### when establishing maritime spatial plans and integrated coastal management strategies , member states shall give due regard to the particularities of the regions and the sub - regions , the respective sector activities , the marine waters and coastal zones concerned and potential climate change impacts . ### when establishing maritime spatial plans and integrated coastal management strategies , member states shall give due regard to the particularities , needs and opportunities of the regions and the sub - regions , the respective sector activities , the marine waters and coastal zones concerned and climate change impacts .


### integrated coastal management strategies shall contain at least , an inventory of existing measures applied in coastal zones and an analysis of the need for additional actions in order to achieve the objectives set out in article 5 . the strategies shall provide for integrated and cross - sectoral policy implementation and consider interactions between terrestrial and maritime activities . ### if a member state does not address land - sea interactions via maritime spatial planning , integrated coastal management shall be established either in the form of a set of practices or by establishing one or more strategies . member states shall identify existing measures applied in coastal zones and draw up an analysis of the need for additional actions in order to achieve the objectives set out in article 5 . integrated coastal management shall enhance integrated and cross - sectoral policy implementation and consider interactions between terrestrial and maritime activities to ensure land - sea connectivity .


### ‘ integrated maritime policy’ means the union policy with the aim to foster coordinated and coherent decision - making to maximise the sustainable development , economic growth and social cohesion of member states , in particular with regard to coastal , insular and outermost regions in the union , as well as maritime sectors , through coherent maritime - related policies and relevant international cooperation . ### ' integrated maritime policy ' means the union policy established to foster a coordinated and coherent cross - sectoral and trans - boundary maritime governance designed to maximise the sustainable development , economic growth and social cohesion of member states , in particular with regard to coastal , insular and outermost regions in the union .


### the main purpose of maritime spatial planning is to identify and manage spatial uses and conflicts in maritime areas . in order to achieve that purpose , member states need at least to ensure that the planning process or processes result in a comprehensive map identifying the different uses of maritime space , taking into consideration long term changes due to climate change . ### the main purposes of maritime spatial planning are to identify and manage spatial uses , to minimise cross - sectoral conflicts in maritime areas and to enhance sustainable growth in the maritime sector . in order to achieve those purposes , member states need at least to ensure that the planning process or processes result in a comprehensive map identifying the different uses of maritime space , taking into consideration long term changes due to climate change .


### in order to ensure consistency and legal clarity , the geographical scope for maritime spatial planning and integrated coastal management strategies should be defined in conformity with existing legislative instruments of the union and international maritime law . ### in order to ensure consistency and legal clarity , the geographical scope for maritime spatial planning and integrated coastal management strategies should be defined in conformity with existing legislative instruments of the union , the united nations convention on the law of the sea and international maritime law .


### maritime spatial plans and integrated coastal management strategies shall apply an ecosystem - based approach to facilitate the co - existence and prevent conflicts between competing sector activities in marine waters and coastal zones , and shall aim to contribute to : ### maritime spatial plans and integrated coastal management strategies shall facilitate the co - existence and prevent conflicts between competing sector activities in marine waters and coastal zones . in that connection , the ecosystem - based approach pursuant to article 1 of directive 2008 / 56 / ec shall be employed , on the same basis as economic and social criteria , as the environmental pillar of sustainable development . maritime spatial plans and integrated coastal management shall aim to contribute to :


### the pharmacovigilance risk assessment advisory committee shall be composed of the following : ten members and ten alternates appointed by the management board , on the basis of proposals by the national competent authorities ; five members and five alternates appointed by the commission , on the basis of a public call for expressions of interest , after consulting the european parliament . the alternates shall represent and vote for the members in their absence . the commission may adapt the number of members and alternates in the light of technical and scientific needs . those measures , designed to amend non - essential elements of this regulation , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 87 . ### the pharmacovigilance risk assessment committee shall be composed of the following : one member and one alternate per member state , appointed by the national competent authority in consultation with the management board ; seven additional members and five alternates appointed by the commission , including at least one healthcare professional representative , and at least one patient representative , on the basis of a public call for expressions of interest , after consulting the european parliament . a member state may request another member state to take its place in the committee . the alternates shall represent and vote for the members in their absence .


### where a medicinal product is authorized subject to the requirement to conduct a post - authorisation safety study or subject to conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be intensively monitored on the market . patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products , and a publicly available list of such medicinal products should be kept up to date by the agency . ### where a medicinal product is authorized subject to the requirement to conduct a post - authorisation safety study or subject to conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be intensively monitored on the market . patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products , identified by a black triangle and a corresponding explanatory sentence on the summary of product characteristics , and on the patient information leaflet , and a publicly available list of such medicinal products should be kept up to date by the agency .


### the opinions and decisions referred to in paragraphs 3 to 5 of this article shall be made public by means of the european medicines safety web - portal referred to in article 26 . ### the final opinions and final decisions referred to in paragraphs 3 to 5 of this article shall be made public by means of the european medicines safety web - portal referred to in article 26 .


### in order to allow all competent authorities to receive and access , at the same time , pharmacovigilance information for medicinal products for human use authorised in the community , and share it , the eudravigilance database should be maintained and strengthened as the single point of receipt of such information . member states should therefore not impose on marketing authorisation holders any additional reporting requirements . the database should be fully accessible to the member states , the agency and the commission , and accessible to an appropriate extent to marketing authorisation holders and the public . ### in order to allow all competent authorities to receive and access , at the same time , pharmacovigilance information for medicinal products for human use authorised in the community , and share it , the eudravigilance database should be maintained and strengthened as the single point of receipt of such information . member states should therefore not impose on marketing authorisation holders any additional reporting requirements . instead , the eudravigilance database should simultaneously notify the relevant member states of reports submitted by market authorisation holders . in order to ensure the high quality of information , member states should support the development of the expertise of national and regional pharmacovigilance centres . national competent authorities should collect the reports from those centres and should then transfer data to the eudravigilance database . the database should be fully accessible to the member states , the agency and the commission , and accessible to an appropriate extent to marketing authorisation holders and the public .


### the agency , in collaboration with the member states , shall develop standard web - based structured forms for the reporting of suspected adverse reactions by health - care professionals and patients . ### the agency , in collaboration with the member states and all relevant stakeholders , shall develop standard structured forms and procedures , including web - based forms , for the reporting of suspected adverse reactions by health - care professionals and patients . to ensure the traceability of biological medicinal products prescribed , dispensed or sold in the territory of the union the standard forms and procedures shall include the name of the mah , the inn , the name of the medicinal product as defined in article 1 and the batch number .


### the pharmacovigilance risk assessment advisory committee shall be composed of the following : ten members and ten alternates appointed by the management board , on the basis of proposals by the national competent authorities ; five members and five alternates appointed by the commission , on the basis of a public call for expressions of interest , after consulting the european parliament . the alternates shall represent and vote for the members in their absence . the commission may adapt the number of members and alternates in the light of technical and scientific needs . those measures , designed to amend non - essential elements of this regulation , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 87 . ### the pharmacovigilance risk assessment committee shall be composed of the following : one member and one alternate for each member state , appointed by the competent national authority in agreement with the management board ; seven members and seven alternates appointed by the commission , among whom one should represent health professionals and one should represent patients , on the basis of a public call for expressions of interest , after consulting the european parliament . the alternates shall represent and vote for the members in their absence .


### where a medicinal product is authorized subject to the requirement to conduct a post - authorisation safety study or subject to conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be intensively monitored on the market . patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products , and a publicly available list of such medicinal products should be kept up to date by the agency . ### for any newly authorised medicinal product on the market for less than 3 years or where a medicinal product is authorized subject to the requirement to conduct a post - authorisation safety study or subject to conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be intensively monitored on the market . patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products , identified by a black triangle ▼and a corresponding explanatory sentence on the summary of product characteristics , on the outer packaging and on the patient information leaflet , and a publicly available list of such medicinal products should be kept up to date by the agency .


### in order to allow all competent authorities to receive and access , at the same time , pharmacovigilance information for medicinal products for human use authorised in the community , and share it , the eudravigilance database should be maintained and strengthened as the single point of receipt of such information . member states should therefore not impose on marketing authorisation holders any additional reporting requirements . instead , the eudravigilance database should simultaneously notify the relevant member states of reports submitted by market authorisation holders . the database should be fully accessible to the member states , the agency and the commission , and accessible to an appropriate extent to marketing authorisation holders and the public . ### in order to allow all competent authorities to receive and access , at the same time , pharmacovigilance information for medicinal products for human use authorised in the union , and share it , the eudravigilance database should be maintained and strengthened as the single point of receipt of such information . member states should therefore not impose on marketing authorisation holders any additional reporting requirements . instead , the eudravigilance database should simultaneously notify the relevant member states of reports submitted by market authorisation holders . in order to ensure the high quality of information , member states should support the development of national and regional pharmacovigilance centres ' expertise . national competent authorities should collect the reports from these centres and should then transfer data to eudravigilance database . the database should be fully accessible to the member states , the agency and the commission , and accessible to an appropriate extent to marketing authorisation holders and the public .


### on the basis of explanations submitted by the marketing authorisation holder , the commission shall withdraw or confirm the requirement . where the commission confirms the requirement , the marketing authorisation shall be varied to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly . ### on the basis of explanations submitted by the marketing authorisation holder , the commission shall withdraw or confirm the requirement . where the commission confirms the requirement , the marketing authorisation shall be varied to include the requirement as a condition of the marketing authorisation and the risk management system shall be updated accordingly . irrespective of whether the requirement is confirmed or withdrawn , the commission must state the grounds for its decision in detail , and the decision shall be duly recorded .


### in order to further ensure that marketing authorisation holders disseminate only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be disseminated should be defined . it is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements , and other well - defined medicinal product - related information . ### in order to further ensure that marketing authorisation holders make available only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be made available should be defined . it is appropriate to allow marketing authorisation holders to make available the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements , and other well - defined medicinal product - related information .


### the member state where the internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website . ### the member state where the internet website has been registered shall be responsible for the monitoring of the contents relating to medicinal products subject to medical prescription made available on that website .


### in the area of information , directive 2001 / 83 / ec lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes : the summary of product characteristics and the package leaflet . on the other hand , as regards the dissemination of information from the marketing authorisation holder to the general public , the directive only provides that certain information activities are not covered by the rules on advertising , without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated . ### in the area of information , directive 2001 / 83 / ec lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes : the summary of product characteristics and the package leaflet . on the other hand , as regards the making available of information from the marketing authorisation holder to patients and the general public , the directive only provides that certain information activities are not covered by the rules on advertising , without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be made available .


### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring . ### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its supply . only such information that has been approved in advance by the competent authorities should be provided , and it should be provided in the approved form only .


### information to the general public on prescription - only medicinal products should only be provided through specific channels of communication , including internet and health - related publications , to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public . where information is disseminated via television or radio , patients are not protected against such unsolicited information and such dissemination should therefore not be allowed . ### information to the general public on prescription - only medicinal products should only be made available by the marketing authorisation holder through specific channels of communication to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public . where information is made available by the marketing authorisation holder via television , radio , or newspapers , magazines and similar publications , patients are not protected against such unsolicited information and such making available of information should therefore not be allowed .


### internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof . those websites shall not contain web - tv . ### internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites without their explicit prior consent , or the appearance therein of unsolicited content distributed to the general public or members thereof . internet websites may provide video content if it is useful for the safe and effective use of the medicine .


### in accordance with the principle of proportionality , it is appropriate to limit the scope of this directive to prescription - only medicinal products , as current community rules allow the advertising to the general public of medicinal products not subject to prescription , under certain conditions . ### in accordance with the principle of proportionality , it is appropriate to limit the scope of this directive to the supply of information on prescription - only medicinal products that has been approved by the competent authorities by the marketing authorisation holder , as current community rules allow the advertising to the general public of medicinal products not subject to prescription , under certain conditions .


### after consulting the member states , the commission shall draw up guidelines concerning information allowed under this title and containing a code of conduct for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescription . the commission shall draw up these guidelines on the entry into force of this directive and update them regularly on the basis of the experience gained . ### after consulting the member states , patients and consumers organisations , social health insurance organisations and healthcare professionals , the commission shall draw up guidelines concerning announcements allowed under this title , the elaboration of the package leaflets , publication of clinical trial results promotional practices toward prescribers , and containing a mandatory code of conduct and dissuasive sanctions for marketing authorisation holders that do not respect the code of conduct . the guidelines shall also contain provisions to ensure that members of the public may lodge complaints with competent authorities regarding misleading practices in the making available of information . the commission shall draw up these guidelines on the entry into force of this directive and update them regularly on the basis of the experience gained .


### member states shall allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . ### member states shall require the marketing authorisation holder to make available , either directly or indirectly through a third party acting on behalf of the marketing authorisation holder , information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that such information and the manner in which it is made available is in accordance with the provisions of this title . such information shall not be considered advertising for the purposes of the application of title viii . when such information is made available , the marketing authorisation holder and any third party shall be identified , and any third party acting on behalf of the marketing authorisation holder shall be clearly indentified as such .


### information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio . it shall only be made available through the following channels : ### information on authorised medicinal products subject to medical prescription made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television , radio or newspapers , magazines and similar publications . it shall only be made available through the following channels :


### - information by the marketing authorisation holder to the general public on medicinal products subject to medical prescription , which is subject to the provisions of title viiia . ### - information on medicinal products that has been approved by the competent authorities in the member states and that has been made available to the general public in approved form by the marketing authorisation holder and that is subject to medical prescription , which is subject to the provisions of title viiia .


### in the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the european union have become increasingly active as regards healthcare , it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good - quality , objective , reliable and non promotional information on medicinal products . ### in the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the european union have become increasingly active as regards healthcare , it is necessary to amend the existing legislation in order to reduce differences in access to relevant , independent , and comparative health information and to protect patients from misleading or biased information .


### a statement indicating that the information is disseminated by a marketing authorisation holder ; ### a statement indicating that the information is made available by or on behalf of a named marketing authorisation holder ;


### comparisons between medicinal products ; ### comparisons between medicinal products regarding their quality , safety and efficiency , if disseminated by marketing authorisation holders except : - where those comparisons are included in officially approved documents , such as the summary of product characteristics ; - where those comparisons are based on comparative scientific studies published by the relevant national authorities or the european medicines agency ; - where those comparisons are contained in the summary of the european public assessment reports referred to in article 13 of regulation no 726 / 2004 , which shall list the other available therapeutic options and whether the new medicinal product brings about a therapeutic value .


### member states shall allow marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this directive . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval . ### member states shall require marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a message at the top of each website page informing the public that information contained therein is developed by the marketing authorisation holder and is therefore subject to monitoring in order to avoid advertising of prescription medicines . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval and include a link to the eudrapharm database specifying that validated information is available there .


### member states shall allow marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this directive . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval . ### member states shall require marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the website has been registered and is subject to monitoring in accordance with this directive . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval .


### medicinal product - related information about non - interventional scientific studies , or accompanying measures to prevention and medical treatment , or information which presents the medicinal product in the context of the condition to be prevented or treated . ### measures to prevention and medical treatment . such information shall be vetted by the agency prior to its being made available in accordance with article 20 b of regulation ec 726 / 2004 .


### member states shall ensure that marketing authorisation holders register internet websites containing information on medicinal products with the national competent authorities of the member state of the country code top level domain used by the website concerned , prior to making it available to the general public . where the website does not use a country code top level domain , the marketing authorisation holder shall select the member state of registration . ### member states shall ensure that marketing authorisation holders register internet websites under their control that are directed specifically at citizens of one or more member states and that contain information on prescription only medicines covered by this title , prior to making it available to the general public . where the website does not use a country code top level domain , the marketing authorisation holder shall select the member state of registration .


### after consulting the member states , the commission shall draw up guidelines concerning information allowed under this title and containing a code of conduct for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescription . the commission shall draw up these guidelines on the entry into force of this directive and update them regularly on the basis of the experience gained . ### after consulting the member states , patient organisations and healthcare professionals , the commission shall draw up guidelines concerning information allowed under this title and containing a code of conduct for marketing authorisation holders providing information to the general public or members thereof on authorised medicinal products subject to medical prescription . the guidelines shall contain provisions to ensure that members of the public may lodge complaints with competent authorities regarding misleading practices in the making available of information . the commission shall draw up these guidelines on the entry into force of this directive and update them regularly on the basis of the experience gained .


### in order to further ensure that marketing authorisation holders disseminate only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be disseminated should be defined . it is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflet , information that is compatible with those documents without going beyond their key elements , and other well - defined medicinal product - related information . ### in order to further ensure that marketing authorisation holders make available only high - quality information and to distinguish non - promotional information from advertising , the types of information which may be made available should be defined . it is appropriate to clarify that marketing authorisation holders can disseminate the contents of the approved summaries of product characteristics , package leaflet , and public assessment report .


### the following types of information on authorised medicinal products subject to medical prescription may be disseminated by the marketing authorisation holder to the general public or members thereof : the summary of product characteristics , labelling and package leaflet of the medicinal product , as approved by the competent authorities , and the publicly accessible version of the assessment report drawn up by the competent authorities . information which does not go beyond the elements of the summary of product characteristics , labelling and the package leaflet of the medicinal product , and the publicly accessible version of the assessment report drawn up by the competent authorities , but presents them in a different way ; information on the environmental impact of the medicinal product , prices and factual , informative announcements and reference material relating , for example , to pack changes or adverse - reaction warnings ; medicinal product - related information about non - interventional scientific studies , or accompanying measures to prevention and medical treatment , or information which presents the medicinal product in the context of the condition to be prevented or treated . ### the marketing authorisation holder shall , in respect of authorised medicinal products subject to medical prescription , make available to the general public or members thereof the summary of product characteristics , labelling and package leaflet of the medicinal product , as approved by the competent authorities , and the publicly accessible version of the assessment report drawn up by the competent authorities . this information should be made available both in electronic and printed form , and in a format accessible to people with disabilities . 2 . the following types of information on authorised medicinal products subject to medical prescription may be made available by the marketing authorisation holder to the general public or members thereof : information which does not go beyond the elements of the summary of product characteristics , labelling and the package leaflet of the medicinal product , and the publicly accessible version of the assessment report drawn up by the competent authorities , but presents them in a way that is comprehensible to the general public or members thereof without compromising the quality and reliability of the information ; information relating to the disposal of unused medicinal products or waste derived from medicinal products , as well as reference to any collection system in place ; information on prices and factual , informative announcements and reference material relating , for example , to pack changes or adverse - reaction warnings ; medicinal product - related information about non - interventional scientific studies , or accompanying measures to prevention and medical treatment , or information which presents the medicinal product in the context of the condition to be prevented or treated . such information shall be vetted by the agency prior to its being made available in accordance with article 20b of regulation ec 726 / 2004 ; the pharmaceutical and pre - clinical tests and the clinical trials of the medicinal product concerned that are contained in the publicly accessible version of the assessment report referred to in paragraph 1 .


### a mail address or e - mail address allowing members of the general public to send comments to the marketing authorisation holder . ### a mail address or e - mail address allowing members of the general public to send comments to , or request for further information from , the marketing authorisation holder .


### information which does not go beyond the elements of the summary of product characteristics , labelling and the package leaflet of the medicinal product , and the publicly accessible version of the assessment report drawn up by the competent authorities , but presents them in a different way ; ### information which does not go beyond the elements of the summary of product characteristics , labelling and the package leaflet of the medicinal product , and the publicly accessible version of the assessment report drawn up by the competent authorities , but presents them in a way that is comprehensible to the general public or member thereof without jeopardising the quality or reliability of the information ;


### national competent authorities and health care professionals should remain important sources of information on medicinal products for the general public . member states should facilitate the access of citizens to high - quality information through appropriate channels . marketing authorisation holders may be a valuable source of non promotional information on their medicinal products . this directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisation holders to the general public . the ban on advertising to the general public for prescription - only medicinal products should be maintained . ### national competent authorities and health care professionals should remain the main source of information on medicinal products for the general public . while there is already a lot of independent information on pharmaceuticals , for example by national authorities or health care professionals , the situation differs very much between member states and among the different products available . member states and commission should take much more efforts to facilitate the access of citizens to high - quality information through appropriate channels .


### information to the general public on prescription - only medicinal products should only be provided through specific channels of communication , including internet and health - related publications , to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public . where information is disseminated via television or radio , patients are not protected against such unsolicited information and such dissemination should therefore not be allowed . ### information to the general public on prescription - only medicinal products should only be made available by the marketing authorisation holder through specific channels of communication to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public . where information is made available by the marketing authorisation holder via television , radio , or newspapers , magazines and similar publications , patients are not protected against such unsolicited information and such making available of information should therefore not be allowed .


### in the area of information , directive 2001 / 83 / ec lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes : the summary of product characteristics and the package leaflet . on the other hand , as regards the dissemination of information from the marketing authorisation holder to the general public , the directive only provides that certain information activities are not covered by the rules on advertising , without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated . ### in the area of information , directive 2001 / 83 / ec lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes : the summary of product characteristics and the package leaflet . on the other hand , as regards the making available of information from the marketing authorisation holder to patients and the general public , the directive only provides that certain information activities are not covered by the rules on advertising , without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be made available .


### after registration of the internet website , the information on a medicinal product contained therein may be provided by the marketing authorisation holder on other internet websites throughout the community if the contents are identical . ### after registration of the internet website , the information on a medicinal product contained therein may be provided by the marketing authorisation holder on other internet websites registered by the marketing authorisation holder in accordance with the provisions of the first subparagraph throughout the community if the contents are identical .


### in accordance with the principle of proportionality , it is appropriate to limit the scope of this directive to prescription - only medicinal products , as current community rules allow the advertising to the general public of medicinal products not subject to prescription , under certain conditions . ### in accordance with the principle of proportionality , it is appropriate to limit the scope of this directive to the making available of information on prescription - only medicinal products by the marketing authorisation holder , as current community rules allow the advertising to the general public of medicinal products not subject to prescription , under certain conditions . the provisions of this directive are without prejudice to the right of any other person or organisation , in particular the press or patients and patient organisations , to express their views on prescription - only medicinal products , provided that they are acting independently and not directly or indirectly on behalf of , on the instructions of , or in the interest of the marketing authorisation holder .


### member states shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereof . ### member states shall ensure that misuse is avoided by securing that only the marketing authorisation holder supplies information , and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription , and in the form which has been approved for the dissemination to the general public or members thereof . by way of derogation member states may continue those types of control mechanism which they have been implemented before 31 . 12 . 2008 . the commission verifies and approves these systems .


### internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof . those websites shall not contain web - tv . ### internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites without their explicit prior consent , or the appearance therein of unsolicited content distributed to the general public or members thereof . internet websites may provide video content if it is useful for the safe and effective use of the medicine .


### member states shall allow marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this directive . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval . ### member states shall require marketing authorisation holders which have registered internet websites in accordance with paragraphs 1 to 4 to include a message at the top of each website page informing the public that information contained therein is developed by the marketing authorisation holder and is therefore subject to monitoring in order to avoid advertising of prescription medicines . the statement shall identify the national competent authority monitoring the website concerned . it shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval and shall include a link to the eudrapharm database specifying that validated information is available there .


### in the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the european union have become increasingly active as regards healthcare , it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good - quality , objective , reliable and non promotional information on medicinal products . ### in the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the european union have become increasingly active as regards healthcare , it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good - quality , objective , reliable and non promotional information on medicinal products by placing emphasis on the interests of patients . they should have the right to easily access certain information such as a summary of product characteristics , and the package leaflet in electronic and printed form .


### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring . ### monitoring of information on authorised prescription - only medicinal products under this directive should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . in cases of non - compliance , procedures should be put into place by means of which marketing authorisation holders can be represented and heard in the course of the consideration of their case . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure adequate , effective and independent monitoring .


### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination , unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring . ### monitoring of information on prescription - only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with directive 2001 / 83 / ec . member states should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its supply . only such information that has been approved in advance by the competent authorities should be provided , and it should be provided in the approved form only .


### regulation no 1760 / 2000 and more in particular bovine identification and voluntary beef labelling were listed as ' information obligations with special importance in terms of the burdens they impose on businesses ' in the communication from the commission to the council and the european parliament on an ' action programme for reducing administrative burdens in the eu ' . ### regulation no 1760 / 2000 and more in particular bovine identification and the voluntary beef labelling system were listed as ' information obligations with special importance in terms of the burdens they impose on businesses ' in the communication from the commission to the council and the european parliament on an ' action programme for reducing administrative burdens in the eu ' .


### making eid mandatory throughout the union may have economically adverse effects on certain operators . it is therefore appropriate that a voluntary regime for the introduction of eid is established . under such a regime , eid would be chosen by keepers that are likely to have immediate economic benefits . ### making eid mandatory throughout the union may have economically adverse effects on certain operators . it is therefore appropriate that a voluntary regime is established . such a regime would enable eid to be chosen only by keepers that are likely to have rapid economic benefits ;


### member states have very different husbandry systems , farming practices and sector organisations . member states should therefore be allowed to make eid compulsory on their territory only when they deem it appropriate , after considering all those factors . ### member states have very different husbandry systems , farming practices and sector organisations . member states should therefore be allowed to make eid compulsory on their territory only when they deem it appropriate , after considering all those factors and following consultation with organisations representing the beef industry .


### the member states that make use of this option shall provide the commission with the text of such national provisions . ### the member states that make use of this option shall provide the commission with the text of such national provisions . the commission shall then supply the other member states , in a language which is readily understandable by those member states , with a summary of the national rules governing the movement of animals to member states that have opted for compulsory eid .


### regulation of the european parliament and of the council amending regulation no 1760 / 2000 as regards electronic identification of bovine animals and deleting the provisions on voluntary beef labelling ### regulation of the european parliament and of the council amending regulation no 1760 / 2000 as regards electronic identification of bovine animals and deleting the provisions on the system of voluntary beef labelling


### member states shall ensure that any person responsible for the identification and registration of animals receives instructions and guidance on the relevant provisions of this regulation and of any delegated and implementing acts adopted by the commission on the basis of articles 10 and 10a , and that appropriate training courses are available . ' ### member states shall ensure that any person responsible for the identification and registration of animals receives instructions and guidance on the relevant provisions of this regulation and of any delegated and implementing acts adopted by the commission on the basis of articles 10 and 10a , and that appropriate training courses are available . this information shall be supplied , at no cost to the recipient , every time a change is made to the relevant provisions and as often as necessary . ”


### in order to ensure that the necessary rules for the proper functioning of the identification , registration and traceability of bovine animals and beef are applied , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of requirements for alternative means of identification of bovine animals , special circumstances in which member states may extend the maximum periods for the application of the means of identification , data to be exchanged between the computerised databases of the member states , the maximum period for certain reporting obligations , the requirements for means of identification , the information to be included in the passports and in the individual registers to be kept on each holding , the minimum level of official controls , the identification and registration of movements of bovine animals when put out to summer grazing in different mountain areas , rules for labelling certain products which should be equivalent to the rules laid down in regulation no 1760 / 2000 , the definitions of minced beef , beef trimmings or cut beef , the specific indications that may be put on labels , the labelling provisions related to the simplification of the indication of origin , the maximum size and composition of certain groups of animals , the approval procedures related to labelling conditions on packaging of cut meat it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### in order to ensure that the necessary rules for the proper functioning of the identification , registration and traceability of bovine animals and beef are applied , the power to adopt acts in accordance with article 290 of the treaty should be delegated to the commission in respect of requirements for alternative means of identification of bovine animals , special circumstances in which member states may extend the maximum periods for the application of the means of identification , data to be exchanged between the computerised databases of the member states , the maximum period for certain reporting obligations , the requirements for means of identification , the information to be included in the passports and in the individual registers to be kept on each holding , the minimum level of official controls , the identification and registration of movements of bovine animals when put out to summer grazing in different mountain areas , rules for labelling certain products which should be equivalent to the rules laid down in regulation no 1760 / 2000 , the definitions of minced beef , beef trimmings or cut beef , the maximum size and composition of certain groups of animals , the approval procedures related to labelling conditions on packaging of cut meat it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level .


### ' risk - sharing instrument for project bonds ' means a credit enhancement provided to projects of common interest . the risk - sharing instrument for project bonds covers the debt service risk of a project and mitigates the credit - risk of bond holders . it is used only for projects whose financial viability is based on project revenues . ### ' risk - sharing instrument for project bonds ' means a credit enhancement provided to projects of common interest . the risk - sharing instrument for project bonds covers the debt service risk of a project and mitigates the credit - risk of bond holders . it is used only :


### the pilot phase of the europe 2020 project bond initiative should be launched in preparation of the proposed connecting europe facility . this pilot phase will help to pave the way for the risk - sharing financial instrument under the connecting europe facility . ### the pilot phase of the europe 2020 project bond initiative is without prejudice to the decision about the union’s multiannual financial framework after 2013 and , in particular , the commission proposal for the establishment of the connecting europe facility . the pilot phase should therefore be launched to test whether this risk - sharing financial instrument can offer an added value to be implemented under the proposed connecting europe facility . the decision about the continuation of the europe 2020 project bond initiative after the end of the pilot phase will only be taken after an independent evaluation of the pilot phase has taken place . the commission should provide for an exit from the initiative if the predicted market uptake is not satisfactory or when sufficient alternative sources of long - term debt financing become available .


### the union support should mitigate the risk inherent in project bonds to the extent that capital market participants are willing to invest in a larger volume infrastructure project bonds than would be possible without union support . ### the union support should mitigate the risk inherent in project bonds to the extent that capital market participants are willing to invest in a larger volume infrastructure project bonds than would be possible without union support . project bonds should be extended to innovation and demonstration projects as well .


### therefore , a pilot phase for the europe 2020 project bond initiative should be launched during the current financial framework in order to develop debt capital market financing in the area of infrastructure more generally and to extend the range of financial instruments currently available for transport projects . ### therefore , a pilot phase for the europe 2020 project bond initiative should be launched during the current financial framework in order to ascertain whether and to what extent such risk - sharing financial instruments offer additional benefits in the area of infrastructure financing .


### the detailed terms and conditions for implementing the risk - sharing instrument for project bonds , including its monitoring and control , shall be laid down in a delegation agreement between the commission and the eib . ### the detailed terms and conditions for implementing the risk - sharing instrument for project bonds , including its monitoring and control , shall be laid down in a delegation agreement between the commission and the eib and disclosed to the european parliament and the council . risk assessment by the eib shall be guaranteed in accordance with the banking directives .


### where the value of a modification can be expressed in monetary terms , the modification shall not be considered to be substantial within the meaning of paragraph 1 , where its value does not exceed the thresholds set out in article 12 and where it is below 5% of the price of the initial contract , provided that the modification does not alter the overall nature of the contract . where several successive modifications are made , the value shall be assessed on the basis of the cumulative value of the successive modifications . ### where the value of a modification can be expressed in monetary terms , the modification shall not be considered to be substantial within the meaning of paragraph 1 , where its value does not exceed the thresholds set out in article 12 and where it is below 15% of the price of the initial contract , provided that the modification does not alter the overall nature of the contract . where several successive modifications are made , the value shall be assessed on the basis of the cumulative value of the successive modifications .


### rail freight transport ### rail transport


### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed , the commission to make a report and if appropriate proposals made for targets beyond 2020 . ### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed and that the commission comes up with a proposal for targets beyond 2020 before the expiration of this regulation . in order to guarantee planning security , such a proposal shall not take place before 2018 , since the implementation of such targets shall be based on a new test cycle and the relevant test procedures , to be applied for the purpose of measuring specific co2 emissions and for monitoring the target only after 2020 .


### ‘ in order to reflect any change in the regulatory test procedure for the measurement of specific co2 emissions , the commission shall adapt the formulae set out in annex i by means of delegated acts in accordance with article 15 , and subject to the conditions laid down in articles 16 and 17 while ensuring that reduction requirements of comparable stringency for manufacturers and vehicles of different utility are required under the old and new test procedures . ’ ### ' the regulatory test procedure and cycle shall remain as the basis for the target as set out in annex i , paragraph 1 of the regulation n° 510 / 2011 and as set in regulation no 715 / 2007 , annex iii and xii to regulation no 692 / 2008 . the new test procedure and cycle shall be fully defined and implemented by the 31st of december 2018 at the latest . sufficient monitoring data shall be available by then . the commission shall then consider the possibility for new targets for the period beyond 2020 . '


### ‘ by 31 december 2014 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 . ’ ### ' by 31 december 2018 the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 based on a new implemented test procedure and test cycle . '


### by 31 december 2014 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 . ### no later than 2017 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 based on a new test procedure and test cycle which take into account the worldwide harmonised light vehicles procedure .


### ‘ from 2020 : indicative specific emissions of co2 = 147 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 096 . ’ ### ' from 2020 : indicative specific emissions of co2 = 147 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 096 . '


### ‘ serious crime’ means the offences under national law referred to in article 2 of council framework decision 2002 / 584 / jha if they are punishable by a custodial sentence or a detention order for a maximum period of at least three years under the national law of a member state , however , member states may exclude those minor offences for which , taking into account their respective criminal justice system , the processing of pnr data pursuant to this directive would not be in line with the principle of proportionality ; ### ‘ serious crime’ means the offences under national law referred to in article 2 of council framework decision 2002 / 584 / jha if they are punishable by a custodial sentence or a detention order for a maximum period of at least five years under the national law of a member state ; however , member states shall exclude those offences for which , taking into account their respective criminal justice system , the processing of pnr data pursuant to this directive would not be in line with the principle of proportionality ;


### ' serious transnational crime ' means the offences under national law referred to in article 2 of council framework decision 2002 / 584 / jha if they are punishable by a custodial sentence or a detention order for a maximum period of at least three years under the national law of a member state , and if ### ' serious transnational crime ' means the offences under national law referred to in article 2 of council framework decision 2002 / 584 / jha if they are punishable by a custodial sentence or a detention order for a maximum period of at least five years under the national law of a member state , and if


### the passenger information unit of a member state shall have the right to request , if necessary , the passenger information unit of any other member state to provide it with pnr data that are kept in the latter’s database in accordance with article 9 , and , if necessary , also the result of the processing of pnr data . the passenger information unit may request access to specific pnr data kept by the passenger information unit of another member state in their full form without the masking out only in exceptional circumstances in response to a specific threat or a specific investigation or prosecution related to terrorist offences or serious crime . ### the passenger information unit of a member state and , where the conditions of council decision 2009 / 371 / ji of 6 april 2009 are met , europol shall have the right to request , if necessary , the passenger information unit of any other member state to provide it with pnr data that are kept in the latter’s database in accordance with article 9 , and , if necessary , also the result of the processing of pnr data . the requesting body may request access to specific pnr data kept by the passenger information unit of another member state in their full form without the masking out only in exceptional circumstances in response to a specific threat or a specific investigation or prosecution related to terrorist offences or serious crime .


### the member states should take all necessary measures to enable air carriers to fulfil their obligations under this directive . dissuasive , effective and proportionate penalties , including financial ones , should be provided for by member states against those air carriers failing to meet their obligations regarding the transfer of pnr data . where there are repeated serious infringements which might undermine the basic objectives of this directive , these penalties may include , in exceptional cases , measures such as the immobilisation , seizure and confiscation of the means of transport , or the temporary suspension or withdrawal of the operating licence . ### the member states which use pnr data should take all necessary measures to enable air carriers to fulfil their obligations under this directive . dissuasive , effective and proportionate penalties , including financial ones , should be provided for by member states against those air carriers failing to meet their obligations regarding the transfer of pnr data . where there are repeated serious infringements which might undermine the basic objectives of this directive , these penalties may include , in exceptional cases , measures such as the immobilisation , seizure and confiscation of the means of transport , or the temporary suspension or withdrawal of the operating licence .


### nullity or annulment declared by a judicial body of the appointment or of the election of non - executive directors made contrary to the national provisions adopted pursuant to article 4 . ### nullity or annulment declared by a judicial body of the appointment or of the election of non - executive directors made contrary to the national provisions adopted pursuant to article 4 . the nullity or annulment of the appointment or of the election of non - executive directors should not have any consequence on the validity of the decisions taken by the board .


### esma shall only take a decision under paragraph 1 if all of the following conditions are fulfilled : ### esma shall take a decision under paragraph 1 if all of the following conditions are fulfilled :


### member states shall transmit the data collected according to this article to the commission . they shall also ensure that a consolidated review of these statistical reports is published . ### member states shall transmit the data collected according to this article to the commission , europol and the european network and information security agency . they shall also ensure that a consolidated review of these statistical reports is published .


### attacks against information systems , in particular as a result of the threat from organised crime , are a growing menace , and there is increasing concern about the potential for terrorist or politically motivated attacks against information systems which form part of the critical infrastructure of member states and the union . this constitutes a threat to the achievement of a safer information society and an area of freedom , security and justice , and therefore requires a response at the level of the european union . ### attacks against information systems , in particular as a result of the threat from organised crime , are a growing menace to the functioning of information systems in the union and globally , and there is increasing concern about the potential for terrorist or politically motivated attacks against information systems which form part of the critical infrastructure of member states and the union . this constitutes a threat to the achievement of a safer information society and an area of freedom , security and justice , and therefore requires a response at the level of the european union as well as internationally , for example through the 2001 council of europe convention on cybercrime .


### the objective of this directive is to approximate rules on criminal law in the member states in the area of attacks against information systems , and improve cooperation between judicial and other competent authorities , including the police and other specialised law enforcement services of the member states . ### the objective of this directive is to approximate rules on criminal law in the member states in the area of attacks against information systems , and improve cooperation between judicial and other competent authorities , including the police and other specialised law enforcement services of the member states , the commission , enisa , europol and eurojust to enable a common and comprehensive union approach .


### there is evidence of a tendency towards increasingly dangerous and recurrent large scale attacks conducted against information systems which are critical to states or to particular functions in the public or private sector . this tendency is accompanied by the development of increasingly sophisticated tools that can be used by criminals to launch cyber - attacks of various types . ### there is evidence of a tendency towards increasingly dangerous and recurrent large scale attacks conducted against information systems which are critical to states or to particular functions in the public or private sector . such attacks can cause substantial economic damage both through interruption of information systems and communications themselves and through loss of commercially important confidential information . innovative smes , dependent on the proper functioning and availability of information systems while potentially able to devote fewer resources to information security , risk being especially affected . this tendency is accompanied by the development of increasingly sophisticated tools that can be used by criminals to launch cyber - attacks of various types .


### the member states shall notify those provisions to the commission by [ one year after the date of application of this regulation ] at the latest and shall notify without delay any subsequent amendment affecting them . ### the member states shall notify those provisions to the commission by [ one year after the date of application of this directive ] at the latest and shall notify without delay any subsequent amendment affecting them .


### member states shall designate a national contact point responsible for the exchange of information with the other member states and the commission with regard to the application of this regulation . ### member states shall designate a national contact point responsible for the exchange of information with the other member states and the commission with regard to the application of this directive .


### directive 2009 / 40 / ec and commission recommendation 2010 / 378 / eu are repealed with effect from [ the date of application of this regulation ] . ### directive 2009 / 40 / ec and commission recommendation 2010 / 378 / eu are repealed with effect from [ the date of application of this directive ] .


### this regulation shall not apply to : ### this directive shall not apply to :


### the commission shall examine the feasibility , costs and benefits of the establishment of an electronic vehicle information platform with a view to exchange information on data related to roadworthiness testing between the competent authorities of member states responsible for testing , registration and vehicle approval , the testing centres and the vehicle manufacturers . ### the commission shall examine the feasibility , costs and benefits of the establishment of an electronic vehicle information platform with a view to exchange information on data related to roadworthiness testing between the competent authorities of member states responsible for testing , registration and vehicle approval , the testing centres , the vehicle manufacturers and the independent operators .


### the delegation of power referred to in article 17 shall be conferred for an indeterminate period of time from [ the date of entry into force of this regulation ] . ### the power to adopt the delegated acts referred to in article 17 shall be conferred on the commission for a period of five years from [ the date of entry into force of this directive ] , the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### the regulation shall enter into force on the twentieth day following that of its publication in the official journal of the european union . ### the directive shall enter into force on the twentieth day following that of its publication in the official journal of the european union .


### 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 . those penalties shall be effective , proportionate , dissuasive and non - discriminatory . ### the member states shall lay down the rules on penalties applicable to infringements of the provisions of this directive and shall take all measures necessary to ensure that they are implemented . those penalties shall be effective , proportionate , dissuasive and non - discriminatory .


### member states shall apply the requirements laid down in annex vii at the latest as from the fifth year following the date of application of this regulation . ### member states shall apply the requirements laid down in annex vii at the latest as from the fifth year following the date of application of this directive .


### this regulation establishes a regime of periodic roadworthiness tests of vehicles . ### this directive establishes a regime of periodic roadworthiness tests of vehicles carried out on the basis of minimum technical standards and requirements with the aim of ensuring a high level of road safety and environmental protection .


### as from the date of entry into force of this regulation and at the latest 3 years afterwards , the testing centres shall communicate electronically , to the competent authority of a member state the information mentioned in roadworthiness certificates which they deliver . this communication shall take place within a reasonable time after the issuance of the roadworthiness certificates . until this date , the testing centres may communicate this information to the competent authority by any other means . the competent authority shall keep this information for 36 months from the date of its reception . ### as from the date of entry into force of this directive and at the latest 3 years afterwards , the testing centres shall communicate electronically , to the competent authority of a member state the information mentioned in roadworthiness certificates which they deliver . this communication shall take place within a reasonable time after the issuance of the roadworthiness certificates . until this date , the testing centres may communicate this information to the competent authority by any other means . the competent authority shall keep this information for 36 months from the date of its reception .


### – vehicles of category m1 , n1 and o2 : four years after the date on which the vehicle was first registered , then two years and thereafter annually ; ### – vehicles of category m1 , n1 and o2 : four years after the date on which the vehicle was first registered and thereafter every two years ;


### inspectors employed by competent authorities of the member states or a testing centre at the date of application of this regulation shall be exempted from the requirements laid down in annex vi , point 1 . the member states shall deliver a certificate of equivalence to these inspectors . ### inspectors employed by competent authorities of the member states or a testing centre at the date of application of this directive shall be exempted from the requirements laid down in annex vi , point 1 . the member states shall deliver a certificate of equivalence to these inspectors .


### this regulation shall be binding in its entirety and directly applicable in all member states . ### this directive shall be binding in its entirety and directly applicable in all member states .


### it shall , on the basis of that examination , put forward and evaluate different policy options , including the possibility to remove the requirement of a proof of test as provided for in article 10 . within two years after the date of application of this regulation , the commission shall report to the european parliament and to the council on the results of the examination , and accompany it with a legislative proposal , if appropriate . ### it shall , on the basis of that examination , put forward and evaluate different policy options , including the possibility to remove the requirement of a proof of test as provided for in article 10 . within two years after the date of application of this directive , the commission shall report to the european parliament and to the council on the results of the examination , and accompany it with a legislative proposal , if appropriate .


### – vehicles of category m1 , n1 and o2 : four years after the date on which the vehicle was first registered , then two years and thereafter annually ; ### – vehicles of category m1 , n1 and o2 : four years after the date on which the vehicle was first registered , and thereafter every two years ;


### testing facilities and equipment referred to in article 11 which do not comply with the minimum requirements laid down in annex v on [ the date of application of this regulation ] may be used for carrying out roadworthiness tests for a period of not more than five years following that date . ### testing facilities and equipment referred to in article 11 which do not comply with the minimum requirements laid down in annex v on [ the date of application of this directive ] may be used for carrying out roadworthiness tests for a period of not more than five years following that date .


### proposal for a regulation of the european parliament and of the council on periodic roadworthiness tests for motor vehicles and their trailers and repealing directive 2009 / 40 / ec ### proposal for a directive of the european parliament and of the council on periodic roadworthiness tests for motor vehicles and their trailers and repealing directive 2009 / 40 / ec


### this regulation shall apply to vehicles with a design speed exceeding 25 km / h of the following categories , as referred to in directive 2002 / 24 / ec , directive 2007 / 46 / ec and directive 2003 / 37 / ec : ### this directive shall apply to vehicles with a design speed exceeding 25 km / h of the following categories , as referred to in directive 2002 / 24 / ec , directive 2007 / 46 / ec and directive 2003 / 37 / ec :


### six persons injured within the establishment and hospitalized for at least 24 hours ; ### two or more persons injured within the establishment and hospitalized for at least 24 hours ;


### ‘ new establishment’ means an establishment that is newly constructed or has yet to enter into operation ; ### ‘ new establishment’ means an establishment that enters into operation after 31 may 2015 ;


### support under article 22 shall be granted to natural persons , private forest owners , private law and semi - public bodies , municipalities and their associations . in the case of state forests support may also be granted to bodies managing such forests , which are independent from the state budget . ### support under article 22 and shall be granted to private and public forest owners under the terms provided for in this article .


### improving the urban environment , including regeneration of brownfield sites and reduction of air pollution . ### improving the urban environment , including regeneration of brownfield sites , creation of green spaces , reduction of air pollution and adopting measures aimed at protecting and preserving historical and cultural heritage .


### promoting the production and distribution of renewable energy sources ; ### promoting the production and further developing the infrastructural capacity for the distribution of renewable energy ;


### supporting energy efficiency and renewable energy use in public infrastructures ; ### supporting energy efficiency and renewable energy use in public infrastructures as well as in the housing sector ;


### enhancing institutional capacity and an efficient public administration by strengthening of institutional capacity and the efficiency of public administrations and public services related to implementation of the cohesion fund . ### enhancing institutional capacity and efficient public administration by providing technical assistance and fostering the efficiency of public administrations and public services with a view to an effective and transparent implementation of the cohesion fund .


### protecting and restoring biodiversity , including through green infrastructures ; ### protecting and restoring biodiversity , soil quality , landscapes of importance to cultural heritage and promoting ecosystem services , including through green infrastructures ;


### technical assistance . ### technical assistance and capacity building .


### developing environment - friendly and low - carbon transport systems including promoting sustainable urban mobility ; ### developing integrated , intermodal , environment - friendly and low - carbon local public transport systems including promoting sustainable urban and suburban mobility ;


### the country of origin or place of provenance where failure to indicate this might mislead the consumer to a material degree as to the true country of origin or place of provenance of the food , in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance ; in such cases the indication shall be in accordance with the rules laid down in article 35 and and those established in accordance with article 35 ; ### the country of origin or place of provenance of the food and of its basic ingredient / s , where this represents over 50% of the net quantity of the product ;


### implementing rules concerning the conditions and criteria of use of particulars voluntarily provided may be established by the commission . those measures designed to amend non - essential elements of this regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 49 . ### implementing rules concerning the conditions and criteria of use of particulars voluntarily provided may be established by the commission . those measures , designed to amend non - essential elements of this regulation by supplementing it , shall be adopted in accordance with the procedure referred to in article 290 of the feu treaty , in consultation with interested parties .


### articles 29 to 34 shall apply from [ the first day of the month 3 years after the entry into force ] except in the case of foods labelled by food business operators with , on the date of entry into force , less than 10 employees and whose annual turnover and / or annual balance sheet total does not exceed eur 2 million where they shall apply [ the first day of the month 5 years after the entry into force ] . ### articles 29 to 34 shall apply from [ the first day of the month 3 years after the entry into force ] except in the case of foods labelled by food business operators with , on the date of entry into force , less than 50 employees and whose annual turnover and / or annual balance sheet total does not exceed eur 2 million where they shall apply [ the first day of the month 5 years after the entry into force ] . foods placed on the market prior to the entry into force of this regulation which do not comply with its provisions may be marketed until their expiry date , but not beyond 31 december 2011 .


### without prejudice to specific community legislation applicable to particular foods as regards to the requirements referred to in article 9 to , when appearing on the package or on the label attached thereto , the mandatory particulars listed in article&#160 ; 9 shall be printed on the package or on the label in characters of a font size of at least 3 mm and shall be presented in a way so as to ensure a significant contrast between the print and background . ### without prejudice to specific community legislation applicable to particular foods as regards the requirements referred to in article 9 to , the mandatory particulars listed in article&#160 ; 9 shall be printed on the package or on the label in a way which ensures that they are clearly legible .


### the particulars referred to article&#160 ; 31 related to the mandatory nutrition declaration shall be included in the principal field of vision . they shall be presented , where appropriate , together in a clear format in the following order : energy , fat , saturates , carbohydrates with specific reference to sugars , and salt . ### the particulars referred to article&#160 ; 31 related to the mandatory nutrition declaration shall be included in the same field of vision . they shall be presented , where appropriate , together in a clear format in the following order : energy , proteins , carbohydrates with specific reference to sugars , fat , saturates , fibre and sodium .


### the country of origin or place of provenance where failure to indicate this might mislead the consumer to a material degree as to the true country of origin or place of provenance of the food , in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance ; in such cases the indication shall be in accordance with the rules laid down in article 35 and and those established in accordance with article 35 ; ### particulars of the country of origin where failure to give such particulars might mislead the consumer to a material degree as to the true origin or provenance of the food ;


### the availability of certain mandatory particulars by means other than on the package or on the label may be established by the commission provided the general principles and requirements laid down in chapter ii of this regulation are met . those measures designed to amend non - essential elements of this regulation by supplementing it , shall be adopted , in accordance with the regulatory procedure with scrutiny referred to in article 49 . ### in the interests of reducing packaging as much as possible , the commission shall encourage the provision of mandatory particulars by means other than on the package or on the label , through the use of , for example , new information and communication technologies , provided the general principles and requirements laid down in chapter ii of this regulation are met . those measures designed to amend non - essential elements of this regulation by supplementing it , shall be adopted , in accordance with the procedure referred to in article 290 tfeu .


### without prejudice to labelling in accordance with specific community legislation , paragraphs 3 and 4 shall apply where the country of origin or the place of provenance of a food is voluntarily indicated to inform consumers that a food originates or comes from the european community or a given country or place . ### without prejudice to labelling in accordance with specific community legislation , paragraphs 3 and 4 shall apply where the country of origin or the place of provenance of a food is voluntarily indicated to inform consumers that a food originates or comes from the european community or a given country , region or place .


### articles 29 to 34 shall apply from [ the first day of the month 3 years after the entry into force ] except in the case of foods labelled by food business operators with , on the date of entry into force , less than 10 employees and whose annual turnover and / or annual balance sheet total does not exceed eur 2 million where they shall apply [ the first day of the month 5 years after the entry into force ] . ### articles 29 to 34 shall apply from [ the first day of the month 3 years after the entry into force ] except in the case of foods labelled by food business operators with , on the date of entry into force , less than 50 employees and whose annual turnover and / or annual balance sheet total does not exceed eur 10 million where they shall apply [ the first day of the month 5 years after the entry into force ] . foods placed on the market or labelled prior to [ date of entry into force ] which do not comply with this regulation may continue to be sold until their date of minimum durability or use - by date .


### the amounts of fat , saturates , carbohydrates with specific reference to sugars , and salt . ### the amounts of fat , saturates , industrial transfatty acids and carbohydrates with specific reference to natural and added sugars , and salt .


### without prejudice to specific community legislation applicable to particular foods as regards to the requirements referred to in article 9 to , when appearing on the package or on the label attached thereto , the mandatory particulars listed in article&#160 ; 9 shall be printed on the package or on the label in characters of a font size of at least 3 mm and shall be presented in a way so as to ensure a significant contrast between the print and background . ### without prejudice to specific community legislation applicable to particular foods as regards the requirements referred to in article 9 to , when appearing on the package or on the label attached thereto , the mandatory particulars listed in article&#160 ; 9 shall be printed on the package or on the label in characters of a font size of at least 2 mm , scaled with reference to a lower case letter ' o ' , and shall be presented in such a way as to ensure a significant contrast between the print and background .


### without prejudice to specific community legislation applicable to particular foods as regards to the requirements referred to in article 9 to , when appearing on the package or on the label attached thereto , the mandatory particulars listed in article&#160 ; 9 shall be printed on the package or on the label in characters of a font size of at least 3mm and shall be presented in a way so as to ensure a significant contrast between the print and background . ### without prejudice to specific community legislation applicable to particular foods as regards to the requirements referred to in article 9 to , the mandatory particulars listed in article&#160 ; 9 shall appear on the package or on the label in a clearly legible way .


### the particulars referred to article 31 related to the mandatory nutrition declaration shall be included in the principal field of vision . they shall be presented , where appropriate , together in a clear format in the following order : energy , fat , saturates , carbohydrates with specific reference to sugars , and salt . ### the particulars referred to article 31 related to the mandatory nutrition declaration shall be included in the same field of vision . they shall be presented , where appropriate , together in a clear format in the following order : energy , protein , fat , saturates , carbohydrates with specific reference to sugars , fibre and salt . in addition , the amount of energy referred to in article 29 and the percentage of the reference intake for energy referred to in article 31 shall appear in the principal field of vision in accordance with article 32 and 32 . it shall be expressed per portion .


### the availability of certain mandatory particulars by means other than on the package or on the label may be established by the commission provided the general principles and requirements laid down in chapter ii of this regulation are met . those measures designed to amend non - essential elements of this regulation by supplementing it shall be adopted , in accordance with the regulatory procedure with scrutiny referred to in article 49 . ### the availability of certain mandatory particulars by means other than on the package or on the label , notably by means of new information and communication technologies such as the internet , may be established by the commission provided the general principles and requirements laid down in chapter ii of this regulation are met . those measures designed to amend non - essential elements of this regulation by supplementing it shall be adopted , in accordance with the procedure referred to in article 290 of the treaty on the functioning of the european union .


### without prejudice to specific community legislation applicable to particular foods as regards to the requirements referred to in article 9 to , when appearing on the package or on the label attached thereto , the mandatory particulars listed in article&#160 ; 9 shall be printed on the package or on the label in characters of a font size of at least 3mm and shall be presented in a way so as to ensure a significant contrast between the print and background . ### without prejudice to specific community legislation applicable to particular foods as regards to the requirements referred to in article 9 to , the mandatory particulars listed in article 9 shall be printed on the package or on the label in a clearly legible manner with regard to font , colour and contrast .