### 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 .


### 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 average number of employees , balance sheet total and net turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the management report should only apply to those large undertakings and groups , whose average number of employees exceeds 500 .


### 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 .


### 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 , disclosure requirements under directive 78 / 660 / eec , directive 83 / 349 / eec and directive 2013 / 34 / eu should only apply to certain listed undertakings with total assets of more than eur 20 million or a net turnover of more than eur 40 million and groups ; smes with fewer than 500 employees are permanently exempted .


### 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 bring into line the scope and requirements concerning the extent of the information to ensure a similarly high level in all member states .


### 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 , undertakings should rely , as a general rule , on 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 and the ilo tripartite declaration of principles concerning multinational enterprises and social policy . undertakings may also rely on national frameworks , union - based frameworks such as the eco - management and audit scheme , and international frameworks such as the united nations global compact , the international organisation for standardisation 26000 , the global reporting initiative , the carbon disclosure project and the climate disclosure standards board .


### 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 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 , or on a set of quantifiable , sector - specific social criteria endorsed by the european union under , for example , a ‘ social labelling’ scheme .


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


### 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 78 / 660 / eec and directive 83 / 349 / eec should only apply to certain large listed undertakings ; smes with fewer than 500 employees are permanently exempted .


### 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 , 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 , and anti - corruption , bribery , and tax evasion matters . such a statement should include a description of the policies , results , and the risks related to those matters .


### 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 .


### 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 average number of employees , balance sheet total and net turnover . smes should be exempted from additional requirements , and the obligation to disclose a non - financial statement in the management report should only apply to those large undertakings and groups , whose average number of employees exceeds 500 .


### 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 listed 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 .


### 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 , large companies should include in their annual report a non - financial statement containing information relating to at least 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 , 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 , 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 , anti - discrimination measures , respect for human rights , anti - corruption and bribery matters . this statement should include a description of the policies and results and the precise purpose of social investments , as well as the risks related to those matters , including for the entire supply chain .


### 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 .


### 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 , disclosure requirements under directive 78 / 660 / eec , directive 83 / 349 / eec and directive 2013 / 34 / eu should only apply to certain large undertakings and groups .


### 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 average number of employees , total assets and turnover . micro - enterprises and 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 .


### 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 .


### 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 , undertakings should rely , as a general rule , on 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 and the ilo tripartite declaration of principles concerning multinational enterprises and social policy . undertakings may also rely on national frameworks , union - based frameworks such as the eco - management and audit scheme , and international frameworks such as the united nations global compact , the international organisation for standardisation 26000 , the global reporting initiative , the carbon disclosure project and the climate disclosure standards board .


### 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


### 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 .


### 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 , welcomed the intention of the commission to propose ways of exempting micro - enterprises from certain regulations , 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 .


### in order to alleviate those problems and to speed up the implementation of the operational programmes and projects , as well as to strengthen the economic recovery , it is appropriate that the managing authorities of the member states having experienced serious difficulties with respect to financial stability and which have been granted financial assistance according to one of the financial assistance mechanisms set out above may contribute financial resources from operational programmes to the establishment of risk sharing instruments providing loans or guarantees or other financial facilities , in support of projects and operations foreseen under an operational programme . ### in order to alleviate those problems and to speed up the implementation of the operational programmes and projects , as well as to strengthen the economic recovery , it is appropriate that the managing authorities of all member states may contribute financial resources from operational programmes to the establishment of risk sharing instruments providing loans or guarantees or other financial facilities , in support of projects and operations foreseen under an operational programme . in addition , infrastructure and sme projects relevant to the economic recovery and job creation in the member states concerned can also be supported .


### such risk sharing instrument shall be used exclusively for loans and guarantees , as well as other financial facilities , to finance operations co - financed by the european regional development fund or the cohesion fund , regarding expenditure which is not covered by article 56 . ### such risk sharing instrument shall be used exclusively for loans and guarantees , as well as other financial facilities , to finance operations co - financed by the european regional development fund or the cohesion fund , or infrastructure and sme projects relevant to the economic recovery and job creation in the member states concerned .


### the eit , shall on the basis of key performance indicators and in cooperation with the commission , organise continuous monitoring and periodic external evaluations of the outputs , results and impact of each kic . ### the eit , shall on the basis of key performance indicators and in cooperation with the commission , organise continuous monitoring and periodic external evaluations of the outputs , results and impact of each kic . in order to improve the delivery of the eit outputs , the activities performed by the kics shall have a measurable impact on the creation of sustainable innovative start ups and spin - offs , notably by way of supporting the networking and entrepreneurial activities of the receivers of eit degrees and trainings .


### 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 .


### 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 . studies highlighting the annoyance and health effects from road traffic noise , and the associated costs and benefits should also be heeded . the commission should ensure that regulation no 1222 / 2009 of the european parliament and of the council of 25 november 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters1 is correctly implemented , and in particular tyres are labelled with respect to their noise performance . __________________ 1 oj l 342 , 22 . 12 . 2009 , p . 46 .


### 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 .


### 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 recast substantively 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 .


### 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 .


### 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 .


### 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 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 . 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 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 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 30 days , provided that the reference medicinal product is essentially similar , within the meaning of directive 2001 / 83 / ec of 6 november 2001 , and has already been included in the public health insurance system .


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


### member states have been confronted to a steady rise in pharmaceutical expenditure over the last decades , leading to the adoption of increasingly innovative and complex policies to manage the consumption of medicines in the framework of their public health insurance systems . in particular , member states’ authorities have implemented a broad range of measures to control the prescription of medicines , to regulate their prices or to establish the conditions of their public funding . such measures mainly aim at promoting public health by ensuring the availability of adequate supplies of medicinal products at reasonable costs , while ensuring the financial stability of public health insurance systems . ### member states have been confronted to a steady rise in pharmaceutical expenditure over the last decades , leading to the adoption of increasingly innovative and complex policies to manage the consumption of medicines in the framework of their public health insurance systems . in particular , member states’ authorities have implemented a broad range of measures to control the prescription of medicines , to regulate their prices or to establish the conditions of their public funding . such measures mainly aim at promoting public health by ensuring the availability of adequate supplies of medicinal products at reasonable costs , while ensuring the financial stability of public health insurance systems . these measures should also aim to promote research and development of new medicinal products and to recognise medical innovation .


### 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 what detailed additional information is 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 .


### 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 .


### 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 .


### 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 an application to increase the price of the product can be submitted by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to increase the price of the product can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt within 10 days .


### 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 60 days of the receipt of the application . 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 . 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 .


### 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 . member states may also provide the possibility for marketing authorisation holders to submit such requests once the committee for medicinal products for human use established by regulation no 726 / 2004 or the national competent authority has issued a positive opinion . 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 within 10 days .


### 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 .


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


### 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 or by the applicant once the committee for medicinal products for human use no 726 / 2004 ) or a competent national authority has delivered a favourable opinion . if the public health insurance system comprises several schemes or categories of coverage , the marketing authorisation holder or the applicant 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 .


### 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 .


### measures referred to in paragraph 1 , including any evaluation , expert opinion or recommendation on which they are based , shall be published in an appropriate publication . ### measures referred to in paragraph 1 , including any evaluation , expert opinion or recommendation on which they are based , shall be published in an appropriate publication and made available to public view .


### 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 what detailed additional information is 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 .


### 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 .


### 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 .


### 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 .


### member states shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time . member states may also provide the possibility for marketing authorisation holders to submit such requests once the committee for medicinal products for human use established by regulation no 726 / 2004 or the national competent authority has issued a positive opinion . the competent authorities shall provide the applicant with an official acknowledgement of receipt within 10 days .


### 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 .


### 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 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 30 days , provided that the reference medicinal product is essentially similar , within the meaning of directive 2001 / 83 / ec of 6 november 2001 , and has already been included in the public health insurance system .


### 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 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 .


### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt within 10 days .


### 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 . 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 and that the generic product is essentially similar to the reference product , within the meaning of directive 2001 / 83 / ec of 6 november 2001 .


### 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 individual gmos , particular groups of gmos or all 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 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 :


### 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 harmonise the conditions of cultivation in member states but to grant freedom to member states to restrict or ban cultivation of gmos on their territory because of health and environmental risks or other legitimate factors , such as , for example , on socio - economic grounds . 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 .


### 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 all or particular gmos , on a case - by - case basis , in all or part of their territory , provided the relevant measures are adopted and are made publicly accessible to all operators concerned , including producers , at least six months before the start of the cultivation season , and to 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 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 .


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