### there are significant differences in the national rules governing the functioning of collecting societies , in particular as regards their transparency and accountability towards their members and rightholders . beyond the difficulties non - domestic rightholders face when exercising their rights and the too often poor financial management of the revenues collected , problems with the functioning of collecting societies lead to inefficiencies in the exploitation of copyright and related rights across the internal market to the detriment of the members of collecting societies , rightholders and users alike . these difficulties do not arise in the functioning of independent rights management service providers who act as agents for rightholders for the management of their rights on a commercial basis and in which rightholders do not exercise membership rights . ### there are significant differences in the national rules governing the functioning of collecting societies , in particular as regards their transparency and accountability towards their members and rightholders , which makes for fragmentation of the internal market in this sector . beyond the difficulties non - domestic rightholders face when exercising their rights and the too often poor financial management of the revenues collected , problems with the functioning of collecting societies lead to inefficiencies in the exploitation of copyright and related rights across the internal market to the detriment of the members of collecting societies , rightholders and users alike , for whom it is too complicated to assert their rights in other member states . these difficulties do not arise in the functioning of independent rights management service providers who act as agents for rightholders for the management of their rights on a commercial basis and in which rightholders do not exercise membership rights .


### having the freedom to provide and to receive collective management services across national borders entails that rightholders are able to freely choose the collecting society for the management of their rights , such as public performance or broadcasting rights , or categories of rights , such as interactive communication to the public , provided the collecting society already manages such rights or categories of rights . this implies that rightholders can easily withdraw their rights or categories of rights from a collecting society and entrust or transfer all or part of them to another collecting society or another entity irrespective of the member state of residence or the nationality of either the collecting society or the rightholder . collecting societies managing different types of works and other subject matter , such as literary , musical or photographic works , should also allow this flexibility to rightholders as regards the management of different types of works and other subject matter . collecting societies should inform rightholders of this choice and allow them to exercise it as easily as possible . finally , this directive should not prejudice the possibilities of rightholders to manage their rights individually , including for non - commercial uses . ### having the freedom to receive services for collective management of copyright and related rights across national borders entails that rightholders are able to freely choose the collective management organisation for the management of their rights , such as public performance or broadcasting rights , or categories of rights , such as interactive communication to the public , provided the collective management organisation already manages such rights or categories of rights . this implies that rightholders can easily withdraw their rights or categories of rights from a collective management organisation and entrust or transfer all or part of them to another collective management organisation or another entity irrespective of the member state of residence or the nationality of either the collective management organisation or the rightholder . collective management organisations managing different types of works and other subject matter , such as literary , musical or photographic works , should also allow this flexibility to rightholders as regards the management of different types of works and other subject matter . collective management organisations should inform rightholders of this choice and allow them to exercise it as easily as possible . finally , this directive should not prejudice the possibilities of rightholders to manage their rights individually , including for non - commercial uses .


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


### broadcasting organisations generally rely on a licence from a local collecting society , for their own broadcasts of television and radio programmes which include musical works . this licence is often limited to broadcasting activities . a licence for online rights in musical works would be required in order to allow such television or radio broadcasts to be also available online . to facilitate the licensing of online music rights for the purposes of simultaneous and delayed transmission online of television and radio broadcasts , it is necessary to provide for a derogation from the rules that would otherwise apply to the multi - territorial licensing of musical works for online uses . such derogation should be limited to what is necessary to allow access to television or radio programmes online and to material having a clear and subordinate relationship to the original broadcast produced for purposes such as supplementing , previewing or reviewing that television or radio programme . that derogation should not operate so as to distort competition with other services which give consumers access to individual musical or audiovisual works online , or lead to restrictive practices , such as market or customer sharing , in breach of articles 101 or 102 of the treaty on the functioning of the european union . ### broadcasting organisations generally rely on a blanket licence from a local collecting society for the rights to the world repertoire of musical works in order to communicate and make available to the public their own television and radio programmes and online services related to their broadcasts , such as material which supplements , enriches or otherwise expands on the broadcaster ' s programme offerings . such blanket licences for broadcasters respond to an actual need , are well established and generally accepted by right holders , broadcasters and collecting societies alike . this directive should therefore maintain that established practice so as to avoid the application of different rules for the licensing of broadcasters ' offline and online services . for this reason it is necessary to exempt collecting societies from the application of title iii when they license online services to broadcasters that are related to their offline broadcast services . this should not operate so as to distort competition with other services which give consumers access to individual musical works online , or lead to restrictive practices , such as market or customer sharing , and should remain in compliance with national and eu law , in particular articles 101 or 102 of the treaty on the functioning of the european union .


### it is necessary to ensure the effective enforcement of the provisions of the national law adopted pursuant to this directive . collecting societies should offer their members specific procedures for the handling of complaints and the resolution of disputes . these procedures should also be made available to other rightholders represented by the collecting society . it is also appropriate to ensure that member states have independent , impartial and effective dispute resolution bodies capable of settling commercial disputes between collecting societies and users on existing or proposed licensing conditions as well as on situations in which the granting of a licence is refused . furthermore , the effectiveness of the rules on the multi - territorial licensing of online rights in musical works could be undermined if disputes between collecting societies and their counterparts were not solved quickly and efficiently by independent and impartial bodies . as a result , it is appropriate to provide , without prejudice to the right of access to a tribunal , for an easily accessible , efficient and impartial out - of - court procedure for resolving conflicts between collecting societies , on the one hand , and online music service providers , rightholders or other collecting societies , on the other . ### it is necessary to ensure the effective enforcement of the provisions of the national law adopted pursuant to this directive . collecting societies should offer their members specific procedures for the handling of complaints and the resolution of disputes . these procedures should also be made available to other rightholders represented by the collecting society . it is also appropriate to ensure that member states have independent , impartial and effective dispute resolution bodies capable of settling commercial disputes between collecting societies and users on existing or proposed licensing conditions as well as on situations in which the granting of a licence is refused . furthermore , the effectiveness of the rules on the multi - territorial licensing of online rights in musical works could be undermined if disputes between collecting societies and their counterparts were not solved quickly and efficiently by independent and impartial bodies . as a result , it is appropriate to provide , without prejudice to the right of access to a tribunal , for an easily accessible , efficient and impartial out - of - court procedure for resolving conflicts between collecting societies , on the one hand , and online music service providers , rightholders or other collecting societies , on the other . these dispute resolution bodies should have special knowledge of intellectual property matters and they should base their decisions on objective standards and criteria , such as the ' fair value in trade ' established by the cjeu . in order to secure payment , users should be required to make payments to the collective management organisations , while the process is pending , according to the existing tariff where such tariff exists or based on an interim order by the court where no pre - existing applicable tariff is set .


### ' collecting society ' means any organisation which is authorised by law or by way of assignment , licence or any other contractual arrangement , by more than one rightholder , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or controlled by its members ; ### a ' collective management organisation ' is any non - profit organisation , which is authorised by law or by way of assignment , licence or any other contractual arrangement , by more than one rightholder , to manage copyright or rights related to copyright as its sole or main purpose and which is owned or directly or indirectly controlled by its rightholders ;


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


### member states shall ensure that the collecting society regularly and diligently distributes and pays amounts due to all rightholders it represents . the collecting society shall carry out such distribution and payments no later than 12 months from the end of the financial year in which the rights revenue was collected , unless objective reasons related in particular to reporting by users , the identification of rights , rightholders or to the matching of information on works and other subject matter with rightholders prevent the collecting society from respecting this deadline . the collecting society shall carry out such distribution and payments accurately , ensuring equal treatment of all categories of rightholders . ### member states shall ensure that the collecting society regularly and diligently distributes and pays amounts due to all rightholders it represents and this on the basis of the information provided by users within 6 months after the use of the content . the collecting society shall carry out such distribution and payments no later than 12 months from the end of the financial year in which the rights revenue was collected , unless objective reasons related in particular to reporting by users , the identification of rights , rightholders or to the matching of information on works and other subject matter with rightholders prevent the collecting society from respecting this deadline . the collecting society shall carry out such distribution and payments accurately , ensuring equal treatment of all categories of rightholders .


### tariffs for exclusive rights shall reflect the economic value of the rights in trade and of the service provided by the collecting society . ### tariffs for exclusive rights and rights to equitable remuneration shall reflect the economic value of the rights in trade and the economic benefit that users derive from the collective management of rights .


### in the absence of any national law which establishes the amounts due to rightholders in respect of a right to remuneration and a right to compensation , the collecting society shall base its own determination of those amounts due , on the economic value of those rights in trade . ### in the absence of any national law which establishes the amounts due to rightholders in respect of a right to compensation , the collective management organisation shall base its own determination of those amounts due , on the economic value of those rights in trade .


### dispute resolution for users ### dispute resolution with users


### member states shall ensure that disputes between collecting societies and users concerning existing and proposed licensing conditions , tariffs , and any refusal to grant a licence can be submitted to a court , and if appropriate , to an independent and impartial dispute resolution body . ### member states shall ensure that disputes between collecting societies and users concerning existing and proposed licensing conditions , tariffs , and any refusal to grant a licence or to comply with its terms can be submitted to a court , and if appropriate , to an independent and impartial dispute resolution body . member states shall ensure that these dispute resolution bodies are specialised in intellectual property matters and that their decisions are made on the basis of the criteria set out in article 15 .


### member states shall provide that their respective competent authorities may take appropriate administrative sanctions and measures where the provisions of the national provisions adopted in the implementation of this directive have not been complied with , and shall ensure that they are applied . the sanctions and measures shall be effective , proportionate and dissuasive . ### member states shall ensure that competent authorities have the power to impose appropriate sanctions on collective management organisations and to take appropriate measures where the provisions of national law adopted in the implementation of this directive have not been complied with . these sanctions and measures shall be effective and proportionate .


### ‘ activity dependent on the passing of the seasons’ means an activity that is tied to a certain time of the year by an event or pattern during which labour levels are required that are far above those necessary for usually ongoing operations ; ### ‘ activity dependent on the passing of the seasons’ means an activity that is tied to a certain time of the year by an event or pattern during which labour levels are required that are far above those necessary for usually ongoing operations ; the member states should be given a possibility to define the sectors to which the directive is applied .


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


### the mandatory equipping of vehicles with the ecall in - vehicle system should initially apply only to new passenger cars and light commercial vehicles for which an appropriate triggering mechanism already exists . ### the mandatory equipping of vehicles with the 112 - based ecall in - vehicle system should initially apply only to new types of passenger cars and light commercial vehicles for which an appropriate triggering mechanism already exists . the possibility of extending the application of the ecall in - vehicle system requirement in the near future to include other vehicle categories , such as heavy goods vehicles , buses and coaches , and powered two - wheelers should be further assessed by the commission with a view to presenting a legislative proposal .


### according to the recommendations made by the article 29 data protection working party and contained in the ' working document on data protection and privacy implications in ecall initiative ' , adopted on 26 september 20069 , any processing of personal data through the ecall in - vehicle system should comply with the personal data protection rules provided for in directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data10 and in directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector 11 , in particular to guarantee that vehicles equipped with ecall in - vehicle systems , in their normal operational status related to 112 ecall , are not traceable and are not subject to any constant tracking and that the minimum set of data sent by the in - vehicle ecall system includes the minimum information required for the appropriate handling of emergency calls . __________________ 9 1609 / 06 / en – wp 125 . 10 oj l 281 , 23 . 11 . 1995 , p . 31 . 11 oj l 201 , 31 . 7 . 2002 , p . 37 . ### according to the recommendations made by the article 29 data protection working party and contained in the ' working document on data protection and privacy implications in ecall initiative ' , adopted on 26 september 20069 , any processing of personal data through the ecall in - vehicle system should comply with the personal data protection rules provided for in directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data10 and in directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector , in particular to guarantee that vehicles equipped with ecall in - vehicle systems , in their normal operational status related to 112 ecall , are not traceable and are not subject to any constant tracking and that the minimum set of data sent by the in - vehicle ecall system includes the minimum information required for the handling of emergency calls by public service answering points . __________________ 9 1609 / 06 / en – wp 125 . 10 oj l 281 , 23 . 11 . 1995 , p . 31 . 11 oj l 201 , 31 . 7 . 2002 , p . 37 .


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


### this regulation establishes the technical requirements for the ec type - approval of vehicles regarding the ecall in - vehicle system . ### this regulation establishes the technical requirements for the ec type - approval of vehicles regarding the 112 - based ecall in - vehicle system and private ecall services .


### ' e - call in - vehicle system ' means a system activated either automatically via in - vehicle sensors or manually , which carries , by means of mobile wireless communications networks , a standardised minimum set of data and establishes a 112 - based audio channel between the occupants of the vehicle and a public safety answering point ; ### ' 112 - based ecall in - vehicle system ' or ' public ecall ' means a sleeping system activated either automatically via in - vehicle sensors or manually , which carries , by means of public mobile wireless communications networks , a standardised minimum set of data and establishes a 112 - based audio channel between the occupants of the vehicle and a public safety answering point ;


### manufacturers shall demonstrate that all their new types of vehicle are constructed to ensure that in the event of a severe accident which occurs in the territory of the union , an ecall to the single european emergency number 112 is triggered automatically . ### manufacturers shall demonstrate that all their new types of vehicle are constructed to ensure that in the event of a severe accident , detected through activation of one or more sensors and / or processors within the vehicle , which occurs in the territory of the union , an ecall to the emergency number 112 is triggered automatically .


### manufacturers shall demonstrate that new vehicles are constructed as to ensure that an ecall to the single european emergency number 112 can also be triggered manually . ### manufacturers shall demonstrate that new types of vehicles are constructed as to ensure that an ecall to the single european emergency number 112 can also be triggered manually .


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


### the ecall in - vehicle system shall be accessible to all independent operators free of charge and without discrimination at least for repair and maintenance purposes . ### the 112 - based ecall in - vehicle system shall be accessible to all independent operators free of charge and without discrimination at least for repair and maintenance purposes .


### the minimum set of data sent by the ecall in - vehicle system shall include only the minimum information required for the appropriate handling of emergency calls . ### the minimum set of data sent by the ecall in - vehicle system shall include only the minimum information required for the appropriate handling of emergency calls . this msd should be reviewed periodically for revaluation of optional msd to mandatory msd , or for the possible addition of beneficial information to the msd .


### the minimum set of data sent by the ecall in - vehicle system shall include only the minimum information required for the appropriate handling of emergency calls . ### the minimum set of data sent by the public 112 - based ecall system to psaps shall include only the minimum information required for the appropriate handling of emergency calls by psaps .


### manufacturers shall ensure that ecall users are provided with clear and comprehensive information about the processing of data carried out through the ecall in - vehicle system , in particular about : ### manufacturers shall ensure that ecall users can freely choose from among services supplied by ecall service providers and are provided with clear and comprehensive information , by those providers , about the processing of data carried out through the private ecall system , in particular about :


### any necessary additional information regarding the processing of personal data in relation to the provision of a private ecall service and / or other added value services . ### any necessary additional information regarding the processing of personal data in relation to the provision of a private ecall service and / or other added value services , taking particular account of the fact that differences may exist between the data processing carried out through the ecall in - vehicle system and the private ecall systems or other added value service , especially with regard to constant tracking of the vehicle .


### exemptions ### exemptions and retrofitting


### in view of the significant increase in the numbers and severity of natural and man - made disasters in recent years and in a situation where future disasters are likely to be more extreme and more complex with far reaching and longer - term consequences , resulting , in particular , from climate change and potential interaction between several natural and technological hazards , an integrated approach to disaster management is increasingly important . the union should support , coordinate and supplement actions of member states in the field of civil protection with a view to improving the effectiveness of systems for preventing , preparing for and responding to natural and man - made disasters . ### in view of the significant increase in the numbers and severity of natural and man - made disasters in recent years , and in a situation where future disasters are likely to be more extreme and more complex with far reaching and longer - term consequences , resulting , in particular , from climate change , which has a disproportionate effect on developing countries , and potential interaction between several natural and technological hazards , an integrated approach to disaster management is increasingly important . the union should support , coordinate and supplement actions of member states in the field of civil protection with a view to improving the effectiveness of systems for preventing , preparing for and responding to natural and man - made disasters .


### with respect to disaster response assistance interventions outside the union , the mechanism should facilitate and support actions undertaken by the member states and the union as a whole in order to promote consistency in international civil protection work . the united nations , where present , has an overall coordinating role for relief operations in third countries . assistance provided under the mechanism should be coordinated with the united nations and other relevant international actors to maximise the use of available resources and avoid any unnecessary duplication of effort . enhanced coordination of civil protection assistance through the mechanism is a prerequisite to supporting the overall coordination effort and ensuring a comprehensive union contribution to the overall relief effort . in major disasters where assistance is provided under both the mechanism and council regulation no 1257 / 96 of 20 june 1996 concerning humanitarian aid , the commission shall ensure the effectiveness , coherence and complementarities of the overall union response respecting the european consensus on humanitarian aid . ### with respect to disaster response assistance interventions outside the union , the mechanism should facilitate and support actions undertaken by the member states and the union as a whole in order to promote consistency in international civil protection work . the majority of the union’s civil protection mechanism interventions take place outside the union , mainly in developing countries . the united nations , where present , has an overall coordinating role for relief operations in third countries . assistance provided under the mechanism should be coordinated with the united nations and other relevant international actors to maximise the use of available resources , and avoid any unnecessary duplication of effort . enhanced coordination of civil protection assistance through the mechanism is a prerequisite to supporting the overall coordination effort and ensuring a comprehensive union contribution to the overall relief effort . in major disasters where assistance is provided under both the mechanism and council regulation no 1257 / 96 of 20 june 1996 concerning humanitarian aid , the commission shall ensure the effectiveness , coherence and complementarities of the overall union response respecting the european consensus on humanitarian aid .


### where the use of military capacities is considered in support of civil protection operations to be appropriate , cooperation with the military should follow the modalities , procedures and criteria established by the council or its competent bodies for making available to the mechanism military capacities relevant to the protection of civilian populations . ### the use of military resources may constitute essential support for humanitarian operations in response to natural disasters . where the use of military capacities – as a last resort – is considered in support of civil protection operations to be appropriate , cooperation with the military must follow the modalities , procedures and criteria established by the council or its competent bodies for making available to the mechanism military capacities relevant to the protection of civilian populations , as well as the ‘ guidelines on the use of foreign military and civil defence assets in disaster relief’ and the ‘ guidelines on the use of military and civil defence assets to support united nations humanitarian activities in complex emergencies’ .


### ' disaster ' means any situation , which has or may have an adverse impact on people , the environment or property ; ### ' disaster ' means any situation &#8211 ; whether of man - made origin or resulting from natural phenomena &#8211 ; which has or may have an adverse impact on people , the environment or property ;


### the commission and the member states shall identify and ensure synergies between in - kind assistance and humanitarian aid funding provided by the union and member states in the planning of response operations outside the union . ### the commission and the member states shall identify and ensure synergies between in - kind assistance and humanitarian aid funding provided by the union and member states in the planning of response operations outside the union and in tackling humanitarian crises .


### member states and the commission shall ensure an appropriate visibility of the interventions of the european emergency response capacity . ### the eu shall clearly display its presence and its actions ; member states and the commission shall ensure an appropriate visibility of the interventions of the european emergency response capacity both on individuals and on vehicles , by displaying , in particular , the national and european emblems .


### setting up a programme of lessons learned from the interventions , exercises and trainings conducted within the framework of the mechanism , including relevant prevention , preparedness and response aspects , disseminating these lessons and implementing them as appropriate ; ### setting up a programme of lessons learned from the interventions , including outside the union , exercises and trainings conducted within the framework of the mechanism , including relevant prevention , preparedness and response aspects , disseminating these lessons and implementing them as appropriate ;


### liaising with all relevant actors , in particular in the closing phase of the assistance intervention under the mechanism , to facilitate a smooth handover ; ### liaising with all relevant actors , in particular in the closing phase of the assistance intervention under the mechanism , to facilitate a smooth handover ; contributing to strengthening the link between emergency measures , rehabilitation and development with humanitarian and development operators ;


### synergies shall be sought with other instruments of the union , in particular , with actions financed under regulation no 1257 / 96 . ### synergies shall be sought with other instruments of the union , in particular , with actions financed under council regulation no 1257 / 96 of 20 june 1996 concerning humanitarian aid . actions under this decision that may be eligible for funding under this decision shall not receive financing under the said regulation concerning humanitarian aid .


### the financial reference amount for the implementation of this decision for the period 2014 to 2020 shall be eur 513 000 000 at current prices . eur 276 000 000 at current prices shall derive from heading 3 ' security and citizenship ' of the financial framework and eur 237 000 000 at current prices from heading 4 ' global europe . ' ### the financial reference amount for the implementation of this decision for the period 2014 to 2020 shall be [ . . . ] at current prices . 50 % of this amount shall derive from heading 3 ' security and citizenship ' of the financial framework and 50 % from heading 4 ' global europe . '


### synergies and complementarity shall be sought with other instruments of the union . in the case of a response in third countries , the commission shall ensure the complementarity and coherence of actions financed under this decision and actions financed under regulation no 1257 / 96 . ### synergies and complementarity shall be sought with other instruments of the union . in the case of a response in third countries to tackle a humanitarian crisis , the commission shall ensure the complementarity and coherence of actions financed under this decision and actions financed under regulation no 1257 / 96 .


### when assistance under the mechanism contributes to a wider union humanitarian response , actions receiving financial assistance under this decision shall be consistent with the humanitarian principles referred to in the european consensus on humanitarian aid . ### when assistance under the mechanism contributes to a union humanitarian response , particularly in complex emergencies , actions receiving financial assistance under this decision shall be consistent with the humanitarian principles referred to in the european consensus on humanitarian aid . use of european emergency response capacity resources must be based on the needs identified and must be in compliance with the principles on the use of civil protection and military resources and equipment as formulated in the european consensus on humanitarian aid .


### financial assistance referred to in articles 20 and article 21 to may also be granted to countries coming under the european neighbourhood policy as well as potential candidate countries not participating in the mechanism . ### financial assistance referred to in articles 20 and article 21 to may also be granted to countries coming under the european neighbourhood policy , potential candidate countries not participating in the mechanism and , as proposed by the rapporteur , the least developed developing countries , on a case by case basis and in accordance with the strategy for supporting disaster risk reduction in developing countries1 . _______________ 1 communication from the commission to the council and the european parliament : eu strategy for supporting disaster risk reduction in developing countries , 23 . 2 . 2009 . com0084 final .


### producer organisations are the key actors for the appropriate application of the common fisheries policy and the common market organisation . it is therefore necessary to strengthen their objectives to ensure that their members carry out fishing and aquaculture activities in a sustainable manner , improve the placing on the market of products , and collect economic information on aquaculture . when realising these objectives , producer organisations should take account the different conditions of the fishery and aquaculture sectors prevailing in the union , in particular the specificities of small - scale fisheries . ### producer organisations are the key actors for the appropriate application of the common fisheries policy and the common market organisation . it is therefore necessary to strengthen their objectives to ensure that their members carry out fishing and aquaculture activities in a sustainable manner , improve the placing on the market of products , and collect economic information on aquaculture . when realising these objectives , producer organisations should take account of the different conditions of the fishery and aquaculture sectors prevailing in the union , especially as regards the outermost regions , which should be accorded differentiated treatment tailored to their specificities , and of the specificities of small - scale fisheries .


### it is appropriate to lay down competition rules applicable to the production and marketing of fishery and aquaculture products , taking into account the specific features of the fishery and aquaculture sector , including fragmentation of the sector , the fact that fish is a shared resource and the large extent of imports . for the sake of simplification , the relevant provisions of regulation no 1184 / 2006 of 24 july 2006 applying certain rules of competition to the production of and trade in certain agricultural products should be incorporated into the present regulation . regulation no 1184 / 2006 should therefore no longer apply to fishery and aquaculture products . ### it is appropriate to lay down competition rules applicable to the production and marketing of fishery and aquaculture products , taking into account the specific features of the fishery and aquaculture sector , including fragmentation of the sector , the fact that fish is a shared resource and the large extent of imports , which should be governed by the same rules as union fishery and aquaculture products . for the sake of simplification , the relevant provisions of regulation no 1184 / 2006 of 24 july 2006 applying certain rules of competition to the production of and trade in certain agricultural products should be incorporated into this regulation . regulation no 1184 / 2006 should therefore no longer apply to fishery and aquaculture products .


### in order to be able to supplement or amend the conditions and requirements for recognition of producers organisations , supplement or amend the content of the production and marketing plan , define and amend the common marketing standards , supplement or amend mandatory information and set minimum criteria for information voluntarily provided by operators to the consumers , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of articles 24 , 33 , 41 and 46 . ### in order to be able to establish rules that may concern the internal functioning of producer organisations , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of article 24 .


### measures deployable by fishery producer organisations ### measures to be deployed by fishery producer organisations


### fishery producer organisations may make use of the following measures to achieve the objectives set out in article 7 : ### fishery producer organisations shall make use of the following measures to achieve the objectives set out in article 7 :


### – distributing landed products free of charge to philanthropic or charitable purposes . ### – distributing landed products to philanthropic or charitable purposes .


### channelling the supply and the marketing of members ' products ; ### concentrating the supply and the marketing of their members ' products ;


### coordinating and developing activities of common interest for the member producer organisations . ### coordinating and developing activities of common interest for the member producer organisations , including the improved marketing of products for consumers .


### promoting union fishery and aquaculture products in a non - discriminatory manner by using the potential of certification , in particular designations of origin , quality seals , geographical designations and sustainability merits ; ### promoting union fishery and aquaculture products in a non - discriminatory manner by using the potential of certification , in particular designations of origin , quality seals , geographical designations and sustainability merits , making provision for a clear identification of union products by comparison with imported products ;


### improving quality , knowledge of and the transparency of production and the market ; ### improving quality , knowledge of and the transparency of production and the market , as well as product traceability and food safety ;


### in order to ensure that the conditions for recognition of producer organisations or inter - branch organisations laid down in articles 17 and 18 are complied with , the commission may carry out checks and may , where appropriate , request that member states withdraw the recognition of producer organisations or inter - branch organisations . ### in order to ensure that the conditions for recognition of producer organisations or inter - branch organisations laid down in articles 17 and 18 are complied with , the commission may carry out checks and shall , where appropriate , request that member states withdraw the recognition of producer organisations or inter - branch organisations .


### the commission shall be empowered to adopt delegated acts in accordance with article 50 to ### the commission shall be empowered to adopt delegated acts in accordance with article 50 to lay down rules which may concern the internal functioning of producer organisations or inter - branch organisations , their rules of association , financial and budgetary provisions , obligations for their members and enforcement of the application of the rules including penalties ;


### the products for which marketing standards have been laid down may be marketed for human consumption in the union only in accordance with those standards . ### the products for which marketing standards have been laid down may be marketed in the union only in accordance with those standards .


### fishery and aquaculture products referred to in points , , and of annex i which are marketed within the union , irrespective of their origin , may only be offered for retail to the final consumer where appropriate marking or labelling indicates : ### fishery and aquaculture products referred to in points , , and of annex i which are marketed within the union , irrespective of their origin , may only be offered for retail to the final consumer where appropriate marking or labelling includes the mandatory food information specified in chapter iv of regulation no 1169 / 2011 of the european parliament and of the council , of 25 october 2011 , on the provision of food information to consumers . 1a . the marking or labelling shall also indicate the following :


### the area where the product was caught or farmed ; ### the product’s provenance , i . e . where it was caught or farmed ;


### indication of the catch or production area ### indication of the catch , rearing or cultivation area


### the indication of the catch or production area in accordance with article 42 , paragraphs 1 and 2 shall consist of the following : ### the indication of the catch or production area in accordance with article 42 , paragraph 1 shall consist of the following :


### the indication of the catch or production area in accordance with article 42 , paragraphs 1 and 2 shall consist of the following : ### the indication of products ' provenance , i . e . where they were caught or farmed , in accordance with article 42 , paragraphs 1 and 2 shall consist of the following :


### in the case of fishery products caught in freshwater , a reference to the member state or third country of provenance of the product ; ### in the case of fishery products caught in freshwater , a reference to the member state or third country of catch of the product ;


### in addition to the mandatory information required pursuant to article&#160 ; 42 , the following information may be provided on a voluntary basis : ### in addition to the mandatory information required pursuant to article&#160 ; 42 , the following information may be provided on a voluntary basis , on condition that it is presented in a clear and unambiguous manner :


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


### organised criminal groups operate without borders and increasingly acquire assets in other member states and in third countries . there is an increasing need for effective international law enforcement cooperation on asset recovery and mutual legal assistance . ### organised criminal groups operate without borders and increasingly acquire assets in other member states and in third countries . there is an increasing need for effective international law enforcement cooperation on asset recovery and mutual legal assistance . the adoption of minimum rules will harmonise the member state ' s freezing and confiscation regimes facilitating mutual trust and effective cross - border cooperation .


### 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 proceeds 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 and therefore require harmonisation , not least in order to ensure full and complete performance of the confiscation itself .


### 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 , both based on a conviction or in the absence of criminal conviction , 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 .


### the issuance of confiscation orders generally requires a criminal conviction . in some cases , even where a criminal conviction cannot be achieved , it should still be possible to confiscate assets in order to disrupt criminal activities and ensure that profits resulting from criminal activities are not reinvested into the licit economy . some member states allow confiscation where there is insufficient evidence for a criminal prosecution , if a court considers on the balance of probabilities that the property is of illicit origin , and also in situations where a suspect or accused person becomes a fugitive to avoid prosecution , is unable to stand trial for other reasons or died before the end of criminal proceedings . this is referred to as non - conviction based confiscation . provision should be made to enable non - conviction based confiscation in at least the latter , limited , circumstances in all member states . this is in line with article 54 . 1 . c ) of the united nations convention against corruption , which provides that each state party is to consider taking the necessary measures to allow confiscation of illicitly acquired property without a criminal conviction , including in cases in which the offender cannot be prosecuted by reason of death , flight or absence . ### the issuance of confiscation orders generally requires a criminal conviction . in some cases non - conviction based confiscation should be possible in order to disrupt criminal activities and ensure that profits resulting from criminal activities are not reinvested into the licit economy .


### property frozen with a view to later confiscation should be managed adequately in order not to lose its economic value . member states should take the necessary measures including sale or transfer of the property to minimise such losses . member states should take relevant measures , such as the establishment of national centralised asset management offices or equivalent mechanisms , in order to properly manage the assets frozen before confiscation and preserve their value , pending judicial determination . ### property frozen with a view to later confiscation should be managed adequately in order not to lose its economic value . member states should take the necessary measures , including transfer of the property , to minimise such losses . member states should take all relevant measures , be these legislative or otherwise , such as the establishment of national centralised asset management offices or equivalent mechanisms , in order to properly manage the assets frozen before confiscation and preserve their value , pending judicial determination .


### 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 it to confiscate all instrumentalities and proceeds following a final conviction for a criminal offence .


### 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 it to confiscate , either wholly or in part , instrumentalities , assets and proceeds following 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 it to confiscate all property belonging to a person convicted of a criminal offence where , based on specific facts , a court finds that the property in question has been derived by the convicted person from similar criminal activities and not from any other activities .


### 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 of the convicted person , which was transferred to third parties in order to avoid confiscation of property , of a value equivalent to the proceeds , profits or value of the crime .


### 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 a percentage amount lower than their market value when the third party :


### each member state shall take the necessary measures to enable it to freeze property in danger of being dissipated , hidden or transferred out of the jurisdiction with a view to possible later confiscation . such measures shall be ordered by a court . ### each member state shall take the necessary measures to enable it to freeze property in danger of being dissipated , hidden or transferred out of the jurisdiction with a view to possible later confiscation . such measures shall be ordered by a court . it includes the introduction of non - conviction based confiscation , with full respect of the rights of the defence and of bona fide third parties , and that they can be challenged before a court .


### each member state shall take the necessary measures to enable it to freeze property in danger of being dissipated , hidden or transferred out of the jurisdiction with a view to possible later confiscation . such measures shall be ordered by a court . ### each member state shall take the necessary measures to enable it to freeze property without delay where there is a danger of its being dissipated , hidden or transferred out of the jurisdiction with a view to possible later confiscation , or where there is reason to suppose that the conditions for confiscation are met . such measures shall require an order by the competent national authority , which shall be obtained without delay following the freezing of the property , except where the property consists of movable items , in which case an order shall be required only where it applied for by the person affected . the person affected by the measures under this article shall have a right to contest the order and appeal against it to a court .


### each member state shall take the necessary measures to ensure that the persons affected by the measures provided for under this directive have the right to an effective remedy and that suspects have the right to a fair trial , in order to preserve their rights . ### each member state shall take the necessary measures to ensure that the persons affected by the measures provided for under this directive have the full right to an effective remedy , including the full right to a fair trail and the possibility to appeal the decision .


### each member state shall take the necessary measures , such as the establishment of national centralised offices or equivalent mechanisms , to ensure the adequate management of property frozen with a view of possible later confiscation . ### each member state shall take the necessary measures , such as the establishment of national centralised offices or equivalent mechanisms , to ensure the adequate management of property frozen with a view to possible later confiscation , and shall provide for the possibility of confiscated property being used for social purposes .


### member states shall regularly collect and maintain comprehensive statistics from the relevant authorities in order to review the effectiveness of their confiscation systems . the statistics collected shall be sent to the commission each year and shall include for all criminal offences : ### member states shall regularly collect and maintain comprehensive statistics from the relevant authorities in order to review the effectiveness of their confiscation systems . the statistics collected shall be sent to the commission each year and shall include for all criminal offences falling within the scope of this directive :


### draft legislative resolution ### recalls its resolution of 8 june 2011 on ' investing in the future : a new multiannual financial framework for a competitive , sustainable and inclusive europe ' 1 ; reiterates that sufficient additional resources are needed in the next mff in order to enable the union to fulfil its existing policy priorities and the new tasks provided for in the treaty of lisbon , as well as to respond to unforeseen events ; challenges the council , if it does not share this approach , to clearly identify which of its political priorities or projects could be dropped altogether , despite their proven european added value ; _________________ 1 texts adopted , p7_ta0266 .


### the union also aims to ensure coherence with other areas of its external action . this should be ensured when formulating the union ' s development cooperation policy and its strategic planning programming and implementation of measures . ### the union also aims to ensure coherence with other areas of its external action as well as its internal policies . this should be ensured when formulating the union ' s development cooperation policy and its strategic planning programming and implementation of measures .


### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , nondiscrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids . ### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , entrepreneurship , rights of workers , environmental protection , gender equality , women empowerment , nondiscrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids .


### in implementing this regulation , consistency shall be ensured with other areas of union external action and with other relevant union policies . to this end , measures financed under this regulation , including those managed by the eib , shall be based on the cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the third countries and regions concerned , and on the union ' s decisions , specific interests , policy priorities and strategies . ### in implementing this regulation , consistency shall be ensured with other areas of union external action , including other relevant instruments for external action where applicable , and with other relevant union policies . to this end , measures financed under this regulation , including those managed by the eib , shall be based on the cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the third countries and regions concerned , and on the union ' s decisions , specific interests , policy priorities and strategies .


### in implementing this regulation , consistency shall be ensured with other areas of union external action and with other relevant union policies . to this end , measures financed under this regulation , including those managed by the eib , shall be based on the cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the third countries and regions concerned , and on the union’s decisions , specific interests , policy priorities and strategies . ### in implementing this regulation , consistency shall be ensured with other areas of union external action and with other relevant union internal and external policies . to this end , measures financed under this regulation , including those managed by the eib , shall be based on the cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the third countries and regions concerned , and on the union’s decisions , specific interests , policy priorities and strategies .


### the commission and the member states shall seek regular and frequent exchanges of information , including with other donors , and promote better donor coordination and complementarity by working towards joint multiannual programming , based on partner countries ' poverty reduction or equivalent strategies , by common implementation mechanisms including shared analysis , by joint donor - wide missions and by the use of co - financing and delegated cooperation arrangements . ### the commission and the member states shall seek regular and frequent exchanges of information , including with other donors , and promote better donor consistency , coordination and complementarity by working towards joint multiannual programming , based on partner countries ' poverty reduction or equivalent strategies , by common implementation mechanisms including shared analysis , by joint donor - wide missions and by the use of co - financing and delegated cooperation arrangements .


### the commission and the member states shall seek regular and frequent exchanges of information , including with other donors , and promote better donor coordination and complementarity by working towards joint multiannual programming , based on partner countries ' poverty reduction or equivalent strategies , by common implementation mechanisms including shared analysis , by joint donor - wide missions and by the use of co - financing and delegated cooperation arrangements ### the commission and the member states shall seek regular and frequent exchanges of information , including with other international , regional and local donors , and promote better donor coordination and complementarity by working towards joint multiannual programming , based on partner countries ' poverty reduction or equivalent strategies , by common implementation mechanisms including shared analysis , by joint donor - wide missions and by the use of co - financing and delegated cooperation arrangements .


### within their respective spheres of competence , the union and the member states shall promote a multilateral approach to global challenges and , where appropriate , foster cooperation with international organisations and bodies and other bilateral donors . ### within their respective spheres of competence , the union and the member states shall promote a multilateral approach to global challenges and , where appropriate , foster cooperation with local , national and international organisations and bodies and other bilateral donors .


### effective and innovative cooperation modalities and instruments as set out in article 4 of the common implementing regulation , such as blending grants and loans and other risk - sharing mechanisms in selected sectors and countries and private - sector engagement , in line with oecd / dac best practices . these modalities and instruments shall be adapted to the particular circumstances of each partner country or region , with a focus on programme - based approaches , on delivery of predictable aid funding , on the mobilisation of private resources , on the development and use of country systems and on results - based approaches to development including , where appropriate , internationally agreed targets and indicators such as those of the mdgs ; and ### effective and innovative cooperation modalities and instruments as set out in article 4 of the common implementing regulation in line with oecd / dac best practices and based on the common union standards and best practices on the use of union funds and reporting , as laid down in the financial rules and other relevant union legislation . these modalities and instruments shall be adapted to the particular circumstances of each partner country or region , with a focus on programme - based approaches , on delivery of predictable aid funding , on the mobilisation of private resources , on the development and use of country systems and on results - based approaches to development including , where appropriate , internationally agreed targets and indicators such as those of the mdgs ; and


### improved impact of policies and programming through coordination and harmonisation between donors to reduce overlap and duplication , to improve complementarity and to support donor - wide initiatives . ### improved impact of policies and programming through coordination , consistency and harmonisation between donors to create synergies and avoid overlap and duplication , to improve complementarity and to support donor - wide initiatives .


### consistent with the overall purpose and scope , objectives and general principles of this regulation , actions undertaken through thematic programmes shall add value to and , be complementary to , actions funded under geographic programmes . ### consistent with the overall purpose and scope , objectives and general principles of this regulation , actions undertaken through thematic programmes shall add value to and , be complementary to , actions funded under geographic programmes . thematic support offered to the countries eligible for geographical support shall not be contradictory to the priority areas set up for those countries .


### the actions address global initiatives supporting internationally agreed goals , or global public goods and challenges , in which case , by way of derogation from article 9 of the common implementing regulation , they may include actions in member states , candidate countries and potential candidates and other third countries , as envisaged in the relevant thematic programme ; ### the actions address global initiatives supporting internationally agreed goals , or global public goods and challenges , in which case they may include actions in member states , candidate countries and potential candidates , and in other third countries by way of derogation from article 9 of the common implementing regulation , as envisaged in the relevant thematic programme ;


### the objective of the programme on civil society organisations and local authorities in development shall be to finance initiatives in the area of development by or for civil society organisations and local authorities originating from partner countries , the union , candidate countries and potential candidates . ### the objective of the programme on civil society organisations and local authorities in development shall be to finance initiatives in the area of development by or for local authorities and civil society organisations originating from partner countries , candidate countries and potential candidates .


### the commission shall adopt the implementing measures laid down in article 2 of the common implementing regulation on the basis of the programming documents referred to in articles 11 and 13 . in particular circumstances , however , union support may also take the form of measures not covered in these documents , as provided for in the common implementing regulation . ### the commission shall adopt the implementing measures laid down in article 2 of the common implementing regulation on the basis of the programming documents referred to in articles 11 and 13 . in particular circumstances , however , union support may also take the form of individual and special measures not covered in these documents , as provided for in the common implementing regulation .


### the union and its member states shall consult each other , and other donors and development actors including representatives of civil society and regional and local authorities , at an early stage of the programming process in order to promote complementarity and consistency among their cooperation activities . this consultation may lead to joint programming between the union and its member states . ### the union and its member states shall consult each other , and other donors and development actors including representatives of civil society and regional and local authorities , at an early stage of the programming process in order to promote coherence , complementarity and consistency among their cooperation activities . this consultation may lead to joint programming between the union and its member states .


### the union and its member states shall consult each other , and other donors and development actors including representatives of civil society and regional and local authorities , at an early stage of the programming process in order to promote complementarity and consistency among their cooperation activities . this consultation may lead to joint programming between the union and its member states . ### the union and its member states shall consult each other , and other donors and development actors including representatives of civil society and regional and local authorities , at an early stage of the programming process in order to promote complementarity and consistency among their cooperation activities . this consultation shall lead to joint programming between the union and its member states .


### the commission shall determine the multiannual indicative allocations within each geographic programme in accordance with the general principles of this regulation , based on the criteria laid down in article 3 , and taking into account , alongside the specificity of the different programmes , the particular difficulties faced by countries or regions that are in crisis , vulnerable , fragile , in conflict or disaster prone . ### without prejudice to the powers of the budgetary authority , the commission shall determine the multiannual indicative allocations within each geographic programme in accordance with the general principles of this regulation , based on the criteria laid down in article 3 , and taking into account , alongside the specificity of the different programmes , the particular difficulties faced by countries or regions that are in crisis , vulnerable , fragile , in conflict or disaster prone .


### multiannual indicative programmes shall set out the priority areas selected for union financing , the specific objectives , the expected results , the performance indicators and the indicative financial allocation , both overall and per priority area . where appropriate , this allocation may be given in the form of a range and / or some funds may be left unallocated . ### multiannual indicative programmes shall set out the priority areas selected for union financing , the specific objectives , the expected results , clear , specific and transparent performance indicators and , without prejudice to the prerogatives of the budgetary authority , lay down the indicative financial allocation , both overall and per priority area , broken down by year . where appropriate , this allocation may be given in the form of a range , with a variation of not more than 10% of the lower amount of the programme , and / or some funds may be left unallocated .


### multiannual indicative programmes for thematic programmes shall set out the union ' s strategy for the theme concerned , the priorities selected for financing by the union , the specific objectives , the expected results , the performance indicators , the international situation and the activities of the main partners . where applicable , resources and intervention priorities shall be laid down for participation in global initiatives . multiannual indicative programmes shall be consistent with the documents referred to in article 11 . ### multiannual indicative programmes for thematic programmes shall set out the union ' s strategy for the theme concerned , the priorities selected for financing by the union , the specific objectives , the expected results , clear , specific and transparent performance indicators , the international situation and the activities of the main partners . where applicable , resources and intervention priorities shall be laid down for participation in global initiatives . multiannual indicative programmes shall be consistent with the documents referred to in article 11 .


### the multiannual indicative programmes shall give the indicative financial allocation , both overall and by priority area . where appropriate , this allocation may , be given in the form of a range , and / or some funds may be left unallocated . multiannual indicative programmes should be adjusted where necessary for an effective policy implementation , taking into account any mid - term or ad hoc reviews . ### without prejudice to the prerogatives of the budgetary authority , the multiannual indicative programmes , shall give the indicative financial allocation , both overall and by priority area , broken down by year . where appropriate , this allocation may , be given in the form of a range , with a variation of no more than 10% of the lower amount of the programme , and / or some funds may be left unallocated . multiannual indicative programmes should be adjusted where necessary for an effective policy implementation , taking into account any mid - term or ad hoc reviews .


### the procedure referred to in paragraph 1 shall not apply to non - substantial modifications to strategy papers and multiannual indicative programmes , making technical adjustments , reassigning funds within the indicative allocations per priority area , or increasing or decreasing the size of the initial indicative allocation by less than 20% , provided that these modifications do not affect the priority areas and objectives set out in these documents . in such case , adjustments shall be communicated to the european parliament and to the council within one month . ### the procedure referred to in paragraph 1 shall not apply to non - substantial modifications to strategy papers and multiannual indicative programmes , making technical adjustments , reassigning funds within the indicative allocations per priority area , or increasing or decreasing the size of the initial indicative allocation by less than 20% , provided that these modifications do not affect the priority areas and objectives set out in these documents . in such case , adjustments shall be communicated to the european parliament and to the council within one month . if the total amount of non - substantial amendments or their budgetary impact exceeds the thresholds for small - scale financing , as stipulated in article 2 of the common implementing regulation , the procedure referred to in article 15 of the said regulation shall apply .


### the procedure referred to in paragraph 1 shall not apply to non - substantial modifications to strategy papers and multiannual indicative programmes , making technical adjustments , reassigning funds within the indicative allocations per priority area , or increasing or decreasing the size of the initial indicative allocation by less than 20% , provided that these modifications do not affect the priority areas and objectives set out in these documents . in such case , adjustments shall be communicated to the european parliament and to the council within one month . ### the procedure referred to in paragraph 1 shall not apply to non - substantial modifications to strategy papers and multiannual indicative programmes , making technical adjustments , reassigning funds within the indicative allocations per priority area , or increasing or decreasing the size of the initial indicative allocation within the relevant percentage limit set out in article 2 of the common implementing regulation , provided that these modifications do not affect the priority areas and objectives set out in these documents . in such case , adjustments shall be communicated to the european parliament and to the council within one month .


### without prejudice to the provisions on suspension of aid in partnership and cooperation agreements with partner countries and regions , where a partner country fails to observe the principles referred to in article 3 , the union shall invite the partner country to hold consultations in view of finding a solution acceptable to both parties , except in cases of special urgency . where consultations with the partner country do not lead to a solution acceptable to both parties , or if consultations are refused or in cases of special urgency , the council may take appropriate measures in accordance with article 215 of the treaty on the functioning of the european union , which may include full or partial suspension of union assistance . ### without prejudice to the provisions on suspension of aid in partnership and cooperation agreements with partner countries and regions , where a partner country fails to observe the principles referred to in article 3 , the union shall invite the partner country to hold consultations in view of finding a solution acceptable to both parties , except in cases of special urgency . where consultations with the partner country do not lead to a solution acceptable to both parties , or if consultations are refused or in cases of special urgency , the council may take appropriate measures in accordance with article 215 of the treaty on the functioning of the european union , which may include full or partial suspension of union assistance . the european parliament shall be fully and immediately informed of any decision taken in this respect .


### as referred to in article 13 , paragraph 2 of the ' erasmus for all ' regulation , in order to promote the international dimension of higher education , an indicative amount of eur 1 812 100 000 from the different external instruments , will be allocated to actions of learning mobility to or from non eu countries and to cooperation and policy dialogue with authorities / institutions / organisations from these countries . the provisions of the ' erasmus for all ' regulation will apply to the use of those funds . ### as referred to in article 13 , paragraph 2 of the ' erasmus for all ' regulation , in order to promote the international dimension of higher education , an indicative amount corresponding to 2% of the financial allocations available for the participating instruments , will be allocated to actions of learning mobility to or from non eu countries and to cooperation and policy dialogue with authorities / institutions / organisations from these countries . the provisions of the ' erasmus for all ' regulation will apply to the use of those funds .


### in a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust . ### in a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust . the interests of the participants should always take priority over other interests .


### in a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust . ### in a clinical trial the safety , rights and well - being of subjects should be protected and the data generated should be relevant , reliable and robust .


### the procedure should be flexible and efficient , in order to avoid administrative delays for starting a clinical trial . ### the procedure should be flexible and efficient , in order to avoid administrative delays for starting a clinical trial , without compromising patient safety or public health .


### the timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file , while ensuring quick access to new , innovative treatments and ensuring that the union remains an attractive place for conducting clinical trials . against this background , directive 2001 / 20 / ec introduced the concept of tacit authorisation . this concept should be maintained in order to ensure that timelines are adhered to . in the event of a public health crisis , member states should have the possibility to assess and authorise a clinical trial application swiftly . no minimal timelines for approval should therefore be established . ### the timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file , while ensuring quick access to new , innovative treatments and ensuring that the union remains an attractive place for conducting clinical trials . against this background , directive 2001 / 20 / ec introduced the concept of tacit authorisation . this concept should be maintained in order to ensure that timelines are adhered to . if a member state concerned and a reporting member state do not produce the assessment report , the assessment or the decision within the set deadlines , the concept of tacit authorisation should apply automatically . in the event of a public health crisis , member states should have the possibility to assess and authorise a clinical trial application swiftly . no minimal timelines for approval should therefore be established .


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


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


### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval . ### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent administrative rules , such as shorter deadlines for approval .


### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval . ### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ minimal - risk clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . given that minimal - risk clinical trials have only a very limited and temporary adverse effect – if any – on the subject’s health , they should be subject to less stringent rules , such as shorter deadlines for approval . they should , however , be subject to the vigilance and traceability rules governing normal clinical practice .


### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval . ### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ' low - intervention clinical trials ' are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval , without compromising scientific excellence , and guaranteeing patient safety at all times .


### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . this decision is a matter of internal organisation of each member state . member states , when determining the appropriate body or bodies , should ensure the involvement of lay persons and patients . they should also ensure that the necessary expertise is available . in any case , however , and in accordance with international guidelines , the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . the persons assessing the application should be independent from the sponsor , the institution of the trial site , and the investigators involved , as well as free of any other undue influence . ### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . these bodies should be established according to the ich topic e 6 guideline for good clinical practice , which details the responsibilities , composition , functions , operations and procedures . this decision is a matter of internal organisation of each member state . member states , when determining the appropriate body or bodies , should ensure the involvement of lay persons and patients . they should also ensure that the necessary expertise is available . in any case , however , and in accordance with international guidelines , the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . the persons assessing the application should be independent from the sponsor , the institution of the trial site , and the investigators involved , as well as free of any other undue influence .


### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . this decision is a matter of internal organisation of each member state . member states , when determining the appropriate body or bodies , should ensure the involvement of lay persons and patients . they should also ensure that the necessary expertise is available . in any case , however , and in accordance with international guidelines , the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . the persons assessing the application should be independent from the sponsor , the institution of the trial site , and the investigators involved , as well as free of any other undue influence . ### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . this decision is a matter of internal organisation of each member state . however , irrespective of the organisation of the assessment process and the bodies involved , member states should make sure that the assessment is entirely completed within the deadlines provided for in this regulation and that no further assessment can prevent the sponsor from starting the clinical trial after the notification of the decision granting the authorisation .


### the sponsor should be allowed to withdraw the application for authorisation of a clinical trial . to ensure the reliable functioning of the assessment procedure , however , an application for authorisation of a clinical trial should be withdrawn only for the entire clinical trial . it should be possible for the sponsor to submit a new application for authorisation of a clinical trial following the withdrawal of an application . ### the sponsor should be allowed to withdraw the application for authorisation of a clinical trial . to ensure the reliable functioning of the assessment procedure , however , an application for authorisation of a clinical trial should be withdrawn only for the entire clinical trial . it should be possible for the sponsor to submit a new application for authorisation of a clinical trial following the withdrawal of an application , provided that the new application contains explanations regarding any previous withdrawals .


### in order to increase transparency in the area of clinical trials , clinical trial data submitted in support of a clinical trial application should be based only on clinical trials recorded in a publicly accessible database . ### in order to increase transparency in the area of clinical trials , clinical trial data submitted in support of a clinical trial application should be based only on clinical trials recorded in a publicly and easily accessible database without imposing any cost on the access to the database .


### the human dignity and right to the integrity of the person are recognized in the charter of fundamental rights of the european union . in particular , the charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned . directive 2001 / 20 / ec contained an extensive set of rules for the protection of subjects . these rules should be upheld . regarding the rules concerning the determination of the legal representative of incapacitated persons and minors , those rules diverge in member states . it should therefore be left to member states to determine the legal representative of incapacitated persons and minors . ### the human dignity and right to the integrity of the person are recognized in the charter of fundamental rights of the european union . in particular , the charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned . subjects from vulnerable population groups such as incapacitated subjects , minors or other vulnerable people , require additional protection measures . directive 2001 / 20 / ec contained an extensive set of rules for the protection of subjects including children and incapacitated subjects . in addition , specific rules to be applied to the paediatric population have been stated in the ethical recommendation . these rules should be upheld and further integrated in order to cover all the vulnerable groups . regarding the rules concerning the determination of the legal representative of incapacitated persons and minors , those rules diverge in member states . it should therefore be left to member states to determine the legal representative of incapacitated subjects and minors .