### an internal selection limited to staff who have contracts with the committee of european banking supervisors or its secretariat shall be carried out after the entry into force of this regulation by the authority authorised to conclude contracts in order to check the ability , efficiency and integrity of those to be engaged . ### an internal selection limited to staff who have contracts with the level 3 committee or its secretariat shall be carried out after the entry into force of this regulation by the authority authorised to conclude contracts in order to check the ability , efficiency and integrity of those to be engaged . the internal selection procedure should take full account of the skills and experience demonstrated by the individual in the performance of his / her role prior to the transition .


### derivative trading and commodity trading are used together on wholesale energy markets . it is therefore important that the definitions of market abuse , which consists of insider trading and market manipulation , are compatible between derivatives and commodity markets . ### derivative trading and commodity trading are used together on wholesale energy markets . it is therefore important that the definitions of market abuse , which consists of insider trading and market manipulation , are compatible between derivatives and commodity markets but at the same time taking into account the specific characteristics of the wholesale energy markets .


### specification of the definitions of inside information and market manipulation is necessary to account for the specificities of wholesale energy markets , which are dynamic and subject to change . the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty in respect to such detailed rules . ### specification of the definitions of inside information and market manipulation is necessary to account for the specificities of wholesale energy markets and to ensure coherence with other relevant eu legislation in the fields of financial services and energy , which are all dynamic and subject to change . the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty in respect to such detailed rules . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . expertise could be provided inter alia by experts from the agency for the cooperation of energy regulators , the committee of european securities regulators , the european networks of transmission system operators for gas and for electricity , the european securities and markets authority , national regulatory authorities , competent financial authorities in the member states and market participants . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### specification of the definitions of inside information and market manipulation is necessary to account for the specificities of wholesale energy markets , which are dynamic and subject to change . the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty in respect to such detailed rules . ### specification of the definitions of inside information and market manipulation is necessary to account for the specificities of wholesale energy markets , which are dynamic and subject to change , and to guarantee consistency with other eu legislation in this area . the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty in respect to such detailed rules . acer and other market participants should be involved in the consultations and preparations in good time and the european parliament and the council should be informed at an early stage .


### in order to ensure the necessary flexibility in collecting information on transactions in wholesale energy products , the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty setting out the timing , form and content of the information which market participant are required to provide . reporting obligations should not create unnecessary costs for market participants . persons reporting transactions to a competent authority in accordance with the provisions of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments16 , and to trade repositories and competent authorities in accordance with the provisions of regulation . . / . . of the european parliament and the council on otc derivatives , central counterparties and trade repositories should therefore not be subject to additional reporting obligations under this regulation . ### in order to ensure the necessary flexibility in collecting information on transactions in wholesale energy products , the commission should be empowered to adopt upon due consultation with market participants , interested parties and authorities including the agency delegated acts in accordance with article 290 of the treaty setting out the timing , form and content of the information which market participant are required to provide . reporting obligations should not create unnecessary costs or administrative burdens for market participants and should therefore undergo an ex ante cost benefit analysis . persons reporting transactions to a competent authority in accordance with the provisions of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments16 , and to trade repositories and competent authorities in accordance with the provisions of regulation . . / . . of the european parliament and the council on otc derivatives , central counterparties and trade repositories should therefore not be subject to additional reporting obligations under this regulation . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council and carry out appropriate and transparent consultations well in advance , including at expert level .


### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public . such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets . ### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public . such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets . to ensure greater transparency and public access to information on wholesale energy prices , the agency should prepare monthly country - by - country reports on price developments in wholesale energy markets .


### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public . such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets . ### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public . such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets . to ensure greater transparency and public access to information on wholesale energy prices the agency should prepare monthly country by country report on price developments in energy wholesale markets .


### it is important that the penalties for breaches of this regulation are proportionate and dissuasive , and reflect the gravity of the infringements and the potential gains from trading on the basis of inside information and market manipulation . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec . ### it is important that the penalties for breaches of this regulation are proportionate and dissuasive , and reflect the gravity of the infringements , the potential gains from trading on the basis of inside information and market manipulation and the damage caused to consumers . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec . to avoid regulatory arbitrage , whereby contracts are concluded in countries where the risk of incurring penalties is the lowest , the commission should regularly review the situation and propose in time a system of minimum harmonised penalties in the european union .


### by way of example , making it appear that the availability of electricity generation capacity or gas availability , or the availability of transmission capacity is other that the capacity which is actually physically available constitutes market manipulation . ### by way of example , making it appear that the availability of electricity generation capacity or gas availability , or the availability of transmission capacity is other that the capacity which is actually physically available constitutes market manipulation . conduct by a person , or persons acting in collaboration , with the aim of securing a dominant trading position over the supply of or demand for a wholesale energy product , including by withholding electricity generation capacity or gas , or the availability of transmission capacity , or by voluntarily and significantly without legitimate economic or commercial rationale reducing the availability of its own capacity , which has the effect of influencing , directly or indirectly , purchase or sale prices or creating other unfair trading conditions , constitutes market manipulation .


### market participants shall publicly disclose inside information in respect of business or facilities which the participant concerned owns or controls or for which the participant is responsible for operational matters , either in whole or in part . such information shall include information relevant to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas . ### in relation to paragraph 1 , market participants shall effectively and publicly disclose inside information in respect of business or facilities which the participant concerned owns or controls or for which the participant is responsible for operational matters , either in whole or in part . such information shall include information relevant to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas .


### each member state shall ensure that national regulatory authorities have the investigatory powers necessary for the exercise of this function . these powers shall be exercised in a proportionate manner . these powers may be exercised : ### each member state shall ensure that national regulatory authorities have the investigatory and enforcement powers necessary for the exercise of this function . these powers shall be exercised in a proportionate manner . these powers may be exercised :


### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . taking account of the consultation on the commission communication of com716 entitled ' reinforcing sanctioning regimes in the financial services sector ' , the commission shall define recommendations with the aim of striving towards a harmonised penalties system of member states . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them .


### the union is founded on the values of democracy , the rule of law , the universality and indivisibility of and respect for human rights and fundamental freedoms , respect for human dignity , the principles of equality and solidarity and respect for the principles of the un charter and international law . it seeks to develop and consolidate commitment to these values in partner countries and regions through dialogue and cooperation . ### the union is founded on the values of democracy , the rule of law , the universality and indivisibility of and respect for human rights and fundamental freedoms , respect for human dignity , the principles of equality and solidarity and respect for the principles of the un charter and international law . it seeks to develop and consolidate commitment to these values in partner countries , territories and regions through dialogue and cooperation .


### the union ' s policy and international action for development cooperation are guided by the mdgs , such as the eradication of extreme poverty and hunger , including any subsequent modifications thereto , and by the development objectives and principles approved by the union and its member states , including in the context of their cooperation within the united nations and other competent international organisations in the field of development cooperation , ### the union ' s policy and international action for development cooperation are guided by the mdgs , such as the eradication of extreme poverty , gender - based discrimination and hunger , promotion of equality between men and women , the reduction of maternal and infant mortality , including any subsequent modifications thereto , and by the development objectives and principles approved by the union and its member states , including in the context of their cooperation within the united nations and other competent international organisations in the field of development cooperation ,


### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . ### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development , worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , each country analysis and programming should contain a conflict analysis and the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . to ensure the greatest impact of union assistance in the world , the implementation of this regulation should be strictly coordinated with programmes and actions funded under other regulations establishing external financing instruments , namely regulation no [ . . . / . . . ] of the european parliament and of the council establishing an instrument for stability and regulation no [ . . . / . . . ] of the european parliament and of the council establishing a financing instrument for the promotion of democracy and human rights worldwide and regulation eu no [ . . . / . . . ] 843 ) of the european parliament and of the council establishing a partnership instrument for cooperation with third countries .


### this regulation should provide an enabling framework for programming , allowing enhanced consistency between union policies by using a joint framework document as a basis for programming . it should enable full alignment with partner countries and regions by relying , where appropriate , on national development plans or similar comprehensive development documents ; and pursue a better coordination amongst donors , in particular between the union and its member states , through joint programming . ### this regulation should allow for enhanced consistency between union policies while respecting the overall requirement of policy coherence for development . it should enable full alignment with partner countries and regions by using , where possible , national development plans or similar comprehensive development documents as the basis for the programming of the union ' s action ; and pursue a better coordination amongst donors , in particular between the union and its member states , through joint programming . it should enable structured annual meetings between representatives of national parliaments of member states and the european parliament to ensure consistency in the spending of development aid .


### the achievement of these objectives shall be measured using relevant indicators , in particular mdg 1 for subparagraph and mdgs 1 to 8 for subparagraph , and other indicators agreed by the union and its member states . ### the achievement of these objectives shall be measured using relevant indicators , in particular mdg 1 for subparagraph and mdgs 1 to 8 for subparagraph , and other indicators agreed by the union and its member states . no reference in this regulation and especially the one to the millennium development goals , in particular to mdg 5 , maternal health or maternal mortality , shall be interpreted as providing a legal basis for using union assistance to fund abortion , either directly or indirectly , including through the financing of any public or private entity that provides or promotes it .


### the union seeks to promote , develop and consolidate the principles of democracy , the rule of law and respect for human rights and fundamental freedoms on which it is founded , through dialogue and cooperation with partner countries and regions . ### the union seeks to promote , develop and consolidate the principles of democracy , the rule of law and respect for human rights and fundamental freedoms , women ' s rights and the principles of gender equality and non - discrimination on which it is founded , through dialogue and cooperation with partner countries and regions .


### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , non - discrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids , ### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , improvement of working conditions and promotion of a better balance between professional and private life , access to highly qualified positions via equal access training courses and equal pay at work , promotion of the right to stable employment , combating all forms of gender violence in the workplace , in family and society , the right to live with dignity , without poverty and social exclusion , non - discrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids , while stressing the importance of looking at these issues from the perspective that women , children and older people can be particularly vulnerable .


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


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


### the union and its member states shall consult each other , and other donors and development actors including representatives of civil society and regional and local authorities , at an early stage of the programming process in order to promote complementarity and consistency among their cooperation activities . this consultation may lead to joint programming between the union and its member states . ### the union and its member states shall consult each other , and other donors and development actors including representatives of civil society and regional and local authorities , at an early stage of the programming process in order to promote complementarity and consistency among their cooperation activities . this consultation may lead to joint programming between the union and its member states . in those consultations the capacities of , and the role that can be played by , overseas countries and territories associated with the european union should be taken into account .


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


### multiannual indicative programmes shall set out the priority areas selected for union financing , the specific objectives , the expected results , the performance indicators and the indicative financial allocation , both overall and per priority area . where appropriate , this allocation may be given in the form of a range and / or some funds may be left unallocated . ### multiannual indicative programmes shall set out the priority areas selected for union financing , the specific objectives , the expected results , clear , specific and transparent performance indicators and , without prejudice to the prerogatives of the budgetary authority , lay down the indicative financial allocation , both overall and per priority area . where appropriate , this allocation may be given in the form of a range and / or some funds may be left unallocated .


### where partner countries or groups of partner countries are directly involved in , or affected by , a crisis , post - crisis or fragility situation , special emphasis shall be placed on stepping up coordination between relief , rehabilitation and development to help them make the transition from an emergency situation to the development phase . programmes for countries and regions in fragility or regularly subject to natural disasters shall provide for disaster preparedness and prevention and for managing the consequences of such disasters . ### where partner countries or regions are directly involved in , or affected by , a crisis , post - crisis or fragility situation , special emphasis shall be placed on stepping up coordination between relief , rehabilitation and development amongst all relevant actors to help the transition from an emergency situation to the development phase . programmes for countries and regions in fragility or regularly subject to natural disasters shall provide for disaster preparedness , prevention and response . reducing risk and building resilience of communities are effective measures to prevent natural hazards from turning into disasters . disaster risk reduction measures protect people , people ' s livelihoods , social equity and economic growth , as well as crucial infrastructure such as schools , hospitals and airports from disasters . a disaster risk management approach shall therefore be an integral part of development planning and programmes .


### when drawing up the programming documents for countries in crisis , post - crisis , or fragility situations , due account shall be taken of the vulnerability , special needs and circumstances of the countries or regions concerned . proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures . where partner countries or groups of partner countries are directly involved in , or affected by , a crisis , post - crisis or fragility situation , special emphasis shall be placed on stepping up coordination between relief , rehabilitation and development to help them make the transition from an emergency situation to the development phase . programmes for countries and regions in fragility or regularly subject to natural disasters shall provide for disaster preparedness and prevention and for managing the consequences of such disasters . ### when drawing up the programming documents for countries in crisis , post - crisis , or fragility situations , due account shall be taken of the vulnerability of different social groups , special needs of women and circumstances of the countries or regions concerned . proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures . where partner countries or groups of partner countries are directly involved in , or affected by , a crisis , post - crisis or fragility situation , special emphasis shall be placed on stepping up coordination between relief , rehabilitation and development to help them make the transition from an emergency situation to the development phase . programmes for countries and regions in fragility or regularly subject to natural disasters shall provide for disaster preparedness and prevention and for managing the consequences of such disasters . special attention should be given to women , who are often the major victims in crisis situations .


### proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures . ### proper attention should be given to conflict prevention , state and peace building , post - conflict reconciliation and reconstruction measures . it is therefore vital to include women so that they can benefit from equal participation in negotiations and initiatives aimed at the pacification , stabilisation and reconstruction of countries and institutions . it is therefore essential to complement the image of women as vulnerable victims with an image of women as a highly differentiated group of social actors who possess valuable resources and capacities , who have their own priorities , and who can influence and steer the process of conflict resolution . moreover , it is important to stress that the understanding of the role of women in post - war societies and of their contributions to post - war reconstruction must entail a global approach to promoting the key role of education in the empowerment of women and girls , in order to combat stereotypes and to change mentalities .


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


### the multiannual indicative programmes shall give the indicative financial allocation , both overall and by priority area . where appropriate , this allocation may , be given in the form of a range , and / or some funds may be left unallocated . multiannual indicative programmes should be adjusted where necessary for an effective policy implementation , taking into account any mid - term or ad hoc reviews . ### without prejudice to the prerogatives of the budgetary authority , the multiannual indicative programmes , shall give the indicative financial allocation , both overall and by priority area . where appropriate , this allocation may , be given in the form of a range , and / or some funds may be left unallocated . multiannual indicative programmes should be adjusted where necessary for an effective policy implementation , taking into account any mid - term or ad hoc reviews .


### the judicial remedies available in the member states have played a limited role in ensuring compliance with the time limits due to the often lengthy procedures in national jurisdictions , which deter affected companies from initiating legal action . therefore , effective mechanisms are necessary to control and enforce compliance with the time limits for pricing and reimbursement decisions . ### the judicial remedies available in the member states have played a limited role in ensuring compliance with the time limits due to the often lengthy procedures in national jurisdictions , which deter affected companies from initiating legal action . therefore , effective mechanisms are necessary to control and enforce compliance with the time limits for pricing and reimbursement decisions . to this end , member states shall designate a body , which may be an existing one , entrusted with the power to impose the remedies provided in this directive .


### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products an the similarity of biosimilar medicines with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product .


### “health technology assessment” means an assessment of the relative efficacy or of the short - and long - term effectiveness of the medicinal product compared to other health technologies in use for treating the associated condition . ### “health technology assessment” means an assessment of the medical , social , economic and ethical issues related to the use of a health technology in a systematic , transparent , unbiased , robust manner . its aim is to inform the formulation of safe , effective health policies that are patient focused and seek to achieve best value .


### member states shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time . member states may also provide the possibility for marketing authorisation holders to submit such requests once the committee for medicinal products for human use established by regulation no 726 / 2004 or the national competent authority has issued a positive opinion . the competent authorities shall provide the applicant with an official acknowledgement of receipt within 10 days .


### member states shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to increase the price of the product can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt within 10 days .


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted or , where appropriate , of the formal receipt of the marketing authorisation , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### member states shall establish in detail the particulars and documents to be submitted by the applicant . the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### member states shall establish in detail and publish in an appropriate publication the particulars and documents to be submitted by the applicant . the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### in the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a member state , that member state shall publish a statement of reasons for its decision based on objective and verifiable criteria , including , if applicable , a justification of the categories of products subject to the price freeze or price reduction . ### in the event of a temporary price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a member state , that member state shall publish a statement of reasons for its decision based on objective and verifiable criteria , including , if applicable , a justification of the categories of products subject to the price freeze or price reduction .


### in the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a member state , that member state shall publish a statement of reasons for its decision based on objective and verifiable criteria , including , if applicable , a justification of the categories of products subject to the price freeze or price reduction . ### in the event of a price freeze or price reduction imposed on all medicinal products or on certain categories of medicinal products by the competent authorities of a member state , that member state shall&#160 ; publish a statement of reasons for its decision based on objective and verifiable criteria , including , if applicable , a justification of the categories of products subject to the price freeze or price reduction . furthermore , at least once a year , that member state shall carry out a review to ascertain whether the macro - economic conditions justify that the freeze be continued unchanged .


### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt within 10 days .


### member states shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time . if the public health insurance system comprises several schemes or categories of coverage , the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time . member states may also provide the possibility for marketing authorisation holders to submit such requests once the committee for medicinal products for human use established by regulation no 726 / 2004 or the national competent authority has issued a positive opinion . if the public health insurance system comprises several schemes or categories of coverage , the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice . the competent authorities shall provide the applicant with an official acknowledgement of receipt within 10 days .


### paragraphs 2 , 3 and 4 shall apply where a member state adopts measures intended to control or promote the prescription of specific named medicinal products . ### paragraphs 2 , 3 and 4 shall apply where a member state adopts measures intended to control or promote the prescription of specific named medicinal products or of a category of medicinal products .


### in the framework of pricing and reimbursement decisions , member states shall not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### in the framework of pricing and reimbursement decisions , member states shall not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or , where appropriate , the bioequivalence or biosimilarity of the medicinal product or the criteria for orphan designation . however , this directive shall not prevent member states from using the data generated in the marketing authorisation process for health technology assessment or pharmaco - economic evaluation purposes .


### in the framework of pricing and reimbursement decisions , member states shall not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### in the framework of pricing and reimbursement decisions , member states shall not re - assess the criteria on which the marketing authorisation is based .


### in the framework of pricing and reimbursement decisions , member states shall not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### in the framework of pricing and reimbursement decisions , member states shall not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or , where appropriate , bioequivalence of the medicinal product or the criteria for orphan designation . however , this directive does not prevent member states from using the data generated in the marketing authorisation process for health technology assessment or pharmaco - economic evaluation purposes .


### where member states intend to adopt or amend any measure falling within the scope of this directive , they shall immediately communicate to the commission the draft measure envisaged , together with the reasoning on which the measure is based . ### where member states intend to adopt or amend any measure falling within the scope of this directive , they shall immediately communicate to the commission the draft measure envisaged , together with the reasoning on which the measure is based and the date foreseen for definitive adoption .


### the commission may send its observations to the member state which has communicated the draft measure within three months . ### the commission shall send its observations to the member state .


### by 31 january of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 31 january and 1 july of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information : the number of applications received in accordance with articles 3 , 4 and 7 during the preceding year ; the amount of time taken to issue a decision on each of the applications received in accordance with articles 3 , 4 , and 7 . an analysis of the main reasons for delays , if any , together with recommendations to bring decision - making processes into line with the time limits laid down in this directive . ### by 1 july of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 1 july of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information : the number of applications received in accordance with articles 3 , 4 and 7 during the preceding year ; the amount of time taken to issue a decision on each of the applications received in accordance with articles 3 , 4 , and 7 . an analysis of the main reasons for delays , if any .


### the commission shall publish every six months a report on the information submitted by member states according to paragraph 1 . ### the commission shall publish every year a report on the information submitted by member states according to paragraph 1 .


### in a labour - intensive sector such as groundhandling , continuous staff development and training have a strong impact on service quality . minimum training requirements should therefore be set to ensure the quality of operations in terms of reliability , resilience , safety and security , and to create a level playing field among operators . ### in a labour - intensive sector such as groundhandling , continuous staff development and training have a strong impact on both service quality and operational safety . minimum training requirements should therefore be set to ensure the quality of operations in terms of reliability , resilience , safety and security , and to create a level playing field among operators .


### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services , member states may require supplier of groundhandling services which subsequently provide these services to grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec17 . ### where , following the selection procedure laid down in articles 7 to 10 , a supplier of groundhandling services mentioned in paragraph 1 loses its authorisation to provide these services , and when the supplier of groundhandling services ceases the performance of groundhandling services for an airport user or when a self - handling airport user decides to cease self - handling , member states may recommend that supplier of groundhandling services which subsequently provide these services grant staff previously hired to provide these services the rights to which they would have been entitled if there had been a transfer within the meaning of council directive 2001 / 23 / ec17 .


### member states shall limit the requirement in paragraph to the employees of the previous supplier who are involved in the provision of services for which the previous supplier lost authorisation , and who voluntarily accept to be taken on by the new supplier . ### member states shall limit the recommendation in paragraph to the employees of the previous supplier who are involved in the provision of services for which the previous supplier lost authorisation , and who voluntarily accept to be taken on by the new supplier .


### suppliers of groundhandling services and self - handling airport users shall ensure that all their employees involved in the provision of groundhandling services , including managing staff and supervisors , regularly attend specific and recurrent training to enable them to perform the tasks assigned to them ### suppliers of groundhandling services and self - handling airport users must require that all their employees involved in the provision of groundhandling services , including managing staff and supervisors , regularly attend specific and recurrent training , harmonised at european level , to enable them to perform those tasks assigned to them


### where relevant for the activity of groundhandling services in question , training shall cover at least ### where relevant for the type of groundhandling services in question , training , the scope and manner of execution of which shall be determined by regulations in the individual member states , shall cover at least :


### where relevant for the activity of groundhandling services in question , training shall cover at least : ### where relevant for the activity of groundhandling services in question , training which is harmonised at a european level and can be completed using specific tests appropriate to certain member states shall cover , at least :


### where relevant for the activity of groundhandling services in question , training shall cover at least : ### the specific content of the tests and courses and their proper conduct shall be regulated by national provisions in the member states . where relevant for the activity of the groundhandling services in question , training and tests shall cover at least :


### functional training for passenger handling , including training on passenger boarding bridge training and passenger information and assistance in accordance with regulations no 261 / 2004 and no 1107 / 2006 ; ### functional training for passenger handling , with emphasis on those passengers with special needs , in particular those with limited mobility or disabilities ; including training on passenger boarding bridge training and passenger information and assistance in accordance with regulations no 261 / 2004 and no 1107 / 2006 ;


### emergency measures and contingency management ; ### emergency measures , first aid training and contingency management ;


### training features ; ### the state of training and further training with reference to the fields listed in article 34 to ; examination of the connection between delays caused by groundhandling services and the state of training and further training ;


### transfer of staff and its impact on the protection of employees ; ### transfer of staff , if applicable , and its impact on the protection of employees ;


### employment and working conditions in the groundhandling sector . ### employment and working conditions in the groundhandling sector , particularly trends in wages and salaries in comparison with trends in the prices charged for handling and in comparison with changes in the productivity of groundhandling services at the airport as a whole and those supplied by individual groundhandling service providers .


### on the basis of this report the commission may decide if a revision of this regulation is necessary . ### on the basis of this report the commission , in close cooperation with the european parliament , may decide if a revision of this regulation is necessary .


### the evolution and specialisation of agriculture and forestry and the particular challenges faced by micro - , small and medium - sized enterprises in rural areas require an appropriate level of technical and economic training as well as an increased capacity to access and exchange knowledge and information including in the form of diffusion of best agricultural and forestry production practices . knowledge transfer and information actions should take not only the form of traditional training courses but be adapted to the needs of rural actors . workshops , coaching , demonstration activities , information actions but also short - term farm exchange or visit schemes should therefore also be supported . knowledge and information acquired should enable farmers , forest holders , persons engaged in the food sector and rural smes to enhance in particular their competitiveness and resource efficiency and improve their environmental performance while at the same time contributing to the sustainability of the rural economy . in order to ensure that knowledge transfer and information actions are effective in delivering these results it should be required that the providers of knowledge transfer services have all the appropriate capabilities . ### the evolution and specialisation of agriculture and forestry and the particular challenges faced by micro - , small and medium - sized enterprises in rural areas require an appropriate level of technical and economic training as well as an increased capacity to access and exchange knowledge and information including in the form of diffusion of best agricultural and forestry production practices . knowledge transfer and information actions should take not only the form of traditional training courses but be adapted to the needs of rural actors . workshops , coaching , demonstration activities , information actions , regional platforms for exchanging experiences but also short - term farm exchange or visit schemes should therefore also be supported . knowledge and information acquired should enable farmers , forest holders , persons engaged in the food sector and rural smes to enhance in particular their competitiveness and resource efficiency and improve their environmental performance while at the same time contributing to the sustainability of the rural economy . in order to ensure that knowledge transfer and information actions are effective in delivering these results it should be required that the providers of knowledge transfer services have all the appropriate capabilities .


### the creation and development of new economic activity in the form of new farms , new businesses or new investments in non - agricultural activities is essential for the development and competitiveness of rural areas . a farm and business development measure should facilitate the initial establishment of young farmers and the structural adjustment of their holdings after initial setting up , diversification of farmers into non - agricultural activities and the setting up and development of non - agricultural smes in rural areas . the development of small farms which are potentially economically viable should also be encouraged . in order to ensure the viability of new economic activities supported under this measure , support should be made conditional on the submission of a business plan . support for business start up should cover only the initial period of the life of a business and not become operating aid . therefore , where member states opt to grant aid in instalments these should be for a period of no more than five years . in addition in order to encourage the restructuring of the agricultural sector , support in the form of annual payments should be provided for farmers participating in the small farmers scheme established by title v of regulation no dp / 2012 who commit to transfer their entire holding and the corresponding payment entitlements to another farmer who does not participate in that scheme . ### the creation and development of new economic activity in the form of new farms , new areas of activity , new agriculture - or forestry - related businesses or new investments in non - agricultural activities , new investments in social agriculture and new investments in tourist activity is essential for the development and competitiveness of rural areas . a farm and business development measure should facilitate the initial establishment of young farmers and the structural adjustment of their holdings after initial setting up , diversification of farmers into non - agricultural activities and the setting up and development of non - agricultural smes in rural areas . the development of small agriculture - and forestry - related businesses which are potentially economically viable should also be encouraged . in order to ensure the viability of new economic activities supported under this measure , support should be made conditional on the submission of a business plan . support for business start up should cover only the initial period of the life of a business and not become operating aid . therefore , where member states opt to grant aid in instalments these should be for a period of no more than five years . in addition in order to encourage the restructuring of the agricultural sector , support in the form of annual payments should be provided for farmers participating in the small farmers scheme established by title v of regulation no dp / 2012 who commit to transfer their entire holding and the corresponding payment entitlements to another farmer who does not participate in that scheme .


### smes are the backbone of the union rural economy . farm and non - agricultural business development should be aimed at employment promotion and the setting up of quality jobs in rural areas , maintenance of already existing jobs , reduction of seasonality fluctuations in employment , development of non - agricultural sectors outside agriculture and agricultural and food processing while fostering at the same time business integration and local inter - sectoral links . projects integrating at the same time agriculture , rural tourism through promotion of sustainable and responsible tourism in rural areas , natural and cultural heritage should be encouraged as well as renewable energy investments . ### smes are the backbone of the union rural economy . farm and non - agricultural business development should be aimed at employment promotion and the setting up of quality jobs in rural areas , above all for young people , maintenance of already existing jobs , reduction of seasonality fluctuations in employment , development of non - agricultural sectors outside agriculture and agricultural and food processing while fostering at the same time business integration and local inter - sectoral links . projects integrating at the same time agriculture , rural tourism through promotion of sustainable and responsible tourism in rural areas , natural and cultural heritage should be encouraged as well as renewable energy investments .


### the development of local infrastructure and local basic services in rural areas , including leisure and culture , the renewal of villages and activities aimed at the restoration and upgrading of the cultural and natural heritage of villages and rural landscapes is an essential element of any effort to realise the growth potential and promote the sustainability of rural areas . support should therefore be granted to operations with this aim , including the access to information and communication technologies and the development of fast and ultra - fast broadband . in line with these objectives , development of services and infrastructure leading to social inclusion and reversing trends of social and economic decline and depopulation of rural areas should be encouraged . in order to achieve the maximum effectiveness for such support , covered operations should be implemented in accordance with plans for the development of municipalities and their basic services , where such plans exist , elaborated by one or more rural communes . in order to ensure coherence with the unions climate objectives the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of defining the types of renewable energy infrastructure that shall be eligible for support ### the development of local infrastructure and local basic services in rural areas , including leisure and culture , the renewal of villages and activities aimed at the restoration and upgrading of the cultural and natural heritage of villages and rural landscapes is an element without which it is not possible to realise the growth potential and promote the sustainability of rural areas . support should therefore be granted to operations with this aim , including the access to information and communication technologies and the development of fast and ultra - fast broadband . in line with these objectives , development of services and infrastructure leading to social inclusion and reversing trends of social and economic decline and depopulation of rural areas should be encouraged . in order to achieve the maximum effectiveness for such support , covered operations should be implemented in accordance with plans for the development of municipalities and their basic services , where such plans exist , elaborated by one or more rural communes . in order to ensure coherence with the unions climate objectives the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of defining the types of renewable energy infrastructure that shall be eligible for support


### in order to ensure efficient use of union funds and equal treatment for farmers across the union mountain areas and areas facing natural or other specific constraints should be defined in accordance with objective criteria . in the case of areas facing natural constraints these should be bio - physical criteria underpinned by robust scientific evidence . transitional arrangements should be adopted in order to facilitate the phasing out of payments in areas that will no longer be considered as areas facing natural constraints as a result of the application of these criteria . ### in order to ensure efficient use of union funds and equal treatment for farmers across the union mountain areas and areas facing natural or other specific constraints should be defined in accordance with objective criteria . in the case of areas facing natural constraints these should be criteria underpinned by robust scientific evidence which take account of the specific characteristics and development objectives of the areas concerned and which are properly tailored to the scale of the inherent natural disadvantages those areas face and the type of production and / or the economic structure of holdings in a given area .


### implementation of innovative projects in the context of the eip for agricultural productivity and sustainability should be undertaken by operational groups bringing together farmers , researchers , advisors , businesses and other actors concerned by innovation in the agricultural sector . in order to ensure that results of such projects profit to the sector as a whole , their results should be disseminated . ### implementation of innovative projects in the context of the eip for agricultural productivity and sustainability should be undertaken by operational groups bringing together farmers , researchers , advisors , businesses and other actors concerned by innovation in the agricultural sector . in order to ensure that results of such projects profit to the sector as a whole , the dissemination of their results should be encouraged and dissemination activities should be financed as part of technical assistance .


### the eafrd shall contribute to the europe 2020 strategy by promoting sustainable rural development throughout the union in a complementary manner to the other instruments of the common agricultural policy , to cohesion policy and to the common fisheries policy . it shall contribute to a more territorially and environmentally balanced , climate - friendly and resilient and innovative union agricultural sector . ### the eafrd shall contribute to the europe 2020 strategy by promoting sustainable rural development and economic growth in rural areas throughout the union in a complementary manner to the other instruments of the common agricultural policy , to cohesion policy and to the common fisheries policy . it shall contribute to a more territorially and environmentally balanced , climate - friendly and resilient and competitive , productive and innovative union agricultural , food and forestry sector .


### support under paragraph 1 shall be granted to farmers or members of the farm household diversifying into non - agricultural activities and to non - agricultural micro - and small - enterprises in rural areas . ### support under paragraph 1 shall be granted to farmers or members of the farm household diversifying into non - agricultural activities , to other inhabitants of rural areas and to non - agricultural micro - and small - enterprises in rural areas .


### support under paragraph 1 shall be granted to non - agricultural micro - and small - enterprises in rural areas and to farmers or members of the farm household . ### support under paragraph 1 shall be granted to non - agricultural micro - and small - enterprises in rural areas and to farmers or members of the farm household and to other inhabitants of rural areas .


### agri - environment - climate payments shall be granted to farmers , groups of farmers or groups of farmers and other land - managers who undertake , on a voluntary basis , to carry out operations consisting of one or more agri - environment - climate commitments on agricultural land . where duly justified to achieve environmental objectives , agri - environment - climate payments may be granted to other land - managers or groups of other land - managers . ### agri - environment - climate payments shall be granted to farmers , groups of farmers or groups of farmers and other land - managers who undertake , on a voluntary basis , to carry out operations consisting of one or more agri - environment - climate commitments on agricultural land or land suitable for agriculture or who have invested in measures to adapt to climate change . where duly justified to achieve environmental objectives , agri - environment - climate payments may be granted to groups of farmers .


### agri - environment - climate payments cover only those commitments going beyond the relevant mandatory standards established pursuant to chapter i of title vi of regulation no hr / 2012 and other relevant obligations established under chapter 2 of title iii of regulation no dp / 2012 , relevant minimum requirements for fertiliser and plant protection products use as well as other relevant mandatory requirements established by national legislation . all such mandatory requirements shall be identified in the programme . ### agri - environment - climate payments cover only those commitments going beyond the relevant mandatory standards established pursuant to chapter i of title vi of regulation no hr / 2012 , relevant minimum requirements for fertiliser and plant protection products use as well as other relevant mandatory requirements established by national legislation . all such mandatory requirements shall be identified in the programme


### payments shall be granted annually and shall compensate beneficiaries for all or part of the additional costs and income foregone resulting from the commitments made . where necessary they may also cover transaction costs to a value of up to 20% of the premium paid for the agri - environment - climate commitments . where commitments are undertaken by groups of farmers , the maximum level shall be 30% . ### payments shall be granted annually and shall compensate beneficiaries for all or part of the additional costs and income foregone resulting from the commitments made . where necessary they may also cover transaction costs to a value of up to 20% of the premium paid for the agri - environment - climate commitments . where commitments are undertaken by groups of farmers , the maximum level shall be 30% . funding from the eafrd may be used for measures which come under chapter 2 of title iii of regulation no dz / 2012 .


### additional costs and income foregone shall be calculated in comparison to areas which are not affected by natural or other specific constraints , taking into account payments pursuant to chapter 3 of title iii of regulation no dp / 2012 . ### additional costs and income foregone shall be calculated in comparison to areas which are not affected by natural or other specific constraints , taking into account payments pursuant to chapter 3 of title iii of regulation no dp / 2012 . payments shall be duly differentiated , taking into account : - the situation and development objectives peculiar to a region , - the severity of any permanent natural handicap affecting farming activities , - the type of production and , where appropriate , the economic structure of the holding .


### in addition to the tasks referred to in article 30 of regulation no [ csf / 2012 ] local action groups may also perform additional tasks delegated to them by the managing authority and / or the paying agency . ### in addition to the tasks referred to in article 30 of regulation no [ csf / 2012 ] local action groups may also :


### local action groups may request the payment of an advance from the competent paying agency if such possibility is provided for in the rural development programme . the amount of the advances shall not exceed 50% of the public support related to the running and animation costs . ### local action groups may request the payment of an advance from the competent paying agency if such possibility is provided for in the rural development programme . the amount of the advances shall not exceed 80% of the public support related to the running and animation costs .


### shall examine the activities and outputs related to the evaluation plan of the programme ; ### shall examine the evaluation plan presented by the managing authority and progress in its implementation .


### by 31 may 2016 and by 31 may each subsequent year until and including 2023 , the member state shall submit to the commission an annual implementation report on implementation of the rural development programme in the previous calendar year . the report submitted in 2016 shall cover the calendar years 2014 and 2015 . ### by 30 june 2016 and by 30 june each subsequent year until and including 2022 , the member state shall submit to the commission an annual implementation report on implementation of the rural development programme in the previous calendar year . the final implementation report shall be submitted by the member state by 31 december 2023 . the report submitted in 2016 shall cover the calendar years 2014 and 2015 .


### in its policy orientations on road safety 2011 - 2020 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community . a new cab profile will also contribute to improving road safety by reducing the blind spot in the drivers’ vision , including under the windscreen , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile could also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver’s comfort and safety . ### in its policy orientations on road safety 2011 - 2020 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community . a new cab profile will also contribute to improving road safety by reducing the blind spot in the drivers ' vision , including under the windscreen , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile must also incorporate energy absorption structures in the event of a collision , in the light of the successful implementation of directive 2003 / 102 / ec . the potential gain in the volume of the cab would also improve the driver ' s comfort , in the interest of job quality , and the driver’s safety .


### in its policy orientations on road safety 2011 - 20207 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community8 . a new cab profile will also contribute to improving road safety by reducing the blind spot in the drivers ' vision , including under the windscreen , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile could also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver ' s comfort and safety . __________________ 7 com 389 8 com 258 ### in its policy orientations on road safety 2011 - 20207 , the commission set out measures to make vehicles safer and better protect vulnerable road users . the importance of visibility for vehicle drivers was also underlined in the commission’s report to the european parliament and the council on the implementation of directive 2007 / 38 / ec on the retrofitting of mirrors to heavy goods vehicles registered in the community8 . however , safety improvements will not come automatically after the re - design and the extension of the cab . safety has to be addressed by the general safety regulation and under the corresponding unece legislation . in these legislations , additional safety measures may be introduced to reduce the blind spot in the driver’s vision , including under the windscreen and to avoid potential collisions so as to help save the lives of many vulnerable road users such as pedestrians or cyclists . this new profile could also incorporate energy absorption structures in the event of a collision . the potential gain in the volume of the cab would also improve the driver’s comfort and safety . __________________ 7 com 389 8 com 258


### – ‘ hybrid propulsion vehicle’ means a vehicle within the meaning of directive 2007 / 46 / ec of the european parliament and of the council of 5 september 2007 establishing a framework for the approval of motor vehicles and their trailers , and of systems , components and separate technical units intended for such vehicles10 , equipped with one or more traction motor operated by electric power and not permanently connected to the grid and one or more traction motor operated by internal combustion ; __________________ 10 oj l 263 , 9 . 10 . 2007 , p . 1 . ### – ‘ alternative fuels’ means fuels which provide a substitute for fossil oil sources in the energy supply to transport and which have the potential to contribute to the decarbonisation of transport . they include : – electricity , – hydrogen , – biofuels as defined in directive 2009 / 28 / ec of the european parliament and of the council , – synthetic fuels , – natural gas , including biomethane , in gaseous form and liquefied form , – liquefied petroleum gas , and – waste heat .


### – ‘ intermodal transport unit’ means a unit belonging to one of the following categories : container , swap body , semi - trailer ; ### ‘ intermodal transport unit’ means a unit belonging to one of the following categories : container , swap body , semi - trailer , truck ;


### day and night markings , effective even in poor weather conditions , that allows other road users to gauge the external bodywork of the vehicle , ### day and night markings in accordance with type - approval rules on the installation of lighting and light - signalling devices , effective even in poor weather conditions , that allow other road users to gauge the external bodywork of the vehicle ,


### before being put on the market , the additional aerodynamic devices and their installation on vehicles shall be authorised by the member states , which shall issue a certificate to this effect , attesting compliance with the requirements mentioned in paragraph 2 above and indicating that the device contributes significantly to improving aerodynamic performance . the certificates of authorisation issued in one member state shall be recognised by the other member states . ### before being put on the market , the additional aerodynamic devices and their installation on vehicles shall be authorised by the member states . the rules governing vehicle authorisation throughout europe must be identical and applicable in practice . member states shall issue a certificate accordingly , attesting compliance with the requirements mentioned in paragraph 2 above and indicating that the device contributes significantly to improving aerodynamic performance . the certificates of authorisation issued in one member state shall be recognised by the other member states .


### - the comfort and safety of the drivers . ### - the comfort and safety of the drivers with a view to improving workplace conditions .


### the maximum dimensions laid down in annex i points 1 . 1 and 1 . 6 may be exceeded by 15 cm for vehicles or combinations of vehicles engaged in the transport of 45 - foot containers or swap bodies , if the road transport of the container or swap body is part of an intermodal transport operation . ### to enhance intermodal / combined transport performance and increase energy efficiency , the dimensions of vehicles / vehicle combinations shall be adapted to intermodal transport unit specifications in compliance with the maximum admissible dimensions specified in annex i .


### an overload of more than 20 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall be considered a very serious infringement within the meaning of this directive , because of the increased risks incurred by other road users . this shall give rise to an immediate immobilisation of the vehicle for unloading until it reaches the maximum authorised weight , and to a financial penalty . the procedure leading to the loss of good repute of the transport company shall be implemented in accordance with article 6 of regulation no 1071 / 200914 . __________________ 14 oj l300 , 14 . 11 . 2009 , p . 51 . ### an overload of more than 20 % of the maximum authorised weight in points 2 , 3 , 4 . 1 and 4 . 3 of annex 1 shall be considered a very serious infringement within the meaning of this directive , because of the increased risks incurred by other road users . this shall give rise to an immediate immobilisation of the vehicle for unloading until it reaches the maximum authorised weight , and to a penalty .


### for the transport of containers , the shipper shall give the road haulier to whom it entrusts the transport of a container a statement indicating the weight of the container moved . if this information is missing or incorrect , the shipper shall incur liability in the same way as the haulier if the vehicle is overloaded . ### for the transport of containers , the shipper shall give the road haulier to whom it entrusts the transport of a container a statement indicating the weight of the container moved . if this information is missing or incorrect , the shipper shall incur liability in the same way as all transport sectors involved if the vehicle is overloaded .


### sustainable development of air transport necessitates the introduction of measures aimed at reducing the noise nuisance from aircraft at airports with particular noise problems . a large number of eu citizens are exposed to high noise levels which may lead to negative health effects . ### sustainable development of air transport necessitates the introduction of measures aimed at reducing the noise nuisance from aircraft at airports with noise problems . a large number of eu citizens are exposed to high noise levels which may lead to negative health effects .


### to facilitate the achievement of specific environmental noise abatement objectives , as laid down in union , national and local rules , and to assess their interdependence with other environmental objectives , at the level of individual airports ; ### to facilitate the achievement of specific environmental noise abatement objectives , as laid down in union , national and local rules , and to assess their interdependence with other environmental objectives , including health aspects , at the level of individual airports ;


### to enable selection of the most cost - effective noise mitigation measures in accordance with the balanced approach so as to achieve the sustainable development of the airport and air traffic management network capacity from a gate - to - gate perspective . ### to enable selection of the most cost - effective noise mitigation measures in accordance with the balanced approach so as to achieve the sustainable and responsible development of the airport and air traffic management network capacity from a gate - to - gate perspective .


### this regulation shall apply to aircraft engaged in civil aviation . ### this regulation shall apply to movements of aircraft engaged in civil aviation .


### it shall not apply to aircraft engaged in military , customs , police , or similar services . ### it shall not apply to movements of aircraft engaged in military , customs , police , or similar services .


### ‘ balanced approach’ means the method under which the range of available measures , namely reduction of aircraft noise at source , land - use planning and management , noise abatement operational procedures and operating restrictions , is considered in a consistent way with the view to addressing the noise problem in the most cost - effective way on an airport by airport basis . ### ' balanced approach ' means the process established by the international civil aviation organisation under which the range of available measures , namely reduction of aircraft noise at source , land - use planning and management , noise abatement operational procedures and operating restrictions , is considered in a consistent way with the view to minimising the noise problem in the most cost - effective way on an airport by airport basis .


### member states shall adopt a balanced approach in regard to aircraft noise management . to this end , they shall : ### member states shall implement the balanced approach in regard to aircraft noise management , on an airport - by - airport basis , within the scope of this regulation . to this end , they shall assess the noise situation at an individual airport in accordance with annex ii of directive 2002 / 49 . where a noise problem is identified , they shall :


### evaluate the likely cost - effectiveness of the available measures ; ### the likely cost - effectiveness of the noise mitigation measures is evaluated ;


### evaluate the likely cost - effectiveness of the available measures ; ### carry out a formal and comprehensive assessment of the likely cost - effectiveness of the available measures ;


### where the operating restriction concerns the withdrawal of marginally compliant aircraft from an airport , no new services shall be allowed with marginally compliant aircraft at that airport six months after the notification . the competent authorities shall decide on the annual rate for removing marginally compliant aircraft from the fleet of affected operators at that airport , taking due account of the age of the aircraft and the composition of the total fleet . without prejudice to paragraph 3 of article 4 , this rate shall not be more than 20% of that operator’s fleet of marginally compliant aircraft serving that airport . ### where the operating restriction concerns the withdrawal of marginally compliant aircraft from an airport , no new services shall be allowed with marginally compliant aircraft at that airport six months after the notification . the competent authorities shall decide on the annual rate for removing marginally compliant aircraft at that airport . this annual rate may not exceed 20% of movements and must apply uniformly to every operator concerned on the basis of the number of movements of its marginally compliant aircraft at a given airport .


### article 4 is replaced by the following : “2 . where insurance undertakings or reinsurance undertakings authorised in two or more member states have as their parent undertaking the same insurance holding company , non - member - country insurance undertaking , non - member country reinsurance undertaking , mixed financial holding company or mixed - activity insurance holding company , the competent authorities of the member states concerned may reach an agreement as to which of them shall be responsible for exercising supplementary supervision . ” ### article 4 is replaced by the following : “2 . where insurance undertakings or reinsurance undertakings authorised in two or more member states have as their parent undertaking the same insurance holding company , non - member - country insurance undertaking , non - member country reinsurance undertaking , mixed financial holding company or mixed - activity insurance holding company , the competent authorities of the member states concerned may reach an agreement as to which of them shall be responsible for exercising supplementary supervision . where the authorities are unable to reach an agreement , supervision shall be performed by the competent authority of the member state on whose territory the largest subsidiary – based on the balance - sheet criterion – is operating . ”


### when applying method 2 referred to in annex i , the calculation shall take account of the proportional share held by the parent undertaking or undertaking which holds a participation in another entity of the group . ‘ proportional share’ means the proportion of the subscribed capital which is directly or indirectly held by that undertaking . ” ### when applying method 2 referred to in annex i , the calculation shall take account of the proportional share held by the parent undertaking or undertaking which holds a participation in another entity of the group . ‘ proportional share’ means the proportion of the subscribed capital which is directly or indirectly held by that undertaking or , where there are multiple voting shares , of the voting rights pertaining to the shareholders . ”


### they shall apply those provisions from [ 1 july 2011 ] . ### they shall apply those provisions from [ 31 october 2011 ] .


### in order to ensure that measures are taken to maintain the land under permanent pasture at the level of farmers , the commission shall , by means of delegated acts , adopt provisions including individual obligations at the level of farmers to be respected where it is established that the share of land under permanent pasture is decreasing . ' ### in order to ensure that measures are taken to maintain the land under permanent pasture at the level of farmers , the commission shall , by means of delegated acts , adopt provisions including individual obligations to be respected where it is established that the share of land under permanent pasture is decreasing .


### rules on any further measures to be taken by the member states for the proper application of this chapter as well as arrangements for any mutual assistance needed between member states . ### rules which enable the member states to take any further measures for the proper application of this chapter as well as arrangements for any mutual assistance needed between member states .


### rules on the definition in the national legislation for ' inheritance ' and ' anticipated inheritance ' ; ### rules on the definition given in the national legislation for ' inheritance ' and ' anticipated inheritance ' ;


### ' ' competent local authority ' means any competent authority whose geographical area of competence is not national and which covers the transport needs of an urban agglomeration or a rural district ; ### ' ' competent local authority ' means any competent authority whose geographical area of competence is not that of a member state and which covers the transport needs of an urban agglomeration or a rural district ;


### ‘ competent local authority’ means any competent authority whose geographical area of competence is not national and which covers the transport needs of an urban agglomeration or a rural district ; ### ‘ competent local authority’ means any competent authority whose geographical area of competence is not national and which covers the transport needs of , for example , a region , an urban agglomeration or a rural district ;


### operational requirements such as transport of bicycles , traffic management , contingency plan in case of disturbances . ### other operational requirements .


### in the cases referred to in points and , the competent authority shall have the right to require the public service operator to transfer the rolling stock after the expiry of the public service contract to the new operator to whom a contract is awarded . the competent authority may oblige the new public transport operator to take the rolling stock over . the transfer shall be done at market rates . ### in the cases referred to in points and , the competent authority shall have the right to require the public service operator to transfer the rolling stock after the expiry of the public service contract to the new operator to whom a contract is awarded . the competent authority may oblige the new public transport operator to take the rolling stock over . the transfer shall be done at market prices .


### each competent authority shall make public once a year an aggregated report on the public service obligations for which it is responsible , the starting date and duration of the public service contracts , the selected public service operators and the compensation payments and exclusive rights granted to the said public service operators by way of reimbursement . the report shall distinguish between bus transport and rail transport , allow the performance , quality and financing of the public transport network to be monitored and assessed and , if appropriate , provide information on the nature and extent of any exclusive rights granted . member states shall facilitate central access to these reports , for instance through a common web portal . ### each competent authority shall make public once a year an aggregated report on the public service obligations for which it is responsible , the starting date and duration of the public service contracts , the selected public service operators and the compensation payments and exclusive rights granted to the said public service operators by way of reimbursement . the report shall distinguish between bus transport and rail transport , allow the performance , quality and financing of the public transport network to be monitored and assessed and , if appropriate , provide information on the nature and extent of any exclusive rights granted . member states shall facilitate central access to these reports , for instance through a common web portal . the commission shall produce a summary of these reports and submit it , in all the working languages , to the council and parliament .


### this regulation shall enter into force on the day following that of its publication in the official journal of the european union . ### this regulation shall enter into force on the day following its publication in the official journal of the european union . it shall be made available in consolidated form within three months of its entry into force .