### the information referred to in paragraph 1 shall include as a minimum : – the right of access to a lawyer , where necessary free of charge , – the right to be informed of the charge and , where appropriate , to be given access to the case - file , – the right to interpretation and translation , – the right to be brought promptly before a court if the suspected or accused person is arrested . ### the information referred to in paragraph 1 shall include as a minimum : – the right of access to a lawyer , where necessary free of charge , – the right to be informed of the charge and , where appropriate , to be given access to evidentiary materials of the case , – the right to interpretation and translation , – the right to be brought promptly before a court if the suspected or accused person is arrested , – the right to remain silent , and any implications there may be in exercising that right under national law .


### member states shall ensure that a procedure is in place to ascertain whether a suspected or accused person has received all information relevant to him in accordance with articles 3 to 7 . ### member states shall ensure that a procedure is in place to ascertain whether a suspected or accused person has received all information relevant to him / her in accordance with this directive .


### member states shall ensure that any person subject to proceedings for the execution of a european arrest warrant receives an appropriate letter of rights setting out the rights of that person as laid down in the framework decision 2002 / 584 / jha . annex ii to this directive contains an indicative model of such letter . ### member states shall ensure that any person subject to proceedings for the execution of a european arrest warrant receives an appropriate letter of rights setting out the rights of that person as laid down in the framework decision 2002 / 584 / jha . the letter of rights shall be drafted in simple language and shall contain at least the elements set out in annex ii to this directive .


### member states shall ensure that any person who is suspected or accused of having committed a criminal offence is provided promptly with information on his procedural rights in simple and accessible language . ### member states shall ensure that any person who is suspected or accused of having committed a criminal offence is immediately provided with written information on his procedural rights .


### where a person is arrested by the competent authorities of a member state in the course of criminal proceedings , he shall be promptly provided with information about his procedural rights in writing . he shall be given an opportunity to read the letter of rights and be allowed to keep it in his possession throughout the time he is deprived of his liberty . ### where a person is deprived of liberty by the authorities of a member state in the course of criminal proceedings , he / she shall immediately be provided with information about his procedural rights in writing . he / she shall be given an opportunity to read the letter of rights and be allowed to keep it in his / her possession throughout the time during which he / she is deprived of his / her liberty . this provision shall apply to all cases where persons are deprived of liberty by public authorities .


### the right to written information about rights on arrest where a person is arrested by the competent authorities of a member state in the course of criminal proceedings , he shall be promptly provided with information about his procedural rights in writing . he shall be given an opportunity to read the letter of rights and be allowed to keep it in his possession throughout the time he is deprived of his liberty . 2 . the letter of rights shall be drafted in simple language and shall include at least that information referred to in article 3 . annex i to this directive contains an indicative model of such a letter . 3 . member states shall ensure that , where the suspected or accused person does not speak or understand the language of the proceedings , he receives the letter of rights in a language he understands . member states shall ensure that a mechanism is in place to convey the information to a suspected or accused person who is partially sighted or cannot read . where the suspected or accused person is a child , the information contained in the letter of rights shall also be provided orally in a manner adapted to the child ' s age , level of maturity and intellectual and emotional capacities . 4 . where a letter of rights is not available in the appropriate language , the suspected or accused person shall be informed of his rights orally in a language he understands . a letter of rights in a language he understands shall then be given to him without undue delay . ### the right to written information about rights on arrest or upon detention where a person is arrested or detained by the competent authorities of a member state in the course of criminal proceedings , he or she shall be promptly provided with information about his or her procedural rights in writing . he or she shall be given an opportunity to read the letter of rights and be allowed to keep it in his possession throughout the time he or she is deprived of his liberty . 2 . the letter of rights shall be drafted in simple language and shall include at least that information referred to in article 3 and 2 . the letter of rights shall contain at least the elements set out in annex i to this directive . 2a . in addition of to the information to be given under article 3 , the person arrested or detained shall be informed about the following : for how many hours or days he or she may be deprived of liberty before being brought before a judicial authority ; how to challenge the arrest and how to obtain a review of his or her detention ; the maximum period of pre - trial detention applicable to his or her case ; the right to contact family , friends , and consular officials ; the right to medical care ; where applicable , the right to apply for supervision measures as an alternative to provisional detention . 3 . member states shall ensure that , where the suspected or accused person does not speak or understand the language of the proceedings , he or she receives the letter of rights in a language he or she understands . member states shall ensure that a mechanism is in place to convey the information to a suspected or accused person who is partially sighted or cannot read . where the suspected or accused person is vulnerable due to age , incapacity or any other reason , the information contained in the letter of rights shall also be provided orally in a manner adapted to the person ' s age , level of maturity and intellectual and emotional capacities . 4 . where a letter of rights is not available in the appropriate language , the suspected or accused person shall be informed of his or her rights orally by a qualified interpreter in a language he or she understands in accordance with directive 2010 / 64 / eu . a letter of rights in a language he understands shall then be given to him or her without undue delay .


### member states shall ensure that an accused person or his lawyer is granted access to the case - file once the investigation of the criminal offence is concluded . access to certain documents contained in the case - file may be refused by a competent judicial authority where access to these documents may lead to serious risk to the life of another person or may seriously harm the internal security of the member state in which the proceedings take place . where it is in the interests of justice , the accused person or his lawyer may request an index of the documents contained in the case - file . ### member states shall ensure that an accused person or his lawyer is granted access to the evidentiary materials of the case once the investigation of the criminal offence is concluded . access to certain documents may be refused by a competent judicial authority where access to these documents may lead to serious risk to the life of another person or may seriously harm the internal security of the member state in which the proceedings take place . where it is in the interests of justice , the accused person or his lawyer may request an index of the evidentiary materials of the case .


### where a suspected or accused person is arrested at any stage of the criminal proceedings , member states shall ensure that he or his lawyer is granted access to those documents contained in the case - file which are relevant for the determination of the lawfulness of the arrest or detention . ### where a suspected or accused person is arrested or detained at any stage of the criminal proceedings , member states shall ensure that he or his lawyer is granted access to documents which are relevant for the determination of the lawfulness of the arrest or detention .


### the information required pursuant to paragraph 1 shall be delivered promptly and in detail and in a language that the suspected or accused person understands . in the case of a child , information about the charges shall be provided in a manner adapted to his age , level of maturity and intellectual and emotional capacities . ### the information required pursuant to paragraph 1 shall be delivered promptly and in detail and in a language that the suspected or accused person understands . in the case a person is vulnerable due to age , incapacity or any other reason , information about the charges shall be provided in a manner adapted to his or her age , level of maturity and intellectual and emotional capacities .


### member states shall ensure that an accused person or his lawyer is granted access to the case - file once the investigation of the criminal offence is concluded . access to certain documents contained in the case - file may be refused by a competent judicial authority where access to these documents may lead to serious risk to the life of another person or may seriously harm the internal security of the member state in which the proceedings take place . where it is in the interests of justice , the accused person or his lawyer may request an index of the documents contained in the case - file . ### member states shall ensure that a suspected or accused person or his lawyer is granted full access to the evidentiary material related to the case in the possession of the competent authorities , at the latest when the investigation of the criminal offence is concluded . the suspected or accused person or his lawyer may request a schedule of the evidentiary material in the possession of the competent authorities .


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


### prohibited elements and features may include but are not limited to texts , symbols , names , trade marks , figurative or other signs , misleading colours , inserts or other additional material such as adhesive labels , stickers , onserts , scratch - offs and sleeves or relate to the shape of the tobacco product itself . cigarettes with a diameter of less than 7 . 5 mm shall be deemed to be misleading . ### prohibited elements and features may include but are not limited to texts , symbols , names , trade marks , figurative or other signs or other additional material such as adhesive labels , stickers , onserts , scratch - offs and sleeves .


### prohibited elements and features may include but are not limited to texts , symbols , names , trade marks , figurative or other signs , misleading colours , inserts or other additional material such as adhesive labels , stickers , onserts , scratch - offs and sleeves or relate to the shape of the tobacco product itself . cigarettes with a diameter of less than 7 . 5 mm shall be deemed to be misleading . ### prohibited elements and features shall be symbols , names , trade marks , figurative or other signs , misleading colours , inserts or other additional material giving the impression that a particular tobacco product is less harmful than others .


### surrounded by a black border not less than 3 mm and not more than 4 mm in width inside the surface reserved for the text of the warning . ### surrounded by a black border inside the surface reserved for the text of the warning .


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


### the commission should monitor the developments and submit a report 5 years after the date of transposition of this directive , in order to assess whether amendments to this directive are necessary . ### the commission should monitor the developments and submit a report 3 years after the date of transposition of this directive , in order to assess whether amendments to this directive are necessary .


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


### printed in black helvetica bold type on a white background . in order to accommodate language requirements , member states may determine the point size of the font , provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required ; ### printed in black bold type on a white background . the warnings may be affixed by means of stickers , provided that the stickers are permanently attached to the packaging . in order to accommodate language requirements , member states may determine the point size of the font , provided that the font size specified in their legislation is such as to occupy the greatest possible proportion of the area set aside for the text required ;


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


### no later than five years from the date specified in article 25 paragraph 1 , the commission shall submit to the european parliament , the council , the european economic and social committee and the committee of the regions a report on the application of this directive . ### no later than three years from the date specified in article 25 paragraph 1 , the commission shall submit to the european parliament , the council , the european economic and social committee and the committee of the regions a report on the application of this directive .


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


### by way of derogation , paragraphs 1 and 2 shall not apply to the armed forces in member states where an equivalent and more specific protection system such as nato standard stanag 2345 is already in place and implemented . member states shall inform the commission of the existence and effective implementation of such protection systems when notifying the transposition of the provisions of this directive into national legislation in accordance with article 14 . ### by way of derogation , the exposure limits as set out in paragraphs 1 and 2 shall not apply to the armed forces in member states where an equivalent and more specific protection system such as nato standard stanag 2345 is already in place and implemented . member states shall inform the commission of the existence and effective implementation of such protection systems when notifying the transposition of the provisions of this directive into national legislation in accordance with article 14 .


### this directive lays down minimum requirements , thus giving member states the option of maintaining or adopting more favourable provisions for the protection of workers , in particular the fixing of lower values for the orientation values and action values or the exposure limit values for electromagnetic fields . however , the implementation of this directive should not serve to justify any regression in relation to the situation already prevailing in each member state . ### this directive lays down minimum requirements , thus giving member states the option of maintaining or adopting more favourable provisions for the protection of workers , in particular the fixing of lower values for the orientation values and action values or the exposure limit values for electromagnetic fields . however , the implementation of this directive must not serve to justify any regression in relation to the situation already prevailing in each member state .


### directive 2004 / 40 / ec should be repealed and more appropriate and proportionate measures protecting workers from the risks associated with electromagnetic fields should be introduced . however , it does not address the long - term effects , including possible carcinogenic effects of exposure to time - varying electric , magnetic and electromagnetic fields , for which there is currently no conclusive scientific evidence establishing a causal relationship . the present measures should be intended not only to ensure the health and safety of each worker on an individual basis , but also to create a minimum basis of protection for all union workers , while reducing possible distortions of competition . ### directive 2004 / 40 / ec should be repealed and more appropriate and proportionate measures protecting workers from the risks associated with electromagnetic fields should be introduced . the present measures should be intended not only to ensure the health and safety of each worker on an individual basis , but also to create a minimum basis of protection for all union workers , while reducing possible distortions of competition . this directive , by proposal of the commission , should be revised within 5 years in order to include the protection of workers to long - term effects as well as safety effects according to the scientific evidence to such effects caused by electromagnetic field exposure .


### ‘ adverse health effects’ : biological effects that have a detrimental effect on mental , physical and / or general well - being of exposed workers . in this directive , only short - term effects are considered ; ### ‘ adverse health effects’ : biological effects that have a detrimental effect on mental , physical and / or general well - being of exposed workers ;


### in any event , workers shall not be exposed above the exposure limit values for health effects unless the conditions under article 3 are fulfilled . if , despite the measures taken by the employer to comply with this directive , the exposure limit values for health effects are exceeded , the employer shall take immediate action to reduce exposure below these exposure limit values . the employer shall identify the reasons why the exposure limit values for health effects have been exceeded , and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again . ### in any event , workers shall not be exposed above the exposure limit values for health effects . if , despite the measures taken by the employer to comply with this directive , the exposure limit values for health effects are exceeded , the employer shall have a direct obligation to reduce exposure below these exposure limit values . the employer shall identify the reasons why the exposure limit values for health effects have been exceeded , and shall amend the protection and prevention measures accordingly in order to prevent them being exceeded again .


### without prejudice to articles 10 and 12 of directive 89 / 391 / eec , the employer shall ensure that workers who are exposed to risks from electromagnetic fields at work and / or their representatives receive any necessary information and training relating to the outcome of the risk assessment provided for in article 4 of this directive , concerning in particular : ### without prejudice to articles 10 and 12 of directive 89 / 391 / eec , the employer shall have an obligation to provide workers who are exposed to risks from electromagnetic fields at work and / or their representatives with any necessary information and training relating to the outcome of the risk assessment provided for in article 4 of this directive , concerning in particular :


### the amounts of direct payments within the meaning of article 2 of regulation no 73 / 2009 to be granted to a farmer in excess of eur 5000 for an aid application submitted in respect of calendar year 2013 shall be reduced by 4 . 981759&#160 ; % . ### the amounts of direct payments within the meaning of article 2 of regulation no 73 / 2009 to be granted to a farmer for an aid application submitted in respect of calendar year 2013 shall be reduced by [ xxx ] &#160 ; % .


### the amounts of direct payments within the meaning of article 2 of regulation no 73 / 2009 to be granted to a farmer in excess of eur 5000 for an aid application submitted in respect of calendar year 2013 shall be reduced by 4 . 981759% . ### the amounts of direct payments within the meaning of article 2 of regulation no 73 / 2009 to be granted to a farmer in excess of eur 5000 for an aid application submitted in respect of calendar year 2013 shall be reduced by 0 , 748005 % .


### the commission may declare a community emergency at the request of one competent authority or when the community loses more than 10% of its daily gas import from third countries as calculated by entso - g . it shall declare a community emergency where more than one competent authority has declared emergency following the verification in accordance with article 9 . it may declare a community emergency for specifically affected geographical regions comprising more than one member state . ### the commission may declare a community emergency at the request of one competent authority or when the community loses more than 10% of its daily gas import from third countries as calculated by entso - g . it shall declare a community emergency where at least one competent authority has declared emergency following the verification in accordance with article 9 . it may declare a community emergency for specifically affected geographical regions comprising at least one member state .


### however , under the current measures regarding the security of gas supply that have been taken at community level , member states still enjoy a large margin of discretion as to the choice of measures . where the security of supply of a member state is threatened , there is a clear risk that measures developed unilaterally by that member state may jeopardise the proper functioning of the internal gas market . recent experience has demonstrated the reality of that risk . to allow the internal gas market to function even in the face of a shortage of supply , it is therefore necessary to provide for a more coordinated response to supply crises , both concerning preventive action and the reaction to concrete disruptions of supply . ### however , under the current measures regarding the security of gas supply that have been taken at community level , member states still enjoy a large margin of discretion as to the choice of measures . where the security of supply of a member state is threatened , there is a clear risk that measures developed unilaterally by that member state may jeopardise the proper functioning of the internal gas market and the security of the protected and vulnerable customer . recent experience has demonstrated the reality of that risk . to allow the internal gas market to function even in the face of a shortage of supply , it is therefore necessary to provide for solidarity and coordination in the response to supply crisis , both concerning preventive action and the reaction to concrete disruptions of supply .


### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union for the purpose of amending the annexes to this regulation . ### the commission should be empowered to adopt delegated acts in accordance with article 290 of the treaty on the functioning of the european union for the purpose of amending the annexes to regulation no 648 / 2004 . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level .


### by 31 december 2014 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in household automatic dishwasher detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ” ### by 31 december 2016 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in industrial and institutional detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ”


### by 31 december 2014 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in household automatic dishwasher detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications . ### by 31 december 2016 , the commission shall evaluate , submit a report to the european parliament and to the council on the use of phosphates and other phosphorous compounds in industrial and institutional detergents and , if justified , present a legislative proposal with a view to their gradual phase - out or restriction to specific applications .


### pursuant to article 16 of regulation no 648 / 2004 , the commission has evaluated the use of phosphates in detergents in the report to the council and the european parliament concerning the use of phosphates6 . following further analysis , the commission has concluded that the use of phosphates in household laundry detergents should be limited in order to reduce the contribution of phosphates from detergents to eutrophication risks and to reduce the costs of phosphates removal in waste water treatment plants . those cost savings outweigh the cost of reformulating household laundry detergents with alternatives to phosphates . ### pursuant to article 16 of regulation no 648 / 2004 , the commission has evaluated the use of phosphates in detergents in the report to the council and the european parliament concerning the use of phosphates6 . following further analysis , the commission has concluded that the use of phosphates in household laundry detergents should be limited in order to reduce the contribution of phosphates from detergents to eutrophication risks and to reduce the costs of phosphates removal in waste water treatment plants . those cost savings outweigh the cost of reformulating household laundry detergents with alternatives to phosphates . however , it is critical to implement the adoption of technologies and related equipment to recover phosphorous in order to address the problem of the scarcity of that element .


### member states bordering a coastal zone or maritime area of a third country shall make every effort to coordinate their maritime spatial plans and integrated coastal management strategies with that third country in the marine region or sub - region and the related coastal zone concerned . ### member states bordering a coastal zone or maritime area of a third country shall , in compliance with international maritime law and conventions , consult that country and make every effort to cooperate and coordinate their maritime spatial plans and integrated coastal management strategies with that third country in the marine region or sub - region and the related coastal zone concerned .


### this directive establishes a framework for maritime spatial planning and integrated coastal management aiming at promoting the sustainable growth of maritime and coastal economies and the sustainable use of marine and coastal resources . ### this directive establishes a framework for maritime spatial planning and integrated coastal management , incorporating union - level sea basin strategies and macro - regional strategies where applicable , and aiming at promoting the sustainable socioeconomic and environmental development and growth of maritime and coastal spaces and the sustainable use of marine and coastal ecosystems and resources .


### ensuring climate resilient coastal and marine areas . ### ensuring that coastal and marine areas are more resilient to climate change impacts in order to protect vulnerable coastal areas ;


### when organising the collection and exchange of the data referred to in paragraph 1 , member states shall make use , as far as possible , of instruments and tools developed under the integrated maritime policy . ### when organising the collection and exchange of the data referred to in paragraph 1 , member states shall make use , as far as possible , of instruments and tools developed under the integrated maritime policy and other eu policies , such as the inspire directive .


### the integrated maritime policy identifies maritime spatial planning and integrated coastal management as cross - cutting policy tools for public authorities and stakeholders to apply a coordinated , integrated approach . the application of an ecosystem - based approach will contribute to promoting the sustainable growth of the maritime and coastal economies and the sustainable use of marine and coastal resources . ### the integrated maritime policy identifies maritime spatial planning and integrated coastal management as cross - cutting policy tools for public authorities and stakeholders to apply a coordinated , integrated approach . the application of an ecosystem - based approach will contribute to promoting the sustainable growth of the maritime and coastal economies and the sustainable use of marine and coastal resources and to preserving the social and economic traditions of coastal communities , in line with article 12 and article 6 of the protocol on integrated coastal zone management in the mediterranean .


### member states shall organise the collection of the best available data and the exchange of information necessary for maritime spatial plans and integrated coastal management strategies . ### member states shall organise the collection of the best and most recent available data and the exchange of information necessary for maritime spatial plans and integrated coastal management strategies , with the assistance of the european fisheries control agency and environmental or other agencies which may have relevant information .


### ‘ good environmental status’ means the environmental status referred to in article 3 of directive 2008 / 56 / ec . ### ‘ good environmental status’ means the environmental status referred to in article 3 of directive 2008 / 56 / ec and commission decision 2010 / 477 / eu .


### oil and gas extraction sites and infrastructures ; ### oil and gas – including shale gas – extraction sites and infrastructures ;


### ensuring the preservation , protection and improvement of the environment as well as the prudent and rational use of natural resources , notably in order to achieve good environmental status , halt the loss of biodiversity and degradation of ecosystem services and reduce marine pollution risks ; ### ensuring the preservation , protection and improvement of the environment through a representative and coherent network of protected areas , as well as the prudent , precautionary and rational use of natural resources , notably in order to achieve good environmental status , halt the loss of biodiversity and degradation of ecosystem services and to reduce and prevent marine and coastal areas pollution risks ;


### 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 apply an ecosystem - based approach , which equally promotes all three pillars of sustainable development , take account of land - sea interactions , and facilitate the co - existence and compatibility , and prevent conflicts over use , between competing sector activities in marine waters and coastal zones , and shall aim to contribute to the following eu objectives :


### 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 apply an ecosystem - based approach , which also takes due account of the need for economic balance and social acceptability , to facilitate the co - existence and prevent conflicts between competing sector activities in marine waters and coastal zones , and shall aim to contribute to :


### member states shall establish means for the public participation of all interested parties at an early stage in the development of maritime spatial plans and integrated coastal management strategies . ### member states shall establish means for the public participation of all stakeholders , the authorities at the various levels and the public concerned at an early stage in the development of maritime spatial plans and integrated coastal management strategies , in compliance with their national legal systems .


### fishing areas ; sea farming sites ; ### fishing , aquaculture , shellfishing and seaweed farming areas , and the potential for developing them ;


### each member state bordering a coastal zone or maritime area of another member state shall cooperate to ensure that maritime spatial plans and integrated coastal management strategies are coherent and coordinated across the coastal zone or marine region and / or sub - region concerned . such cooperation shall in particular take into account issues of a transnational nature , such as cross - border infrastructure . ### each member state bordering a coastal zone or maritime area of another member state shall cooperate to ensure that maritime spatial plans and integrated coastal management strategies are coherent and coordinated across the coastal zone or marine region and / or sub - region concerned . such cooperation shall in particular take into account issues of a transnational nature , such as cross - border infrastructure and the environment .


### maritime spatial plans shall contain at least a mapping of marine waters which identifies the actual and potential spatial and temporal distribution of all relevant maritime activities in order to achieve the objectives as set out in article 5 . ### in order to achieve the objectives as set out in article 5 , maritime spatial plans shall contain at least a mapping of marine waters and the land - sea interface which identifies the actual and potential spatial and temporal distribution of all relevant uses and human activities .


### maritime spatial planning and integrated coastal management should apply the ecosystem - based approach as referred to in article 1 of directive 2008 / 56 / ec so as to ensure that the collective pressure of all activities is kept within levels compatible with the achievement of good environmental status and that the capacity of marine ecosystems to respond to human - induced changes is not compromised , while enabling the sustainable use of marine goods and services by present and future generations . ### maritime spatial planning and integrated coastal management should apply the ecosystem - based approach as referred to in article 1 of directive 2008 / 56 / ec , having regard to the principle of subsidiarity and taking account of the precautionary principle and of the principle that preventive action should be taken , as laid down in article 191 of the treaty on the functioning of the european union , so as to ensure that the collective pressure of all maritime and coastal activities is kept within levels compatible with the achievement of good environmental status and with the conservation of natural resources , and that the capacity of marine ecosystems to respond to human induced changes is not compromised , while enabling the sustainable use of marine goods and services by present and future generations .


### 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 planning and integrated coastal management strategies , member states shall give due regard to the particularities of the marine and coastal regions and sub - regions , the existing and planned sector activities , their impact on the environment , the impact on the local communities and the expected impacts of climate change .


### ‘ marine waters’ means the waters , the seabed and subsoil as defined in article 3 of directive 2008 / 56 / ec . ### ‘ marine waters’ means the waters , the seabed and subsoil on the seaward side of the baseline from which the breadth of territorial waters is measured extending to the outmost reach of the area where a member state has and / or exercises jurisdiction , in accordance with the unclos , with the exception of waters adjacent to the countries and territories mentioned in annex ii to the treaty and the french overseas departments and collectivities ;


### 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 .


### the pharmacovigilance risk assessment advisory committee , which shall be responsible for providing advice to the committee for medicinal products for human use and the coordination group on any question relating to the pharmacovigilance of medicinal products for human use ; ### the pharmacovigilance risk assessment committee , which shall be responsible for making a recommendation to the committee for medicinal products for human use and the coordination group on any question relating to the pharmacovigilance of medicinal products for human use ;


### for the fulfilment of its pharmacovigilance tasks , it shall be assisted by the pharmacovigilance risk assessment advisory committee referred to in article 56 . ### for the fulfilment of its pharmacovigilance tasks , it shall rely on the recommendation of the pharmacovigilance risk assessment committee referred to in article 56 . the word « advisory » should be removed from the title of the pharmacovigilance risk assessment committee so that it better reflects the powers of the committee . if adopted the name will be changed throughout the text .


### within 30 days of receipt of the report by the pharmacovigilance risk assessment advisory committee , the committee for medicinal products for human use shall consider the report and adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisation concerned . where the opinion states that regulatory action is necessary , the commission shall adopt a decision to vary , suspend or revoke the marketing authorisation . article 10 of this regulation shall apply to the adoption of that decision . where the commission adopts such decision , it may also adopt a decision addressed to the member states pursuant to article 127a of directive 2001 / 83 / ec . ### within 30 days of receipt of the recommendation by the pharmacovigilance risk assessment committee , the committee for medicinal products for human use shall adopt an opinion on the maintenance , variation , suspension or revocation of the marketing authorisation concerned . the chmp shall only adopt an opinion which differs from the recommendation of the pharmacovigilance risk assessment committee , if there exist strong scientific and public health grounds for doing so . the chmp shall explain these grounds in a justification which it shall annex to its opinion . where the opinion states that regulatory action is necessary , the commission shall adopt a decision to vary , suspend or revoke the marketing authorisation . article 10 of this regulation shall apply to the adoption of that decision . where the commission adopts such decision , it may also adopt a decision addressed to the member states pursuant to article 127a of directive 2001 / 83 / ec .


### 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 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 advisory committee shall be composed of the following : ten members and ten alternates appointed by the management board , following consultation with the national competent authorities and on the basis of their relevant expertise in pharmacovigilance and the risk assessment of medicinal products for human use , as laid down in paragraph 2 ; 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 represent it in the committee . the alternates shall represent and vote for the members in their absence .


### activities relating to pharmacovigilance , to the operation of communications networks and to market surveillance shall be under the permanent control of the management board in order to guarantee the independence of the agency . this shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of these activities by the agency . ### activities relating to pharmacovigilance , to the operation of communications networks and to market surveillance shall be under the permanent control of the management board in order to guarantee the independence of the agency and shall receive public financing commensurate with the tasks set . this shall not preclude the indirect collection of additional resources for the carrying out of these activities by the agency , on condition that its independence is strictly guaranteed .


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


### sustainable and inclusive development in all aspects , poverty reduction , including through private - sector development ; promotion of internal economic , social and territorial cohesion , rural development , climate action and disaster resilience ; ### sustainable , equitable and inclusive development , hunger and poverty reduction , promotion of economic , social and territorial cohesion , rural development , combating climate change , disaster resilience and promotion of r&d ;


### 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 .


### 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 disseminate only validated information and to distinguish non - promotional information from advertising , the types of information , it is appropriate to allow marketing authorisation holders to make available the last updated version of the approved summaries of product characteristics and of the approved package leaflet .


### member states shall ensure that requests for information to a marketing authorisation holder on a medicinal product subject to medical prescription by a member of the general public may be drafted in any of the official languages of the community which are official languages in the member states where the medicinal product is authorised . the reply shall be drafted in the language of the request . ### member states shall ensure that requests for information to a marketing authorisation holder on a medicinal product subject to medical prescription by a member of the general public may be drafted in any of the official languages of the community which are official languages in the member states where the medicinal product is authorised . the reply shall be drafted in the language of the request . the replies shall be kept available for inspections by national competent authorities .


### 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 .


### 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 .


### 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 . ### communication to the general public on prescription - only medicinal products by marketing authorisation holders should only be provided in writing through specific channels of communication , including internet , to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited communication to the public . where information is disseminated via television , web tv , video broadcast materials , newspapers , magazines and similar publications , or radio , patients are not protected against such unsolicited communication and such dissemination should therefore not be allowed .


### 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 .


### 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 allow the marketing authorisation holder to disseminate , either directly or indirectly through a third party , information that has been officially approved by national or european competent authorities 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 . 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 :


### 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 .


### 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 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 patient leaflet .


### 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 .


### 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 make available material which is in compliance with title viiia of directive 2001 / 83 / ec . member states should adopt rules establishing effective independent 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 .


### 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 be made available through specific channels of communication including health professionals , officially validated internet websites , information booklets and medical journals 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 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 .


### 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 make available material which is in compliance with title viiia of directive 2001 / 83 / ec . member states should adopt rules establishing effective independent monitoring mechanisms and allowing effective enforcement in cases of non - compliance . monitoring should be based on the control of information prior to its dissemination .


### 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 .


### 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 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 make available the contents of the approved summaries of product characteristics and package leaflet and the public assessment reports .


### the member state where the internet website has been registered shall be responsible for the monitoring of the contents disseminated on that website . ### the marketing authorisation holder shall send the new contents and changes to the competent authorities of the member state where the internet website has been registered for prior approval before making available the monitoring of the contents or changes on its website .


### member states shall ensure that marketing authorisation holders ' internet websites for the dissemination of information on medicinal products subject to medical prescription reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official languages of the member states where they are authorised . ### member states shall ensure that marketing authorisation holders ' internet websites reproduce the last updated version as approved by the competent authorities of the summary of product characteristics and of the package leaflet of the medicinal products subject to medical prescription they commercialise in the official languages of the member states where they are authorised .


### 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 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 there are adequate and effective methods of monitoring to avoid misuse when announcements on authorised medicinal products subject to medical prescription are made available by the marketing authorisation holder to the general public or members thereof .


### 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 : health - related publications as defined by the member state of publication , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; b ) internet websites on medicinal products , to the exclusion of unsolicited material actively distributed to the general public or members thereof ; c ) written answers to requests for information of a member of the general public . ### communication 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 , web tv , video broadcast materials , newspapers , magazines and similar publications or radio . it shall only be made available through the internet websites of the marketing authorisation holder , in order to prevent that unsolicited material is actively distributed to the general public or members thereof ;


### - factual , informative announcements and reference material relating , for example , to pack changes , adverse - reaction warnings as part of general drug precautions , trade catalogues and price lists , provided they include no product claims ; ### - factual , informative announcements and reference material relating , for example , to information on the environmental risk of the medicinal product , availability , pack changes , adverse - reaction warnings as part of general drug precautions , trade catalogues and price lists , provided they include no product claims and do not induce to or promote the consumption of the medicinal product ;


### provisions should be established to ensure that only high - quality non - promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated . the information should take into account patients needs and expectations in order to empower patients , allow informed choices and enhance the rational use of medicinal products . therefore , any information to the general public on prescription - only medicinal products should comply with a set of quality criteria . ### provisions should be established to ensure that only high - quality non - promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated . the information should take into account patients needs and expectations in order to empower patients , allow informed choices and enhance the rational use of medicinal products . therefore , any information to the general public on prescription - only medicinal products should comply with a set of quality criteria : objective and unbiased , patient - oriented , evidence - based , up - to - date , reliable , understandable , accessible , transparent , relevant , consistent with statutory information .


### 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 .


### experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to provide information result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the community . ### experience gained from the application of the current legal framework has also shown that the distinction between the notions of advertising and information is not clear across the community , resulting in exposure of the general public is disguised advertising .


### 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 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 in the context of a wider information to patients’ strategy . furthermore , the directive does not provide channels through which this information may be disseminated and does not provide for a package leaflet which is patient - friendly and responds to the real needs of patients . the package leaflet should therefore be transformed into a patient leaflet .


### provisions should be established to ensure that only high - quality non - promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated . the information should take into account patients needs and expectations in order to empower patients , allow informed choices and enhance the rational use of medicinal products . therefore , any information to the general public on prescription - only medicinal products should comply with a set of quality criteria . ### provisions should be established to ensure that only reliable and comparative information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated , notably using the community database referred to in articles 57 and 57 of regulation no 726 / 2004 . the information should take into account patients needs and expectations in order to empower patients , allow informed choices and enhance the rational use of medicinal products .


### 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 .


### articles 16 , 17 and 18 are deleted . ### articles 16 , 17 and 18 are deleted . without prejudice to the provisions of article 1a , the commission shall ensure that the provisions contained in the deleted articles are reflected in community rules relating to beef , updated and improved as necessary .


### section ii of title ii of regulation no 1760 / 2000 lays down rules for a voluntary beef labelling system which provide for the approval of certain labelling specifications by the competent authority of the member state . the administrative burden and the costs incurred by member states and economic operators in applying this system are not proportionate to the benefits of the system . that section should therefore be deleted . ### section ii of title ii of regulation no 1760 / 2000 lays down rules for a voluntary beef labelling system which provide for the approval of certain labelling specifications by the competent authority of the member state . all labelling specifications which go beyond the mandatory labelling , for example , breed , feed and husbandry , are extremely important to consumers as well as to farmers who use this labelling to market their products . in order to ensure that the information is accurate and reliable , this section must therefore be maintained .


### electronic identification systems based on radio frequency identification have considerably improved in the last ten years . that technology allows a faster and more accurate reading of individual animal identity codes directly into data processing systems resulting on a reduction of time needed to trace potential infected animals or infected food , saving labour costs but at the same time increasing equipment costs . ### electronic identification systems based on radio frequency identification have considerably improved in the last ten years . that technology allows a faster and more accurate reading of individual animal identity codes directly into data processing systems resulting on a reduction of time needed to trace potential infected animals or infected food , leading to improved data bases and an increased capacity to react promptly in the event of disease outbreaks , saving labour costs but at the same time increasing equipment costs .


### 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 would guarantee exemplary food safety levels for eu citizens . it is therefore appropriate that a transition period for the introduction of eid is established in order to use up the stock of traditional ear tags . under such a regime , eid would quickly be chosen by keepers that are likely to have immediate economic benefits .


### electronic identification systems based on radio frequency identification have considerably improved in the last ten years . that technology allows a faster and more accurate reading of individual animal identity codes directly into data processing systems resulting on a reduction of time needed to trace potential infected animals or infected food , saving labour costs but at the same time increasing equipment costs . ### electronic identification systems based on radio frequency identification have considerably improved in the last ten years , even though iso standards still need to be applied , and they need to be tested for bovines . that technology allows a faster and more accurate reading of individual animal identity codes directly into data processing systems resulting on a reduction of time needed to trace potential infected animals or infected food , saving labour costs but at the same time increasing equipment costs .


### a financial contribution to the eib to the provisioning and capital allocation for loans or guarantees to be issued by the eib on its own resources under the risk - sharing instrument for project bonds in the field of ten - t and ten - e . the union exposure to the risk sharing instrument , including management fees and other eligible costs , shall be strictly limited to the amount of the union contribution to the risk - sharing instrument for project bonds and there shall be no further liability on the general budget of the union . the residual risk inherent in all operations shall be borne by 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 . in 2012 and 2013 , an amount of up to eur 210 million , of which up to eur 200 million for transport projects and up to eur 10 million for energy projects , may be redeployed for the risk - sharing instrument for project bonds in accordance with the procedure referred to in article 15 from the ten - t and ten - e budget lines , respectively . the risk - sharing instrument for project bonds may reuse any revenues received within the investment period for new loans and guarantees . ### during a pilot phase in the years 2012 and 2013 , a financial contribution to the eib to the provisioning and capital allocation for loans or guarantees to be issued by the eib on its own resources under the risk - sharing instrument for project bonds in the field of ten - t and ten - e . the union exposure to the risk sharing instrument , including management fees and other eligible costs , shall in no case exceed the amount of the union contribution to the risk - sharing instrument for project bonds . there shall be no further liability on the general budget of the union . the residual risk inherent in all operations shall always be borne by 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 . in 2012 and 2013 , an amount of up to eur 210 million , of which up to eur 200 million for transport projects and up to eur 10 million for energy projects , may be redeployed for the risk - sharing instrument for project bonds in accordance with the procedure referred to in article 15 from the ten - t and ten - e budget lines , respectively . the risk - sharing instrument for project bonds may reuse any revenues received within the investment period for new loans and guarantees . in addition to the reporting requirements set out in point 49 of the interinstitutional agreement on budgetary discipline and sound financial management and without prejudice to any other regulatory reporting requirements , the commission shall submit a report to the european parliament and the council every 6 months during the pilot phase . on the basis of the evaluation referred to in article 16 of this regulation , the commission shall propose appropriate regulatory changes , in particular if the predicted market uptake is not satisfactory or in the event that alternative sources of long - term debt financing become sufficiently available .


### 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 should be launched no later than 31 july 2012 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 europe 2020 project bond initiative has a double objective : first to help finance projects of european policy priorities , and second , to facilitate greater private sector involvement in the long - term capital market financing of infrastructure projects . it will redirect some eu budget spending towards growth - enhancing areas , taking into account the unions budgetary discipline and the ceilings under the current multiannual financial framework . ### the pilot phase for the europe 2020 project bond initiative has a double objective : first to help finance projects of european policy priorities , and second , to facilitate greater private sector involvement in the long - term capital market financing of infrastructure projects . it will redirect some eu budget spending towards growth - enhancing areas , taking into account the union’s budgetary discipline and the ceilings under the current multiannual financial framework .


### ‘ 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 2014 , the commission shall submit a proposal concerning co2 emission targets for new light commercial vehicles for the period beyond 2020 . the new target value shall be calculated so as to enable the objectives set out the ‘ roadmap to a single european transport area – towards a competitive and resource - efficient transport system’ , including a 60% reduction in ghg emissions from traffic by 2050 , to be achieved . this proposal shall be based on the new worldwide test cycle . if no agreement is reached on this standard by april 2014 , the proposal shall be based on the established test cycle . the proposal for a new co2 limit value shall also incorporate : - a life - cycle assessment of co2 emissions from new light vehicles as indicated in the commission communication of 20 september 2011 ‘ roadmap to a resource - efficient europe’ the results shall be taken into account in the limit value assessment . - rde data .


### 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 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 with the aim of reaching , by the year 2025 , a target within a range of 100 g co2 / km to 115 g co2 / km , unless a lower target is duly justified in the light of the use of low - emission technologies and their uptake by the market . on the basis of this review , which shall include an overall assessment of the impact on the automotive industry and its dependent industries , the commission shall , if appropriate , make a proposal to amend this regulation in a way which is cost - effective and as neutral as possible from the point of view of competition and ensures the achievement of the union ' s long term objectives in combating climate change .