### where an applicant intends to request infrastructure capacity with a view to operating a passenger service , it shall inform the infrastructure managers and the regulatory bodies concerned no less than 18 months before the entry into force of the working timetable to which the request for capacity relates . in order to enable regulatory bodies concerned to assess the potential economic impact on existing public service contracts , regulatory bodies shall ensure that any competent authority that has awarded a rail passenger service on that route defined in a public service contract , any other interested competent authority with the right to limit access under article 11 and any railway undertaking performing the public service contract on the route of that passenger service is informed without undue delay and at the latest within five days . ### where an applicant intends to request infrastructure capacity with a view to operating a passenger service , it shall inform the infrastructure managers and the regulatory bodies concerned no less than 12 months before the entry into force of the working timetable to which the request for capacity relates . in order to enable regulatory bodies concerned to assess the potential economic impact on existing public service contracts , regulatory bodies shall ensure that any competent authority that has awarded a rail passenger service on that route defined in a public service contract , any other interested competent authority with the right to limit access under article 11 and any railway undertaking performing the public service contract on the route of that passenger service is informed without undue delay and at the latest within five days .


### for the entire duration of gmes initial operations , a financial envelope of eur 107m constituting the prime reference , within the meaning of point 37 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management should be established . it is envisaged that this financial envelope will be complemented by an amount of eur 43 million from the space theme of the seventh framework programme for research actions accompanying gmes initial operations . ### for the entire duration of gmes initial operations , a financial envelope of eur 107m constituting the prime reference , within the meaning of point 37 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management should be established . it is envisaged that this financial envelope will be complemented by an amount of eur 209 000 000 from the space theme of the seventh framework programme for research actions accompanying gmes initial operations . these two sources of financing should be managed in a coordinated manner so that real progress can be made in deploying gmes services . the funds from the seventh framework programme should be used in full compliance with the objectives and criteria established by the framework programme .


### community grants may be provided in specific forms , including framework partnership agreement , or co - funding of operating or action grants . operating grants to bodies pursuing objectives of general european interest shall not be subject to the degressivity provisions of the financial regulation . for grants , the maximum rate of co - financing shall be adopted in accordance with the procedure of article 11 . ### public procurement should be the preferred funding instrument for implementing the gmes programme . where justified , community grants may be provided in specific forms , including framework partnership agreement , or co - funding of operating or action grants . operating grants to bodies pursuing objectives of general european interest shall not be subject to the degressivity provisions of the financial regulation . for grants , the maximum rate of co - financing shall be adopted in accordance with the procedure of article 11 .


### in order for the sponsor to assess all potentially relevant safety information , the investigator should report to him all serious adverse events . ### in order for the sponsor to assess all potentially relevant safety information , the investigator should record and register in the electronic database all serious adverse events .


### – the reliability and robustness of the data generated in the clinical trial , taking account of statistical approaches , design of the trial and methodology ; ### – the reliability and robustness of the data generated in the clinical trial , taking account of statistical approaches , design of the trial , methodology and the prevalence of the condition , especially for rare diseases , and ultra - rare diseases .


### in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . ### in the assessment , the view of an independent ethics committee shall be taken into account .


### the application may be submitted only after the notification date of the initial authorisation decision . ### the application may be submitted in any member state only after the notification date of the initial authorisation decision .


### 25 days from the date of submission of the application referred to in paragraph 1 for low - intervention clinical trials ; ### 10 days from the date of submission of the application referred to in paragraph 1 for low - intervention clinical trials ;


### 35 days from the date of submission of the application referred to in paragraph 1 for clinical trials other than low - intervention clinical trials ; ### 25 days from the date of submission of the application referred to in paragraph 1 for clinical trials other than low - intervention clinical trials ;


### 40 days from the date of submission of the application referred to in paragraph 1 for any clinical trial with an advanced therapy investigational medicinal product . ### 30 days from the date of submission of the application referred to in paragraph 1 for any clinical trial with an advanced therapy investigational medicinal product .


### between the date of submission of the application referred to in paragraph 1 and the expiry of the relevant time period referred to in paragraph 3 , the additional member state concerned may communicate to the reporting member state any considerations relevant to the application . ### the additional member state concerned may communicate to the reporting member state any considerations relevant to part 1 of the application within the timelines laid down in paragraph 3 starting from the date of submission referred to in paragraph 1 .


### the reporting member state , and only the reporting member state , may , between the date of submission of the application referred to in paragraph 1 and the expiry of the relevant time period referred to in paragraph 3 , request additional explanations from the sponsor concerning part i of the assessment report , taking into account the considerations referred to in paragraph 5 . ### the reporting member state , and only the reporting member state , may , within the timelines specified in paragraph 5 , request additional explanations from the sponsor concerning part i of the assessment report .


### the eu database shall contain the data and information submitted in accordance with this regulation . ### public access to detailed and summary raw clinical data is particularly important to safeguard public health . the eu database shall contain the data and information submitted in accordance with this regulation .


### no personal data of subjects shall be publicly accessible . ### no personal data of subjects , commercially confidential information or information undermining intellectual property rights shall be publicly accessible .


### it is of particular importance that the commission carries out the appropriate consultations during its preparatory work , including at expert level . when preparing and drawing - up delegated acts , the commission should ensure the simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council . ### it is of particular importance that the commission carries out the appropriate consultations during its preparatory work , including at expert level . the commission should previously inform the member states on who will be consulted and on what basis ensuring the respect of impartiality and avoiding possible conflicts of interest . when preparing and drawing - up delegated acts , the commission should ensure the simultaneous , timely and appropriate transmission of relevant documents to the european parliament and the council .


### the commission should ensure that these delegated acts do not impose a significant additional administrative burden on the member states and on the respondent units . ### the commission should ensure that these delegated acts do not impose a significant additional costs or administrative burden on the member states and on the respondent units .


### regulation no 638 / 2004 should be amended by replacing the reference to the intrastat committee with a reference to the essc . ### regulation no 638 / 2004 should be amended by replacing the reference to the intrastat committee with a reference to the essc . the essc should keep the same structure of the intrastat committee , that is one member for each member state .


### the definition of statistical value should be clarified and aligned with the definition of this data element under the extra - eu trade statistics . ### the definition of statistical value must be clarified and aligned with the definition of this data element under the extra - eu trade statistics in order to guarantee a better comparability of intra eu trade statistics with the extra eu trade ones .


### in accordance with the principle of proportionality , it is necessary and appropriate to lay down rules on the communication of information by the customs administration , the exchange of confidential data between ms and the definition of statistical value in the domain of intra - eu trade statistics . this regulation does not go beyond what is necessary to achieve that objective , in accordance with article 5 of the treaty on the european union . ### in accordance with the principle of proportionality , it is necessary and appropriate to lay down harmonized rules on the communication of information by the customs administration , the exchange of confidential data between ms and the definition of statistical value in the domain of intra - eu trade statistics . this regulation does not go beyond what is necessary to achieve that objective , in accordance with article 5 of the treaty on the european union .


### the statistical information on dispatches and arrivals of goods which are the subject of a single administrative document for customs or fiscal purposes shall be provided directly by customs to the national authorities , at least once a month . ### the statistical information on dispatches and arrivals of goods which are the subject of a single administrative document for customs or fiscal purposes shall be provided directly by customs to the national authorities once a month .


### the exchange of confidential data , as defined by article 3 of regulation no 223 / 2009 of the european parliament and of the council of 11 march 2009 on european statistics , shall for statistical purposes only , be allowed between the respective national authorities of each member state , where the exchange serves the efficient development , production and dissemination of european statistics relating to the trading of goods between member states or improves their quality . __________________ oj l 87 , 31 . 3 . 2009 , p . 164 . ' ### the exchange of confidential data , as defined by article 3 of regulation no 223 / 2009 of the european parliament and of the council of 11 march 2009 on european statistics , shall for statistical purposes only , be allowed between the respective national authorities of each member state , where it proves that the exchange serves the efficient development , production and dissemination of european statistics relating to the trading of goods between member states or improves their quality . the exchange should not entail additional costs or administrative burden on the member states and on the respondent units . __________________ oj l 87 , 31 . 3 . 2009 , p . 164 . '


### member states may , under certain conditions that meet quality requirements , simplify the information to be provided for small individual transactions . the commission shall be empowered to adopt , in accordance with article 13a , delegated acts to define these conditions . ### member states may , under certain conditions that meet quality requirements , simplify the information to be provided for small individual transactions without detrimental effects on the quality of the statistics . the commission shall be empowered to adopt , in accordance with article 13a , delegated acts to define these conditions .


### the growing proportion of older people in europe makes it more important than ever to promote healthy ageing . healthy ageing can help raise labour market participation of older people , enable them to be active in society for longer , improve their individual quality of life and curb the strains on health and social care systems . ### the growing proportion of older people in europe makes it more important than ever to promote healthy ageing by ensuring universal and equal access to healthcare . healthy ageing with maximum functional ability can help raise labour market participation of older people , enable them to be active in society for longer , improve their individual quality of life and curb the strains on health and social care systems . with a view to achieving this , fitness classes and sporting activities should be promoted among older people , who should accordingly be afforded easier access to public sports facilities .


### the council adopted on 22 february 2007 a resolution on ‘ opportunities and challenges of demographic change in europe : the contribution of older people to economic and social development’ , which emphasised the need to increase the possibilities of active participation by older people , the new economic opportunities created by the growing demand of older people for certain goods and services as well as the importance of a positive public image of older people . ### the council adopted on 22 february 2007 a resolution on ‘ opportunities and challenges of demographic change in europe : the contribution of older people to economic and social development’ , which emphasised the need to increase the possibilities of active participation by older people , including in the form of voluntary work , the new economic opportunities created by the growing demand of older people for certain goods and services as well as the importance of a positive public image of older people .


### the council adopted on 8 june 2009 conclusions on ‘ equal opportunities for women and men : active and dignified ageing’ , which recognises that , throughout the eu , older women and men face serious challenges as they seek to live active lives and to age with dignity , and proposes a number of measures to member states and the commission . ### the council adopted on 8 june 2009 conclusions on ‘ equal opportunities for women and men : active and dignified ageing’ , which recognises that , throughout the eu , older women and men face serious challenges as they seek to live active lives and to age with dignity , and proposes a number of measures to member states and the commission . the measures planned for older people should include cultural activities and activities to promote general well - being , with a view to shielding older people against social exclusion and loneliness by including and involving them .


### the commission emphasised it its communication on ‘ europe 2020 - a strategy for smart , sustainable and inclusive growth’ the importance to the european union of promoting a healthy and active ageing population in the interests of social cohesion and higher productivity . it proposed a flagship initiative ‘ an agenda for new skills and jobs’ , under which member states should notably promote active ageing policies , and a flagship initiative on a ‘ european platform against poverty’ . achieving these policy goals requires action from all levels of government and various non - governmental stakeholders ; they can in turn be supported , at the union level , by european year activities aimed at raising awareness and fostering the exchange of good practice . national coordinators should see to it that national action is coordinated and is consistent with the overall objectives of the european year . the participation of other institutions and stakeholders is also planned . ### the commission emphasised in its communication on ‘ europe 2020 - a strategy for smart , sustainable and inclusive growth’ the importance to the european union of promoting a healthy and active ageing population in the interests of social cohesion and higher productivity . it proposed a flagship initiative ‘ an agenda for new skills and jobs’ , under which member states should notably promote active ageing policies , and a flagship initiative on a ‘ european platform against poverty’ . new technologies should be used to promote educational schemes to broaden the knowledge of older people and enable them to acquire technical skills . achieving these policy goals requires action from all levels of government and various non - governmental stakeholders ; they can in turn be supported , at the union level , by european year activities aimed at raising awareness and fostering the exchange of good practice . national coordinators should see to it that national action is coordinated and is consistent with the overall objectives of the european year . the participation of other institutions and stakeholders is also planned .


### active ageing is targeted by several union programmes , such as the european social fund , the european regional and development fund , the progress programme , the life long learning programme , the public health programme , the specific programmes on information and communication technologies and on socio - economic sciences and humanities in the seventh framework programme for research and development , the action plan on ‘ ageing well in the information society’ , the ambient assisted living joint programme for research and innovation , the competitiveness and innovation programme with pilot deployment projects on ict for ageing well and the action plan on urban mobility . union co - financing of european year activities will be in accordance with the priorities and rules applying , on an annual or multi - annual basis , to existing programmes and autonomous budget lines in the field of employment , social affairs and equal opportunities . where appropriate , programmes and policies in other fields , such as education and culture , health , research , the information society , regional policy and transport policy , may support the european year . ### active ageing is targeted by several union programmes , such as the european social fund , the european regional and development fund , the progress programme , the life long learning programme , and in particular the grundtvig programme , the public health programme , the specific programmes on information and communication technologies and on socio - economic sciences and humanities in the seventh framework programme for research and development , the action plan on ‘ ageing well in the information society’ , the ambient assisted living joint programme for research and innovation , the competitiveness and innovation programme with pilot deployment projects on ict for ageing well and the action plan on urban mobility . union co - financing of european year activities will be in accordance with the priorities and rules applying , on an annual or multi - annual basis , to existing programmes and autonomous budget lines in the field of employment , social affairs and equal opportunities . where appropriate , programmes and policies in other fields , such as education and culture , health , research , the information society , regional policy and transport policy , may support the european year .


### active ageing is targeted by several union programmes , such as the european social fund , the european regional and development fund , the progress programme , the life long learning programme , the public health programme , the specific programmes on information and communication technologies and on socio - economic sciences and humanities in the seventh framework programme for research and development , the action plan on ‘ ageing well in the information society’ , the ambient assisted living joint programme for research and innovation , the competitiveness and innovation programme with pilot deployment projects on ict for ageing well and the action plan on urban mobility . union co - financing of european year activities will be in accordance with the priorities and rules applying , on an annual or multi - annual basis , to existing programmes and autonomous budget lines in the field of employment , social affairs and equal opportunities . where appropriate , programmes and policies in other fields , such as education and culture , health , research , the information society , regional policy and transport policy , may support the european year . ### active ageing is targeted by several union programmes , such as the european social fund , the european regional and development fund , the progress programme , the life long learning programme , the public health programme , the specific programmes on information and communication technologies and on socio - economic sciences and humanities in the seventh framework programme for research and development , the action plan on ‘ ageing well in the information society’ , the ambient assisted living joint programme for research and innovation , the competitiveness and innovation programme with pilot deployment projects on ict for ageing well , the calypso preparatory action on social tourism and the action plan on urban mobility . union co - financing of european year activities will be in accordance with the priorities and rules applying , on an annual or multi - annual basis , to existing programmes and autonomous budget lines in the field of employment , social affairs and equal opportunities . where appropriate , programmes and policies in other fields , such as education and culture , health , research , the information society , regional policy and transport policy , may support the european year .


### to raise general awareness of the value of active ageing in order to highlight the useful contribution older persons make to society and the economy , to promote active ageing and to do more to mobilise the potential of older persons ; ### to raise general awareness of the value of active ageing and combat negative stereotypes about old age in order to highlight the useful contribution older persons make to society and the economy , to promote active ageing and to do more to mobilise the potential of older persons ;


### – information , promotion and educational campaigns ; ### – information , promotion and educational campaigns to disseminate the message of the european year , using new media and the internet in order to do so ;


### – exchange of information , experience and good practices ; ### – exchange of information , experience and good practices through national coordinators and networks of contacts set up by stakeholders working to achieve the goals of the european year ;


### the commission and the member states shall take account of gender mainstreaming in the running of the european year . ### the commission and the member states shall take account of gender mainstreaming and the disabled in the running of the european year .


### each member state shall appoint a national coordinator responsible for organising its involvement in the european year . the national coordinators should also see to it that national activities are properly coordinated . ### each member state shall appoint a national coordinator responsible for organising its involvement in the european year . the national coordinators should also see to it that national activities are properly coordinated and that civil society organisations are fully involved in the design and implementation of the european year at local , regional and national level .


### the application of a percentage to verified emissions for flights to and from aerodromes in third countries , or the use of an alternative approach by operators , should relate to emissions from 2014 onwards to give time for operators to understand these approaches when planning their flight activities , ### the application of a percentage to verified emissions for flights to and from aerodromes in third countries , or the use of an alternative approach by operators , should relate to emissions from 2014 to 2016 to give time for operators to understand these approaches when planning their flight activities ,


### without prejudice to the global market - based measure applying from 2020 , emissions from flights to and from countries which are developing countries and whose share of total revenue ton kilometres of international civil aviation activities is less than 1% should be exempted for the period 2014 to 2020 . countries considered to be developing for the purposes of this proposal should be those which benefit at the time of adoption of this proposal from preferential access to the union market in accordance with regulation no 978 / 2012 of the european parliament and of the council , that is those which are not classified in 2013 by the world bank as high - income or upper - middle income countries . ### without prejudice to the global market - based measure applying from 2020 , emissions from flights to and from countries which are developing countries and whose share of total revenue ton kilometres of international civil aviation activities is less than 1% should be exempted for the period 2014 to 2016 . countries considered to be developing for the purposes of this proposal should be those which benefit at the time of adoption of this proposal from preferential access to the union market in accordance with regulation no 978 / 2012 of the european parliament and of the council , that is those which are not classified in 2013 by the world bank as high - income or upper - middle income countries .


### by way of derogation from articles 3g , 12 , 15 and 18a , where an aircraft operator has total annual emissions lower than 25000 tonnes , its emissions shall be considered to be verified emissions if determined using a small emitters tool approved by the commission and populated by eurocontrol with data from its ets support facility , and member states may implement simplified procedures for non - commercial aircraft operators as long as there is no less accuracy than such a tool provides . ### by way of derogation from articles 3g , 12 , 15 and 18a , where an aircraft operator has total annual emissions lower than 25000 tonnes , its emissions shall be considered to be verified emissions if determined using data from eurocontrol ' s ets support facility , and member states may implement simplified procedures for non - commercial aircraft operators as long as there is no less accuracy than such a tool provides .


### in regulation no 1198 / 2006 , paragraph 5 of article 77a is deleted . ### regulation no 1198 / 2006 is amended as follows :


### the fight against poverty remains the primary objective of the development policy of the european union , as laid down in title v , chapter 1 of the treaty on european union and title iii , chapter 1 of part five of the treaty on the functioning of the european union , in line with the millennium development goals , or other objectives accepted by the union and its member states . ### the fight against poverty , extreme poverty and social exclusion , while recognising that women , children and older people are particularly vulnerable , remains the primary objective of the development policy of the european union , as laid down in title v , chapter 1 of the treaty on european union and title iii , chapter 1 of part five of the treaty on the functioning of the european union , in line with the millennium development goals , or other objectives accepted by the union and its member states .


### the fight against poverty remains the primary objective of the development policy of the european union , as laid down in title v , chapter 1 of the treaty on european union and title iii , chapter 1 of part five of the treaty on the functioning of the european union , in line with the millennium development goals , or other objectives accepted by the union and its member states . ### the fight against poverty remains the primary objective of the development policy of the european union , as laid down in title v , chapter 1 of the treaty on european union and title iii , chapter 1 of part five of the treaty on the functioning of the european union , in line with the millennium development goals , or other objectives accepted by the union and its member states , such as the fight against social and gender - based discrimination .


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


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


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


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


### the union should promote a comprehensive approach in response to crisis and disaster and to conflict - affected and fragile situations , including those of transition . this should in particular build on the conclusions on security and development on an eu response to situations of fragility on conflict prevention as well as any relevant subsequent conclusions . this should provide the necessary mix of approaches , responses and instruments in particular by ensuring an appropriate balance between the security - oriented , development and humanitarian approaches , and by linking short - term reaction with the long term support . ### the union should promote a comprehensive approach in response to crisis and disaster and to conflict - affected and fragile situations , including those of transition . this should include , whenever necessary , a cross - cutting gender dimension that not only addresses the particular vulnerability of women and girls but also promotes the image of women as agents of social change who possess valuable resources and capacities that are able to influence and steer the process of pacification , stabilisation , reconstruction and development . this should also in particular build on the conclusions on security and development on an eu response to situations of fragility on conflict prevention as well as any relevant subsequent conclusions . this should provide the necessary mix of approaches , responses and instruments in particular by ensuring an appropriate balance between the security - oriented , development and humanitarian approaches , and by linking short - term reaction with the long term support .


### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . ### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , the rule of law , human rights and fundamental freedoms , women’s rights , gender equality , non - discrimination , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance .


### commission communication ' increasing the impact of eu development policy : an agenda for change ' envisages continued support for social inclusion and human development through at least 20% of the union ' s development aid . to contribute to that end , at least 20% of the global public goods and challenges programme should support that area of development . ### commission communication ' increasing the impact of eu development policy : an agenda for change ' envisages continued support for social inclusion and human development , including gender equality and women ' s empowerment , through at least 20% of the union ' s development aid . to contribute to that end , at least 20% of the global public goods and challenges programme should support that area of development . under this aid , particular programmes should be targeted at women ' s empowerment , gender equality and against discrimination .


### thematic programmes to address global public goods and challenges and support civil society organisations and local authorities in countries , territories and regions eligible for union funding under geographic programmes , in accordance with annex i of this regulation , regulation no [ . . . / … ] of the european parliament and the council establishing a european neighbourhood instrument , and council decision [ 2001 / 822 / ec of 27 november 2001 on the association of the overseas countries and territories ] , and in african , caribbean and pacific countries signatories to the acp - eu partnership agreement signed in cotonou on 23 june 2000 ; ### thematic programmes to address global public goods and challenges and support local authorities and local civil society groups , especially women’s associations and gender equality associations , in countries , territories and regions eligible for union funding under geographic programmes , in accordance with annex i of this regulation , regulation no [ . . . / … ] of the european parliament and the council establishing a european neighbourhood instrument , and council decision [ 2001 / 822 / ec of 27 november 2001 on the association of the overseas countries and territories with the european community ] , and in african , caribbean and pacific countries signatories to the acp–eu partnership agreement signed in cotonou on 23 june 2000 ;


### the primary objective of cooperation under this regulation shall be the reduction and , in the long term , the eradication of poverty ; ### the primary objective of cooperation under this regulation shall be the reduction and , in the long term , the eradication of poverty , extreme poverty and social exclusion , while recognising that women , children and older people are particularly vulnerable ;


### the primary objective of cooperation under this regulation shall be the reduction and , in the long term , the eradication of poverty ; ### the primary objective of cooperation under this regulation shall be the eradication of poverty ;


### promoting democracy , the rule of law , good governance and respect for human rights . ### promoting democracy , the rule of law , good governance , gender equality , women ' s empowerment and respect for human rights .


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


### the 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 , equality between men and women , the rule of law and respect for human rights and fundamenta freedoms on which it is founded , through dialogue and cooperation with partner countries and regions .


### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , non - discrimination , democracy , good governance , the rights of the child and indigenous peoples ' rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids . ### the following cross - cutting issues shall be mainstreamed in all programmes : the promotion of human rights , gender equality , women empowerment , non - discrimination , democracy , good governance , the rights of the child and indigenous peoples’ rights , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids , while stressing the importance of looking at these issues from the perspective that women , children and older people can be particularly vulnerable .


### the 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 as enshrined in the universal declaration of human rights , equal opportunities for women and men , non - discrimination , democracy and rule of low , good governance , the rights of the child and indigenous peoples ' rights , the promotion of knowledge about and respect for local cultures and traditions in developing countries , social inclusion and the rights of persons with disabilities , environmental sustainability including addressing climate change and combating hiv / aids .


### particular attention shall be given to strengthening the rule of law , improving access to justice and supporting civil society , trade and sustainable development , access to icts , health and food security , as well as promoting dialogue , participation and reconciliation , and institution - building . ### particular attention shall be given to strengthening the rule of law , improving access to justice and supporting civil society , trade and sustainable development , access to icts , health and food security , as well as promoting dialogue , participation and reconciliation , and institution - building , while recognising the added value of adopting the gender perspective and promoting the role of women as equal agents of social change .


### particular attention shall be given to strengthening the rule of law , improving access to justice and supporting civil society , trade and sustainable development , access to icts , health and food security , as well as promoting dialogue , participation and reconciliation , and institution - building . ### particular attention shall be given to strengthening the rule of law , gender equality , improving access to justice and supporting civil society and particularly organisations focusing on women ' s rights , trade and sustainable development , access to icts , health and food security , as well as promoting dialogue , participation and reconciliation , and institution - building .


### the objective of union assistance under the programme ' global public goods and challenges ' shall be to support actions in areas such as the environment and climate change , sustainable energy , human development , food security , and migration and asylum . ### the objective of union assistance under the programme ' global public goods and challenges ' shall be to support actions in areas such as the environment and climate change , sustainable energy , human development , food security , and migration and asylum . any future actions that are taken within this framework shall adopt the gender perspective and promote non - discrimination .


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


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


### the commission shall determine the multiannual indicative allocations within each geographic programme in accordance with the general principles of this regulation , based on the criteria laid down in article 3 , and taking into account , alongside the specificity of the different programmes , the particular difficulties faced by countries or regions that are in crisis , vulnerable , fragile , in conflict or disaster prone . ### the commission shall determine the multiannual indicative allocations within each geographic programme in accordance with the general principles of this regulation , based on the criteria laid down in article 3 , and taking into account , alongside the specificity of the different programmes , the particular difficulties faced by social groups and particularly by women , by countries or regions that are in crisis , vulnerable , fragile , in conflict or disaster prone . special provision should be made for the establishment of a programme for information on and awareness of gender issues as well as for the empowerment of women and for tackling gender discrimination .


### strategy papers may be reviewed at their mid - term , or ad hoc if necessary , in accordance , as appropriate , with the principles and procedures laid down in the partnership and cooperation agreements concluded with the partner countries and regions . ### strategy papers may be reviewed at their mid - term , or ad hoc if necessary , in accordance , as appropriate , with the principles and procedures laid down in the partnership and cooperation agreements concluded with the partner countries and regions . these reviews should include a gender dimension for the purposes of non - discrimination and respect the breakdown by gender of information and data .


### multiannual indicative programmes shall set out the priority areas selected for union financing , the specific objectives , the expected results , the performance indicators and the indicative financial allocation , both overall and per priority area . where appropriate , this allocation may be given in the form of a range and / or some funds may be left unallocated . ### multiannual indicative programmes shall set out the priority areas selected for union financing , the specific objectives , the expected results , the performance indicators , while respecting the breakdown by gender of data and information , 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 .


### 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 . ### pursuant to the principle of mutual accountability in the pursuit and fulfilment of agreed objectives , including those referring to good governance , democracy , the rule of law , respect for human rights and fundamental freedoms , women’s rights and the principles of gender equality and non - discrimination , 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 , while taking into account the gender approach .


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


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


### 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 crises , post crisis and fragility situations or threats to democracy , the rule of law , human rights , fundamental freedoms or women’s rights 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 .


### as referred to in article 13 , paragraph 2 of the ' erasmus for all ' regulation , in order to promote the international dimension of higher education , an indicative amount of eur 1 812 100 000 from the different external instruments , will be allocated to actions of learning mobility to or from non eu countries and to cooperation and policy dialogue with authorities / institutions / organisations from these countries . the provisions of the ' erasmus for all ' regulation will apply to the use of those funds . the funding will be made available through 2 multiannual allocations only covering the first 4 years and the remaining 3 years respectively . this funding will be reflected in the multiannual indicative programming of these instruments , in line with the identified needs and priorities of the countries concerned . the allocations can be revised in case of major unforeseen circumstances or important political changes in line with the eu external priorities . ### as referred to in article 13 , paragraph 2 of the ' erasmus for all ' regulation , in order to promote the international dimension of higher education , an indicative amount of eur 1 812 100 000 from the different external instruments , will be allocated to actions of learning mobility to or from non eu countries and to cooperation and policy dialogue with authorities / institutions / organisations from these countries . the provisions of the ' erasmus for all ' regulation will apply to the use of those funds . the funding will be made available through 2 multiannual allocations only covering the first 4 years and the remaining 3 years respectively . this funding will be reflected in the multiannual indicative programming of these instruments , in line with the identified needs and priorities of the countries concerned . the allocations can be revised in case of major unforeseen circumstances or important political changes in line with the eu external priorities . particular attention should be given to a gender balance approach for those who participate in the ' erasmus for all ' programme .


### supporting country level programmes to promote women ' s economic and social empowerment and political participation ; ### supporting country level programmes to combat violence against women and promote women ' s economic and social empowerment and political participation ;


### maximising the development impact of the increased regional and global mobility of people , while promoting and protecting the rights of migrants , through support to the formulation and implementation of sound regional and national migration and asylum policies and through integration of the migration dimension into other regional and national policies ; ### maximising the development impact of the increased regional and global mobility of people , while promoting and protecting the rights of migrants , taking into account the gender aspect of the issue and the situation of women migrants , through support to the formulation and implementation of sound regional and national migration and asylum policies and through integration of the migration dimension into other regional and national policies ;


### in 2010 a conference between the state parties to the stcw convention was held in manila and introduced several significant changes to the convention , namely on the prevention of fraudulent practices for certificates , in the field of medical standards , in the matter of training on security and with respect to training in technology - related matters . the manila amendments have also introduced requirements for able seafarers and established new professional profiles , such as electro - technical officers . ### a conference of parties to the stcw convention was held in manila in 2010 and introduced significant amendments to the stcw convention , namely on the prevention of fraudulent practices for certificates , in the field of medical standards , in the matter of training on security including on anti - piracy practices , and with respect to training in technology - related matters . the manila amendments have also introduced requirements for able seafarers and established new professional profiles , such as electro - technical officers .


### for the purpose of updating the knowledge of masters , officers and radio operators , each member state shall ensure that the texts of recent changes in national and international regulations concerning the safety of life at sea , security and the protection of the marine environment are made available to ships entitled to fly its flag . ’ . ### for the purpose of updating the knowledge of masters , officers and radio operators , each member state shall ensure that the texts of recent changes in national and international regulations concerning the safety of life at sea , security and the protection of the marine environment are made available to ships entitled to fly its flag . ’ , ensuring that the text is available in the working language of the vessel and in english and that the provisions of article 14 and article 18 concerning multilingualism are respected .


### companies shall ensure that masters , officers and other personnel assigned specific duties and responsibilities on board their ro - ro passenger ships shall have completed familiarization training to attain the abilities that are appropriate to the capacity to be filled and duties and responsibilities to be taken up , taking into account the guidance given in section b - i / 14 of the stcw code . ### companies shall ensure that masters , officers and other personnel assigned specific duties and responsibilities on board their ro - ro passenger ships shall have completed familiarization training to attain the abilities that are appropriate to the capacity to be filled and duties and responsibilities to be taken up , so as to be able to operate the vessel in accordance with maximum security and safety standards and be able to respond to hazards and emergencies , taking into account the guidance given in section b - i / 14 of the stcw code .


### the requirements for rest periods laid down in paragraphs 4 and 5 need not be maintained in the case of an emergency or drill or in other overriding operational conditions . musters , fire - fighting and lifeboat drills , and drills prescribed by national laws and regulations and by international instruments , shall be conducted in a manner that minimizes the disturbance of rest periods and does not induce fatigue . ### the requirements for rest periods laid down in paragraphs 4 and 5 need not be maintained in the case of an emergency or when conducting an evacuation or emergency drill or in other overriding operational conditions . musters , fire - fighting and lifeboat drills , and drills prescribed by national laws and regulations and by international instruments , shall be conducted in a manner that minimizes the disturbance of rest periods and does not induce fatigue and shall entitle those concerned to adequate compensatory rest periods as provided for in this article .


### in march 2003 , the commission launched a process to identify and assess the impact of barriers to the internal market for credit agreements relating to residential immovable property . in 2007 , it adopted a white paper on the integration of eu mortgage credit markets . the white paper announced the commission ' s intention to assess the impact of , among other things , the policy options for pre - contractual information , credit databases , creditworthiness , the annual percentage rate of charge and advice . the commission also established an expert group on credit histories to assist the commission in preparing measures to improve the accessibility , comparability and completeness of credit data . studies on the role and operations of credit intermediaries and non - credit institutions providing credit agreements relating to residential immovable property were also launched . ### in march 2003 , the commission launched a process to identify and assess the impact of barriers to the internal market for credit agreements relating to residential immovable property and credit agreements secured by mortgages . in 2007 , it adopted a white paper on the integration of eu mortgage credit markets . the white paper announced the commission ' s intention to assess the impact of , among other things , the policy options for pre - contractual information , credit databases , creditworthiness , the annual percentage rate of charge and advice . the commission also established an expert group on credit histories to assist the commission in preparing measures to improve the accessibility , comparability and completeness of credit data . studies on the role and operations of credit intermediaries and non - credit institutions providing credit agreements relating to residential immovable property and credit agreements secured by mortgages were also launched .


### in accordance with the treaty , the internal market comprises an area without internal frontiers in which the free movement of goods and services and the freedom of establishment are ensured . the development of a more transparent and efficient credit market within that area is vital to promote the development of cross - border activity and create an internal market in credit agreements relating to residential immovable property . there are substantial differences in the laws of the various member states with regard to conduct of business in the granting of credit agreements relating to residential immovable property and in the regulation and supervision of credit intermediaries and non - credit institutions providing credit agreements relating to residential immovable property . such differences create obstacles that restrict the level of cross - border activity on the supply and demand sides , thus reducing competition and choice in the market , raising the cost of lending for providers and even preventing them from doing business . ### in accordance with the treaty , the internal market comprises an area without internal frontiers in which the free movement of goods and services and the freedom of establishment are ensured . the development of a more transparent and efficient credit market within that area is vital to promote the development of cross - border activity and create an internal market in credit agreements relating to residential immovable property and credit agreements secured by mortgages . there are substantial differences in the laws of the various member states with regard to conduct of business in the granting of credit agreements relating to residential immovable property and credit agreements secured by mortgages and in the regulation and supervision of credit intermediaries and non - credit institutions providing credit agreements relating to residential immovable property and credit agreements secured by mortgages . such differences create obstacles that restrict the level of cross - border activity on the supply and demand sides , thus reducing competition and choice in the market , raising the cost of lending for providers and even preventing them from doing business .


### for those areas not covered by this directive , member states should be free to maintain or introduce national legislation . member states should be able to maintain or introduce national provisions in areas such as contract law relating to the validity of credit agreements , property valuation , land registration , contractual information , post - contractual issues , and handling defaults . ### for those areas not covered by this directive , member states should be free to maintain or introduce national legislation . member states should be able in particular to maintain or introduce national provisions in areas such as contract law relating to the validity of credit agreements , property law , property valuation , land registration , contractual information , post - contractual issues , and handling defaults .


### the objective of this directive is to ensure that all credits provided to consumers benefit from a high level of protection . it should therefore apply to credits secured by real estate , or credits which are used to purchase a property in some member states and to credits for the renovation of residential property that are not covered by directive 2008 / 48 / ec of the european parliament and of the council of 23 april 2008 on credit agreements for consumers and repealing council directive 87 / 102 / eec which lays down rules at union level concerning consumer credit agreements . furthermore , this directive should not be applied to certain types of credit agreements where the credit is granted by an employer to his employees under certain circumstances , as already provided in directive 2008 / 48 / ec . ### the objective of this directive is to ensure that all credits provided to consumers benefit from a high level of protection . it should therefore apply to credits secured by a mortgage , or consumer credit agreements which are used to finance properties in some member states and to credits for the renovation of residential property that are not covered by directive 2008 / 48 / ec of the european parliament and of the council of 23 april 2008 on credit agreements for consumers and repealing council directive 87 / 102 / eec which lays down rules at union level concerning consumer credit agreements . furthermore , this directive should not be applied to certain types of credit agreements where the credit is granted by an employer to his employees under certain circumstances , as already provided in directive 2008 / 48 / ec .


### the applicable legal framework should give consumers the confidence that creditors and credit intermediaries are acting in the best interests of the consumer . a key aspect of ensuring such consumer confidence is the requirement to ensure a high degree of fairness , honesty and professionalism in the industry . while this directive should require relevant knowledge and competence to be proven at the level of the institution , member states should be free to introduce or maintain such requirements applicable to individual natural persons . ### the applicable legal framework should give consumers the confidence that creditors and credit intermediaries are acting in the best interests of the consumer . a key aspect of ensuring such consumer confidence is the requirement to ensure a high degree of fairness , honesty and professionalism in the industry . this directive should require relevant knowledge and competence to be proven at the level of the institution as well as at the level of the natural person in case of a credit intermediary who works alone .


### the applicable legal framework should give consumers the confidence that creditors and credit intermediaries are acting in the best interests of the consumer . a key aspect of ensuring such consumer confidence is the requirement to ensure a high degree of fairness , honesty and professionalism in the industry . while this directive should require relevant knowledge and competence to be proven at the level of the institution , member states should be free to introduce or maintain such requirements applicable to individual natural persons . ### the applicable legal framework should give consumers the confidence that creditors and credit intermediaries are taking into account the rights and interests of the consumer . a key aspect of ensuring such consumer confidence is the requirement to ensure a high degree of fairness , honesty and professionalism in the industry . while this directive should require relevant knowledge and competence to be proven at the level of the institution , member states should be free to introduce or maintain such requirements applicable to individual natural persons .


### the consumer may still need additional assistance in order to decide which credit agreement , within the range of products proposed , is the most appropriate for his needs and financial situation . creditors , and where the transaction is through a credit intermediary , credit intermediaries should provide such assistance in relation to the credit products which they offer to the consumer . the relevant information , as well as the essential characteristics of the products proposed , should therefore be explained to the consumer in a personalised manner so that the consumer can understand the effects which they may have on his economic situation . member states could determine when and to what extent such explanations are to be given to the consumer , taking into account the particular circumstances in which the credit is offered , the consumer’s need for assistance and the nature of individual credit products . ### despite the pre - contractual information to be provided , the consumer may still need additional assistance in order to decide which credit agreement , within the range of products proposed , is the most appropriate for his needs and financial situation . therefore , member states should ensure that creditors provide such assistance in relation to the credit products which they offer to the consumer . where appropriate , the relevant pre - contractual information , as well as the essential characteristics of the products proposed , should be explained to the consumer in a personalised manner so that the consumer can understand the effects which they may have on his economic situation . where applicable , this duty to assist the consumer should also apply to credit intermediaries . member states could determine when and to what extent such explanations are to be given to the consumer , taking into account the particular circumstances in which the credit is offered , the consumer’s need for assistance and the nature of individual credit products .


### in order to promote the establishment and functioning of the internal market and to ensure a high degree of protection for consumers throughout the union , it is necessary to ensure the comparability of information relating to annual percentage rates of charge throughout the union . the total cost of the credit to the consumer should comprise all the costs that the consumer has to pay in connection with the credit agreement , except for notarial costs . it should therefore include interest , commissions , taxes , fees for credit intermediaries and any other fees as well as the cost of insurance or other ancillary products , where these are obligatory in order to obtain the credit on the terms and conditions marketed . as the annual percentage rate of charge can at the pre - contractual stage be indicated only through an example , such an example should be representative . therefore , it should correspond , for instance , to the average duration and total amount of credit granted for the type of credit agreement under consideration . given the complexities of calculating an annual percentage rate of charge and in order to be able to accommodate product innovation , technical regulatory standards could be employed to amend or specify the method of calculation of the annual percentage rate of charge . the definition of and methodology used for calculating the annual percentage rate of charge in this directive should be the same as those in directive 2008 / 48 / ec in order to facilitate consumer understanding and comparison . those definitions and methodologies may , however , differ in the future should directive 2008 / 48 / ec be modified at a later date . member states are free to maintain or introduce prohibitions on unilateral changes to the borrowing rate by the creditor . ### in order to promote the establishment and functioning of the internal market and to ensure a high degree of protection for consumers throughout the union , it is necessary to uniformly ensure the comparability of information relating to annual percentage rates of charge throughout the union . the total cost of the credit to the consumer should comprise all the costs that the consumer has to pay in connection with the credit agreement , except for costs incurred in connection with credit protection such as registration fees and notarial costs . it should therefore include interest , commissions , taxes , fees for credit intermediaries and any other fees as well as the cost of insurance or other ancillary products , where these are obligatory in order to obtain the credit on the terms and conditions marketed . as the annual percentage rate of charge can at the pre - contractual stage be indicated only through an example , such an example should be representative . therefore , it should correspond , for instance , to the average duration and total amount of credit granted for the type of credit agreement under consideration . given the complexities of calculating an annual percentage rate of charge and in order to be able to accommodate product innovation , technical regulatory standards could be employed to amend or specify the method of calculation of the annual percentage rate of charge . in order to facilitate comparison , the aim should be to create uniformity as far as possible between the definition of and methodology used for calculating the annual percentage rate of charge in this directive and those in directive 2008 / 48 / ec . however , in the case of credits with a fixed initial interest rate , calculating the apcr in accordance with directive 2008 / 48 / ec may lead to serious misapprehensions among consumers . this should be corrected . further discrepancies may arise in the future should the two directives be modified . member states are free to maintain or introduce prohibitions on unilateral changes to the borrowing rate by the creditor .


### an assessment of creditworthiness should take into consideration all necessary factors that could influence a consumer ' s ability to repay over the lifetime of the loan including , but not limited to , the consumer ' s income , regular expenditures , credit score , past credit history , ability to handle interest rate adjustments , and other existing credit commitments . additional provisions may be necessary to further elaborate on the different elements that may be taken into consideration in a creditworthiness assessment . member states may issue guidance on the method and criteria to assess a consumer ' s creditworthiness , for example by setting limits on loan - to - value or loan - to - income ratios . ### an assessment of creditworthiness should take into consideration all necessary factors that could influence a consumer ' s ability to repay over the lifetime of the loan including , but not limited to , the consumer ' s income , regular expenditures , credit score , past credit history , ability to handle interest rate adjustments , and other existing credit commitments . additional provisions may be necessary to further elaborate on the different elements that may be taken into consideration in a creditworthiness assessment .


### consumers should provide all available relevant information on their financial situation and personal circumstances to the creditor or intermediary in order to facilitate the creditworthiness assessment . the consumer should not , however , be penalised where he is not in a position to provide certain information or assessments of the future evolution of his financial situation . in situations where consumers knowingly provide incomplete or inaccurate information , member states should be able to determine the appropriate penalties . ### consumers should provide all available relevant information on their financial situation and personal circumstances to enable the creditor or intermediary to carry out the creditworthiness assessment , since failure to do so will result in refusal of the credit they seek to obtain . . in situations where consumers knowingly provide incomplete or inaccurate information , member states should be able to determine the appropriate penalties .


### where a decision to reject an application for credit is based on data obtained through the consultation of a database or the lack of data therein , the creditor should inform the consumer thereof , of the name of the database consulted and of any other elements required by directive 95 / 46 / ec so as to enable the consumer to exercise his right to access and , where necessary , rectify , erase or block personal data concerning him and processed therein . where a decision to reject an application for credit is based on an automated decision or on systematic methods such as credit scoring systems , the creditor should inform the consumer thereof and explain the logic involved in the decision and of the arrangements enabling the consumer to request the automated decision to be reviewed manually . however , the creditor should not be required to give such information when to do so would be prohibited by other union legislation such as legislation on money laundering or the financing of terrorism . neither should such information be provided where to do so would be contrary to the objectives of public policy or public security such as the prevention , investigation , detection or prosecution of criminal offences . ### where a decision to reject an application for credit is based on data obtained through the consultation of a database or the lack of data therein , the creditor should inform the consumer thereof , of the particulars of the database consulted and of any other elements required by directive 95 / 46 / ec . where a decision to reject an application for credit is based on an automated decision or on systematic methods such as credit scoring systems , the creditor should notify the consumer thereof and inform him that such automated results can also be reviewed manually , though this will not create an obligation for the creditor . however , the creditor should not be required to give such information when to do so would be prohibited by other union legislation such as legislation on money laundering or the financing of terrorism . neither should such information be provided where to do so would be contrary to the objectives of public policy or public security such as the prevention , investigation , detection or prosecution of criminal offences .


### in order to be in a position to understand the nature of the service , consumers should be made aware of what constitutes a personalised recommendation on suitable credit agreements for that consumer ' s needs and financial situation and when it is being provided and when it is not . those providing advice should comply with general standards in order to ensure that the consumer is presented with a range of products suitable for his needs and circumstances . that service should be based on a fair and sufficiently wide - ranging analysis of the products available on the market , and on a close inspection of the consumer ' s financial situation , preferences and objectives . such an assessment should be based on up - to - date information and reasonable assumptions on the consumer ' s circumstances during the lifetime of the loan . member states may clarify how the suitability of a given product for a consumer should be assessed in the context of the provision of advice . ### in order to be in a position to understand the nature of the service , consumers should be made aware of what constitutes a personalised recommendation on suitable credit agreements for that consumer ' s needs and financial situation and when it is being provided and when it is not . those providing advice should comply with general standards in order to ensure that the consumer is presented with a range of products suitable for his needs and circumstances . that service should be based on a fair and sufficiently wide - ranging analysis of the products available within the creditor’s or the credit intermediary’s range of offered products or on the whole market when advice is provided by an independent body , and on a close inspection of the consumer ' s financial situation , preferences and objectives . such an assessment should be based on up - to - date information and reasonable assumptions on the consumer ' s circumstances during the lifetime of the loan . member states may clarify how the suitability of a given product for a consumer should be assessed in the context of the provision of advice .


### in order to be in a position to understand the nature of the service , consumers should be made aware of what constitutes a personalised recommendation on suitable credit agreements for that consumer’s needs and financial situation and when it is being provided and when it is not . those providing advice should comply with general standards in order to ensure that the consumer is presented with a range of products suitable for his needs and circumstances . that service should be based on a fair and sufficiently wide - ranging analysis of the products available on the market , and on a close inspection of the consumer’s financial situation , preferences and objectives . such an assessment should be based on up - to - date information and reasonable assumptions on the consumer’s circumstances during the lifetime of the loan . member states may clarify how the suitability of a given product for a consumer should be assessed in the context of the provision of advice . ### where the consumer is provided with advice as a service separate from the credit , he should be made clearly aware of this fact . a charge should only be made if the consumer is clearly informed about the charge and the method of its calculation . those providing advice should comply with general standards in order to ensure that the consumer is presented with a range of products suitable for his needs and circumstances . that advice should be based on a fair and sufficiently wide - ranging analysis of the products available , and on a close inspection of the consumer’s financial situation , preferences and objectives , and should be based on up - to - date information and reasonable assumptions on the consumer’s circumstances during the lifetime of the loan . if the advice relates only to the adviser’s own range of products , this should be drawn to the consumer’s attention . member states may clarify how the suitability of a given product for a consumer should be assessed in the context of the provision of advice .


### a consumer’s ability to repay his credit prior to the expiry of his credit agreement may play an important role in promoting competition in the single market and the free movement of eu citizens . however , substantial differences exist between the national principles and conditions under which consumers have the ability to repay and the conditions under which such early repayment can take place . whilst recognising the diversity in mortgage funding mechanisms and the range of products available , certain standards with regard to early repayment of credit are essential at union level in order to ensure that consumers have the possibility to discharge their obligations before the date agreed in the credit agreement and the confidence to shop around for the best products to meet their needs . member states should therefore ensure , either by legislation or by means of contractual clauses , that consumers have a statutory or contractual right to early repayment ; nevertheless , member states should be able to define the conditions for the exercise of such a right . these conditions may include time limitations on the exercise of the right , different treatment depending on the type of the borrowing rate , whether fixed or variable , restrictions with regard to the circumstances under which the right may be exercised . member states could also provide that the creditor should be entitled to fair and objectively justified compensation for potential costs directly linked to early repayment of the credit . in any event , if the early repayment falls within a period for which the borrowing rate is fixed , exercise of the right may be made subject to the existence of a special interest on the part of the consumer . such special interest may for example occur in case of divorce or unemployment . where a member state chooses to lay down such conditions , these should not make the exercise of the right excessively difficult or onerous for the consumer . ### a consumer’s ability to repay his credit prior to the expiry of his credit agreement may play an important role in promoting competition in the single market and the free movement of eu citizens . however , substantial differences exist between the national principles and conditions under which consumers have the ability to repay and the conditions under which such early repayment can take place . whilst recognising the diversity in mortgage funding mechanisms and the range of products available , certain standards with regard to early repayment of credit are essential at union level in order to ensure that consumers have the possibility to discharge their obligations before the date agreed in the credit agreement and the confidence to shop around for the best products to meet their needs . member states should therefore ensure , either by legislation or by means of contractual clauses , that consumers have a statutory or contractual right to early repayment ; nevertheless , member states should be able to define the conditions for the exercise of such a right . these conditions may include time limitations on the exercise of the right , different treatment depending on the type of the borrowing rate , whether fixed or variable , restrictions with regard to the circumstances under which the right may be exercised . member states could also provide that the creditor should be entitled to fair and objectively justified compensation for potential costs directly linked to early repayment of the credit . in any event if the early repayment falls within a period for which the borrowing rate is fixed , exercise of the right may be made subject to the existence of a legitimate interest on the part of the consumer . such legitimate interest may for example occur in case of divorce or unemployment .


### a consumer ' s ability to repay his credit prior to the expiry of his credit agreement may play an important role in promoting competition in the single market and the free movement of eu citizens . however , substantial differences exist between the national principles and conditions under which consumers have the ability to repay and the conditions under which such early repayment can take place . whilst recognising the diversity in mortgage funding mechanisms and the range of products available , certain standards with regard to early repayment of credit are essential at union level in order to ensure that consumers have the possibility to discharge their obligations before the date agreed in the credit agreement and the confidence to shop around for the best products to meet their needs . member states should therefore ensure , either by legislation or by means of contractual clauses , that consumers have a statutory or contractual right to early repayment ; nevertheless , member states should be able to define the conditions for the exercise of such a right . these conditions may include time limitations on the exercise of the right , different treatment depending on the type of the borrowing rate , whether fixed or variable , restrictions with regard to the circumstances under which the right may be exercised . member states could also provide that the creditor should be entitled to fair and objectively justified compensation for potential costs directly linked to early repayment of the credit . in any event if the early repayment falls within a period for which the borrowing rate is fixed , exercise of the right may be made subject to the existence of a special interest on the part of the consumer . such special interest may for example occur in case of divorce or unemployment . where a member state chooses to lay down such conditions , these should not make the exercise of the right excessively difficult or onerous for the consumer . ### a consumer ' s ability to repay his credit prior to the expiry of his credit agreement may play an important role in promoting competition in the single market and the free movement of eu citizens . however , substantial differences exist between the national principles and conditions under which consumers have the ability to repay and the conditions under which such early repayment can take place . whilst recognising the diversity in mortgage funding mechanisms and the range of products available , certain standards with regard to early repayment of credit are essential at union level in order to ensure that consumers have the possibility to discharge their obligations before the date agreed in the credit agreement and the confidence to shop around for the best products to meet their needs . member states should therefore ensure that consumers have a statutory right to early repayment ; nevertheless , member states should be able to define the conditions for the exercise of such a right . these conditions may include time limitations on the exercise of the right , different treatment depending on the type of the borrowing rate , whether fixed or variable , restrictions with regard to the circumstances under which the right may be exercised . member states could also provide that the creditor should be entitled to fair and objectively justified compensation for potential costs directly linked to early repayment of the credit . in any event if the early repayment falls within a period for which the borrowing rate is fixed , exercise of the right may be made subject to the existence of a legitimate interest on the part of the consumer . such special interest may for example occur in case of divorce or unemployment . where a member state chooses to lay down such conditions , these should not make the exercise of the right excessively difficult or onerous for the consumer .


### a consumer’s ability to repay his credit prior to the expiry of his credit agreement may play an important role in promoting competition in the single market and the free movement of eu citizens . however , substantial differences exist between the national principles and conditions under which consumers have the ability to repay and the conditions under which such early repayment can take place . whilst recognising the diversity in mortgage funding mechanisms and the range of products available , certain standards with regard to early repayment of credit are essential at union level in order to ensure that consumers have the possibility to discharge their obligations before the date agreed in the credit agreement and the confidence to shop around for the best products to meet their needs . member states should therefore ensure , either by legislation or by means of contractual clauses , that consumers have a statutory or contractual right to early repayment ; nevertheless , member states should be able to define the conditions for the exercise of such a right . these conditions may include time limitations on the exercise of the right , different treatment depending on the type of the borrowing rate , whether fixed or variable , restrictions with regard to the circumstances under which the right may be exercised . member states could also provide that the creditor should be entitled to fair and objectively justified compensation for potential costs directly linked to early repayment of the credit . in any event , if the early repayment falls within a period for which the borrowing rate is fixed , exercise of the right may be made subject to the existence of a special interest on the part of the consumer . such special interest may for example occur in case of divorce or unemployment . where a member state chooses to lay down such conditions , these should not make the exercise of the right excessively difficult or onerous for the consumer . ### a consumer’s ability to repay his credit prior to the expiry of his credit agreement may play an important role in promoting competition in the single market and the free movement of eu citizens . however , substantial differences exist between the national principles and conditions under which consumers have the ability to repay and the conditions under which such early repayment can take place . whilst recognising the diversity in mortgage funding mechanisms and the range of products available , certain standards with regard to early repayment of credit are essential at union level in order to ensure that consumers have the possibility to discharge their obligations before the date agreed in the credit agreement and the confidence to shop around for the best products to meet their needs . member states should therefore ensure , either by legislation or by means of contractual clauses , that consumers have a statutory or contractual right to early repayment while adhering to the principle that fixed interest periods , once agreed , are binding . member states should be able to define the conditions for the exercise of such a right . these conditions may include time limitations on the exercise of the right , different treatment depending on the type of the borrowing rate , whether fixed or variable , restrictions with regard to the circumstances under which the right may be exercised . member states could also provide that the creditor should be entitled to fair and objectively justified compensation for potential costs including any loss of interest directly linked to early repayment of the credit . in any event , if the early repayment falls within a period for which the borrowing rate is fixed , exercise of the right may be made subject to the existence of a special interest on the part of the consumer . such special interest may for example occur in case of divorce or unemployment .


### credit intermediaries should be registered with the competent authority of the member state where they have their residence or their head office , provided that they have been authorised in accordance with strict professional requirements in relation to their competence , good repute , and professional indemnity cover . with a view to promoting consumer confidence in credit intermediaries , member states should ensure that authorised credit intermediaries are subject to ongoing and thorough supervision by their home member state competent authority . such requirements should apply at least at the level of the institution ; however , member states may clarify whether such requirements for authorisation and subsequent registration apply to individual employees within the credit intermediary . ### credit intermediaries should be registered with the competent authority of the member state where they have their residence or their head office , provided that they have been authorised in accordance with strict professional requirements in relation to their competence , good repute , and professional indemnity cover . with a view to promoting consumer confidence in credit intermediaries , member states should ensure that authorised credit intermediaries are subject to ongoing and thorough supervision by their home member state competent authority . such requirements should apply at least at the level of the institution and at the level of the natural person in the case of a credit intermediary who works alone ; however , member states may clarify whether such requirements for authorisation and subsequent registration apply to individual employees within the credit intermediary .