### member states shall , at the request of the commission , provide the assistance from experts on statistical issues related to the macroeconomic imbalances procedure , including for the preparation and carrying - out of the missions . in the exercise of their duties , these experts shall provide independent expertise . a list of those experts shall be constituted by on the basis of proposals sent to the commission by the national authorities responsible for the mip relevant data . ### member states shall , at the request of the commission , provide the assistance from experts on statistical issues related to the macroeconomic imbalances procedure , including for the preparation and carrying - out of the visits . in the exercise of their duties , these experts shall provide independent expertise . a list of those experts shall be constituted by [ oj please insert date : six months after publication of this regulation ] on the basis of proposals sent to the commission by the national authorities responsible for the mip relevant data .


### the commission shall not delay the provision of the mip relevant data of member states where a member state has not transmitted its own data . ### the commission shall determine the publication date for the news release and communicate it to member states within ten working dates after the cut - off date referred to in article 2 . it shall not delay the provision of the mip relevant data of member states where a member state has not transmitted its own data .


### the commission may express a reservation on the quality of a member state ' s mip relevant data . no later than three working days before the planned publication date , the commission shall communicate to the member state concerned and to the president of the economic policy committee the reservation it intends to express and make public . where the issue is resolved after publication of the data and the reservation , withdrawal of the reservation shall be made public immediately thereafter . ### the commission may express a reservation on the quality of a member state ' s mip relevant data . the member state concerned shall be given the opportunity to defend its position . no later than three working days before the planned publication date , the commission shall communicate to the member state concerned and to the president of the economic policy committee the reservation it intends to express and make public . where the issue is resolved after publication of the data and the reservation , withdrawal of the reservation shall be made public immediately thereafter .


### the commission may amend data transmitted by member states and provide the amended data and a justification of the amendment where there is evidence that the data reported by member states do not comply with the requirements of article 3 . no later than three working days before the planned publication date , the commission shall communicate to the member state concerned and to the president of the economic policy committee the amended data and the justification for the amendment . ### the commission may amend data transmitted by member states and provide the amended data and a justification of the amendment where there is evidence that the data reported by member states do not comply with the requirements of article 3 as well as with the applicable methodological standards and the requirements of completeness , reliability , timeliness and consistency of statistical data . no later than three working days before the planned publication date , the commission shall communicate to the member state concerned and to the president of the economic policy committee the amended data and the justification for the amendment .


### the commission may conduct all investigations necessary to establish the existence of the misrepresentations referred to in paragraph 1 . it may decide to initiate an investigation when it finds that there are serious indications of the existence of facts liable to constitute such a misrepresentation . in investigating the putative misrepresentations , the commission shall take into account any comments submitted by the member state concerned . in order to carry out its tasks , the commission may request the member state to provide information , and may conduct on - site inspections and access the underlying statistical information and documents related to the mip relevant data . if the law of the member state concerned requires prior judicial authorisation for on - site inspections , the commission shall make the necessary applications . ### the commission may , in accordance with the treaties and specific sectoral legislation , initiate and conduct all investigations necessary to establish the existence of the misrepresentations referred to in paragraph 1 . it may decide to initiate an investigation when it finds that there are serious indications of the existence of facts liable to constitute such a misrepresentation . in investigating the putative misrepresentations , the commission shall take into account any comments submitted by the member state concerned . in order to carry out its tasks , the commission may request the member state under investigation to provide information , and may conduct on - site inspections and access the underlying statistical information and documents related to the mip relevant data . if required by the law of the member state subject to investigation , authorisation by the judicial authority shall be obtained before an on - site inspection .


### upon completion of its investigation , and before submitting any proposal to the council , the commission shall give the member state concerned the opportunity of being heard in relation to the matters under investigation . the commission shall base any proposal to the council only on facts on which the member state concerned has had the opportunity to comment . ### upon completion of its investigation , and before submitting any recommendation to the council , the commission shall give to the member state subject to investigation the opportunity of being heard on the matters being investigated . the commission shall base any recommendation to the council only on facts on which the member state concerned has had the opportunity to comment .


### for the measures referred to in article 9 the council shall act without taking into account the vote of the member of the council representing the member state concerned . ### for the measures referred to in article 9 , only members of the council representing member states whose currency is the euro shall act without taking into account the vote of the member of the council representing the member state concerned . the decision referred to in article 9 shall be deemed to be adopted by the council unless the council decides , by a qualified majority , to reject the recommendation within 10 days of its adoption by the commission . the council may decide , by qualified majority , to amend the recommendation .


### in line with article 5 of regulation no 223 / 2009 , the national statistical institutes of the member states shall ensure the required coordination on the mip relevant data at national level . all other national authorities shall report to the nsi for this purpose . the member states shall take the necessary measures to ensure the application of this provision . ### in line with article 5 of regulation no 223 / 2009 , the national statistical institutes of the member states shall ensure the required coordination on the mip relevant data at national level . national central banks , in their capacity as escb members producing mip relevant data , and where appropriate , other relevant national authorities shall cooperate with the nsis for this purpose . the member states shall take the necessary measures to ensure the application of this provision .


### the commission shall report regularly to the european parliament and to the council on the activities carried out by the commission for the purpose of implementing this regulation . ### the commission shall report at least annually to the european parliament and to the council in the context of the european semester as referred to in regulation no 1175 / 2011 of the european parliament and of the council7a . ________________ 7a regulation no 1175 / 2011 of the european parliament and of the council of 16 november 2011 amending council regulation no 1466 / 97 on the strengthening of the surveillance of budgetary positions and the surveillance and coordination of economic policies .


### by 14 december 2014 and every five years thereafter , the commission shall review the application of this regulation and report its findings to the european parliament and the council . ### by 14 december 2014 and every five years thereafter , the commission shall review and report to the european parliament and the council on the application of this regulation . where appropriate , such a report shall be accompanied by a legislative proposal .


### 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 .


### ‘ 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 ;


### ‘ 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 and / or geographical disturbances , beyond the control of , and not materially influenced by , a member state . these exclude harvesting and prescribed burning ;


### ‘ half - life value’ is the number of years it takes for the carbon content of a wood product to decrease to one half of its initial quantity ; ### ' half - life value ' is the number of years it takes for the quantity of carbon stored in a wood product to decrease to one half of its initial value ;


### 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 eighteen months after the beginning of each accounting period specified in annex i , member states shall draw up and transmit to the commission lulucf action plans to limit or reduce emissions and maintain or increase removals resulting from the activities referred to in the first subparagraph of article 3 and where systems are in place and data available from activities referred to in subparagraph 2 of article 3 . member states shall consult with stakeholders in drawing up action plans .


### when an electronic identification using an electronic identification means and authentication is required under national legislation or administrative practice to access a service online , any electronic identification means issued in another member state falling under a scheme included in the list published by the commission pursuant to the procedure referred to in article 7 shall be recognised and accepted for the purposes of accessing this service . ### when an electronic identification using an electronic identification means and authentication is required under national legislation or administrative practice to access a public service online in one member state , the electronic identification means issued in another member state under a scheme , which is included in the list published by the commission pursuant to article 7 , shall be recognised in the first member state for the purposes of accessing that service online , provided that those electronic identification means correspond to an identity assurance level equal to or higher than the identity assurance level required for access to that service online in the first member state .


### the electronic identification means can be used to access at least public services requiring electronic identification in the notifying member state ; ### the electronic identification means under that scheme can be used to access at least one service provided by a public sector body requiring electronic identification in the notifying member state ;


### the notifying member state ensures the availability of an authentication possibility online , at any time and free of charge so that any relying party can validate the person identification data received in electronic form . member states shall not impose any specific technical requirements on relying parties established outside of their territory intending to carry out such authentication . when either the notified identification scheme or authentication possibility is breached or partly compromised , member states shall suspend or revoke without delay the notified identification scheme or authentication possibility or the compromised parts concerned and inform the other member states and the commission pursuant to article 7 ; ### the notifying member state ensures the availability of authentication online , so that any relying party established outside of the territory of that member state can validate the person identification data received in electronic form . such authentication shall be provided free of charge when accessing a service online provided by a public sector body . member states shall not unduly impose any specific technical requirements on relying parties intending to carry out such authentication ;


### if the commission receives a notification after the period referred to in paragraph 2 expired , it shall amend the list within three months . ### if the commission receives a notification after the period referred to in paragraph 2 has expired , it shall publish in the official journal of the european union the amendments to the list referred to in paragraph 2 within one month from the date of receipt of that notification .


### the commission may , by means of implementing acts , define the circumstances , formats and procedures for the purpose of paragraphs 1 , 2 and 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define the formats and procedures for the purpose of paragraphs 1 and 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### coordination member states shall cooperate in order to ensure the interoperability of electronic identification means falling under a notified scheme and to enhance their security . ### cooperation and interoperability the national electronic identification infrastructures need to provide for interoperability with the electronic identification infrastructures of other member states . the interoperability between the national electronic identification infrastructures shall be ensured through an interoperability model .


### 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 .


### the commission may , by means of implementing acts , define the circumstances , formats and procedures , including deadlines , applicable for the purpose of paragraphs 1 to 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 . ### the commission may , by means of implementing acts , define further specification of the measures referred to in paragraph 1 and the formats and procedures , including deadlines , applicable for the purpose of paragraph 2 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 39 .


### supervisory bodies shall cooperate with a view to exchange good practice and provide each other , within the shortest possible time , with relevant information and mutual assistance so that activities can be carried out in a consistent manner . mutual assistance shall cover , in particular , information requests and supervisory measures , such as requests to carry out inspections related to the security audits as referred to in articles 15 , 16 and 17 . ### supervisory bodies shall cooperate with a view to exchanging good practice . a supervisory body shall , upon a receiving a request from another supervisory body , provide that body with assistance so that their activities can be carried out in a consistent manner . supervisory bodies shall also cooperate where a request is made under the regulation no 765 / 2008 of the european parliament and of the council of 9 july 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products1 . in addition , mutual assistance may also cover information requests and supervisory measures related to the conformity assessment reports as referred to in articles 15 , 16 and 17 . _____________ 1 oj l 218 , 13 . 8 . 2008 , p . 30 .


### qualified trust service providers shall notify the supervisory body of their intention to start providing a qualified trust service and shall submit to the supervisory body a security audit report carried out by a recognised independent body , as provided for in article 16 . qualified trust service providers may start to provide the qualified trust service after they have submitted the notification and security audit report to the supervisory body . ### where trust service providers intend to start providing qualified trust services , they shall submit to the supervisory body a notification of their intention together with a conformity assessment report provided by a conformity assessment body , as provided for in article 16 .


### bear the risk of liability for damages by maintaining sufficient financial resources or by an appropriate liability insurance scheme ; ### with regard to the risk of liability for damages , maintain sufficient financial resources or obtain appropriate liability insurance ;


### before entering into a contractual relationship , inform any person seeking to use a qualified trust service of the precise terms and conditions regarding the use of that service ; ### before entering into a contractual relationship , inform any person seeking to use a qualified trust service of the terms and conditions regarding the use of that service , including any limitation on its use ;


### use trustworthy systems to store data provided to them , in a verifiable form so that : – they are publicly available for retrieval only where the consent of the person to whom the data has been issued has been obtained , – only authorised persons can make entries and changes , – information can be checked for authenticity ; ### use trustworthy systems to store data provided to them , in a verifiable form so that : - they are publicly available for retrieval only where the consent of the person to whom the data relates has been obtained , - only authorised persons can make entries and changes to the stored data , - the data can be checked for authenticity ;


### take measures against forgery and theft of data ; ### take appropriate measures against forgery and theft of data ;


### record for an appropriate period of time all relevant information concerning data issued and received by the qualified trust service provider , in particular for the purpose of providing evidence in legal proceedings . such recording may be done electronically ; ### record and keep accessible for an appropriate period of time , including after the activities of the qualified trust service provider have ceased , all relevant information concerning data issued and received by the qualified trust service provider , in particular for the purpose of providing evidence in legal proceedings and for the purpose of ensuring continuity of the service in accordance with the termination plans referred to in article 13 . such recording may be done electronically ;


### proposing , based on the information contained in the electronic complaint form , one or more competent adr entities to the parties and providing information on their fees , if applicable , the language or languages in which the procedure will be conducted , the approximate length of the procedures or informing the complainant party that based on the information submitted , no competent adr entity could be identified ; ### proposing , based on the information contained in the electronic complaint form , one or more competent adr entities to the complainant based upon those entities the trader has committed to use , and providing information on their fees , if applicable , the language or languages in which the procedure will be conducted , the approximate length of the procedures or informing the complainant party that based on the information submitted , no competent adr entity could be identified ;


### the absence of community rules and the disparities between the systems in force in the member states , as regards the indication on certain products of their country of origin , has given rise to a situation where in a number of sectors a major part of products imported from third countries and distributed within the community market are found to carry no or misleading information concerning their country of origin . ### the absence of community rules and the disparities between the systems in force in the member states , as regards the indication on certain products of their country of origin , has given rise to a situation where in a number of sectors a major part of products imported from third countries and distributed within the community market are found to carry no or misleading information concerning their country of origin . this disparity is also leading to a situation where import traffic from third countries is shifting towards particular eu points of entry which suit the exporting country most ;


### 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 measures necessary for the implementation of this regulation should be adopted in accordance with council decision 1999 / 468 / ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission . ### according to article 291 of the treaty on the functioning of the european union , rules and general principles concerning mechanisms for the control by member states of the commission ' s exercise of its implementing powers shall be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure . pending the adoption of that new regulation , the provisions of council decision 1999 / 468 / ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission continues to apply , with the exception of the regulatory procedure with scrutiny which is not applicable .


### goods that require marking are those listed in the annex to this regulation , and imported from third countries , except for goods originating in the territory of the european , bulgaria , romania , turkey , and the contracting parties of the eea agreement . goods may be exempted from origin marking , when for technical or commercial reasons , it appears impossible to mark them . ### goods that require marking are those listed in the annex to this regulation , and imported from third countries , except for goods originating in the territory of the european union , turkey , and the contracting parties of the eea agreement . goods may be exempted from origin marking , when for technical reasons , it appears impossible to mark them .


### 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 .


### where reference is made to this paragraph , articles 5 and 7 of decision 1999 / 468 / ec shall apply . the period laid down in article 5 of decision 1999 / 468 / ec shall be set at one month . ### where reference is made to this paragraph , articles 3 and 7 of decision 1999 / 468 / ec shall apply .


### past support for such initiatives has made it possible to enhance the activities undertaken by the union and the member states in terms of fighting fraud , corruption and any other illegal activities affecting the financial interests of the union . the objectives of the hercule programme for both the period 2004 - 2006 and the period 2007 - 2013 were successfully achieved . ### past support for such initiatives has made it possible to enhance the activities undertaken by the union and the member states in terms of fighting fraud , corruption and any other illegal activities affecting the financial interests of the union .


### the commission should present to the european parliament and to the council an independent interim report on the implementation of this programme , as well as a final report on the achievement of the objectives of this programme . ### the commission should present to the european parliament and to the council an annual report on the implementation of this programme , an interim report on the implementation of this programme , as well as a final report on the achievement of the objectives of this programme .


### this regulation complies with the principles of subsidiarity and proportionality . the hercule iii programme facilitates cooperation between the member states and between the commission and the member states in order to protect the financial interests of the union , without however impinging on member states ‘ responsibilities , and using resources more efficiently than could be done at national level . action at eu level is necessary and justified as it clearly assists member states collectively to protect the eu and national budgets and encourages the use of common eu structures to increase cooperation and information exchange between competent authorities . ### this regulation complies with the principles of subsidiarity and proportionality . the hercule iii programme facilitates cooperation between the member states and between the commission and the member states in order to protect the financial interests of the union , using resources more efficiently than could be done at national level . action at eu level is necessary and justified as it clearly assists member states collectively to protect the eu and national budgets and encourages the use of common eu structures to increase cooperation and information exchange between competent authorities . the programme must not however impinge on member states ' responsibilities .


### 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 ] .


### the programme shall provide , under the same conditions set out in the annual work programme referred to in article 10 , financial support for the following actions : ### the programme shall provide , under the same conditions set out in the annual work programme referred to in article 10 , appropriate financial support for the following actions :


### – increasing data exchange , developing and providing it tools for investigations , and monitoring intelligence work . ### – increasing data exchange , including between the member states and the commission , developing and providing it tools for investigations , and monitoring intelligence work .


### organisation of specialised training , and risk analysis training workshops , as well as conferences , aimed at : ### organisation of targeted specialised training , and risk analysis training workshops , as well as , where appropriate , conferences , aimed at :


### – 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 ;


### – 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 and best practices 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 ;


### – developing high - profile research activities , including studies ; ### – developing high - profile research activities , including comparative - law studies ;


### the financial envelope for the implementation of the programme for the period 2014 to 2020 shall be eur 110 000 000 , in current prices . ### within the meaning of point [ 17 ] of the interinstitutional agreement between the european parliament , the council and the commission of xxx / yyy on cooperation in budgetary matters and on sound financial management , the financial reference amount for the budgetary authority during the annual budgetary procedure in terms of the indicative financial envelope for the implementation of the programme for the period 2014 to 2020 shall be eur 110 000 000 , in current prices . the annual appropriations shall be authorised by the budgetary authority .


### grants ; ### grants , including relating to the maintenance of technical material purchased under the programme ;


### the co - financing rate for grants awarded under the programme shall not exceed 80 % of the eligible costs . in exceptional and duly justified cases , defined in the annual work programme referred to in article 10 , the co - financing rate shall not exceed 90 % of the eligible costs . ### the co - financing rate for grants awarded under the programme shall not be less than 50% and not exceed 80 % of the eligible costs . in exceptional and duly justified cases , when the beneficiary is a research and educational institute and non - profit making entity , as defined in the annual work programme referred to in article 10 , the co - financing rate shall not exceed 90 % of the eligible costs . the co - financing rate for grants awarded under the programme shall not exceed 30% of the eligible costs when it concerns the funding of the maintenance of technical material purchases under the programme . in case of funding of maintenance , the award decision shall be subject to the submission by the national authorities to the commission of a report detailing output , results and added value of the implementation of the technical equipment purchased under the programme .


### 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 .


### a member state that deems it necessary to maintain more stringent national provisions for aspects falling inside the scope of this directive should be allowed to do so , for all products alike , on grounds of overriding needs relating to the protection of public health . a member state should also be allowed to introduce more stringent provisions , applying to all products alike , on grounds relating to the specific situation of this member state and provided the provisions are justified by the need to protect public health . more stringent national provisions should be necessary and proportionate , not constitute a means of arbitrary discrimination or a disguised restriction on trade between member states . stricter national provisions require prior notification to , and approval from , the commission taking into account the high level of health protection achieved through this directive . ### in order to improve the functioning of the internal market , a member state shall not be allowed to introduce more stringent national provisions , applying to all products falling within the scope of this directive .


### member states should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this directive , provided they are compatible with the treaty and do not jeopardise the full application of this directive . accordingly , member states could , for instance , maintain or introduce provisions providing standardisation of packaging of tobacco products provided that those provisions are compatible with the treaty , with wto obligations and do not affect the full application of this directive . a prior notification is required for technical regulations pursuant to directive 98 / 34 / ec of the european parliament and of the council of 22 june 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and on rules on information society services44 . ### with respect for current international market rules , and in order to improve the functioning of the internal market , member states , when they maintain or introduce more stringent national provisions in areas outside the scope of this directive , shall not prohibit or place restrictions on the import , sale and consumption of tobacco and related products that comply with this directive .


### 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 information message and , where applicable , the general warning shall cover 50% of the surface on which they are printed .


### width : not less than 55 mm . ### width : not less than 42 mm .


### where computerised systems are available for the purpose of receiving and processing applications , applications shall be submitted using electronic data - processing techniques . ### when computerised systems are available for the purpose of receiving and processing applications by january 2014 , applications shall be made available using electronic data - processing techniques .


### where the applicant does not provide the missing information within the period referred to in paragraph 1 , the competent customs department shall reject the application . ### where the applicant does not provide the missing information within the period referred to in paragraph 1 , the competent customs department shall reject the application . in that event the competent customs department shall provide reasons for its decision and include information on the appeal procedure .


### the reliability and results of own controls that have been performed by the operators , or by a third party at their request , for the purpose of ascertaining compliance with the rules referred to in article 1 ; ### the reliability and results of own controls that have been performed by the operators , or by a third party at their request , for the purpose of ascertaining compliance with the rules referred to in article 1 . transfer of information on these own controls shall be utilised as much as possible , in a manner that minimizes the burden on operators ;


### on substances , materials or objects which may influence the characteristics of animals and goods , at all stages of production , processing and distribution ; ### on substances , materials or objects which may influence the characteristics or health of animals and goods , at all stages of production , processing and distribution ;


### an examination of documents and other records which may be relevant to the assessment of compliance with the rules referred to in article 1 ; ### an examination of documents , traceability records and other records which may be relevant to the assessment of compliance with the rules referred to in article 1 ;


### in the absence of the union rules referred to in paragraph 1 , official laboratories shall use state - of - the - art methods for their specific analytical , testing and diagnostic needs , taking into account : ### in the absence of the union rules referred to in paragraph 1 , official laboratories shall use the most relevant fit for purpose methods for their specific analytical , testing and diagnostic needs , taking into account :


### order that the operator destroy the consignment in compliance , where appropriate , with the rules referred to in article 1 , taking all the measures necessary to protect human , animal or plant health , animal welfare or the environment ; or ### order that the operator destroy the consignment , humanely in the case of live animals , in compliance , where appropriate , with the rules referred to in article 1 , taking all the measures necessary to protect human , animal or plant health , animal welfare or the environment ; or


### the commission may , by means of implementing acts , designate european union reference laboratories in the areas governed by the rules referred to in article 1 where the effectiveness of official controls also depends on the quality , uniformity and reliability of : ### the commission shall , by means of implementing acts , designate european union reference laboratories in the areas governed by the rules referred to in article 1 where the effectiveness of official controls also depends on the quality , uniformity and reliability of :


### the organisation and the implementation of coordinated control plans of limited duration in one of the areas governed by the rules referred to in article 1 ; ### the preparation , organisation and the implementation of coordinated control plans of limited duration in one of the areas governed by the rules referred to in article 1 ;


### the commission shall make available to the public an annual report on the operation of official controls in the member states , taking into account : ### the commission shall , by 31st december every second year after the entry into force of this regulation , make available to the public an annual report on the operation of official controls in the member states , taking into account :


### order the suspension or withdrawal of the approval of the establishment , plant , holding or means of transport concerned , or of the authorisation of a transporter ; ### order the suspension or withdrawal of the approval of the establishment , plant , holding or means of transport concerned , or of the authorisation of a transporter or of the certificate of competence of the driver ;


### false or misleading official certification ; ### false or misleading official certification and declarations ;


### in order to enhance the independence of statutory auditors and audit firms from the audited entity when carrying out statutory audits , any person or entity that holds rights in an audit firm should be independent of the audited entity and should not be involved in the process of decision making of the audited entity . ### in order to enhance the independence of statutory auditors and audit firms from the audited entity when carrying out statutory audits , any person or entity that holds rights in an audit firm should be independent of the audited entity .


### the public oversight of statutory auditors and audit firms encompasses the approval , registration of statutory auditors and audit firms , the adoption of standards on professional ethics and internal quality control of audit firms , the continuing education , as well as the systems of quality assurance , investigation , and penalties for statutory auditors and audit firms . in order to enhance the transparency of the auditor supervision and to allow for more accountability , each member state should designate a single authority in charge of the public oversight of statutory auditors and audit firms . the independence of such public oversight authorities from the audit profession is a core prerequisite for integrity , efficiency and orderly functioning of the public oversight of statutory auditors and audit firms . therefore , the public oversight authorities should be governed by non - practitioners and member states should establish independent and transparent procedures for the selection of non - practitioners . ### the public oversight of statutory auditors and audit firms encompasses the approval , registration of statutory auditors and audit firms , the adoption of standards on professional ethics and internal quality control of audit firms , the continuing education , as well as the systems of quality assurance , investigation , and penalties for statutory auditors and audit firms . in order to enhance the transparency of the auditor supervision and to allow for more accountability , each member state should designate a single authority in charge of the public oversight of statutory auditors and audit firms . the independence of such public oversight authorities from the audit profession is a core prerequisite for integrity , efficiency and orderly functioning of the public oversight of statutory auditors and audit firms . therefore , the public oversight authorities should be governed by a wide range of stakeholders , including non - practitioners , and member states should establish independent and transparent procedures for the selection of non - practitioners and for the identification , assessment and use of relevant and up to date expertise and experience from practitioners .


### the burdens weighing on small and medium - sized undertakings within the union in connection to the audit of their financial statements should be reviewed to the necessary minimum without compromising investor protection . member states should ensure that the application of auditing standards according to which the statutory audit of the financial statements of those undertakings is performed is proportionate to the scale of small and medium - sized undertakings . ### the burdens weighing on small and medium - sized undertakings within the union in connection to the audit of their financial statements should be reviewed to the necessary minimum without compromising investor protection . member states should ensure that the application of auditing standards according to which the statutory audit of the financial statements of those undertakings is performed is proportionate to the scale of small and medium - sized undertakings . it should also be taken into account that both small and medium - sized undertakings exist in different sizes and that , moreover , their operations vary in complexity .


### since the objective of this directive , namely reinforcing investor protection in the financial statements published by undertakings by further enhancing the quality of statutory audits that are performed within the union cannot be sufficiently achieved by member states and can therefore , by reason of its scale and effects , be better achieved at union level , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective . ### since the objective of this directive , namely reinforcing investor confidence in the truthfulness and fairness of the financial statements published by undertakings by further enhancing the quality of statutory audits that are performed within the union cannot be sufficiently achieved by member states and can therefore , by reason of its scale and effects , be better achieved at union level , the union may adopt measures in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective .


### 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 .


### credit institutions as defined in point 1 of article 4 of directive 2006 / 48 / ec of the european parliament and of the council ; ### credit institutions as defined in point 1 of article 4 of directive 2006 / 48 / ec of the european parliament and of the council excluding those credit institutions which have not issued transferable securities admitted to trading on a regulated market within the meaning of point 14 of article 4 of directive 2004 / 39 / ec unless the total value of its assets exceeds eur 30 billion ;


### in paragraph 2 , the second subparagraph is deleted ; ### paragraph 2 is deleted ;


### ' if applicable , whether the audit firm is registered pursuant to articles 3a and 3b . ' . ### ' if applicable , whether the audit firm is registered pursuant to article 3b . ' .


### member states shall ensure that when carrying out a statutory audit , the statutory auditor and / or the audit firm is independent of the audited entity and is not involved in the decision - taking of the audited entity . ### member states shall ensure that when carrying out a statutory audit , a statutory auditor or an audit firm and any natural person in a position to directly or indirectly influence the outcome of the statutory audit is independent of the audited entity . independence shall be required during both the period covered by the financial statements to be audited and the period during which the statutory audit is carried out . the statutory auditor or audit firm shall not carry out a statutory audit if there is any threat of self - review , self - interest , advocacy , familiarity or intimidation created by financial , personal , business , employment or other relationships between : – the statutory auditor , the audit firm , its network , and any natural person in a position to influence the outcome of the statutory audit , and – the audited entity ; of which an objective , reasonable and informed third party , taking into account the safeguards applied , would conclude that the statutory auditor ' s or audit firm ' s independence is compromised .


### member states may impose audit procedures or requirements in addition to the international auditing standards only if those audit procedures or requirements stem from specific national legal requirements relating to the scope of statutory audits . member states shall ensure that those audit procedures or requirements comply with the following conditions : ### member states may also stipulate in more detail about the application of the international auditing standards .


### ‘ 3 . any contractual clause entered into between the audited entity and a third party restricting the choice by the general meeting of shareholders or members of that entity pursuant to paragraph 1 to certain categories or lists of statutory auditors or audit firms regarding the appointment of or restricting the choice of a particular statutory auditor or audit firm to carry out the statutory audit of that entity shall be null and void . ’ ### ‘ 3 . any contractual clause entered into between the audited entity and a third party restricting the choice by the general meeting of shareholders or members of that entity pursuant to paragraph 1 to certain categories or lists of statutory auditors or audit firms regarding the appointment of or restricting the choice of a particular statutory auditor or audit firm to carry out the statutory audit of that entity shall be prohibited . any such existing clauses shall be null and void . ’


### member states shall ensure that the application of the auditing standards to the statutory audit of annual or consolidated financial statements of medium - sized undertakings is proportionate to the scale and complexity of the business of those undertakings . ### member state shall ensure that the application of the auditing standards in accordance with article 26 to the statutory audit of annual or consolidated financial statements of medium - sized undertakings is proportionate to the scale and complexity of the business of those undertakings .


### 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 .


### the commission shall adopt the measures necessary for the implementation of point of article 54 and of paragraphs and of this article . ### the commission shall adopt the measures necessary for the implementation of point of article 54 and of paragraphs and of this article . before a specific measure is proposed in accordance with point of article 54 , the commission shall carry out a public impact assessment on the costs and benefits of existing safety features , as well as a consultation with the parties involved in the implementation and use of such safety features .


### 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 ; ’ ;


### 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 ] . when member states adopt those provisions , they shall contain a reference to this directive or be accompanied by such a reference on the occasion of their official publication . member states shall determine how such reference is to be made . ### 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 24 months after publication ] ; the provisions necessary to comply with article 1 and from [ insert concrete date 48 months after publication ] ; the provisions necessary to comply with article 1 in so far as it relates to article 54a and articles 54a and 54a to the extent they are referred to 54a 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 except in so far as it relates to article 54a and articles 54a and 54a to the extent they are referred to 54a of directive 2001 / 83 / ec as amended by this directive from [ insert concrete date 48 months after publication ] . when member states adopt those provisions , they shall contain a reference to this directive or be accompanied by such a reference on the occasion of their official publication . member states shall determine how such reference is to be made .


### the use and exchange of sst data and information for the purposes of the implementation of the objectives referred to in article 3 shall be subject to the following rules : ### the use and exchange of sst data and sst information for the purposes of the implementation of the objectives referred to in article 3 shall be subject to the following rules and an implementing act shall be established to specify the means by which these aims are to be achieved and the measures that are to be put in place to ensure compliance with relevant criteria :


### the proper functioning of the internal energy market requires that the energy imported into the union from third countries , is fully governed by the rules establishing an internal energy market . an internal energy market that is not functioning properly puts the eu in a vulnerable position with regard to security of energy supply . a high degree of transparency with regard to agreements between member states and third countries in the field of energy would allow the union to take coordinated action , in a spirit of solidarity , in order to ensure that such agreements are in accordance with union legislation and effectively secure the supply of energy . ### the proper functioning of the internal energy market requires that the energy imported into the union from third countries , is fully governed by the rules establishing an internal energy market . an internal energy market that is not functioning properly puts the eu in a vulnerable position with regard to security of energy supply . an appropriate degree of transparency with regard to agreements between member states and third countries in the field of energy would allow the union to take coordinated action , in a spirit of solidarity , in order to ensure that such agreements are in accordance with union legislation and effectively secure the supply of energy .


### member states should already notify the intention to open negotiations to the commission with regard to new intergovernmental agreements or amendments to existing intergovernmental agreements . the commission should be kept informed regularly on the ongoing negotiations . it should have the right to participate as an observer in the negotiations . member states may also request the commission to assist them during their negotiations with third countries . ### member states should already notify the intention to open negotiations to the commission with regard to new intergovernmental agreements or amendments to existing intergovernmental agreements . the commission should be kept informed regularly on the ongoing negotiations . member states may request the commission to participate as an observer or to assist them in their negotiations with third countries .


### a determination by the commission whether the producer meets the abovementioned criteria shall be made within six months of the initiation of the investigation after the union industry has been given an opportunity to comment . this determination shall remain in force throughout the investigation . ### a determination by the commission whether the producer meets the abovementioned criteria shall be made within a standard period of three months of the initiation of the investigation after the union industry has been given an opportunity to comment for at least one month .


### draft by the court of justice ### the following paragraph shall be added to article 35 : ‘ in cases concerning fundamental questions pertaining to the legal order of the european union , where a judge has declared , in the deliberations of the court of justice , his disagreement with the judgment to be delivered or the reasons on which that judgment is based , he shall be entitled to deliver a dissenting opinion . that opinion shall be published together with the judgment . implementing rules relating to the admissibility , and the detailed procedure for the delivery , of such opinions shall be laid down in the rules of procedure . ’ .


### draft by the court of justice ### the following paragraph shall be added to article 35 : ‘ where a judge has declared , in the deliberations of the court of justice , his disagreement with the judgment to be delivered or the reasons on which that judgment is based , he shall be entitled to deliver a dissenting opinion . that opinion shall be published together with the judgment . implementing rules relating to the admissibility , and the detailed procedure for the delivery , of such opinions shall be laid down in the rules of procedure of the court of justice . ’ .


### draft by the court of justice ### whilst there is a need for the court of justice to introduce a mechanism allowing dissenting opinions to be expressed , this must not jeopardise the independence of judges ; a thorough debate on this issue is needed between experts , practitioners and other interested parties .


### the objectives of the csf funds should be pursued in the framework of sustainable development and the union ' s promotion of the aim of protecting and improving the environment as set out in article 11 and 19 of the treaty , taking into account the polluter pays principle . the member states should provide information on the support for climate change objectives in line with the ambition to devote at least 20% of the union budget to this end , using a methodology adopted by the commission by implementing act . ### the objectives of the csf funds should be pursued in the framework of sustainable development and the union ' s promotion of the aim of protecting and improving the environment as set out in article 11 and 19 of the treaty , taking into account primarily the polluter pays principle . the member states should provide information on the support for climate change objectives in line with the ambition to devote at least 20% of the union budget to this end , using a methodology adopted by the commission by implementing act .


### the objectives of the csf funds shall be pursued in the framework of sustainable development and the union ' s promotion of the aim of protecting and improving the environment , as set out in article 11 of the treaty , taking into account the polluter pays principle . ### the objectives of the csf funds shall be pursued in the framework of sustainable development and the union ' s promotion of the aim of protecting and improving the environment , as set out in article 11 of the treaty , taking into account primarily the polluter pays principle .


### 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 ] .


### 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 .


### where processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature , their scope or their purposes , the controller or the processor acting on the controller ' s behalf shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data . ### where processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature , their scope or their purposes , the controller or the processor acting on the controller ' s behalf shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data , unless the activities concerned do not present a risk to the privacy of the data subject .


### the controller or processor shall designate the data protection officer on the basis of professional qualities and , in particular , expert knowledge of data protection law and practices and ability to fulfil the tasks referred to in article 37 . the necessary level of expert knowledge shall be determined in particular according to the data processing carried out and the protection required for the personal data processed by the controller or the processor . ### the controller or processor may designate the data protection officer on the basis of professional qualities and , in particular , expert knowledge of data protection law and practices and ability to fulfil the tasks referred to in article 37 . the necessary level of expert knowledge shall be determined in particular according to the data processing carried out and the protection required for the personal data processed by the controller or the processor .


### where the commission has taken no decision pursuant to article 41 , a controller or processor may transfer personal data to a third country or an international organisation only if the controller or processor has adduced appropriate safeguards with respect to the protection of personal data in a legally binding instrument . ### where the commission has taken no decision pursuant to article 41 , a controller or processor may transfer personal data to a third country or an international organisation only if the controller or processor has adduced appropriate safeguards with respect to the protection of personal data in a legally binding instrument , and where appropriate pursuant to an impact assessment , where the controller or processor has ensured that the recipient of data in a third country maintains high standards of data protection .


### for the purposes of applying the first subparagraph , information a reasonable market participant would be likely to use as part of the basis of his decision to enter into a transaction relating to a wholesale energy product is information which , if it were made public , would be likely to have a significant effect on the prices of such wholesale energy products . such information includes information related to the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas , as well as information which is required to be disclosed in accordance with legal or regulatory provisions at union or national level , market rules , and contracts or customs on the relevant wholesale energy market . ### for the purposes of applying the first subparagraph , information a reasonable market participant would be likely to use as part of the basis of his decision to enter into a transaction relating to a wholesale energy product is information which , if it were made public , would be likely to have a significant effect on the prices of such wholesale energy products . such information includes information related to updated estimates of energy reserves , the capacity of facilities for production , storage , consumption or transmission of electricity or natural gas , as well as information which is required to be disclosed in accordance with legal or regulatory provisions at union or national level , market rules , and contracts or customs on the relevant wholesale energy market .


### over the past decade , the growth of passenger traffic by rail has been insufficient to increase its modal share in comparison to cars and aviation . the 6% modal share of passenger transport for rail in the european union has remained fairly stable . rail passenger services have not kept pace with evolving needs in terms of availability and quality . ### over the past decade , the growth of passenger traffic by rail has been insufficient to increase its modal share in comparison to cars and aviation . the 6% modal share of passenger transport for rail in the european union has remained fairly stable . rail passenger services have not kept pace with the evolution of other modes of transport in terms of availability , price and quality .


### to facilitate the preparation of tenders , and hence enhance competition competent authorities need to ensure that all public service operators interested in making such a submission receive certain information on the transport services and infrastructure covered by the public service contract . ### to facilitate the preparation of tenders , and hence enhance competition competent authorities need to ensure that all public service operators interested in making such a submission receive certain information on the transport services and infrastructure covered by the public service contract to the extent that they are not placed at a disadvantage with regard to other competitors by the contracting authority .


### where the market does not ensure it under suitable economic and non - discriminatory conditions , public service operators ' access to rail rolling stock needs to be facilitated by competent authorities through adequate and effective measures . ### where the market does not ensure it under suitable economic and non - discriminatory conditions , the competent authorities should facilitate public service operators ' access to rail rolling stock . however , in such matters they must proceed in such a way as not to favour one operator at the expense of others .


### ‘ competent local authority’ means any competent authority whose geographical area of competence is not national and which covers the transport needs of an urban agglomeration or a rural district ; ### ‘ competent local authority’ means any competent authority whose geographical area of competence is not national and which covers the transport needs of a specific local area , e . g . a village , a town , an urban agglomeration or a rural district ;


### competent authorities shall establish and regularly update public passenger transport plans covering all relevant transport modes for the territory for which they are responsible . these public transport plans shall define the objectives of public transport policy and the means to implement them covering all relevant transport modes for the territory for which they are responsible . they shall at least include : ### competent authorities shall establish and regularly update multiannual public passenger transport plans covering all relevant transport modes for the territory for which they are responsible . these public transport plans shall define the objectives of public transport policy and the means to implement them covering all relevant transport modes for the territory for which they are responsible . they shall at least include :


### member states shall in compliance with state aid rules take the necessary measures to ensure effective and non - discriminatory access to suitable rolling stock for public passenger transport by rail for operators wishing to provide public passenger transport services by rail under public service contract . ### member states shall in compliance with state aid rules take the necessary measures to ensure equal conditions and non - discriminatory access to suitable rolling stock for public passenger transport by rail for operators wishing to provide public passenger transport services by rail under public service contract .


### to promote effective , comprehensive and consistent application of union legislation in the areas of judicial cooperation in civil and criminal matters . the indicator to measure the achievement of this objective shall be , inter alia , the number of cases of trans - border cooperation . ### to promote effective , comprehensive and consistent application of union legislation in the areas of judicial cooperation in civil and criminal matters , as well as better procedural rules , particularly as regards the rights of victims of crime , sexual violence and exploitation , with a focus on the most vulnerable victims , such as women and children . the indicator to measure the achievement of this objective shall be , inter alia , the number of cases of trans - border cooperation .


### fish belonging to the taxon elasmobranchii , including sharks , skates and rays are generally very vulnerable to overexploitation due to their life cycle characteristics of slow growth , late maturity and small number of young . in recent years , some shark populations have been severely targeted and put under serious threat as a result of a dramatic increase in demand for shark products , fins in particular . ### fish belonging to the taxon elasmobranchii , including sharks , skates and rays are generally very vulnerable to overexploitation due to their life cycle characteristics of slow growth , late maturity and small number of young . in recent years , some shark populations have been severely targeted , including by eu flagged vessels operating in eu and non - eu waters , and put under serious threat as a result of a dramatic increase in demand for shark products , fins in particular .


### regional fisheries management organisations are increasingly addressing the issue of shark finning and their scientific bodies are showing preference for the landing of sharks with their fins naturally attached to the body . ### regional fisheries management organisations are increasingly addressing the issue of shark finning and their scientific bodies are showing preference for the landing of sharks with their fins naturally attached to the body . the annual resolutions on sustainable fisheries issued by united nations general assembly since 2007 , the 2008 iucn ' s global policy against shark finning and the 2010 meeting of the fish stocks agreement review conference have called upon nations to take measures to require that all sharks be landed with their fins naturally attached .


### where fishing vessels flying the flag of a member state catch , retain on board , tranship or land sharks , the flag member state shall send to the commission , by 1 may at the latest , a comprehensive annual report on the implementation of this regulation during the previous year . the report shall describe the monitoring of compliance of vessels with the regulation , and the enforcement measures taken by member states in cases of non - compliance . in particular , the following information shall be provided : ### where fishing vessels flying the flag of a member state catch , retain on - board , tranship or land sharks , the flag member state shall , in accordance with regulations n&#186 ; 1224 / 2009 establishing a community control system for ensuring compliance with the rules of the common fisheries policy and n&#186 ; 404 / 2011 laying down detailed rules for the implementation of the above regulation , send to the commission , by 1 may at the latest , a comprehensive annual report on the implementation of this regulation during the previous year . the report shall describe the monitoring of compliance with the regulation of vessels in the eu and non - eu waters , and the enforcement measures taken by member states in cases of non - compliance . in particular , the following information shall be provided :


### the rules on clinical investigations should be in line with major international guidance in this field , such as the international standard iso 14155 : 2011 on good clinical practice for clinical investigations of medical devices for human subjects and the most recent version of the world medical association declaration of helsinki on ethical principles for medical research involving human subjects to ensure that clinical investigations conducted in the union are accepted elsewhere and that clinical investigations conducted outside the union in accordance with international guidelines can be accepted under this regulation . ### the rules on clinical investigations should be in line with major international guidance in this field , such as the international standard iso 14155 : 2011 or any subsequent version of it on good clinical practice for clinical investigations of medical devices for human subjects and the most recent version of the world medical association declaration of helsinki on ethical principles for medical research involving human subjects to ensure that clinical investigations conducted in the union are accepted elsewhere and that clinical investigations conducted outside the union in accordance with international guidelines can be accepted under this regulation .


### sponsors should report certain adverse events occurring during clinical investigations to the member states concerned , which should have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation . such information should be communicated to the other member states . ### sponsors should report certain adverse events , including serious adverse device effects , device effects and device deficiencies occurring during clinical investigations to the member states concerned , which should have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation . such information should be communicated to the other member states .


### ‘ 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 the device to be used in accordance with its / their intended purpose ; or to specifically assist the medical functionality of the medical device in view of 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 ; ### ' 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 ;


### ‘ 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 of patients and which has the legal capacity to engage in such activities ;


### ‘ reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning , disinfection , sterilisation and related procedures , as well as testing and restoration of the technical and functional safety of the used device ; ### ‘ reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning , disinfection , sterilisation and related procedures , as well as testing and restoration of the technical and functional safety of the used device ; routine device maintenance service activities are not included in this definition ;


### hospitalisation or extending the duration of hospitalisation , ### hospitalisation or prolongation of patient hospitalisation ,


### the commission may , at the request of a member state or on its own initiative , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### the commission may , at the request of a member state , or after consultation with the member states , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### devices that are manufactured and used within a single health institution shall be considered as being put into service . the provisions regarding ce marking referred to in article 18 and the obligations laid down in articles 23 to 27 shall not apply to those devices , provided that manufacture and use of those devices occur under the health institution ' s single quality management system . ### devices that are manufactured and used within a single health institution shall be considered as being put into service . the provisions regarding ce marking referred to in article 18 and the obligations laid down in articles 23 , 26 and 27 shall not apply to those devices , provided that manufacture and use of those devices occur under the health institution ' s single quality management system .


### manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately take the necessary corrective action to bring that product into conformity , withdraw it or recall it , as appropriate . they shall inform the distributors and , where applicable , the authorised representative accordingly . ### manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately take the necessary corrective action to bring that product into conformity , withdraw it or recall it , as appropriate . they shall inform the distributors , the importers and , where applicable , the authorised representative accordingly .


### 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


### that the reporting obligations in accordance with articles 61 to 66 are fulfilled ; ### that the reporting obligations in accordance with articles 59 and 61 to 66 are fulfilled ;


### prior to making the relabelled or repackaged device available , the distributor or importer referred to in paragraph 3 shall inform the manufacturer and the competent authority of the member state where he plans to make the device available and , upon request , shall provide them with a sample or a mock - up of the relabelled or repackaged device , including any translated label and instructions for use . he shall submit to the competent authority a certificate , issued by a notified body referred to in article 29 , designated for the type of devices that are subject to activities mentioned in points and of paragraph 2 , attesting that the quality management system complies with the requirements laid down in paragraph 3 . ### at least 28 calendar days prior to making the relabelled or repackaged device available , the distributor or importer referred to in paragraph 3 shall inform the manufacturer and the competent authority of the member state where he plans to make the device available and , upon request , shall provide them with a sample of the relabelled or repackaged device , including any translated label and instructions for use . within the same period of 28 calendar days , he shall submit to the competent authority a certificate , issued by a notified body referred to in article 29 , designated for the type of devices that are subject to activities mentioned in points and of paragraph 2 , attesting that the quality management system complies with the requirements laid down in paragraph 3 .


### the manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device . ### the commission shall be empowered to adopt delegated acts in accordance with article 89 identifying for which implantable devices the manufacturer shall provide together with the device an implant card , which can be provided by electronic form or other means containing the information referred to in paragraph 2 which shall be made available to the particular patient who has been implanted with the device .


### for devices , other than custom - made and investigational devices , a system for unique device identification shall be put in place in the union . the udi system shall allow the identification and traceability of devices and shall consist of the following : ### for devices , other than custom - made and investigational devices , a single system for unique device identification shall be put in place in the union . the udi system shall allow the identification and traceability of devices , be coherent if possible with the global regulatory approach for udi in medical devices , and shall consist of the following :


### to enable the public to be adequately informed about devices placed on the market , about the corresponding certificates issued by notified bodies and about the relevant economic operators ; ### to enable the public to be adequately informed via a central information point where patients can ask , seek and find information about devices placed on the market , about the corresponding certificates issued by notified bodies and about the relevant economic operators ; the commission should develop guidelines in consultation with stakeholders , including member state competent authorities , the research community and patient and consumer organisations , and to specify the exact content and format of the information that should be published .


### all the information collated and processed by eudamed shall be accessible to the member states and to the commission . the information shall be accessible to notified bodies , economic operators , sponsors and the public to the extent defined in the provisions referred to in paragraph 2 . ### all the information collated and processed by eudamed shall be accessible to the member states and to the commission . the information shall be accessible to notified bodies , economic operators , healthcare professionals , sponsors and the public to the extent defined in the provisions referred to in paragraph 2 .


### where the commission ascertains that a notified body no longer meets the requirements for its notification , it shall inform the notifying member state accordingly and request it to take the necessary corrective measures , including the suspension , restriction or withdrawal of the notification if necessary . ### where the commission ascertains that a notified body no longer meets the requirements for its notification , it shall inform the notifying member state accordingly and request it to take the necessary corrective measures , including the suspension , restriction or withdrawal of the notification if necessary . a report with the opinions of member states should be made publicly available by the european commission after the assessment .


### the certificates issued by the notified bodies in accordance with annexes viii , ix and x shall be in an official union language determined by the member state in which the notified body is established or otherwise in an official union language acceptable to the notified body . the minimum content of the certificates is set out in annex xii . ### the certificates issued by the notified bodies in accordance with annexes viii , ix and x shall be in an official union language acceptable to the notified body . the minimum content of the certificates is set out in annex xii .


### member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . ### member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . in the assessment , the view of more than one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account .


### the exchange of information between the member states and between them and the commission in accordance with article 56 ; ### the exchange of information between the member states and between them and the commission in accordance with article 56 ; all relevant updates to the information concerning an investigation should be posted on the database , such as measures taken by member states to terminate , suspend or modify an investigation , as well as updated information on the benefit - risk balance or any urgent safety measures taken .


### the commission shall , in collaboration with the member states , set up and manage an electronic system to collate and process the following information : ### the commission shall , in collaboration with the member states , develop further the existing european databank on medical devices set up by the commission decision 2010 / 227 / eu and manage an electronic system to collate and process the following information :


### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public . ### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every two year and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public .


### if the device bears an indication that the device is for single use , information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re - used . if in accordance with point c ) of section 19 . 1 no instructions for use are needed , the information shall be made available to the user upon request . ### if the device bears an indication that the device is for single use , information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re - used . if the device is included on the list of single - use devices pursuant to article 15 , information to the effect that the device may not under any circumstances be reused . if in accordance with point c ) of section 19 . 1 no instructions for use are needed , the information shall be made available to the user upon request .


### 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 . ### 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 . permanent ' in house ' staff shall be used , but notified bodies must have the flexibility to hire external experts on an ad hoc and temporary basis as and when needed .


### all devices intended to be used for aphaeresis , such as aphaeresis machines , sets , connectors and solutions , are in class iii . ### all devices intended to be used for aphaeresis , such as aphaeresis machines , sets , connectors and solutions , are in class iib .