### by way of derogation from article 4 and , where the payment service provider of the payee is established outside the union , transfers of funds amounting to eur 1 000 or less shall be accompanied only by : ### by way of derogation from article 4 and , where the payment service provider of the payee is established within the union or outside the union , transfers of funds amounting to eur 1 000 or less shall be accompanied only by :


### the full traceability of transfers of funds can be a particularly important and valuable tool in the prevention , investigation and detection of money laundering or terrorist financing . it is therefore appropriate , in order to ensure the transmission of information throughout the payment chain , to provide for a system imposing the obligation on payment service providers to have transfers of funds accompanied by information on the payer and the payee . ### the full traceability of transfers of funds can be a particularly important and valuable tool in the prevention , investigation and detection of money laundering or terrorist financing . it is therefore appropriate , in order to ensure the transmission of information throughout the payment chain , to provide for a system imposing the obligation on payment service providers to have transfers of funds accompanied by information on the payer and the payee . this system should also ensure the inclusion of payment service providers situated in developing countries whose financial systems are often abused for these illegal purposes .


### in its communication to the european parliament , the council , the economic and social committee and the committee of the regions entitled ' single market act twelve levers to boost growth and strengthen confidence ' working together to create new growth ' ' , 9 adopted on 13 april 2011 , the commission identifies the need to improve the transparency of the social and environmental information provided by companies in all sectors , in order to ensure a level playing field . __________________ 9 com 206 final of 13 april 2011 . ### in its communication to the european parliament , the council , the european economic and social committee and the committee of the regions entitled ' single market act &#8211 ; twelve levers to boost growth and strengthen confidence &#8211 ; ' working together to create new growth ' ' 9 , adopted on 13 april 2011 , the commission identifies the need to improve the transparency of the social and environmental information provided by undertakings in all sectors , in order to ensure a level playing field . __________________ 9 com0206 of 13 april 2011 .


### it is also necessary to establish a certain minimum legal requirement as regards the extent of the information that should be made available to the public by undertakings across the union . annual reports should give a fair and comprehensive view of an undertaking ' s policies , results , and risks . ### it is also necessary to establish a certain minimum legal requirement as regards the extent of the information that should be made available to the public by undertakings across the union . management reports should give a fair and comprehensive view of an undertaking ' s policies , results , and risks .


### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . ### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to gender and other aspects such as age , geographical diversity , disability , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case .


### some of the companies and groups falling under the scope of directive 78 / 660 / eec and directive 83 / 349 / eec already prepare non - financial reports on a voluntary basis . those companies should not be subject to the obligation to provide a non - financial statement in the annual report , provided that the report corresponds to the same financial year , covers at least the same content required by this directive , and is annexed to the annual report . ### some of the undertakings and groups falling under the scope of directive 2013 / 34 / eu already prepare non - financial reports on a voluntary basis . those undertakings should not be subject to the obligation to provide a non - financial statement in the management report , provided that the report corresponds to the same financial year , covers at least the same content as required by this directive , and is annexed to the management report .


### in providing this information , companies may rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and international frameworks such as the united nations global compact , the guiding principles on business and human rights implementing the un ‘ protect , respect and remedy’ framework , the organisation for economic co - operation and development guidelines for multinational enterprises , the international organisation for standardisation 26000 , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative . ### in providing non - financial information on their compliance with rights and values protected by norms of international law companies shall apply the guiding principles on business and human rights implementing the un ' protect , respect and remedy ' framework and the oecd guidelines for multinational enterprises , companies may also rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and other international frameworks such as the united nations global compact , the international organisation for standardisation 26000 , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative . companies should specify which frameworks they have relied on .


### proposal for a directive of the european parliament and of the council amending council directives 78 / 660 / eec and 83 / 349 / eec as regards disclosure of non - financial and diversity information by certain large companies and groups ### proposal for a directive of the european parliament and of the council amending directive 2013 / 34 / eu as regards disclosure of non - financial and diversity information by certain large undertakings and groups


### in providing this information , companies may rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and international frameworks such as the united nations global compact , the guiding principles on business and human rights implementing the un ‘ protect , respect and remedy’ framework , the organisation for economic co - operation and development guidelines for multinational enterprises , the international organisation for standardisation 26000 , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative . ### in providing this information , companies should rely , as a general rule , on national , eu - based or international normative frameworks such as the united nations global compact , the guiding principles on business and human rights implementing the un ' protect , respect and remedy ' framework , the organisation for economic co - operation and development guidelines for multinational enterprises . this may also be complemented by other reporting frameworks such as the eco - management and audit scheme , the international organisation for standardisation 26000 , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , the global reporting initiative , the carbon disclosure project and the climate disclosure standards board or other recognised national , eu - based or international reporting frameworks . in their statement , undertakings should specify which framework they have relied upon .


### directives 78 / 660 / eec and 83 / 349 / eec should therefore be amended accordingly , ### directive 2013 / 34 / eu should therefore be amended accordingly ,


### the necessity to improve company disclosure of social and environmental information , by presenting a legislative proposal in this field , was reiterated in the communication from the commission to the european parliament , the council , the economic and social committee and the committee of the regions entitled ‘ a renewed eu strategy 2011 - 14 for corporate social responsibility’10 adopted on 25 october 2011 . __________________ 10 com 681 final of 25 october 2011 . ### the necessity to improve undertakings ' disclosure of social and environmental information , by presenting a legislative proposal in this field , was reiterated in the communication from the commission to the european parliament , the council , the european economic and social committee and the committee of the regions entitled ‘ a renewed eu strategy 2011 - 14 for corporate social responsibility’10 , adopted on 25 october 2011 . __________________ 10 com0681 of 25 october 2011 .


### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , companies should be required to include in their annual report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . ### in order to enhance consistency and comparability of non - financial information disclosed throughout the union , undertakings should be required to include in their management report a non - financial statement containing information relating to at least environmental matters , social and employee - related matters , respect for human rights , anti - corruption and bribery matters . such statement should include a description of the policies , results , and the risks related to those matters . the non - financial statement should also include , where appropriate , a reference to the due diligence processes implemented by the undertaking in order to identify , prevent and mitigate existing and potential adverse impacts as appropriate to the their size and the nature and context of operations .


### directive 78 / 660 / eec is amended as follows : ### directive 2013 / 34 / eu is amended as follows :


### the coordination of national provisions concerning the disclosure of non - financial information in respect of large undertakings with limited liability is of importance for the interests of companies , shareholders and other stakeholders alike . coordination is necessary in those fields because most of these undertakings operate in more than one member state . ### the coordination of national provisions concerning the disclosure of non - financial information in respect of large undertakings with limited liability is of importance for the interests of undertakings , shareholders and other stakeholders alike . coordination is necessary in those fields because most of these undertakings operate in more than one member state .


### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . ### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , language , disability , educational and professional background should only apply to large listed undertakings . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 20 of directive 2013 / 34 / eu .


### the european council of 24 and 25 march 2011 called for the overall regulatory burden , in particular for small and medium - sized enterprises , to be reduced at both european and national levels and suggested measures to increase productivity while the europe 2020 strategy for smart , sustainable and inclusive growth aims to improve the business environment for smes and to promote their internationalisation . thus , according to the ‘ think - small - first’ principle , the disclosure requirements under directive 78 / 660 / eec and directive 83 / 349 / eec should only apply to certain large undertakings and groups . ### the european council of 24 and 25 march 2011 called for the overall regulatory burden , in particular for small and medium - sized enterprises , to be reduced at both european and national levels and suggested measures to increase productivity while the europe 2020 strategy for smart , sustainable and inclusive growth aims to improve the business environment for smes and to promote their internationalisation . thus , according to the ' think - small - first ' principle , the disclosure requirements under directive 2013 / 34 / eu should only apply to certain large undertakings and groups .


### amendments to directive 78 / 660 / eec ### amendments to directive 2013 / 34 / eu


### the european council of 24 and 25 march 2011 called for the overall regulatory burden , in particular for small and medium - sized enterprises , to be reduced at both european and national levels and suggested measures to increase productivity while the europe 2020 strategy for smart , sustainable and inclusive growth aims to improve the business environment for smes and to promote their internationalisation . thus , according to the ‘ think - small - first’ principle , the disclosure requirements under directive 78 / 660 / eec and directive 83 / 349 / eec should only apply to certain large undertakings and groups . ### the european council of 24 and 25 march 2011 called for the overall regulatory burden , in particular for small and medium - sized enterprises , to be reduced at both european and national levels and suggested measures to increase productivity , while the europe 2020 strategy for smart , sustainable and inclusive growth aims to improve the business environment for smes and to promote their internationalisation . thus , according to the ‘ think - small - first’ principle , the disclosure requirements under directive 2013 / 34 / eu should only apply to certain large undertakings and groups .


### diversity of competences and views of the members of administrative , management and supervisory bodies of companies facilitates a good understanding of the business organisation and affairs . it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ‘ group - think’ phenomenon . it contributes thus to effective oversight of the management and a successful governance of the company . it would therefore be important to enhance transparency regarding the diversity policy companies have in place . this would inform the market of corporate governance practices and thus put indirect pressure on companies to have more diversified boards . ### diversity of competences and views of the members of administrative , management and supervisory bodies of undertakings facilitates a good understanding of the business organisation and affairs . it enables members of these bodies to exercise a constructive challenge of the management decisions and to be more open to innovative ideas , addressing the similarity of views of members , the ‘ group - think’ phenomenon . it contributes thus to effective oversight of the management and a successful governance of the undertaking . it would therefore be important to enhance transparency regarding the diversity policy undertakings have in place . this would inform the market of corporate governance practices and thus put indirect pressure on undertakings to have more diversified boards .


### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , educational and professional background should only apply to large listed companies . therefore small and medium - sized companies that may be exempted from certain accounting obligations under article 27 of directive 78 / 660 / eec should not be covered to by this obligation . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 46a of directive 78 / 660 / eec . companies not having a such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case . ### the obligation to disclose their diversity policies for their administrative , management and supervisory bodies with regard to aspects such as age , gender , geographical diversity , integration of persons with a disability , educational and professional background should only apply to large listed undertakings . disclosure of the diversity policy should be part of the corporate governance statement , as laid down by article 20 of directive 2013 / 34 / eu . undertakings not having such a diversity policy should not be obliged to put one in place , but they should clearly explain why this is the case .


### the scope of these non - financial disclosure requirements should be defined by reference to the average number of employees , total assets and turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to those companies whose average number of employees exceeds 500 , and exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million . ### the scope of these non - financial disclosure requirements should be defined by reference to the turnover of the company . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the annual report should only apply to those undertakings which exceed either a balance sheet total of eur 20 million or a net turnover of eur 40 million .


### since the objective of this directive , namely to increase the relevance , consistency and comparability of information disclosed by companies across the union , cannot be sufficiently achieved by the member states , and can therefore by reason of its effect be better achieved at union level , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary to achieve the pursued objective . ### since the objective of this directive , namely to increase the relevance , consistency and comparability of information disclosed by undertakings across the union , cannot be sufficiently achieved by the member states , and can therefore by reason of its effect be better achieved at union level , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary to achieve the pursued objective .


### some of the companies and groups falling under the scope of directive 78 / 660 / eec and directive 83 / 349 / eec already prepare non - financial reports on a voluntary basis . those companies should not be subject to the obligation to provide a non - financial statement in the annual report , provided that the report corresponds to the same financial year , covers at least the same content required by this directive , and is annexed to the annual report . ### some of the undertakings and groups falling under the scope of directive 2013 / 34 / eu already prepare non - financial reports on a voluntary basis . those undertakings should not be subject to the obligation to provide a non - financial statement in the management report , provided that the report corresponds to the same financial year , covers at least the same content as required by this directive , and is annexed to the management report .


### paragraph 47 of the final declaration of the united nations rio + 20 conference , ‘ the future we want’13 , recognises the importance of corporate sustainability reporting and encourages companies , where appropriate , to consider integrating sustainability information into their reporting cycle . it also encourages industry , interested governments and relevant stakeholders with the support of the united nations system , as appropriate , to develop models for best practice and facilitate action for the integration of financial and non - financial information , taking into account experiences from already existing frameworks . __________________ 13 united nations , ‘ the future we want’ , outcome document of the united nations conference on sustainable development rio + 20 , a / conf . 216 / l . 1 ### paragraph 47 of the final declaration of the united nations rio + 20 conference , ‘ the future we want’13 , recognises the importance of corporate sustainability reporting and encourages undertakings , where appropriate , to consider integrating sustainability information into their reporting cycle . it also encourages industry , interested governments and relevant stakeholders with the support of the united nations ' system , as appropriate , to develop models for best practice and facilitate action for the integration of financial and non - financial information , taking into account experiences from already existing frameworks . __________________ 13 united nations , ‘ the future we want’ , outcome document of the united nations conference on sustainable development rio + 20 , a / conf . 216 / l . 1


### this directive shall enter into force on the twentieth day following that of its publication in the official journal of the european union . ### this directive shall enter into force on the twentieth day following that of its publication in the official journal of the european union . it shall be consolidated with the directive which it amends within three months of its entry into force .


### information provided to rightholders , members , other collecting societies and users on request ### information provided to rightholders , members , other collecting societies and users


### the requested collecting society shall accept such a request if it is already granting or offering to grant multi - territorial licences for the same category of online rights in musical works in the repertoire of one or more other collecting societies . ### the requested collecting society shall accept such a request within a reasonable time if it is already granting or offering to grant multi - territorial licences for the same category of online rights in musical works in the repertoire of one or more other collecting societies .


### member states shall ensure that the collecting society regularly and diligently distributes and pays amounts due to all rightholders it represents . the collecting society shall carry out such distribution and payments no later than 12 months from the end of the financial year in which the rights revenue was collected , unless objective reasons related in particular to reporting by users , the identification of rights , rightholders or to the matching of information on works and other subject matter with rightholders prevent the collecting society from respecting this deadline . the collecting society shall carry out such distribution and payments accurately , ensuring equal treatment of all categories of rightholders . ### member states shall ensure that the collective management organisations regularly and diligently distributes and pays amounts due to all rightholders it represents . the collective management organisation shall carry out such distribution and payments without undue delay and no later than three months after the rights revenue was collected , unless objective reasons related in particular to reporting by users , the identification of rights , rightholders or to the matching of information on works and other subject matter with rightholders prevent the collective management organisation from respecting this deadline . the collective management organisation shall carry out such distribution and payments accurately , ensuring equal treatment of all categories of rightholders .


### collecting societies collect , manage and distribute revenue from the exploitation of the rights entrusted to them by rightholders . this revenue is ultimately due to rightholders who may be members of that society , or another society . it is therefore important that collecting societies exercise the utmost diligence in collecting , managing and distributing that revenue . accurate distribution is only possible where collecting societies maintain proper records of membership , licences and use of works and other subject matter . where appropriate , data should also be provided by rightholders and users and verified by the collecting societies . amounts collected and due to rightholders should be managed separately from any own assets of the collecting society and , if they are invested , pending their distribution to rightholders , this should be carried out in accordance with the investment policy decided by the collecting societies ' general meeting . in order to maintain a high level of protection for the rights of rightholders and to ensure that any income which may be derived from exploitation of their rights accrues for the benefit of rightholders , the investments made and held by the collecting society should be managed in accordance with criteria which would oblige the collecting society to act prudently , while allowing the collecting society to decide on the most secure and efficient investment policy . this should allow the colleting society to opt for an asset allocation that suits the precise nature and duration of any exposure to risk of any rights revenue invested and which does not unduly prejudice any rights revenue owed to rightholders . moreover , in order to ensure that the amounts due to rightholders are appropriately and effectively distributed , it is necessary to require collecting societies to undertake diligent and good faith reasonable measures to identify and locate the relevant rightholders . it is also appropriate to provide for the approval by members of collecting societies of the rules governing any situation where , due to the lack of identified or located rightholders , amounts collected cannot be distributed . ### collective management organisations collect , manage and distribute revenue from the exploitation of the rights entrusted to them by rightholders . this revenue is ultimately due to rightholders who may be members of that society , or another society . it is therefore important that collective management organisations exercise the utmost diligence in collecting , managing and distributing that revenue . accurate distribution is only possible where collective management organisations maintain proper records of membership , licences and use of works and other subject matter . where appropriate , data should also be provided by rightholders and users and verified by the collective management organisations . amounts collected and due to rightholders should be managed separately from any own assets of the collective management organisation and , if they are invested , pending their distribution to rightholders , this should be carried out in accordance with the investment policy decided by the collective management organisations ' general meeting . in order to maintain a high level of protection for the rights of rightholders and to ensure that any income which may be derived from exploitation of their rights accrues for the benefit of rightholders , the investments made and held by the collective management organisation should be managed in accordance with criteria which would oblige the collective management organisation to act prudently , while allowing the collective management organisation to decide on the most secure and efficient investment policy . this should allow the collective management organisation to opt for a secure and profitable asset allocation that prevents exposure to risk of any rights revenue invested and which does not unduly prejudice any rights revenue owed to rightholders . moreover , in order to ensure that the amounts due to rightholders are appropriately and effectively distributed , it is necessary to require collective management organisations to undertake diligent and good faith reasonable measures to identify and locate the relevant rightholders . it is also appropriate to provide for the approval by members of collective management organisations of the rules governing any situation where , due to the lack of identified or located rightholders , amounts collected cannot be distributed .


### ‘ rights revenue’ means income collected by a collecting society on behalf of rightholders , whether from an exclusive right , a right to remuneration or a right to compensation ; ### ‘ rights revenue’ means income collected by a collective management organisation on behalf of its members , whether from an exclusive right or a right to remuneration and including any income derived from the investments of rights revenue ;


### member states shall ensure that a collecting society makes the following information available at the request of any rightholder whose rights it represents , any collecting society on whose behalf it manages rights under a representation agreement or any user , by electronic means , without undue delay : ### member states shall ensure that a collecting society makes the following information available to any rightholder whose rights it represents , any collecting society on whose behalf it manages rights under a representation agreement or any user , by electronic means , without undue delay :


### members should be allowed to take part in monitoring the management of collecting societies . to this end , collecting societies should establish a supervisory function appropriate to their organisational structure and allow members to be represented in the body that exercises this function . to avoid imposing excessive burden on smaller collecting societies and to make the obligations arising from this directive proportionate , member states should be able to , if they consider this to be necessary , exclude the smallest collecting societies from having to organise such a supervisory function . ### members should be allowed to take part in monitoring the management of collecting societies . to this end , collecting societies should establish a supervisory function appropriate to their organisational structure and allow all categories of members to be represented in the body that exercises this function .


### for reasons of sound management , a collecting society ' s senior management must be independent . managers and executive directors should be required to declare annually to the collecting society whether there are conflicts between their interests and those of the society . ### for reasons of sound management , a collective management organisation ' s senior management must be independent . managers and executive directors should be required to declare before taking up their duties and thereafter annually to the collective management organisation whether there are conflicts between their interests and those of the organisation .


### in addition , a collecting society shall make available at the request of any rightholder or any collecting society , any information on works for which one or more rightholders have not been identified including , where available , the title of the work , the name of the author , the name of the publisher and any other relevant information available which could be necessary to identify the rightholders . ### in addition , a collective management organisation shall make publicly available any information on works for which one or more rightholders have not been identified including , where available , the title of the work , the name of the author , the name of the publisher and any other relevant information available which could be necessary to identify the rightholders .


### to ensure that rightholders are in a position to monitor the performance of their collecting societies and compare their respective performance , collecting societies should make public an annual transparency report comprising comparable audited financial information specific to the activities of collecting societies . collecting societies should also make public an annual special report on the use of amounts dedicated to social , cultural and educational services . to avoid imposing excessive burden on smaller collecting societies and to make the obligations arising from this directive proportionate , member states should be able to , if they consider this to be necessary , exclude the smallest collecting societies from certain transparency obligations . ### to ensure that rightholders are in a position to monitor the performance of their collecting societies and compare their respective performance , collecting societies should make public an annual transparency report comprising comparable audited financial information specific to the activities of collecting societies . collecting societies should also make public an annual special report on the use of amounts dedicated to social , cultural and educational services .


### there are significant differences in the national rules governing the functioning of collecting societies , in particular as regards their transparency and accountability towards their members and rightholders . beyond the difficulties non - domestic rightholders face when exercising their rights and the too often poor financial management of the revenues collected , problems with the functioning of collecting societies lead to inefficiencies in the exploitation of copyright and related rights across the internal market to the detriment of the members of collecting societies , rightholders and users alike . these difficulties do not arise in the functioning of independent rights management service providers who act as agents for rightholders for the management of their rights on a commercial basis and in which rightholders do not exercise membership rights . ### there are significant differences in the national rules governing the functioning of collecting societies , in particular as regards their transparency and accountability towards their members , rightholders and users . beyond the difficulties non - domestic rightholders face when exercising their rights and the too often poor financial management of the revenues collected , problems with the functioning of collecting societies lead to inefficiencies in the exploitation of copyright and related rights across the internal market to the detriment of the members of collecting societies , rightholders and users alike .


### ‘ vehicle type’ means a set of vehicles as defined in annex ii part b to directive 2007 / 46 / ec . ### ‘ vehicle type’ means : for vehicles , tested according to annex ii , paragraph 4 . 1 . 2 . 1 a set of vehicles as defined in annex ii part b to directive 2007 / 46 / ec . for vehicles , tested according to annex ii , paragraph 4 . 1 . 2 . 2 a set of vehicles which do not essentially differ in such respects as : the shape or materials of the bodywork ; the type of engine , number and capacity of cylinders , type of injection system , arrangement of valves , rated engine speed , or the type of electric motor . vehicles having the same type of engine and / or different overall gear ratios , may be regarded as vehicles of the same type . however , if the above differences provide for a different test method , these differences are to be considered as a change of type .


### this regulation should also further reduce noise limits . it should take account of regulation no 661 / 2009 of the european parliament and of the council of 13 july 2009 concerning type - approval requirements for the general safety of motor vehicles , their trailers and systems , components and separate technical units intended therefor , which introduced new stricter noise requirements for motor vehicle tyres . studies highlighting the annoyance and health effects from road traffic noise , and the associated costs and benefits should also be heeded . ### this regulation should also further reduce noise limits . it should take account of regulation no 661 / 2009 of the european parliament and of the council of 13 july 2009 concerning type - approval requirements for the general safety of motor vehicles , their trailers and systems , components and separate technical units intended therefor , which introduced new stricter noise requirements for motor vehicle tyres and which underlined the need for a coherent and comprehensive approach to address the problem of road noise , including taking into account the significant contribution of road surfaces to road noise . studies highlighting the annoyance and health effects from road traffic noise , and the associated costs and benefits should also be heeded .


### member states shall publish in an appropriate publication and communicate to the commission the criteria which the competent authorities must take into account when deciding whether or not to include medicinal products within the scope of the public health insurance system . ### member states shall communicate to the commission the criteria which the competent authorities must take into account when deciding whether or not to include medicinal products within the scope of the public health insurance system . those criteria and information about the decision - making bodies at national or regional level shall be made publicly available .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 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 .


### “health technology assessment” means an assessment of the relative efficacy or of the short - and long - term effectiveness of the medicinal product compared to other health technologies in use for treating the associated condition . ### “health technology assessment” means an assessment which as a minimum includes the relative efficacy or of the short - and long - term effectiveness of the medicinal product compared to other health technologies or interventions in use for treating the associated condition ,


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 90 days of receipt of this additional information . with respect to generic medicinal products , that time limit shall be in all events 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### 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 180 days . with respect to generic medicinal products , that time limit shall not exceed 180 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 or suspended in accordance with the provisions of the preceding paragraph .


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


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 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 90 days of receipt of this additional information . with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall likewise be 90 days . with respect to generic medicinal products , that time limit shall be 30 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 .


### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states . ### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic or biosimilar medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic or biosimilar medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states .


### voluntary contractual agreements concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions ; ### contractual agreements concluded voluntarily between public authorities and the holder of a marketing authorisation , that have as their object to include a medicinal product under the scope of a health insurance system while monitoring elements agreed upfront among both parties relating to the effectiveness and / or relative effectiveness or the appropriate use of the given medicinal product , and with a view to enabling the effective provision of that medicine to patients under specific conditions and during an agreed period of time ;


### the judicial remedies available in the member states have played a limited role in ensuring compliance with the time limits due to the often lengthy procedures in national jurisdictions , which deter affected companies from initiating legal action . therefore , effective mechanisms are necessary to control and enforce compliance with the time limits for pricing and reimbursement decisions . ### the judicial remedies available in the member states have played a limited role in ensuring compliance with the time limits due to the often lengthy procedures in national jurisdictions , which deter affected companies from initiating legal action . therefore , effective mechanisms are necessary to ensure swift infringement resolution by means of administrative mediation in advance of judicial proceedings , as well as to control and enforce compliance with the time limits for pricing and reimbursement decisions .


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


### by 31 january of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 31 january and 1 july of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information : ### by 31 january of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 31 january of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information :


### 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 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 45 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### member states have frequently amended their health insurance schemes or adopted new measures falling within the scope of directive 89 / 105 / eec . it is therefore necessary to establish information mechanisms intended , on the one hand , to ensure the consultation of interested stakeholders and , on the other hand , to facilitate preventive dialogue with the commission as regards the application of this directive . ### member states have frequently amended their health insurance schemes or adopted new measures falling within the scope of directive 89 / 105 / eec . it is therefore necessary to establish an information mechanism intended to ensure the consultation of all interested stakeholders including civil society organisations .


### if the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative , the decision shall contain a statement of reasons based on objective and verifiable criteria , including any evaluation , expert opinion or recommendation on which it is based . the decision shall be communicated to the holder of the marketing authorisation , who shall be informed of all remedies available , including judicial remedies , and of the time limits for applying for such remedies . ### if the competent authorities decide to reduce the price of a specific named medicinal product on their own initiative , the decision shall contain a statement of reasons based on objective and verifiable criteria , including any evaluation , expert opinion or recommendation on which it is based . the decision shall be communicated to the holder of the marketing authorisation , who shall be informed of all remedies available , including judicial remedies , and of the time limits for applying for such remedies . the decision and summary of the statement of reasons shall be made publicly available without delay .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information . with respect to generic medicinal products , that time limit shall be in all events 45 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### 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 or , where appropriate , of the formal receipt of the 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 reference medicinal product has already been included in the public health insurance system .


### member states shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of the application . 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 . if the derogation is granted , the competent authorities shall forthwith publish an announcement of the price increase allowed . ### member states shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 90 days of the receipt of the application . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information . if the derogation is granted , the competent authorities shall forthwith publish an announcement of the price increase allowed .


### 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 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 .


### the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 90 days of receipt of this additional information . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### the provisions of this directive shall apply to measures intended to determine which medicinal products may be included in contractual agreements or public procurement procedures . ### the provisions of this directive shall apply to measures intended to determine which medicinal products may be included in contractual agreements or public procurement procedures . in accordance with union and national law regarding business confidentiality , basic information regarding medicinal products included in contractual agreements or public procurement procedures , such as the name of the product and the name of the marketing authorisation holder , shall be made publicly available once agreements or procedures are concluded .


### “health technology assessment” means an assessment of the relative efficacy or of the short - and long - term effectiveness of the medicinal product compared to other health technologies in use for treating the associated condition . ### “health technology assessment” means an assessment which as a minimum includes the relative efficacy or of the short - and long - term effectiveness of the medicinal product compared to other health technologies or interventions in use for treating the associated condition ,


### 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 and the similarity of biosimilar products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy , bioequivalence or biosimilarity of the medicinal product . the marketing authorisation of an orphan medicinal product is also based on the evaluation of several criteria , including the significant benefit of the product over any available existing alternatives in the union , in accordance with regulation no 141 / 2000 , which should not be re - assessed in the framework of pricing and reimbursement procedures .


### member states shall publish in an appropriate publication and communicate to the commission the criteria which the competent authorities must take into account when approving the prices of medicinal products . ### member states shall communicate to the commission the criteria which the competent authorities must take into account when approving the prices of medicinal products . those criteria and information about the decision - making bodies at national or regional level shall be made publicly available .


### member states shall publish in an appropriate publication and communicate to the commission the criteria which the competent authorities must take into account when deciding whether or not to include medicinal products within the scope of the public health insurance system . ### member states shall communicate to the commission the criteria which the competent authorities must take into account when deciding whether or not to include medicinal products within the scope of the public health insurance system . those criteria and information about the decision - making bodies at national or regional level shall be made publicly available .


### 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 180 days . with respect to generic medicinal products , that time limit shall not exceed 180 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 or suspended in accordance with the provisions of the preceding paragraph .


### member states shall ensure that a decision on an application submitted in accordance with the requirements laid down in the member state concerned , by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 60 days of its receipt . ### member states shall ensure that a decision on an application submitted in accordance with the requirements laid down in the member state concerned , by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 90 days of its 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 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 90 days of its receipt . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system .


### voluntary contractual agreements concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions ; ### contractual agreements concluded voluntarily between public authorities and the holder of a marketing authorisation , that have as their object to include a medicinal product under the scope of a health insurance system while monitoring elements agreed upfront among both parties relating to the effectiveness and / or relative effectiveness or the appropriate use of the given medicinal product , and with a view to enabling the effective provision of that medicine to patients under specific conditions and during an agreed period of time ;


### where a member state intends to adopt or amend any measure falling within the scope of this directive , it shall give interested parties the opportunity to comment on the draft measure within a reasonable period . the competent authorities shall publish the rules applicable to consultations . the results of consultations shall be made publicly available , with the exception of confidential information in accordance with union and national legislation regarding business confidentiality . ### where a member state intends to adopt or amend any legislative measure falling within the scope of this directive , it shall give interested parties , including civil society organisations such as patients and consumers groups , the opportunity to comment on the draft measure within a reasonable period . the competent authorities shall publish the rules applicable to consultations . the results of consultations shall be made publicly available , with the exception of confidential information in accordance with union and national legislation regarding business confidentiality .


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


### 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 to determine their coverage by public health insurance systems should be based on transparent , objective and verifiable criteria that are independent from the origin of the product and should provide adequate legal remedies , including judicial remedies , in accordance with national procedures , 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 .


### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states . ### in accordance with directive 2001 / 83 / ec , intellectual property rights do not provide a valid ground to refuse , suspend or revoke a marketing authorisation . by the same token , applications , decision - making procedures and decisions to regulate the prices of medicinal products or to determine their coverage by health insurance systems should be considered administrative procedures which , as such , are independent from the enforcement of intellectual property rights . the national authorities in charge of those procedures , when examining an application with respect to a generic or biosimilar medicinal product , should not request information concerning the patent status of the reference medicinal product and should not examine the validity of an alleged violation of intellectual property rights should the generic or biosimilar medicinal product be manufactured or placed on the market subsequently to their decision . consequently , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states .


### in order to reduce the effects of the disparities on the internal market , national measures should comply with minimum procedural requirements enabling the parties concerned to verify that those measures do not constitute quantitative restrictions on imports or exports or measures having equivalent effect thereto . however , those requirements should not affect the policies of those member states which rely primarily upon free competition to determine the price of medicinal products . they also should not affect national policies on price setting and on the determination of social security schemes , except as far as it is necessary to attain transparency within the meaning of this directive and to ensure the functioning of the internal market . ### in order to reduce the effects of the disparities on the internal market , national measures should comply with minimum procedural requirements enabling the parties concerned to verify that those measures do not constitute quantitative restrictions on imports or exports or measures having equivalent effect thereto . those minimum procedural requirements should also ensure legal certainty and transparency for the competent authorities when adopting decisions relating to the pricing and coverage of medicinal products by national health insurance systems , while promoting the production of medicinal products , accelerating the entry onto the market of generic medicinal products and encouraging research and development of new medicinal products . however , those requirements should not affect the policies of those member states which rely primarily upon free competition to determine the price of medicinal products . they also should not affect national policies on price setting and on the determination of social security schemes , except as far as it is necessary to attain transparency within the meaning of this directive and to ensure the functioning of the internal market .


### member states have frequently amended their health insurance schemes or adopted new measures falling within the scope of directive 89 / 105 / eec . it is therefore necessary to establish information mechanisms intended , on the one hand , to ensure the consultation of interested stakeholders and , on the other hand , to facilitate preventive dialogue with the commission as regards the application of this directive . ### member states have frequently amended their health insurance schemes or adopted new measures falling within the scope of directive 89 / 105 / eec . it is therefore necessary to establish an information mechanism intended to ensure the consultation of all interested stakeholders including civil society organisations .


### 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 .


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


### 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 90 days of receipt of this additional information . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system .


### the commission shall be empowered to adopt delegated acts in accordance with article 27a in order to establish appropriate measures for collecting , storing and analysing this information . ' . ### the commission shall be empowered to adopt delegated acts in accordance with article 27a in order to establish appropriate measures for collecting , storing and analysing this information ; this shall be done in compliance with the data protection requirements as established in european legislation . the information , as well as the results of analyses based on that information , shall be communicated , collected , stored and analysed in an anonymous format . ' .


### 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 . ### with due regard for the general principles of the protection of the health and safety of workers , member states may have national laws , regulation or a procedure for the competent authority to 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 , 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 seafarers working on board ships on short voyages . exceptions shall , as far as possible , take into account the guidance regarding prevention of fatigue laid down in section b - viii / 1 of the stcw code .


### 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 regulations 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 flexibility to member states to invoke other grounds than scientific assessment of health and environmental risks to restrict or prohibit the cultivation of gmos on their territory in order to ease the decision - making process surrounding the issue of gmos in the union . this regulation , on balance , may therefore benefit the internal market . in addition 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 regulations 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 per se , 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 .


### member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos authorised in accordance with part c of this directive or regulation no 1829 / 2003 , and consisting of genetically modified varieties placed on the market in accordance with relevant eu legislation on the marketing of seed and plant propagating material , in all or part of their territory , provided that : ### member states may adopt measures restricting or prohibiting the cultivation of gmos authorised in accordance with part c of this directive or regulation no 1829 / 2003 , and consisting of genetically modified varieties placed on the market in accordance with relevant eu legislation on the marketing of seed and plant propagating material , on a case - by - case basis , in all or part of their territory , provided that :


### in this context , it appears appropriate to grant to member states , in accordance with the principle of subsidiarity , more freedom to decide whether or not they wish to cultivate gmo crops on their territory without changing the system of union authorisations of gmos and independently of the measures that member states are entitled to take by application of article 26a of directive 2001 / 18 / ec to avoid the unintended presence of gmos in other products . ### in this context , it appears appropriate to grant to member states , in accordance with the principle of subsidiarity , more flexibility to decide whether or not they wish to cultivate gmo crops on their territory without changing the system of union authorisations of gmos and in parallel with the measures that member states must take by application of article 26a of directive 2001 / 18 / ec , as amended by this regulation , to avoid the unintended presence of gmos in other products .


### member states should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory , and respectively amend those measures as they deem appropriate , at all stages of the authorisation , re - authorisation or withdrawal from the market of the concerned gmos . this should apply as well to genetically modified varieties of seed and plant propagating material which are placed on the market in accordance with relevant legislation on the marketing of seeds and plant propagating material and , in particular , in accordance with directives 2002 / 53 / ec and 2002 / 55 / ec . measures should refer to the cultivation of gmos only and not to the free circulation and import of genetically modified seeds and plant propagating material , as or in products , and of the products of their harvest . similarly they should not affect the cultivation of non genetically modified varieties of seed and plant propagating material in which adventitious or technically unavoidable traces of eu authorised gmos are found . ### member states should therefore be authorised to adopt measures restricting or prohibiting the cultivation of gmos on a case - by - case basis in all or part of their territory , as long as those measures are adopted and made publicly available to all operators concerned , including growers , at least three months prior to the start of the growing season , and respectively amend those measures as they deem appropriate . this should apply as well to genetically modified varieties of seed and plant propagating material which are placed on the market in accordance with relevant legislation on the marketing of seeds and plant propagating material and , in particular , in accordance with directives 2002 / 53 / ec and 2002 / 55 / ec . measures should refer to the cultivation of gmos only and not to the free circulation and import of genetically modified seeds and plant propagating material , as or in products , and of the products of their harvest . similarly they should not affect the cultivation of non genetically modified varieties of seed and plant propagating material in which adventitious or technically unavoidable traces of eu authorised gmos are found .


### 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 union 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 gmos on a case - by - case basis 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 union 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 , the principle of proportionality 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 . those measures should also ensure that the freedom of choice of farmers and consumers is duly respected . to achieve that goal , appropriate seed thresholds for labelling gmo traces in conventional seeds should be put in place as a matter of priority . the necessity of such measures was also emphasised in the council conclusions of 4 december 2008 on gmos .


### that they are in conformity with the treaties . ### that those measures are in conformity with the treaties and the union ' s international obligations .


### a european database on drug precursors should be created to simplify the reporting by member states with regard to seizures and stopped shipments , to create a european register of operators and users holding a license or a registration which will facilitate verification of the legitimacy of commercial transactions involving scheduled substances , and to enable operators to provide the competent authorities with information about their legal transactions involving scheduled substances . ### a european database on drug precursors should be created to simplify the reporting by member states with regard to seizures and stopped shipments , in the least intrusive way as regards the processing of personal data , taking into account the principle of data limitation and the state of the art of privacy enhancing technologies , to create a european register of operators and users holding a license or a registration which will facilitate verification of the legitimacy of commercial transactions involving scheduled substances , and to enable operators to provide the competent authorities with information about their legal transactions involving scheduled substances .


### each unit packet and any outside packaging of nicotine - containing products below the thresholds set out in paragraph 1 shall carry the following health warning : this product contains nicotine and can damage your health . ### each unit packet and any outside packaging of nicotine - containing products which do not fall under the scope of directive 2001 / 83 / ec shall carry the following health warning : this product contains nicotine which is addictive and may damage your health .


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of cigarettes shall have a cuboid shape and include at least 20 cigarettes . a unit packet of any other tobacco for smoking shall be packaged in a cuboid or cylindrical composite can or have the form of a pouch i . e . rectangular packet with a flap that covers the opening , and shall contain tobacco weighing at least 40g .