### no later than one year before the end of each accounting period , member states shall communicate to the commission proposed revised reference levels for the following accounting period in accordance with the methodology in decision - / cmp . 7 used for calculating the reference levels set out in that decision . ### no later than one year before the end of each accounting period , member states shall communicate to the commission revised reference levels for the following accounting period in accordance with the methodology in decision - / cmp . 7 used for calculating the reference levels set out in that decision . note : the same change applies to paragraphs 5 and 6 of article 6 .


### the 17th conference of the parties of the unfccc , meeting in durban in december 2011 , adopted decision - / cmp . 7 of the conference of the parties serving as the meeting of the parties to the kyoto protocol . that decision set out rules for accounting for the lulucf sector as of a second commitment period under the kyoto protocol . this decision should be in line with that decision to ensure an appropriate level of coherence between the union’s internal rules and methodologies agreed within the unfccc . this decision should also reflect the particularities of the union lulucf sector . ### the 17th conference of the parties of the unfccc , meeting in durban in december 2011 , adopted decision 2 / cmp . 7 of the conference of the parties serving as the meeting of the parties to the kyoto protocol . that decision set out rules for accounting for the lulucf sector as of a second commitment period under the kyoto protocol . this decision should be in line with that decision to ensure an appropriate level of coherence between the union’s internal rules and methodologies agreed within the unfccc . this decision should also reflect the particularities of the union lulucf sector and the obligations arising from the union as a separate party .


### the commission shall be empowered to adopt delegated acts in accordance with article 12 to amend annex i to add accounting periods and to ensure consistency between those accounting periods and the relevant periods applicable to union emission reduction commitments in other sectors . ### any amendment to the accounting rules set out in this article , including changes to the accounting periods set out in annex i , shall be adopted in accordance with the ordinary legislative procedure .


### for the purposes of paragraphs 4 , 5 and 6 , member states shall specify the amount of annual emissions resulting from natural disturbances which have been included in their proposed revised reference levels and the manner in which they estimated that amount . ### for the purposes of paragraphs 4 , 5 and 6 , member states shall specify the amount of annual emissions resulting from natural disturbances which have been included in their revised reference levels and the manner in which they estimated that amount .


### a list of measures , including , as appropriate , those specified in annex iv , to be adopted in order to pursue the mitigation potential , where identified in accordance with the analysis referred to in point ; ### policies foreseen to promote and foster sustainable forest management and sustainable land management . member states may ask the commission to provide technical and operational guidance on the matters covered by this point . ;


### ‘ natural disturbance’ is any non - anthropogenic event or circumstance that causes significant emissions in forests or agricultural soils and the occurrence of which is beyond the control of the relevant member state provided the member state is also objectively unable to significantly limit the effect of the event or circumstance , even after its occurrence , on emissions ; ### ‘ natural disturbances’ are non - anthropogenic events or non - anthropogenic circumstances . for the purposes of this decision , these events or circumstances are those that cause significant emissions in forests and are beyond the control of , and not materially influenced by , a member state . these may include wildfires , insect and disease infestations , extreme weather events , including droughts and floods , and / or geographical disturbances , beyond the control of , and not materially influenced by , a member state . these exclude harvesting and prescribed burning ;


### the 17th conference of the parties of the unfccc , meeting in durban in december 2011 , adopted decision - / cmp . 7 of the conference of the parties serving as the meeting of the parties to the kyoto protocol . that decision set out rules for accounting for the lulucf sector as of a second commitment period under the kyoto protocol . this decision should be in line with that decision to ensure an appropriate level of coherence between the union ' s internal rules and methodologies agreed within the unfccc . this decision should also reflect the particularities of the union lulucf sector . ### the 17th conference of the parties of the unfccc , meeting in durban in december 2011 , adopted decision 2 / cmp . 7 of the conference of the parties serving as the meeting of the parties to the kyoto protocol and decision 16 / cmp . 1 . that decision set out rules for accounting for the lulucf sector as of a second commitment period under the kyoto protocol . this decision should be in line with that decision to ensure an appropriate level of coherence between the union ' s internal rules and methodologies agreed within the unfccc to avoid any duplication of national reporting . this decision should also reflect the particularities of the union lulucf sector .


### the commission shall be empowered to adopt delegated acts in accordance with article 12 to revise the conditions referred to in the first subparagraph of paragraph 2 in the light of scientific progress or to reflect revisions to acts adopted by unfccc or kyoto protocol bodies . ### the commission shall be empowered to adopt delegated acts in accordance with article 12 to revise the conditions referred to in the first subparagraph of paragraph 2 to reflect minor changes to acts adopted by unfccc or kyoto protocol bodies .


### if improved methodologies become available allowing a member state to calculate reference levels in a significantly more accurate manner or where there are significant improvements in the quality of data available to a member state , the member state concerned shall communicate to the commission proposed revised reference levels reflecting those changes without delay . ### if improved methodologies become available allowing a member state to calculate reference levels in a significantly more accurate manner or where there are significant improvements in the quality of data available to a member state , the member state concerned shall communicate to the commission revised reference levels reflecting those changes without delay .


### member states shall include in their draft lulucf action plans the following information relating to each of the activities referred to in article 3 : ### member states shall consider including the following in their lulucf action plans relating to the first subparagraph of article 3 and where systems are already in place and data available relating to in subparagraph 2 of article 3 :


### article 9 of decision no 406 / 2009 / ec requires the commission to assess modalities to include greenhouse gas emissions and removals resulting from activities related to land use , land use change and forestry into the union’s greenhouse gas emission reduction commitment , whilst ensuring the permanence and environmental integrity of the contribution of the sector , and providing for accurate monitoring and accounting of the relevant emissions and removals . this decision should , therefore , as a first step , set out accounting rules applicable to greenhouse gas emissions and removals from the lulucf sector . to ensure the preservation and enhancement of carbon stocks in the interim , it should also provide for member states to adopt lulucf action plans setting out measures to limit or reduce emissions , and to maintain or increase removals , from the lulucf sector . ### article 9 of decision no 406 / 2009 / ec requires the commission to assess modalities to include greenhouse gas emissions and removals resulting from activities related to land use , land use change and forestry into the union’s greenhouse gas emission reduction commitment , whilst ensuring the permanence and environmental integrity of the contribution of the sector , and providing for accurate monitoring and accounting of the relevant emissions and removals . this decision should , therefore , as a first step , set out accounting rules applicable to greenhouse gas emissions and removals from the lulucf sector . to ensure the preservation and enhancement of carbon stocks in the interim , it should also provide for member states to include measures to encourage sustainable forest management and sustainable land management to limit or reduce emissions , and to maintain or increase removals , from the lulucf sector , in their low - carbon growth strategies .


### no later than six months after the beginning of each accounting period specified in annex i , member states shall draw up and transmit to the commission draft lulucf action plans to limit or reduce emissions and maintain or increase removals resulting from the activities referred to in article 3 . member states shall ensure that a broad range of stakeholders are consulted . ### no later than one year after the beginning of each accounting period specified in annex i , member states shall draw up and transmit to the commission lulucf action plans , as a separate document or as a clearly identifiable part of their national low - carbon development strategies , to limit or reduce emissions and maintain or increase removals resulting from the activities referred to in article 3 . member states shall ensure that a broad range of stakeholders are consulted .


### the 17th conference of the parties of the unfccc , meeting in durban in december 2011 , adopted decision - / cmp . 7 of the conference of the parties serving as the meeting of the parties to the kyoto protocol . that decision set out rules for accounting for the lulucf sector as of a second commitment period under the kyoto protocol . this decision should be in line with that decision to ensure an appropriate level of coherence between the union’s internal rules and methodologies agreed within the unfccc . this decision should also reflect the particularities of the union lulucf sector . ### the 17th conference of the parties of the unfccc , meeting in durban in december 2011 , adopted decision 2 / cmp . 7 of the conference of the parties serving as the meeting of the parties to the kyoto protocol and decision 16 / cmp . 1 . those decisions set out rules for accounting for the lulucf sector as of a second commitment period under the kyoto protocol . this decision should be in line with those decisions to ensure an appropriate level of coherence between the union’s internal rules and methodologies agreed within the unfccc to avoid any duplication of national reporting . this decision should also reflect the particularities of the union lulucf sector .


### emissions and removals resulting from any activity falling within one or more categories of activity referred to in article 3 shall only be accounted for under one category . ### emissions and removals resulting from any activity falling within one or more categories of activity referred to in article 3 shall only be accounted for under one category to prevent double accounting .


### member states shall designate an appropriate body established in their territory or , upon mutual agreement , in another member state under the responsibility of the designating member state . supervisory bodies shall be given all supervisory and investigatory powers that are necessary for the exercise of their tasks . ### member states shall designate a supervisory body established in their territory .


### if , following the notification of the dispute to the parties , the parties agree to institute proceedings before the entity , accomplish the conclusion of the dispute resolution procedure within 30 days from when the proceedings have been instituted . in the case of complex disputes , the adr entity may extend this time limit ; ### if , following the notification of the dispute to the parties , the parties agree to institute proceedings before the entity , accomplish the conclusion of the dispute resolution procedure within 90 days from when the proceedings have been instituted . in the case of complex disputes , the adr entity may extend this time limit for a further period of 90 days ;


### if , following the notification of the dispute to the parties , the parties agree to institute proceedings before the entity , accomplish the conclusion of the dispute resolution procedure within 30 days from when the proceedings have been instituted . in the case of complex disputes , the adr entity may extend this time limit ; ### if , following the notification of the dispute to the parties , the parties agree to institute proceedings before the entity , accomplish the conclusion of the dispute resolution procedure within 90 days from when the proceedings have been instituted . where disputes are of a complex or highly technical nature the adr entity may , at their discretion , choose to extend this time period . any extension shall be informed to the parties , together with an expected approximate length for the conclusion of the dispute .


### in order to limit the burden on industry , trade and administration , origin marking should be made mandatory for those sectors for which the commission , based on prior consultation found that there was value added . provision should be made for an easy adaptation of the sectoral scope of this regulation . provision should also be made for the exemption of specific products for technical or economic reasons or where origin marking is otherwise unnecessary for the purpose of this regulation . this may be the case , in particular , where origin marking would damage the goods concerned , or in case of certain raw materials . ### in order to limit the burden on industry , trade and administration , origin marking should be made mandatory for those sectors for which the commission , based on prior consultation found that there was value added . provision should be made for the exemption of specific products for technical reasons or where origin marking is otherwise unnecessary for the purpose of this regulation . this may be the case , in particular , where origin marking would damage the goods concerned , or in case of certain raw materials .


### the commission may adopt implementing measures , in accordance with the procedure referred to in article 6 , in particular , to : - determine the detailed form and modalities of origin marking . - establish a list of terms in all community languages which clearly express that goods originate in the country indicated in the marking . - determine the cases where commonly used abbreviations unmistakably indicate the country of origin and can be used for the purpose of this regulation . - determine the cases in which goods cannot or need not be marked for technical or economic reasons - determine other rules that may be required when goods are found not in compliance with this regulation . - to update of the annex to this regulation where the assessment has changed as to whether origin marking is necessary for a specific sector . ### the commission may adopt implementing measures , in accordance with the procedure referred to in article 6 , in particular , to : - determine the detailed form and modalities of origin marking . - establish a list of terms in all community languages which clearly express that goods originate in the country indicated in the marking . - determine the cases where commonly used abbreviations unmistakably indicate the country of origin and can be used for the purpose of this regulation . 2 . the commission may adopt by means of delegated acts measures to : - determine the cases in which goods cannot or need not be marked for technical reasons - determine other rules that may be required when goods are found not in compliance with this regulation . - to update of the annex to this regulation where the assessment has changed as to whether origin marking is necessary for a specific sector . such measures and any reviews thereof shall be adopted by the commission in accordance with the procedure set out in article 6a .


### the country of origin of goods shall be marked on these goods . in case where goods are packaged , the marking shall be made separately on the package . the commission may adopt implementing measures , in accordance with the procedure referred to in article 6 , to determine cases in which marking on the packaging shall be accepted in lieu of marking on the goods themselves . this should , in particular , be the case where goods do normally reach the final consumer or user in their usual packaging . ### the country of origin of goods shall be marked on these goods . in case where goods are packaged , the marking shall also be made separately on the package . the commission may adopt by means of delegated acts measures to determine cases in which marking on the packaging shall be accepted in lieu of marking on the goods themselves . this should , in particular , be the case where goods do normally reach the final consumer or user in their usual packaging . such measures and any reviews thereof shall be adopted by the commission in accordance with the procedure set out in article 6a .


### the introduction of an origin mark can contribute to make demanding community standards work in favour of the community industry , especially small and medium enterprises . it will also help to prevent the reputation of the community industry being tainted by inaccurate claims of origin . improved transparency and consumer information about the origin of goods will thus contribute to the objectives of the lisbon agenda . ### the introduction of an origin mark can contribute to make demanding community standards work in favour of the community industry , especially small and medium enterprises which often put a genuine effort into the quality of their products and which also preserve traditional and artisanal jobs and methods of production , but which are also greatly exposed to global competition which does not necessarily distinguish between production methods . it will also help to prevent the reputation of the community industry being tainted by inaccurate claims of origin . improved transparency and consumer information about the origin of goods will thus contribute to the objectives of the lisbon agenda and those of the eu 2020 strategy .


### the union and the member states have set themselves the objective of countering fraud , corruption and any other illegal activities affecting the financial interests of the union , including cigarette smuggling and counterfeiting . together with the commission , the member states should , in particular , organise close and regular cooperation between the competent authorities . ### the union and the member states have set themselves the objective of countering fraud , corruption and any other illegal activities affecting the financial interests of the union , including cigarette smuggling and counterfeiting . together with the commission , the member states should , in particular , organise close and regular cooperation and synergies between the competent authorities in order to improve the long - term impact of spending and to avoid duplication .


### representatives of countries forming part of the stabilisation and association process for countries of south - eastern europe , the russian federation , and certain countries with which the union has concluded an agreement for mutual assistance in fraud - related matters , and representatives of international and other relevant organisations , may take part in activities organised under the programme wherever this is useful for the achievement of the objectives referred to in articles 3 and 4 . these representatives shall be chosen on the basis of their skills , experience and knowledge relevant to the specific activities . ### representatives of countries forming part of the stabilisation and association process for countries of south - eastern europe , the russian federation , and certain countries with which the union has concluded an agreement for mutual assistance in fraud - related matters , and representatives of international and other relevant organisations , may take part in activities organised under the programme wherever this is useful for the achievement of the objectives referred to in articles 3 and 4 . the participation in the programme by these representatives shall be in accordance with the relevant provisions of regulation no xxxx / 2012 [ of the european parliament and of the council on the financial rules applicable to the general budget of the union ] .


### to continue and even develop the activities at union and member state level to counter fraud , corruption and any other illegal activities affecting the financial interests of the union , including the fight against cigarette smuggling and counterfeiting , also taking into account the new challenges in a context of budgetary austerity , a new programme should be adopted . ### to continue and even develop the activities at union and member state level to counter fraud , corruption and any other illegal activities affecting the financial interests of the union , including the fight against cigarette smuggling and counterfeiting , also taking into account the new challenges in a context of budgetary austerity , a new programme with improved performance indicators should be adopted .


### – exchanging experience between the relevant authorities in the member states , and third countries as referred to in article 6 as well as representatives of international organisations as mentioned in article 6 , including specialised law enforcement services ; ### – exchanging experience between the relevant authorities in the member states , and third countries as referred to in article 6 as well as representatives of international public organisations as mentioned in article 6 , including specialised law enforcement services ;


### representatives of countries forming part of the stabilisation and association process for countries of south - eastern europe , the russian federation , and certain countries with which the union has concluded an agreement for mutual assistance in fraud related matters , and representatives of international and other relevant organisations , may take part in activities organised under the programme wherever this is useful for the achievement of the objectives referred to in articles 3 and 4 . these representatives shall be chosen on the basis of their skills , experience and knowledge relevant to the specific activities . ### representatives of countries forming part of the stabilisation and association process for countries of south - eastern europe , the russian federation , and certain countries and representatives of international public organisations with which the union has concluded an agreement for mutual assistance in fraud related matters , may take part in activities organised under the programme wherever this is useful for the achievement of the objectives referred to in articles 3 and 4 . the participation in the programme by these representatives shall be in accordance with the relevant provisions of regulation no xxxx / 2012 [ of the european parliament and of the council of the financial rules applicable to the general budget of the union ] .


### in order to implement the programme the commission shall adopt annual work programmes . they shall set out the objectives pursued , the expected results , the method of implementation and their total amount . they shall also contain a description of the actions to be financed , an indication of the amount allocated to each action and an indicative implementation timetable . they shall include for grants the priorities , the essential evaluation criteria and the maximum rate of co - financing . ### in order to implement the programme the commission shall adopt annual work programmes . the annual work programmes shall set out the objectives pursued , the expected results , the method of implementation and their total amount . the annual work programmes shall also specify the criteria for being awarded a grant covering the maintenance of the technical equipment purchased under the programme . they shall also contain a description of the actions to be financed , an indication of the amount allocated to each action and an indicative implementation timetable . they shall include for grants the priorities , the essential evaluation criteria and the maximum rate of co - financing . after adoption , these annual work programmes shall be sent to european parliament and council .


### budget allocated to communication actions to be carried out by the commission under this regulation shall also cover the corporate communication of the political priorities of the union . ### budget appropriations allocated to communication actions to be carried out by the commission under this regulation shall also cover the corporate communication of the political priorities of the union as far as they are related to the general objectives of this regulation .


### – exchanging experience between the relevant authorities in the member states , and third countries as referred to in article 6 as well as representatives of international organisations as mentioned in article 6 , including specialised law enforcement services ; ### – exchanging experience between the relevant authorities in the member states , and third countries as referred to in article 6 , including specialised law enforcement services , as well as representatives of international public organisations as mentioned in article 6 ;


### ‘ 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 or menthol , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy or vanilla observable before or upon intended use of the tobacco product ;


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


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


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


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


### 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 .


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


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


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


### ' 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 or menthol , resulting from an additive or combination of additives , including but not limited to fruit , spice , herb , alcohol , candy or vanilla observable before or upon intended use of the tobacco product ;


### ‘ 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 distinctive fruit , sweet or candy - flavoured taste other than tobacco or menthol , resulting from a taste substance or combination of taste substances observable upon intended use of the tobacco product ;


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


### cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging ; ### cover 30% of the external area of the front surface and 40% of the external area of the back surface of the unit packet and any outside packaging ;


### cover 75 % of the external area of both the front and back surface of the unit packet and any outside packaging ; ### cover 40 % of the external area of the front surface and 50% of the external area of the back surface of the unit packet and any outside packaging ;


### goods which are subject of an action infringing a trade mark and bear without authorisation a trade mark identical to the trade mark validly registered in respect of the same type of goods , or which cannot be distinguished in its essential aspects from such a trade mark ; ### goods infringing a trade mark and which bear without authorisation a trade mark identical to the trade mark validly registered in respect of the same type of goods , or which cannot be distinguished in its essential aspects from such a trade mark ;


### the review of regulation no 1383 / 2003 showed that certain improvements to the legal framework were necessary to strengthen the enforcement of intellectual property rights , as well as to ensure appropriate legal clarity , thereby taking into account developments in the economic , commercial and legal areas . ### the review of regulation no 1383 / 2003 showed that certain improvements to the legal framework were necessary to strengthen the enforcement of intellectual property rights by customs authorities , as well as to ensure appropriate legal clarity , thereby taking into account developments in the economic , commercial and legal areas . the commission should take all measures to ensure a harmonised application , without unnecessary delay , by the customs authorities of the new legal framework throughout the union to ensure an efficient enforcement of intellectual property rights , which would protect rightholders without hampering trade . the implementation of the modernised customs code and in particular an inter - operable ' ecustoms ' system could , in the future , facilitate such enforcement .


### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls , the competent authorities shall collect fees to recover the costs they incur in relation to : ### for the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls , the competent authorities may collect fees to recover , some or all of the costs they incur in relation to :


### the delegation of power referred to in articles 4 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 40 , 43 , 45 , 46 , 49 , 51 , 52 and , 56 , 60 , 62 , 69 , 75 and , 97 , 98 , 99 , 101 , 106 , 110 , 111 , 114 and 125 , the third subparagraph of article 132 , articles 133 , 138 and , 143 , 144 , 151 , 153 and 159 shall be conferred for an indeterminate period of time from the date of entry into force of this regulation . ### the delegation of power referred to in articles 4 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 40 , 43 , 45 , 46 , 49 , 51 , 52 and , 56 , 60 , 62 , 69 , 75 and , 97 , 98 , 99 , 101 , 106 , 110 , 111 , 114 and 125 , the third subparagraph of article 132 , articles 133 , 138 and , 143 , 144 , 151 , 153 and 159 shall be conferred on the commission for a period of 5 years from . 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 identical duration unless the european parliament or council opposes such an extension not later than 3 months before the end of each period .


### ‘ plant protection products’ means plant protection products as referred to in article 2 of regulation no 1107 / 2009 ; ### ‘ plant protection products’ means plant protection products as referred to in article 2 of regulation no 1107 / 2009 independent of its packaging size ;


### where laboratory analyses , tests or diagnoses are urgently needed and none of the methods referred to in paragraphs 1 and 2 exists , the relevant national reference laboratory or , if no such national reference laboratory exists , any other laboratory designated in accordance with article 36 may use methods other than those referred to in paragraphs 1 and 2 of this article until the validation of an appropriate method in accordance with internationally accepted scientific protocols . ### where laboratory analyses , tests or diagnoses are urgently needed , in exceptional cases due to a developing emergency situation , and none of the methods referred to in paragraphs 1 and 2 exists , the relevant national reference laboratory or , if no such national reference laboratory exists , any other laboratory designated in accordance with article 36 may use methods other than those referred to in paragraphs 1 and 2 of this article until the validation of an appropriate method in accordance with internationally accepted scientific protocols .


### member states should be required to ensure that adequate financial resources are always available in order to appropriately staff and equip the competent authorities performing official controls and other official activities . although operators are primarily responsible for ensuring that their activities are carried out in compliance with union agri - food chain rules , the system of own controls that they put in place for that purpose needs to be complemented by a dedicated system of official controls maintained by each member state to ensure effective market surveillance along the agri - food chain . such a system is , by its very nature , complex and resource demanding and should be provided with a stable influx of resources for official controls , at a level appropriate to the enforcement needs at any given moment . to reduce the dependency of the official control system from public finances , competent authorities should collect fees to cover the costs they incur when performing official controls on certain operators and for certain activities for which union agri - food chain legislation requires registration or approval in accordance with union rules on the hygiene of food and feed or rules governing plant health and plant reproductive material . fees should also be collected from operators to compensate the costs of official controls performed in view of issuing an official certificate or attestation , and costs of official controls performed by the competent authorities at border control posts . ### member states should be required to ensure that adequate financial resources are always available in order to appropriately staff and equip the competent authorities performing official controls and other official activities . although operators are primarily responsible for ensuring that their activities are carried out in compliance with union agri - food chain rules , the system of own controls that they put in place for that purpose needs to be complemented by a dedicated system of official controls maintained by each member state to ensure effective market surveillance along the agri - food chain . such a system is , by its very nature , complex and resource demanding and should be provided with a stable influx of resources for official controls , at a level appropriate to the enforcement needs at any given moment .


### the commission shall set up and manage a computerised information management system for the integrated operation of the mechanisms and tools through which data , information and documents concerning official controls are managed and handled . ### the commission shall set up and manage a computerised information management system for the integrated operation of the mechanisms and tools through which data , information and documents concerning official controls are managed and handled , taking into account existing national systems .


### the verification , by or under the responsibility of an official veterinarian , of the health and welfare of the animals prior to the slaughter ; ### the verification , by an official veterinarian , of the health and welfare of the animals prior to the slaughter ;


### to ensure the uniform implementation of the rules provided for in paragraph 1 of this article , the commission shall , by means of implementing acts , lay down and update as necessary the format in which the information referred to in that paragraph shall be published . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 141 . ### to ensure the most efficient implementation of the rules provided for in paragraph 1 of this article , the commission shall , by means of implementing acts , lay down and update as necessary the minimum requirements for which information referred to in that paragraph must be included . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 141 .


### the cases and conditions where official controls to verify compliance with animal welfare requirements may include the use of specific animal welfare indicators based on measurable performance criteria , and the design of such indicators on the basis of scientific and technical evidence . ### the cases and conditions where official controls to verify compliance with animal welfare requirements shall include the use of specific animal welfare indicators based on measurable performance criteria , and the design of such indicators on the basis of scientific and technical evidence .


### governing the deliberate release into the environment and the contained use of gmos ; ### governing the deliberate release into the environment and the contained use of genetically modified food and feed ;


### uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls , concerning the manufacture , placing on the market , entry into the union , labelling , packaging , transport , storage and use of plant protection products , having regard , in addition to the criteria referred to in article 8 , to the need to ensure the safe and sustainable use of plant protection products and to combat illegal trade of such products ; ### uniform specific requirements for the performance of official controls and uniform minimum frequency of such official controls , concerning the manufacture , placing on the market , entry into the union , labelling , packaging , transport , storage , parallel trade and use of plant protection products , having regard , in addition to the criteria referred to in article 8 , to the need to ensure the safe and sustainable use of plant protection products and to combat illegal trade of such products ;


### fees collected in accordance with point of article 77 shall be paid by the operator responsible for the consignment or its representative . ### fees collected in accordance with point of article 77 may be paid by the operator responsible for the consignment or its representative .


### ’the competent authority referred to in article 32 shall make available to interested parties , upon their request , the report referred to in point of the first subparagraph . the competent authority shall make sure that the report disclosed does not undermine the commercial interests of the audited entity under review , including its industrial and intellectual property . ’ ; ### ‘ the competent authority referred to in article 32 shall publish the report referred to in point of the first subparagraph . the competent authority shall make sure that the report published or disclosed does not undermine the commercial interests of any audited entity under review , including its industrial and intellectual property . ’ ;


### where a member state has established rules on the carrying out of a limited review of the accounts of small undertakings as an alternative to statutory audit , such member state shall not be obliged to adapt the audit standards to the statutory audit of those undertakings . ### member states shall be allowed to establish rules on the carrying out of a limited assurance engagement of the accounts of small undertakings as an alternative to statutory audit .


### it is important to ensure high quality statutory audits within the union . all statutory audits should therefore be carried out on the basis of the international auditing standards which are part of the clarity project issued by the international federation of accountants in 2009 insofar as they are relevant to statutory audits . member states should be allowed to impose additional national audit procedures or requirements only if they stem from specific national legal requirements relating to the scope of the statutory audit of annual or consolidated financial statements , meaning that those requirements have not been covered by the adopted international auditing standards , and only if they add to the credibility and quality of annual financial statements and consolidated financial statements and are conducive to the union public good . the commission should continue to be involved in the monitoring of the content and adoption process of the international auditing standards by the ifac . ### it is important to ensure high quality statutory audits within the union . all statutory audits should therefore be carried out on the basis of the international auditing standards issued by the international auditing and assurance standards board insofar as they are relevant to statutory audits . member states should be allowed to impose additional national audit procedures or requirements only if they stem from specific national legal or regulatory requirements relating to the scope of the statutory audit of annual or consolidated financial statements , meaning that those requirements have not been covered by the adopted international auditing standards , and only if they add to the credibility and quality of annual financial statements and consolidated financial statements . the commission should continue to be involved in the monitoring of the content and adoption process of the international auditing standards by the iaasb .


### for the purposes of paragraph 1 , “international auditing standards” means international standards on auditing and related statement and standards which are part of the clarity project issued by the international federation of accountants in 2009 insofar as they are relevant to the statutory audit . ### for the purposes of paragraph 1 , ' international auditing standards ' means international standards on auditing issued by the international auditing and assurance standards board with an effective date stated therein of 2009 insofar as they are relevant to the statutory audit .


### for the purposes of this article , a “limited review” means a procedure undertaken by a statutory auditor or audit firm with a view to detecting misstatements due to error or fraud in the financial statements of an entity and which provides a lower level of assurance than statutory audit . ### for the purposes of this article , a ' limited assurance engagement ' means an engagement undertaken by a statutory auditor or audit firm in which a lower level of assurance is obtained than in a statutory audit engagement .


### ‘ the competent authorities referred to in article 32 shall cooperate in view of achieving a convergence of the requirements set out in this article . they shall cooperate with the european securities and markets authority and the competent authorities referred to in article x of regulation [ xxx ] of [ xxx ] in so far as such convergence relates to the statutory audit of public - interest entities . ’ ### ‘ the competent authorities referred to in article 32 shall cooperate with a view to achieving a minimum convergence of the requirements set out in this article . ’


### ' 10 . “competent authorities” means the authorities designated by law that are in charge of the regulation and / or oversight of statutory auditors and audit firms or of specific aspects thereof ; the reference to “competent authority” in a specific article means a reference to the authority responsible for the functions referred to in that article ; ' ; ### ' 10 . “competent authorities” means the authorities designated by law that are in charge of the regulation and / or oversight of statutory auditors and audit firms or of specific aspects thereof ; the reference to “competent authority” in a specific article means a reference to the authority or body / ies responsible for the functions referred to in that article ; ' ;


### adequate supervision of statutory auditors and audit firms that have cross - border activities or are part of networks requires the public oversight authorities of the member states to exchange information . in order to protect the confidentiality of the information that may be thus exchanged , member states should subject to the obligation of professional secrecy not only the employees of the public oversight authorities , but also all persons to whom the public oversight authorities have delegated tasks . the competent authority should have the possibility to delegate tasks to other authorities or bodies only with regard to the approval and registration of the statutory auditors . such delegation should be subject to several conditions and the competent authority should bear the ultimate responsibility for it . ### adequate supervision of statutory auditors and audit firms that have cross - border activities or are part of networks requires the public oversight authorities of the member states to exchange information . in order to protect the confidentiality of the information that may be thus exchanged , member states should subject to the obligation of professional secrecy not only the employees of the public oversight authorities , but also all persons to whom the public oversight authorities have delegated tasks . the competent authority should have the possibility to delegate tasks to other authorities or bodies with regard to the approval and registration of the statutory auditors and audit firms , including the education and qualifications of statutory auditors and the organisation of the register of statutory auditors and audit firms . such delegation should be subject to several conditions and the competent authority should bear the ultimate responsibility for it .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 18 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 18 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 24 months after publication ] ; the provisions necessary to comply with article 1 , and from [ insert concrete date 48 months after publication ] . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with this directive by [ insert concrete date 6 months after publication ] at the latest . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . they shall apply those provisions from [ insert concrete date 6 months after publication + one day ] . however , the member states shall apply : the provisions necessary to comply with article 1 in so far as it relates to articles 46b and 46b of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 6 months after publication ] ; the provisions necessary to comply with article 1 , and from [ insert concrete date 12 months after publication ] .


### persons trading medicinal products shall ensure that the traded medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . in addition , the requirements set out in article 80 to shall apply . they shall notify their activity to the competent authority of the member state where they are established . ### persons trading or brokering medicinal products shall ensure that the traded or brokered medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . they shall notify their activity to the competent authority of the member state where they are established , which shall inform the agency .


### persons trading medicinal products shall ensure that the traded medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . in addition , the requirements set out in article 80 to shall apply . they shall notify their activity to the competent authority of the member state where they are established . ### persons trading or brokering medicinal products shall ensure that the traded medicinal products are covered by a marketing authorization granted pursuant to regulation no 726 / 2004 or by the competent authorities of a member state in accordance with this directive . they shall notify their activity to the competent authority of the member state where they are established , which shall inform the agency .


### they must keep records either in the form of purchase / sales invoices or on computer , or in any other form , giving for any transaction in medicinal products received , dispatched or traded at least the following information : – date , – name of the medicinal product , – quantity received , supplied or traded , – name and address of the supplier or consignee , as appropriate ; ’ ; ### they must keep records either in the form of purchase / sales invoices or on computer , or in any other form , giving for any transaction in medicinal products received , dispatched , traded or brokered at least the following information : – date , – name of the medicinal product , – quantity received , supplied , traded or brokered , – name and address of the supplier or consignee , as appropriate ; ’ ;


### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of prescription medicinal products should be established at community level . when introducing obligatory safety features for prescription medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated . ### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of medicinal products should be established at community level . when introducing obligatory safety features for medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines , over - the - counter medicines and medicinal products sold directly by producers , without any intermediary , to clinical establishments in which the products are directly administered to the patient . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated .


### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of prescription medicinal products should be established at community level . when introducing obligatory safety features for prescription medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated . ### in order to take account of new risk profiles , while at the same time ensuring the functioning of the internal market for medicinal products , safety features designed to ensure the identification , authentication and traceability of medicinal products should be established at community level . when introducing obligatory safety features for medicinal products , due account should be taken of the particularities of certain products or categories of products , such as generic medicines or medicines that are delivered directly by producers , without the involvement of third parties , such as wholesale distributors , traders or brokers , to establishments at which the product is administered directly to the patient . this includes the risk of falsifications in view of their price and past incidences in the community and abroad , as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated .


### the report shall in particular assess whether this decision provides for a sufficient framework in order to ensure full compliance of intergovernmental agreements with union law and a high level of coordination between member states with regard to intergovernmental agreements . ### the report shall in particular assess whether this decision provides for a sufficient framework in order to ensure full compliance of intergovernmental agreements with union law and a high level of coordination between member states with regard to intergovernmental agreements . it shall also assess whether the timeframes laid down in this decision are appropriate and the impact they have had on member states ' negotiations with third countries .


### the commission may on its own initiative until four weeks after it has been informed of the closure of the negotiations at the latest or on request from the member state which has negotiated the intergovernmental agreement , assess the compatibility of the negotiated agreement with union law before the agreement has been signed . in case the commission or the member state concerned ask for such an ex - ante assessment of the negotiated intergovernmental agreement with union law , the negotiated but not yet signed draft intergovernmental agreement shall be submitted to the commission for examination . the member state concerned shall refrain from signing the agreement for a period of four months following the submission of the draft intergovernmental agreement . in agreement with the member state concerned , the examination period might be prolonged . when a compatibility control has been requested , in the absence of an opinion by the commission within the examination period , the commission shall be deemed not to have raised objections . ### as early as possible and not later than two weeks after closure of the negotiations the member state concerned shall inform the commission of the closure of the negotiations and shall submit the negotiated but not yet signed draft intergovernmental agreement , including its&#160 ; annexes and other texts it refers to explicitly , &#160 ; to the commission for examination . the commission shall , on its own initiative or at the request of the member state that negotiated the intergovernmental agreement , inform that member state , within two months after being informed of the closure of the negotiations , of any doubts on the compatibility of the negotiated agreement , and its annexes and other texts it refers to explicitly , with union law , in particular with eu competition law and eu internal energy market legislation . the member state concerned shall refrain from signing the agreement for a period of two months following the submission of the intergovernmental agreement . in the absence of a response from the commission within that period , the commission shall be deemed not to have raised objections . the member state shall postpone the signing of an intergovernmental agreement for another two months if it has received a response from the commission that the negotiated but not yet signed agreement , is not compatible with union law . within those two months the commission shall issue a legal opinion . 2 . where the legal opinion identifies incompatibility between the negotiated agreement and union law , the commission shall specify that incompatibility and shall make recommendations on how to eliminate the incompatibility . 3 . member states shall take due account of the commission ' s recommendations and , if necessary , renegotiate the agreement . if the recommendations are not taken into account and serious doubts persist about the compatibility of the signed intergovernmental agreement with union law , the commission shall consider launching infringement proceedings .


### for proceedings pursuant to article 10 , an investigation shall , whenever possible , be concluded within one year . in any event , such investigations shall be concluded within 13 months of initiation , in accordance with the findings made pursuant to article 13 for undertakings or the findings made pursuant to article 15 for definitive action . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 8 months after the initiation of the investigation , to extend this time limit , for a period up to , but in no case longer than , 18 months . ### for proceedings pursuant to article 10 , an investigation shall , whenever possible , be concluded within 11 months . in any event , such investigations shall be concluded within 12 months of initiation , in accordance with the findings made pursuant to article 13 for undertakings or the findings made pursuant to article 15 for definitive action .


### for proceedings initiated pursuant to article 5 , an investigation shall , whenever possible , be concluded within one year . in any event , such investigations shall be concluded within 15 months of initiation , in accordance with the findings made pursuant to article 8 for undertakings or the findings made pursuant to article 9 for definitive action . in exceptional cases , having regard to the complexity of the investigation , the commission may decide , no later than 9 months after the initiation of the investigation , to extend this time limit , for a period up to , but in no case longer than , 18 months . ### for proceedings initiated pursuant to article 5 , an investigation shall , whenever possible , be concluded within one year . in any event , such investigations shall be concluded within 14 months of initiation , in accordance with the findings made pursuant to article 8 for undertakings or the findings made pursuant to article 9 for definitive action .


### the relevant provisions of articles 5 and 6 shall apply to any reinvestigation carried out pursuant to this article , except that such reinvestigation shall be carried out expeditiously and shall normally be concluded within nine months of the date of initiation of the reinvestigation . in any event , such reinvestigations shall in all cases be concluded within one year of initiation of the reinvestigation . ### the relevant provisions of articles 5 and 6 shall apply to any reinvestigation carried out pursuant to this article , except that such reinvestigation shall be carried out expeditiously and shall normally be concluded within six months of the date of initiation of the reinvestigation . in any event , such reinvestigations shall in all cases be concluded within ten months of initiation of the reinvestigation .


### draft by the court of justice ### in order to avoid any doubts as to the authority of the temporary judges , it is of the utmost importance that they be elected in a way which does not compromise the authority of the court and which ensures their total independence ,


### draft by the court of justice the parliament and the council , acting in accordance with article 257 tfeu , may attach temporary judges to the specialised courts in order to cover the absence of judges who , while not suffering from disablement deemed to be total , are prevented from participating in judicial business for an extended period of time . in that event , the parliament and the council shall lay down the conditions under which the temporary judges shall be appointed , their rights and duties , the detailed rules governing the performance of their duties and the circumstances in which they shall cease to perform those duties . ### the parliament and the council , acting in accordance with article 257 tfeu , may attach temporary judges to the specialised courts in order to cover the absence of judges who , while not suffering from disablement deemed to be total , are prevented from participating in judicial business for an extended period of time . in that event , the parliament and the council shall lay down the conditions under which the temporary judges shall be appointed , their rights and duties , the detailed rules governing the performance of their duties and the circumstances in which they shall cease to perform those duties . those provisions shall ensure , moreover , that the temporary judges enjoy the same rights and are entitled to assume the same functions as permanent judges , in order to guarantee the uncompromised authority of the court ' s judgments .


### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 . ### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , transport sustainability and transport efficiency , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 .


### the information and the actions taken on requests referred to in paragraph 1 shall be free of charge . where requests are manifestly excessive , in particular because of their repetitive character , the controller may charge a fee for providing the information or taking the action requested , or the controller may not take the action requested . in that case , the controller shall bear the burden of proving the manifestly excessive character of the request . ### the information and the actions taken on requests referred to in paragraph 1 shall be free of charge . where requests are manifestly excessive , in particular owing to their high volume , complexity or their repetitive character , the controller may charge an appropriate , not for profit , fee for providing the information or taking the action requested , or the controller may decline to take the action requested . in that case , the controller shall bear the burden of proving the manifestly excessive character of the request .


### the administrative sanction shall be in each individual case effective , proportionate and dissuasive . the amount of the administrative fine shall be fixed with due regard to the nature , gravity and duration of the breach , the intentional or negligent character of the infringement , the degree of responsibility of the natural or legal person and of previous breaches by this person , the technical and organisational measures and procedures implemented pursuant to article 23 and the degree of co - operation with the supervisory authority in order to remedy the breach . ### the administrative sanction shall be in each individual case effective , proportionate and dissuasive . the amount of the administrative fine shall be fixed with due regard to the nature , gravity and duration of the breach , the sensitivity of the data in issue , the intentional or negligent character of the infringement , the degree of harm or risk of harm created by the violation , the degree of responsibility of the natural or legal person and of previous breaches by this person , the technical and organisational measures and procedures implemented pursuant to article 23 and the degree of co - operation with the supervisory authority in order to remedy the breach . where appropriate , the data protection authority shall also be empowered to require that a data protection officer is appointed if the body , organisation or association has opted not to do so .


### ‘ the data subject ' s consent’ means any freely given specific , informed and explicit indication of his or her wishes by which the data subject , either by a statement or by a clear affirmative action , signifies agreement to personal data relating to them being processed ; ### ' the data subject ' s consent ' means any form of statement or conduct by the data subject indicating assent to the data processing proposed . silence or inactivity does not in itself indicate acceptance ;


### ‘ the data subject ' s consent’ means any freely given specific , informed and explicit indication of his or her wishes by which the data subject , either by a statement or by a clear affirmative action , signifies agreement to personal data relating to them being processed ; ### ' the data subject ' s consent ' means any freely given specific and informed indication of his or her wishes by which the data subject signifies agreement to personal data relating to them being processed ;


### the data are not collected from the data subject and the provision of such information proves impossible or would involve a disproportionate effort ; or ### the data are not collected from the data subject and the provision of such information proves impossible or would involve a disproportionate effort and generate excessive administrative burden , especially when the processing is carried out by a sme as defined in eu recommendation 2003 / 361 ; or


### the commission may specify the electronic format referred to in paragraph 1 and the technical standards , modalities and procedures for the transmission of personal data pursuant to paragraph 2 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 87 . ### the electronic format , related functionalities and procedures for the transmission of personal data pursuant to paragraph 2 , shall be determined by the controller by reference to the most appropriate industry standards available or as defined by industry stakeholders or standardisation bodies .


### where the controller is a public authority or body and where the processing results from a legal obligation pursuant to point of article 6 providing for rules and procedures pertaining to the processing operations and regulated by union law , paragraphs 1 to 4 shall not apply , unless member states deem it necessary to carry out such assessment prior to the processing activities . ### where the controller is a public authority or body or where the data is processed by another body which has been entrusted with the responsibility of delivering public service tasks , and where the processing results from a legal obligation pursuant to point of article 6 providing for rules and procedures pertaining to the processing operations and regulated by union law , paragraphs 1 to 4 shall not apply , unless member states deem it necessary to carry out such assessment prior to the processing activities .


### where a processing operation is to be carried out on behalf of a controller , the controller shall choose a processor providing sufficient guarantees to implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject , in particular in respect of the technical security measures and organizational measures governing the processing to be carried out and shall ensure compliance with those measures . ### where a processing operation is to be carried out on behalf of a controller and which involves the processing of data that would permit the processor to reasonably identify the data subject , the controller shall choose a processor providing sufficient guarantees to implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject , in particular in respect of the technical security measures and organizational measures governing the processing to be carried out and shall ensure compliance with those measures . the controller remains solely responsible for ensuring compliance with the requirements of this regulation .


### having regard to the state of the art and the cost of implementation , the controller shall , both at the time of the determination of the means for processing and at the time of the processing itself , implement appropriate technical and organisational measures and procedures in such a way that the processing will meet the requirements of this regulation and ensure the protection of the rights of the data subject . ### where required , mandatory measures may be adopted to ensure that categories of goods or services are designed and have default settings meeting the requirements of this regulation relating to the protection of individuals with regard to the processing of personal data . such measures shall be based on standardisation pursuant to [ regulation . . . / 2012 of the european parliament and of the council on european standardisation , amending council directives 89 / 686 / eec and 93 / 15 / eec and directives 94 / 9 / ec , 94 / 25 / ec , 95 / 16 / ec , 97 / 23 / ec , 98 / 34 / ec , 2004 / 22 / ec , 2007 / 23 / ec , 2009 / 23 / ec and 2009 / 105 / ec of the european parliament and of the council and repealing decision 87 / 95 / eec and decision no 1673 / 2006 / ec ] .


### the scoreboard shall be made up of an array of macroeconomic and macrofinancial indicators for member states . the commission may set indicative lower or upper thresholds for these indicators to serve as alert levels . the thresholds applicable to member states whose currency is the euro may be different from those applicable to the other member states . ### the scoreboard , made up of an array of indicators for member states shall allow for comparisons between member states and reflect short - term , structural and medium - long term trends . the commission shall set indicative and symmetric lower or upper thresholds for these indicators to serve as alert levels .


### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ‘ fin - to - carcass’ ratio is established , however , following processing operations , fins and bodies can be landed in different ports . in such cases the use of the ratio becomes ineffective and gives scope for shark finning to occur . under these circumstances , the collection of data , e . g ; species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation measures , is hampered . ### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ' fin - to - carcass ' ratio is established . however , the ratio is theoretical , because it is based on the weight ratio of shark fins to whole sharks , while sharks are usually landed ' dressed ' . therefore , shark fins and carcasses cannot be directly compared against the ratio , and monitoring must rely on species - specific conversion factors , complicating enforcement . the ratio is also higher than the average fin - to - carcass weight for some species . furthermore , following processing operations , fins and bodies can be landed in different ports . for these reasons , the use of the ratio becomes ineffective and gives scope for shark finning to occur . under these circumstances , the collection of data , e . g . species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation and management measures , as well as the enforcement of the regulation and punishment for non - compliance , are hampered .


### – the number and nature of cases of non - compliance detected , including a full identification of the vessel involved . ### – the number and nature of cases of non - compliance detected , including a full identification of the vessel involved and the penalty applied for each case of non - compliance .


### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ‘ fin - to - carcass’ ratio is established , however , following processing operations , fins and bodies can be landed in different ports . in such cases the use of the ratio becomes ineffective and gives scope for shark finning to occur . under these circumstances , the collection of data , e . g ; species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation measures , is hampered . ### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ' fin - to - carcass ' ratio is established . serious control and enforcement difficulties occur with the use of ' fin - to - carcass ' ratio systems . such systems do not eliminate the practice of high - grading and , due to differences in fin cutting techniques and variability of the fin size and weight of different shark species , they could allow finning to occur without being detected . following processing operations , fins and bodies can be landed in different ports . under these circumstances , the collection of data , e . g . species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation and management measures , is hampered .


### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken . ### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that , within the limits of its respective activities , the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken .


### 1 . general 3 . 1 . 1 . a notified body shall be capable of carrying out all the tasks assigned to it by this regulation with the highest degree of professional integrity and the requisite technical competence in the specific field , whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility . in particular , it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified . this presupposes the availability within its organisation of sufficient scientific personnel who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified , having regard to the requirements of this regulation and , in particular , those set out in annex i . 3 . 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with technical knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data . 3 . 1 . 3 . the notified body shall clearly document the extent and the limits of the duties , responsibilities and authorities in relation of the personnel involved in conformity assessment activities and inform the personnel concerned about it . ### 1 . general 3 . 1 . 1 . a notified body shall be capable of carrying out all the tasks assigned to it by this regulation with the highest degree of professional integrity and the requisite technical competence in the specific field , whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility . in particular , it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified . this presupposes the permanent availability within its organisation of sufficient scientific personnel who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified , having regard to the requirements of this regulation and , in particular , those set out in annex i . 3 . 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with pharmacological , medical and technical knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data . 3 . 1 . 3 . the notified body shall clearly document the extent and the limits of the duties , responsibilities and authorities in relation of the personnel involved in conformity assessment activities and inform the personnel concerned about it . 3 . 1 . 3a . the notified body shall make available the list of its personnel and their expertise to the commission and , upon request , to other parties . that list shall be kept up to date .


### this paragraph shall not apply to manufacturers of custom - made devices who are micro - enterprises as defined by commission recommendation 2003 / 361 / ec . ### this paragraph shall not apply to manufacturers of custom - made devices who are registered pharmacies , or micro - enterprises as defined by commission recommendation 2003 / 361 / ec


### a diploma , certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study , in natural sciences , medicine , pharmacy , engineering or another relevant discipline , and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices ; ### a diploma , certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study at university level , in natural sciences , medicine , pharmacy , engineering or another relevant discipline , and at least five years of professional experience in regulatory affairs or in quality management systems relating to medical devices ;


### ‘ accessory to a medical device’ means an article which , whilst not being a medical device , is intended by its manufacturer to be used together with one or several particular medical device to specifically enable or assist the device to be used in accordance with its / their intended purpose ; ### ' accessory to a medical device ' means an article which , whilst not being a medical device , is intended by its manufacturer to be used together with one or several particular medical device to specifically enable or assist the device to be used in accordance with its / their intended purpose or to specifically assist the medical functionality of the device in view of its / their intended purpose ;


### 2 . 4 . notified bodies shall have available personnel with clinical expertise . this personnel shall be integrated in the notified body ' s decision - making process in a steady way in order to : - identify when specialist input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts ; - appropriately train external clinical experts in the relevant requirements of this regulation , delegated and / or implementing acts , harmonised standards , cts and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided ; - be able to discuss the clinical data contained within the manufacturer ' s clinical evaluation with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation ; - be able to scientifically challenge the clinical data presented , and the results of the external clinical experts ' assessment of the manufacturer ' s clinical evaluation ; - be able to ascertain the comparability and consistency of the clinical assessments conducted by clinical experts ; - be able to make an objective clinical judgement about the assessment of the manufacturer ' s clinical evaluation and make a recommendation to the notified body ' s decision maker . ### 2 . 4 . clinical experts : notified bodies shall have available , on a permanent basis , personnel with expertise in clinical investigation design , medical statistics , clinical patient management , good clinical practice in the field of clinical investigations and pharmacology . this personnel shall be integrated in the notified body ' s decision - making process in a steady way in order to : - identify when specialist input is required for the assessment of the clinical investigation plans and the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts ; - appropriately train external clinical experts in the relevant requirements of this regulation , delegated and / or implementing acts , harmonised standards , cts and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided ; - be able to discuss the rationale of the planned study design , the clinical investigation plans and the selection of the control intervention with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation ; - be able to scientifically challenge the clinical investigation plans and the clinical data presented , and the results of the external clinical experts ' assessment of the manufacturer ' s clinical evaluation ; - be able to ascertain the comparability and consistency of the clinical assessments conducted by clinical experts ; - be able to make an objective clinical judgement about the assessment of the manufacturer ' s clinical evaluation and make a recommendation to the notified body ' s decision maker . - provide an understanding of active substances .


### where no objection is raised in accordance with paragraph 7 or where the mdcg or the commission , after having been consulted in accordance with paragraph 8 , is of the opinion that the notification may be accepted fully or partially , the commission shall publish the notification accordingly . ### where no objection is raised in accordance with paragraph 7 or where the mdcg or the commission , after having been consulted in accordance with paragraph 8 , is of the opinion that the notification may be accepted fully or partially , the commission shall publish the notification accordingly . details of the notification , such as the class and the typology of devices shall be made publicly available .


### the member state where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies . these fees shall , wholly or partly , cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this regulation . ### the member state where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies . these fees shall , wholly or partly , cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this regulation . the fees shall be transparent and proportionate in nature and be subject to member state labour markets .


### in order to maintain a high level of health and safety , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission in respect of the products subject to this regulation that are similar to medical devices but do not necessarily have a medical purpose ; adaptation of the definition of nanomaterial to technical progress and to developments at union and international level ; adaptation to technical progress of the general safety and performance requirements , of the elements to be addressed in the technical documentation , of the minimum content of the eu declaration of conformity and of the certificates issued by notified bodies , of the minimum requirements to be met by notified bodies , of the classification rules , of the conformity assessment procedures , and of the documentation to be submitted for the approval of clinical investigations ; the establishment of the udi system ; the information to be submitted for the registration of medical devices and certain economic operators ; the level and structure of fees for the designation and monitoring of notified bodies ; the publicly available information in respect of clinical investigations ; the adoption of preventive health protection measures at eu level ; and the tasks of and criteria for european union reference laboratories and the level and structure of fees for scientific opinions delivered by them . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to maintain a high level of health and safety , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission in respect of the products subject to this regulation that are similar to medical devices but do not necessarily have a medical purpose ; adaptation of the definition of nanomaterial to technical progress and to developments at union and international level ; classification rules and documentation to be submitted for the approval of clinical investigations ; the establishment of the udi system ; the information to be submitted for the registration of medical devices and certain economic operators ; the level and structure of fees for the designation and monitoring of notified bodies ; the publicly available information in respect of clinical investigations ; the adoption of preventive health protection measures at eu level ; and the tasks of and criteria for european union reference laboratories and the level and structure of fees for scientific opinions delivered by them . the essential elements of this regulation , such as the general safety and performance requirements , elements included in the technical documentation and the minimum content of the eu declaration of conformity may only be modified through the ordinary legislative procedure . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### ‘ health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health ; ### ‘ health institution’ means an organisation whose primary purpose is the care or treatment of patients ;


### in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . ### in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall provide a report of safety and clinical performance , including full results of clinical studies and trials . it shall be written in a way that is clear to the intended user , differentiating between the information needs of patients and healthcare professionals . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . the summary shall also be made public .