment and interoperability of projects of common interest in the field of trans - european digital networks .


### ' 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 and wireless access networks , ancillary infrastructure and core networks capable of delivering very high speed connectivity , thereby contributing to the broadband targets of 100 mbps and 1gbps where possible and above .


### economic growth and support to the completion of the digital single market in support of the competitiveness of the european economy , including small and medium sized enterprises . ### economic growth and support to the completion and smooth functioning of the digital single market in support of the competitiveness of the european economy , including small and medium sized enterprises .


### contribute to improvements in daily life for citizens , businesses and governments through the promotion of the interconnection and interoperability of national telecommunication networks as well as access to such networks . ### contribute to improvements in daily life for citizens , businesses and governments through the promotion of the interconnection and interoperability of local , national , and regional telecommunication networks as well as open and non - discriminatory access to such networks . in order to complete the digital single market , close cooperation and coordination of activities under the cef programme with the national and regional broadband actions shall be ensured .


### second priority shall be given to digital service infrastructures in support of specific provisions of eu legislation and based on existing building blocks . ### priority shall be given also to other digital service infrastructures as listed in the annex .


### 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 function of the available budget , the work programmes as defined in regulation no / establishing the connecting europe facility may establish further eligibility and priority criteria in the field of digital service infrastructures .


### make a significant contribution to the realisation of the targets of the digital agenda for europe . ### make a significant contribution to the realisation of broadband targets of 100mbps and 1gbps where possible and above .


### the union may establish contacts , discuss , exchange information and cooperate with public authorities or any other organisations in third countries to achieve any objective pursued by these guidelines . among other objectives , this cooperation shall seek to promote the interoperability between telecommunications networks in the union and telecommunications networks of third countries . ### the union may establish contacts , discuss , exchange information and cooperate with public authorities or any other organisations in third countries to achieve any objective pursued by these guidelines . among other objectives , this cooperation shall seek to promote the interoperability between digital networks in the union and digital networks of third countries .


### planning national plans or national strategies , where applicable ; ### coordinating national plans or national strategies , where applicable ;


### interventions in the area of digital service infrastructure generally rely on a two - layer architecture approach : core service platforms and generic services . as the core service platform is a pre - condition for establishing a digital service infrastructure , the support to core service platforms and their common building blocks shall take priority over generic services . ### interventions in the area of digital service infrastructure generally rely on a two - layer architecture approach : core service platforms and generic services .


### other digital service infrastructures a priori identified as eligible in accordance with article 6 . 1 : ### other digital service infrastructures a priori identified as eligible in accordance with article 6 . 1 and 6 . 3 :


### 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 regulation shall significantly contribute to the achievement of 100mbps and 1gbps and above where possible .


### be based on state - of - the art technology , either wired or wireless , capable of delivering very high - speed broadband services , thus meeting demand for applications which require high bandwidth , or ### be based on state - of - the art technology , either wired or wireless , capable of delivering very high - speed broadband services of speeds to at least 100 mbps , thus meeting demand for applications which require high bandwidth , or


### section 3 . horizontal actions the deployment of trans - european telecommunications networks that will help to remove the bottlenecks existing in the digital single market shall be accompanied by studies and programme support actions . these actions may consist of : ### section 3 . programme support actions the deployment of trans - european digital networks that will help to remove the bottlenecks existing in the digital single market shall be accompanied by programme support actions . these actions may consist of :


### the directive should provide for a flexible entry system based on demand and objective criteria , such as a valid work contract or a binding job offer that specifies the level of remuneration applicable to seasonal workers in the sector concerned . ### the directive should provide for a flexible entry system based on demand and objective criteria as determined by individual member states , such as a valid work contract or a binding job offer that specifies the level of remuneration applicable to seasonal workers in the sector concerned .


### 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 shall take all measures to ensure that they are implemented . the penalties provided for shall be effective , proportionate and dissuasive , in particular where article 6 of this regulation is violated . member states shall notify those provisions to the commission , and shall notify it without delay of any subsequent amendment affecting them .


### before the beginning of each year , each producer organisation may individually make a proposal for a price triggering the storage mechanism referred to in article 35 for fishery products listed in annex ii . ### each producer organisation may individually make a proposal for a price that triggers the storage mechanism referred to in article 35 for fishery products listed in annex ii .


### all fishery products landed , including those not complying with marketing standards , may be , under the responsibility of the member states , distributed free of charge to philanthropic or charitable institutions established in the union or to persons who are recognised by the legislation of the member state concerned as being entitled to public assistance . ### all fishery products landed , including those not complying with marketing standards , may , under the responsibility of the member states , be used for bait , as well as for fishmeal and fish oil . producer organisation members may be eligible for the reimbursement of a proportion of the value of these fishery products .


### the area where the product was caught or farmed ; ### the area where the product was caught or farmed , expressed in terms that are understandable to consumers ;


### gather , analyse and disseminate economic knowledge and understanding of the union market for fishery and aquaculture products along the supply chain , taking into account the international context ; ### provide financial and practical support to producer organisations to create electronic nationwide databases / markets to better coordinate information between market operators and processors .


### the commission shall report to the european parliament and the council on the results of the application of this regulation before the end of 2022 . ### the commission shall report to the european parliament and the council on the results of the application of this regulation before the end of 2019 .


### relations between ukraine and the european union are developing within the framework of the european neighbourhood policy . in 2005 , the community - and ukraine agreed on a european neighbourhood policy action plan identifying medium - term priorities in eu - ukraine relations . since 2007 , the community - and ukraine have been negotiating an association agreement that is expected to replace the existing partnership and cooperation agreement . the framework of eu - ukraine relations is further enhanced by the newly launched eastern partnership . ### relations between ukraine and the european union are developing within the framework of the european neighbourhood policy . in 2005 , the community and ukraine agreed on a european neighbourhood policy action plan identifying medium - term priorities in eu - ukraine relations , replaced by the eu - ukraine association agenda of november 2009 . since 2007 , the community and ukraine have been negotiating an association agreement that is expected to replace the existing partnership and cooperation agreement . the framework of eu - ukraine relations is further enhanced by the newly launched eastern partnership .


### this assistance should be managed by the commission , in consultation with the economic and financial committee . ### this assistance should be managed by the commission , in consultation with the european parliament and the economic and financial committee .


### the release of the community financial assistance shall be managed by the commission in a manner consistent with the agreements or understandings reached between the imf and ukraine . ### the release of the union ' s financial assistance shall be managed by the commission in a manner consistent with the agreements or understandings reached between the imf and ukraine and with the key principles and objectives of economic reform set out in the eu - ukraine association agenda .


### the commission is empowered to agree with the authorities of ukraine , after consulting the economic and financial committee , the economic policy conditions attached to the community macro - financial assistance , to be laid down in a memorandum of understanding . the conditions shall be consistent with the agreements or understandings reached between the imf and ukraine . the detailed financial terms of the assistance shall be laid down in a loan agreement to be agreed between the commission and the authorities of ukraine . ### the commission is empowered to agree with the authorities of ukraine , after consulting the economic and financial committee , the economic policy conditions attached to the union ' s macro - financial assistance , to be laid down in a memorandum of understanding which includes a timeframe for their fulfilment . the conditions shall be consistent with the agreements or understandings reached between the imf and ukraine and with the key principles and objectives of economic reform set out in the eu - ukraine association agenda . the detailed financial terms of the assistance shall be laid down in a loan agreement to be agreed between the commission and the authorities of ukraine .


### during the implementation of the community financial assistance , the commission shall monitor the soundness of ukraine ' s financial arrangements , administrative procedures , and the internal and external control mechanisms which are relevant to such assistance . ### during the implementation of the union ' s financial assistance , the commission shall monitor the soundness of ukraine ' s financial arrangements , administrative procedures , the internal and external control mechanisms which are relevant to such assistance and the adherence to the timeframe agreed upon .


### the economic and financial committee shall be kept informed of developments in the operations referred to in paragraphs 2 and 3 . ### the european parliament and the economic and financial committee shall be kept informed of developments in the operations referred to in paragraphs 2 and 3 .


### the community financial assistance shall be implemented in accordance with the provisions of council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities6 and its implementing rules7 . in particular , the memorandum of understanding and the loan agreement to be agreed with the authorities of ukraine shall provide for appropriate measures by ukraine in relation to the prevention of , and the fight against , fraud , corruption and other irregularities affecting the assistance . they shall also provide for controls by the commission , including the european anti - fraud office , with the right to perform on - the - spot checks and inspections , and for audits by the court of auditors , where appropriate , to be carried out on the spot . ### the union financial assistance shall be implemented in accordance with the provisions of council regulation no 1605 / 2002 of 25 june 2002 on the financial regulation applicable to the general budget of the european communities6 and its implementing rules7 . in particular , the memorandum of understanding and the loan agreement to be agreed with the authorities of ukraine shall provide for appropriate measures by ukraine in relation to the prevention of , and the fight against , fraud , corruption and other irregularities affecting the assistance . they shall also provide for controls by then commission , including the european anti - fraud office , with the right to perform on - the - spot checks and inspections , and for audits by the court of auditors , where appropriate , to be carried out on the spot . the commission shall conduct an operational assessment of the financial circuits and administrative procedures in ukraine no later than three months after the first instalment is made available .


### 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 .


### 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 , is financial gain . in order to be effective , law enforcement and judicial authorities should be given all means to trace , freeze , manage and confiscate the proceeds of crime .


### although existing statistics are limited , the amounts recovered from criminal assets in the union seem insufficient compared to the estimated proceeds of crime . studies have shown that , although regulated by eu legislation and national laws , confiscation procedures remain underutilised . ### although existing statistics are limited , the amounts recovered from criminal assets in the union seem extremely low compared to the estimated proceeds of crime . studies have shown that , although regulated by eu legislation and national laws , confiscation procedures remain underutilised and laws at national level are uneven .


### 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 .


### it should be left to member states to establish the language requirements for the application dossier . to ensure that the assessment of the application for authorisation of a clinical trial functions smoothly , member states should consider accepting a commonly understood language in the medical field as the language for the documentation not destined to the subject . ### it should be left to member states to establish the language requirements for the application dossier . to ensure that the assessment of the application for authorisation of a clinical trial functions smoothly , member states should work towards accepting a commonly understood language in the medical field as the language for the documentation not destined to the subject , such as the patient information and the informed consent sheet .


### in accordance with international guidelines , the free and informed consent of the subject should be in writing , save in exceptional situations . it should be based on information which is clear , relevant and understandable to the subject . ### in accordance with international guidelines , the free and informed consent of the subject should be in writing , save in exceptional situations . it should be based on information which is clear , relevant and understandable to the subject , and should be in the subject ' s own language .


### the agency should forward this information to the member states for them to assess this information . ### the agency should as soon as possible forward this information to the member states for them to assess this information .


### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the proposed reporting member state has not notified the sponsor within 14 days , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state .


### for the purpose of obtaining those additional explanations , the reporting member state may suspend the time period referred to in paragraph 4 for a maximum of 10 days for low - intervention clinical trials and for a maximum of 20 days for trials other than low - intervention clinical trials . ### for the purpose of obtaining those additional explanations , the reporting member state may extend the time period referred to in paragraph 4 for a maximum of 20 days for low - intervention clinical trials and for a maximum of 30 days for trials other than low - intervention clinical trials .


### notification shall be done by way of one single decision within ten days from the validation date . ### notification shall be done by way of one single decision within ten days from the assessment date according to article 6 .


### the subject or , where the subject is not able to give informed consent , his or her legal representative has had the opportunity , in a prior interview with the investigator or a member of the investigating team , to understand the objectives , risks and inconveniences of the clinical trial , and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment ; ### the subject or , where the subject is not able to give informed consent , his or her legal representative has had the opportunity , in a prior interview with a medical doctor who is the investigator or a member of the investigating team , to understand the objectives , risks and inconveniences of the clinical trial , and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment ;


### any subject may , without any resulting detriment , withdraw from the clinical trial at any time by revoking his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal . ### any subject or his legal representative may , without any resulting detriment , withdraw from the clinical trial at any time by revoking his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal .


### the informed consent of the legal representative has been obtained , whereby consent shall represent the subject ' s presumed will ; ### the informed consent of the legal representative has been obtained ; consent shall represent the subject ' s presumed will and may be revoked at any time , without detriment to the subject ;


### the minor has received all relevant information in a way adapted to his or her age and maturity , from professionals trained or experienced in working with children , regarding the trial , the risks and the benefits ; ### the minor has received all relevant information in a way adapted to his or her age and maturity , from a medical doctor trained or experienced in working with children , regarding the trial , the risks and the benefits ;


### the protocol shall be accompanied by a synopsis of the protocol . ### the protocol shall be accompanied by a synopsis of the protocol , and shall be updated with any modifications of the protocol , including the dates of each modification .


### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority may take a decision requiring them to take specific action or to refrain from action in order to settle the matter , in compliance with community law . ### if , at the end of the conciliation phase , the competent authorities concerned have failed to reach an agreement , the authority may take a decision requiring them to take specific action or to refrain from action in order to settle the matter , in order to ensure compliance with union law .


### science can contribute to addressing these challenges and finding solutions to the environmental problems in the baltic sea . however , the gravity of the present situation calls for a qualitative and quantitative stepping up of current research in the baltic region through the development and implementation of a fully - integrated approach whereby the relevant research programmes of all the bordering states can be streamlined and focused in order to address the complex and urgent issues in a coordinated , efficient and effective manner . ### science must contribute to addressing these challenges and finding solutions to the urgent environmental problems in the baltic sea . however , the gravity of the present situation calls for a qualitative and quantitative stepping up of current research in the baltic region through the development and implementation of a fully - integrated approach whereby the relevant research programmes of all the bordering states can be streamlined and focused in order to address the complex and urgent issues in a coordinated , efficient and effective manner .


### while largely focused on environmental research , the bonus - 169 initiative cross - cuts a number of related community research programmes on a range of human activities having accumulated impacts on the ecosystem such as fisheries , aquaculture , agriculture , infrastructure , transport , training and mobility of researchers as well as socioeconomic issues . the initiative is of considerable relevance to a number of community policies and directives including directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy , the eu strategy for the baltic sea region , the common fisheries policy , the common agricultural policy , directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy and international eu commitments such as the helcom baltic sea action plan . as a result , many other areas of community policy will benefit from bonus - 169 . ### while largely focused on environmental research , the bonus initiative cross - cuts a number of related community research programmes on a range of human activities having accumulated impacts on the ecosystem such as fisheries , aquaculture , agriculture , infrastructure , transport , training and mobility of researchers as well as socioeconomic issues . the initiative is of considerable relevance to a number of community policies and directives including directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy , the eu strategy for the baltic sea region , the common fisheries policy , the common agricultural policy , directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy and international eu commitments such as the helcom baltic sea action plan . as a result , many other areas of community policy will benefit from bonus .


### the bonus eeig should encourage the participants in the selected bonus - 169 projects to communicate and disseminate their results widely and to make this information publicly available . ### the bonus eeig should oblige the participants in the selected bonus projects to communicate and disseminate their results widely and to make this information publicly available .


### 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 :


### demonstration by the bonus eeig of its capacity to implement bonus - 169 including receiving , allocating and monitoring the community financial contribution under indirect centralised management in accordance with articles 54 and 56 of the regulation no 1605 / 2002 and articles 35 , 38 and 41 of regulation no 2342 / 2002 and in accordance with sound financial management . ### demonstration by the bonus eeig of its capacity to implement bonus , including achieving the objectives of the baltic sea region’s environmentally sustainable development , receiving , allocating and monitoring the community financial contribution under indirect centralised management in accordance with articles 54 and 56 of the regulation no 1605 / 2002 and articles 35 , 38 and 41 of regulation no 2342 / 2002 and in accordance with sound financial management .


### 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 ;


### the bonus - 169 shall be managed by bonus eeig through its secretariat . bonus eeig shall establish the following structures for the purposes of bonus - 169 : steering committee , secretariat , advisory board , forum of sector research , and the forum of project coordinators . ### the bonus shall be managed by bonus eeig through its secretariat . bonus eeig has established the following structures for the purposes of bonus : steering committee , secretariat , advisory board , forum of sector research , and the forum of project coordinators .


### this regulation shall apply to the airspace within the icao eur and afi and nat regions where member states are responsible for the provision of air traffic services in accordance with the this regulation . member states may also apply this regulation to airspace under their responsibility within other icao regions , on condition that they inform the commission and the other member states thereof . ### this regulation shall apply to the airspace within the icao eur and afi regions where member states are responsible for the provision of air traffic services in accordance with this regulation . member states may also apply this regulation to airspace under their responsibility within other icao regions , on condition that they inform the commission and the other member states thereof .


### the national supervisory authorities shall be legally distinct and independent in particular in organisational , hierarchical and decision - making terms , from any air navigation service providers or any private or public entity having an interest in the activities of such providers . ### the national supervisory authorities shall be legally distinct from any atm / ans service providers , or any private or public entity which oversees the management of atm / ans service providers and has any responsibility for decisions on their management .


### the national supervisory authorities that are not legally distinct from any air navigation service providers or any private or public entity having an interest in the activities of such providers , as provided for in paragraph 2 , on the date of entry into force of this regulation shall meet this requirement by 1 january 2020 at the latest . ### national supervisory authorities which are not compliant with paragraph 2 of this article shall meet this requirement by 1 january 2020 .


### be recruited under clear and transparent rules which guarantee their independence and as regards persons in charge of strategic decisions , be appointed by the national cabinet or council of ministers or another public authority which does not directly control , or benefit from the air navigation service providers ; ### be recruited under clear and transparent rules which ensure their independence . nsa staff who are responsible for strategic decisions should be appointed by the national cabinet or council of ministers or an authorised representative acting on their behalf or the nsa itself . where another public authority makes such appointments it must not directly control or benefit from the atm / ans service providers .


### in the case of provision of air navigation services in an airspace falling under the responsibility of another member state , the arrangements referred to in paragraphs 2 and 4 shall include an agreement on the mutual recognition of the supervisory tasks set out in article 4 and and of the results of these tasks . this mutual recognition shall apply also where arrangements for recognition between national supervisory authorities are made for the certification process of service providers . ### in the case of provision of air navigation services in an airspace falling under the responsibility of another member state , the arrangements referred to in paragraphs 2 , 3 and 4 shall include an agreement on the mutual recognition of the supervisory tasks set out in article 4 and and of the results of these tasks . this mutual recognition shall apply also where arrangements for recognition between national supervisory authorities are made for the certification process of service providers .


### member states shall take all necessary measures to ensure that , in accordance with this article , providers of support services can compete within the union on the basis of equitable , non - discriminatory and transparent conditions for the purpose of providing these services . ### member states shall take all necessary measures to ensure that , in accordance with this article , there are no statutory impediments to the providers of terminal air navigation and / or support services that would prevent their ability to compete within the union on an equitable and non - discriminatory basis . the requirement set out in this article shall be achieved not later than five years after publication of the study referred to in paragraph 2 of this article .


### 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 . ### if support services are provided under market conditions pursuant to annex i of regulation eu no 391 / 2013 , the entity procuring the services must do so under ojeu rules with particular focus on cost efficiency , service quality , interoperability and the safety of those services .


### national plans or plans for functional airspace blocks , including performance targets , ensuring compliance with the union - wide and associated local performance targets ; and ### national plans or plans for functional airspace blocks , including performance targets , ensuring consistency with and their contribution to union–wide and associated local performance targets .


### in the event that the commission identifies that the national or functional airspace block plans or the local targets do not comply with the union - wide targets , it may require the member states concerned to take the necessary corrective measures . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 27 . ### in the event that the commission identifies that the national or functional airspace block plans or the local targets do not demonstrate consistency with or contribute to the union - wide targets , it may require the member states concerned to take the necessary corrective measures . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 27 .


### 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 of union - wide performance targets that shall be defined taking into consideration inputs identified at national level or at the level of functional airspace blocks ;


### , member states shall take all necessary measures in order to ensure the establishment and implementation of functional airspace blocks based on integrated provision of air traffic services with a view to achieving the required capacity and efficiency of the air traffic management network within the single european sky and maintaining a high level of safety and contributing to the overall performance of the air transport system and reduced environmental impact . ### member states shall take all necessary measures in order to ensure the establishment and implementation of functional airspace blocks based , where appropriate , on integrated provision of air traffic services , with a view to achieving the required capacity and efficiency of the air traffic management network within the single european sky and maintaining a high level of safety and contributing to the overall performance of the air transport system and reduced environmental impact ' .


### member states , as well as air traffic service providers shall cooperate to the fullest extent possible with each other in order to ensure compliance with this article . where relevant , cooperation may also include air traffic service providers from third countries taking part in functional airspace blocks . ### member states , national supervisory authorities as well as air traffic service providers shall cooperate to the fullest extent possible with each other , in order to ensure compliance with this article . where relevant , cooperation may also include national supervisory authorities and air traffic service providers from third countries taking part in functional airspace blocks ' .


### be designed to seek maximum synergies from industrial partnerships in order to meet and where possible exceed the performance targets set in accordance with article 11 ; ### be designed to seek maximum synergies from industrial partnerships in order to meet the performance targets set in accordance with article 11 ;


### the air traffic management network services shall allow optimum use of airspace and ensure that airspace users can operate preferred trajectories , while allowing maximum access to airspace and air navigation services . these network services shall be aimed at supporting initiatives at national level and at the level of functional airspace blocks and shall be executed in a manner which respects the separation of regulatory and operational tasks . ### the air traffic management network services shall allow optimum use of airspace and ensure that airspace users can operate preferred trajectories , while allowing maximum access to airspace and air navigation services . these network functions and services shall be aimed at supporting initiatives at national level and at the level of functional airspace blocks and shall be executed in a manner which respects the separation of regulatory and operational tasks .


### in order to achieve the objectives referred to in paragraph 1 and without prejudice to the responsibilities of the member states with regard to national routes and airspace structures , the commission shall ensure that the following services are carried out under the responsibility of a network manager : ### in order to achieve the objectives referred to in paragraph 1 and without prejudice to the responsibilities of the member states with regard to national routes and airspace structures , the commission shall ensure that the following functions and services are coordinated by a network manager :


### the services listed in this paragraph shall not involve the adoption of binding measures of a general scope or the exercise of political discretion . they shall take into account proposals established at national level and at the level of functional airspace blocks . they shall be performed in coordination with military authorities in accordance with agreed procedures concerning the flexible use of airspace . ### the functions and services listed in this paragraph shall not involve the adoption of binding measures of a general scope or the exercise of political discretion . they shall take into account proposals established at national level and at the level of functional airspace blocks . they shall be performed in coordination with military authorities in accordance with agreed procedures concerning the flexible use of airspace .


### on the basis of the objectives set by the white paper , the ten - t guidelines as laid down in regulation no xxx / 2012 of the european parliament and of the council of … identify the infrastructure of the trans - european transport network , specify the requirements to be fulfilled by it and provide for measures for their implementation . the guidelines envisage in particular the completion of the core network by 2030 . ### on the basis of the objectives set by the white paper , the ten - t guidelines as laid down in regulation no xxx / 2012 of the european parliament and of the council of … identify the infrastructure of the trans - european transport network , specify the requirements to be fulfilled by it and provide for measures for their implementation . the guidelines envisage in particular the completion of the core network by 2030 through the creation of new infrastructure as well as the rehabilitation and upgrading of existing infrastructure .


### on the basis of the objectives set by the white paper , the ten - t guidelines as laid down in regulation no xxx / 2012 of the european parliament and of the council of … identify the infrastructure of the trans - european transport network , specify the requirements to be fulfilled by it and provide for measures for their implementation . the guidelines envisage in particular the completion of the core network by 2030 . ### on the basis of the objectives set by the white paper , the ten - t guidelines as laid down in regulation no xxx / 2012 of the european parliament and of the council of … identify the infrastructure of the trans - european transport network , specify the requirements to be fulfilled by it and provide for measures for their implementation . the guidelines envisage in particular the completion of the core network by 2030 through the creation of new infrastructure as well as the revitalisation and upgrading of existing infrastructure .


### experience with the current financial framework shows that many member states , which are eligible to the cohesion fund , are facing significant obstacles in delivering on time complex cross - border transport infrastructure projects with a high union added value . therefore , in order to improve the delivery of transport projects , in particular cross - border ones , with a high union added value , part of the cohesion fund allocation should be transferred to finance transport projects on the transport core network in the member states eligible to the cohesion fund under the connecting europe facility . the commission should support member states eligible to the cohesion fund to develop an adequate pipeline of projects in order to give greatest possible priority to the national allocations under the cohesion fund . ### experience with the current financial framework shows that many member states , which are eligible to the cohesion fund , are facing significant obstacles in delivering on time complex cross - border transport infrastructure projects with a high union added value . therefore , in order to improve the delivery of transport projects , in particular cross - border ones , with a high union added value , part of the cohesion fund allocation should be transferred to finance transport projects on the transport core network in the member states eligible to the cohesion fund under the connecting europe facility . the cohesion fund allocation of each member state under the connecting europe facility shall respect national envelopes , but after the mid - term review , funding not committed by the member state concerned shall be made available to all member states eligible to the cohesion fund . the commission should support member states eligible to the cohesion fund to develop an adequate pipeline of projects in order to give greatest possible priority to the national allocations under the cohesion fund .


### the europe 2020 strategy calls for the implementation of the digital agenda for europe that establishes a stable legal framework to stimulate investments in an open and competitive high speed internet infrastructure and in related services . the june 2010 european council endorsed the digital agenda for europe and called upon all institutions to engage in its full implementation . ### the europe 2020 strategy calls for the implementation of the digital agenda for europe that establishes a stable legal framework to stimulate investments in an open and competitive high speed internet infrastructure and in related services . however , targets for 2020 should be revised , aiming for europe to have the fastest broadband speeds in the world by seeking to ensure that by 2020 all europeans have access to 100 mbps and 50% of eu households have access to 1 gbits or more .


### the connecting europe facility shall enable the preparation and implementation of projects of common interest within the framework of the trans - european networks policy in the sectors of energy , transport and telecommunications . in particular the connecting europe facility shall support the implementation of projects aiming at the development and construction of new or upgrading of existing infrastructure in the field of transport , energy and telecommunications . to this end , the connecting europe facility shall pursue the following objectives : ### the connecting europe facility shall enable the preparation and implementation of projects of common interest within the framework of the trans - european networks policy in the sectors of energy , transport and telecommunications . in particular the connecting europe facility shall support the implementation of projects aiming at the development and construction of new or upgrading and revitalising of existing infrastructure in the field of transport , energy and telecommunications . to this end , the connecting europe facility shall pursue the following objectives :


### accelerating the deployment of fast and ultrafast broadband networks and their uptake , including by small and medium sized enterprises , to be measured by the level of broadband and ultrafast broadband coverage and the number of households having subscribed for broadband connections for above 100 mbps ; ### accelerating the deployment of fast and ultrafast broadband networks to generate jobs and growth and their uptake , in particular connecting small and medium sized enterprises to make them more competitive ; in so doing the indicator for the level of broadband and ultrafast coverage to be attained should be above 100mbps with a view to ensuring the full attainment of the digital agenda for europe ' s objectives as soon as possible ;


### transport : eur 31 694 000 000 , out of which eur 10 000 000 000 shall be transferred from the cohesion fund to be spent in line with this regulation in member states eligible for funding from the cohesion fund ; ### transport : [ eur 31 694 000 000 ] , out of which [ eur 10 000 000 000 ] shall be transferred from the cohesion fund to be spent for projects listed in the annex to this regulation , respecting the national allocations ;


### the european rail traffic management system ; ### the european rail traffic management system ; the river information services and the vessel traffic monitoring and information systems .


### the commission shall cancel , except in duly justified cases , financial aid granted for actions which have not been started within one year following the start date of the action established in the conditions governing the granting of aid . ### the commission shall cancel , except in duly justified cases , financial aid granted for actions which have not been started within two years following the start date of the action established in the conditions governing the granting of aid .


### the committee shall ensure a horizontal overview of the work programmes referred to in article 17 to ensure consistency and that synergies are identified and exploited between sectors . ### the committees shall coordinate their actions , in order to ensure consistency and a horizontal overview of the work programmes referred to in article 17 and to ensure that synergies are identified and exploited between sectors .


### reported fatalities and severe health consequences associated with the consumption of the new psychoactive substance in several member states , related to the serious acute toxicity of the new psychoactive substance ; ### reported fatalities and severe health consequences associated with the consumption of the new psychoactive substance in several member states , related to the toxicity of the new psychoactive substance ;


### member states ' competent authorities should be given the powers to stop or seize those products when there are reasonable grounds for suspecting that they are intended for the illicit drug manufacture , when they are exported , imported or in transit . ### member states ' competent authorities should be given the powers to stop or seize those products when there are reasonable grounds for suspecting that they are intended for the illicit drug manufacture , when they are exported , imported or in transit . member states ' competent authorities should share between themselves and with the commission through a european database information on seizures and stopped shipments to improve the overall level of information on trade in drug precursors and medicinal products containing ephedrine or pseudoephedrine .


### consumers who are legally resident in the union and who do not hold a payment account in a certain member state should be in a position to open and use a payment account with basic features in that member state . in order to ensure the widest possible access to such accounts , consumers should have access to them irrespective of their financial circumstances , such as unemployment or personal bankruptcy , and of their place of residence . moreover , the right to access a payment account with basic features in any member state should be granted in conformity with the requirements set out in directive 2005 / 60 / ec of the european parliament and of the council of 26 october 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing , in particular with regard to customer due diligence procedures . ### consumers who have previously been denied access to a basic payment account , are resident in and can justify a sufficient relationship with the member state of the psp where they apply for access to a payment account with basic features should be in a position to open and use a payment account with basic features in that member state . in order to ensure the widest possible access to such accounts , consumers should have access to them irrespective of their financial circumstances , such as unemployment or personal bankruptcy . moreover , the right to access a payment account with basic features in any member state should be granted in conformity with the requirements set out in directive 2005 / 60 / ec of the european parliament and of the council of 26 october 2005 on the prevention of the use of the financial system for the purpose of money laundering and terrorist financing , in particular with regard to customer due diligence procedures .


### member states shall ensure that when a payment account is offered together with another service or product as part of a package , the payment service provider informs the consumer of whether it is possible to buy the payment account separately and provides separate information regarding the costs and fees associated with each of the products and services offered in the package . ### without prejudice to article 4 , member states shall ensure that when a payment account is offered together with another financial service or product as part of a package , the payment service provider informs the consumer of whether it is possible to buy the payment account separately and , if so , provides separate information regarding the fees associated with each of the other financial products and services offered in the package , where it is possible to buy each of those financial products and services separately .


### needs ; ### needs in terms of sustainable development , as identified in close cooperation with the partner countries ' parliaments and socio - economic stakeholders , and civil society ;


### capacities to generate and access financial resources and absorption capacities ; and ### capacities to generate and access financial resources and absorption and audit capacities ; and


### the objective of union assistance under the programme ' global public goods and challenges ' shall be to support actions in areas such as the environment and climate change , sustainable energy , human development , food security , and migration and asylum . ### the objective of union assistance under the programme ' global public goods and challenges ' shall be to support actions in areas such as the environment and climate change , sustainable energy , human development , food security , and legal migration and asylum .


### human rights , democracy and other key elements of good governance ### human rights , democracy and other key elements of good governance in the public and private sectors


### democracy , human rights and the rule of law ; ### democracy , including fair and transparent elections , the respect for human rights as enshrined in the united nations ' universal declaration of human rights and the rule of law ;


### public sector management ; ### public sector management , including financial management , transparency and accountability ;


### civil society and local authorities ; ### elected local authorities , including , where appropriate , traditional and customary authorities , and civil society ;


### european union assistance shall support actions and sectoral dialogues consistent with article 5 and with the overall purpose and scope , objective and general principles of this regulation . appropriate consideration shall be given to the areas described below , reflecting jointly - agreed strategies , partnership , cooperation and trade agreements . priorities will be established in accordance with the communication ‘ an agenda for change’ and with the subsequent conclusions of the council . ### european union assistance shall support actions and sectoral dialogues consistent with article 5 and with the overall purpose and scope , objective and general principles of this regulation . appropriate consideration shall be given to the areas described below , reflecting jointly - agreed strategies , partnership , cooperation and agreements contributing to open and fair trade . priorities will be established in accordance with the communication ‘ an agenda for change’ and with the subsequent conclusions of the council .


### promoting inclusive and sustainable economic growth , addressing social and regional inequalities , and supporting policies in areas such as education , research , innovation and technology , health , decent work , sustainable energy , agriculture and rural development , fostering smes , while stimulating the development of a market economy , trade and investment , including regulatory reforms and the support for integration into the wto ; ### promoting inclusive and sustainable economic growth , addressing social and regional inequalities , and supporting policies in areas such as education , research , innovation and technology , health , decent work , sustainable energy , agriculture and rural development , fostering smes , while stimulating the development of a market economy , open and fair trade and investment , including regulatory reforms and the support for integration into the wto ;


### complementing resources deployed under this instrument by coherent work and support through other eu instruments , which may focus on wider regional integration , promoting the eu ' s interests in fields such as economy , energy , research , innovation and technology , fighting against production , consumption and trafficking of drugs in the context of the security and development nexus , as well as managing migration and helping displaced persons and refugees in the context of the development and migration nexus . ### complementing resources deployed under this instrument by coherent work and support through other eu instruments , which may focus on wider regional integration , promoting the eu ' s interests in fields such as economy , energy , research , innovation and technology , fighting against production , consumption and trafficking of drugs in the context of the security and development nexus , as well as organising legal migration and fostering well - managed mobility and helping displaced persons and refugees with practical solutions in the context of the development and migration nexus .


### promoting energy security through e . g . diversification of sources and routes , considering price volatility issues , emission reduction potential , improving markets and fostering energy interconnections and trade . ### promoting energy security through e . g . diversification of sources and routes , considering price volatility issues , emission reduction potential , improving markets and fostering energy interconnections and open and fair trade .


### actions improving police cooperation and coordination between law enforcement authorities , including joint investigation teams and any other form of cross - border joint operation , the access to and exchange of information and interoperable technologies ; ### actions improving police cooperation , coordination between law enforcement authorities and inter - agency collaboration , including joint investigation teams and any other form of cross - border joint operation , the access to and exchange of information and interoperable technologies ;


### actions which fall within the scope of this regulation should respect fundamental rights and observe the principles acknowledged in particular by the charter of fundamental rights of the european union . such actions should be in conformity with any legal obligation and with ethical principles , which include avoiding any kind of plagiarism . ### actions which fall within the scope of this regulation shall respect fundamental rights and observe the principles acknowledged in particular by the charter of fundamental rights of the european union . such actions shall be in conformity with any legal obligation and with ethical principles , which include avoiding any kind of plagiarism .


### any proposal for research on human embryonic stem cells shall include , as appropriate , details of licensing and control measures that will be taken by the competent authorities of the member states as well as details of the ethical approvals that will be provided . as regards the derivation of human embryonic stem cells , institutions , organisations and researchers shall be subject to strict licensing and control in accordance with the legal framework of the member states involved . ### any proposal for research on human embryonic stem cells shall include details of licensing and control measures that will be taken by the competent authorities of the member states as well as details of the ethical approvals that will be provided , as appropriate . as regards the derivation of human embryonic stem cells , institutions , organisations and researchers shall be subject to strict licensing and control in accordance with the legal framework of the member states involved .


### the commission or the relevant funding body shall verify the financial capacity in advance only for coordinators when the requested funding from the union for the action is equal or superior to eur 500 000 , unless where , on the basis of available information , there are grounds to doubt the financial capacity of the coordinator or other participants . ### by means that are compatible with national law , the commission or the relevant funding body shall verify the financial capacity in advance only for coordinators when the requested funding from the union for the action is equal or superior to eur 100 000 , unless where , on the basis of available information , there are grounds to doubt the financial capacity of the coordinator or other participants . the commission shall provide a simple , user - friendly electronic tool to applicants to carry out their financial viability check .


### where results are capable of commercial or industrial application , the participant owning these results shall examine the possibility for protection and , if possible and justified given the circumstances , shall adequately protect them for an appropriate period of time and with an appropriate territorial coverage , having due regard to its legitimate interests and the legitimate interests , particularly the commercial interests , of the other participants in the action . ### where results are capable or may reasonably be expected to be capable of commercial or industrial application , the participant owning these results shall examine the possibility for protection and , if possible and justified given the circumstances , shall adequately protect them for an appropriate period of time and with an appropriate territorial coverage , having due regard to its legitimate interests and the legitimate interests , particularly the commercial interests , of the other participants in the action .


### where a participant that has received union funding intends not to protect results generated by it for reasons other than impossibility under union or national law or the lack of potential for commercial exploitation , and unless the participant intends to transfer them to another legal entity established in a member state or associated country in view of their protection , it shall inform the commission or funding body before any dissemination relating to these results takes place . the commission on behalf of the union or the funding body may assume ownership of these results and take the necessary steps for their adequate protection . ### where a participant that has received union funding intends not to protect results generated by it for reasons other than impossibility under union or national law or the lack of potential for commercial exploitation , and unless the participant intends to transfer them to another legal entity established in a member state or associated country in view of their protection , it shall inform the commission or funding body before any dissemination relating to these results takes place . the commission on behalf of the union or the funding body , with the consent of the owning participant , may assume ownership of these results and take the necessary steps for their adequate protection .


### where a participant that has received union funding intends to abandon the protection of results or not to seek extension of such protection for reasons other than the lack of potential for commercial exploitation , it shall inform the commission or the funding body which may continue or extend protection by assuming ownership thereof . the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . the grant agreement shall lay down time - limits in this respect . ### where a participant that has received union funding intends to abandon the protection of results or not to seek extension of such protection for reasons other than the lack of potential for commercial exploitation within five years following the end of the action , it shall inform the commission or the funding body which may , with the consent of the owning participant , continue or extend protection by assuming ownership thereof . the commission or the funding body shall take this decision within 45 days . the participant may refuse consent only if it demonstrates that its legitimate interests would suffer significant harm . the grant agreement shall lay down time - limits in this respect .


### each participant shall report to the commission or funding body on its exploitation and dissemination related activities . for the purposes of monitoring and dissemination by the commission or funding body , participants shall provide any information and documents useful in accordance with the conditions laid down in the grant agreement . ### during the duration of the action and for a period of one year after its end each participant , upon request by the commission , shall report to the commission or funding body on its exploitation and dissemination related activities . for the purposes of monitoring and dissemination by the commission or funding body , participants shall provide any information and documents useful in accordance with the conditions laid down in the grant agreement .


### provided that any access rights to the results can be exercised and that any additional exploitation obligations are complied with , the participant who owns results may grant licences or otherwise give the right to exploit them to any legal entity , including on an exclusive basis . ### provided that any access rights to the results can be exercised and that any additional exploitation obligations are complied with by the participant who owns results , the participant who owns results may grant licences or otherwise give the right to exploit the results to any legal entity , including on an exclusive basis . exclusive licences for results may be granted subject to written confirmation by all the other participants that they waive their access rights thereto .


### a participant shall enjoy access rights to background of another participant in the same action , if such access is needed by the former to exploit its results and subject to any restrictions or limits pursuant to article 43 . ### a participant shall enjoy access rights to background of another participant in the same action , if such background is needed by the former to exploit its own results and subject to any restrictions or limits pursuant to article 43 .


### an affiliated entity established in a member state or associated country shall , unless otherwise provided for in the consortium agreement , also have access rights to results or background under the same conditions if such access is needed to exploit the results generated by the participant to which it is affiliated . ### an affiliated entity shall , unless otherwise provided for in the consortium agreement , also have access rights to results or background under fair and reasonable conditions if such results or background are needed to exploit the results generated by the participant to which it is affiliated . such access shall be requested and obtained directly from the participant owning the results or background .


### in the case of actions to support existing or new research infrastructures , the grant agreement may lay down specific provisions relating to users of the infrastructure . ### in the case of actions to support the operation of existing or new research infrastructures , the grant agreement may lay down specific provisions relating to users ' access of the infrastructure .


### new psychoactive substances , which imitate the effects of substances scheduled under the un conventions , are emerging frequently and are spreading fast in the union . certain new psychoactive substances pose severe health , social and safety risks , as ascertained by [ regulation no … / … on new psychoactive substances ] . under that regulation , measures may be taken to prohibit the production , manufacture , making available on the market including importation to the union , transport , and exportation from the union of new psychoactive substances posing severe health , social and safety risks . to effectively reduce the availability of new psychoactive substances that pose severe risks to individuals and society , and to deter trafficking in those substances across the union , as well as the involvement of criminal organisations , permanent market restriction measures adopted under that regulation should be underpinned by criminal law provisions . ### new psychoactive substances , which imitate the effects of substances scheduled under the un conventions , are emerging frequently and are spreading fast in the union . certain new psychoactive substances pose severe health , social and safety risks , as ascertained by [ regulation no . . . / . . . on new psychoactive substances ] . under that regulation , measures may be taken to prohibit the production , manufacture , making available on the market including importation to the union , transport , and exportation from the union of new psychoactive substances posing severe health , social and safety risks . to effectively reduce the availability of new psychoactive substances that pose severe risks to individuals and society , and to deter trafficking in those substances , as well as the involvement of criminal organisations , permanent market restriction measures adopted under that regulation should be underpinned by national criminal law provisions .


### the new psychoactive substances subjected to permanent market restriction pursuant to [ regulation no … / … on new psychoactive substances ] should , therefore , be covered by the union criminal law provisions on illicit drug trafficking . this would also help streamline and clarify the union legal framework , as the same criminal law provisions would apply to substances covered by the un conventions and to the most harmful new psychoactive substances . the definition of ‘ drug’ in the framework decision 2004 / 757 / jha should , therefore , be amended . ### the new psychoactive substances subjected to permanent market restriction pursuant to [ regulation no . . . / . . . on new psychoactive substances ] should , therefore , be covered by the relevant national criminal law provisions on illicit drug trafficking . this would afford member states the necessary flexibility to respond to the unique challenges of each country . the definition of ' drug ' in the framework decision 2004 / 757 / jha should , therefore , be amended in such a way as to facilitate this flexibility .


### in order to swiftly address the emergence and spread of harmful new psychoactive substances in the union , member states should apply the provisions of the framework decision 2004 / 757 / jha to new psychoactive substances posing severe health , social and safety risks within twelve months from their submission to permanent market restriction under [ regulation no … / … on new psychoactive substances ] . ### in order to swiftly address the emergence and spread of harmful new psychoactive substances in the union , member states should amend national criminal law in order to apply to new psychoactive substances posing severe health , social and safety risks within twelve months from their submission to permanent market restriction under [ regulation no … / … on new psychoactive substances ] .


### to this end , it is necessary to list examples of signs which may constitute a trade mark , provided that such signs are capable of distinguishing the goods or services of one undertaking from those of other undertakings . in order to fulfil the objectives of the registration system for trade marks , which are to ensure legal certainty and sound administration , it is also essential to require that the sign is capable of being represented in a manner which allows for a precise determination of the subject of protection . a sign should therefore be permitted to be represented in any appropriate form , and thus not necessarily by graphic means , as long as the representation offers satisfactory guarantees to that effect . ### to this end , it is necessary to list examples of signs which may constitute a trade mark , provided that such signs are capable of distinguishing the goods or services of one undertaking from those of other undertakings . in order to fulfil the objectives of the registration system for trade marks , which are to ensure legal certainty and sound administration , it is also essential to require that the sign is capable of being represented in a manner which is clear , precise , self - contained , easily accessible , durable and objective . a sign should therefore be permitted to be represented in any appropriate form , and thus not necessarily by graphic means , as long as the representation offers satisfactory guarantees to that effect .


### member states shall ensure that the offices cooperate with each other and with the agency in order to promote convergence of practices and tools and achieve coherent results in the examination and registration of trade marks . ### member states shall ensure that the offices cooperate with each other and with the agency in order to promote convergence of practices and tools .


### with the exception of article 59 , the requirements of this regulation shall not apply to devices classified as class a , b and c , in accordance with the rules set out in annex vii , and manufactured and used only within a single health institution , provided manufacture and use occur solely under the health institution ' s single quality management system , and the health institution is compliant with standard en iso 15189 or any other equivalent recognised standard . member states may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements . ### with the exception of article 59 , the requirements of this regulation shall not apply to devices classified manufactured and used only within a single health institution , provided manufacture and use occur solely under a single quality management system , and the health institution is accredited to standard en iso 15189 or any other equivalent recognised standard . health institutions shall provide to their competent authority a list of such devices which shall include justification of their use , in particular where equivalent devices have been made available on the market . this information shall be made public . member states may also make the manufacture and use of the devices concerned subject to further safety requirements .


### the reporting member state shall submit part i of the assessment report , including its conclusion , to the sponsor and to the other member states concerned within the following time periods : ### for the purposes of this chapter , the assessment date shall be the date on which the assessment report is submitted to the other member states concerned and the reporting date shall be the date when the final assessment report is submitted to the sponsor and to the other member states concerned . the reporting member state shall submit part i of the assessment report , including its conclusion , to the sponsor and to the other member states concerned within the following time periods , which shall include periods for initial assessment , for joint assessment and for consolidation of the final report .


### within 10 days from the validation date for low - intervention clinical trials ; ### within 10 days from the validation date for low - intervention clinical trials ; the time for the joint assessment and for consolidation by member states concerned and the reporting member state shall not be shorter than 5 days ;


### within 25 days from the validation date for clinical trials other than low - intervention clinical trials ; ### within 25 days from the validation date for clinical trials other than low - intervention clinical trials ; the time for the joint assessment and for consolidation by member states concerned and the reporting member state shall not be shorter than 10 days ;


### within 30 days from the validation date for any clinical trial with an advanced therapy investigational medicinal product . ### within 30 days from the validation date for any clinical trial with an advanced therapy investigational medicinal product ; the time for the joint assessment and for consolidation by member states concerned and reporting member state shall not be shorter than 10 days .


### until the assessment date , any member state concerned may communicate to the reporting member state any considerations relevant to the application . the reporting member state shall take those considerations duly into account . ### until the assessment date the reporting member state shall develop and circulate to the member states concerned an initial assessment report . no later than 2 days before the reporting date , the member states concerned may communicate to the reporting member state and all other member states concerned any considerations relevant to the application . the reporting member state shall take those considerations duly into account in finalising the assessment report .


### where , upon receipt of the additional explanations , the remaining time period for submitting part i of the assessment report is less than three days in the case of low - intervention clinical trials , and less than five days for other than low - intervention clinical trials , it shall be extended to three and five days respectively . ### upon receipt of the additional explanations the member states concerned shall communicate until two days before the reporting date , any considerations to the reporting member state . the reporting member state will take these considerations into account in finalising the assessment report . the time for the joint assessment and for consolidation by member states concerned and the reporting member state of the additional explanations shall not be shorter than 5 days for low intervention trials and 10 days for trials other than low - intervention clinical trials .


### the reporting member state for the application referred to in paragraph 1 shall be the reporting member state for the initial authorisation procedure . ### where there was a reporting member state for the initial authorisation procedure it shall be the reporting member state for the application referred to in paragraph 1 .


### due to the urgency of the situation , caused by a sudden life - threatening or other sudden serious medical condition , it is impossible to obtain prior informed consent from the subject and it is impossible to supply prior information to the subject ; ### due to the urgency of the situation , caused by a sudden life - threatening or other sudden serious medical condition , it is impossible to obtain prior informed consent from the subject or its legal representative and it is impossible to supply prior information to the subject or its legal representative ;


### the subject has not previously expressed objections known to the investigator ; ### the subject or legal representative has not previously expressed objections known to the investigator ;


### – protecting commercially confidential information ; ### – protecting commercially confidential information in particular through taking into account the authorization status of the product ;


### the delegation of power referred to in article 3 , article 5 , the third subparagraph of article 17 , articles 19 , 19 and 19 shall be conferred on the commission for an indeterminate period of time from [ the date of entry into force of this directive ] . ### the delegation of power referred to in article 5 , the third subparagraph of article 17 , articles 19 and 19 shall be conferred on the commission for a period of 5 years from [ publications office is to fill in the date of entry into force of this amending act ] . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of five - year period . the delegation of power shall be tacitly extended for periods of identical duration unless the european parliament or council opposes such an extension not later than 3 months before the end of each period .


### those prohibitions or requirements should neither apply to small quantities of plants , plant products and other objects , other than plants for planting , for non - commercial and non - professional purposes nor to the introduction into and movement within frontier zones of plants , plant products and other objects . nor should they apply to the introduction into and movement within the union territory of plants , plant products and other objects for scientific purposes , trials , varietal selection , breeding and exhibitions . proper safeguards should be set and information should be provided to those concerned . ### those prohibitions or requirements should neither apply to small quantities of plants , plant products and other objects for non - commercial and non - professional purposes nor to the introduction into and movement within frontier zones of plants , plant products and other objects . nor should they apply to the introduction into and movement within the union territory of plants , plant products and other objects for scientific purposes , trials , varietal selection , breeding and exhibitions . proper safeguards should be set and information should be provided to those concerned .


### professional operators operating at more than one premise should be given the possibility to register separately for each of those premises . ### professional operators operating at more than one premise should be given the possibility to register separately for each of those premises but should not be required to do so .


### certain operators may desire to establish a phytosanitary risk management plan , ensuring and demonstrating a high level of competence and awareness as regards phytosanitary risks as regards critical points in their professional activities and justifying special control arrangements with the competent authorities . union rules should be established concerning the contents of those plans . ### certain authorised operators may desire to establish a phytosanitary risk management plan , ensuring and demonstrating a high level of competence and awareness as regards phytosanitary risks as regards critical points in their professional activities and justifying special control arrangements with the competent authorities . union rules should be established concerning the contents of those plans .