### the lists of partner countries under this regulation should be adapted on the basis of possible changes to their status as established by the development assistance committee of the organization for economic cooperation and development , as well as important changes in human development , aid dependency , crisis situations , vulnerability and other aspects including the dynamics of the development process . such updates , reviews of the partner countries eligible for bilateral development cooperation and modifications in the definitions of detailed areas of cooperation and activities , and adjustments of the indicative financial allocation per programme , constitute non - essential elements of this regulation . consequently , in order to adapt its scope to the rapidly evolving reality in third countries , the power to adopt acts in accordance with article 290 of the treaty of the functioning of the european union should be delegated to the commission for updating the annexes of this regulation which includes the list of partner countries and regions eligible for union financing , the definition of detailed areas of cooperation under geographic and thematic programmes and the indicative allocations per programme . it is of particular importance that the commission should carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should further ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### the lists of partner countries under this regulation should be adapted on the basis of possible changes to their status as oda recipients , as established by the development assistance committee of the organization for economic cooperation and development . the lists of partner countries under this regulation should also be adapted to respond to important changes in human development , aid dependency , crisis situations , vulnerability and other aspects included in the eligibility criteria defined in this regulation for the establishment of the different categories of partner countries . for such updates , and for modifications in the definitions of areas of cooperation and activities , and adjustments of the indicative financial allocation per programme , the commission should submit legislative proposals introducing the necessary modifications to annexes i , iii , iv , v , vi and vii of this regulation .


### 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 , including social , economic and cultural rights and fundamental freedoms on which it is founded , through dialogue and cooperation with partner countries and regions . this calls for a rights - based approach , promoting in particular the right to universal and non - discriminatory access to basic services , participation in democratic processes , transparency and accountability .


### 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 , non - discrimination , democracy , good governance , the fight against corruption , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change , conflict prevention and combating hiv / aids .


### 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 , empowerment of women , non - discrimination , democracy , good governance , peace and the prevention of violent conflict , the rights of the child , indigenous peoples ' rights , social inclusion and decent work , the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids .


### inclusive and participatory approaches to development and a broad involvement of all segments of society in the development process and in national and regional dialogue , including political dialogue ; ### inclusive and participatory approaches to development and a broad involvement of all segments of society in the development process and in national and regional dialogue , including political dialogue ; the involvement of all segments of society in the development process shall be achieved through a thorough consultation of , in particular , civil society organisations , and also national parliaments , local authorities , the private sector and trade unions , which shall be given the opportunity to provide their input in a timely manner , while being given access to detailed information about the development projects ;


### within each country programme , the union will in principle concentrate its assistance on three sectors . ### within each country programme , the union will in principle concentrate its assistance on a maximum of three sectors .


### 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 civil society organisations and local authorities originating from partner countries , the union , candidate countries and potential candidates . particular attention should be given to those civil society organizations which are basic services providers , such as education and healthcare services .


### 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 civil society organisations and local authorities originating from partner countries , or , where this is provided for in annex v , 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 commission shall be empowered to adopt delegated acts in accordance with article 18 to approve strategy papers and multiannual indicative programmes for geographic programmes and thematic programmes . 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 . ### 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 or other implementing bodies , at an early stage of and throughout the programming process in order to promote complementarity and consistency among their cooperation activities , while keeping the european parliament fully involved . whenever possible and relevant , that consultation shall lead to joint programming between the union and its member states , coordinated by the union or a member state appointed as lead .


### multiannual indicative programmes shall be drawn up for each of the countries or regions receiving an indicative allocation of union funds under this regulation except for countries or regions mentioned in paragraph 4 , these documents shall be drawn up on the basis of the strategy papers or similar documents referred to in this article . for the purpose of this regulation , where it complies with the principles and conditions established in this paragraph , including an indicative allocation of funds , and with the procedures provided for in article 14 , the joint multiannual programming document provided for in paragraph 3 may be considered as the multiannual indicative programme . 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 . the multiannual indicative programmes should be adjusted where necessary , taking into account any mid - term or ad hoc reviews of the strategy document on which they are based . pursuant to the principle of mutual accountability in the pursuit and fulfilment of agreed objectives , including those referring to good governance , democracy and respect for human rights and to the rule of law , indicative allocations may be increased or decreased as a result of reviews , particularly in the light of special needs such as those resulting from a crisis , post - crisis or fragility situation , or where performance has been exceptional or unsatisfactory . ### multiannual indicative programmes shall be drawn up for each of the countries or regions receiving an indicative allocation of union funds under this regulation except for countries or regions mentioned in paragraph 4 , these documents shall be drawn up on the basis of the strategy papers or similar documents referred to in this article . for the purpose of this regulation , where it complies with the principles and conditions established in this paragraph , including an indicative allocation of funds , and with the procedures provided for in article 14 , the joint multiannual programming document provided for in paragraph 3 may be considered as the multiannual indicative programme . multiannual indicative programmes shall set out the priority areas selected for union financing , the specific objectives , the expected results , the performance indicators , the commitments to be fulfilled by partner countries regarding human rights and reforms towards democratisation , the indicative financial allocation , both overall and per priority area and the conditions for suspension of assistance or re - allocation of funds . where appropriate , this allocation may be given in the form of a range and / or some funds may be left unallocated . the multiannual indicative programmes should be adjusted where necessary , taking into account any mid - term or ad hoc reviews of the strategy document on which they are based . serious and systematic violations of human rights shall trigger an automatic ad hoc review of the strategy document . mid - term ad hoc reviews shall be communicated to the european parliament and the council and shall be made public and available to local stakeholders . pursuant to the principle of mutual accountability in the pursuit and fulfilment of agreed objectives , including those referring to good governance , democracy and respect for human rights and to the rule of law , indicative allocations may be increased or decreased as a result of reviews , particularly in the light of special needs such as those resulting from a crisis , post - crisis or fragility situation , or where performance has been exceptional or unsatisfactory . the review process shall allow for consultation with local and international civil society organisations . the european parliament and the council shall be kept fully informed .


### the multiannual indicative programmes should be adjusted where necessary , taking into account any mid - term or ad hoc reviews of the strategy document on which they are based . ### the multiannual indicative programmes may be reviewed , taking into account any mid - term or ad hoc reviews of the strategy document or , where appropriate , any revisions of the national development plans on which they are based .


### 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 , 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 . these efforts shall be coordinated with other possible initiatives being taken by the union and member states , namely under regulation no [ … / … ] of the european parliament and of the council establishing an instrument for stability . 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 , 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 , fragility situations or prone to natural disasters , 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 , as well as to the role of women in those processes . 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 and prevention and for managing the consequences of such disasters and shall address vulnerability to shocks and strengthen people ' s resilience .


### in cases of crises , post crisis and fragility situations or threats to democracy , the rule of law , human rights or fundamental freedoms requiring a swift response by the union , the urgency procedure provided for in article 15 of the common implementing regulation may be used to modify the document referred to in article 11 following an ad hoc review of the country ' s or region ' s cooperation strategy . such reviews may propose a specific and adapted strategy to ensure the transition to long - term cooperation and development , promoting a better coordination and transition between the humanitarian and development policy instruments . ### in cases of crises , post crisis and fragility situations or threats to democracy , peace and stability , the rule of law , human rights or fundamental freedoms requiring a swift response by the union , the urgency procedure provided for in article 15 of the common implementing regulation may be used to modify the document referred to in article 11 following an ad hoc review of the country ' s or region ' s cooperation strategy . the european parliament shall be kept fully informed . any measures undertaken shall not impede and be fully coordinated with any measures undertaken under 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 , as well as any future actions by the union to promote democracy . such reviews may propose a specific and adapted strategy to ensure the engagement of possible new actors in partner countries , the transition to long - term cooperation and development , promoting a better coordination and transition between the peace - building , conflict prevention , humanitarian and development policy instruments .


### in cases of crises , post crisis and fragility situations or threats to democracy , the rule of law , human rights or fundamental freedoms requiring a swift response by the union , the urgency procedure provided for in article 15 of the common implementing regulation may be used to modify the document referred to in article 11 following an ad hoc review of the country ' s or region ' s cooperation strategy . ### in cases of military , institutional or humanitarian crises , or threats to democracy , the rule of law , human rights or fundamental freedoms requiring a swift response by the union , the urgency procedure provided for in article 18a of this regulation may be used to modify the document 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 , 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 , the performance indicators , the conditions for the suspension of assistance or the re - allocation of funds , 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 , 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 , for the theme concerned and , with regard to the global public good programme , for each subtheme , the union ' s strategy , 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 complementary to geographic programmes and consistent with the documents referred to in article 11 , and shall be drawn up and in accordance with the human rights - based approach .


### 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 multiannual indicative programmes shall give the indicative financial allocation , both overall and by priority area under each theme and , for the global public goods programme , each subtheme . where appropriate , this allocation may be given in the form of a range . multiannual indicative programmes shall be reviewed at mid - term , and ad - hoc where necessary to respond to unforeseen challenges or implementation problems .


### strategy papers shall be approved and multiannual indicative programmes shall be adopted by the commission in accordance with the examination procedure referred to in article 15 of the common implementing regulation . this procedure shall also apply to substantial reviews which have the effect of significantly modifying the strategy or its programming . ### the commission shall be empowered to adopt delegated acts in accordance with article 18 to approve strategy papers and multiannual indicative programmes . this procedure shall also apply to substantial reviews which have the effect of significantly modifying the strategy or its programming .


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


### without prejudice to the provisions on suspension of aid in partnership and cooperation agreements with partner countries and regions , where a partner country fails to observe the principles referred to in article 3 , the union shall invite the partner country to hold consultations in view of finding a solution acceptable to both parties , except in cases of special urgency . where consultations with the partner country do not lead to a solution acceptable to both parties , or if consultations are refused or in cases of special urgency , the council may take appropriate measures in accordance with article 215 of the treaty on the functioning of the european union , which may include full or partial suspension of union assistance . ### without prejudice to the provisions on suspension of aid in partnership and cooperation agreements with partner countries and regions , where a partner country fails to observe the principles referred to in article 3 , the union shall invite the partner country to hold consultations in view of finding a solution acceptable to both parties , except in cases of special urgency . where consultations with the partner country do not lead to a solution acceptable to both parties , or if consultations are refused or in cases of special urgency , parliament and council may take a decision which may include full or partial suspension of union assistance . any consequent revision of relevant strategic programming documents shall be carried out in accordance with the urgency procedure referred to in article 18a .


### transition from humanitarian aid and crisis response to long - term development cooperation . ### post - disaster reconstruction in developing partner countries , including rapid reaction and increased flexibility , and transition from humanitarian aid and crisis response to long - term development cooperation .


### interventions in partner countries which support vulnerable and marginalised groups in least developed countries by providing basic services delivered through civil society organisations and local authorities ; ### interventions in partner countries which support vulnerable and marginalised groups in least developed countries by improving local governance and providing basic services delivered through local authorities , and by facilitating their participation and representation in local life and in the development process through civil society organisations .


### interventions in partner countries which support vulnerable and marginalised groups in least developed countries by providing basic services delivered through civil society organisations and local authorities ; ### interventions in partner countries which support vulnerable and marginalised groups by providing basic services delivered through civil society organisations and local authorities ;


### local authorities encompass a large variety of sub - national levels and branches of government , i . e . municipalities , communities , districts , counties , provinces , regions etc . ### local authorities encompass a large variety of sub - national levels and branches of government , i . e . municipalities , communities , districts , counties , provinces , regions , and their associations at national , regional and global level .


### – the right of access to a lawyer , where necessary free of charge , ### – the right of access to a lawyer ,


### – the right to be informed of the charge and , where appropriate , to be given access to the case - file , ### – the right to be informed of the charge and , where appropriate , to be given access to evidentiary materials of the case ,


### member states shall ensure that , where the suspected or accused person does not speak or understand the language of the proceedings , he receives the letter of rights in a language he understands . member states shall ensure that a mechanism is in place to convey the information to a suspected or accused person who is partially sighted or cannot read . where the suspected or accused person is a child , the information contained in the letter of rights shall also be provided orally in a manner adapted to the child ' s age , level of maturity and intellectual and emotional capacities . ### member states shall ensure that , where the suspected or accused person does not speak or understand the language of the proceedings , he receives the letter of rights in a language he understands . member states shall ensure that a mechanism is in place to convey the information to a suspected or accused person who is partially sighted or cannot read . where the suspected or accused person is vulnerable due to age , incapacity or any other reason , the information contained in the letter of rights shall also be provided orally in a manner adapted to the person ' s age , level of maturity and intellectual and emotional capacities .


### where a letter of rights is not available in the appropriate language , the suspected or accused person shall be informed of his rights orally in a language he understands . a letter of rights in a language he understands shall then be given to him without undue delay . ### in the exceptional case that a letter of rights is not available in the appropriate language , the suspected or accused person shall be informed of his rights orally in a language he understands . a letter of rights in a language he understands shall then be given to him without undue delay .


### the right to access to the case - file ### the right to access evidentiary materials of the case


### where a suspected or accused person is arrested at any stage of the criminal proceedings , member states shall ensure that he or his lawyer is granted access to those documents contained in the case - file which are relevant for the determination of the lawfulness of the arrest or detention . ### where a suspected or accused person is arrested or detained at any stage of the criminal proceedings , member states shall ensure that he or his lawyer is granted access to documents which are relevant for the determination of the lawfulness of the arrest or detention .


### member states shall ensure that an accused person or his lawyer is granted access to the case - file once the investigation of the criminal offence is concluded . access to certain documents contained in the case - file may be refused by a competent judicial authority where access to these documents may lead to serious risk to the life of another person or may seriously harm the internal security of the member state in which the proceedings take place . where it is in the interests of justice , the accused person or his lawyer may request an index of the documents contained in the case - file . ### member states shall ensure that an accused person or his lawyer is granted access to the evidentiary materials of the case once the investigation of the criminal offence is concluded . access to certain documents may be refused by a competent judicial authority where access to these documents may lead to serious risk to the life of another person or may seriously harm the internal security of the member state in which the proceedings take place . where it is in the interests of justice , the accused person or his lawyer may request an index of the evidentiary materials of the case .


### member states shall ensure that a procedure is in place to ascertain whether a suspected or accused person has received all information relevant to him in accordance with articles 3 to 7 . ### member states shall ensure that a procedure is in place to ascertain whether a suspected or accused person has received all information relevant to him in accordance with this directive .


### having regard to the treaty on the functioning of the european union , and in particular article 114 thereof , ### having regard to the treaty on the functioning of the european union , and in particular articles 114 and 168 thereof ,


### disparities in national measures may hinder or distort intra - union trade in medicinal products and distort competition , thereby directly affecting the functioning of the internal market in medicinal products . ### disparities in national measures may hinder or distort intra - union trade in medicinal products , thereby directly affecting the functioning of the internal market in medicinal products .


### 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 and the biosimilarity of 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 , bioequivalence or biosimilarity of the medicinal product .


### 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 with the reference product and the similarity of biosimilar medicinal products , are ascertained in the framework of marketing authorisation procedures and may be re - assessed in the framework of pricing and reimbursement procedures .


### 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 guarantee that the marketing authorisation holder has the possibility to introduce an application to approve the price of the product . 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 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 guarantee that the marketing authorisation holder has the possibility to introduce an application to increase the price of a medicinal product . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### 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 reasoned and objectively justified 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 . that decision should be made available to the public in a clear and transparent manner within a reasonable time following adoption .


### 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 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 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 90 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 . with respect to generic medicinal products , that time limit shall be 30 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 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 30 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 .


### 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 publish a statement of reasons for its decision , including , if applicable , a justification of the categories of products subject to the price freeze or price reduction .


### 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 guarantee that the marketing authorisation holder has the possibility to introduce an application for a derogation . 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 . 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 guarantee that the marketing authorisation holder has the possibility to introduce an application to include a medicinal product in the scope of the public health insurance system . 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 a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . 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 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 90 days of its receipt . 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 .


### the body referred to in paragraph 2 shall state reasons for its decision . furthermore , where that body is not judicial in character , provision must be made to guarantee procedures whereby any allegedly illegal measure taken by the independent body or any alleged defect in the exercise of powers conferred on it can be subject to judicial review or review by another body which is a court or tribunal within the meaning of article 267 of the treaty on the functioning of the european union and independent of both the competent authority and the body referred to in paragraph 2 . ### the body referred to in paragraph 2 shall state reasons for its decision . furthermore , where that body does not have judicial authority , provision must be made to guarantee procedures whereby any allegedly illegal measure taken by the independent body or any alleged defect in the exercise of powers conferred on it can be subject to judicial review or review by another body which is a court or tribunal within the meaning of article 267 of the treaty on the functioning of the european union and independent of both the competent authority and the body referred to in paragraph 2 .


### member states shall publish in an appropriate publication and communicate to the commission the objective and verifiable criteria according to which medicinal products are classified in view of their inclusion in the public health insurance system . ### member states shall make publicly available and communicate to the commission the objective and verifiable criteria according to which medicinal products are classified in view of their inclusion in the public health insurance system .


### for the medicinal products subject to such grouping or classification , member states shall publish in an appropriate publication and communicate to the commission the methodologies used to determine the extent or conditions of their inclusion in the public health insurance system . ### for the medicinal products subject to such grouping or classification , member states shall make publicly available and communicate to the commission the methodologies used to determine the extent or conditions of their inclusion in the public health insurance system .


### 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 may re - assess the elements on which the marketing authorisation is based , including the quality , safety or efficacy of the medicinal product .


### ambiguity exists as to whether member states may require the takeover of staff upon a change of provider for groundhandling services to which access is limited . discontinuity of staff can have a detrimental effect on the quality of groundhandling services . it is therefore appropriate to clarify the rules on the takeover of staff beyond the application of directive 2001 / 23 / ec on transfers of undertakings enabling member states to ensure adequate employment and working conditions . ### member states should ensure legally and without any ambiguity the takeover of staff upon a change of provider for groundhandling services . discontinuity of staff has a detrimental effect on the quality of groundhandling services . the rules on the transfer of staff beyond the application of directive 2001 / 23 / ec on the change of groundhandling providers enabling member states to safeguard employee´s rights , high labour standards and decent working conditions should be amended where necessary via provisions for the transfer of staff . dismissal on economic , technical or organisational grounds should not be permitted in this context .


### 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 , education and training have a strong impact on service quality and the safety of operations . the competent authorities in the member states in cooperation with easa , airport operators and the social partners should set ambitious minimum standards to ensure the highest quality for education and training of employees in the groundhandling sector . these standards should be regularly updated and developed in order to contribute to the quality of operations in terms of reliability , resilience , safety and security , and to create a level playing field among operators . no new service providers should be approved until the required standards are met at the respective airport .


### safeguarding of employees ' rights in the event of transfer of staff for services subject to market access restrictions ### safeguarding of employees ' rights in the event of transfer of staff


### this article applies only to groundhandling services for which the member state concerned has limited the number of suppliers in accordance with article 6 or 14 . ### this article applies to all groundhandling services .


### 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 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 accept to be taken on by the new supplier or self - handling airport user . the costs of redundancy plans for departing staff shall be borne by airport users in proportion to their share of traffic .


### the commission shall submit a report to the european parliament and the council on the implementation of this regulation not later than 5 years after the date of application of this regulation . the report shall in particular assess any significant impact on the quality of groundhandling services , employment and working conditions . the report shall include the following set of indicators and criteria for a sample of airports : ### the commission shall submit a report to the european parliament and the council on the implementation of this regulation not later than 3 years after the date of application of this regulation . the report shall in particular assess the impact on the quality of groundhandling services as well as employment and working conditions . the report shall examine the following indicators and criteria :


### 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 prices charged for groundhandling 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 .


### to ensure the sustainable development of rural areas , it is necessary to focus on a limited number of core priorities relating to knowledge transfer and innovation in agriculture , forestry and rural areas , the competitiveness of all types of agriculture and farm viability , food chain organisation and risk management in agriculture , restoring , preserving and enhancing ecosystems dependant on agriculture and forestry , resource efficiency and the shift towards a low carbon economy in the agricultural , food and forestry sectors , and promoting social inclusion , poverty reduction and the economic development of rural areas . in doing so account must be taken of the diversity of situations that affect rural areas with different characteristics or different categories of potential beneficiaries and the cross - cutting objectives of innovation , environment and climate change mitigation and adaptation . mitigation action should relate to both limiting emissions in agriculture and forestry from key activities such as livestock production , fertilizer use and to preserving the carbon sinks and enhancing carbon sequestration with regard to land use , land use change and the forestry sector . the union priority for rural development relating to knowledge transfer and innovation in agriculture , forestry and rural areas should apply horizontally in relation to the other union priorities for rural development . ### to ensure the sustainable development of rural areas , it is necessary to focus on a limited number of core priorities relating to knowledge transfer and innovation in agriculture , forestry and rural areas , the competitiveness of all types of agriculture and farm viability and food chain organisation , restoring , preserving and enhancing ecosystems dependant on agriculture and forestry , resource efficiency and the shift towards a low carbon economy in the agricultural , food and forestry sectors , and promoting social inclusion , poverty reduction and the economic development of rural areas . in doing so account must be taken of the diversity of situations that affect rural areas with different characteristics or different categories of potential beneficiaries and the cross - cutting objectives of innovation , environment and climate change mitigation and adaptation . mitigation action should relate to both limiting emissions in agriculture and forestry from key activities such as livestock production , fertilizer use and to preserving the carbon sinks and enhancing carbon sequestration with regard to land use , land use change and the forestry sector . the union priority for rural development relating to knowledge transfer and innovation in agriculture , forestry and rural areas should apply horizontally in relation to the other union priorities for rural development .


### member states should be able to include in their rural development programmes thematic sub - programmes to address specific needs in areas of particular importance to them . thematic sub - programmes should concern among others young farmers , small farms , mountain areas and the creation of short supply chains . thematic sub - programmes should also be used to provide for the possibility to address restructuring of agricultural sectors which have a strong impact on the development of rural areas . as a means to increase the efficient intervention of such thematic sub - programmes member states should be allowed to provide for higher support rates for certain operations covered by them . ### member states should be able to include in their rural development programmes thematic sub - programmes to address specific needs in areas of particular importance to them . thematic sub - programmes should concern among others young farmers , women active in farming , small farms , mountain areas and the creation of short supply chains . thematic sub - programmes should also be used to provide for the possibility to address restructuring of agricultural sectors which have a strong impact on the development of rural areas . as a means to increase the efficient intervention of such thematic sub - programmes member states should be allowed to provide for higher support rates for certain operations covered by them .


### 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 should use the lifelong learning system , which should also 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 and that public - private partnerships are encouraged for services that are geared to all social categories .


### 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 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 , and encourage entrepreneurship among women , including with regard to the 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 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 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 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 , outermost regions 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 .


### 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 as part of a european rural development strategy by promoting sustainable rural development throughout the union in a complementary manner to the other instruments of the common agricultural policy and in a coordinated and complementary manner to cohesion policy and the common fisheries policy . it shall contribute to a more territorially and environmentally balanced , climate - friendly and resilient and innovative union agricultural sector .


### facilitating restructuring of farms facing major structural problems , notably farms with a low degree of market participation , market - oriented farms in particular sectors and farms in need of agricultural diversification ; ### facilitating restructuring and modernisation of farms ;


### facilitating diversification , creation of new small enterprises and job creation ; ### encouraging economic diversification , creation of new enterprises and jobs ;


### mountain areas as referred to in article 33 ; ### mountain areas as referred to in article 33 and areas facing significant natural constraints as referred to in article 33 ;


### support under this measure shall not include courses of instruction or training , which form part of normal education programmes or systems at secondary or higher levels . ### support under this measure shall not include courses of instruction or training , which form part of normal education programmes or systems at secondary or higher levels , but it may include courses organised through the lifelong learning system and retraining , taking account of the needs of players in the rural environment .


### ' agro - forestry systems ' shall mean land use systems in which trees are grown in combination with extensive agriculture on the same land . the maximum number of trees to be planted per hectare shall be determined by the member states taking account of local pedo - climatic conditions , forestry species and the need to ensure agricultural use of the land . ### ' agro - forestry systems ' shall mean land use systems in which trees are grown in combination with extensive agriculture on the same land . the maximum number of trees to be planted per hectare shall be determined by the member states taking account of local pedo - climatic conditions , forestry species and the need to ensure sustainable agricultural use of the land .


### 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 complying with one or more agri - environment - climate commitments . where duly justified to achieve environmental objectives , agri - environment - climate payments may be granted to other land - managers or groups of other land - managers .


### for the purposes of the allocation of the performance reserve referred to in article 20 of regulation no [ csf / 2012 ] , available assigned revenue collected in accordance with article 45 of regulation no hr / 2012 for the eafrd shall be added to the amounts referred to in article 18 of regulation no [ csf / 2012 ] . it shall be allocated to member states proportionally to their share of the total amount of support from the eafrd . ### the available assigned revenue collected in accordance with article 45 of regulation no hr / 2012 for the eafrd shall be allocated to member states proportionally to their share of the total amount of support from the eafrd .


### 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 . a new cab profile will also contribute to improving road safety by reducing the blind spot in the drivers’ vision , including under the windscreen and to the side of the vehicle , which should help save the lives of many vulnerable road users such as pedestrians or cyclists . this new cab profile should therefore , after an appropriate transitional period , become mandatory . this new profile should also incorporate energy absorption structures in the event of a collision and should be streamlined to deflect other road users in case of collisions to avoid overruns . it is essential that new cab designs benefiting from the length exceedances comply with improved direct vision requirements , energy absorption criteria and pedestrian protection requirements . the potential gain in the volume of the cab would also improve the driver’s comfort and safety , which in turn would also impact on the safe driving of vehicles , particularly heavy goods vehicles . in the interests of improving the drivers fitness to drive safer and thereby road safety , it is also essential that the new cab designs improve the size , safety and comfort of the driver’s cabin . __________________ 7 com 389 8 com 258


### secure attachment of the devices in such a way as to reduce their risk of their detachment over time ### secure attachment of the devices in such a way as to ensure that there is no risk of their detachment , even in extreme circumstances


### 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 , effective even in poor weather conditions , that allows other road users to gauge the external bodywork of the vehicle and its bulk outline ,


### before they are put on the market , the aerodynamic performance of new motor vehicle designs shall be tested by member states , who will issue a certificate to this end . this will certify compliance with the requirements of paragraph 2 above . the test certificates issued in one member state shall be recognised by the other member states . ### before they are put on the market the aerodynamic performance of new motor vehicle design shall be tested and certificated by member states . the test certificates issued in one member state shall be recognised by the other member states . the results of the test procedure and aerodynamic performance and other input values of tested lorries shall be made publicly available .


### the power to adopt delegated acts referred to in article 8 , article 9 and article 12 shall be conferred on the commission for an indeterminate period of time from the [ date of entry into force of this directive ] ### the power to adopt delegated acts referred to in article 8 , article 9 and article 12 shall be conferred on the commission for a period of seven years from the [ date of entry into force of this directive ] the commission shall draw up a report in respect of the delegated power no later than nine months before the end of the seven year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### 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 and around airports with particular noise problems . a large number of eu citizens are exposed to high noise levels which may lead to negative health effects , particularly where night flights are concerned .


### while noise assessments should take place on a regular basis , such assessments should only lead to additional noise abatement measures if the current combination of noise mitigating measures does not achieve the noise abatement objectives . ### while noise assessments should take place on a regular basis , such assessments should only lead to additional noise abatement measures if the current combination of noise mitigating measures , or the measures established by directive 2002 / 49 / ec of the european parliament and of the council of 25 june 2002 relating to the assessment and management of environmental noise1 , do not achieve the noise abatement objectives . additional noise abatement measures should be drawn up following a systematic process of environmental monitoring and control and be based on a conservative approach with the aim of identifying promptly the management and / or operational monitoring - based corrective actions required . __________________ 1 oj l 189 , 18 . 7 . 2002 , p . 12


### noise assessments should build on existing information available and ensure that such information is reliable and accessible to competent authorities and stakeholders . competent authorities should put in place the necessary monitoring and enforcement tools . ### in accordance with directive 2002 / 49 / ec , noise assessments should be based on objective and measurable criteria common to all the member states . this information must be reliable , obtained in a transparent manner , comparable and accessible to all stakeholders . assessments should include monitoring of the latest technological developments and exchanges of the latest findings concerning the procedures to be employed . competent authorities should put in place the necessary monitoring and enforcement tools . noise assessments should be carried out or supervised by outside agencies independent of the airport operator .


### this regulation lays down rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis so as to help improve the noise climate and to limit or reduce the number of people significantly affected by the harmful effects of aircraft noise , in accordance with the balanced approach . ### this regulation lays down the rules on the introduction of noise - related operating restrictions in a consistent manner on an airport - by - airport basis and where a noise problem has been identified so as to help improve the noise climate and to limit or reduce the number of people affected by aircraft noise , in accordance with the balanced approach .


### 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 for each individual airport , as laid down in union , national and local rules , and to assess their interdependence with economic , social and other environmental objectives , at the level of individual airports ;


### it shall not apply to aircraft engaged in military , customs , police , or similar services . ### it shall not apply to aircraft flights 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 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 minimising noise in the most effective way taking account of both the health and the economic aspects , on an airport by airport basis to safeguard the health of the citizens living in the nearby areas . .


### member states shall designate competent authorities responsible for adopting measures on operating restrictions , as well as an independent appeal body . ### member states shall designate competent authorities responsible for adopting measures on operating restrictions , as well as an impartial mediating body and an independent appeal body .


### measures or a combination of measures taken in accordance with this regulation for a given airport shall not be more restrictive than necessary to achieve the environmental noise abatement objectives set for that airport . operating restrictions shall be non - discriminatory , in particular on grounds of nationality , identity or activity of aircraft operators . ### measures or a combination of measures taken in accordance with this regulation for a given airport shall not be more restrictive than necessary to meet the terms of the who night noise guidelines for europe and to achieve the health - related and environmental noise abatement objectives set for that airport and the development of the region it serves . operating restrictions shall be non - discriminatory , in particular on grounds of nationality , identity or activity of aircraft operators .


### the competent authorities shall organise the consultation process with interested parties in a timely and substantive manner , ensuring openness and transparency as regards data and computation methodology . interested parties shall have at least three months prior to the adoption of the new measures to provide comments . the interested parties shall at least include : ### the competent authorities shall organise the participatory process with interested parties in a timely and substantive manner , ensuring openness and transparency as regards data and computation methodology . interested parties shall have at least four months prior to the adoption of the new measures to provide comments . where the measures lead to more far - reaching changes or expansions , such as those described in article 4 , interested parties shall have at least nine months prior to the adoption of the new measures to provide comments . the interested parties shall , in addition to the provisions of article 2 , at least include :


### representatives from local residents living in the surroundings of the airports affected by air traffic noise ; ### representatives from local residents living in the surroundings of the airports affected by air traffic noise and associations of affected persons ;


### data shall be stored in a central database and made available to competent authorities , aircraft operators , air navigation service providers and airport operators for operational purposes . ### data shall be stored in a central database for at least five years and made available to competent authorities , aircraft operators , air navigation service providers and airport operators for operational purposes . other interested parties , as described in articles 2 and 5 , shall have access to this information on request .


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


### 3 details of noise contours for the current and previous years – including an assessment of the number of people affected by aircraft noise . ### details of noise contours for the current and at least the last two previous years – including an assessment of the number of people affected by aircraft noise , carried out according to the provisions of annex iii of directive 2002 / 49 / ec .


### 1 descriptions of airport developments already approved and in the pipeline , for example , increased capacity , runway and / or terminal expansion , and the projected future traffic mix and estimated growth . ### 1 descriptions of airport developments already approved and in the pipeline , for example , increased capacity , runway and / or terminal expansion , approach and take - off forecasts , projected future traffic mix and estimated growth and a detailed study of the noise impact on the surrounding area caused by expanding the capacity , runways and terminals and by modifying flight paths and approach and take - off routes .


### 1 outline of the additional measures available and an indication of the main reasons for their selection . description of those measures chosen for further analysis and information on the outcome of the cost - efficiency analysis , in particular the cost of introducing these measures ; the number of people expected to benefit and timeframe ; and a ranking of the overall effectiveness of particular measures . ### outline of the additional measures available and an indication of the main reasons for their selection . description of those measures chosen for further analysis and information on the outcome of the cost - benefit analysis , in particular the cost of introducing these measures ; the number of people expected to benefit and timeframe ; and a ranking of the overall effectiveness of particular measures .


### 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 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 , the european supervisory authority , the european supervisory authority or both , as appropriate , acting through the joint committee of european supervisory authorities , shall arbitrate between the competent authorities , and if necessary settle the disagreement by issuing a binding decision .


### the commission should have the power to adopt delegated acts in accordance with article 290 of the treaty in order to supplement or amend certain non - essential elements of regulation no 73 / 2009 . the elements for which that power may be exercised should be defined , as well as the conditions to which that delegation is to be subject . ### in order to ensure the proper functioning of the regime established by this regulation , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of supplementing or amending certain non - essential elements of regulation no 73 / 2009 . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . 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 .


### in order to guarantee a uniform application of regulation no 73 / 2009 in all member states , the commission should be empowered to adopt implementing acts in accordance with article 291 of the treaty . save where explicitly provided otherwise , the commission should adopt those implementing acts in accordance with the provisions of regulation no x / xxxx of the european parliament and the council on… ### in order to ensure uniform conditions for the implementation of regulation no 73 / 2009 , implementing powers should be conferred on the commission . those powers , save where explicitly provided otherwise , should be exercised in accordance with regulation no xxx / 2011 of the european parliament and the council of . . . laying down the rules and general principles concerning mechanisms for control by member states of the commission ' s exercise of implementing powers* * oj l… .


### in order to take into account new legislation that may become necessary , the commission shall , by means of a delegated act , amend annex i . ### in order to take into account new legislation , the commission shall , by means of delegated acts , amend annex i in order to include appropriate references to new legislation .


### in order to take into account new legislation that may become necessary , the commission shall , by means of a delegated act , amend annex ix . ### in order to take into account new legislation , the commission shall , by means of delegated acts , amend annex ix .


### the commission shall , by means of implementing acts , review the ceilings set out in annex iv in order to take account of : ### the commission shall , by means of delegated acts , review the ceilings set out in annex iv in order to take account of :


### the commission may , by means of implementing acts , adopt rules for the uniform implementation of the farm advisory system . ### the commission may , by means of implementing acts , adopt technical rules for the uniform implementation of the farm advisory system .


### in paragraph 2 , the third subparagraph is replaced by the following : ‘ unless the farmer has taken immediate remedial action putting an end to the non - compliance found , the competent authority shall take the actions required that may , where appropriate , be limited to an administrative control to verify that the farmer remedies the finding of non - compliance concerned . the finding of minor non - compliance and the obligation to take remedial action shall be notified to the farmer . ’ ### in paragraph 2 , the third subparagraph is deleted .


### implementing rules the commission may adopt , by means of implementing acts , measures which are both necessary and duly justified to resolve , in an emergency , practical and specific problems ; such measures may derogate from certain parts of this regulation , but only to the extent , and for such a period , as is strictly necessary . ### delegation of powers to the commission the commission may adopt , by means of delegated acts , measures which are both necessary and duly justified to resolve , in an emergency , practical and specific problems ; such measures may derogate from certain parts of this regulation , but only to the extent , and for such a period , as is strictly necessary . where imperative grounds of urgency so require , the procedure provided for in article 141ba shall apply to delegated acts adopted pursuant to this article .


### where payment entitlements are allocated to wine growers , the commission shall , taking account of the latest data made available to it by the member states in accordance with articles 103o and the second subparagraph of article 188a of regulation no 1234 / 2007 , by means of implementing acts , adapt the national ceilings determined in annex viii to this regulation . by 1 december of the year preceding the adaptation of the national ceilings , member states shall communicate to the commission the regional average of the value of the entitlements referred to in point b of annex ix to this regulation . ### where payment entitlements are allocated to wine growers , the commission shall , taking account of the latest data made available to it by the member states in accordance with articles 103o and the second subparagraph of article 188a of regulation no 1234 / 2007 , by means of delegated acts , adapt the national ceilings determined in annex viii to this regulation . by 1 december of the year preceding the adaptation of the national ceilings , member states shall communicate to the commission the regional average of the value of the entitlements referred to in point b of annex ix to this regulation .


### the commission shall , by means of implementing acts , adopt measures regarding the reversion of unused payment entitlements to the national reserve . ### the commission shall , by means of implementing acts , adopt measures regarding the practical conditions applicable to the reversion of unused payment entitlements to the national reserve .


### rules on the definition in the national legislation for ' inheritance ' and ' anticipated inheritance ### rules on the definition in the national legislation for ' inheritance ' and ' anticipated inheritance ' for the purposes of article 43 ;


### the commission may , by means of implementing acts , adopt necessary measures regarding the withdrawal and reallocation of unused premium rights established under this section . ### the commission may , by means of delegated acts , adopt necessary measures regarding the withdrawal and reallocation of unused premium rights established under this section .


### the commission shall , by means of implementing acts , adopt necessary measures regarding the amount of the premium to be granted in case the application of the proportional reduction referred to in the first subparagraph gives a number of eligible animals which is not a whole number . ### the commission shall , by means of delegated acts , adopt necessary measures regarding the amount of the premium to be granted in case the application of the proportional reduction referred to in the first subparagraph gives a number of eligible animals which is not a whole number .


### the following paragraph is added : ### the following paragraphs are added :