### action programmes and individual measures provided for in paragraph 1 for which the union ' s financial assistance exceeds eur 10 million and special measures for which the union ' s financial assistance exceeds eur 30 million shall be adopted in accordance with the examination procedure referred to in article 15 . ### action programmes , individual measures , special measures and support measures provided for in paragraph 1 of this article and in article 3 , for which the union ' s financial assistance exceeds eur 10 million shall be adopted in accordance with the examination procedure referred to in article 15 .


### that procedure shall not be required for action programmes and measures below the above - mentioned thresholds , and for non substantial amendments thereto . non - substantial amendments are technical adjustments such as extending the implementation period , reassigning funds within the forecast budget , or increasing or reducing the size of the budget by less than 20 % of the initial budget , provided these amendments do not substantially affect the objectives of the initial action programme or measure . in such case , action programmes and measures and non - substantial amendments thereto shall be communicated to the european parliament and to the council within one month of their adoption . ### that procedure shall not be required for non - substantial amendments to action programmes and measures below the above - mentioned threshold . non - substantial amendments are technical adjustments such as extending the implementation period , reassigning funds within the forecast budget , or increasing or reducing the size of the budget by less than 20 % of the initial budget , provided these amendments do not substantially affect the objectives of the initial action programme or measure . in such case , action programmes and measures and non - substantial amendments thereto shall be communicated to the european parliament and to the council within two weeks of their adoption .


### on duly justified imperative grounds of urgency , such as crises , post crisis and fragility situations or threats to democracy , the rule of law , human rights or fundamental freedoms , the commission may adopt immediately applicable implementing acts , including amendments to existing action programmes and measures , in accordance with the procedure referred to in article 15 . ### on duly justified imperative grounds of urgency , such as military , institutional or humanitarian crises , or threats to democracy , the rule of law , human rights or fundamental freedoms , the commission may adopt immediately applicable implementing acts , including amendments to existing action programmes and measures , in accordance with the procedure referred to in article 15 . the commission shall notify the european parliament of its decision within 24 hours of the adoption of the implementing act .


### appropriate environmental screening , including for climate change and biodiversity impacts , shall be undertaken at project level including where applicable environmental impact assessment for environmentally sensitive projects , in particular for major new infrastructure . where relevant , strategic environmental assessments shall be used in the implementation of sectoral programmes . the involvement of interested stakeholders in environmental assessments and public access to the results shall be ensured . ### appropriate environmental screening , including for climate change and biodiversity impacts , shall be undertaken at project level including where applicable environmental impact assessment for environmentally sensitive projects , in particular for new infrastructure . where relevant , strategic environmental assessments shall be used in the implementation of sectoral programmes . the involvement of interested stakeholders in environmental assessments and public access to the results shall be ensured . development impact assessments shall also be undertaken at project level to ensure that policy coherence for development and aid effectiveness principles are effectively incorporated into project design and selection .


### union financing may cover expenditure for the implementation of the instruments and for the achievement of their objectives , including administrative support associated with the preparation , follow - up , monitoring , audit and evaluation activities directly necessary for such implementation , as well as expenditure at union delegations on the administrative support needed to manage operations financed under the instruments . ### union financing may cover expenditure for the implementation of the instruments and for the achievement of their objectives ; this concerns administrative support associated with the preparation , follow - up , monitoring , audit and evaluation activities directly necessary for such implementation , as well as expenditure at union delegations on the administrative support needed to manage operations financed under the instruments .


### provided that the activities listed in points , and are related to the general objectives of the applicable instrument implemented through the action , union financing may cover ### provided that the activities listed in points , and are related to the specific objectives of the applicable instrument implemented through the action , union financing may cover


### the union ' s financial assistance may be provided , inter alia , through the following types of financing envisaged by the financial regulation : ### the union ' s financial assistance may be provided through the following types of financing envisaged by the financial regulation :


### contributions to trust funds set up by the commission ; ### contributions to trust funds set up by the commission , provided that contributions from a specific instrument will only be used for the achievement of the objectives of that instrument ;


### the union ' s financial assistance may also be provided , in accordance with the financial regulation , through contributions to international , regional or national funds , such as those established or managed by the european investment bank , international organisations , member states or by partner countries and regions , for attracting joint financing from a number of donors , or to funds set up by one or more donors for the purpose of the joint implementation of projects . ### the union ' s financial assistance may also be provided , in accordance with the financial regulation , through contributions to international , regional or national funds , such as those established or managed by the european investment bank , international organisations , member states or by partner countries and regions , for attracting joint financing from a number of donors , or to funds set up by one or more donors for the purpose of the joint implementation of projects . the participation of non - eu international financial institutions to eu financial investment instruments , such as blending mechanisms , shall be conditional on their acceptance of eu standards and policies , and on the opening up of access for eu financial institutions to the shareholders ' funds of these institutions .


### the types of financing referred to in paragraph 1 and in article 6 , and the methods of implementation referred to in paragraph 3 , shall be chosen on the basis of their ability to achieve the specific objectives of the actions , taking into account , inter alia , the costs of controls , the administrative burden , and the expected risk of non - compliance . for grants , this shall include a consideration of the use of lump sums , flat rates and scales of unit costs . ### the types of financing referred to in paragraph 1 and in article 6 , and the methods of implementation referred to in paragraph 3 , shall be chosen on the basis of their ability to achieve the specific objectives of the actions , taking into account the costs of controls , the administrative burden , and the expected risk of non - compliance . for grants , this shall include a consideration of the use of lump sums , flat rates and scales of unit costs .


### while having recourse to a type of financing referred to in paragraph 1 or article 6 , cooperation between the union and its partners may take the form , inter alia , of ### while having recourse to a type of financing referred to in paragraph 1 or article 6 , cooperation between the union and its partners may take the form of


### all supplies and goods purchased under a procurement contract , or in accordance with a grant agreement , financed under this regulation shall originate from an eligible country . however , they may originate from any country when the use of the competitive negotiated procedure is allowed . for the purposes of this regulation , the term ‘ origin’ is defined in the relevant union legislation on rules of origin for customs purposes . ### all supplies and goods , including the goods , works and services covered by the oecd - dac good procurement practices , purchased under a procurement contract , or in accordance with a grant agreement , financed under this regulation shall originate from an eligible country . the use of country procurement systems should be the default option when a country included in the dac list of oda recipients of the oecd is the recipient of said grant . however , they may originate from any country when the use of the competitive negotiated procedure is allowed . for the purposes of this regulation , the term ‘ origin’ is defined in the relevant union legislation on rules of origin for customs purposes .


### where the financial regulation provides for discretion in the choice of the contractor , priority shall be given where appropriate to local and regional procurement . ### where the financial regulation provides for discretion in the choice of the contractor , priority shall be given to local and regional procurement .


### by way of derogation from all other rules , eligibility as defined in this title may be restricted with regard to the nationality , localisation or nature of applicants , where required by the nature and the objectives of the action and as necessary for its effective implementation . such restrictions may apply in particular to the participation in awarding procedures in the case of cross - border cooperation actions . ### in exceptional and duly justified cases , eligibility as defined in this title may be restricted with regard to the nationality , localisation or nature of applicants , where required by the specific nature and objectives of the action and as necessary for its effective implementation .


### developing countries and territories , as defined as defined by the development assistance committee of the organisation for economic cooperation and development , which are not members of the g - 20 group , , and overseas countries and territories covered by council decision [ 2001 / 822 / ec of 27 november 2001 ] ; ### developing countries and territories , as included in the dac list of oda recipients published by the development assistance committee of the organisation for economic cooperation and development , and overseas countries and territories covered by council decision [ 2001 / 822 / ec of 27 november 2001 ] ;


### a member state of the oecd - dac , in the case of contracts implemented in a least developed country , as defined by the oecd - dac . ### a member state of the oecd , in the case of contracts implemented in a least developed country or a highly indebted poor country , as included in the dac list of oda recipients published by the oecd - dac .


### countries having traditional economic , trade or geographical links with neighbouring beneficiary countries , or ### countries having traditional economic , trade or geographical links with neighbouring beneficiary countries or regions , or


### the commission shall regularly monitor and review its actions , and evaluate the results of the implementation of sectoral policies and actions , and the effectiveness of programming , where appropriate by means of independent external evaluations , in order to ascertain whether the objectives have been met and to enable it to formulate recommendations with a view to improving future operations . ### the commission shall regularly monitor and review its actions , and evaluate the results of the implementation of sectoral policies and actions , and the effectiveness of programming , where appropriate by means of independent external evaluations , in order to ascertain whether the objectives have been met and to enable it to formulate recommendations with a view to improving future operations . these evaluations shall be carried out on the basis of pre - defined , clear , transparent and measurable indicators . proposals by the european parliament or the council for independent external evaluations will be taken into due account .


### the commission shall send its evaluation reports to the european parliament and to the council for information . member states may request to discuss specific evaluations in the committees referred to in article 15 . the results shall feed back into programme design and resource allocation . ### the commission shall send its evaluation reports to the european parliament and to the council . the european parliament and member states may request to discuss specific evaluations in the committees referred to in article 15 . the results shall feed back into programme design and resource allocation .


### the commission shall associate to an appropriate extent all relevant stakeholders in the evaluation phase of the union assistance provided under this regulation . ### the commission shall associate all relevant stakeholders , including non - state actors and local authorities , in the evaluation phase of the union assistance provided under this regulation .


### the biennal report shall contain information relating to the previous year on the measures financed , the results of monitoring and evaluation exercises , the involvement of the relevant partners , and the implementation of budgetary commitments and of payments appropriations . it shall assess the results of the union ' s financial assistance , using as far as possible , specific and measurable indicators of its role in meeting the objectives of the instruments . ### the biennial report shall contain information relating to the previous year on the measures financed , the results of monitoring and evaluation exercises , the involvement of all relevant partners , and the implementation of budgetary commitments and of payments appropriations . it shall assess , with a view of achieving the objectives of each instrument , the complementarity and synergies between the instruments financed under the eu budget , and assess the results of the union ' s financial assistance , on the basis of pre - defined , clear , transparent and measurable indicators . for the dci and for all actions related to climate change , the report shall also clearly demonstrate the leverage effect of funds leveraged through the private sector , as well as their contribution to poverty eradication and their alignment to aid effectiveness principles , or , in the case of climate finance , their conformity to unfccc priority areas and commitments .


### the funding allocated in the context of the instruments shall be subject to an annual tracking system based on the oecd methodology , integrated into the existing methodology for performance management of eu programmes , to quantify the expenditure related to climate action and biodiversity at the level of the action programmes , individual and special measures referred to in article 2 , and recorded within evaluations and biennal reports . an annual estimate of the overall spending related to climate action and biodiversity shall be made on the basis of the adopted indicative programming documents . ### the funding allocated in the context of the instruments shall be subject to an annual tracking system based on the oecd methodology , integrated into the existing methodology for performance management of eu programmes , to quantify the expenditure related to climate action and biodiversity at the level of the action programmes , individual and special measures referred to in article 2 , and recorded within evaluations and biennial reports . an annual estimate of the overall spending related to climate action and biodiversity , as well as a separate calculation of the funds provided and to be provided to developing countries for climate change mitigation and adaption in accordance with the union’s international commitments , shall be made on the basis of the adopted strategic programming documents .


### the adopted decision shall remain in force for the duration of the adopted or modified document , action programme or measure . ### the adopted decision shall remain in force for a period to be indicated in the adopted or modified document , action programme or measure , but not exceeding six months from its adoption .


### review and evaluation of the instruments ### mid - term review and evaluation of the instruments


### no later than 31 december 2017 , a report shall be established by the commission on the achievement of the objectives of each of the instruments by means of result and impact indicators measuring the efficiency of the use of resources and the european added value of the instruments , in view of a decision on the renewal , modification or suspension of the types of actions implemented under the instruments . the report shall , in addition , address the scope for simplification , internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities for smart , sustainable and inclusive growth . it shall take into account any findings and conclusions on the long - term impact of the instruments . ### no later than 31 march 2017 , the commission shall submit to the european parliament and the council a report evaluating the implementation of each instrument and of this regulation in the first three years , and on the achievement of the objectives by means of result and impact indicators measuring the efficiency of the use of resources and the added value of the instruments , in view of a decision on the renewal , modification or suspension of the types of actions implemented under the instruments . the report shall , in addition , address the scope for simplification , internal and external coherence , including policy coherence for development , as well as the continued relevance of all objectives . it shall take into account any findings and conclusions on the long - term impact of the instruments .


### it shall apply from 1 january 2014 . ### it shall apply from 1 january 2014 to 31 december 2020


### 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 europe1 ; 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 ; points out that even with an increase in the level of resources for the next mff of at least 5% compared to the 2013 level only a limited contribution can be made to the achievement of the union’s agreed objectives and commitments and the principle of union solidarity ; 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 european parliament has called for a radical simplification of union research and innovation funding in its resolution of 11 november 2010 , has highlighted the importance of the innovation union to transform europe for post - crisis world , in its resolution of 12 may 2011 , has drawn attention to important lessons to be learned following the interim evaluation of the seventh framework programme in its resolution of 8 june 2011 and has supported the concept of a common strategic framework for research and innovation funding in its resolution of 27 september 2011 . ### the european parliament has called for a radical simplification of union research and innovation funding in its resolution of 11 november 2010 , has highlighted the importance of the innovation union to transform europe for post - crisis world , in its resolution of 12 may 2011 , has drawn attention to important lessons to be learned following the interim evaluation of the seventh framework programme in its resolution of 8 june 2011 and has supported the concept of a common strategic framework for research and innovation funding and has called for doubling of the budget for research and innovation in the next mff compared to the seventh framework programme in its resolution of 27 september 2011 .


### horizon 2020 - the framework programme for research and innovation in the european union , focuses on three priorities , namely generating excellent science in order to strengthen the union ' s world - class excellence in science , fostering industrial leadership to support business , including small and medium - sized enterprises and innovation and tackling societal challenges , in order to respond directly to the challenges identified in the europe 2020 strategy by supporting activities covering the entire spectrum from research to market . horizon 2020 should support all stages in the innovation chain , especially activities closer to the market including innovative financial instruments , as well as non - technological and social innovation , and aims to satisfy the research needs of a broad spectrum of union policies by placing emphasis on the widest possible use and dissemination of knowledge generated by the supported activities up to its commercial exploitation . the priorities of horizon 2020 should also be supported through a programme under the euratom treaty on nuclear research and training . ### horizon 2020 - the framework programme for research and innovation in the european union , focuses on three priorities , namely generating excellent science in order to strengthen the union ' s world - class excellence in science , fostering industrial leadership to support business , including small and medium - sized enterprises and innovation and tackling societal challenges , in order to respond directly to the challenges identified in the europe 2020 strategy by supporting activities covering the entire spectrum from research to market . the union added value lies mainly in funding pre - competitive , transnational , collaborative research , which should attain in horizon 2020 at least the levels of the seventh framework programme . it is necessary to place as well emphasis on the widest possible use and dissemination of knowledge generated by the supported activities up to its commercial exploitation . thus , horizon 2020 should support all stages in the innovation chain , including innovative financial instruments , as well as non - technological and social innovation . the priorities of horizon 2020 should also be supported through a programme under the euratom treaty on nuclear research and training .


### in order to maintain a level playing field for all undertakings active in the internal market , funding provided by horizon 2020 should be designed in accordance with state aid rules so as to ensure the effectiveness of public spending and prevent market distortions such as crowding - out of private funding , creating ineffective market structures or preserving inefficient firms . ### in order to maintain a level playing field for all undertakings active in the internal market , funding provided by horizon 2020 should be designed in accordance with state aid rules , including the community framework for state aid for research and development and innovation currently under review , so as to ensure the effectiveness of public spending and prevent market distortions such as crowding - out of private funding , creating ineffective market structures or preserving inefficient firms .


### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for the union ' s research and innovation funding , thus acting as a vehicle for leveraging private investment , creating new job opportunities and ensuring europe ' s long - term sustainable growth and competitiveness . ### horizon 2020 shall play a central role in the delivery of the europe 2020 strategy for smart , sustainable and inclusive growth by providing a common strategic framework for the union ' s research and innovation funding , thus acting as a vehicle for leveraging public and private investment , creating new job opportunities , promoting economic , social and territorial cohesion and ensuring europe ' s long - term sustainable growth and competitiveness .


### the amount for activities under title xix tfeu shall be distributed among the priorities set out in article 5 as follows : excellent science , eur 27818 million ; industrial leadership , eur 20280 million ; societal challenges , eur 35888 million . the maximum overall amount for the union financial contribution from horizon 2020 to the non - nuclear direct actions of the joint research centre shall be eur 2212 million . the indicative breakdown for the specific objectives within the priorities and the maximum overall amount of the contribution to the non - nuclear direct actions of the joint research centre are set out in annex ii . ### the indicative amount for activities under title xix tfeu shall be distributed among the priorities set out in article 5 as follows : excellent science , eur 27818 million ; industrial leadership , eur 20280 million ; societal challenges , eur 35888 million . the indicative maximum overall amount for the union financial contribution from horizon 2020 to the non - nuclear direct actions of the joint research centre shall be eur 2212 million . the indicative breakdown for the specific objectives within the priorities and the maximum overall amount of the contribution to the non - nuclear direct actions of the joint research centre are set out in annex ii . the annual appropriations shall be authorised by the budgetary authority without prejudice to the provisions of the regulation laying down the multiannual financial framework for the years 2014 - 2020 and the interinstitutional agreement of xxx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters .


### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to cooperation with third countries , to responsible research and innovation including gender , and to enhancing the attractiveness of the research profession and to facilitating cross - border and cross - sector mobility of researchers . ### linkages and interfaces shall be implemented across and within the priorities of horizon 2020 . particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies , to bridging from discovery to market application , to cross - disciplinary research and innovation , to social and economic sciences and humanities , to fostering the functioning and achievement of the era , to widening participation across the eu in research and innovation , to cooperation with third countries , to responsible research and innovation including gender , and to enhancing the attractiveness of the research profession and to facilitating cross - border and cross - sector mobility of researchers .


### chronic conditions such as cardiovascular disease , cancer , diabetes , neurological and mental health disorders , overweight and obesity and various functional limitations are major causes of disability , ill - health and premature death , and present considerable social and economic costs . ### chronic conditions such as cardiovascular disease , cancer , diabetes , rheumatic and musculoskeletal diseases , neurological and mental health disorders , overweight and obesity and various functional limitations are major causes of disability , ill - health and premature death , and present considerable social and economic costs .


### in the union , cvd annually accounts for more than 2 million deaths and costs the economy more than eur 192 billion while cancer accounts for a quarter of all deaths and is the number one cause of death in people aged 45 - 64 . over 27 million people in the union suffer from diabetes and the total cost of brain disorders has been estimated at eur 800 billion . environmental , life - style and socio - economic factors are relevant in several of these conditions with up to one third of the global disease burden estimated to be related to these . ### in the union , cvd annually accounts for more than 2 million deaths and costs the economy more than eur 192 billion while cancer accounts for a quarter of all deaths and is the number one cause of death in people aged 45 - 64 . over 120 million citizens suffer from rheumatic and musculoskeletal conditions in the union and 27 million people in the union suffer from diabetes while the total cost of brain disorders has been estimated at eur 800 billion and the total cost of rheumatic and musculoskeletal diseases at eur 240 billion . environmental , life - style and socio - economic factors are relevant in several of these conditions with up to one third of the global disease burden estimated to be related to these .


### draft legislative resolution ### underlines that the provisions of point 47 of the iia shall be applied for the setting - up of the agency ; stresses that , should the legislative authority decide in favour of setting up such an agency , parliament will enter into negotiations with the other arm of the budgetary authority with a view to coming to a timely agreement on the financing of this agency in line with the relevant provisions of the iia ;


### in order to guarantee its full autonomy and independence , the authority should be granted an autonomous budget with revenues mainly from obligatory contributions from national supervisory authorities and from the general budget of the european union . the community budgetary procedure should be applicable as far as the community contribution is concerned . the auditing of accounts should be undertaken by the court of auditors . ### in order to guarantee its full autonomy and independence , the authority should be granted an autonomous budget with revenues mainly from obligatory contributions from national supervisory authorities and from the general budget of the european union . the financing of the authority by the european union is subject to an agreement by the budgetary authority as foreseen in point 47 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management the community budgetary procedure should be applicable . the auditing of accounts should be undertaken by the court of auditors ;


### a subsidy from the community , entered in the general budget of the european union ; ### a subsidy from the community , entered in the general budget of the european union ; the financing of the authority by the european union is subject to an agreement by the budgetary authority as foreseen in point 47 of the interinstitutional agreement of 17 may 2006 on budgetary discipline and sound financial management ;


### the european parliament , following a recommendation from the council acting by qualified majority , shall , before 15 may of the year n + 2 , grant a discharge to the authority for the implementation of the budget for the financial year n . ### the european parliament , following a recommendation from the council acting by qualified majority , shall , before 15 may of the year n + 2 , grant a discharge to the authority for the implementation of the budget consisting of revenues from the general budget of the european union and national supervisory authorities for the financial year n .


### promote the establishing of cross - sectoral cooperation platforms and networks , including interests from industry , research stakeholders , regions , public authorities and ngos ; ### promote the establishing of cross - sectoral cooperation platforms and networks , including interests from industry , research stakeholders , regions , public authorities and ngos , and facilitate the dissemination of information on current research projects ;


### facilitate the development of common methods and approaches ; ### facilitate cross - border cooperation and the development of common methods and support regional strategies , taking account of the specific features of sea basins .


### maritime spatial planning and integrated coastal zone management , both of which provide a fundamental tool for eco - system based management and sustainable development of marine areas and coastal regions ; ### maritime spatial planning and integrated coastal zone management , both of which provide a fundamental tool for eco - system based management and sustainable development of marine areas and coastal regions , with a particular emphasis given to the areas most vulnerable to climate change ;


### ‘ conformity assessment’ means the process demonstrating whether marine equipment complies with the requirements laid down in this directive , in accordance with article 15 ; ### ‘ conformity assessment’ means the process carried out by the notified bodies , in accordance with article 15 demonstrating whether marine equipment complies with the requirements laid down in this directive ;


### this directive shall apply to equipment to be placed on board an eu ship and for which the approval of the flag state administration is required by the international instruments . ### this directive shall apply to equipment to be placed on board an eu ship and for which the approval of the flag state administration is required by the international instruments , regardless of whether the ship is located in the community at the time when it is fitted with the equipment .


### this directive shall apply to equipment to be placed on board an eu ship and for which the approval of the flag state administration is required by the international instruments . ### this directive shall apply to equipment placed on board an eu ship and for which the approval of the flag state administration is required by the international instruments .


### the international instruments , with the exception of testing standards , shall apply in their up - to - date version , without prejudice to article 5 of regulation no 2099 / 2002 of the european parliament and of the council . ### the international instruments , with the exception of testing standards , shall apply in their up - to - date version , without prejudice to article 5 of regulation no 2099 / 2002 of the european parliament and of the council , in accordance with article 35 .


### in the absence of appropriate international standards developed by the imo for a specific item of marine equipment , the commission shall be empowered to adopt , by means of delegated acts in accordance with article 37 , harmonised technical specifications and testing standards for that specific item of marine equipment when it is necessary in order to remove an unacceptable threat to safety or to the environment . those specifications and standards shall apply on an interim basis and until such time as the imo has adopted appropriate standards . ### in the absence of appropriate international standards developed by the imo for a specific item of marine equipment , the commission shall be empowered to adopt , by means of delegated acts in accordance with article 37 , harmonised technical specifications and testing standards for that specific item of marine equipment when it is necessary in order to remove an unacceptable threat to safety or to the environment . those specifications and standards shall apply on an interim basis until such time as the imo has adopted appropriate standards .


### the wheel mark shall be affixed visibly , legibly and indelibly to the product or to its data plate . where that is not possible or not warranted on account of the nature of the product , it shall be affixed to the packaging and to the accompanying documents . ### the manufacturer shall affix the wheel mark visibly , legibly and indelibly to the product or to its data plate . where that is not possible or not warranted on account of the nature of the product , it shall be affixed to the packaging and to the accompanying documents .


### the wheel mark shall be affixed visibly , legibly and indelibly to the product or to its data plate . where that is not possible or not warranted on account of the nature of the product , it shall be affixed to the packaging and to the accompanying documents . ### the wheel mark shall be affixed visibly , legibly and indelibly to the product or to its data plate .


### manufacturers shall ensure that the product is accompanied by instructions and all necessary information for safe installation on board and safe use of the product , including limitations of use , if any , in a language which can be easily understood by the end - users , together with any other documentation required by the international instruments or testing standards . ### manufacturers shall ensure that the product is accompanied by instructions and all necessary information for safe installation on board and safe use of the product , including limitations of use , if any , in english or a language which can be easily understood by the end - users , together with any other documentation required by the international instruments or testing standards .


### manufacturers shall , further to a reasoned request from a competent national authority , promptly provide it with all the information and documentation necessary to demonstrate the conformity of the product , in a language which can be easily understood by that authority , and grant to that authority access to their premises for market surveillance purposes in accordance with article 19 of regulation no 765 / 2008 . they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by products which they have placed on the market . ### manufacturers shall , further to a reasoned request from a competent national authority , promptly provide it with all the information and documentation necessary to demonstrate the conformity of the product , in english or a language which can be easily understood by that authority , and grant to that authority access to their premises for market surveillance purposes in accordance with article 19 of regulation no 765 / 2008 . « they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by products which they have placed on the market .


### a manufacturer who is not located in the territory of a member state shall , by a written mandate , appoint an authorised representative . ### a manufacturer who is not located in the territory of a member state or a state of the european economic area shall , by a written mandate , appoint an authorised representative in the community .


### importers and distributors shall , further to a reasoned request from a competent national authority , provide it with all the information and documentation necessary to demonstrate the conformity of a product in a language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by products which they have placed on the market . ### importers and distributors shall , further to a reasoned request from a competent national authority , provide it with all the information and documentation necessary to demonstrate the conformity of a product in english or a language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any action taken to eliminate the risks posed by products which they have placed on the market .


### member states shall ensure that the manufacturer or his authorized representative carry out the conformity assessment , for a specific item of marine equipment , by using one of the options provided by means of implementing acts adopted by the commission in accordance with the examination procedure referred to in article 38 , from among one of the following procedures : ### member states shall ensure that the manufacturer or his authorized representative carry out the conformity assessment , through a notified body , for a specific item of marine equipment , by using one of the options provided by means of implementing acts adopted by the commission in accordance with the examination procedure referred to in article 38 , from among one of the following procedures :


### – production - quality assurance ; ### – production - quality assurance , or


### when marine equipment is placed on board an eu ship , a copy of the eu declaration of conformity covering the equipment concerned shall be provided to the ship , and shall be kept on board until the said equipment is removed from the ship . it shall be translated into the language or languages required by the flag state . ### when marine equipment is placed on board an eu ship , a copy of the eu declaration of conformity covering the equipment concerned shall be provided to the ship , and shall be kept on board until the said equipment is removed from the ship . it shall be drawn up in english or translated into the language or languages required by the flag state .


### notified bodies shall provide the commission and the member states , on request , with relevant information on issues relating to negative and positive conformity assessment results . notified bodies shall provide the other notified bodies carrying out conformity assessment activities covering the same products with information concerning negative and , on request , positive conformity assessment results . ### notified bodies shall provide the commission and the member states , on request , with relevant information on issues relating to negative and positive conformity assessment results . notified bodies shall provide the other notified bodies carrying out conformity assessment activities covering the same products on request with information concerning the applications submitted .


### the commission shall provide for the organisation of exchange of experience between the member states’ national authorities responsible for notification policy . ### the commission shall provide for the organisation of exchange of experience between the member states’ national authorities responsible for policy on notification , especially as regards market surveillance .


### for each item of marine equipment for which the approval of the flag state administration is required by the international conventions , the commission shall identify by means of implementing acts the respective design , construction and performance requirements and the testing standards provided for in the international instruments . ### for each item of marine equipment for which the approval of the flag state administration is required by the international conventions , the commission shall identify by means of implementing acts the respective design , construction and performance requirements and the testing standards provided for in the international instruments . when adopting these acts , the commission shall also indicate the date from which these requirements are to apply .


### the list and essential details of the conformity certificates issued under this directive ; ### the list and essential details of the conformity certificates issued under this directive , provided by the notified bodies ;


### the list and essential details of the declarations of conformity issued under this directive ; ### the list and essential details of the declarations of conformity issued under this directive , provided by the manufacturers ;


### an up - to - date list of the applicable international instruments , requirements and testing standards , including any updates becoming applicable by virtue of article 4 ; ### an up - to - date list of the applicable international instruments and their content , of the requirements and of the testing standards , including any updates becoming applicable by virtue of article 4 ;


### the delegation of power referred to in articles 8 , 11 , 29 and 36 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this directive . ### the delegation of power referred to in articles 8 , 11 , 29 and 36 shall be conferred on the commission for a period of five years from the date of entry into force of this directive . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of identical duration unless the european parliament or council opposes such an extension not later than 3 months before the end of each period .


### 2 . verify that the specimen have been manufactured in conformity with the technical documentation , and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and / or technical specifications , as well as the elements which have been designed without applying the relevant provisions of those standards ; ### 2 . verify that the specimen have been manufactured in conformity with the technical documentation , and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards and / or technical specifications , applicable requirements and testing standards as well as the elements which have been designed without applying the relevant provisions of those standards ;


### it is necessary to provide for transitional arrangements that allow making available on the market and putting into use measuring instruments that have already been placed on the market in accordance with directive 2004 / 22 / ec . ### manufacturers and importers need to be given reasonable , but limited , time to exercise any rights under national rules in force before the date of application of national rules transposing this directive in order , for example , to sell their stocks of manufactured products . it is necessary to provide for transitional arrangements that allow making available on the market and putting into use measuring instruments that have already been placed on the market in accordance with directive 2004 / 22 / ec .


### manufacturers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9 . 3 of annex i , in a language which can be easily understood by end - users , as determined by the member state concerned . ### manufacturers shall ensure that the measuring instrument is accompanied by a copy of the eu declaration of conformity and instructions and information in accordance with point 9 . 3 of annex i , in a language which can be easily understood by end - users , as determined by the member state concerned .


### importers shall ensure that the measuring instrument is accompanied by instructions and information in accordance with point 9 . 3 of annex i , in a language which can be easily understood by end - users , as determined by the member state concerned . ### importers shall ensure that the measuring instrument is accompanied by a copy of the eu declaration of conformity and instructions and information in accordance with point 9 . 3 of annex i , in a language which can be easily understood by end - users , as determined by the member state concerned .


### the office should offer a forum that brings together public authorities and the private sector , ensuring the collection , analysis and dissemination of relevant objective , comparable and reliable data regarding the value of intellectual property rights and the infringements of those rights , the development of best practices and strategies to protect intellectual property rights , and raising public awareness of the impacts of intellectual property rights infringements . furthermore , the office should fulfil additional tasks , such as to improve the understanding of the value of intellectual property rights , enhance the expertise of persons involved in the enforcement of intellectual property rights by appropriate training measures , increase knowledge on techniques to prevent counterfeiting , and improve cooperation with third countries and international organisations . ### the office should offer a forum that brings together public authorities , the private sector and civil society , ensuring the collection , analysis and dissemination of relevant objective , comparable and reliable data regarding the value of intellectual property rights and the infringements of those rights , the development of best practices and strategies to protect intellectual property rights , and raising public awareness of the impacts of intellectual property rights infringements . furthermore , the office should fulfil additional tasks , such as to improve the understanding of the value of intellectual property rights , enhance the expertise of persons involved in the enforcement of intellectual property rights by appropriate training measures , increase knowledge on techniques to prevent counterfeiting , and improve cooperation with third countries and international organisations .


### with regard to representatives of the private sector , the office should involve , when assembling the observatory in the context of its activities , a representative selection of the economic sectors most concerned by and most experienced in the fight against infringements of intellectual property rights , in particular representatives of right holders and internet service providers . also , a proper representation of consumers and of small and medium sized enterprises should be ensured . ### with regard to representatives of the private sector , the office should involve , when assembling the observatory in the context of its activities , a representative selection of right holders , internet service providers and consumer associations . also , a proper representation of small and medium sized enterprises should be ensured .


### collecting , analysing and disseminating relevant objective , comparable and reliable data regarding the economic value of intellectual property and its contribution to economic growth , welfare , innovation , creativity , cultural diversity , the creation of high quality jobs and the development of high quality products and services within the union ; ### collecting , analysing and disseminating relevant objective , comparable and reliable data regarding the economic value of intellectual property and its contribution to economic growth , welfare , innovation , creativity , cultural diversity , the creation of high quality jobs and the development of high quality products and services within the union , and to consumer protection and safety ;


### organising ad hoc meetings of experts to support its work under this regulation ; ### organising ad hoc meetings of experts and of representatives of all the relevant stakeholders to support its work under this regulation ;


### representatives meeting as the observatory invited from the private sector shall include a broad and representative range of union and national bodies representing the different economic sectors most concerned by and most experienced in the fight against infringements of intellectual property rights . ### representatives meeting as the observatory invited from the private sector shall include a broad and representative range of union and national bodies representing the different economic sectors concerned by infringements of intellectual property rights , as well as representatives of civil society including consumer associations .


### the maximum union financial contribution , including efta appropriations , to the edctp2 programme shall be eur 683 million , as follows : ### the maximum union financial contribution , including efta appropriations , to the edctp2 programme shall be eur 597 . 625 million , as follows :


### eur 89 million to equal the contributions of any other member state or any other country associated to horizon 2020 framework programme participating in the edctp2 programme in accordance with article 1 . 2 . ### eur 77 . 875 million to equal the contributions of any other member state or any other country associated to horizon 2020 framework programme participating in the edctp2 programme in accordance with article 1 . 2 .


### the commitment by each participating state to contribute to the financing of the edctp2 programme . ### the commitment by each participating state to contribute in cash and in kind to the financing of the edctp2 programme .


### regulation no &#8230 ; [ rules for the participation and dissemination in horizon 2020 ] shall apply to indirect actions selected and funded by edctp - is in accordance with the work plan referred to in article 4 or following calls for proposals managed by edctp2 - is . in accordance with that regulation , the edctp2 - is shall be considered a funding body and shall provide financial support to indirect actions in accordance with annex ii to this decision . ### regulation no &#8230 ; [ rules for the participation and dissemination in horizon 2020 ] shall apply to indirect actions selected and funded by edctp - is following calls for proposals managed by edctp2 - is . in accordance with that regulation , the edctp2 - is shall be considered a funding body and shall provide financial support to indirect actions in accordance with annex ii to this decision .


### establish cooperation and launch joint actions with union , national and international development assistance initiatives in order to ensure complementarity and increase the impact of the results of edctp - funded activities . ### establish cooperation and launch joint actions with union , national and international development assistance initiatives in order to ensure complementarity and increase the impact of the results of edctp - funded activities . in particular , coordinate edctp2 - funded activities with initiatives resulting from the who consultative expert working group process on financing and coordination of r&d .


### the sac shall be appointed by the ga and consist of european and african independent experts competent in areas relevant to the edctp2 programme . ### the sac shall be appointed by the ga and consist of european and african independent experts competent in areas relevant to the edctp2 programme . its composition shall seek to achieve gender equality in accordance with article 15 of the regulation no . . . / 2013 of the european parliament and of the council of . . . 2013 establishing horizon 2020


### in case the financing needs of the beneficiary country decline fundamentally during the period of disbursement of the macro - financial assistance , the commission , acting in accordance with article 14 , may decide to reduce the amount of funds made available in the context of the assistance , suspend or cancel the assistance . ### in case the financing needs of the beneficiary country decline fundamentally during the period of disbursement of the macro - financial assistance , the commission shall be empowered to adopt delegated acts , in accordance with article 14a , to amend annex ii to reduce the amount of funds made available in the context of the assistance , suspend or cancel the assistance .


### following the approval of the decision granting macro - financial assistance , the commission , acting in accordance with article 14 , shall agree the policy measures referred to in article 6 , , and with the beneficiary country . ### following the approval of the decision granting macro - financial assistance , the commission , acting in accordance with article 14 , shall agree the policy measures referred to in article 6 , , , and with the beneficiary country .


### the assistance shall be disbursed in successive instalments , conditional upon the fulfilment of the conditions referred to in article 6 and 6 . ### the assistance shall be disbursed in successive instalments , conditional upon the fulfilment of the conditions referred to in article 6 , 6 and 6 .


### the commission shall verify at regular intervals that the conditions referred to in article 6 and 6 continue to be met . ### the commission shall verify at regular intervals that the conditions referred to in article 6 , 6 and 6 continue to be met . the monitoring of the compliance with article 6 shall be made in close cooperation with the eeas and civil society organisations .


### in case the conditions referred to in article 6 and 6 are not met , the commission can temporarily suspend , reduce or cancel the disbursement of the assistance . ### in case the conditions referred to in article 6 , 6 and 6 are not met , the commission can temporarily suspend , reduce or cancel the disbursement of the assistance and inform the european parliament and the council thereof .


### where it has been established that , in relation to the management of assistance under this regulation , a beneficiary country has engaged in any act of fraud or corruption or any other illegal activity detrimental to the financial interests of the union , the commission shall be entitled to the full repayment of the grant and / or the early repayment of the loan . ### where it has been established that , in relation to the management of assistance under this regulation , a beneficiary country has engaged in any act of fraud or corruption or any other illegal activity detrimental to the financial interests of the union , the commission shall be entitled to the full repayment of the grant and / or the early repayment of the loan . the memorandum of understanding shall include provisions on mechanisms allowing the beneficiary country to seize the assets wrongfully misappropriated .


### the annual report shall assess the economic situation and prospects of the beneficiary countries , as well as the progress made with the implementation of the policy measures referred to in article 6 . ### the annual report shall assess the economic situation and prospects of the beneficiary countries , as well as the progress made with the implementation of the policy measures referred to in article 6 and 6 .


### draft legislative resolution proposal for a regulation of the european parliament and of the council establishing a health for growth programme , the third multi - annual programme of eu action in the field of health for the period 2014 - 2020 ### proposal for a regulation of the european parliament and of the council establishing a better health for sustainable growth programme , the third multi - annual programme of eu action in the field of health for the period 2014 - 2020


### a high level of health protection should be ensured in the definition and implementation of all union policies and activities , in accordance with article 168 of the treaty . the union shall complement and support national health policies , encourage the cooperation between member states and promote the coordination between their programmes , in full respect of the responsibilities of the national authorities for shaping their health policies and organising and delivering health services and medical care . ### a high level of health protection needs to be ensured in the definition and implementation of all union policies and activities , in accordance with article 168 of the treaty . the union shall complement and support national health policies , encourage the cooperation between member states and promote the coordination between their programmes , in full respect of the responsibilities of the national authorities for shaping their health policies and organising and delivering health services and medical care .


### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer will have positive overall health effects , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health . ### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer and empowering them to take an active role in managing their health , inter alia by improving people ' s health literacy , will have positive overall effects on health , including reduction of health inequalities , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in all factors and measures having an impact on health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health .


### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer will have positive overall health effects , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health . ### continued effort is required in order to meet the requirements set out in article 168 of the treaty . promoting good mental and physical health at eu level is an integral part of the ‘ europe 2020 : a european strategy for smart , sustainable and inclusive growth’ . keeping people healthy and active for longer will have positive overall health effects , and a positive impact on productivity and competitiveness , while reducing pressures on national budgets . innovation in health helps take up the challenge of sustainability in the sector in the context of demographic change , and action to reduce inequalities in mental and physical health is important to achieve ‘ inclusive growth’ . it is appropriate in this context to establish a ‘ health for growth’ programme , the third programme of eu action on health .


### the world health organisation european health report 2009 identifies scope for increasing investment in public health and health systems . in this regard , member states are encouraged to identify health improvement as a priority in their national programmes and to benefit from better awareness of the possibilities of eu funding for health . therefore , the programme should facilitate the uptake of its results into the national health policies . ### the world health organisation european health report 2009 identifies scope for increasing investment in public health and health systems . in this regard , member states are encouraged to identify mental and physical health improvement as a priority in their national programmes and to benefit from better awareness of the possibilities of eu funding for health . therefore , the programme should facilitate the uptake of its results into the national health policies .


### innovation in health in terms of products and services , and the organisation and provision of care , has the potential to enhance the quality of care to patients and respond to unmet needs , while also improving the cost - efficiency and sustainability of care . therefore , the programme should facilitate the uptake of innovation in healthcare . ### innovation in health in terms of products , and services , health promotion , disease prevention , timely diagnosis , appropriate treatment and rehabilitation and the organisation and provision of care , has the potential to enhance the quality of care to patients and respond to unmet needs , while also improving the cost - efficiency and sustainability of care . therefore , the programme should facilitate the uptake of innovation in healthcare in the broadest sense .


### the position of the patient should be strengthened to achieve better and safer health outcomes . patients need to be empowered to manage their health and their healthcare more pro - actively . the transparency of healthcare activities and systems and the availability of information to patients should be optimised . healthcare practices should be informed by feedback from and communication with patients . support for member states , patient organisations and stakeholders is essential and should be coordinated at eu level in order to effectively help patients and in particular those affected by rare diseases to benefit from cross border healthcare . ### the position of the patient should be strengthened by enhancing health literacy to achieve better and safer health outcomes . citizens need to be empowered to manage their health , prevent poor health , cooperate with healthcare more pro - actively and to make informed choices , inter alia by enhancing their health literacy . the transparency and patient - centredness of healthcare activities and systems , and the availability of reliable , independent and user - friendly information to patients should be optimised . healthcare practices should be informed by feedback from and communication with patients . support for member states , patient organisations and stakeholders is essential and should be coordinated at eu level in order to effectively help patients and in particular those affected by rare diseases to benefit from cross border healthcare .


### in the context of an ageing society , well - directed investments to promote health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature . ### in the context of an ageing society , well - directed investments to promote physical and mental health and prevent diseases can increase the number of ‘ healthy life years’ and thus enable the elderly to continue working as they grow older . chronic diseases are responsible for over 80% of premature mortality in the eu , and are often accompanied by mental health problems . by identifying , disseminating and promoting the up - take of validated best practices for cost - effective prevention measures focused on the key risk factors , namely smoking , abuse of alcohol and obesity , as well as on hiv / aids , the programme will contribute to prevent diseases and promote good health , also bearing in mind underlying factors of a social and environmental nature .


### to minimise the public health consequences of cross - border health threats which could range from mass contamination caused by chemical incidents to pandemics , like those unleashed recently by e coli , influenza strain h1n1 or sars , the programme should contribute to the creation and maintenance of robust mechanisms and tools to detect , assess and manage major cross - border health threats . . due to the nature of these threats , the programme should support coordinated public health measures at eu level to address different aspects , building on preparedness and response planning , robust and reliable risk assessment and a strong risk and crisis management framework . in this context , it is important that the programme should benefit from complementarity with the work programme of the european centre for disease prevention and control12 in the fight against communicable diseases and the activities supported under the unions programmes for research and innovation . special efforts should be undertaken to ensure coherence and synergies between the programme and global health work carried out under other community programmes and instruments that address in particular the areas of influenza , hiv / aids , tuberculosis and other cross - border health threats in third countries . action under the programme may also cover cross - border threats to health caused by biological and chemical incidents , environment and climate change . as stated in the commission ' s communication ‘ a budget for europe 2020’ , the commission has committed to mainstreaming climate change into overall union spending programmes and to direct at least 20% of the union budget to climate - related objectives . spending in the health for growth programme under objective 4 will contribute in a general manner to this objective by addressing health threats associated to climate change . the commission will provide information on climate change expenditure within the health for growth programme . ### to minimise the public health consequences of cross - border health threats which could range from mass contamination caused by chemical incidents to pandemics , like those unleashed recently by e coli , influenza strain h1n1 or sars or diseases from developing countries which through global population movements are an increasing reality in some european countries , the programme should contribute to the creation and maintenance of robust mechanisms and tools to detect , assess and manage major cross - border health threats . . due to the nature of these threats , the programme should support coordinated public health measures at eu level to address different aspects , building on preparedness and response planning , robust and reliable risk assessment and a strong risk and crisis management framework . in this context , it is important that the programme should benefit from complementarity with the work programme of the european centre for disease prevention and control12 in the fight against communicable diseases and the activities supported under the unions programmes for research and innovation . special efforts should be undertaken to ensure coherence and synergies between the programme and global health work carried out under other community programmes and instruments that address in particular the areas of influenza , hiv / aids , tuberculosis and other cross - border health threats in third countries . action under the programme may also cover cross - border threats to health caused by biological and chemical incidents , environment and climate change . as stated in the commission ' s communication ‘ a budget for europe 2020’ , the commission has committed to mainstreaming climate change into overall union spending programmes and to direct at least 20% of the union budget to climate - related objectives . spending in the health for growth programme under objective 4 will contribute in a general manner to this objective by addressing health threats associated to climate change . the commission will provide information on climate change expenditure within the health for growth programme .


### the programme should promote synergies while avoiding duplication with related union programmes and actions . appropriate use should be made of other union funds and programmes , in particular the current and future union framework programmes for research and innovation and their outcomes , the structural funds , the programme for social change and innovation , the european solidarity fund , the european strategy for health at work , the competitiveness and innovation programme , the framework programme for environment and climate action , the programme of union action in the field of consumer policy , the justice programme , the ambient assisted living joint programme , and the union statistical programme within their respective activities . ### the programme should promote synergies while avoiding duplication with related union programmes and actions . appropriate use should be made of other union funds and programmes , in particular the current and future union framework programmes for research and innovation and their outcomes , the structural funds , the programme for social change and innovation , the european solidarity fund , the european strategy for health at work , the competitiveness and innovation programme , the framework programme for environment and climate action , the programme of union action in the field of consumer policy , the justice programme , the ambient assisted living joint programme , and the union statistical programme within their respective activities and the european innovation partnership on active and healthy ageing .


### the general objectives of the health for growth programme shall be to work with the member states to encourage innovation in healthcare and increase the sustainability of health systems , to improve the health of the eu citizens and protect them from cross - border health threats . ### the general objectives of the health for all programme shall be to work with the member states and representative non - governmental bodies and health stakeholders , in particular patients ' organisations and health professionals ' associations , to encourage innovation in healthcare and increase the sustainability of health systems , promote healthy lifestyles and reduce inequalities within and between member states to improve the health of all eu citizens , and protect them from cross - border health threats .


### the general objectives of the health for growth programme shall be to work with the member states to encourage innovation in healthcare and increase the sustainability of health systems , to improve the health of the eu citizens and protect them from cross - border health threats . ### the general objectives of the health for growth programme shall be to work with the member states to encourage innovation in healthcare and increase the sustainability of health systems , to improve the physical and mental health of the eu citizens and protect them from cross - border health threats .


### to increase access to medical expertise and information for specific conditions also beyond national borders , and to develop shared solutions and guidelines to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens . ### to increase access to medical expertise and information for specific conditions also beyond national borders and to develop shared solutions and guidelines to improve health literacy , patient empowerment , healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens .


### to increase access to medical expertise and information for specific conditions also beyond national borders , and to develop shared solutions and guidelines to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens . ### to increase access to medical expertise and information for specific conditions also beyond national borders , and to develop shared solutions and guidelines to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens throughout the eu .


### to increase access to medical expertise and information for specific conditions also beyond national borders , and to develop shared solutions and guidelines to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens . ### to increase access to medical expertise , information and treatment for specific conditions also beyond national borders , and to develop shared solutions and guidelines to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens .


### increase access to medical expertise and information for specific conditions also beyond national borders and developing shared solutions and guidelines to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens ### increase access to medical expertise and information for specific conditions also beyond national borders and developing shared solutions and guidelines to improve healthcare quality and patient safety in order to increase access to better and safer healthcare for eu citizens in line with the union ' s fundamental values of universality , high quality , equity of access and solidarity .


### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health . ### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measures addressing key risk factors such as smoking , abuse of alcohol , a sedentary lifestyle , obesity and an unhealthy diet , as well as hiv / aids , and by supporting awareness raising campaigns promoting healthy lifestyles , including the development of healthy lifestyle behaviours in young children , in order to prevent diseases and promote good health .


### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health . ### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health , and to empower eu citizens and patients to play an active role in managing their health and healthcare , inter alia by enhancing their health literacy skills .


### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health . ### to identify , disseminate and promote the up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol , obesity and drugs , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health .


### identifying , disseminating and promoting up - take of validated best practices for cost - effective prevention measure by addressing the key risk factors , namely smoking , abuse of alcohol and obesity , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health ### identifying , disseminating and promoting up - take of validated best practices for cost - effective prevention measures addressing key risk factors such as smoking , abuse of alcohol , a sedentary lifestyle , obesity and an unhealthy diet , as well as hiv / aids , with a focus on the cross border dimension , in order to prevent diseases and promote good health , and by supporting awareness raising campaigns promoting healthy lifestyles , with special attention being paid to encouraging the development of healthy lifestyle behaviours in young children .


### the commission shall implement the programme by establishing annual work programmes setting out the elements provided in the financial regulation and in particular : ### the commission shall implement the programme by establishing annual work programmes , with the input from health stakeholders and their representative organizations , including patients , setting out the elements provided in the financial regulation and in particular :


### at the request of the commission , which shall avoid causing any disproportionate increase in the administrative burden on the member states , member states shall submit any available information on the implementation and impact of the programme . ### the member states shall report every two years on the measures undertaken and the resources spent on actions under the programme , including , in particular , networking activities , exchange of best practices and expertise across borders .


### no later than mid - 2018 , an evaluation report shall be established by the commission on the achievement of the objectives of all the measures , the efficiency of the use of resources and its european added value , in view of a decision on the renewal , modification or suspension of the measures . the evaluation shall additionally address the scope for simplification , its internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities of smart , sustainable and inclusive growth . it shall take into account evaluation results on the long - term impact of the predecessor programme . ### no later than mid - 2016 , an evaluation report shall be established by the commission on the achievement of the objectives of all the measures , the efficiency of the use of resources and its european added value , in view of a decision on the renewal , modification or suspension of the measures . the evaluation shall additionally address the scope for simplification , its internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities of smart , sustainable and inclusive growth . it shall take into account evaluation results on the long - term impact of the predecessor programme .


### no later then mid - 2018 , an evaluation report shall be established by the commission on the achievement of the objectives of all the measures , the efficiency of the use of resources and its european added value , in view of a decision on the renewal , modification or suspension of the measures . the evaluation shall additionally address the scope for simplification , its internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities of smart , sustainable and inclusive growth . it shall take into account evaluation results on the long - term impact of the predecessor programme . ### no later then mid - 2018 , an evaluation report shall be established by the commission and presented to the european parliament on the achievement of the objectives of all the measures , the efficiency of the use of resources and its european added value , in view of a decision on the renewal , modification or suspension of the measures . the evaluation shall additionally address the scope for simplification , its internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities of smart , sustainable and inclusive growth . it shall take into account evaluation results on the long - term impact of the predecessor programme .


### the commission shall make the results of actions undertaken pursuant to this regulation publicly available and shall ensure they are widely disseminated . ### the commission shall make the results publicly available and shall ensure they are widely disseminated in order to document the contribution of the programme to increasing quality in health care for union citizens .


### 3 . health workforce : develop effective health workforce forecasting and planning in terms of numbers , scope of practice and skills , monitor mobility and migration of health professionals , establish efficient recruitment and retention strategies and capacity development . ### 3 . health workforce : develop effective health workforce forecasting and planning in terms of numbers , scope of practice and skills , including the ability to make use of new information systems and other advanced technologies , monitor mobility and migration of health professionals , establish efficient recruitment and retention strategies and capacity development .


### 1 . cost - effective promotion and prevention measures : this will include actions towards the setting up of pan - european networks and partnerships engaging wide range of actors in communication and awareness raising actions on key health issues such as smoking prevention , abuse of alcohol , addressing obesity with a focus on the cross - border dimension and on member states with no or little action on these issues . ### 1 . cost - effective promotion and prevention measures : this will include actions towards the setting up of pan - european networks and partnerships engaging wide range of actors in improving health literacy through communication and awareness raising actions on key health issues such as smoking prevention , abuse of alcohol , addressing obesity and low physical activity with a focus on the cross - border dimension and on member states with no or little action on these issues .


### 2 . chronic diseases : support european cooperation and networking on preventing and improving the response to chronic diseases including cancer , by sharing knowledge , good practice and developing joint activities on prevention . cancer : follow - up work already undertaken ; set up a european cancer information system with comparable data ; support cancer screening , including voluntary accreditation mechanisms ; support the development of european guidelines for prevention where major inequalities exist . ### 2 . chronic diseases : support european cooperation and networking through joint actions on preventing and improving the response to chronic diseases including cancer , by sharing knowledge , good practice and developing joint activities on prevention ; follow - up work already undertaken ; set up a european cancer information system and an information system on chronic diseases with comparable data ; support cancer screening and early diagnosis of chronic diseases , including voluntary accreditation mechanisms ; support the development of european guidelines for prevention and early diagnosis where major inequalities exist .


### 1 . preparedness to and response for serious cross border health threats taking into account and coordinating with global initiatives : put in place common components of generic and specific preparedness planning , including for pandemic influenza , and report regularly on implementation of preparedness plans . ### 1 . preparedness to and response for serious cross border health threats taking into account and coordinating with global initiatives : put in place common components of generic and specific preparedness planning , including for pandemic influenza , and report regularly on implementation of preparedness plans ; bring innovation to patients for the prevention , diagnosis and treatment of diseases originating in developing countries which are increasingly becoming a reality in some european countries .


### draft legislative resolution ### as regards the union´s research framework programmes , further simplification and harmonisation of rules and procedures should be introduced , as stated in the european parliament resolution of 11 november 2010 on simplifying the implementation of the research framework programmes1 , and in the final report of the expert group on interim evaluation of the seventh framework programme , published on 12 november 2010 on the basis of the article 7 of the decision no 1982 / 2006 / ec ; 1 texts adopted , p7_ta0401 .


### the legislative authority shall , in accordance with the procedure laid down in article 322 of the tfeu , decide on a level of tolerable risk of error at an appropriate aggregation of the budget . that decision shall be taken into account during the annual discharge procedure , in accordance with article 157 . ### when presenting revised or new spending proposals , the commission shall analyse , estimate and , when necessary , modify the system of risk management . on the basis of a clear methodology , the commission shall also assess the level of risk of error or non - compliance with the proposed legislation per funds and per member state .


### the level of tolerable risk of error shall be based on an analysis of the costs and benefits of controls . member states and entities and persons referred to in point article 55 shall on request report to the commission on the costs of controls borne by them as well as the number and size of activities financed by the budget . ### if , during the programme implementation , the error rate or level of non compliance is persistently higher than the risk level as identified in the spending proposal , the commission shall identify the weaknesses in the control systems and analyse the cost and benefits of possible corrective measures and take appropriate action such as simplification of the applicable provisions , re - design of the programme , tightening of controls or , if necessary , termination of the activity .


### this regulation lays down the conditions under which member states are empowered to amend or conclude international agreements relating to investment . ### this regulation lays down the conditions under which member states are empowered to amend existing or conclude new international agreements relating to investment .


### as the authorisation to maintain , amend or conclude agreements covered by this regulation is granted in an area of exclusive union competence , it must be regarded as an exceptional measure . the authorisation is without prejudice to the application of article 258 of the treaty with respect to failures of member states to fulfil obligations under the treaties other than those concerning incompatibilities arising from the allocation of competences between the union and its member states . ### as this regulation concerns an area of exclusive union competence , it must be regarded as an exceptional measure . the arrangements under this regulation are without prejudice to the application of article 258 of the treaty with respect to failures of member states to fulfil obligations under the treaties other than those concerning incompatibilities arising from the allocation of competences between the union and its member states .


### this directive respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union , including the right to property . nothing in this directive should be interpreted or implemented in a manner that is inconsistent with the european convention on human rights . ### this directive respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union , including the right to protection of personal data in all aspects of life and the right to property . nothing in this directive should be interpreted or implemented in a manner that is inconsistent with the european convention on human rights .


### the commission should assist the member states in implementing the directive in a consistent way by giving guidance , particularly on charging and calculation of costs , on recommended licensing conditions and on formats , after consulting interested parties . ### the commission should assist the member states in implementing the directive in a consistent way by giving guidance , particularly on charging and calculation of costs , on recommended licensing conditions and on formats , after consulting interested parties . thus , cross - border exchange of best practices and knowledge between stakeholders , public bodies and regulators should be promoted by the commission and the member states .


### subject to paragraph member states shall ensure that documents referred to in article 1 shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv . ### subject to paragraph member states shall ensure that documents of public sector bodies referred to in article 1 shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv , provided that the documents concerned are of types classified as accessible under the rules which exist in the member states regarding access to public sector information . where possible , these documents shall be disseminated in technology - neutral , machine - readable form .


### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata . ' . ### article 5 , paragraph 1 is replaced by the following : public sector bodies shall make their documents available in any pre existing format or language and where possible and appropriate , in machine - readable format based on open standards together with their metadata . documents created after entry into force of this directive shall in principle be made available in machine readable format . this shall not imply an obligation where the adaptation of existing documents , including the provision of extracts , would involve disproportionate effort , according to transparent , objective and verifiable criteria .


### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction and dissemination . ### documents will be made available at zero cost wherever possible . where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction and dissemination .


### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction and dissemination . ' ### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction , provision and dissemination .


### on 20 december 2007 , the commission submitted a communication to the european parliament and the council concerning the ' report on current practices with regard to the provision of information to patients on medicinal products ' . the report concludes that member states have adopted divergent rules and practices with regard to the provision of information , resulting in a situation where patients and the public at large have unequal access to information on medicinal products . experience gained from the application of the current legal framework has also shown disparities in the interpretation of the community rules on advertising , and between national provisions on information . ### on 20 december 2007 , the commission submitted a communication to the european parliament and the council concerning the ' report on current practices with regard to the provision of information to patients on medicinal products ' . the report concludes that member states have adopted divergent rules and practices with regard to the provision of information , resulting in a situation where patients and the public at large have unequal access to information on medicinal products . experience gained from the application of the current legal framework has also shown disparities in the interpretation of the community rules on advertising , and between national provisions on information , highlighting the urgent need for a more precise distinction between advertising and information .