### ”director’ means any member of the administrative , management or supervisory bodies of a company ; ### ”director’ means : - any member of the administrative , management or supervisory bodies of a company ; - chief executive officers even where they are not members of administrative , management or supervisory bodies .


### member states shall ensure that shareholders have the right to vote on the remuneration policy as regards directors . companies shall only pay remuneration to their directors in accordance with a remuneration policy that has been approved by shareholders . the policy shall be submitted for approval by the shareholders at least every three years . ### member states shall ensure that companies establish a remuneration policy as regards directors . companies shall only pay remuneration to their directors in accordance with a remuneration policy . member states shall ensure that shareholders have the right to vote on the remuneration policy . such vote shall be binding . however , member states may provide an advisory vote , provided that where shareholders vote against the remuneration policy and where the company identifies the reasons for the rejection , it shall explain in the next general meeting whether or not and , if so , how , the vote of the shareholders has been taken into account . the policy shall be submitted to a vote by the shareholders each time there is a material change to the policy and in any case at least every five years .


### the policy shall explain how it contributes to the long - term interests and sustainability of the company . it shall set clear criteria for the award of fixed and variable remuneration , including all benefits in whatever form . ### the policy shall explain how it contributes to the long - term interests and sustainability of the company without obliging companies to disclose business sensitive information . it shall give clear guidelines on the criteria applicable for the award of fixed and variable remuneration .


### member states shall ensure that companies , in case of transactions with related parties that represent more than 1% of their assets , publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether or not it is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the amount of the transaction and any other information necessary to assess the transaction . ### member states shall ensure that companies , in case of material transactions with related parties , publicly announce such transactions at the time of the conclusion of the transaction . the announcement shall contain information on the nature of the related party relationship , the name of the related party , the value of the transaction and any other information necessary to assess the transaction . member states may provide that the announcement published pursuant to paragraph 1 is accompanied by a report assessing whether or not the transaction is fair and reasonable from the perspective of the shareholders who are not related party , in particular minority shareholders . this report is produced by an independent third party or the administrative or the supervisory body of the company or the audit committee or any committee the majority of which is composed by independent directors , provided that the related parties are prevented from having a role in the preparation of the report .


### transactions with related parties may cause prejudice to companies and their shareholders , as they may give the related party the opportunity to appropriate value belonging to the company . thus , adequate safeguards for the protection of shareholders’ interests are of importance . for this reason member states should ensure that related party transactions representing more than 5 % of the companies’ assets or transactions which can have a significant impact on profits or turnover should be submitted to a vote by the shareholders in a general meeting . where the related party transaction involves a shareholder , this shareholder should be excluded from that vote . the company should not be allowed to conclude the transaction before the shareholders’ approval of the transaction . for transactions with related parties that represent more than 1% of their assets companies should publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether the transaction is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . member states should be allowed to exclude transactions entered into between the company and its wholly owned subsidiaries . member states should also be able to allow companies to request the advance approval by shareholders for certain clearly defined types of recurrent transactions above 5 percent of the assets , and to request from shareholders an advance exemption from the obligation to produce an independent third party report for recurrent transactions above 1 percent of the assets , under certain conditions , in order to facilitate the conclusion of such transactions by companies . ### transactions with related parties may cause prejudice to companies and their shareholders , as they may give the related party the opportunity to appropriate value belonging to the company . thus , adequate safeguards for the protection of shareholders ' interests are of importance . for this reason member states should ensure that related party transactions should be submitted to a vote by the shareholders in a general meeting or to the approval of the administrative or supervisory body or the audit committee or another committee the majority of which is composed by independent directors . where the related party transaction involves a shareholder or a director , this shareholder or director should be excluded from having a determining role in the approval process member states should ensure also that companies , in case of material transactions with related parties , publicly announce such transactions at the latest at the time of the conclusion of the transaction , member states should be allowed to exclude transactions entered into in the ordinary course of business and concluded on normal market terms or on market equivalent terms ; transactions entered into between the company and one or more members of its group and clearly defined types of transactions for which national law provides for adequate protection of minority shareholders .


### transactions with related parties may cause prejudice to companies and their shareholders , as they may give the related party the opportunity to appropriate value belonging to the company . thus , adequate safeguards for the protection of shareholders’ interests are of importance . for this reason member states should ensure that related party transactions representing more than 5 % of the companies’ assets or transactions which can have a significant impact on profits or turnover should be submitted to a vote by the shareholders in a general meeting . where the related party transaction involves a shareholder , this shareholder should be excluded from that vote . the company should not be allowed to conclude the transaction before the shareholders’ approval of the transaction . for transactions with related parties that represent more than 1% of their assets companies should publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether the transaction is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . member states should be allowed to exclude transactions entered into between the company and its wholly owned subsidiaries . member states should also be able to allow companies to request the advance approval by shareholders for certain clearly defined types of recurrent transactions above 5 percent of the assets , and to request from shareholders an advance exemption from the obligation to produce an independent third party report for recurrent transactions above 1 percent of the assets , under certain conditions , in order to facilitate the conclusion of such transactions by companies . ### transactions with related parties may cause prejudice to companies and their shareholders , as they may give the related party the opportunity to appropriate value belonging to the company . thus , adequate safeguards for the protection of shareholders’ interests are of importance . for this reason member states should ensure that related party transactions should be submitted to a vote by the shareholders in a general meeting or to the approval of the administrative or supervisory body or the audit committee or another committee the majority of which is composed by independent directors . where the related party transaction involves a shareholder or a director , this shareholder or director should be excluded from having a determining role in the approval process . member states should ensure also that companies , in case of material transactions with related parties , publicly announce such transactions at the time of the conclusion of the transaction . member states should be allowed to exclude transactions entered into in the ordinary course of business and concluded on normal market terms or on market equivalent terms ; transactions entered into between the company and one or more members of its group and clearly defined types of transactions for which national law provides for adequate protection of minority shareholders .


### member states shall ensure that proxy advisors adopt and implement adequate measures to guarantee that their voting recommendations are accurate and reliable , based on a thorough analysis of all the information that is available to them . ### member states shall ensure that proxy advisors make recommendations on the exercise of voting rights available to shareholders in good time . advisors shall be guided by the interests of the shareholder and shall ensure that they are not influenced by their own interests . proxy advisors shall point out that they will exercise their voting rights in accordance with their own proposals if shareholders do not issue different instructions in time . member states shall ensure that proxy advisors adopt adequate measures to guarantee accurate and reliable voting recommendations that are based on a thorough analysis of all the information that is available to them .


### member states shall ensure that shareholders have the right to vote on the remuneration policy as regards directors . companies shall only pay remuneration to their directors in accordance with a remuneration policy that has been approved by shareholders . the policy shall be submitted for approval by the shareholders at least every three years . ### member states shall ensure that companies draw up a remuneration policy for corporate governance . this policy shall ensure that shareholders have the right to vote on the remuneration policy as regards directors . the result of the vote at the general meeting shall be recommendatory in nature . the policy shall be submitted for approval by the shareholders at least every three years .


### institutional investors should annually disclose to the public how their equity investment strategy is aligned with the profile and duration of their liabilities and how it contributes to the medium to long - term performance of their assets . where they make use of asset managers , either through discretionary mandates involving the management of assets on an individual basis or through pooled funds , they should disclose to the public the main elements of the arrangement with the asset manager with regard to a number of issues , such as whether it incentivises the asset manager to align its investment strategy and decisions with the profile and duration of the liabilities of the institutional investor , whether it incentivises the asset manager to make investment decisions based on medium to long - term company performance and to engage with companies , how it evaluates the asset managers performance , the structure of the consideration for the asset management services and the targeted portfolio turnover . this would contribute to a proper alignment of interests between the final beneficiaries of institutional investors , the asset managers and the investee companies and potentially to the development of longer - term investment strategies and longer - term relationships with investee companies involving shareholder engagement . ### regulated institutional investors should report to the relevant supervisory body on how their equity investment strategy is aligned with the profile and duration of their liabilities and how it contributes to the medium to long - term performance of their assets . non - regulated investors should disclose this to the public . where they make use of asset managers , either through discretionary mandates involving the management of assets on an individual basis or through pooled funds , they should report on , or disclose to the public , the main elements of the arrangement with the asset manager with regard to a number of issues , such as whether it incentivises the asset manager to align its investment strategy and decisions with the profile and duration of the liabilities of the institutional investor , whether it incentivises the asset manager to make investment decisions based on medium to long - term company performance and to engage with companies , and the targeted portfolio turnover . this would contribute to a proper alignment of interests between the final beneficiaries of institutional investors , the asset managers and the investee companies and potentially to the development of longer - term investment strategies and longer - term relationships with investee companies involving shareholder engagement .


### ”director’ means any member of the administrative , management or supervisory bodies of a company ; ### director ' means any member of the administrative , management or supervisory bodies of a company , nominated by shareholders of the company in accordance with national law . however , member states may extend the definition of director in order to comply with their existing national regulation .


### institutional investors should annually disclose to the public how their equity investment strategy is aligned with the profile and duration of their liabilities and how it contributes to the medium to long - term performance of their assets . where they make use of asset managers , either through discretionary mandates involving the management of assets on an individual basis or through pooled funds , they should disclose to the public the main elements of the arrangement with the asset manager with regard to a number of issues , such as whether it incentivises the asset manager to align its investment strategy and decisions with the profile and duration of the liabilities of the institutional investor , whether it incentivises the asset manager to make investment decisions based on medium to long - term company performance and to engage with companies , how it evaluates the asset managers performance , the structure of the consideration for the asset management services and the targeted portfolio turnover . this would contribute to a proper alignment of interests between the final beneficiaries of institutional investors , the asset managers and the investee companies and potentially to the development of longer - term investment strategies and longer - term relationships with investee companies involving shareholder engagement . ### regulated institutional investors should report to the relevant supervisory body on how their equity investment strategy is aligned with the profile and duration of their liabilities and how it contributes to the medium to long - term performance of their assets . non - regulated investors should disclose this to the public . where they make use of asset managers , either through discretionary mandates involving the management of assets on an individual basis or through pooled funds , they should report on , or disclose to the public , the main elements of the arrangement with the asset manager with regard to a number of issues , such as whether it incentivises the asset manager to align its investment strategy and decisions with the profile and duration of the liabilities of the institutional investor , whether it incentivises the asset manager to make investment decisions based on medium to long - term company performance and to engage with companies , how it evaluates the asset managers performance , the structure of the consideration for the asset management services and the targeted portfolio turnover . this would contribute to a proper alignment of interests between the final beneficiaries of institutional investors , the asset managers and the investee companies and potentially to the development of longer - term investment strategies and longer - term relationships with investee companies involving shareholder engagement .


### transactions with related parties may cause prejudice to companies and their shareholders , as they may give the related party the opportunity to appropriate value belonging to the company . thus , adequate safeguards for the protection of shareholders’ interests are of importance . for this reason member states should ensure that related party transactions representing more than 5 % of the companies’ assets or transactions which can have a significant impact on profits or turnover should be submitted to a vote by the shareholders in a general meeting . where the related party transaction involves a shareholder , this shareholder should be excluded from that vote . the company should not be allowed to conclude the transaction before the shareholders’ approval of the transaction . for transactions with related parties that represent more than 1% of their assets companies should publicly announce such transactions at the time of the conclusion of the transaction , and accompany the announcement by a report from an independent third party assessing whether the transaction is on market terms and confirming that the transaction is fair and reasonable from the perspective of the shareholders , including minority shareholders . member states should be allowed to exclude transactions entered into between the company and its wholly owned subsidiaries . member states should also be able to allow companies to request the advance approval by shareholders for certain clearly defined types of recurrent transactions above 5 percent of the assets , and to request from shareholders an advance exemption from the obligation to produce an independent third party report for recurrent transactions above 1 percent of the assets , under certain conditions , in order to facilitate the conclusion of such transactions by companies . ### transactions with related parties may cause prejudice to companies and their shareholders , as they may give the related party the opportunity to appropriate value belonging to the company . thus , adequate safeguards for the protection of shareholders ' interests are of importance . for this reason member states should ensure that related party transactions representing more than 5 % of the companies ' assets or transactions should be submitted either to a vote by the shareholders in a general meeting or to the approval of an administrative body of the company such as independent directors assessing whether the transaction is fair and reasonable from the perspective of the company and consequently its shareholders . for transactions with related parties that represent more than 1% of their assets companies should publicly announce such transactions at the time of the conclusion of the transaction . transactions entered into in the ordinary course of business or concluded on market terms or market equivalent terms should be excluded . transactions entered into between the company and its wholly or partly owned subsidiaries or joint ventures should also be excluded . member states should also be able to allow companies to request the advance approval by shareholders or an independent administrative body for certain clearly defined types of recurrent transactions above 5 percent of the assets .


### to ensure that the implementation of the remuneration policy is in line with the approved policy , shareholders should be granted the right to vote on the company’s remuneration report . in order to ensure accountability of directors the remuneration report should be clear and understandable and should provide a comprehensive overview of the remuneration granted to individual directors in the last financial year . where the shareholders vote against the remuneration report , the company should explain in the next remuneration report how the vote of the shareholders has been taken into account . ### to ensure that the implementation of the remuneration policy , member states should be able to provide that shareholders have the right to vote on the company’s remuneration report . in order to ensure accountability of directors the remuneration report should be clear and understandable and should provide a comprehensive overview of the remuneration granted to individual directors in the last financial year . where the shareholders vote against the remuneration and the company is able to identify the reasons for the rejection , it should explain in the next general meeting whether or not and , if so , how the vote of the shareholders has been taken into account .


### to ensure that the implementation of the remuneration policy is in line with the approved policy , shareholders should be granted the right to vote on the company’s remuneration report . in order to ensure accountability of directors the remuneration report should be clear and understandable and should provide a comprehensive overview of the remuneration granted to individual directors in the last financial year . where the shareholders vote against the remuneration report , the company should explain in the next remuneration report how the vote of the shareholders has been taken into account . ### to ensure that the implementation of the remuneration policy is in line with the approved policy , member states should be able to grant shareholders the right to vote on the company’s remuneration report . in order to ensure accountability of directors the remuneration report should be clear and understandable and should provide a comprehensive overview of the remuneration granted or still due to directors in the last financial year . where the shareholders vote against the remuneration report , the company should explain in the next remuneration report how the vote of the shareholders has been taken into account .


### a balancing contribution from the union , entered in the general budget of the union which shall not exceed 40% of the estimated revenues of the authority ; ### a balancing contribution from the union , entered in the general budget of the union which shall be at least 35% of the estimated revenues of the authority ;


### one member of the executive board , the representative of the commission and the esrb shall be invited to the meetings of the joint committee , as well as of any sub - committees referred to in article 57 , as observers . ; ### one member of the executive / management board , a representative of the commission and the second chair of the esrb and , where relevant , the chairperson of any sub - committee of the joint committee shall be invited to the meetings of the joint committee , as well as where relevant of any sub - committees referred to in article 57 , as observers .


### ' when carrying out its tasks in accordance with this regulation , the authority shall take account of technological innovation , innovative and sustainable business models , and the integration of environmental , social and governance related factors . ; ### when carrying out its tasks in accordance with this regulation , the authority shall take account of and anticipate technological innovation , innovative and sustainable business models , and the integration of environmental , social and governance related factors , including monitoring of how financial institutions identify , report , and address risks that environmental , social and governance factors may pose to financial stability , providing guidance on how sustainability considerations can be effectively embodied in relevant eu financial legislation , and promoting coherent implementation of these provisions upon adoption .


### one member of the executive board , the representative of the commission and the esrb shall be invited to the meetings of the joint committee , as well as of any sub - committees referred to in article 57 , as observers . ; ### the executive director , the representative of the commission and the esrb shall be invited to the meetings of the joint committee , as well as of any sub - committees referred to in article 57 , as observers . ;


### the commission shall submit the shortlist to the european parliament for approval . following the approval of that shortlist , the council shall adopt a decision to appoint the full time members of the executive board including the member in charge . the executive board shall be balanced and proportionate and shall reflect the union as a whole . ### after submission to the board of supervisors and if no objection is expressed by the board on the shortlist of candidates , the commission shall submit the shortlist to the european parliament for approval . following the approval of that shortlist , the council shall adopt a decision to appoint the full time members of the executive board including the member in charge . the executive board shall be balanced and proportionate and shall reflect the union as a whole .


### the abolition of retail roaming surcharges introduced by regulation no 2015 / 2120 , also named ' roam - like - at - home’ , is necessary to establish and ease the functioning of a digital single market across the union . however , that regulation alone is not sufficient to ensure the correct functioning of the roaming market . ### the abolition of retail roaming surcharges introduced by regulation no 2015 / 2120 , also named ' roam - like - at - home’ , is necessary to establish and ease the functioning of a digital single market across the union . however , that regulation alone is not sufficient to ensure the correct and sustainable functioning of the roaming market . this regulation should therefore ensure that pricing models in domestic markets are not affected .


### in addition , the commission shall submit a report to the european parliament and the council every two years after 15 june 2017 . ### in addition , the commission shall submit a report to the european parliament and the council by 15 june 2018 and every two years thereafter , accompanied , if appropriate , by a legislative proposal to amend the wholesale caps for regulated roaming services laid down in this regulation .


### with effect from 15 june 2017 , the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 0 . 0085 per megabyte of data transmitted and shall , without prejudice to article 19 , remain at eur 0 . 0085 per megabyte of data transmitted until 30 june 2022 . ### with effect from 15 june 2017 the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 5 per gigabyte of data transmitted . the safeguard limit shall , on 1 july 2018 , decrease to eur 4 per gigabyte of data transmitted , on 1 july 2019 to eur 3 per gigabyte of data transmitted , and , on 1 july 2020 , to eur 2 per gigabyte of data transmitted , and on 1 july 2021 , to eur 1 per gigabyte of data transmitted . it shall , without prejudice to article 19 , remain at eur 1 per gigabyte of data transmitted until 30 june 2022 .


### the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of a regulated roaming call originating on that visited network , inclusive , among others , of origination , transit and termination costs , shall not exceed a safeguard limit of eur 0 . 04 per minute as of 15 june 2017 and shall , without prejudice to article 19 , remain at eur 0 . 04 until 30 june 2022 . ### the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of a regulated roaming call originating on that visited network , inclusive , among others , of origination , transit and termination costs , shall not exceed a safeguard limit of eur 0 . 03 per minute as of 15 june 2017 and shall , without prejudice to article 19 , remain at eur 0 . 03 until 30 june 2022 .


### in particular , the current functioning of wholesale roaming markets could affect competition and investments in home operators’ domestic markets due to excessive wholesale roaming charges compared to the domestic retail prices applied to end - users . this applies in particular for smaller or net out - bound operators , thus making rlah structurally unsustainable . ### in particular , the current functioning of wholesale roaming markets could affect competition and investments in home operators’ domestic markets due to excessive wholesale roaming charges compared to the domestic retail prices applied to end - users . this applies in particular for smaller or net out - bound operators , thus making rlah structurally unsustainable . therefore it is crucial to ensure that the union telecom framework legislation provides clear and consistent long term incentives for private investment in telecommunication infrastructure .


### with effect from 15 june 2017 , the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 0 . 0085 per megabyte of data transmitted and shall , without prejudice to article 19 , remain at eur 0 . 0085 per megabyte of data transmitted until 30 june 2022 . ### with effect from 15 june 2017 , the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 4 per gigabyte of data transmitted . the safeguard limit shall , on 1 july 2018 , decrease to eur 3 per gigabyte of data transmitted , on 1 july 2019 to eur 2 per gigabyte of data transmitted , on 1 july 2020 to eur 1 . 5 per gigabyte of data transmitted , and on 1 july 2021 to eur 1 per gigabyte of data transmitted . it shall , without prejudice to article 19 , remain at eur 1 per gigabyte of data transmitted until 30 june 2022 .


### with effect from 15 june 2017 , the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 0 . 0085 per megabyte of data transmitted and shall , without prejudice to article 19 , remain at eur 0 . 0085 per megabyte of data transmitted until 30 june 2022 . ### with effect from 15 june 2017 , the average wholesale charge that a visited network operator may levy on a roaming provider for the provision of regulated data roaming services by means of that visited network shall be set based on the principle of reciprocal charging .


### with effect from 15 june 2017 , the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 0 . 0085 per megabyte of data transmitted and shall , without prejudice to article 19 , remain at eur 0 . 0085 per megabyte of data transmitted until 30 june 2022 . ### with effect from 15 june 2017 , the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 2 . 5 per gigabyte of data transmitted . this safeguard limit shall , on 1 july 2018 , decrease to eur 2 per gigabyte of data transmitted , on 1 july 2019 to eur 1 . 5 per gigabyte of data transmitted , and on 1 july 2020 , to eur 1 per gigabyte of data transmitted . it shall remain , without prejudice to article 19 , at eur 1 per gigabyte of data transmitted until 30 june 2022 .


### with effect from 15 june 2017 , the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 0 . 0085 per megabyte of data transmitted and shall , without prejudice to article 19 , remain at eur 0 . 0085 per megabyte of data transmitted until 30 june 2022 . ### with effect from 15 june 2017 , the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of eur 4 per gigabyte of data transmitted . the safeguard limit shall , on 1 july 2018 , decrease to eur 2 per gigabyte of data transmitted , and , without prejudice to article 19 , on 1 july 2019 to eur 1 per gigabyte of data transmitted . it shall remain at eur 1 per gigabyte of data transmitted until 30 june 2022 .


### the average wholesale charge that the visited network operator may levy on the roaming provider for the provision of a regulated roaming call originating on that visited network , inclusive , among others , of origination , transit and termination costs , shall not exceed a safeguard limit of eur 0 . 04 per minute as of 15 june 2017 and shall , without prejudice to article 19 , remain at eur 0 . 04 until 30 june 2022 ### as of 15 june 2017 , the average wholesale charge that a visited network operator may levy on a roaming provider for the provision of a regulated roaming call originating on that visited network , inclusive , among others , of origination , transit and termination costs , shall be set based on the principle of reciprocal charging .


### therefore , the existing maximum wholesale roaming charges for voice calls , sms and data services should be lowered . ### therefore , the existing maximum wholesale roaming charges for voice calls , sms and data services should be lowered to levels much closer to the actual cost of those service .


### therefore , the existing maximum wholesale roaming charges for voice calls , sms and data services should be lowered . ### therefore , the existing maximum wholesale roaming charges for voice calls , sms and data services should be lowered . if operators can demonstrate that the lowered wholesale roaming charges are not sufficient any more for them to cover the underlying cost , under the long run incremental cost plus method , for providing wholesale roaming services , they should be entitled to adequate compensation of such losses from the rlah fund which should be set up by a commission implementing act pursuant to this regulation . the rlah fund should be administered by berec . it should be funded by all market participants using the existing mobile networks as main underlying infrastructure for the services to their customers above a certain traffic threshold , which shall be determined by berec based on the principles set out in that implementing act .


### the union can best support tunisia’s economy , in accordance with the objectives set out in the european neighbourhood policy and in the euro - mediterranean agreement , by providing an attractive and reliable market for tunisia’s exports of olive oil . this requires autonomous trade measures allowing for the import of this product into the union on the basis of a duty free tariff quota . ### the union can best support tunisia’s economy , in accordance with the objectives set out in the european neighbourhood policy and in the euro - mediterranean agreement , by providing an attractive and reliable market for tunisia’s exports . to that end , one possible concession that the union could make to tunisia , as a result of the attack referred to , is to introduce autonomous trade measures allowing for the import of tunisian oil into the union on the basis of a duty free tariff quota .


### an analysis of the relative effects of the health technology being assessed on the patient - relevant health outcomes chosen for the assessment ; ### a description of the relative effects of the health technology being assessed on the patient - relevant health outcomes agreed for the assessment ;


### this regulation establishes : ### taking into account the results of the work already undertaken in the eunethta joint actions , this regulation establishes :


### the designated sub - group shall ensure that stakeholders , including patients and clinical experts , are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time - frame in which they may submit comments . ### the designated sub - group shall ensure that all relevant stakeholders , including patient organisations , health professionals and clinical experts , are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time - frame in which they may submit comments .


### ' clinical assessment ' means a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment : the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem , the description and technical characterisation of the health technology , the relative clinical effectiveness , and the relative safety of the health technology ; ### ' clinical assessment ' means a compilation and analysis of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment : the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem , the description and technical characterisation of the health technology , the relative clinical effectiveness , and the relative safety of the health technology at the time of regulatory approval ;


### the designated sub - group shall request relevant health technology developers to submit documentation containing the information , data and evidence necessary for the joint clinical assessment . ### the designated sub - group shall meet with relevant health technology developers on the scope of the assessment and on the documentation containing the information , data and evidence necessary for the joint clinical assessment to be submitted . the relationship between evaluators and health technology developers shall be independent and impartial . developers of health technologies may be consulted , but shall not participate actively in the evaluation process .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 __________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish , after consulting the coordination group , a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission and the coordination group should take into account the results of the work already undertaken in the eunethta joint actions and in particular the methodological guidelines and evidence submission template . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . the procedural and methodological frameworks should be updated at the frequency deemed necessary by the commission and the coordination group to ensure that those frameworks are adapted to scientific evolution . in developing the methodological framework , the commission , in collaboration with the coordination group , should consider the specificity and corresponding challenges of certain types of health technologies , advanced therapies or life - prolonging therapies where innovative clinical study designs may be required . these may result in evidential uncertainty at the time of the marketing authorisation . as such innovative clinical study designs are often accepted for the purposes of regulatory assessments , the methodology for joint clinical assessments should not prevent these health technologies from reaching patients . the commission and the coordination group should therefore ensure that the methodology provides for a high standard of clinical evidence , while preserving the necessary flexibility , to enable an adequate assessment of such health technologies . such clinical evidence should include the acceptance of the best available scientific evidence at the time of the submission , including , for instance , data from case control studies , real world observational data , as well as the acceptance of indirect treatment comparators . the methodological rules to be developed should cover the possibilities for improvement of clinical evidence in the cases where further scientific evidence is nevertheless needed . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 __________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors . ### when preparing those implementing and delegated acts , the commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors and shall consider the work already undertaken in the eunethta joint actions .


### in order to ensure a uniform approach to the joint work provided for in this regulation , implementing powers should be conferred on the commission to establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission should take into account the results of the work already undertaken in the eunethta joint actions . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 __________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers . ### in order to ensure a uniform approach to the joint work provided for in this regulation , the coordination group together with the commission should establish a common procedural and methodological framework for clinical assessments , procedures for joint clinical assessments and procedures for joint scientific consultations . where appropriate , distinct rules should be developed for medicinal products and medical devices . in the development of such rules , the commission and the coordination group should take into account the results of the work already undertaken in the eunethta joint actions and in particular the methodological guidelines and evidence submission template . it should also take into account initiatives on hta funded through the horizon 2020 research programme , as well as regional initiatives on hta such as the beneluxa and valletta declaration initiatives . in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission to establish procedures for joint clinical assessments and procedures for joint scientific consultations . those powers should be exercised in accordance with regulation no 182 / 2011 of the european parliament and of the council . 13 the procedural and methodological framework are updated at the frequency deemed necessary by the commission and the coordination group to ensure that they should be adapted to the evolution of science . in developing the methodological framework , the commission and in collaboration with the coordination group should consider the specificity and corresponding challenges of certain types of health technologies , advanced therapies or life - prolonging therapies where innovative clinical study designs may be required . these may result in evidential uncertainty at the time of the marketing authorization . as such innovative clinical study designs are often accepted for the purposes of regulatory assessments , the methodology for joint clinical assessments should not prevent these health technologies from reaching patients . the commission and the coordination group should therefore ensure that the methodology provides for a sufficient level of clinical evidence to enable an adequate assessment of such health technologies . such clinical evidence should include the acceptance of the best available scientific evidence at the time of the submission , including , for instance , data from case control studies , real world evidence , as well as the acceptance of indirect treatment comparators . __________________ 13 regulation no 182 / 2011 of the european parliament and of the council of 16 february 2011 laying down the rules and general principles concerning mechanisms for control by the member states of the commission ' s exercise of implementing powers .


### the consultation of patients , clinical experts and other relevant stakeholders ; ### the consultation of patient organisations , health professionals , clinical experts and other relevant stakeholders ;


### submissions of information , data and evidence by health technology developers ; ### submissions of information , data and evidence by health technology developers , including the protection of developers ' confidential information ;


### the designated sub - group shall ensure that stakeholders , including patients , and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time - frame in which they may submit comments . ### the designated sub - group shall ensure that all relevant stakeholders , including patient organisations , health professionals and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time - frame in which they may submit comments .


### ensure appropriate involvement of stakeholders in its work ; ### ensure appropriate and regular involvement of stakeholders in its work ;


### member states shall notify the commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion . that notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment . the commission shall facilitate the exchange of this information between member states through the it platform referred to in article 27 . ### member states shall notify the commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion . that notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment . the final report shall be made publicly available . the commission shall facilitate the exchange of this information between member states through the it platform referred to in article 27 .


### member states shall designate their national authorities and bodies responsible for health technology assessment as members of the coordination group and its sub - groups and inform the commission thereof and of any subsequent changes . member states may designate more than one authority or body responsible for health technology assessment as members of the coordination group and one or more of its sub - groups . ### member states shall designate their national authorities and bodies responsible for health technology assessment that inform decision - making at national level as members of the coordination group and its sub - groups and inform the commission thereof and of any subsequent changes . member states may designate more than one authority or body responsible for health technology assessment as members of the coordination group and one or more of its sub - groups . each member state may appoint to the coordination group at least one authority or body responsible with expertise in the field of medicinal products .


### ' single - use plastic product ' means a product that is made wholly or partly from plastic and that is not conceived , designed or placed on the market to accomplish , within its life span , multiple trips or rotations by being returned to the producer for refill or re - used for the same purpose for which it was conceived ; ### ‘ single - use plastic product’ means a product that is largely made from plastic and that is not conceived , designed or placed on the market to accomplish , within its lifespan , multiple trips or rotations by being returned to the producer for refill or re - used for the same purpose for which it was conceived ; products of which only the lining , coating or covering is plastic shall be excluded from this definition ;


### single use plastic products can be manufactured from a wide range of plastics . plastics are usually defined as polymeric materials to which additives may have been added . however , this definition would cover certain natural polymers . unmodified natural polymers should not be covered as they occur naturally in the environment . therefore , the definition of polymer in article 3 of regulation no 1907 / 2006 of the european parliament and of the council43should be adapted and a separate definition should be introduced for the purposes of this directive . plastics manufactured with modified natural polymers , or plastics manufactured from bio - based , fossil or synthetic starting substances are not naturally occurring and should therefore be addressed by this directive . the adapted definition of plastics should therefore cover polymer - based rubber items and bio - based and biodegradable plastics regardless of whether they are derived from biomass and / or intended to biodegrade over time . certain polymeric materials are not capable of functioning as a main structural component of final materials and products , such as polymeric coatings , paints , inks , and adhesives . those materials should not be addressed by this directive and should therefore not be covered by the definition . _________________ 43 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals , establishing a european chemicals agency , amending directive 1999 / 45 / ec and repealing council regulation no 793 / 93 and commission regulation no 1488 / 94 as well as council directive 76 / 769 / eec and commission directives 91 / 155 / eec , 93 / 67 / eec , 93 / 105 / ec and 2000 / 21 / ec . ### single - use plastic products can be manufactured from a wide range of plastics . plastics are usually defined as polymeric materials to which additives may have been added . however , this definition would cover certain natural polymers . unmodified natural polymers should not be covered as they occur naturally in the environment . therefore , the definition of polymer in article 3 of regulation no 1907 / 2006 of the european parliament and of the council43 should be adapted and a separate definition should be introduced for the purposes of this directive . certain polymeric materials are not capable of functioning as a main structural component of final materials and products , such as polymeric coatings , paints , inks , and adhesives . those materials should not be addressed by this directive and should therefore not be covered by the definition . _________________ 43 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals , establishing a european chemicals agency , amending directive 1999 / 45 / ec and repealing council regulation no 793 / 93 and commission regulation no 1488 / 94 as well as council directive 76 / 769 / eec and commission directives 91 / 155 / eec , 93 / 67 / eec , 93 / 105 / ec and 2000 / 21 / ec .


### sufficient scientific and technical progress has been made , and criteria or a standard for biodegradability in the marine environment applicable to single - use plastic products within the scope of this directive and their single - use substitutes have been developed , in order to determine which products no longer need to be subject to the restrictions on placing on the market , where appropriate . ### sufficient scientific and technical progress has been made , and an european standard for biodegradability in the marine environment applicable to single - use plastic products within the scope of this directive and their single - use substitutes have been developed , in order to determine which products no longer need to be subject to the restrictions on placing on the market , where appropriate .


### the commission shall carry out an evaluation of this directive by &#8230 ; [ six years after the end - date for transposition of this directive ] . the evaluation shall be based on the information available in accordance with article 13 . member states shall provide the commission with any additional information necessary for the purposes of the evaluation and the preparation of the report referred to in paragraph 2 . ### the commission shall carry out an evaluation of this directive by &#8230 ; [ three years after the end - date for transposition of this directive ] . the evaluation shall be based on the information available in accordance with article 13 . member states shall provide the commission with any additional information necessary for the purposes of the evaluation and the preparation of the report referred to in paragraph 2 .


### ' plastic ' means a material consisting of a polymer within the meaning of article 3 of regulation no 1907 / 2006 , to which additives or other substances may have been added , and which can function as a main structural component of final products , with the exception of natural polymers that have not been chemically modified ; ### ' plastic ' means a material consisting of a polymer within the meaning of article 3 of regulation no 1907 / 2006 , to which additives or other substances may have been added , and which functions as the main structural component of final products , with the exception of natural polymers that have not been chemically modified and polymeric coatings , paints , inks and adhesives which are not capable of functioning as a main structural component of final articles and products ;


### the financial envelope referred to in article shall finance the european fund for sustainable development plus and the external action guarantee . ### the financial envelope referred to in article shall finance efsd + , elm + and the external action guarantee .


### information on the seafarers employed from third countries has become available at union level through the communication by the member states of the relevant information kept in their national registers regarding issued certificates and endorsements . this information should be used not only for statistical and policy making purposes but also for the purpose of improving the efficiency of the centralised system recognising third countries . based on the information communicated by the member states , recognised third countries which have not provided the union fleet with seafarers for a period of at least five years shall be withdrawn from the list of recognised third countries . in addition , this information shall be also used in order to prioritise the reassessment of the recognised third countries . ### information on the seafarers employed from third countries has become available at union level through the communication by the member states of the relevant information kept in their national registers regarding issued certificates and endorsements . this information should be used not only for statistical and policy making purposes but also for the purpose of improving the efficiency of the centralised system recognising third countries . based on the information communicated by the member states , the recognition of third countries which have not provided the union fleet with seafarers for a period of at least 10 years should be re - examined . the re - examination process should cover the possibility of retaining or withdrawing the recognition of the relevant third country , in accordance with the examination procedure . in addition , this information shall be also used in order to prioritise the reassessment of the recognised third countries .


### if there are no endorsements attesting recognition issued by a member state in relation to certificates of competency or certificates of proficiency , referred to in paragraph 1 of article 19 , issued by a third country for a period of more than 5 years , the recognition of that country ' s certificates shall be withdrawn . to this end , the commission shall adopt implementing decisions , in accordance with the examination procedure referred to in article 28 , after notifying the member states as well as the third country concerned at least two months in advance ### if there are no endorsements attesting recognition issued by a member state in relation to certificates of competency or certificates of proficiency , referred to in article 19 , issued by a third country for a period of more than 10 years , the recognition of that country ' s certificates shall be re - examined in consultation with the member states and the relevant stakeholders . to this end following the abovementioned re - examination procedure , the commission shall adopt implementing decisions , in accordance with the examination procedure referred to in article 28 , after notifying the member states as well as the third country concerned at least two months in advance .


### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme evaluation14 showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of seafarers was subsequently employed in union vessels . therefore , in order to use the available human and financial resources in a more efficient way , the procedure for the recognition of third countries should be based on an analysis of the need for such recognition , including an estimation of the number of masters and officers originating from that country who are likely to be employed in union vessels . _______________________________ 14 swd19 ### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme evaluation14 showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of endorsements attesting to the recognition of certificates were issued by member states in relation to certificates of competency or certificates of proficiency issued by those third countries . _________________________________ 14 swd19


### when a positive decision for initiating the recognition procedure has been adopted , the commission , assisted by the european maritime safety agency and with the possible involvement of the member state submitting the request , shall collect the information referred to in annex ii and shall carry out an assessment of the training and certification systems in the third country for which the request for recognition was submitted , in order to verify whether the country concerned meets all the requirements of the stcw convention and whether appropriate measures have been taken to prevent issuance of fraudulent certificates . ### the commission , assisted by the european maritime safety agency and with the possible involvement of the member state submitting the request , shall collect the information referred to in annex ii and shall carry out an assessment of the training and certification systems in the third country for which the request for recognition was submitted , in order to verify whether the country concerned meets all the requirements of the stcw convention and whether appropriate measures have been taken to prevent issuance of fraudulent certificates .


### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme 14 evaluation showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of seafarers was subsequently employed in union vessels . therefore , in order to use the available human and financial resources in a more efficient way , the procedure for the recognition of third countries should be based on an analysis of the need for such recognition , including an estimation of the number of masters and officers originating from that country who are likely to be employed in union vessels . _________________ 14 swd19 . ### directive 2008 / 106 / ec also contains a centralised mechanism for the recognition of seafarers ' certificates issued by third countries . the regulatory fitness programme 14 evaluation showed that significant cost savings for the member states were achieved since the introduction of the centralised mechanism . however , the evaluation also revealed that , with regard to some of the recognised third countries , only a very limited number of visas attesting to the recognition of certificates were issued by member states in relation to certificates of competency or certificates of proficiency issued by these third countries . _________________ 14 swd19 .


### if there are no endorsements attesting recognition issued by a member state in relation to certificates of competency or certificates of proficiency , referred to in paragraph 1 of article 19 , issued by a third country for a period of more than 5 years , the recognition of that country ' s certificates shall be withdrawn . to this end , the commission shall adopt implementing decisions , in accordance with the examination procedure referred to in article 28 , after notifying the member states as well as the third country concerned at least two months in advance . ### if there are no endorsements attesting recognition issued by a member state in relation to certificates of competency or certificates of proficiency , referred to in paragraph 1 of article 19 , issued by a third country for a period of more than 10 years , the recognition of that country ' s certificates shall be re - examined . to this end , the commission shall adopt implementing decisions , in accordance with the examination procedure referred to in article 28 , after notifying the member states as well as the third country concerned at least two months in advance .


### if there are no endorsements attesting recognition issued by a member state in relation to certificates of competency or certificates of proficiency , referred to in paragraph 1 of article 19 , issued by a third country for a period of more than 5 years , the recognition of that country ' s certificates shall be withdrawn . to this end , the commission shall adopt implementing decisions , in accordance with the examination procedure referred to in article 28 , after notifying the member states as well as the third country concerned at least two months in advance . ### if there are no endorsements attesting recognition issued by a member state in relation to certificates of competency or certificates of proficiency , referred to in article 19 , paragraph 1 , issued by a third country for a period of more than 10 years , the recognition of that country ' s certificates shall be re - examined in consultation with the member states and the relevant stakeholders . to this end following the re - examination procedure in question , the commission shall adopt implementing decisions , in accordance with the examination procedure referred to in article 28 , after notifying the member states as well as the third country concerned at least two months in advance


### information on the seafarers employed from third countries has become available at union level through the communication by the member states of the relevant information kept in their national registers regarding issued certificates and endorsements . this information should be used not only for statistical and policy making purposes but also for the purpose of improving the efficiency of the centralised system recognising third countries . based on the information communicated by the member states , recognised third countries which have not provided the union fleet with seafarers for a period of at least five years shall be withdrawn from the list of recognised third countries . in addition , this information shall be also used in order to prioritise the reassessment of the recognised third countries . ### information on the seafarers employed from third countries has become available at union level through the communication by the member states of the relevant information kept in their national registers regarding issued certificates and endorsements . this information should be used not only for statistical and policy making purposes but also for the purpose of improving the efficiency of the centralised system recognising third countries . based on the information communicated by the member states , the recognition of third countries which have not provided the union fleet with seafarers for a period of at least ten years should be re - examined . the re - examination process should cover the possibility of retaining or withdrawing the recognition of the relevant third country . in addition , this information shall be also used in order to prioritise the reassessment of the recognised third countries .


### with a view to ascertaining whether beneficiaries of international protection are still in need of that protection , determining authorities should review the granted status when the residence permit has to be renewed , for the first time in the case of refugees , and for the first and second time in the case of beneficiaries of subsidiary protection , as well as when a significant relevant change in the beneficiaries ' country of origin occurs as indicated by common analysis and guidance on the situation in the country of origin provided at union level by the agency and the european networks on country of origin information in accordance with articles 8 and 10 of regulation37 . __________________ 37 com271 final . ### with a view to ascertaining whether beneficiaries of international protection are still in need of protection , determining authorities might review the granted status when a significant relevant change in the beneficiaries ' country of origin occurs as indicated by common analysis and guidance on the situation in the country of origin provided at union level by the agency and the european networks on country of origin information in accordance with articles 8 and 10 of regulation37 . __________________ 37 com271 final .


### decisions of the determining authority revoking , ending or refusing to renew subsidiary protection status pursuant to paragraph 1 shall only take effect three months after the decision is taken , in order to provide the third - country national or stateless person with the opportunity to apply for residence in the member state on other grounds in accordance with relevant union and national law . ### decisions of the determining authority revoking , ending or refusing to renew subsidiary protection status pursuant to paragraph 1 shall take effect immediately after the decision is adopted . member states may decide , in specific and well - argued cases , to provide the third - country national or stateless person with an additional 3 months in order to apply for residence in the member state on other grounds in accordance with relevant union and national law .


### the applicant shall submit all the elements available to him or her which substantiate the application for international protection . he or she shall cooperate with the determining authority and shall remain present and available throughout the procedure . ### the determining authority shall consider it the duty of the applicant to submit as soon as possible all the elements needed to substantiate the application for international protection . in cooperation with the applicant , it is the duty of the determining authority to assess the relevant elements of the application . the applicant shall remain present and available throughout the procedure .


### ' guardian ' means a person or an organisation appointed by the competent bodies in order to assist and represent an unaccompanied minor in procedures provided for in this regulation with a view to ensuring the best interests of the child and exercising legal capacity for the minor where necessary . ### ' guardian ' means a person or an organisation appointed to assist and represent an unaccompanied minor with a view to safeguarding the best interests of the child and his or her general well - being in procedures provided for in this regulation and exercising legal capacity for the minor where necessary ;


### decisions of the determining authority revoking , ending or refusing to renew refugee status pursuant to point of paragraph 1 shall only take effect three months after the decision is adopted , in order to provide the third - country national or stateless person with the opportunity to apply for residence in the member state on other grounds in accordance with relevant union and national law . ### decisions of the determining authority revoking , ending or refusing to renew refugee status pursuant to point of paragraph 1 shall take effect immediately after the decision is adopted . member states may decide , in specific and well - argued cases , to provide the third - country national or stateless person with an additional 3 months in order to apply for residence in the member state on other grounds in accordance with relevant union and national law .


### shall base itself on precise and up - to - date information obtained from all relevant sources , including union level country of origin information and common analysis of country of origin information referred to in articles 8 and 10 of the regulation no xxx / xx [ regulation on the european union agency for asylum ] or information and guidance issued by the united nations high commissioner for refugee . ### shall take into account precise and up - to - date information obtained from all relevant sources , including union level country of origin information and common analysis of country of origin information referred to in articles 8 and 10 of the regulation no xxx / xx [ regulation on the european union agency for asylum ] or information and guidance issued by the united nations high commissioner for refugee .


### decisions of the determining authority revoking , ending or refusing to renew subsidiary protection status pursuant to paragraph 1 shall only take effect three months after the decision is taken , in order to provide the third - country national or stateless person with the opportunity to apply for residence in the member state on other grounds in accordance with relevant union and national law . ### decisions of the determining authority revoking , ending or refusing to renew subsidiary protection status pursuant to paragraph 1 shall take effect one month after the decision is taken , unless specified otherwise .


### decisions of the determining authority revoking , ending or refusing to renew subsidiary protection status pursuant to paragraph 1 shall only take effect three months after the decision is taken , in order to provide the third - country national or stateless person with the opportunity to apply for residence in the member state on other grounds in accordance with relevant union and national law . ### decisions of the determining authority withdrawing subsidiary protection status pursuant to paragraph 1 shall only take effect three months after the decision is taken , in order to provide the third - country national or stateless person with the opportunity to apply for residence in the member state on other grounds in accordance with relevant union and national law .


### for a well - functioning ceas , including of the dublin system , substantial progress should be made regarding the convergence of national asylum systems with special regard to differing recognition rates and type of protection status in the member states . in addition , rules on status review should be strengthened to ensure that protection is only granted to those who need it and for so long as it continues to be needed . moreover , divergent practices regarding the duration of the residence permits should be avoided , and the rights granted to beneficiaries of international protection should be further clarified and harmonised . ### for a well - functioning ceas , including of the dublin system , substantial progress should be made regarding the convergence of national asylum systems with special regard to differing recognition rates and type of protection status in the member states . in addition , rules on status review should be strengthened to ensure that protection is only granted to those who need it and for so long as it continues to be needed . moreover , divergent practices regarding the duration of the residence permits should be avoided , and the rights granted to beneficiaries of international protection should be further clarified .


### decisions of the determining authority revoking , ending or refusing to renew refugee status pursuant to point of paragraph 1 shall only take effect three months after the decision is adopted , in order to provide the third - country national or stateless person with the opportunity to apply for residence in the member state on other grounds in accordance with relevant union and national law . ### decisions of the determining authority revoking , ending or refusing to renew refugee status pursuant to point of paragraph 1 shall take effect one month after the decision is adopted , unless specified otherwise .


### when assessing whether an international organisation controls a state or a substantial part of its territory and provides protection as referred to in paragraph 2 , determining authorities shall base themselves on any guidance provided in relevant union law , in particular available union level country of origin information and the common analysis of country of origin information referred to in articles 8 and 10 of regulation no xxx / xx [ regulation on the european union agency for asylum ] . ### when assessing whether an international organisation controls a state or a substantial part of its territory and provides protection as referred to in paragraph 2 , determining authorities may take into account any guidance provided in relevant union law , in particular available union level country of origin information and the common analysis of country of origin information referred to in articles 8 and 10 of regulation no xxx / xx [ regulation on the european union agency for asylum ] .


### internal protection against persecution or serious harm should be effectively available to the applicant in a part of the country of origin where he or she can safely and legally travel to , gain admittance to and can reasonably be expected to settle . the assessment of whether such internal protection exists should be an inherent part of the assessment the application for international protection and should be carried out once it has been established by the determining authority that the qualification criteria would otherwise apply . the burden of demonstrating the availability of internal protection should fall on the determining authority . ### internal protection against persecution or serious harm should be effectively available to the applicant in a part of the country of origin where he or she can safely and legally travel to , gain admittance to and can reasonably be expected to settle . the assessment of whether such internal protection exists might form part of the assessment the application for international protection and should be carried out once it has been established by the determining authority that the qualification criteria would otherwise apply . the burden of demonstrating the availability of internal protection should fall on the determining authority . however , the applicant should collaborate with the determining authority in order to establish whether the conditions for internal protection are satisfied in a part of his / her country of origin .


### the resources of the asylum , migration and refugee fund should be used to provide adequate support to member states’ efforts in implementing the standards set by the regulation , in particular to those member states which are faced with specific and disproportionate pressure on their asylum systems , due in particular to their geographical or demographic situation . ### the resources of the asylum , migration and integration fund should be used to provide adequate support to member states’ efforts in implementing the standards set by the regulation , with priority to those member states which are faced with specific and disproportionate pressure on their asylum systems , due in particular to their geographical or demographic situation . such support should be limited to the asylum , migration and integration fund in line with the general principle of no double funding .


### in order to facilitate the integration of beneficiaries of international protection into society , beneficiaries of international protection shall have access to integration measures , modalities to be set by the member states . member states may make the participation in such integration measures , such as language courses , civic integration courses , vocational training and other employment - related courses compulsory . ### in order to facilitate the integration of beneficiaries of international protection into society , beneficiaries of international protection should have access to integration measures , modalities to be set by the member states . member states may make the participation in such integration measures , such as language courses , civic integration courses , vocational training and other employment - related courses compulsory .


### in order to apply article 14 , the determining authority shall review the refugee status in particular : ### the determining authorities of the member state may review the refugee status at any time when they have reasonable grounds for considering that article 14 may apply . they shall review the refugee status in particular :


### the resources of the asylum , migration and refugee fund should be used to provide adequate support to member states’ efforts in implementing the standards set by the regulation , in particular to those member states which are faced with specific and disproportionate pressure on their asylum systems , due in particular to their geographical or demographic situation . ### the resources of the asylum , migration and integration fund should be used to provide adequate support to member states’ efforts in implementing the standards set by the regulation , in particular to those member states that are faced with specific and disproportionate pressure on their asylum systems , due in particular to their geographical or demographic situation . in addition , member states should take full advantage , at all levels of governance , of the possibilities offered by funds which are not directly related to asylum and migration policy but which can be used to fund actions in that area , for example integration actions , such as those available under the european social fund , the fund for european aid to the most deprived , horizon 2020 , the european regional development fund and the rights , equality and citizenship programme . those funds should be made directly accessible to local and regional authorities for actions that fall directly under their responsibilities .


### the assessment of the availability of internal protection shall be carried out once it has been established by the determining authority that the qualification criteria would otherwise apply . the burden of demonstrating the availability of internal protection shall rest on the determining authority . the applicant shall not be required to prove that , before seeking international protection , he or she has exhausted all possibilities to obtain protection in his or her country of origin . ### the assessment of the availability of internal protection may be carried out once it has been established by the determining authority that the qualification criteria would otherwise apply . the burden of demonstrating the availability of internal protection shall rest on the determining authority . however , the applicant shall collaborate with the determining authority in order to establish whether the conditions for internal protection are satisfied in a part of his / her country of origin .


### when considering the general circumstances prevailing in that part of the country which is the source of the protection as referred to in article 7 , the accessibility , effectiveness and durability of that protection shall be taken into account . when considering personal circumstances of the applicant , health , age , gender , sexual orientation , gender identity and social status shall in particular be taken into account together with an assessment of whether living in the part of the country of origin regarded as safe would not impose undue hardship on the applicant . ### when considering the general circumstances prevailing in that part of the country which is the source of the protection as referred to in article 7 , the accessibility , effectiveness and durability of that protection shall be taken into account . when considering personal circumstances of the applicant , health , age , gender , sexual orientation , gender identity and social status shall be taken into account .


### committing a political crime is not in principle a ground justifying exclusion from refugee status . however , in accordance with relevant case law of the court of justice of the european union , particularly cruel actions , where the act in question is disproportionate to the alleged political objective , and terrorist acts which are characterised by their violence towards civilian populations , even if committed with a purportedly political objective , should be regarded as non - political crimes and therefore can give rise to exclusion from refugee status . ### committing a political crime is not in principle a ground justifying exclusion from refugee status . however , in accordance with relevant case law of the court of justice of the european union , particularly cruel actions , where the act in question is disproportionate to the alleged political objective , and terrorist acts which are characterised by their violence towards civilian populations , even if committed with a purportedly political objective , should be regarded as non - political crimes and therefore should give rise to exclusion from refugee status .


### the assessment of the availability of internal protection shall be carried out once it has been established by the determining authority that the qualification criteria would otherwise apply . the burden of demonstrating the availability of internal protection shall rest on the determining authority . the applicant shall not be required to prove that , before seeking international protection , he or she has exhausted all possibilities to obtain protection in his or her country of origin . ### the assessment of the availability of internal protection shall be carried out once it has been established by the determining authority that the qualification criteria would otherwise apply .


### decisions of the determining authority revoking , ending or refusing to renew refugee status pursuant to point of paragraph 1 shall only take effect three months after the decision is adopted , in order to provide the third - country national or stateless person with the opportunity to apply for residence in the member state on other grounds in accordance with relevant union and national law . ### decisions of the determining authority withdrawing refugee status pursuant to point of paragraph 1 shall only take effect three months after the decision is adopted , in order to provide the third - country national or stateless person with the opportunity to apply for residence in the member state on other grounds in accordance with relevant union and national law .


### a regulation is therefore necessary to ensure a more consistent level of harmonisation throughout the union and to provide a higher degree of legal certainty and transparency . ### a regulation is therefore necessary to ensure a faster and more consistent level of harmonisation throughout the union and to provide a higher degree of legal certainty and transparency .


### the applicant shall submit all the elements available to him or her which substantiate the application for international protection . he or she shall cooperate with the determining authority and shall remain present and available throughout the procedure . ### the determining authority shall consider it the duty of the applicant to submit as soon as possible all the elements needed to substantiate the application for international protection . in cooperation with the applicant , it is the duty of the determining authority to assess the relevant elements of the application . the applicant shall remain present and available throughout the procedure .


### in order to facilitate the integration of beneficiaries of international protection into society , beneficiaries of international protection shall have access to integration measures , modalities to be set by the member states . member states may make the participation in such integration measures , such as language courses , civic integration courses , vocational training and other employment - related courses compulsory . ### in order to facilitate the integration of beneficiaries of international protection into society , beneficiaries of international protection shall have access to integration measures , modalities to be set by the member states . member states may make the participation in such integration measures , such as language courses , civic integration courses , vocational training and other employment - related courses compulsory . continuous refusal to actively integrate may , as a measure of last resort , lead to the cessation of the eligibility for international protection .


### beneficiaries of international protection who have special needs , such as pregnant women , disabled people , persons who have undergone torture , rape or other serious forms of psychological , physical or sexual violence or minors who have been victims of any form of abuse , neglect , exploitation , torture , cruel , inhuman and degrading treatment or who have suffered from armed conflict shall be provided adequate healthcare , including treatment of mental disorders when needed , under the same eligibility conditions as nationals of the member state that has granted protection . ### beneficiaries of international protection who have special needs , such as pregnant women , disabled people , persons who have undergone torture , rape or other serious forms of psychological , physical or sexual violence or minors who have been victims of any form of abuse , neglect , exploitation , torture , cruel , inhuman and degrading treatment or who have suffered from armed conflict shall be provided with adequate healthcare , including treatment of mental disorders when needed , under the same eligibility conditions as nationals of the member state that has granted protection .


### decisions of the determining authority revoking , ending or refusing to renew subsidiary protection status pursuant to paragraph 1 shall only take effect three months after the decision is taken , in order to provide the third - country national or stateless person with the opportunity to apply for residence in the member state on other grounds in accordance with relevant union and national law . ### decisions of the determining authority revoking , ending or refusing to renew subsidiary protection status pursuant to paragraph 1 shall take effect one month after the decision is taken , unless specified otherwise .


### the radio spectrum policy group recommends in its opinion on a long - term strategy on the future use of the 470 - 790 mhz frequency band in the union the adoption of a coordinated approach across the union to make the 700 mhz frequency band available for effective use for wireless broadband electronic communications services by the end of 2020 . this would be in conjunction with ensuring long - term availability until 2030 of the sub - 700 mhz frequency band for the downlink - only provision of audiovisual media services . the rspg particularly recommends introducing flexibility so that the sub - 700 mhz frequency band can also be used for downlink - only wireless broadband electronic communications services . ### the radio spectrum policy group recommends in its opinion on a long - term strategy on the future use of the 470 - 790 mhz frequency band in the union the adoption of a coordinated approach across the union to make the 700 mhz frequency band available for effective use for wireless broadband electronic communications services by the end of 2022 . this would be in conjunction with ensuring long - term availability at least until the end of 2030 of the sub - 700 mhz frequency band for terrestrial broadcasting and for use by wireless audio pmse equipment . the rspg recognises the importance of the dtt platform and the need to provide certainty for investments in broadcasting infrastructure . therefore , the rspg recommends that the frequency band 470 - 694 mhz remain available for dtt in the foreseeable future , at least until the end of 2030 .


### by 30 june 2022 , member states shall allow the transfer or leasing of the rights of use of spectrum for electronic communications services in the 694 - 790 mhz frequency band . ### by 31 december 2024 , member states shall allow the transfer or leasing of the rights of use of spectrum for electronic communications services in the 694 - 790 mhz frequency band .


### in any case , spectrum usage in the 470 - 694 mhz frequency band should be reassessed at union level no later than 2025 . such an assessment should also take into account the planned review of this frequency band at the world radiocommunication conference in 2023 . changes in the use of the sub - 700 mhz frequency band should take into consideration technological developments , consumer behaviour , the importance of continuing the delivery of free television26 service and social , economic and cultural general interest objectives . in this context , studies on technical and regulatory conditions for co - existence between incumbent and new spectrum uses in the sub - 700 mhz frequency band are necessary . these would ensure coherence between the approaches taken by different member states on flexible and efficient spectrum use and would enable technical harmonisation measures for use and co - existence in this band . such studies and measures may be developed pursuant to decision no 676 / 2002 / ec . __________________ 26 in the meaning of directive 2010 / 13 / eu of the european parliament and of the council . ### spectrum usage in the 470 - 694 mhz frequency band should be reassessed at union level no later than 2025 . such an assessment should also take into account the planned review of this frequency band at the world radiocommunication conference in 2023 . any option for the use of the sub - 700 mhz frequency band after 2030 should take into consideration technological developments , consumer behaviour , the importance of continuing the delivery of free television26 service and social , economic and cultural general interest objectives . in this context , studies on technical and regulatory conditions for co - existence between incumbent and new spectrum uses in the sub - 700 mhz frequency band are necessary . __________________ 26 in the meaning of directive 2010 / 13 / eu of the european parliament and of the council .


### member states should adopt coherent national roadmaps to facilitate the use of the 700 mhz frequency band for terrestrial wireless broadband electronic communications services while ensuring continuity for the television broadcasting services that vacate the band . once adopted , member states should communicate the roadmaps in a transparent manner around the union . the roadmaps should cover activities and timescales for frequency re - planning , technical developments for network and end - user equipment , co - existence between radio and non - radio equipment , existing and new authorisation regimes and information on the possibility to offer compensation for migration costs , where these would arise , in order to avoid , inter alia , costs for end - users . where member states intend to maintain dtt , the roadmaps should give particular attention to facilitating upgrades of broadcasting equipment to more spectrum - efficient technologies such as advanced video formats or signal transmission technologies . ### member states should adopt coherent national roadmaps to facilitate the use of the 700 mhz frequency band for terrestrial wireless broadband electronic communications services while ensuring continuity for the television broadcasting services that vacate the band . once adopted , member states should communicate the roadmaps in a transparent manner around the union . the roadmaps should cover activities and timescales for frequency re - planning , technical developments for network and end - user equipment , co - existence between radio and non - radio equipment , existing and new authorisation regimes , mechanisms to avoid harmful interference to spectrum users in adjacent bands and information on the possibility to offer compensation for migration costs , in order to avoid , inter alia , costs for end - users and broadcasters . as for dtt , the roadmaps should give particular attention to facilitating , where necessary , upgrades of broadcasting equipment to more spectrum - efficient technologies such as advanced video formats or signal transmission technologies .