### a description of the company ' s diversity policy for its administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background , the objectives of this diversity policy , how it has been implemented and the results in the reporting period . if the company has no such policy , the statement shall contain a clear and reasoned explanation as to why this is the case . ### a description of the company ' s diversity policy for its administrative , management and supervisory bodies with regard to equality aspects and other aspects such as age , gender , geographical diversity , educational and professional background , the objectives of this diversity policy , how it has been implemented and the results in the reporting period . if the company has no such policy , it shall be subject to administrative and financial sanctions .


### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following : ### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement , without prejudice to audit requirements being determined by member states , containing information relating to matters which are material for understanding the company ' s development , performance or position , which can include not only environmental but also social , equality and employee matters as well as respect for human rights , anti - corruption and bribery matters , including the following :


### the consolidated annual report shall include a fair review of the development and performance of the business and of the position of the undertakings included in the consolidation taken as a whole , together with a description of the principal risks and uncertainties that they face . ### the consolidated annual report shall include a fair review of the development and performance of the business and of the position of the undertakings included in the consolidation taken as a whole , together with a description of the principal risks and uncertainties that they face , and a description of its impacts on gender , and social , environmental and human rights impacts .


### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following : ### for parent undertakings of undertakings to be consolidated that together exceed an average number of 250 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , gender equality , social , employee and diversity matters , respect for human rights , anti - corruption and bribery matters , taking into account the company ' s complete supply chain including the following :


### to the extent necessary for an understanding of such development , performance or position , the analysis shall include both financial and non - financial key performance indicators relevant to the particular business . ### to the extent necessary for an understanding of such development performance or position , and its social , environmental and human rights , including from a gender equality perspective the analysis shall include both financial and non - financial key performance indicators relevant to the particular business .


### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following : ### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information regarding companies ' activity impact on society relating to at least environmental , social , gender and employment matters , and respect for human rights , anti - corruption and bribery matters , including :


### a description of the policy pursued by the company in relation to these matters ; ### a description of the policy pursued by the company in relation to these matters , also referring to due diligence processes implemented ;


### the risks related to these matters and how the company manages those risks . ### the risks for company and society related to these matters and how the company manages those risks .


### where the undertakings included in the consolidation taken as a whole do not pursue policies in relation to one or more of these matters , the company shall provide an explanation for not doing so . ### where the undertakings included in the consolidation taken as a whole do not pursue policies in relation to one or more of these matters , they shall provide a clear and reasoned explanation for not doing so . the explanation shall contain an assessment of the decision of not pursuing policies relating to these matters .


### in providing such information the consolidated annual report may rely on national , eu - based or international frameworks and if so , shall specify which frameworks it has relied upon . ### in providing such information the consolidated annual report shall rely on the guidelines for the application of the measures of this directive relating to the non - financial statement , as from one year after their adoption . before that time , the consolidated annual report shall rely as minimum on the guiding principles on business and human rights implementing the united nations ' protect , respect and remedy ' framework and the organisation for economic co - operation and development guidelines for multinational enterprises . the consolidated annual report may additionally rely also on national , eu - based or international frameworks and , if so , shall specify which frameworks it has relied upon .


### to the extent necessary for an understanding of such development , performance or position , the analysis shall include both financial and non - financial key performance indicators relevant to the particular business . ### to the extent necessary for an understanding of the companies ' development , performance or position and impact on society and for the transparency and comparability of the review , the analysis shall include both financial and non - financial key performance indicators relevant to the particular business . the analysis shall include the kpis defined in the guidelines developed by the european commission , as from one year after their adoption .


### for parent undertakings of undertakings to be consolidated that together exceed an average number of 500 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million , the review shall also include a non - financial statement containing information relating to at least environmental , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following : ### for parent undertakings of undertakings to be consolidated that together exceed an average number of 250 employees during the financial year , and , on their balance sheet dates , exceed either a balance sheet total of eur 17 . 5 million or a net turnover of eur 20 million , the review shall also include a non - financial statement containing information relating to at least environmental , equality , social and employee matters , respect for human rights , anti - corruption and bribery matters , including the following :


### the results of these policies ; ### the results and the consequences of these policies ;


### where the undertakings included in the consolidation taken as a whole do not pursue policies in relation to one or more of these matters , the company shall provide an explanation for not doing so . ### where the undertakings included in the consolidation taken as a whole do not pursue policies in relation to one or more of these matters , the company shall be subject to administrative and financial sanctions .


### in providing such information the consolidated annual report may rely on national , eu - based or international frameworks and if so , shall specify which frameworks it has relied upon . ### in providing such information the consolidated annual report shall rely on the framework of the un guiding principles on business and human rights and the oecd guidelines for multinational enterprises . it shall undertake due diligence on the company´s supply chain .


### draft legislative resolution ### recalls its resolution of 8 june 2011 on investing in the future : a new multiannual financial framework for a competitive , sustainable and inclusive europe1 ; reiterates that sufficient additional resources are needed in the next mff in order to enable the union to fulfil its existing policy priorities and the new tasks provided for in the treaty of lisbon , as well as to respond to unforeseen events ; points out that even with an increase in the level of resources for the next mff of at least 5% compared to the 2013 level only a limited contribution can be made to the achievement of the union’s agreed objectives and commitments and the principle of union solidarity ; challenges the council , if it does not share this approach , to clearly identify which of its political priorities or projects could be dropped altogether , despite their proven european added value ; _______________ 1texts adopted , p7_ta0266 .


### the financial envelope from horizon 2020 for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 is set at eur 3 . 182 , 230 million the annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . the eit financial contribution to the kics shall be provided under this financial envelope . ### within the meaning of point [ 17 ] of the interinstitutional agreement of . . . / . . . . between the european parliament , the council and the commission on cooperation in budgetary matters and on sound financial management , the financial envelope from horizon 2020 for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 is set at a maximum of eur 3 . 182 , 230 million . this amount shall constitute the prime reference for the budgetary authority during the annual budgetary procedure . the annual appropriations shall be authorised by the budgetary authority without prejudice to the provisions of the regulation laying down the multiannual financial framework for the years 2014 - 2020 and to the interinstitutional agreement of xxx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management . the eit financial contribution to the kics shall be provided under this financial envelope .


### the environmental benefits expected from hybrid electric and pure electric road transport vehicles have resulted in a substantial reduction of the noise emitted by such vehicles . this has resulted in the removal of an important source of audible signal that is used by blind and low vision pedestrians and cyclists , amongst other road users , to become aware of the approach , presence or departure of these vehicles . for that purpose , industry is developing acoustic systems to compensate for this lack of audible signal in electric and hybrid electric vehicles . the performance of approaching vehicle audible systems fitted to vehicles should be harmonised . the fitting of such systems should however , remain an option at the discretion of vehicle manufacturers . ### the environmental benefits expected from hybrid electric and pure electric road transport vehicles have resulted in a substantial reduction of the noise emitted by such vehicles . this has resulted in the removal of an important source of audible signal that is used by blind and low vision pedestrians and cyclists , amongst other road users , to become aware of the approach , presence or departure of these vehicles . for that purpose , industry is developing acoustic systems to compensate for this lack of audible signal in electric and hybrid electric vehicles . the performance of approaching vehicle audible systems fitted to vehicles should be harmonised . the fitting of such systems should however , remain an option at the discretion of vehicle manufacturers . the commission should also be asked to look into the contribution that active safety systems can make to meeting the objective of improving the safety of vulnerable road users in urban areas .


### the environmental benefits expected from hybrid electric and pure electric road transport vehicles have resulted in a substantial reduction of the noise emitted by such vehicles . this has resulted in the removal of an important source of audible signal that is used by blind and low vision pedestrians and cyclists , amongst other road users , to become aware of the approach , presence or departure of these vehicles . for that purpose , industry is developing acoustic systems to compensate for this lack of audible signal in electric and hybrid electric vehicles . the performance of approaching vehicle audible systems fitted to vehicles should be harmonised . the fitting of such systems should however , remain an option at the discretion of vehicle manufacturers . ### the environmental benefits expected from hybrid electric and pure electric road transport vehicles have resulted in a substantial reduction of the noise emitted by such vehicles . this has resulted in the removal of an important source of audible signal that is used by blind and low vision pedestrians and cyclists , amongst other road users , to become aware of the approach , presence or departure of these vehicles . for that purpose , industry is developing acoustic systems to compensate for this lack of audible signal in electric and hybrid electric vehicles . the performance of approaching vehicle audible systems fitted to vehicles should be harmonised . the fitting of such systems should be compulsory for all vehicle manufacturers .


### in order to enable the commission to replace the technical requirements of this regulation with a direct reference to unece regulations no 51 and no 59 once the limit values relating to the new test method are laid down in those regulations , or to adapt those requirements to technical and scientific developments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the amendment of the provisions in annexes to this regulation related to the test methods and sound levels . it is of particular importance that the commission carry out appropriate consultations during its preparatory work . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to enable the commission to replace the technical requirements of this regulation with a direct reference to unece regulations no 51 and no 59 once the limit values relating to the new test method are laid down in those regulations , or to adapt those requirements to technical and scientific developments , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the amendment of the provisions in annexes to this regulation related to the test methods and sound levels . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including consultation of experts . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### where manufacturers choose to install an avas in vehicles , the requirements of annex x shall be fulfilled . ### where manufacturers choose to install an avas in vehicles , the requirements of annex ix shall be fulfilled .


### acoustic vehicle alerting system 9 . where manufacturers choose to install an avas in vehicles , the requirements of annex x shall be fulfilled . ### acoustic vehicle alerting system 9 . where manufacturers install an avas in vehicles , the requirements of annex x shall be fulfilled .


### the commission shall be empowered to adopt delegated acts to amend annexes i to xi . ### the commission shall be empowered to adopt delegated acts , pursuant to article 11 , to amend annexes i to xi .


### a delegated act adopted pursuant to article 10 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by one month at the initiative of the european parliament or of the council . ### a delegated act adopted pursuant to article 10 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### in order to take into account the evolution of the pharmaceutical market and of national policies to control public expenditure on medicines , substantive changes are necessary to all major provisions of directive 89 / 105 / eec . therefore , in the interest of clarity , directive 89 / 105 / eec should be replaced ; ### in order to take into account the evolution of the pharmaceutical market and of national policies to control public expenditure on medicines , substantive changes are necessary to all major provisions of directive 89 / 105 / eec . therefore , in the interest of clarity , directive 89 / 105 / eec should be amended .


### any measure to regulate , either directly or indirectly , the prices of medicinal products , as well as any measure to determine their coverage by public health insurance systems should be based on objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies , including judicial remedies , to affected companies . these requirements should equally apply to national , regional or local measures to control or promote the prescription of specific medicinal products as such measures also determine their effective coverage by health insurance systems . ### any measure to regulate , either directly or indirectly , the prices of medicinal products , as well as any measure , including recommendations that may be required , to determine their coverage by public health insurance systems should be based on objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies , including judicial remedies , to affected companies . these requirements should equally apply to national , regional or local measures to control or promote the prescription of specific medicinal products as such measures also determine their effective coverage by health insurance systems .


### applications to approve the price of a medicinal product or to determine its coverage by the health insurance system should not delay the placing on the market of that product beyond what is necessary . it is therefore desirable that this directive sets out mandatory time limits within which national decisions should be made . in order to be effective , the prescribed time periods should run from the receipt of an application until the entry into force of the corresponding decision . they should include all expert evaluations , including health technology assessments where applicable , and all administrative steps required for the decision to be adopted and take legal effect . ### applications to approve the price of a medicinal product or to determine its coverage by the health insurance system should not delay the placing on the market of that product beyond what is necessary . it is therefore desirable that this directive sets out mandatory time limits within which national decisions should be made . in order to be effective , the prescribed time periods should run from the receipt of an application until the entry into force of the corresponding decision . they should include all recommendations and expert evaluations , including health technology assessments where applicable , and all administrative steps required for the decision to be adopted and take legal effect .


### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product and the similarity of biosimilar medicinal products , are ascertained in the framework of marketing authorisation procedures , and member states should have full access to the data used in the marketing authorisation procedure so that they can assess the relative safety and efficacy of a medicinal product in the context of pricing and reimbursement procedures .


### member states shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall guarantee that the marketing authorisation holder has the possibility to introduce an application to approve the price of the product . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### member states shall ensure that an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall guarantee that the marketing authorisation holder has the possibility to introduce an application to increase the price of a medicinal product . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 90 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . with respect to generic medicinal products , that time limit shall be 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the generic product is essentially similar to the reference medicinal product , according to directive 2001 / 83 / ec and that the price of the reference medicinal product has been approved by the competent authorities .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the generic product is essentially similar to the reference medicinal product , according to directive 2001 / 83 / ec and that the reference medicinal product has already been included in the public health insurance system .


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


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


### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . these reasons must be drawn from a pre - defined list determined and published in an appropriate publication by the member state . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### member states shall ensure that an application to include a medicinal product in the scope of the public health insurance system can be introduced by the marketing authorisation holder at any point in time . if the public health insurance system comprises several schemes or categories of coverage , the marketing authorisation holder shall be entitled to apply for the inclusion of its product in the scheme or category of its choice . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall guarantee the marketing authorisation holder the right to submit an application to include a medicinal product in the scope of the public health insurance scheme . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 90 days of its receipt . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the generic product is essentially similar to the reference medicinal product , according to directive 2001 / 83 / ec and that the reference medicinal product has already been included in the public health insurance system .


### irrespective of the organisation of their internal procedures , member states shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this article and the price approval procedure set out in article 3 does not exceed 120 days . however , with respect to the medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall not exceed 180 days . with respect to generic medicinal products , that time limit shall not exceed 30 days , provided that the reference medicinal product has already been included in the public health insurance system . those time - limits may be extended in accordance with paragraph 5 of this article or article 3 . ### irrespective of the organisation of their internal procedures , member states shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this article and the price approval procedure set out in article 3 does not exceed 120 days . however , with respect to the medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall not exceed 180 days . with respect to generic medicinal products , that time limit shall not exceed 60 days , provided that the generic product is essentially similar to the reference medicinal product , according to directive 2001 / 83 / ec and that the reference medicinal product has already been included in the public health insurance system . those time - limits may be extended in accordance with paragraph 5 of this article or article 3 .


### any decision to exclude a medicinal product from the scope of the public health insurance system , or to modify the extent or the conditions of coverage of the product concerned , shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication . ### any decision to exclude a category of medicinal products from the scope of the public health insurance system , or to modify the extent or the conditions of coverage of the category concerned , shall contain a statement of reasons based on objective and verifiable criteria .


### any decision to exclude a category of medicinal products from the scope of the public health insurance system , or to modify the extent or the conditions of coverage of the category concerned , shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication . ### any decision to exclude a category of medicinal products from the scope of the public health insurance system , or to modify the extent or the conditions of coverage of the category concerned , shall contain a statement of reasons based on objective and verifiable criteria and be published in an appropriate publication . these criteria shall include assessments of unmet medical needs , the clinical impact and social costs and the protection of the most vulnerable groups of the population


### all the member states are parties to the convention and none of them has objected to the manila amendments under the procedure foreseen to that effect . member states have therefore to align their national rules with the manila amendments . a conflict between the international commitments of member states and their eu commitments should be avoided . moreover , given the global nature of shipping , the union rules on training and certification of seafarers , should be kept in line with international rules . several provisions of directive 2008 / 106 / ec should be consequently amended in order to reflect the manila amendments . ### all the member states are parties to the convention and none of them has objected to the manila amendments under the procedure foreseen to that effect . member states have therefore to align their national rules with the manila amendments . a conflict between the international commitments of member states and their eu commitments should be avoided . moreover , given the global nature of shipping , the union rules on training and certification of seafarers , should be kept in line with international rules . directive 2005 / 36 / ec of 7 september 2005 on the recognition of professional qualifications does not offer a suitable legal framework for the purpose of setting the required standards on training and certification of seafarers . therefore , specific eu provisions are necessary . directive 2008 / 106 / ec should be consequently amended in order to reflect the manila amendments .


### at the manila conference the state - parties intended , amongst others , to set objective limits to the exceptions to the minimum rest hours for watchkeeping personnel and seafarers with designated safety , security and prevention of pollution related tasks . also such new provisions should be integrated into eu law . however , they should respect the provisions on hours of rest applicable to seafarers under council directives 1999 / 63 / ec of 21 june 199910 and 2009 / 13 / ec of 16 february 200911 . furthermore , the faculty of authorising exceptions should be limited in terms of maximum duration , frequency and scope . provisions to this effect should be introduced in the directive . ### european social partners have agreed on minimum hours of rest applicable to seafarers and council directive 1999 / 63 / ec has been adopted for the implementation of such agreement . directive 1999 / 63 / ec also allows for the possibility of authorising exceptions to the minimum hours of rest for seafarers . at the manila conference the state - parties intended , amongst others , to set objective limits to the exceptions to the minimum rest hours for watchkeeping personnel and seafarers with designated safety , security and prevention of pollution related tasks , with a view to preventing fatigue . such new provisions should be integrated into eu law in a manner that ensures coherence with directive 1999 / 63 / ec as amended by directive 2009 / 13 / ec .


### available statistics on european seafarers are incomplete and often inaccurate , which makes policy - making in this delicate sector more difficult . detailed data on certification of seafarers can not entirely solve this problem but they would clearly help . under the stcw convention state parties are obliged to maintain registers of all certificates and endorsements and the relevant revalidations or other measures affecting them ) . member states , under article 11 of directive 2008 / 106 , have the obligation to maintain a register of issued certificates and endorsements . in order to have a complete as possible picture of the labour employment situation in europe , member states should be required to send to the commission selected information already contained in their registers of seafarers ' certificates . this information should be used for statistical purposes and be in line with the data protection requirements of the union . a provision to that effect should be introduced in directive 2008 / 106 / ec . ### available statistics on european seafarers are incomplete and often inaccurate , which makes policy - making in this delicate sector more difficult . detailed data on certification of seafarers can not entirely solve this problem but they would clearly help . under the stcw convention state parties are obliged to maintain registers of all certificates and endorsements and the relevant revalidations or other measures affecting them ) . member states , under article 11 of directive 2008 / 106 / ec , have the obligation to maintain a register of issued certificates and endorsements . in order to have a complete as possible picture of the labour employment situation in europe , member states should be required to send to the commission selected information already contained in their registers of seafarers ' certificates . this information should be limited to what is necessary to enable evidence - based policy - making , should be used for statistical purposes only and should be collected , stored and analysed in full compliance with the data protection requirements of the union .


### in order to gather data on the seafaring profession consistently with the evolution of the latter and of technology , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of adaptations of annex v of directive 2008 / 106 / ec . those delegated acts would regard , in particular , the content of the information on endorsements , on certificates of competency or proficiency and on the number and details of seafarers whose certificates are issued or endorsed , taking into account the safeguards on data protection indicated in the mentioned annex . also , the commission should have the power to adopt delegated acts in order to establish measures for collecting , storing and analysing this kind of statistical information by member states with a view to accommodating new statistical needs on seafarers , and with a view to gathering information up - to - date and consistent with reality . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council . ### in order to gather data on the seafaring profession consistently with the evolution of the latter and of technology , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of adaptations of annex v of directive 2008 / 106 / ec . those delegated acts would regard , in particular , updating provisions on the content of the information on endorsements , on certificates of competency or proficiency and on the number and details of seafarers whose certificates are issued or endorsed , taking into account the safeguards on data protection indicated in the mentioned annex . also , the commission should have the power to adopt delegated acts in order to establish measures for collecting , storing and analysing this kind of statistical information by member states with a view to accommodating new statistical needs on seafarers , and with a view to gathering information up - to - date and consistent with reality . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and council .


### each candidate for certification shall provide satisfactory proof : ### candidates for certification shall provide satisfactory proof :


### of his identity ; ### of&#160 ; their identity ;


### that his age is not less than that prescribed in the regulations listed in annex i relevant to the certificate applied for ; ### that their age is not less than that prescribed in the regulations listed in annex i relevant to the certificate applied for ;


### that he meets the standards of medical fitness , specified in section a - i / 9 of the stcw code ; ### that they meet the prescribed standards of medical fitness as applicable to the specific duties to be performed ;


### that he meets the standards of competence prescribed in the regulations listed in annex i for the capacities , functions and levels that are to be identified in the endorsement to the certificate . ### that they meet the standards of competence prescribed in the regulations listed in annex i for the capacities , functions and levels that are to be identified in the endorsement to the certificate .


### all training , assessment of competence , certification , including medical certification , endorsement and revalidation activities carried out by non - governmental agencies or entities under its authority are continuously monitored through a quality standards system to ensure the achievement of defined objectives , including those concerning the qualifications and experience of instructors and assessors ; ### all training , assessment of competence , certification , including medical certification , endorsement and revalidation activities carried out by non - governmental agencies or entities under its authority are continuously monitored through a quality standards system to ensure the achievement of defined objectives , including those concerning the qualifications and experience of instructors and assessors , in accordance with the provisions of sections a - i / 6 and&#160 ; a - i / 8 of the stcw code ;


### education and training objectives and related quality standards of competence to be achieved are clearly defined and that the levels of knowledge , understanding and skills appropriate to the examinations and assessments required under the stcw convention identified . the objectives and related quality standards may be specified separately for different courses and training programmes and shall cover the administration of the certification system ; ### education and training objectives and related quality standards of competence to be achieved are clearly defined and the levels of knowledge , understanding and skills appropriate to the examinations and assessments required under the stcw convention are identified .


### each member state shall establish standards of medical fitness for seafarers and procedures for the issue of a medical certificate in accordance with the provisions of this article and section a - i / 9 of the stcw code . ### each member state shall establish standards of medical fitness for seafarers and procedures for the issue of a medical certificate in accordance with the provisions of this article and section a - i / 9 of the stcw code . the guidance given in section b - i / 9 of the stcw code should also be taken into account when establishing medical standards .


### every candidate for certification shall : ### candidates for medical certification shall :


### provide satisfactory proof of his identity ; and ### provide satisfactory proof of their identity ; and


### meet the applicable medical fitness standards established by the member state concerned . ### meet the medical fitness standards established by the member state concerned as applicable to the specific duties to be performed .


### establish and enforce rest periods for watchkeeping personnel and those whose duties involve designated safety , security and prevention of pollution duties in accordance with paragraphs 3 to 15 ; ### establish and enforce rest periods for watchkeeping personnel and those whose duties involve designated safety , security and prevention of pollution duties in accordance with paragraphs 3 to 13 ;


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


### with due regard for the general principles of the protection of the health and safety of workers , member states may authorise or register collective agreements permitting exceptions to the required hours of rest in paragraph 4 and 5 provided that the rest period is no less than 70 hours in any 7 - day period . such exceptions shall , in accordance with directive 1999 / 63 / ec , as far as possible , follow the standards set out but may take account of more frequent or longer leave periods , or the granting of compensatory leave and should equally , as far as possible , take into account the guidance regarding prevention of fatigue laid down in section b - viii / 1 of the stcw code . ### exceptions to the required hours of rest provided for in paragraphs 4 and 5 for seafarers who are assigned duty as officer in charge of a watch or as rating forming part of a watch or those whose duties involve designated safety , prevention of pollution and security duties may be allowed in accordance with directive 1999 / 63 / ec . with due regard for the general principles of the protection of the health and safety of workers , member states may have national laws , regulations or a procedure for the competent authority to authorise or register collective agreements permitting exceptions to the required hours of rest . such exceptions shall , as far as possible , follow the standards set out but may take account of more frequent or longer leave periods , or the granting of compensatory leave for watchkeeping seafarers or seafarers working on board ship on short voyages . however , for the purpose of preventing the danger posed by fatigue , exceptions to the minimum hours of rest provided for in paragraph 4 shall not be allowed and exceptions to the required hours of rest in paragraphs 4 and 5 shall respect the limits set in paragraphs 12 and 13 . such exceptions should equally take into account the guidance regarding prevention of fatigue laid down in section b - viii / 1 of the stcw code .


### exceptions referred to in paragraph 11 to the weekly rest period provided for in paragraph 4 shall not be allowed for more than two consecutive weeks . the intervals between two periods of exceptions on board shall not be less than twice the duration of the exception . ### exceptions referred to in paragraph 11 to the minimum weekly rest period provided for in paragraph 4 shall be allowed for no more than two consecutive weeks and provided that the minimum rest period is no less than 70 hours in any 7 - day period . in addition , the intervals between two periods of exceptions on board shall not be less than twice the duration of the exception .


### in the framework of possible exceptions to paragraph 5 referred to in paragraph 11 , the hours of rest provided for in paragraph 4 may be divided into no more than three periods , one of which shall be at least 6 hours in length and neither of the two other periods shall be less than one hour in length . the intervals between consecutive periods of rest shall not exceed 14 hours . exceptions shall not extend beyond two 24 - hour periods in any 7 - day period . ### in the framework of possible exceptions to paragraph 5 referred to in paragraph 11 , the minimum hours of rest in any 24 - hour period provided for in paragraph 4 may be divided into no more than three periods of rest , one of which shall be at least 6 hours in length and neither of the two other periods shall be less than one hour in length . the intervals between consecutive periods of rest shall not exceed 14 hours . exceptions shall not extend beyond two 24 - hour periods in any 7 - day period .


### the commission shall be empowered to adopt delegated acts amending annex v to this directive with respect to specific and relevant content and details of the information that need to be reported by member states , while taking into account the safeguards on data protection , in accordance with article 27a . ### the commission shall be empowered to adopt delegated acts amending annex v to this directive with respect to specific and relevant content and details of the information that need to be reported by member states , while respecting the safeguards on data protection established by applicable eu legislation , in accordance with article 27a .


### under this set of legislation , gmos for cultivation shall undergo an individual risk assessment before being authorised to be placed on the union market . the aim of this authorisation procedure is to ensure a high level of protection of human life and health , animal health and welfare , the environment and consumer interests , whilst ensuring the effective functioning of the internal market . ### under this set of legislation , gmos for cultivation shall undergo an individual risk assessment before being authorised to be placed on the union market , taking into account , in accordance with annex ii of directive 2001 / 18 / ec , the direct , indirect , immediate and delayed effects , as well as the cumulative long - term effects , on human health and the environment . the aim of this authorisation procedure is to ensure a high level of protection of human life and health , animal health and welfare , the environment and consumer interests , whilst ensuring the effective functioning of the internal market .


### according to the legal framework for the authorisation of gmos , the level of protection of human / animal health and of the environment chosen in the eu cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of eu rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . those measures should furthermore be in conformity with the treaties , in particular as regards the principle of non discrimination between national and non national products and articles 34 and 36 of the treaty on the functioning of the european union , as well as with the relevant international obligations of the union , notably in the context of the world trade organisation . ### according to the legal framework for the authorisation of gmos , the level of protection of human / animal health and of the environment chosen in the eu cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of eu rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . such measures may be justified on the basis of : - environmental grounds different and complementary to those which have been the subject of an evaluation pursuant to directive 2001 / 18 / ec , and providing scientific data clearly showing the importance of conserving the receiving environments ; - grounds supporting the protection and development of agricultural practices which offer the best combination of production with ecosystem sustainability ; - grounds relating to the appearance of resistance or invasive plants ; - grounds suggesting that there are agricultural practices which present an alternative to gmo cultivation and yield more beneficial results in technical , economic and environmental terms . those measures should furthermore be in conformity with the treaties , in particular as regards the principle of non discrimination between national and non national products and articles 34 and 36 of the treaty on the functioning of the european union , as well as with the relevant international obligations of the union , notably in the context of the world trade organisation .


### on the basis of the subsidiarity principle , the purpose of this regulation is not to harmonize the conditions of cultivation in member states but to grant freedom to member states to invoke other grounds than scientific assessment of health and environmental risks to ban cultivation of gmos on their territory . in addition one of the purposes of directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations27 which is to allow the commission to consider the adoption of binding acts at eu level would not be served by the systematic notification of member states ' measures under that directive . moreover , since measures which member states can adopt under this regulation cannot have as a subject the placing of the market of gmos and thus does not modify the conditions of placing on the market of gmos authorised under the existing legislation , the notification procedure under directive 98 / 34 / ec does not appear the most appropriate information channel for the commission . therefore , by derogation , directive 98 / 34 / ec should not be applicable . a simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the commission to be aware of these measures . measures which member states intend to adopt should thus be communicated together with their reasons to the commission and to the other member states one month prior to their adoption for information purposes . ### on the basis of the subsidiarity principle , the purpose of this regulation is not to harmonize the conditions of cultivation in member states but to grant freedom to member states to restrict or ban cultivation of gmos on their territory for reasons linked to legitimate environmental or other considerations , resulting from the authorisation or placing on the market of gmos , which were not concerned by the harmonised procedure referred to in part c of directive 2001 / 18 / ec or which were not sufficiently taken into account . moreover , since measures which member states can adopt under this regulation cannot have as a subject the placing of the market of gmos and thus does not modify the conditions of placing on the market of gmos authorised under the existing legislation , the notification procedure under directive 98 / 34 / ec does not appear the most appropriate information channel for the commission . therefore , by derogation , directive 98 / 34 / ec should not be applicable . a simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the commission to be aware of these measures . measures which member states intend to adopt should thus be communicated together with their reasons to the commission and to the other member states one month prior to their adoption for information purposes .


### in order to achieve the objectives of regulation no 273 / 2004 , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to specify the requirements and conditions for the granting of the licence and registration , for obtaining and using customer declarations , for the documentation and labelling of mixtures , for provision of information by the operators on transactions involving scheduled substances , for listing operators and users having obtained a licence or registration in the european register and in order to amend the annexes . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### in order to achieve the objectives of regulation no 273 / 2004 , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission to specify the requirements and conditions for the granting of the licence and registration , for obtaining and using customer declarations , for the documentation and labelling of mixtures , for provision of information by the operators on transactions involving scheduled substances , for listing operators and users having obtained a licence or registration in the european register and in order to amend the annexes . delegated acts , under article 290 of the treaty on the functioning of the european union , should also be used to determine those categories of personal data which can be processed by member states and operators pursuant to this regulation , categories of personal data which can be stored in the european database , the procedures by which data subjects can exercise their rights to information , access , rectification , erasure or blocking of personal data processed in the european database , and the categories of personal data which should be processed by operators for reporting unusual or suspected transactions . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that it seek the opinion of the european data protection supervisor when preparing delegated acts relating to the processing of personal data pursuant to this regulation .


### operators and users shall be required to obtain a licence from the competent authorities before they may possess or place on the market scheduled substances of category 1 of annex i . special licences may be granted by the competent authorities to pharmacies , dispensaries of veterinary medicine , certain types of public authorities or armed forces . such special licences shall only be valid for the use of scheduled substances of category 1 of annex i within the scope of the official duties of the operators concerned . ### operators and users shall be required to obtain a licence from the competent authorities of the member state in which they are domiciled or established before they may possess or place on the market scheduled substances of category 1 of annex i . special licences may be granted by the competent authorities to pharmacies , dispensaries of veterinary medicine , certain types of public authorities or armed forces . such special licences shall only be valid for the use of scheduled substances of category 1 of annex i within the scope of the official duties of the operators concerned .


### from [ 18 months after the date of publication ] operators shall be required to obtain a registration from the competent authorities before placing on the market scheduled substances of category 2 of annex i . furthermore , users shall be required to obtain a registration from the competent authorities before possessing scheduled substances of subcategory 2a of annex i . special registrations may be granted by competent authorities to pharmacies , dispensaries of veterinary medicine , certain types of public authorities or the armed forces . such registrations shall be considered valid only for the use of scheduled substances of category 2 of annex i within the scope of the official duties of the operators or users concerned . ### from . . . * operators shall be required to obtain a registration from the competent authorities of the member state in which they are domiciled or established before placing on the market scheduled substances of category 2 of annex i . furthermore , users shall be required to obtain a registration from the competent authorities before possessing scheduled substances of subcategory 2a of annex i . special registrations may be granted by competent authorities to pharmacies , dispensaries of veterinary medicine , certain types of public authorities or the armed forces . such registrations shall be considered valid only for the use of scheduled substances of category 2 of annex i within the scope of the official duties of the operators or users concerned . ______________ * oj please insert date : 18 months after the date of entry into force of this regulation .


### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning : the requirements and conditions for the granting of the licence referred to in paragraph 2 ; the requirements and conditions for the granting of the registration referred to in paragraph 6 the requirements and conditions for listing operators an users having obtained a licence or registration in a european database on drug precursors referred to in paragraph 8 . ### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning : the requirements and conditions for the granting of the licence referred to in paragraph 2 , and the categories of data , including of personal data , to be provided ; the requirements and conditions for the granting of the registration referred to in paragraph 6 and the categories of data , including of personal data , to be provided ; and the requirements and conditions for listing operators an users having obtained a licence or registration in a european database on drug precursors referred to in paragraph 8 . the categories of personal data referred to in points and of the first subparagraph shall not include sensitive data within the meaning of article 8 of directive 95 / 46 / ec .


### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning the requirements and conditions for operators to provide information as referred to in paragraph 2 . ' ### the commission shall be empowered to adopt delegated acts in accordance with article 15a concerning the requirements and conditions for operators to provide information , the categories of personal data to be processed for that purpose , and the safeguards for the processing of that personal data , as referred to in paragraph 2 . '


### facilitating the communication of information pursuant to article 13 , its synthesis and analysis on the level of the union , and the reporting to the international narcotics control board pursuant to article 13 ; ### facilitating the communication of information , where possible in an aggregrated and anonymised manner , pursuant to article 13 , its synthesis and analysis on the level of the union , and the reporting to the international narcotics control board pursuant to article 13 ;


### the processing of personal data by the competent authorities in the member states shall be carried out in accordance with directive 95 / 46 / ec and under the supervision of the public independent authority of the member state referred to in article 28 of this directive . ### the processing of personal data by the competent authorities shall be carried out in accordance with directive 95 / 46 / ec and under the supervision of the supervisory authority of the member state as referred to in article 28 of that directive . the latter shall ensure that the rights of data subjects are protected in accordance with directive 95 / 46 / ec .


### the prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether , but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour . the use of additives necessary for manufacturing of tobacco products should be allowed , as long as they do not result in a characterising flavour . . the commission should ensure uniform conditions for the implementation of the provision on characterising flavour . independent panels should be used by the member states and by the commission to assist in such decision making . the application of this directive should not discriminate between different tobacco varieties . ### the prohibition of tobacco products with characterising flavours does not prohibit the use of individual additives altogether , but obliges the manufactures to reduce the additive or the combination of additives to such an extent that the additives no longer result in a characterising flavour . the use of additives necessary for manufacturing of tobacco products is allowed . the commission should ensure uniform conditions for the implementation of the provision on characterising flavour . independent panels should be used by the member states and by the commission to assist in such decision making . the application of this directive should not discriminate between different tobacco varieties .


### ' age verification system ' means a computing system that unambigouisly confirms the consumer ' s age in electronic form according to national requirements ; ### ' age verification system ' means a computing system that unambigouisly confirms the consumer ' s age in electronic form according to national requirements ; it can also mean a physical verification system in form accordant to national requirements , that unambiguously confirms the consumer age in situations other than direct purchase for example by the usage of vending machines ;


### ‘ place on the market’ means to make products available to consumers located in the union , with or without payment , including by means of distance sale ; in case of cross - border distance sales the product is deemed to be placed on the market in the member state where the consumer is located ; ### ‘ place on the market’ means to make products available to consumers located in the union , with or without payment , including by means of distance sale or by use of vending machines ; in case of cross - border distance sales the product is deemed to be placed on the market in the member state where the consumer is located ;


### member states shall not prohibit the use of additives which are essential for the manufacture of tobacco products , as long as the additives do not result in a product with a characterising flavour . ### member states shall not prohibit the use of additives which are essential for the manufacture of tobacco products ,


### member states shall prohibit the use of flavourings in the components of tobacco products such as filters , papers , packages , capsules or any technical features allowing modification of flavour or smoke intensity . filters and capsules shall not contain tobacco . ### member states shall prohibit the use of flavourings in the components of tobacco products such as filters , papers , packages , capsules or any technical features allowing modification of flavour or smoke intensity , where it was unequivocally proved by scientific studies that the additive increases toxicity of the products or facilitate addiction . filters and capsules shall not contain tobacco .


### include smoking cessation information such as phone numbers , e - mail addresses and / or internet sites designed to inform consumers about the programmes available to support those who want to stop smoking ; ### include smoking cessation information such as phone numbers , e - mail addresses and / or internet sites designed to inform consumers about the programmes available to support those who want to stop smoking ; those platforms designed to inform consumers about the programmes available to support those who want to stop smoking should play active role in promoting knowledge on the severe effects of smoking among children and youth as those most at risk of becoming dependent on tobacco ;


### member states shall ensure that all unit packets of tobacco products shall be marked with a unique identifier . in order to ensure their integrity , unique identifiers shall be irremovably printed / affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or by the opening of the packet . in relation to products manufactured outside the union the obligations laid down in this article apply only to those destined to or placed on the union market . ### for the purposes of effective tracking and tracing , member states shall ensure that all unit packets of tobacco products including any external packaging , shall be marked with a unique , safe and indelible identifier . in order to ensure their integrity , unique identifiers shall be irremovably printed / affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or by the opening of the packet . in relation to products manufactured outside the union the obligations laid down in this article apply only to those destined to or placed on the union market .


### member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . the penalties provided for shall be effective , proportionate and dissuasive . ### member states shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . the penalties provided for shall be effective , proportionate and dissuasive . all fines shall be greater than any financial rewards for infringement .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ publications office , please insert the exact date : entry into force + 18 months ] at the latest . they shall forthwith communicate to the commission the text of those provisions . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ publications office , please insert the exact date : entry into force + 36 months ] at the latest . they shall forthwith communicate to the commission the text of those provisions .


### energy markets are increasingly interlinked across the union . market abuse in one member state affects wholesale prices for electricity and gas across national borders . therefore the concern to ensure the integrity of markets cannot be a matter only for individual member states . ### energy markets are increasingly interlinked across the union . market abuse in one member state affects both wholesale prices for electricity and gas across national borders and retail prices for consumers . therefore the concern to ensure the integrity of markets cannot be a matter only for individual member states . therefore a strong cross - border market monitoring is essential for the completion of a fully functioning , interconnected and integrated internal energy market .


### efficient market monitoring is vital to detecting and deterring market abuse on wholesale energy markets . the agency is best placed to carry out such monitoring as it has both a union wide view of electricity and gas markets , and the necessary expertise in the operation of electricity and gas markets and systems in the union . national regulatory authorities having an important understanding of developments on energy markets in their member state should have an important role in ensuring efficient market monitoring . ### efficient market monitoring is vital to detecting and deterring market abuse on wholesale energy markets . the agency is best placed to carry out such monitoring as it has both a union wide view of electricity and gas markets , and the necessary expertise in the operation of electricity and gas markets and systems in the union . national regulatory authorities having an important understanding of developments on energy markets in their member state should have an important role in ensuring efficient market monitoring . therefore the concern to ensure proper monitoring and transparency of the energy market depends upon the close cooperation and enhanced coordination between various european agencies and national authorities .


### the decision of revocation shall put an end to the delegation of the powers specified in that decision . it shall take effect immediately or at a later date specified therein . it shall not affect the validity of the delegated acts already in force . it shall be published in the official journal of the european union . ### the decision of revocation shall put an end to the delegation of the powers specified in that decision . it shall take effect on the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of the delegated acts already in force . it shall be published in the official journal of the european union .


### cooperation of member states should serve the technical interoperability of the notified electronic identification schemes with a view to foster a high level of trust and security appropriate to the degree of risk . the exchange of information and the sharing of best practices between member states with a view to their mutual recognition should help such cooperation . ### cooperation of member states should serve the technical interoperability of the notified electronic identification schemes with a view to foster a high level of trust and security appropriate to the degree of risk . the exchange of information and the sharing of best practices between member states , particularly on e - services considered as having significant cross - border relevance , with a view to their mutual recognition should help such cooperation .


### this regulation should be technology - neutral . the legal effects it grants should be achievable by any technical means provided that the requirements of this regulation are met . ### this regulation should be technology - neutral with regards to both electronic identification systems and trust services . the legal effects it grants should be achievable by any technical means provided that the requirements of this regulation are met .


### a trust service provider is a controller of personal data and therefore has to comply with the obligations set out in directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data . in particular the collection of data should be minimised as much as possible taking into account the purpose of the service provided . ### a trust service provider is a controller of personal data and therefore has to comply with the obligations set out in national law on data protection and in directive 95 / 46 / ec of the european parliament and of the council of 24 october 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data . in particular the collection and retention of data should be minimised as much as possible taking into account the purpose of the service provided .


### it should be incumbent on all trust service providers to apply good security practice appropriate to the risks related to their activities so as to boost users ' trust in the single market . ### it should be incumbent on all trust service providers to apply good security practice appropriate to the risks related to their activities so as to build users ' trust in the services concerned .


### notification of security breaches and security risk assessments is essential with a view to providing adequate information to concerned parties in the event of a breach of security or loss of integrity . ### a breach of security may , if not addressed in an adequate and timely manner , result in substantial economic loss and social harm for the individuals concerned , including identity fraud . therefore notification of security breaches without undue delay and security risk assessments is essential with a view to providing adequate information to concerned parties in the event of a breach of security or loss of integrity , especially to give them the opportunity to mitigate potential adverse effects .


### the electronic identification means can be used to access at least public services requiring electronic identification in the notifying member state ; ### the electronic identification means can be used to access at least public services offering electronic identification for the purpose of accessing the service in the notifying member state ;


### the commission may , by means of implementing acts , define the circumstances , formats and procedures for the report referred to in paragraph 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define the formats for the report referred to in paragraph 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### the commission may , by means of implementing acts , define the circumstances , formats and procedures , including deadlines , applicable for the purpose of paragraphs 1 to 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define the formats applicable for the purpose of paragraphs 1 to 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### the commission may , by means of implementing acts , define the circumstances , procedures and formats applicable for the purpose of paragraphs 1 , 2 and 4 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define the formats applicable for the purpose of paragraphs 1 , 2 and 4 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### record for an appropriate period of time all relevant information concerning data issued and received by the qualified trust service provider , in particular for the purpose of providing evidence in legal proceedings . such recording may be done electronically ; ### record relevant information concerning data issued and received by the qualified trust service provider , in particular for the purpose of providing evidence in legal proceedings . the retention of this information shall be strictly limited to the time period necessary and be consistent with the data minimization principle . such recording may be done electronically ;


### a qualified electronic signature shall have the equivalent legal effect of a handwritten signature . ### a qualified electronic signature which has associated a qualified electronic time stamp shall have the equivalent legal effect of a handwritten signature .


### a delegated act adopted pursuant to articles 8 , 13 , 15 , 16 , 18 , 20 , 21 , 23 , 25 , 27 , 28 , 29 , 30 , 31 , 35 and 37 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act adopted pursuant to articles 8 , 15 , 18 , 20 , 21 , 23 , 25 , 27 , 28 , 29 , 30 , 31 , 35 and 37 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of three months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


### the commission shall report to the european parliament and to the council on the application of this regulation . the first report shall be submitted no later than four years after the entry into force of this regulation . subsequent reports shall be submitted every four years thereafter . ### the commission shall report to the european parliament and to the council on the application of this regulation . the first report shall be submitted no later than two years after the entry into force of this regulation . subsequent reports shall be submitted every two years thereafter .


### the electronic signature creation data used for electronic signature generation cannot , with reasonable assurance , be derived and the electronic signature is protected against forgery using currently available technology ; ### the electronic signature creation data used for electronic signature generation cannot be derived and the electronic signature is protected against forgery using currently available technology ;


### a set of data unambiguously representing the legal person to whom the certificate is issued , including at least name and registration number as stated in the official records ; ### a set of data unambiguously representing the natural or legal person to whom the certificate is issued , including at least name and registration number as the case may be , as stated in the official records ;


### elements of the address , including at least city and member state , of the legal person to whom the certificate is issued as stated in the official records ; ### elements of the address , including at least city and member state , of the natural or legal person to whom the certificate is issued as stated in the official records ;


### implementation of the common fisheries policy should take into account interactions with other maritime affairs as addressed by the integrated maritime policy , recognizing that all matters related to europe’s oceans and seas are interlinked , including maritime spatial planning . coherence and integration should be ensured in the management of different sectoral policies within the baltic sea , north sea , celtic seas , bay of biscay and the iberian coast , mediterranean and black sea sea basins . ### implementation of the common fisheries policy should take into account interactions with other maritime affairs as addressed by the integrated maritime policy , recognizing that all matters related to the seas and oceans which border european territory are interlinked , including maritime spatial planning . coherence and integration should be ensured in the management of different sectoral policies within the atlantic ocean , indian ocean , baltic sea , north sea , celtic seas , bay of biscay and the iberian coast , mediterranean and black sea sea basins .


### marine biological resources around the azores , madeira and the canary islands should continue to be especially protected since they contribute to the preservation of the local economy of these islands , having regard to the structural , social and economic situation of those islands . the limitation of certain fishing activities in those waters to fishing vessels registered in the ports of the azores , madeira and the canary islands should therefore be maintained . ### marine biological resources around the outermost regions should continue to be especially protected since they contribute to the preservation of the local economy of these islands , having regard to the structural , social and economic situation of those islands . the limitation of certain fishing activities in those waters to fishing vessels registered in the ports of the outermost regions should therefore be maintained .


### the objective of sustainable exploitation of marine biological resources is more effectively achieved through a multi - annual approach to fisheries management , establishing as a priority multi - annual plans reflecting the specificities of different fisheries . ### the objective of sustainable exploitation of marine biological resources is more effectively achieved through a multi - annual approach to fisheries management , establishing as a priority multi - annual plans reflecting the specificities of different sea basins and different fisheries .


### in view of the precarious economic state of the fishing industry and the dependence of certain coastal communities on fishing activities , it is necessary to ensure the relative stability of fishing activities by allocating fishing opportunities among member states , based on a predictable share of stocks for each member state . ### in view of the precarious economic state of the fishing industry and the dependence of many coastal and island communities on fishing activities , it is necessary to revise the concept of relative stabililty and to ensure the stability of fishing activities and the socio - economic viability of the sector and the regions that are dependent on it by allocating fishing opportunities among member states , based on a predictable share of stocks for each member state and the fishing capacity that they have .


### member states should be able to adopt conservation measures and technical measures for the implementation of the common fisheries policy to allow for the policy to better address the realities and specificities of individual fisheries and to increase the adherence to the policy . ### member states should be able to adopt conservation measures and technical measures for the implementation of the common fisheries policy to allow for the policy to better address the realities and specificities of different sea basins and individual fisheries and to increase the adherence to the policy .


### member states should manage and make available to end - users of scientific - data the collected data , on the basis of a multi - annual union program . member states should also cooperate with each other to coordinate data collection activities . where relevant , member states should also cooperate with third countries within the same sea basin regarding data collection . ### member states should manage and make available to end - users of scientific - data the collected data , on the basis of a multi - annual union program . member states should also cooperate with each other to coordinate data collection activities . where relevant , member states should also cooperate with third countries within the same sea basin regarding data collection , if possible using a regional body established for this very purpose .


### policy - oriented fisheries science should be reinforced by means of nationally - adopted fisheries scientific data collection , research and innovation programs in coordination with other member states as well as by union research and innovation framework tools . ### fisheries science should be reinforced by means of nationally - adopted fisheries scientific data collection , research and innovation programs in coordination with other member states as well as by research and innovation framework tools and increasing human resources , expertise and union financial assistance .


### there is a need to strengthen the competitiveness of the union fishery and aquaculture sector , and a call for simplification in support of better management of production and marketing activities of the sector ; the common market organisation for fishery and aquaculture products should ensure a level - playing field for all fishing and aquaculture products marketed in the union , should enable consumers to make better informed choices and support responsible consumption , and should improve the economic knowledge and understanding of the union markets along the supply chain . ### there is a need to strengthen the competitiveness of the union fishery and aquaculture sector , and a call for simplification in support of better management of production and marketing activities of the sector ; the common market organisation for fishery and aquaculture products should ensure a level - playing field for all fishing and aquaculture products marketed , whether from the union or third countries , should enable consumers to make better informed choices and support responsible consumption , and should improve the economic knowledge and understanding of the union markets along the supply chain . the provisions of the common organisation of the markets in fishery and aquaculture products should impose conditions on imports of fishery and aquaculture products while respecting the internationally recognised social and environmental regulations .


### there is a need to strengthen the competitiveness of the union fishery and aquaculture sector , and a call for simplification in support of better management of production and marketing activities of the sector ; the common market organisation for fishery and aquaculture products should ensure a level - playing field for all fishing and aquaculture products marketed in the union , should enable consumers to make better informed choices and support responsible consumption , and should improve the economic knowledge and understanding of the union markets along the supply chain . ### there is a need to strengthen the competitiveness of the union fishery and aquaculture sector , and a call for simplification in support of better management of production and marketing activities of the sector , ensuring reciprocity in trade with third countries in order to guarantee market conditions equal to those within the european union , not only in terms of fishery sustainability , but also of health controls . the common market organisation for fishery and aquaculture products should also ensure a level - playing field for all fishing and aquaculture products marketed in the union , should enable consumers to make better informed choices and support responsible consumption , and should improve the economic knowledge and understanding of the union markets along the supply chain .


### it appears appropriate that the commission be empowered by delegated acts to create a new advisory council and to modify areas of competence of existing ones , in particular considering the specificities of the black sea . ### it appears appropriate that the commission be empowered by delegated acts to create two new advisory councils and to modify areas of competence of existing ones , in particular considering the specificities of the black sea and the outermost regions .


### the common fisheries policy shall implement the ecosystem - based approach to fisheries management to ensure that the impacts of fishing activities on the marine ecosystem are limited . ### the common fisheries policy shall implement the ecosystem - based approach to fisheries management as the core principle for securing the sustainability of fisheries , in accordance with the resources available in a framework of equal opportunities , and so as to ensure that the impacts of fishing activities on the marine ecosystem are limited .


### provide conditions for efficient fishing activities within an economically viable and competitive fishing industry ; ### provide conditions for efficient fishing activities within an economically sustainable and competitive fishing industry , since it is crucial to guarantee the sector’s future ;


### provide conditions for efficient fishing activities within an economically viable and competitive fishing industry ; ### provide conditions for socially and economically sustainable and efficient fishing activities within an economically viable and competitive fishing industry ;


### broad involvement of stakeholders at all stages from conception to implementation of the measures ; ### broad involvement of stakeholders at all stages from conception to implementation of the measures and evaluation ;