### the scope of the eit contribution to the knowledge and innovation communities should be defined and the origins of kics ' financial resources clarified . ### the scope of the eit contribution to the knowledge and innovation communities should be defined and the origins of kics ' financial resources clarified . eit should build greater synergy and as much complementarity as possible with the structural funds .


### the criteria and procedures for the financing , monitoring and evaluation of the activities of the kics should be adopted by the eit prior to launching the kic selection process . ### the criteria and procedures for the financing , monitoring and evaluation of the activities of the kics should be adopted by the eit prior to launching the kic selection process being of utmost importance the implementation of simplification measures .


### manufacturers shall ensure that the noise reduction system is designed , constructed and assembled so as to be able to reasonably resist the corrosive phenomena to which it is exposed having regard to the conditions of use of the vehicle . ### manufacturers shall ensure that the noise reduction system is designed , constructed and assembled so as to be able to reasonably resist the corrosive phenomena to which it is exposed having regard to the conditions of use of the vehicle and to regional climate differences .


### the sound level measured in accordance with the provisions of annex ii shall not exceed the limits set out in annex iii . ### testing conditions set in annex ii should take into account typical on - road driving conditions and testing requirements of other essential components of the vehicle , which have been already regulated by the eu1 . the sound level measured in accordance with the provisions of annex ii shall not exceed the limits set out in annex iii . __________________ 1 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 . oj l200 , 31 . 7 . 2009 , p . 1 .


### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate . on the basis of the conclusions of the study , the commission may , where appropriate , present proposals for amendment to this regulation . ### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate . on the basis of the conclusions of the study , the commission may , where appropriate , present proposals for amendment to this regulation . the results of the study shall be communicated to the european parliament .


### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate . on the basis of the conclusions of the study , the commission may , where appropriate , present proposals for amendment to this regulation . ### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate and whether there have been no detrimental effects on road safety . on the basis of the conclusions of the study , the commission may , where appropriate , present proposals for amendment to this regulation .


### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate . on the basis of the conclusions of the study , the commission may , where appropriate , present proposals for amendment to this regulation . ### within three years following the date referred to in annex iii , third column , phase 1 , to this regulation , the commission shall carry out a detailed study to ascertain whether the noise limits prove to be appropriate . on the basis of the conclusions of the study , the commission may , where justified , present proposals for amendment to this regulation that relate to the noise limits .


### 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 with 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 on equal terms to all eu citizens at reasonable costs , while ensuring the financial stability of public health insurance systems . medicines classed as essential on the who list should be available to patients in all member states , whatever the size of the market .


### 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 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 procedures for reimbursement of generic medicines 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 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 bioequivalent generic medicinal product , should not request information concerning the patent status of the reference medicinal product , but they should be allowed to examine the validity of an alleged violation of intellectual property rights should the bioequivalent generic medicinal product be manufactured or placed on the market subsequently to their decision . that responsibility may not be removed from member states . without prejudice to the responsibility of member states to examine information , intellectual property issues should neither interfere with nor delay pricing and reimbursement procedures in the member states .


### member states shall ensure that any national , regional or local measure , whether laid down by law , regulation or administrative action , to control the prices of medicinal products for human use or to determine the range of medicinal products covered by public health insurance systems , including the extent and conditions of their coverage , complies with the requirements of this directive . ### member states shall ensure that any national , regional or local measure , whether laid down by law , regulation or administrative action , to control the prices of medicinal products for human use or to determine the range of medicinal products covered by public health insurance systems , including the extent and conditions of their coverage , complies with the requirements of this directive . member states shall ensure that these measures are not duplicated at regional or local level in their respective states .


### voluntary contractual agreements concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions ; ### voluntary contractual agreements , subject to verification of elements concerning the efficacy and / or relative efficacy or the proper use of the given medicine , concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions for the agreed period ;


### 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 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 price of the reference medicinal product has been approved by the competent authorities .


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


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 25 days , provided that the price of the reference medicinal product has been approved by the competent authorities . with respect to biosimilar medicinal products , that time limit shall be 60 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 90 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . with respect to generic medicinal products , that time limit shall be 45 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 90 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . with respect to generic medicinal products , that time limit shall be 45 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall consider basing their decision on the price which may be charged for a medicinal produce on a health technology assessment .


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


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


### 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 time limit shall be suspended and 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 90 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to 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 45 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


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


### member states shall establish in detail the particulars and documents to be submitted by the applicant . 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 . ### member states shall establish in detail and publish in an appropriate publication the particulars and documents to be submitted by the applicant . 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 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 . 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 temporary 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 . furthermore , at least once a year , that member state shall carry out a review to ascertain whether the macro - economic conditions justify that the freeze be continued unchanged .


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


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


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 25 days , provided that the reference medicinal product has already been included in the public health insurance system . with respect to biosimilar medicinal products , that time limit shall be 60 days , provided that the reference medicinal product has already been included in the public health insurance system .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 90 days of its receipt . with respect to generic medicinal products , that time limit shall be 45 days , provided that the reference medicinal product has already been included in the public health insurance system .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 90 days of its receipt . with respect to generic medicinal products , that time limit shall be 45 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall consider basing their decision on an application to include a medicinal product in the scope of the national health insurance system on a health technology assessment .


### 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 .


### 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 50 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 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 the medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall likewise 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 .


### 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 .


### paragraphs 2 , 3 and 4 shall apply where a member state adopts measures intended to control or promote the prescription of specific named medicinal products . ### paragraphs 2 , 3 and 4 shall apply where a member state adopts measures intended to control or promote the prescription of specific named medicinal products or of a category of medicinal products .


### the commission may send its observations to the member state which has communicated the draft measure within three months . ### the commission may send its observations to the member state which has communicated the draft measure within two months .


### where member states intend to adopt or amend any measure falling within the scope of this directive , they shall immediately communicate to the commission the draft measure envisaged , together with the reasoning on which the measure is based . ### where member states intend to adopt or amend any measure falling within the scope of this directive , they should communicate to the commission the draft measure envisaged , together with the reasoning on which the measure is based .


### where appropriate , member states shall simultaneously communicate the texts of the basic legislative or regulatory provisions principally and directly concerned , if knowledge of such texts is necessary to assess the implications of the measure proposed . ### where appropriate , member states should simultaneously communicate the texts of the basic legislative or regulatory provisions principally and directly concerned , if knowledge of such texts is necessary to assess the implications of the measure proposed .


### the commission may send its observations to the member state which has communicated the draft measure within three months . ### the commission may send its observations to the member state which has communicated the draft measure before the definitive adoption by the member state .


### when the member state concerned definitively adopts the draft measure , it shall communicate the final text to the commission without delay . if observations have been made by the commission in accordance with paragraph 4 , this communication shall be accompanied by a report on the actions taken in response to the observations of the commission . ### when the member state concerned definitively adopts the draft measure , it shall communicate the final text to the commission without delay , which shall publish it in the form of a public on - line database .


### experience has shown that cultivation of gmos is an issue which is more thoroughly addressed by member states , either at central or at regional and local level . contrary to issues related to the placing on the market and the import of gmos , which should remain regulated at eu level to preserve the internal market , cultivation has been acknowledged as an issue with a strong local / regional dimension . in accordance with article 2 tfeu member states should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of gmos in their territory after the gmo has been legally authorised to be placed on the eu market . ### experience has shown that cultivation of gmos is an issue which is more thoroughly addressed by member states , either at central or at regional and local level . contrary to issues related to the placing on the market and the import of gmos , which should remain regulated at eu level to preserve the internal market , cultivation has been acknowledged as an issue with a strong local / regional / territorial dimension and as of particular importance for the self - determination of member states . in accordance with article 2 tfeu member states should therefore be entitled to have a possibility to adopt binding legislative provisions concerning the effective cultivation of gmos in their territory after the gmo has been legally authorised to be placed on the eu market .


### according to the legal framework for the authorisation of gmos , the level of protection of human / animal health and of the environment chosen in the eu cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of eu rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . those measures should furthermore be in conformity with the treaties , in particular as regards the principle of non discrimination between national and non national products and articles 34 and 36 of the treaty on the functioning of the european union , as well as with the relevant international obligations of the union , notably in the context of the world trade organisation . ### according to the legal framework for the authorisation of gmos , the level of protection of human / animal health and of the environment chosen in the eu cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of grounds relating to the public interest complementary to or other than those which have already been the subject of an assessment pursuant to the harmonised eu rules . the reasons that may be cited by the member states include complementary environmental effects other than those already covered by the risk assessment provided for in part c of directive 2001 / 18 / ec , such as the evaluation of scientific data in relation to the environmental impact at national , regional or local level , or reasons related to risk management . these reasons may include agronomic justifications related to specific geographical features , the diversification of agricultural structures and the specific nature of farming practices , as well as socio - economic considerations such as the feasibility and cost of measures to ensure separation , prevent contamination and carry out checks on seeds , or to protect quality agricultural products , as well as consumer habits . those measures should furthermore be in conformity with the treaties , in particular as regards the principle of non discrimination between national and non national products and articles 34 and 36 of the treaty on the functioning of the european union , as well as with the relevant international obligations of the union , notably in the context of the world trade organisation .


### according to the legal framework for the authorisation of gmos , the level of protection of human / animal health and of the environment chosen in the eu cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of eu rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . those measures should furthermore be in conformity with the treaties , in particular as regards the principle of non discrimination between national and non national products and articles 34 and 36 of the treaty on the functioning of the european union , as well as with the relevant international obligations of the union , notably in the context of the world trade organisation . ### according to the legal framework for the authorisation of gmos , the level of protection of human / animal health and of the environment chosen in the eu cannot be revised by a member state and this situation must not be altered . however member states may adopt measures restricting or prohibiting the cultivation of all or particular gmos in all or part of their territory on the basis of properly substantiated grounds relating to the public interest other than those already addressed by the harmonised set of eu rules which already provide for procedures to take into account the risks that a gmo for cultivation may pose on health and the environment . those measures should furthermore be in conformity with the treaties , in particular as regards the principle of non discrimination between national and non national products and articles 34 and 36 of the treaty on the functioning of the european union , as well as with the relevant international obligations of the union , notably in the context of the world trade organisation .


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


### on the basis of the subsidiarity principle , the purpose of this regulation is not to harmonize the conditions of cultivation in member states but to grant freedom to member states to 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 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 their territory , provided that :


### 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 limiting 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 :


### that they are in conformity with the treaties . ### that those measures are in conformity with the treaties , in particular with the principle of proportionality and the union ' s international obligations .


### ' user ' means any natural or legal person who possesses a scheduled substance and is engaged in the processing , formulation , consumption , storage , keeping , treatment , filling into containers , transfer from one container to another , mixing , transformation or any other utilisation of scheduled substances . ' user ' means any natural or legal person who possesses a scheduled substance and is engaged in the processing , formulation , consumption , storage , keeping , treatment , filling into containers , transfer from one container to another , mixing , transformation or any other utilisation of scheduled substances . ' ### ' user ' means any natural or legal person who is not an operator and who possesses a scheduled substance and is engaged in the processing , formulation , consumption , storage , keeping , treatment , filling into containers , transfer from one container to another , mixing , transformation or any other utilisation of scheduled substances .


### the commission shall develop a european database on drug precursors with the following functions : the commission shall develop a european database on drug precursors with the following functions : ### in accordance with the delegated acts referred to in article 3 , the commission shall establish a european database on drug precursors with the following functions :


### this regulation shall enter into force on the twentieth day following that of its publication in the official journal of the european union . this regulation shall be binding in its entirety and directly applicable in all member states . ### this regulation shall enter into force on the twentieth day following that of its publication in the official journal of the european union . it shall be consolidated with the regulation it is amending within one month of its entry into force . this regulation shall be binding in its entirety and directly applicable in all member states .


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


### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ‘ low - tar’ , ‘ light’ , ‘ ultra - light’ , ‘ mild’ , ‘ natural’ , ‘ organic’ , ‘ without additives’ , ‘ without flavours’ , ‘ slim’ , names , pictures , and figurative or other signs . likewise , the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful . a recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful . this should be addressed . ### in order to ensure the integrity and the visibility of health warnings and maximise their efficacy , provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package , including the opening mechanism . the package and the products may mislead consumers , in particular young people , suggesting that products are less harmful . for instance , this is the case with certain texts or features , such as ' low - tar ' , ' light ' , ' ultra - light ' , ' mild ' , ' natural ' or ' organic ' .


### considerable volumes of illicit products , which do not comply with the requirements laid down in directive 2001 / 37 / ec , are placed on the market and indications are that these volumes might increase . such products undermine the free circulation of compliant products and the protection provided for by tobacco control legislations . in addition , the fctc obliges the union to fight against illicit products , as part of a comprehensive tobacco control policy . provision should thus be made for unit packets of tobacco products to be marked in a unique and secure way and their movements to be recorded so that these products can be tracked and traced in the union and their compliance with this directive can be monitored and better enforced . in addition , provision should be made for the introduction of security features that will facilitate the verification of whether or not products are authentic . ### considerable volumes of illicit products , which do not comply with the requirements laid down in directive 2001 / 37 / ec , are placed on the market and indications are that these volumes might increase . such products undermine the free circulation of compliant products and the protection provided for by tobacco control legislations . in addition , the fctc obliges the union to fight against illicit products , as part of a comprehensive tobacco control policy . provision should thus be made for unit packets of tobacco products to be marked in a unique and secure way and their movements to be recorded so that these products can be tracked and traced in the union and their compliance with this directive can be monitored and better enforced .


### an interoperable tracking and tracing system and a common security feature should be developed . for an initial period only cigarettes and roll - your - own tobacco should be subjected to the tracking and tracing system and the security features . this would allow producers of other tobacco products to benefit from the experiences gained in the meantime . ### an interoperable tracking and tracing system should be developed . for an initial period only cigarettes and roll - your - own tobacco should be subjected to the tracking and tracing system . this would allow producers of other tobacco products to benefit from the experiences gained in the meantime .


### member states should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this directive , provided they are compatible with the treaty and do not jeopardise the full application of this directive . accordingly , member states could , for instance , maintain or introduce provisions providing standardisation of packaging of tobacco products provided that those provisions are compatible with the treaty , with wto obligations and do not affect the full application of this directive . a prior notification is required for technical regulations pursuant to 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 and on rules on information society services . ### member states should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this directive , provided they are compatible with the treaty and do not jeopardise the full application of this directive . with regard to measures already harmonized by this directive , such as labelling und packaging requirements , the procedure foreseen in article 114 tfeu shall apply .


### ‘ characterising flavour’ means a distinguishable aroma or taste other than tobacco , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy , menthol or vanilla observable before or upon intended use of the tobacco product ; ### ' characterising flavour ' means a distinguishable aroma or taste other than tobacco and traditional flavours such as menthol , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy or vanilla observable before or upon intended use of the tobacco product ;


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


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


### tobacco products other than cigarettes , roll - your - own tobacco and smokeless tobacco products shall be exempted from the prohibitions laid down in paragraphs 1 and 5 . the commission shall be empowered to adopt delegated acts in accordance with article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a commission report . ### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the prohibitions laid down in paragraphs 1 and 5 .


### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . these warnings shall have a width of not less than 20 mm and a height of not less than 43 mm . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 50% of the surface on which they are printed . ### for cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets . for roll - your - own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet . both the general warning and the information message shall cover 50% of the surface on which they are printed .


### be positioned at the top edge of the unit packet and any outside packaging , and in the same direction as any other information appearing on the packaging ; ### be positioned in the same direction as any other information appearing on the packaging ;


### the product name ; ### the product description ;


### the invoice , order number and payment records of all purchasers from manufacturing to the first retail outlet . ### the invoice , order number and payment records of the first customer who is not affiliated with the manufacturer .


### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , record the entry of all unit packets into their possession , as well as all intermediate movements and the final exit from their possession . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible . ### member states shall ensure that all economic operators involved in the trade of tobacco products from the manufacturer to the first client , record the entry of all unit packets into their possession , as well as all intermediate movements and the final exit from their possession . this obligation can be fulfilled by recording in aggregated form , e . g . of outside packaging , provided that tracking and tracing of unit packets remains possible .


### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the last economic operator before the first retail outlet , including importers , warehouses and transporting companies with the necessary equipment allowing for the recording of the tobacco products purchased , sold , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6 . ### member states shall ensure that manufacturers of tobacco products provide all economic operators involved in the trade of tobacco products from the manufacturer to the first customer who is not affiliated with the with the necessary equipment allowing for the recording of the tobacco products purchased , sold to the first customer who is not affiliated with the manufacturer , stored , transported or otherwise handled . the equipment shall be able to read and transmit the data electronically to a data storage facility pursuant to paragraph 6 .


### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations . ### member states shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party , which shall host the data storage facility for data relating to the manufacturer and importer concerned . the data storage facility shall be physically located and accessible on the territory of the union . the suitability of the third party , in particular its independence and technical capacities , as well as the contract , shall be approved and monitored by an external auditor , who is proposed and paid by the tobacco manufacturer and approved by the commission . member states shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the member states , the commission and the independent third party on a permanent basis . in duly justified cases member states or the commission can provide manufacturers or importers access to this information , provided commercially sensitive information remains adequately protected in conformity with the relevant national and union legislations .


### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 5 years following the date referred to in paragraph 1 of article 25 . ### tobacco products other than cigarettes and roll - your - own tobacco shall be exempted from the application of paragraph 1 to 8 during a period of 10 years following the date referred to in paragraph 1 of article 25 .


### novel tobacco products placed on the market shall respect the requirements set out in this directive . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 . ### novel tobacco products placed on the market shall respect the requirements set out in this directive . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 . nonetheless , novel tobacco products which , based on the information provided in accordance with this article , are less harmful than cigarettes are exempted from the provision of the article 12 paragraph 1 letter .


### novel tobacco products placed on the market shall respect the requirements set out in this directive . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 . ### novel tobacco products placed on the market shall respect the requirements set out in this directive , unless otherwise authorised as provided for in paragraph 2 of this article . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 .


### the power to adopt delegated acts referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] . ### the power to adopt delegated acts referred to in articles 4 , 4 , 8 , 9 , 11 and 14 shall be conferred on the commission for an indeterminate period of time from [ office of publications : please insert the date of the entry into force of this directive ] .


### the delegation of powers referred to in articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of powers referred to in articles 4 , 4 , 8 , 9 , 11 and 14 may be revoked at any time by the european parliament or by the council . a decision to revoke shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### a delegated act pursuant to articles 3 , 3 , 4 , 4 , 6 , 6 , 6 , 8 , 9 , 10 , 11 , 13 , 13 , 14 , 18 and 18 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council . ### a delegated act pursuant to articles 4 , 4 , 8 , 9 , 11 and 14 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by two months at the initiative of the european parliament or of the council .


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


### wholesale energy markets encompass both commodity markets and derivative markets , with price formation in both sectors interlinked . ### wholesale energy markets encompass both commodity markets and derivative markets , with price formation in both sectors interlinked . they include inter alia both regulated and non - regulated markets and over the counter transactions .


### wholesale energy markets encompass both commodity markets and derivative markets , with price formation in both sectors interlinked . ### wholesale energy markets encompass both commodity markets and derivative markets , with price formation in both sectors interlinked . they include both regulated and non - regulated markets and over the counter transactions .


### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public . such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets . ### where information is not commercially sensitive , the agency should be able to make that information available to market participants and the wider public . such transparency can help build confidence in the market and help the development of knowledge about the functioning of wholesale energy markets . to ensure greater transparency and public access to information on wholesale energy prices the agency should prepare monthly country by country report on price developments in energy wholesale markets .


### it is important that the penalties for breaches of this regulation are proportionate and dissuasive , and reflect the gravity of the infringements and the potential gains from trading on the basis of inside information and market manipulation . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec . ### it is important that the penalties for breaches of this regulation are proportionate and dissuasive , and reflect the gravity of the infringements , the potential gains from trading on the basis of inside information and market manipulation and the damage caused to consumers . recognising the interactions between trading in electricity and gas derivative products and trading in actual electricity and gas , the penalties for breaches of this regulation should be in line with the penalties adopted by the member states in implementing directive 2003 / 6 / ec .


### ' inside information ' means precise information which has not been made public , relating directly or indirectly to one or more wholesale energy products and which , if it were made public , could significantly affect the prices of such wholesale energy products ; ### ' inside information ' means precise information which has not been made public , relating directly or indirectly to one or more wholesale energy products and which , if it were made public , would be likely to have a significant affect on the prices of such wholesale energy products ;


### ' wholesale energy market ' means any marketplace within the union on which wholesale energy products are traded ; ### ' wholesale energy market ' means any market , both regulated and non - regulated and over the counter transactions , within the union on which wholesale energy products are traded ;


### market participants shall publicly disclose inside information in respect of business or facilities which the participant concerned owns or controls or for which the participant is responsible for operational matters , either in whole or in part . such information shall include information relevant to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas . ### in relation to paragraph 1 , market participants shall publicly disclose inside information in respect of business or facilities which the participant concerned owns or controls or for which the participant is responsible for operational matters , either in whole or in part . such information shall include information relevant to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas .


### in order to take account of future developments on wholesale energy markets , the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 an 17 , specifying the definitions set out at article 2 to . ### in order to take account of future developments on wholesale energy markets and to ensure uniform application of this regulation in the union , the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 , specifying the definitions set out at article 2 to .


### the agency shall at least on an annual basis submit a report to the commission on its activities under this regulation . such reports shall bring to the notice of the commission flaws in market rules , standards , and procedures which could facilitate insider trading and market manipulation or undermine the internal market . reports may be combined with the report referred to in article 11 of regulation no 713 / 2009 . ### the agency shall at least on an annual basis submit a report to the commission and to the european parliament on its activities under this regulation . such reports shall bring to the notice of the commission flaws in market rules , standards , and procedures which could facilitate insider trading and market manipulation or undermine the internal market . reports may be combined with the report referred to in article 11 of regulation no 713 / 2009 .


### the agency may make recommendations as to the records of transactions , including orders to trade , which it considers are necessary to effectively and efficiently monitor wholesale energy markets . before making such recommendations the agency shall consult with interested parties in accordance with the provisions of article 10 of the regulation no 713 / 2009 . in particular the agency shall consult with esma , national regulatory authorities and competent financial authorities in the member states . ### the agency may make recommendations as to the records of transactions , including orders to trade and transactions of bilateral trading , which it considers are necessary to effectively and efficiently monitor wholesale energy markets . before making such recommendations the agency shall consult with interested parties in accordance with the provisions of article 10 of the regulation no 713 / 2009 . in particular the agency shall consult with esma , national regulatory authorities and competent financial authorities in the member states .


### the agency may make recommendations as to the records of transactions , including orders to trade , which it considers are necessary to effectively and efficiently monitor wholesale energy markets . before making such recommendations the agency shall consult with interested parties in accordance with the provisions of article 10 of the regulation no 713 / 2009 . in particular the agency shall consult with esma , national regulatory authorities and competent financial authorities in the member states . ### the agency may make recommendations as to the records of all direct bilateral trading and of transactions , including orders to trade , which it considers are necessary to effectively and efficiently monitor wholesale energy markets . before making such recommendations the agency shall consult with interested parties in accordance with the provisions of article 10 of the regulation no 713 / 2009 . in particular the agency shall consult with esma , national regulatory authorities and competent financial authorities in the member states .


### the agency shall be provided with a record of wholesale energy market transactions , including orders to trade . the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 , laying down the timing , form and content in which this information is reported and , where appropriate , defining thresholds for the reporting of transactions as well as specifying types of contracts for which transactions shall be reported . ### the agency shall be provided with a record of wholesale energy market transactions , including orders to trade . the commission shall adopt delegated acts in accordance with article 15 and subject to conditions of articles 16 and 17 , laying down the timing , form and content in which this information is reported and defining thresholds for the reporting of transactions as well as specifying types of contracts for which transactions shall be reported .


### the delegated acts referred to in paragraph 1 shall ensure that persons referred to in paragraph 3 a ) , b ) and c ) who have reported transactions in accordance with directive 2004 / 39 / ec or regulation - - - / - - - - of the european parliament and of the council on otc derivatives , central counterparties and trade repositories of the european parliament and of the council [ european market infrastructure regulation – 2010 / 0250 ] are not subject to reporting obligations in addition to those set out in that legislation . ### the delegated acts referred to in paragraph 1 shall ensure that persons referred to in paragraph 3 a ) , b ) and c ) who have reported transactions in accordance with directive 2004 / 39 / ec or regulation - - - / - - - - of the european parliament and of the council on otc derivatives , central counterparties and trade repositories of the european parliament and of the council [ european market infrastructure regulation – 2010 / 0250 ] are not subject to reporting obligations in addition to those set out in that legislation , provided that the reporting obligations of this regulation are fulfilled .


### the agency shall establish mechanisms to share information it receives in accordance with article 6 and article 7 with national regulatory authorities , the competent financial authorities of the member states , competition authorities of the member states and other relevant authorities . the agency shall only give access to the mechanisms referred to in paragraph 1 to bodies which have set up systems enabling the agency to meet the requirements of article 9 . ### the agency shall establish mechanisms to share information it receives in accordance with article 6 and article 7 with national regulatory authorities , the competent financial authorities of the member states , competition authorities of the member states , esma and other relevant authorities . the agency shall only give access to the mechanisms referred to in paragraph 1 to bodies which have set up systems enabling the agency to meet the requirements of article 9 .


### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the damage caused to consumers shall be taken into account when determining the penalties . the member states shall notify those provisions to the commission by . . . at the latest and shall notify it without delay of any subsequent amendment affecting them .


### the european parliament and the council may object to the delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by one month . ### the european parliament and the council may object to the delegated act within a period of two months from the date of notification . at the initiative of the european parliament or the council this period shall be extended by two months .


### one of the objectives of this regulation is to remove existing barriers to the cross - border use of electronic identification means used in the member states to access at least public services . this regulation does not aim at intervening on electronic identity management systems and related infrastructures established in the member states . the aim of this regulation is to ensure that for the access to cross - border online services offered by the member states , secure electronic identification and authentication is possible . ### one of the objectives of this regulation is to remove existing barriers to the cross - border use of electronic identification means used in the member states to access at least public services . this regulation does not aim at intervening on electronic identity management systems and related infrastructures established in the member states . rather , it aims to introduce different security levels to guarantee a minimum common set of security requirements . the aim of this regulation is to ensure that for the access to cross - border online services offered by the member states , secure electronic identification and authentication is possible , with full respect to technology neutrality .


### member states should remain free to use or introduce means , for electronic identification purposes , for accessing online services . they should also be able to decide whether to involve the private sector in the provision of these means . member states should not be obliged to notify their electronic identification schemes . the choice to either notify all , some or none of the electronic identification schemes used at national level to access at least public online services or specific services is up to the member states . ### member states should remain free to use or introduce means , for electronic authentication or identification purposes , for accessing online services . they should also be able to decide whether to involve the private sector in the provision of these means . member states should not be obliged to notify their electronic identification schemes . the choice to either notify all , some or none of the electronic identification schemes used at national level to access at least public online services or specific services is up to the member states .


### some conditions need to be set in the regulation with regard to which electronic identification means have to be accepted and how the schemes should be notified . these should help member states to build the necessary trust in each other ' s electronic identification schemes and to mutually recognise and accept electronic identification means falling under their notified schemes . the principle of mutual recognition and acceptance should apply if the notifying member state meets the conditions of notification and the notification was published in the official journal of the european union . however , the access to these online services and their final delivery to the applicant should be closely linked to the right to receive such services under the conditions set by national legislation . ### some conditions need to be set in the regulation with regard to which electronic identification means have to be accepted and how the schemes should be notified . these should help member states to build the necessary trust in each other ' s electronic identification schemes and to mutually recognise and accept electronic identification means falling under their notified schemes . the principle of mutual recognition and acceptance should apply if the notifying member state meets the conditions of notification and the notification , including the description of the notified electronic identification scheme and the information on the different security levels , was published in the official journal of the european union . however , the access to these online services and their final delivery to the applicant should be closely linked to the right to receive such services under the conditions set by national legislation .


### some conditions need to be set in the regulation with regard to which electronic identification means have to be accepted and how the schemes should be notified . these should help member states to build the necessary trust in each other ' s electronic identification schemes and to mutually recognise and accept electronic identification means falling under their notified schemes . the principle of mutual recognition and acceptance should apply if the notifying member state meets the conditions of notification and the notification was published in the official journal of the european union . however , the access to these online services and their final delivery to the applicant should be closely linked to the right to receive such services under the conditions set by national legislation . ### some conditions need to be set in the regulation with regard to which electronic authentication or identification means have to be accepted and how the schemes should be notified . these should help member states to build the necessary trust in each other ' s electronic identification schemes and to mutually recognise and accept electronic identification means falling under their notified schemes . the principle of mutual recognition and acceptance should apply if the notifying member state meets the conditions of notification and the notification was published in the official journal of the european union . however , the access to these online services and their final delivery to the applicant should be closely linked to the right to receive such services under the conditions set by national legislation .