### 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 to interpreting and translation , – the right of access to legal assistance and the conditions for access to legal assistance free of charge , – the right to be informed of the charge , – the right to be given access to the case - file and to the evidence , including evidence held by the authorities , insofar as this does not compromise investigations , – the right to remain silent , – the right to request the collection of evidence , – the right to be brought promptly before a court if the suspected or accused person is arrested .


### 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 in a language that the suspected or accused person understands . in the case of a child or a person with a mental disability , information about the accusation shall be provided in a manner appropriate to his age , level of maturity and intellectual and emotional capabilities .


### the size of the internal market in tobacco and related products , the increasing tendency of manufacturers of tobacco products to concentrate production for the whole of the union in only a small number of production plants within the member states and the resulting significant cross - border trade of tobacco and related products calls for legislative action at union rather than national level to achieve the smooth operation of the internal market . ### the size of the internal market in tobacco and related products , the increasing tendency of manufacturers of tobacco products to concentrate production for the whole of the union in only a small number of production plants within the member states and the resulting significant cross - border trade of tobacco and related products calls for stronger legislative action at union level to achieve the smooth operation of the internal market .


### in accordance with article 114 of the treaty of the functioning of the european union , a high level of health protection should be taken as a basis , regard being had , in particular , to any new developments based on scientific facts . tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco , health protection should be given high importance , in particular to reduce smoking prevalence among young people . ### in accordance with article 114 of the treaty of the functioning of the european union , a high level of health protection should be taken as a basis , regard being had , in particular , to any new developments based on scientific facts . tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco , health protection should be given high importance , in particular to reduce smoking prevalence among young people . smoking is a current and global problem with devastating consequences , and adolescence is when most smokers start consuming tobacco .


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


### council directive 89 / 622 / eec of 13 november 1989 on the approximation of the laws , regulations and administrative provisions of the member states concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use38 prohibited the sale in the member states of certain types of tobacco for oral use . directive 2001 / 37 / ec confirmed this prohibition . article 151 of the act of accession of austria , finland and sweden grants the kingdom of sweden derogation from this prohibition39 . the prohibition of the sale of oral tobacco should be maintained in order to prevent the introduction to the internal market of a product that is addictive , has adverse health effects and is attractive to young people . for other smokeless tobacco products that are not produced for the mass market , a strict labelling and ingredients regulation is considered sufficient to contain market expansion beyond their traditional use . ### council directive 89 / 622 / eec of 13 november 1989 on the approximation of the laws , regulations and administrative provisions of the member states concerning the labelling of tobacco products and the prohibition of the marketing of certain types of tobacco for oral use38 prohibited the sale in the member states of certain types of tobacco for oral use . directive 2001 / 37 / ec confirmed this prohibition . article 151 of the act of accession of austria , finland and sweden grants the kingdom of sweden derogation from this prohibition39 . however , the ban on tobacco products for oral use , should not affect historically traditional tobacco products for oral use , marketing of which may be allowed by individual member states . for other smokeless tobacco products that are not produced for the mass market , a strict labelling and ingredients regulation is considered sufficient to contain market expansion beyond their traditional use .


### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . 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 . ### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . 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 . children and young people must be educated , as this is the simplest and most effective way of preventing young people from starting to smoke . consideration should also be given to creating a fund financed by the manufacturers of tobacco products , which would be used to fund anti - smoking campaigns . member states should harmonise the legal age for purchasing tobacco products at 18 .


### all tobacco products have the potential to cause mortality , morbidity and disability and their consumption should be contained . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the development and submit a report 5 years after the transposition deadline of this directive , in order to assess whether amendments to this directive are necessary . ### all tobacco products have the potential to cause mortality , morbidity and disability and their manufacture , distribution and consumption should be regulated . it is therefore important to monitor developments as regards novel tobacco products . a notification obligation for novel tobacco products should be put on manufacturers and importers , without prejudice to the power of the member states to ban or to authorise them . the commission should monitor the development and submit a report 5 years after the transposition deadline of this directive , in order to assess whether amendments to this directive are necessary .


### ' additive ' means substance contained in a tobacco product , its unit packet or any outside packaging with the exception of tobacco leaves and other natural or unprocessed parts of tobacco plants ; ### ‘ additive’ means substance contained in a tobacco product with the exception of tobacco leaves and other natural or unprocessed parts of tobacco plants ;


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


### vitamins and other additives that create the impression that a tobacco product has a health benefit or presents reduced health hazards , or ### vitamins , or


### caffeine and taurine and other additives and stimulant compounds that are associated with energy and vitality , or ### caffeine and taurine , or


### in order to ensure their graphic integrity and visibility , health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet . ### in order to ensure their graphic integrity and visibility , and without prejudice to the labelling provisions in article 10 and 11 , health warnings shall be irremovably printed , indelible and in no way hidden or interrupted , including by tax stamps , price marks , tracking and tracing marks , security features or by any type of wrapper , pouch , jacket , box or other device or by the opening of the unit packet .


### height : not less than 64 mm ; ### height : not less than 50 mm ;


### define the position , format , layout , design , rotation and proportions of the health warnings ; ### define the position , layout , design and rotation of the health warnings ;


### the general warning shall be printed on the most visible surface of the unit packet and any outside packaging . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed on the other most visible surface of the unit packet and any outside packaging . ### the general text warning shall be printed on the most visible surface of the unit packet and any outside packaging with the exception of transparent packaging used in retail sales . the text warnings listed in annex i shall be rotated in such a way as to guarantee their regular appearance . these warnings shall be printed on the other most visible surface of the unit packet and any outside packaging with the exception of transparent packaging used in retail sales .


### the general warning and the text warning referred to in paragraph 1 shall be : ### the general text warning and the text warning referred to in paragraph 1 shall be :


### 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 helvetica bold type on a white background . the warnings may be displayed by means of stickers , provided that such stickers cannot be removed . 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 part of the area set aside for the text required ;


### be printed on the two largest surfaces of the unit packet and any outside packaging ; ### be printed on the most visible surface of the unit packet and additionally on any outside packaging used in connection with the product , with the exception of additional fully transparent wrappers .


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of cigarettes shall have a cuboid shape . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g .


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with or without a flap that covers the opening . the flap , if any , of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g .


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


### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 20 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g . ### a unit packet of cigarettes shall have a cuboid shape . a unit packet of roll - your - own tobacco shall have the form of a pouch , i . e . a rectangular pocket with a flap that covers the opening . the flap of the pouch shall cover at least 70% of the front of the packet . a unit packet of cigarettes shall include at least 19 cigarettes . a unit packet of roll - your - own tobacco shall contain tobacco weighing at least 40 g .


### a cigarette packet can be of carton or soft material and shall not contain an opening that can be re - closed or re - sealed after the opening is first opened , other than the flip - top lid . the flip - top lid of a cigarette packet shall be hinged only at the back of the packet . ### a cigarette packet can be of carton or soft material and shall not contain an opening that can be re - closed or re - sealed after the opening is first opened , other than the flip - top lid . the flip - top lid , if any , of a cigarette packet shall be hinged only at the back of the packet .


### member states shall ensure that all unit packets of tobacco products shall be marked with a unique identifier . in order to ensure their integrity , unique identifiers shall be irremovably printed / affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or by the opening of the packet . in relation to products manufactured outside the union the obligations laid down in this article apply only to those destined to or placed on the union market . ### member states shall ensure that all unit packets of tobacco products shall be marked with a unique , safe and impossible to duplicate identifier . in order to ensure their integrity , unique identifiers shall be irremovably printed / affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or by the opening of the packet . in relation to products manufactured outside the union the obligations laid down in this article apply only to those destined to or placed on the union market .


### the unique identifier shall allow determining : ### the identifier referred to in paragraph 1 shall allow determining :


### in addition to the unique identifier , member states shall require that all unit packets of tobacco products which are placed on the market carry a visible , tamper proof security feature of at least 1 cm² , which shall be irremovably printed or affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or other elements mandated by legislation . ### in addition to the identifier referred to in paragraph 1 , member states shall require that all unit packets of tobacco products which are placed on the market carry a visible , tamper proof security feature of at least 1 cm² , which shall be irremovably printed or affixed , indelible and in no way hidden or interrupted in any form , including through tax stamps and price marks , or other elements mandated by legislation .


### member states shall prohibit the placing on the market of tobacco for oral use , without prejudice to article 151 of the act of accession of austria , finland and sweden . ### member states shall prohibit the placing on the market of tobacco for oral use , without prejudice to article 151 of the act of accession of austria , finland and sweden . this ban shall , however , not affect traditional tobacco products for oral use , which may be allowed by individual member states .


### member states shall prohibit the placing on the market of tobacco for oral use , without prejudice to article 151 of the act of accession of austria , finland and sweden . ### member states shall regulate the placing on the market of tobacco for oral use , without prejudice to article 151 of the act of accession of austria , finland and sweden .


### notification of novel tobacco products ### market approval for and notification of novel tobacco products and less harmful products


### member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco product they intend to place on the markets of the member states concerned . the notification shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers notifying a novel tobacco product shall also provide the competent authorities in question with : ### member states shall conduct a market approval system for tobacco products with a lower risk which shall be carried out for a reasonable fee . member states shall require that manufacturers and importers of tobacco products notify the competent authorities of member states of any novel tobacco products and for all tobacco products with a lower risk they intend to place on the markets of the member states concerned by means of an application . this application shall be submitted in electronic form six months before the intended placing on the market and shall be accompanied by a detailed description of the product in question , all proposed labelling , conditions of use , the product composition , manufacturing and control processes as well as information on ingredients and emissions in accordance with article 5 . the manufacturers and importers applying for a marketing authorization for tobacco products with a lower risk shall also provide the competent authorities in question with :


### available scientific studies on toxicity , addictiveness and attractiveness of the product , in particular as regards its ingredients and emissions ; ### relevant scientific studies on the toxicity of the product , in particular as regards its ingredients and emissions ;


### available studies and market research on preferences of various consumer groups , including young people and ### available studies and market research on the perception and use of the product including labelling by consumers as well as to the preferences of various consumer groups , especially young people and


### novel tobacco products placed on the market shall respect the requirements set out in this directive . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 . ### lower - risk tobacco products placed on the market shall respect the requirements set out in this directive . because of the various risk - reducing properties of these tobacco products , it is necessary to adjust accordingly the measuring methods referred to in article 4 , content regulation referred to in article 6 and labelling and packaging referred to in articles 7 , 8 , 9 , 10 , 12 and 13 . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 .


### novel tobacco products placed on the market shall respect the requirements set out in this directive . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 . ### novel tobacco products placed on the market shall respect the requirements set out in this directive . the provisions applicable depend on whether the products fall under the definition of smokeless tobacco product in point of article 2 or tobacco for smoking in point of article 2 . new tobacco products that have been scientifically proven to be less harmful than conventional tobacco products may , by way of derogation from the provisions of article 12 , be labelled with information on their reduced harmfulness .


### the level of exposure to electromagnetic fields can be more effectively reduced by incorporating preventive measures into the design of workstations and by selecting work equipment , procedures and methods so as to give priority to reducing the risks at source . provisions relating to work equipment and methods thus contribute to the protection of the workers involved . there is however a need to avoid the duplication of assessments , where work equipment meets the requirements of eu product legislation that establishes more severe safety levels than those provided for by this directive and especially directive 1999 / 5 / ec and 2006 / 95 / ec . this allows for simplified assessment in a large group of cases . ### the level of exposure to electromagnetic fields can be more effectively reduced by incorporating preventive measures into the design of workstations and by selecting work equipment , procedures and methods so as to give priority to reducing the risks at source . provisions relating to work equipment and methods thus contribute to the protection of the workers involved . in addition , it is imperative that the work procedures and methods are linked to compulsory training in awareness and prevention of the risks involved in failing to wear safety equipment or follow safety instructions and that training and work methods are assessed in accordance with directive 1999 / 5 / ec of the european parliament and of the council of 9 march 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity1 and directive 2006 / 95 / ec of the european parliament and of the council of 12 december 2006 on the harmonisation of the laws of member states relating to electrical equipment designed for use within certain voltage limits2 and be subject to strict controls and dissuasive sanctions for employers who fail to comply . ________________ 1 oj l 91 , 7 . 4 . 1999 p . 10 . 2 oj l 374 , 27 . 12 . 06 p . 10 .


### this directive , which is the 20th individual directive within the meaning of article 16 of directive 89 / 391 / eec , lays down minimum requirements for the protection of workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields during their work . ### this directive , which is the 20th individual directive within the meaning of article 16 of directive 89 / 391 / eec , lays down minimum requirements for the protection of workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields in the context of their professional activity . in accordance with the annex to directive 89 / 391 / eec , the present directive covers the following areas : workplaces , work equipment , personal protection equipment , work with visual display equipment , handling heavy loads where there is a risk of back injury , temporary and mobile construction sites , fishery and agriculture .


### directive 89 / 391 / eec shall apply fully to the whole area referred to in paragraph 1 , without prejudice to more stringent and / or more specific provisions contained in this directive . ### directive 89 / 391 / eec shall apply fully to the whole area referred to in paragraph 1 , without prejudice to more stringent or more specific provisions and / or certain exemptions for mri and related activities contained in this directive .


### ‘ exposure limit values’ : limits on exposure to electromagnetic fields which have been established on the basis of known health effects and biological considerations . compliance with the exposure limits values for health effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health effects . compliance with the exposure limits values for safety effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health and safety effects ; ### ‘ exposure limit values’ : limits on exposure to electromagnetic fields which have been established on the basis of known health effects and biophysical considerations . compliance with the exposure limits values for safety effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health and safety effects . compliance with the exposure limits values for safety effects will ensure that workers exposed to electromagnetic fields are protected against all known adverse health and safety effects ;


### exposure limit values as well as orientation and action values for both electric and magnetic fields in the frequency range from 0 to 100 khz shall be as set out in annex ii . ### exposure limit values as well as orientation and action values for both electric and magnetic fields in the frequency range from 0 to 100 khz shall be as set out in annex ii . the limit values shall apply whether the applications are technical or medical in nature .


### exposure limit values as well as orientation and action values for both electric and magnetic fields in the frequency range from 0 to 100 khz shall be as set out in annex ii . ### exposure limit values as well as orientation and action values for both electric and magnetic fields in the frequency range from 0 to 100 khz shall be as set out in annex ii and shall apply to all technical and medical applications .


### without prejudice to paragraphs 4 and 5 , workers may not be exposed above the exposure limit values for health effects . for specific situations where these values may temporarily be exceeded , member states may put in place a system authorising work under controlled conditions and on the basis of a comprehensive risk assessment setting out the actual exposure levels and their likelihood and comparing them to the exposure limit values defined in annexes ii and iii . such specific situations shall be reported to the commission in the report referred to rin article 17a of directive 89 / 391 / eec . ### without prejudice to paragraphs 4 and 5 , workers may not be exposed above the exposure limit values for health effects . for specific situations where these values may temporarily be exceeded , member states may put in place a system authorising work under controlled conditions and on the basis of a comprehensive risk assessment setting out the actual exposure levels and their likelihood and comparing them to the exposure limit values defined in annexes ii and iii . such specific situations shall be reported to the commission in the report referred to in article 17a of directive 89 / 391 / eec .


### the reduction of risks arising from exposure to electromagnetic fields shall be based on the general principles of prevention set out in directive 89 / 391 / eec . ### the reduction of risks arising from exposure to electromagnetic fields shall be based on general principles which , in line with article 6 of directive 89 / 391 / eec , are similar to the general obligations on employers . these general principles are : avoiding risks ; evaluating the risks which cannot be avoided ; combating the risks at source ; adapting the work to the individual , especially as regards the design of work places , the choice of work equipment and the choice of working and production methods ; adapting to technical progress ; replacing the dangerous by the non - dangerous or the less dangerous ; developing a prevention policy ; giving collective protective measures priority over individual protective measures ; giving appropriate instructions to the workers .


### 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 ensure that workers who are exposed to risks from electromagnetic fields at work and 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 :


### safe working practices to minimise risks from exposure . ### safe working practices and equipment to minimise risks from exposure .


### take into account the adoption of directives in the field of technical harmonisation and standardisation with regard to the design , building , manufacture or construction of work equipment or workplaces ; ### take into account the adoption of directives in the field of technical harmonisation and standardisation with regard to the building , manufacture or construction of work equipment or workplaces ;


### the delegation of power referred to in article 10 shall be conferred for an indeterminate period of time from [ the date of entry into force of the present directive ] . ### the delegation of power referred to in article 10 shall be conferred on the commission for a period of five years from … [ the date of entry into force of the present directive ] . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### delegated acts adopted under this article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2 . the notification of a delegated act to the european parliament and to the council shall state the reasons for the use of the urgency procedure . ### delegated acts adopted under this article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2 . the notification of a delegated act to the european parliament and to the council shall state the reasons for the use of the urgency procedure for compelling reasons relating to the health and protection of workers .


### the report to be established in accordance to article 17 of directive 89 / 391 / eec shall notably report on the effectiveness of the directive in reducing exposure to electromagnetic fields and the percentage of workplaces that required corrective action . ### without prejudice to the report to be established in accordance with article 17 of directive 89 / 391 / eec , the commission shall draft a specific report within five years from … [ the date of entry into force of this directive ] . this specific report shall notably report on the effectiveness of the exposure directive in reducing exposure to electromagnetic fields and the percentage of workplaces that required corrective action .


### a relevant notification threshold is a percentage that equals 0 . 2% of the value of the issued share capital of the company concerned and each 0 . 1% above that . ### a relevant notification threshold is a percentage that equals 1% of the value of the issued share capital of the company concerned and each 0 . 1% above that .


### by posting firm , simultaneous two way quotes of comparable size and at competitive prices , with the result of providing liquidity on a regular and ongoing basis to the market ; ### by posting regular and permanent two way quotes of comparable size and at competitive prices , with the result of providing liquidity on a regular and ongoing basis to the market ;


### the competent authority of the home member state may prohibit the use of the exemption if it considers that the natural or legal person does not satisfy the conditions of the exemption . any prohibition shall be imposed within the thirty calendar day period referred to in the first subparagraph or subsequently if the competent authority becomes aware that there has been any changes in the circumstances of the person so that they no longer satisfy the conditions . ### the competent authority of the home member state may prohibit the use of the exemption if it considers that the natural or legal person does not satisfy the conditions of the exemption . any prohibition shall be imposed within the fifteen calendar day period referred to in the first subparagraph or subsequently if the competent authority becomes aware that there has been any changes in the circumstances of the person so that they no longer satisfy the conditions .


### the fall in value shall be 10% or more in the case of a share and for other classes of financial instruments an amount to be specified by the commission . ### the fall in value shall be 15% or more in the case of a share and for other classes of financial instruments an amount to be specified by the commission .


### powers are delegated to the commission to adopt regulatory technical standards specifying the method of calculation of the 10% fall for shares and of the fall in value specified by the commission as referred to in paragraph 4 . ### powers are delegated to the commission to adopt regulatory technical standards specifying the method of calculation of the 15% fall for shares and of the fall in value specified by the commission as referred to in paragraph 4 .


### a competent authority shall publish on its website notice of any decision to impose or renew any measure referred to in articles 16 to 19 . ### both the esma and the competent authority shall publish on its website notice of any decision to impose or renew any measure referred to in articles 16 to 19 .


### an explanation about the purpose of the transaction and whether it is for the purposes of hedging against a risk or otherwise ; ### an explanation about the purpose of the transaction ;


### the forecasts for the direct payments and market related expenditure determined in the preparation of the 2014 draft budget show that the annual ceiling for the european agricultural guarantee fund in respect of financial year 2014 is likely to be exceeded taking into account the need to establish the reserve for crises referred to in the conclusions of the european council on the multiannual financial framework . an adjustment rate to the direct payments listed in annex i to regulation no 73 / 2009 should therefore be determined . ### pending the adoption of a regulation laying down the multiannual financial framework on the basis of article 312 of the treaty on the functioning of the european union , the level of the applicable ceiling for the year 2014 remains uncertain . until there is clarity on the level of the applicable ceiling , it is not possible to determine whether an adjustment of the direct payments for 2013 is necessary and , if so , what the rate should be . the amount of financial discipline required shall be revised by the budget authority in the framework of the adoption of the budget 2014 on the basis inter alia of the amending letter to the draft general budget 2014 whereby the commission provides updated estimated needs on market related expenditures and direct payments .


### a major disruption of gas supply to the community can affect all member states and contracting parties of the energy community treaty and lead to severe economic damages across the community economy . likewise , the disruption of gas supply can have severe social impacts in particular on vulnerable groups of customers . ### a major disruption of gas supply to the community is liable to impact on the eu ' s strategic interests , as well as affecting all member states and contracting parties of the energy community treaty and lead to severe economic damage across the community economy , as well as indirectly affecting subsidiary sectors . likewise , the disruption of gas supply can have severe social impacts in particular on vulnerable groups of customers .


### this regulation should enable natural gas undertakings and customers to rely on market mechanisms for as long as possible when coping with disruptions . it should also provide for emergency mechanisms to be used when markets are no longer able to deal adequately with a gas supply disruption . even in an emergency , market based instruments should be given priority to mitigate the effects of the supply disruption . ### this regulation should enable natural gas undertakings and customers to rely on market mechanisms for as long as possible when coping with disruptions . it should also provide for emergency mechanisms to be used when markets are no longer able to deal adequately with a gas supply disruption . even in an emergency , market based instruments should be given priority to mitigate the effects of the supply disruption , provided the general interest of consumers in the member states concerned is not affected .


### it is important that gas supply is maintained , particularly as regards household customers , as well as other protected customers such as schools and hospitals , in cases in which the market cannot continue to supply them . it is essential that the measures to be taken during a crisis are defined in advance of any crisis . ### it is important that gas supply is maintained , particularly as regards household customers , as well as other protected customers such as schools and hospitals , in cases in which the market cannot continue to supply them . it is essential that the measures to be taken during a crisis are defined in advance of any crisis , in the framework of a joint representative committee which would be the only authority empowered to centralise requirements and propose measures to be taken at union level in case of a disturbance of security of supply .


### it is important that gas supply is maintained , particularly as regards household customers , as well as other protected customers such as schools and hospitals , in cases in which the market cannot continue to supply them . it is essential that the measures to be taken during a crisis are defined in advance of any crisis . ### it is important that gas supply to protected customers is maintained in cases in which the market cannot continue to supply them . it is essential that the measures to be taken during a crisis are defined in advance of any crisis .


### to strengthen the solidarity between member states in the case of a community emergency and in particular to support member states which are exposed to less favourable geographical or geological conditions , member states should devise specific measures to exercise solidarity , including measures such as commercial agreements between natural gas undertakings , compensation mechanisms , increased gas exports or increased releases from storages . solidarity measures may be particularly appropriate between member states for which the commission recommends the establishment of joint preventive actions plans or emergency plans at regional level . ### to strengthen the solidarity between member states in the case of a community emergency and in particular to support member states which are exposed to less favourable geographical or geological conditions , member states should devise specific measures to exercise solidarity as stipulated in the treaty on the functioning of the european union , including measures such as commercial agreements between natural gas undertakings , compensation mechanisms , increased gas exports or increased releases from storages . solidarity measures may be particularly appropriate between member states for which the commission recommends the establishment of joint preventive actions plans or emergency plans at regional level .


### this regulation establishes measures aimed at safeguarding the security of gas supply so as to ensure the proper and continuous functioning of the internal market for gas by providing for a clear definition and attribution of responsibilities and for a coordination of the response at the level of the member states and the community regarding both preventive action and the reaction to concrete disruptions of supply . ### this regulation establishes measures aimed at safeguarding the security of gas supply so as to ensure the proper and continuous functioning of the internal market for gas by providing for a clear definition and attribution of responsibilities and for a coordination of the response at the level of the member states and the community regarding both preventive action and the reaction to concrete disruptions of supply , as well as to constitute a practical expression of the spirit of solidarity contained in the treaty on the functioning of the european union .


### this regulation establishes measures aimed at safeguarding the security of gas supply so as to ensure the proper and continuous functioning of the internal market for gas by providing for a clear definition and attribution of responsibilities and for a coordination of the response at the level of the member states and the community regarding both preventive action and the reaction to concrete disruptions of supply . ### this regulation establishes measures aimed at safeguarding the security of gas supply so as to ensure the proper and continuous functioning of the internal market for gas by providing for a clear definition and attribution of responsibilities and for a coordination of the response at the level of natural gas undertakings , the member states and the community regarding both preventive action and the reaction to concrete disruptions of supply .


### ' protected customers ' means all household customers already connected to a gas distribution network , and , if the member state concerned so decides , can also include small and medium - sized enterprises , schools and hospitals provided that they are already connected to a gas distribution network ; ### ' protected customers ' means all household customers , including vulnerable customers , schools and hospitals provided that they are already connected to a gas distribution network , and small and medium - sized enterprises provided that they are already connected to a gas distribution network to the extent that additional supply is available ;


### ' protected customers ' means all household customers already connected to a gas distribution network , and , if the member state concerned so decides , can also include small and medium - sized enterprises , schools and hospitals provided that they are already connected to a gas distribution network ; ### ' protected customers ' means all household customers , schools and hospitals provided that they are already connected to a gas distribution network , and small and medium - sized enterprises provided that they are already connected to a gas distribution network to the extent additional supply is available ;


### the competent authority shall take the measures to ensure the gas supply to the protected customers for the period of sixty days also in the event of an emergency as defined in article 9 . the competent authority shall endeavour to maintain the supply for the protected customers as long as necessary . ### the competent authority shall oblige supply undertakings to ensure the gas supply to the protected customers for the period of thirty days also in the event of an emergency as defined in article 9 . the supply undertakings in cooperation with the competent authority shall endeavour to maintain the supply for the protected customers as long as possible based on market based security of gas supply measures .


### identify the contribution of the non - market based measures planned or to be implemented for the emergency level listed in annex iii and assess the degree to which the use of non - market based measures is necessary to cope with the crisis , assess their effects and define the procedures to implement them ; ### identify the contribution of the non - market based measures planned or to be implemented for the emergency level listed in annex iii and assess the degree to which the use of non - market based measures is necessary to cope with the crisis , assess their effects and define the procedures to implement them ; non - market based measures shall be used to ensure the security of gas supply only as a last resort ;


### member states shall submit to the commission the existing inter - governmental agreements concluded with third countries which have an impact on the development of gas infrastructures and supplies ; before concluding new inter - governmental agreements , the member states shall inform the commission to assess their compliance with the internal market legislation ; ### member states shall submit to the commission the existing inter - governmental agreements concluded with third countries which have an impact on the development of gas infrastructures and supplies ; before concluding new inter - governmental agreements , the member states shall consult the commission to assess their compliance with the internal market legislation ;


### 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 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 phase - out or restriction to specific applications . this report shall evaluate the impact of chemicals used in phosphate - free formulations , water and energy consumption in the consumer use phase , hygiene - related aspects , the economic costs to consumers and the costs of reformulation and the impact on smes .


### such an approach to ocean management has been developed in the integrated maritime policy for the european union , including , as its environmental pillar , directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy . the objective of the integrated maritime policy is to support the sustainable development of seas and oceans and to develop coordinated , coherent and transparent decision - making in relation to the union’s sectoral policies affecting the oceans , seas , islands , coastal and outermost regions and maritime sectors , including through sea - basin strategies or macro - regional strategies . ### such an approach to ocean management has been developed in the integrated maritime policy for the european union , including , as its environmental pillar , directive 2008 / 56 / ec of the european parliament and of the council of 17 june 2008 establishing a framework for community action in the field of marine environmental policy . the objective of the integrated maritime policy is to support the sustainable development of seas and oceans , to promote the development of renewable marine energy sources and to develop coordinated , coherent and transparent decision - making in relation to the union’s sectoral policies affecting the oceans , seas , islands , coastal and outermost regions and maritime sectors , including through sea - basin strategies or macro - regional strategies .


### in its recent communication on blue growth , opportunities for marine and maritime sustainable growth , the commission has identified a number of ongoing eu initiatives which are intended to implement the europe 2020 strategy for smart , sustainable and inclusive growth . the communication has also identified a number of sector activities on which blue growth initiatives should focus in the future and which should be adequately supported by maritime spatial plans and integrated coastal management strategies . ### in its recent communication on blue growth , opportunities for marine and maritime sustainable growth , the commission has identified a number of ongoing eu initiatives which are intended to implement the europe 2020 strategy for smart , sustainable and inclusive growth . the communication has also identified a number of sector activities on which blue growth initiatives should focus in the future and which should be adequately supported by maritime spatial plans and integrated coastal management strategies . the member states’ clear support for these identified strategic areas will provide legal certainty and predictability for public and private investment , which will have a leverage effect on all sectoral policies linked to the maritime and coastal space .


### member states should consult and coordinate their plans and strategies with the relevant member state or third country authorities in the marine region or sub - region or coastal zone concerned in conformity with the rights and obligations of these member states and third countries under european and international law . effective cross border cooperation between member states and with neighbouring third countries requires that the competent authorities in each member state are identified . member states therefore need to designate the competent authority or authorities responsible for cooperation with other member states or third countries . given the differences between various marine regions or sub - regions and coastal zones , it is not appropriate to prescribe in detail in this directive how these cooperation mechanisms should look . ### member states should consult and coordinate their plans and strategies with the relevant member state or third country authorities in the marine region or sub - region or coastal zone concerned in conformity with the rights and obligations of these member states and third countries under european and international law . effective cross border cooperation between member states and with neighbouring third countries requires that the competent authorities in each member state are identified . member states therefore need to designate the competent authority or authorities responsible for cooperation with other member states or third countries .


### timely transposition of the provisions of this directive is essential since the eu has adopted a number of policy initiatives that are to be implemented by the year 2020 and which this directive aims to support . the shortest possible deadline for the transposition of this directive should therefore be adopted . ### timely transposition of the provisions of this directive is essential since the eu has adopted a number of policy initiatives that are to be implemented by the year 2020 and which this directive aims to support . the deadline for the transposition of this directive should therefore be harmonised .


### 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 involving - where appropriate - integrated coastal management aiming at promoting the sustainable development 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 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 aiming at promoting the sustainable growth of maritime and coastal economies and the sustainable use of marine and coastal resources , in particular by supporting the priority areas identified in the commission communication of 13 september 2012 on blue growth , opportunities for marine and maritime sustainable growth ,


### within the integrated maritime policy of the union , this framework provides for the establishment and implementation by member states of maritime spatial plans and of integrated coastal management strategies with the aim of meeting the objectives specified in article 5 . ### within the integrated maritime policy of the union , this framework provides for the establishment and implementation by member states of maritime spatial plans and integrated coastal management with the aim of meeting the objectives specified in article 5 .


### within the integrated maritime policy of the union , this framework provides for the establishment and implementation by member states of maritime spatial plans and of integrated coastal management strategies with the aim of meeting the objectives specified in article 5 . ### within the integrated maritime policy of the union , this directive provides a framework for the establishment and implementation by member states of maritime spatial plans and of integrated coastal management strategies with the aim of meeting the objectives specified in article 5 , taking into account land - sea interactions and enhanced cross - border cooperation on the basis of the respective unclos provisions .


### this directive shall not apply to activities the sole purpose of which is defence or national security . each member state shall , however , endeavour to ensure that such activities are conducted in a manner compatible with the objectives of this directive . ### this directive shall not apply to activities the sole purpose of which is defence or national security . member states shall , however , endeavour to ensure that such activities are conducted in a manner that is compatible , so far as reasonable and practicable , with the objectives of this directive .


### ' coastal zone ' means the geomorphologic area on both sides of the seashore area with as the seaward limit the external limit of the territorial seas of member states and as the landward limit , the limit as defined by the member states in their integrated coastal management strategies . ### ' coastal zone ' means the geomorphologic area on either side of the seashore area with as the seaward limit the external limit as defined by member states , not exceeding the territorial seas of member states and with the landward limit , as defined by the member states in their respective legislation .


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


### ‘ 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 united nations convention on the law of the sea , with the exception of the waters adjacent to the territories mentioned in annex ii to the treaty and the french departments and collectivities .


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


### 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 restoration 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 ;


### maritime spatial plans and integrated coastal management strategies shall establish operational steps to achieve the objectives as set out in article 5 taking into account all relevant activities and measures applicable to them . ### each member state shall establish procedural steps to achieve the objectives set out in article 5 , taking into account the relevant activities , uses and measures applicable to them .


### identify the trans - boundary effects of maritime spatial plans and integrated coastal management strategies on the marine waters and coastal zones under the sovereignty or jurisdiction of third countries in the same marine region or sub - region and related coastal zones and deal with them in cooperation with the competent authorities of these countries in accordance with articles 12 and 13 ; ### identify the trans - boundary aspects and consequences of maritime spatial plans and integrated coastal management strategies on the marine waters and coastal zones under the sovereignty or jurisdiction of third countries in the same marine region or sub - region and related coastal zones and deal with them in cooperation with the competent authorities of these countries in accordance with articles 12 and 13 ;


### installations for the extraction of energy and the production of renewable energy ; ### installations for the extraction of energy and the production of renewable energy and for bringing energy onshore ;


### maritime transport routes ; ### maritime transport and port access routes ;


### 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 are coherent and coordinated across the coastal zone or marine region and / or sub - region concerned . where appropriate , this may involve the use of integrated coastal management . such cooperation shall in particular take into account issues of a transnational nature , such as cross - border infrastructure .


### the commission may , by means of implementing acts , adopt provisions on : ### the commission may , by means of implementing acts , adopt provisions on the procedural framework for :


### in order to allow all competent authorities to receive and access , at the same time , pharmacovigilance information for medicinal products for human use authorised in the community , and share it , the eudravigilance database should be maintained and strengthened as the single point of receipt of such information . member states should therefore not impose on marketing authorisation holders any additional reporting requirements . the database should be fully accessible to the member states , the agency and the commission , and accessible to an appropriate extent to marketing authorisation holders and the public . ### in order to allow all competent authorities to receive and access , at the same time , pharmacovigilance information for medicinal products for human use authorised in the community , and share it , the eudravigilance database should be maintained and strengthened as the single point of receipt of such information . member states should therefore not impose on marketing authorisation holders any additional reporting requirements . the database should be fully accessible to the member states , the agency and the commission , and accessible to an appropriate extent to marketing authorisation holders and the public in all the official languages of the european union .


### in order to increase transparency as regards pharmacovigilance issues , a european medicines safety web - portal should be created and maintained by the agency . ### in order to increase transparency as regards pharmacovigilance issues , a european medicines safety web - portal should be created and maintained by the agency in all the official languages of the european union .


### 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 , and a publicly available list of such medicinal products should be kept up to date by the agency . patient reports should always be drawn up with the aid of a healthcare professional .


### after the granting of a marketing authorisation , the agency may require a marketing authorisation holder to conduct a post - authorisation safety study if there are concerns about the risks of an authorised medicinal product . the requirement shall be made in writing , provide a detailed justification and include the objectives and timeframe for submission and conduct of the study . ### after the granting of a marketing authorisation , the agency may require a marketing authorisation holder to conduct a post - authorisation safety study if there are concerns about the risks of an authorised medicinal product . the requirement shall be made in writing , provide a detailed justification on the basis of scientific arguments and include the objectives and timeframe for submission and conduct of the study .


### once renewed , the marketing authorisation shall be valid for an unlimited period , unless the national competent authority decides , on justified grounds relating to pharmacovigilance or to insufficient exposure to the product , to proceed with one additional five - year renewal in accordance with paragraph 2 . ” ### once renewed , the marketing authorisation shall be valid for an unlimited period , unless the competent authority decides , on justified grounds relating to pharmacovigilance , to proceed with one additional five - year renewal in accordance with paragraph 2 . ”


### the requirement shall be made in writing , provide a detailed justification , and include the timeframe for submission of the detailed description of the risk - management system . ### the requirement shall be made in writing , provide a detailed justification on the basis of scientific arguments and include the timeframe for submission of the detailed description of the risk - management system .


### the list of medicinal products under intensive monitoring referred to in article 23 of this regulation ; ### the list of medicinal products referred to in article 23 of this regulation whose authorisation is subject to certain conditions or requirements ; the most up - to - date electronic version of the package leaflet and summary of product characteristics for all existing and new medicinal products ; a brief document history of changes made to the product information ; all information on the medicines safety web - portals , including all of the above , shall be presented in a manner that is comprehensible to the general public .


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


### this regulation shall not affect the obligation for member states to issue residence permits to third - country nationals as provided by other instruments of community law . ### this regulation shall not affect the obligation for member states to issue residence permits to third - country nationals as provided by other instruments of community law , notably - council directive 2005 / 71 / ec - council directive 2004 / 114 / ec - council directive 2003 / 86 / ec - directive 2004 / 38 / ec and - council directive 2003 / 109 / ec .


### draft legislative resolution ### points out that the financial envelope specified in the legislative proposal constitutes only an indication to the legislative authority and cannot be fixed until agreement is reached on the proposal for a regulation laying down the multiannual financial framework for the years 2014 - 2020 ;


### draft legislative resolution ### emphasises that , in view of the tasks already identified and concluded by the union , the commission needs to reflect those policy priorities in a foresighted and adequate manner in the proposal ;


### draft legislative resolution ### reiterates that the lisbon treaty provides for delegated acts only as non - legislative acts of general application relating to non - essential elements of a legislative act ; therefore upholds its criticism of the widespread use of delegated acts and insists that any essential element must be laid down in the legislative act in question ;


### gradually establishing an integrated management system for external borders , including the reinforcement of interagency co - operation between migration and law enforcement authorities of member states at the external borders and measures within the territory and the necessary flanking measures related to document security and identity management ; ### gradually establishing an integrated management system for external borders , including the reinforcement of interagency co - operation between migration and law enforcement authorities of member states at the external borders and measures within the territory and the necessary flanking measures related to document security and identity management as well as the interoperability of acquired technical equipment ;


### within the objectives defined in article 3 , this instrument shall support actions in relation to and in third countries and in particular the following : ### within the objectives defined in article 3 , and in the light of the agreed conclusions of the policy dialogue as provided for in article 13 of regulation no … / 2012 [ horizontal regulation ] , this instrument shall support actions in relation to and in third countries and in particular the following :


### the budget allocated under the instrument shall be implemented under shared management in accordance with article 55 of regulation n° … . / 2012 [ new financial regulation ] , with the exception of union actions referred to in article 13 , the emergency assistance referred to in article 14 and the technical assistance referred to in article 16 . ### the budget allocated under the instrument shall be implemented under direct management ) or under shared management in accordance with article 55 of regulation n° … . / 2012 [ new financial regulation ] .


### a number of major developments have taken place since the european neighbourhood policy was launched and the european neighbourhood and partnership instrument was set up . these include a deepening of the relationship with the partners , the launch of regional initiatives and democratic transition processes in the region . this triggered a new european neighbourhood policy vision set out in 2011 as a result of a comprehensive strategic review of the policy . it outlines key objectives for union cooperation with neighbourhood countries and provides for greater support to partners committed to building democratic societies and undertaking reforms , in line with the ‘ more for more’ and ‘ mutual accountability’ principles . ### a number of major developments have taken place since the european neighbourhood policy was launched and the european neighbourhood and partnership instrument was set up . these include a deepening of the relationship with the partners , the launch of regional initiatives and democratic transition processes , particularly in the countries on the southern shore of the mediterranean following the events of spring 2011 . this triggered a new european neighbourhood policy vision set out in 2011 as a result of a comprehensive strategic review of the policy . this policy outlines key objectives for promoting cooperation and support to partners committed to building more equitable and democratic societies which respect human rights and fundamental freedoms , in line with the ‘ more for more’ and ‘ mutual accountability’ principles .


### union support under this regulation should in principle be aligned to corresponding national , regional or local strategies and measures of partner countries . ### union support under this regulation should be aligned to corresponding national , regional or local strategies and measures of partner countries .


### in neighbourhood countries where alignment to union rules and standards is one of the key policy objectives , the union is best placed to deliver this support . certain specific support can only be provided at union level . ### in neighbourhood countries where alignment to union rules and standards is one of the key policy objectives , the union should commit to delivering timely and cost - effective assistance . certain specific support can only be provided at union level .


### fighting climate change is one of the great challenges which the union faces and urgent international action is needed . in accordance with the intent stated in the commission june 2011 mff communication of increasing the climate related proportion of the union budget to at least 20% , this regulation should contribute to that goal . ### fighting climate change and securing safe energy supplies are two of the great challenges which the union faces and urgent international action is needed . in accordance with the intent stated in the commission june 2011 mff communication of increasing the climate related proportion of the union budget to at least 20% , this regulation should contribute to that goal .


### achieving progressive integration into the union internal market and enhanced sector and cross - sectoral co - operation including through legislative approximation and regulatory convergence towards union and other relevant international standards , related institution building and investments , notably in interconnections ; ### achieving progressive integration into the union internal market and enhanced sector and cross - sectoral co - operation , through legislative approximation and regulatory convergence towards union and other relevant international standards , related institution building and investments , notably in infrastructure interconnections aimed at ensuring diversification and reliability of transit routes ;


### promoting confidence building and other measures contributing to security and the prevention and settlement of conflicts ; ### promoting confidence building through concrete measures contributing to security and the prevention and settlement of conflicts ;


### the commission , the member states and the european investment bank shall ensure coherence between support provided under this regulation and other support provided by the union , the member states and the european investment bank . ### the commission , the member states and the european investment bank shall ensure coherence between support provided under this regulation and other support and financial instruments , such as the financing instrument for development cooperation , provided by the union , the member states and the eib .


### when it is necessary to implement more effectively measures for the common benefit of the union and partner countries , in areas such as transnational co - operation and inter - connections , funding under this regulation can be pooled together with funding covered by other relevant union regulations establishing financial instruments . in this case , the commission shall decide which single set of rules should apply to implementation . ### when it is necessary to implement more effectively measures for the common benefit of the union and partner countries , in areas such as transnational co - operation and inter - connections , funding under this regulation can be pooled together with funding covered by other relevant union regulations establishing financial instruments , such as the connecting europe facility . in this case , the commission shall decide which single set of rules should apply to implementation .


### in the event of crises or threats to democracy , the rule of law , human rights and fundamental freedoms , or of natural or man - made disasters , an ad hoc review of the programming documents may be conducted . such emergency review shall ensure that coherence between union support provided under this regulation and support provided under other union financial instruments is maintained . an emergency review may lead to the adoption of revised programming documents . where this is the case , the commission shall send the revised programming documents to the european parliament and to the council for information within one month of their adoption . ### in the event of economic , political or energy crises or threats to democracy , the rule of law , human rights and fundamental freedoms , or of natural or man - made disasters , an ad hoc review of the programming documents may be conducted . such emergency review shall ensure that coherence between union support provided under this regulation and support provided under other union financial instruments is maintained . an emergency review may lead to the adoption of revised programming documents . where this is the case , the commission shall send the revised programming documents to the european parliament and to the council for information within one month of their adoption .


### the indicative allocations of funds to the joint operational programmes shall be based primarily on the population of the eligible areas . when determining the indicative allocations , adjustments may be made to reflect the need for a balance between the contributions from the european regional development fund and the contributions provided under the budget of this instrument as well as other factors affecting the intensity of cooperation , such as the specific characteristics of border areas and their capacity to manage and absorb union support . ### when determining the indicative allocations of funds , adjustments may be made to reflect the need for a balance between the contributions from the european regional development fund and the contributions provided under the budget of this instrument as well as other factors affecting the intensity of cooperation , such as the specific characteristics of border areas and their capacity to manage and absorb union support .


### the financial envelope available for implementing this regulation over the period 2014 to 2020 shall be eur 18 182 300 000 . up to 5% of the financial envelope shall be allocated to the cross - border cooperation programmes referred to in article 6 . ### the financial envelope available for implementing this regulation over the period 2014 to 2020 shall be eur 18 182 300 000 . up to 10 % of the financial envelope shall be allocated to the cross - border cooperation programmes referred to in article 6 .


### 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 certain restrictions on the possibilities of pharmaceutical companies to make information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the community .


### those disparities in the interpretation of the community rules on advertising , and between national provisions on information have a negative impact on the uniform application of community rules on advertising , and on the effectiveness of the provisions on product information contained in the summary of products characteristics and the package leaflet . although those rules are fully harmonised to ensure the same level of protection of public health across the community , this objective is undermined if widely divergent national rules on the dissemination of such key information are allowed . ### those disparities in the interpretation of the community rules on providing information to patients and the public at large , and between national provisions on information have a negative impact on the uniform application of community rules on providing information to patients and the public at large , and on the effectiveness of the provisions on product information contained in the summary of products characteristics and the package leaflet . although those rules are fully harmonised to ensure the same level of protection of public health across the community , this objective is undermined if widely divergent national rules on the dissemination of such key information are allowed .


### 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 .


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


### as this directive introduces for the first time harmonised rules on the provision of information on medicinal products subject to medical prescription to the general public , the commission should assess its operation and the necessity for a review five years after its entry into force . provision should also be made for the drawing up of guidelines by the commission based on member states ' experience in the monitoring of information . ### as this directive introduces for the first time harmonised rules on the provision of information on medicinal products subject to medical prescription to the general public , the commission should assess its operation and the necessity for a review five years after its entry into force . provision should also be made for the drawing up of guidelines by the commission based on member states ' experience , in cooperation with patient organisations and healthcare professionals , in the monitoring of information


### 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 . ### without prejudice to the importance of the role played by national competent authorities and health care professionals in informing the patients and the general public on authorised medicinal products subject to medical prescription , 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 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 make available , either directly or indirectly through a third party that is acting in the name of the marketing authorization holder , information that has been approved by the competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that this information and the way it is supplied 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 that acts on behalf of the marketing authorisation holder shall be clearly identified 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 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 .


### it must take into account the general needs and expectations of patients ; ### it must be patient - oriented to better meet their needs ;


### the commission shall adopt the measures necessary for the implementation of paragraphs 1 , 2 and 3 . those measures , designed to amend non - essential elements of this directive by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 121 . ### in order to ensure the quality of information made available to the general public and members thereof , the commission shall adopt , by means of delegated acts in accordance with article 100 kb and subject to the conditions of articles 100 kc and 100 kd , the measures necessary for the application of paragraphs 1 , 2 and 3 .


### the commission may amend this paragraph to take account of technical progress . this measure , designed to amend non - essential elements of this directive , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 121 . ### in order to take account of technical progress , the commission may adopt , by means of delegated acts in accordance with article 100 kb and subject to the conditions of articles 100 kc and 100 kd , measures necessary for the application of this paragraph .


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


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


### internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites or the appearance therein of unsolicited material actively distributed to the general public or members thereof . those websites shall not contain web - tv . ### internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites without their explicit prior consent or the appearance therein of unsolicited material actively distributed to the general public or members thereof . internet websites may provide video content if it is useful for the safe and effective use of the medicine . video contents shall only reflect the package leaflet , the summary of the characteristics and the drug - fact - box and hints how to use this medicine safe and effectively . before publication video contents must be approved by the competent authorities .


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


### if a member state has reasons for doubts as to whether the translation of the reproduced information is correct , it may require a marketing authorisation holder to provide for a certified translation of the information disseminated on the internet website registered with the national competent authority of another member state . ### if a member state has reasons for doubts as to whether the translation of the reproduced information is correct , it may require a marketing authorisation holder to provide for a certified translation of the authority - approved information disseminated on the internet website registered with the national competent authority of another member state .


### if a member state has reasons for doubts as to whether the information disseminated on an internet website registered with the national competent authorities of another member state complies with the requirements of this title , it shall inform that member state of the reasons for its doubts . the member states concerned shall use their best endeavours to reach agreement on the action to be taken . if they fail to reach an agreement within two months , the case shall be referred to the pharmaceutical committee set up by decision 75 / 320 / eec . any necessary measures may only be adopted after an opinion has been delivered by that committee . member states shall take account of opinions delivered by the pharmaceutical committee and shall inform the committee of how its opinion has been taken into account . ### if a member state has reasons for doubts as to whether the authority - approved information disseminated on an internet website registered with the national competent authorities of another member state complies with the requirements of this title , it shall inform that member state of the reasons for its doubts . the member states concerned shall use their best endeavours to reach agreement on the action to be taken . if they fail to reach an agreement within two months , the case shall be referred to the pharmaceutical committee set up by decision 75 / 320 / eec . any necessary measures may only be adopted after an opinion has been delivered by that committee . member states shall take account of opinions delivered by the pharmaceutical committee and shall inform the committee of how its opinion has been taken into account .