### the union is committed to implement the resolutions adopted by the general assembly of the united nations , in particular resolutions 61 / 105 and 64 / 72 , which call on states and regional fisheries management organisations to ensure the protection of vulnerable deep - sea marine ecosystems from the destructive impact of bottom fishing gears , as well as the sustainable exploitation of deep - sea fish stocks . ### the union is committed to implement the resolutions adopted by the general assembly of the united nations , in particular resolutions 61 / 105 and 64 / 72 , which call on states and regional fisheries management organisations to ensure the protection of vulnerable deep - sea marine ecosystems from the impact of bottom fishing gears , as well as the sustainable exploitation of deep - sea fish stocks .


### in order to maintain necessary reductions in fishing capacity achieved so far in deep - sea fisheries , it is appropriate to provide that fishing for deep - sea species is subject to a fishing authorisation which limits the capacity of vessels eligible to land deep - sea species . with a view to focus management measures on the part of the fleet most relevant for deep - sea fisheries , the fishing authorisations should be issued according to target or by - catch fishery . ### in order to maintain necessary reductions in fishing capacity achieved so far in deep - sea fisheries , and to focus management measures on the most relevant part of the fleet for deep sea fisheries , it is appropriate to provide that fishing for deep - sea species is subject to a fishing authorisation which limits the capacity of vessels eligible to fish deep - sea species in a targeted manner . it is however necessary that fishing licenses are also delivered for bycatch fishing of deep - sea species , considering that all these fishing activities are likely to occur in areas where deep water vulnerable marine ecosystems may be present , and that they should be protected against the adverse effects that may have these activities , including those using bottom gears . however , the council and parliament regulation no xxx / 2013 from xxx 2013 on the common fisheries policy defines a goal of eliminating discards that also apply to deep - sea species . the novelty of this new requirement should be taken into account so that vessels incidentally capturing deep - sea species and which are not currently subjected to a licensing regime for fishing , are not totally deprived of the opportunity to continue their traditional fishing activities .


### scientific advice concerning certain fish stocks found in the deep - sea indicates that these stocks are particularly vulnerable to exploitation , and that fishing for these stocks should be limited or reduced as a precautionary measure . fishing opportunities for deep - sea stocks should not go beyond those levels which are scientifically advised as precautionary . in the case of advice being absent for lack of sufficient information about stocks or species , no fishing opportunities should be allocated . ### scientific advice concerning certain fish stocks found in the deep - sea indicates that these stocks are particularly vulnerable to exploitation , however there have been quantified improvements in some stocks such as the roundnose grenadier , blue ling and black scabbardfish . fishing opportunities for deep - sea stocks should not go beyond those levels which are scientifically advised as precautionary . in the case of advice being absent for lack of sufficient information about stocks or species , no fishing opportunities should be allocated .


### the vessel ' s master records in the logbook a percentage of deep - sea species equal or superior to 10% of the overall catch weight in the fishing day concerned . ### the vessel ' s master records in the logbook a percentage of the species defined in annex i which is equal or superior to 25% of the overall catch weight in the fishing trip concerned .


### the aggregate fishing capacity measured in gross tonnage and in kilowatt of all fishing vessels holding a fishing authorisation issued by a member state , allowing the catch of deep - sea species , whether as target or by - catch species , shall at no time exceed the aggregate fishing capacity of vessels of that member state which have landed 10 tonnes or more of deep - sea species during any of the two calendar years preceding the entry into force of this regulation , whichever year provides the higher figure . ### the aggregate fishing capacity measured in gross tonnage and in kilowatt of all fishing vessels holding a fishing authorisation issued by a member state , allowing the targeted catch of deep - sea species as defined in article 4 shall at no time exceed the aggregate fishing capacity of vessels of that member state which have landed 10 tonnes or more of deep - sea species during any of the calendar years 2009 - 2011 , whichever year provides the higher figure .


### each application for a fishing authorisation allowing for the catch of deep - sea species whether as target or by - catch species , and for its renewal shall be accompanied by a description of the area where it is intended to conduct fishing activities , the type of gears , the depth range at which the activities will be deployed , and of the individual species targeted . ### each application for a fishing authorisation allowing for the catch of deep - sea species within areas of existing fishing activities , and for its renewal shall be accompanied by a description of the area where it is intended to conduct fishing activities , the type of gears , the depth range at which the activities will be deployed , and of the relevant species .


### in addition to the requirements set out in article 6 , each application for a fishing authorisation for targeted deep sea fisheries , as referred to in article 4 , that allows the use of bottom gears in union waters as referred to in article 2 , shall be accompanied by a detailed fishing plan specifying : ### in addition to the requirements set out in article 6 , each application for an authorisation for fishing deep - water stocks that allows for the use of bottom gears in union waters as defined in article 2 , or in waters under neafc jurisdiction as referred to in article 2 , shall :


### the locations of the intended activities targeting deep - sea species in the deep - sea m&#233 ; tier . the location shall be defined by coordinates in accordance with the world geodetic system of 1984 ; ### list the bottom - sea gear that will be used ;


### any fishing authorization issued on the basis of an application made in accordance with paragraph 1 shall specify the bottom gear to be used and limit the fishing activities authorized to the area in which the intended fishing activity as set out in paragraph 1 , and the existing fishing activity , as set out in paragraph 1 , overlap . however , the area of the intended fishing activity can be extended beyond the area of the existing fishing activity if the member state has assessed and documented , based on scientific advice that such extension would not have significant adverse impacts on vulnerable marine ecosystems . ### any fishing authorization issued during the first two years after the entry into force of this regulation on the basis of an application made in accordance with paragraph 1 shall specify the bottom gear to be used and limit the fishing activities authorized to the area in which the intended fishing activity as set out in paragraph 1 , and the existing fishing activity , as set out in paragraph 1 , overlap . however , the area of the intended fishing activity can be extended beyond the area of the existing fishing activity if the member state has assessed and documented , based on scientific advice that such extension would not have significant adverse impacts on vulnerable marine ecosystems . 2a . for all authorizations to fish not covered under article 7 , each application for a fishing authorization shall only be issued for an area which has been subject to a prior impact assessment in accordance with the criteria established in annex iii . the impact assessment shall be made publicly available . the impact assessment shall be reviewed by a scientific advisory body . the commission can make , or require member states to make , adjustments or improvements to the assessment based on any recommendations of the scientific advisory body . the commission shall also review all assessments to take into account individual , collective and cumulative impacts , and make or require adjustments or improvements to the individual impact assessments . 2b . the competent authorities shall apply precautionary criteria in the conduct of the assessment referred to in paragraph 3 . in case of doubt as to whether the adverse impacts are significant or not , they shall consider that the likely adverse impacts resulting from the scientific advice provided are significant . 2c . beginning the third year after the entry into force of the regulation , any authorization to fish for areas covered under paragraph 2 shall also require prior impact assessments pursuant to paragraph 3 as a condition for the authorization to fish . 2d . in the areas where no proper scientific assessment as referred to in paragraph 3 has been carried out and made available , the use of bottom gears shall be prohibited . 2e . bottom fishing activities shall be permitted under the conditions laid down in this regulation where the impact assessment shows that vulnerable marine ecosystems will not be at risk .


### any fishing authorisation issued on the basis of an application made in accordance with paragraph 1 shall specify the bottom gear to be used and limit the fishing activities authorised to the area in which the intended fishing activity , as set out in paragraph 1 , and the existing fishing activity , as set out in paragraph 1 , overlap . however , the area of the intended fishing activity can be extended beyond the area of the existing fishing activity if the member state has assessed and documented , based on scientific advice , that such extension would not have significant adverse impacts on vulnerable marine ecosystems . ### without prejudice to article 7 , fishing activities that are to take place in waters defined in paragraph 1 but that are defined as new fishing areas in the meaning of article 3 paragraph 2b shall be subject to a fishing authorisation . applications for such authorisations shall include a detailed project for the exploratory fishing activity that follows the neafc guidelines outlined in annex iia . applications will be accepted if it can be shown that the activity described will have no harmful effects on vulnerable marine ecosystems .


### failure to conform to the conditions set in the fishing authorisation with regard to limits on the use of gears , allowed areas of operation or , as appropriate , catch or effort limits on the species whose targeting is allowed ; or ### failure to conform to the conditions set in the fishing authorisation with regard to limits on the use of gears , allowed areas of operation or , as appropriate , catch or effort limits on the species whose targeting is allowed ; ba ) failure to implement accompanying measures in accordance with article 12 ; or


### the power to adopt delegated acts as referred to in article 13 shall be conferred on the commission for an indeterminate period of time . ### the power to adopt delegated acts as referred to in article 13 shall be conferred on the commission for period of three years from the date of entry into force of this regulation . the commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the three year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council oppose such extension no later than three months before the end of each period .


### in june 2008 the commission adopted the communication ‘ think small first - a ’small business act for europe ‘ , which was endorsed by the european council of december 2008 . the small business act provides a comprehensive policy framework for small and medium - sized enterprises , promotes entrepreneurship and anchors the ’think small first ' principle in law and policy in order to strengthen the competitiveness of smes . the sba establishes 10 principles and outlines policy and legislative actions to promote smes ' potential to grow and create jobs . implementation of the sba contributes to achieving the objectives of the europe 2020 strategy . several actions for smes have already been set out in the flagship initiatives . ### in june 2008 the commission adopted the communication ‘ think small first - a ’small business act for europe ‘ , which was endorsed by the european council of december 2008 . the small business act provides a comprehensive policy framework for small and medium - sized enterprises , promotes entrepreneurship , aims to better exploit entrepreneurship potential among young people and women and anchors the ’think small first ' principle in law and policy in order to strengthen the competitiveness of smes . the sba establishes 10 principles and outlines policy and legislative actions to promote smes ' potential to grow and create jobs . implementation of the sba contributes to achieving the objectives of the europe 2020 strategy . several actions for smes have already been set out in the flagship initiatives .


### the principles of transparency and equal gender opportunity should be taken into account in all relevant initiatives and actions covered by the programme . the respect of human rights and fundamental freedom for all citizens should be also considered in those initiatives and activities . ### the principles of transparency should be taken into account , and equality between men and women should be promoted in all relevant initiatives and actions covered by the programme . the respect of human rights and fundamental freedom for all citizens should be also considered in those initiatives and activities .


### sme growth in terms of added - value and number of employees , ### sme growth in terms of added - value and number of employees , broken down by gender , ethnicity , age , area , size and length of business and in accordance with the member states ' rules on the protection of personal data ,


### the consolidated annual accounts and the report on budgetary and financial management drawn up by each institution shall be published in the official journal of the european union . ### the consolidated annual accounts and the report on budgetary and financial management drawn up by each institution shall be published immediately upon adoption in the official journal of the european union .


### the ex ante controls shall be carried by the members of staff other than those responsible for the ex post controls . the members of staff responsible for the ex post controls shall not be subordinate to the members of staff responsible for the ex ante controls . ### the ex ante controls shall be carried out by members of staff other than those responsible for the ex post controls . the members of staff responsible for the ex post controls shall not be subordinate to the members of staff responsible for the ex ante controls .


### any member of staff , involved in the financial management and control of transactions who considers that a decision he is required by his superior to apply or to agree to is irregular or contrary to the principles of sound financial management or the professional rules he is required to observe , shall inform the authorising officer by delegation in writing and , if that officer fails to take action , the panel referred to in article 70 . in the event of any illegal activity , fraud or corruption which may harm the interests of the union , he shall inform the authorities and bodies designated by the applicable legislation . ### any member of staff , involved in the financial management and control of transactions who considers that a decision he is required by his superior to apply or to agree to is irregular or contrary to the principles of sound financial management or the professional rules he is required to observe , shall inform the authorising officer by delegation unless the superior in question is the authorising officer by delegation . if that officer fails to take action within a period of three weeks of being informed , or in the event of the officer in question being the authorising officer by delegation , the report should be addressed to the panel referred to in article 70 . in the event of any illegal activity , fraud or corruption which may harm the interests of the union , he shall inform the member state authorities and bodies designated by the applicable legislation .


### the figures and the report on implementation of the budget shall at the same time be sent to the court of auditors . ### the figures and the report on implementation of the budget shall at the same time be sent to the court of auditors and published on the internet .


### the accounting system must be such as to leave a trail for all accounting entries . ### the accounting system must be such as to leave a clear audit trail for all accounting entries .


### the budgetary accounts provide a detailed record of budgetary implementation . ### the budgetary accounts provide a detailed record of the implementation of the budget .


### the commission , the other institutions , the bodies administering revenue or expenditure on the union ' s behalf and the final beneficiaries of payments from the budget shall afford the court of auditors all the facilities and give it all the information which the court of auditors considers necessary for the performance of its task . they shall place at the disposal of the court of auditors all documents concerning the award and performance of contracts financed by the budget and all accounts of cash or materials , all accounting records or supporting documents , and also administrative documents relating thereto , all documents relating to revenue and expenditure , all inventories , all organisation charts of departments , which the court of auditors considers necessary for auditing the budgetary and financial outturn report on the basis of records or on the spot and , for the same purposes , all documents and data created or stored on a magnetic medium . ### the commission , the other institutions , the bodies administering revenue or expenditure on the union ' s behalf and the final beneficiaries of payments from the budget shall afford the court of auditors all the facilities and give it all the information which the court of auditors considers necessary for the performance of its task . they shall place at the disposal of the court of auditors all documents concerning the award and performance of contracts financed by the budget and all accounts of cash or materials , all accounting records or supporting documents , and also administrative documents relating thereto , all documents relating to revenue and expenditure , all inventories , all organisation charts of departments , which the court of auditors considers necessary for auditing the budgetary and financial outturn report on the basis of records or on the spot and , for the same purposes , all documents and data created or stored on a data carrier .


### member states shall designate competent authorities for issuing european professional cards . those authorities shall ensure an impartial , objective and timely processing of applications for european professional cards . the assistance centers referred to in article 57b may also act in the capacity of a competent authority to issue a european professional card . member states shall ensure that competent authorities inform citizens , including prospective applicants , on the advantages of a european professional card where it is available . ### member states shall designate competent authorities for processing european professional cards . the authorities shall ensure an impartial , objective and timely processing of applications for european professional cards . the assistance centers referred to in article 57b may also act in the capacity of a competent authority to create a european professional card . member states shall ensure that competent authorities inform professionals , including prospective applicants , on the possibility of a european professional card where it is available .


### in the cases referred to in articles 7 and 14 , a host member state shall decide on whether to recognise the holder ' s qualifications or to subject him to compensation measures within two months from the date of receipt for validation of the european professional card transmitted by the home member state . in case of justified doubts , the host member state may request additional information from the home member state . that request shall not suspend the period of two months . ### in the cases referred to in articles 7 and 14 , a host member state shall decide on whether to issue a european professional card or to subject the professional concerned to compensation measures within two months from the date of receipt the draft european professional card transmitted by the home member state . in case of justified doubts , the host member state may request additional information from the home member state . that request shall not suspend the period of two months .


### the competent authorities of the home and the host member states shall update in a timely manner the corresponding imi file with information regarding disciplinary action or criminal sanctions taken or any other serious specific circumstances which are likely to have consequences for the pursuit of activities of the holder of the european professional card under this directive . such updates include the deletion of information which is no longer required . the holder of the european professional card and the competent authorities involved in the corresponding imi file shall be informed of any updates by the competent authorities concerned . ### without prejudice to the presumption of innocence , the competent authorities of the home and the host member states shall update in a timely manner the corresponding imi file with information regarding disciplinary action or criminal sanctions taken or any other serious specific circumstances which are likely to have consequences for the pursuit of activities of the holder of the european professional card under this directive . such updates include the deletion of information which is no longer required . the holder of the european professional card and the competent authorities involved in the corresponding imi file shall be informed of any updates by the competent authorities concerned .


### member states shall provide that employers , customers , patients and other interested parties may verify the authenticity and validity of a european professional card presented to them by the card holder without prejudice to paragraphs 2 and 3 . ### host member states may provide that employers , customers , patients and other interested parties may verify the authenticity and validity of a european professional card presented to them by the card holder without prejudice to paragraphs 2 and 3 .


### a diploma certifying that the holder has successfully completed a post - secondary course of more than four years ' duration , or of an equivalent duration on a part - time basis , or if applicable in the home member state , of an equivalent number of ects credits , at a university or establishment of higher education or another establishment of equivalent level and , where appropriate , that he has successfully completed the professional training required in addition to the post - secondary course . ### a diploma certifying that the holder has successfully completed a post - secondary course of at least four years ' duration , or of an equivalent duration on a part - time basis , or if applicable in the home member state , of an equivalent number of ects credits , at a university or establishment of higher education or another establishment of equivalent level and , where appropriate , that he has successfully completed the professional training required in addition to the post - secondary course .


### for the purposes of paragraphs 1 and 5 , ‘ substantially different matters’ shall mean matters of which knowledge is essential for pursuing the profession and with regard to which the training received by the migrant shows important differences in terms of content from the training required by the host member state . ### for the purposes of paragraphs 1 and 5 , ‘ substantially different matters’ shall mean matters of which knowledge and competence is essential for pursuing the profession and with regard to which the training received by the migrant shows important differences in terms of content from the training required by the host member state .


### member states shall notify to the commission a list of existing regulated professions according to their national law by [ insert date &#8211 ; end of transposition period ] . any change to this list of regulated professions shall also be notified to the commission without delay . the commission shall set up and maintain a publicly available database for such information . ### member states shall notify to the commission a list of existing regulated professions in their territory [ insert date &#8211 ; end of transposition period ] . any change to this list of regulated professions shall also be notified to the commission without delay . the commission shall set up and maintain a publicly available database for such information .


### requirements must be justified by an overriding reason relating to a public interest ; ### requirements must be justified by an overriding reason relating to the public interest ;


### similarly , the complexity of the challenge and the interdependency of its components demand a european level response . many approaches , tools and technologies have applicability across many of the research and innovation areas of this challenge and are best supported at union level . these include the development of long term cohorts and the conduct of clinical trials , the clinical use of ‘ - omics’ or the development of ict and their applications in healthcare practice , notably e - health . the requirements of specific populations are also best addressed in an integrated manner , for example in the development of stratified and / or personalised medicine , in the treatment of rare diseases , and in providing assisted and independent living solutions . ### similarly , the complexity of the challenge and the interdependency of its components demand a european level response . many approaches , tools and technologies have applicability across many of the research and innovation areas of this challenge and are best supported at union level . these include the development of long term cohorts and the conduct of clinical trials , the clinical use of ‘ - omics’ or the development of ict and their applications in healthcare practice , notably e - health . the requirements of specific populations are also best addressed in an integrated manner , for example in the development of stratified and / or personalised medicine , in the diagnosis , prevention and treatment of rare diseases , and in providing assisted and independent living solutions .


### to maximise the impact of union level actions , support will be provided to the full spectrum of research and innovation activities . from basic research through translation of knowledge to large trials and demonstration actions , mobilising private investment ; to public and pre - commercial procurement for new products , services , scalable solutions , which are when necessary , interoperable and supported by defined standards and / or common guidelines . this co - ordinated , european effort will contribute to the ongoing development of the era . it will also interface , as and when appropriate , with activities developed in the context of the health for growth programme and the european innovation partnership on active and health ageing . ### to maximise the impact of union level actions and create long - term benefits to its objectives , support will be provided to the full spectrum of research and innovation activities . from basic research through translation of knowledge to large trials and demonstration actions , mobilising private investment ; to public and pre - commercial procurement for new products , services , scalable solutions , which are when necessary , interoperable and supported by defined standards and / or common guidelines . this co - ordinated , european effort will contribute to the ongoing development of the era . it will also interface , as and when appropriate , with activities developed in the context of the health for growth programme and the european innovation partnership on active and health ageing .


### ' fluorinated greenhouse gases ' means the hydrofluorocarbons , perfluorocarbons , sulphur hexafluoride and other greenhouse gases that contain fluorine , as listed in annex i , whether alone or in a mixture ; ### ' fluorinated greenhouse gases ' means the hydrofluorocarbons , perfluorocarbons , sulphur hexafluoride and other greenhouse gases that contain fluorine , as listed in annex i , or mixtures containing any of these substances ;


### the commission shall be empowered to adopt delegated acts in accordance with article 20 amending the list set out in annex iii to include other products and equipment that contain fluorinated greenhouse gases with a global warming potential of 150 or more , or that rely on them to work , if it has been established that alternatives to the use of fluorinated greenhouse gases or to the use of specific types of fluorinated greenhouse gases are available , and their use would result in lower overall greenhouse gas emissions and to exclude , where appropriate for a specified period of time , certain categories of products or equipment for which alternative substances which fall below the specified global warming potential limit are not available for technical , economic or safety reasons . ### the commission may , following a request by a competent authority of a member state , by means of implementing acts authorise a time - limited exemption to exclude certain categories of products or equipment listed in annex iii where alternative substances are not available or cannot be used for technical , economic or safety reasons . those implementing acts shall be adopted in accordance with the examination procedure in article 21 .


### this article shall not apply to hydrofluorocarbons imported into the union to be destroyed . ### this article shall not apply to the following : hydrofluorocarbons imported into the union for destruction ; hydrofluorocarbons supplied for direct export outside the union ; hydrofluorocarbons supplied for use in feedstock applications ; hydrofluorocarbons supplied for repackaging and subsequent export outside the union ; hydrofluorocarbons produced or imported into the union for use in medical applications .


### as regards the funds and with a view to ensuring an appropriate allocation to each category of regions , resources should not be transferred between less developed , transition and more developed regions except in duly justified circumstances linked to the delivery of one or more thematic objectives and for no more than 2 % of the total appropriation for that category of region . ### as regards the funds and with a view to ensuring an appropriate allocation to each category of regions , resources should not be transferred between less developed and more developed regions except in duly justified circumstances linked to the delivery of one or more thematic objectives and for no more than 2 % of the total appropriation for that category of region .


### 85 % for the less developed regions of member states whose average gdp per capita for the period 2007 to 2009 was below 85 % of the eu - 27 average during the same period and for the outermost regions ; ### 85 % for the less developed regions of member states , and for the outermost regions including additional funding and for member states consisting of one single region eligible for the transitional regime of the cohesion fund on 1 january 2014 ;


### eib activity in neighbourhood countries should take place in the framework of the european neighbourhood policy , under which the eu aims to develop a special relationship with neighbouring countries with a view to establishing an area of prosperity and good neighbourliness , founded on the values of the eu and characterised by close and peaceful relations based on co - operation . to achieve these objectives the eu and its partners implement jointly agreed bilateral action plans defining a set of priorities including on political and security issues , trade and economic matters , environmental concerns and integration of transport and energy networks . the union for the mediterranean , the eastern partnership , and the black sea synergy are multilateral and regional initiatives complementary to the european neighbourhood policy aimed at fostering co - operation between the eu and the respective group of neighbouring partner countries facing common challenges and / or sharing a common geographical environment . the union for the mediterranean supports improved socio - economic , solidarity , regional integration , sustainable development and knowledge building , underlining the need to increase financial co - operation to support regional and trans - national projects . the eastern partnership aims to create the necessary conditions to accelerate political association and further economic integration between the eu and eastern partner countries . the russian federation and the eu have a wide - ranging strategic partnership , distinct from the european neighbourhood policy and expressed through the common spaces and roadmaps . this is complemented at multilateral level by the northern dimension which provides a framework for co - operation between the eu , russia , norway and iceland . ### eib activity in neighbourhood countries should take place in the framework of the european neighbourhood policy , under which the eu aims to develop a special relationship with neighbouring countries with a view to establishing an area of prosperity and good neighbourliness , founded on the values of the eu and characterised by close and peaceful relations based on co - operation . to achieve these objectives the eu and its partners implement jointly agreed bilateral action plans defining a set of priorities including on political and security issues , trade and economic matters , environmental concerns and integration of transport and energy networks such as the nabucco gas pipeline project , which is of particular interest to the eu . the union for the mediterranean , the eastern partnership , and the black sea synergy are multilateral and regional initiatives complementary to the european neighbourhood policy aimed at fostering co - operation between the eu and the respective group of neighbouring partner countries facing common challenges and / or sharing a common geographical environment . the union for the mediterranean supports improved socio - economic , solidarity , regional integration , sustainable development and knowledge building , underlining the need to increase financial co - operation to support regional and trans - national projects . the eastern partnership aims to create the necessary conditions to accelerate political association and further economic integration between the eu and eastern partner countries . the russian federation and the eu have a wide - ranging strategic partnership , distinct from the european neighbourhood policy and expressed through the common spaces and roadmaps . this is complemented at multilateral level by the northern dimension which provides a framework for co - operation between the eu , russia , norway and iceland .


### the commission shall present a final report on the application of this decision by 31 october 2014 . ### the commission shall present to the european parliament and the council a final report on the application of this decision by 31 october 2014 .


### there are other various instruments of union law which lay down requirements and conditions , inter alia in order to ensure the free movement of goods within the internal market or for environmental purposes , for certain products which are similar in nature to equipment used on board ships , but which do not meet the international standards – which may substantially differ from the internal legislation of the union and are in constant evolution . these products cannot therefore be certified by the member states in accordance with the relevant international maritime safety conventions . equipment to be placed onboard eu ships in accordance with international safety standards should therefore be regulated exclusively by this directive , which should in any event be considered the lex specialis ; furthermore , a specific marking should be established to indicate that the equipment bearing that mark complies with the requirements laid down in the relevant international conventions and instruments . ### there are other various instruments of union law which lay down requirements and conditions , inter alia in order to ensure the free movement of goods within the internal market or for environmental purposes , for certain products which are similar in nature to equipment used on board ships , but which do not meet the international standards – which may substantially differ from the internal legislation of the union and are in constant evolution . these products cannot therefore be certified by the member states in accordance with the relevant international maritime safety conventions . equipment to be placed onboard eu ships in accordance with international safety standards should therefore be regulated exclusively by this directive , which should in any event be considered the lex specialis ; furthermore , a specific marking should be established to indicate that the equipment bearing that mark complies with the requirements laid down in the relevant fully ratified international conventions and instruments .


### it is necessary to ensure that the objectives of this directive are not impaired by shortcomings in the applicable testing standards or in case the imo failed to produce appropriate standards for marine equipment falling under the scope of this directive . it is also necessary to adopt appropriate technical criteria so that electronic tags can be affixed and used in a safe and reliable way . moreover , it is necessary to keep up - to - date a number of non - essential elements of this directive , namely the list of international conventions laying down safety requirements for marine equipment contained in article 2 and the references to specific standards contained in annex iii . the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should therefore be delegated to the commission in respect of the adoption , on an interim basis , of harmonised technical specifications and testing standards and in order to amend the said lists and references . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . ### it is necessary to adopt appropriate technical criteria so that electronic tags can , where chosen as an option to protect intellectual property rights , be affixed and used in a safe and reliable way . moreover , it is necessary to keep up - to - date a number of non - essential elements of this directive , namely the list of international conventions laying down safety requirements for marine equipment contained in article 2 and the references to specific standards contained in annex iii . the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should therefore be delegated to the commission in respect of the adoption , on an interim basis , of harmonised technical specifications and testing standards and in order to amend the said lists and references . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level .


### ‘ international conventions’ means the conventions , together with their protocols and codes of mandatory application , adopted under the auspices of the international maritime organization which lay down specific requirements for the approval by the flag state of equipment to be placed on board ships . this includes : ### ‘ international conventions’ means the conventions , together with their protocols and codes of mandatory application , adopted under the auspices of the international maritime organization and ratified by the member states which lay down specific requirements for the approval by the flag state of equipment to be placed on board ships . this includes :


### in the absence of appropriate international standards developed by the imo for a specific item of marine equipment , the commission shall be empowered to adopt , by means of delegated acts in accordance with article 37 , harmonised technical specifications and testing standards for that specific item of marine equipment when it is necessary in order to remove an unacceptable threat to safety or to the environment . those specifications and standards shall apply on an interim basis and until such time as the imo has adopted appropriate standards . ### implementing powers shall be conferred upon the commission in order to adopt harmonised technical specifications and testing standards when , in exceptional circumstances and in order to remove an unacceptable threat to safety or to the environment , it is necessary due to a weakness or anomaly in an existing standard or the absence of an appropriate international standard . those specifications and standards shall apply on an interim basis and until such time as the imo has adopted appropriate standards . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 38 .


### where the national measure is considered justified and the non - compliance of the marine equipment is attributed to shortcomings in the testing standards referred to in article 4 , the commission may confirm , modify or revoke the said measure by means of implementing acts in accordance with the advisory procedure referred to in article 38 . the commission shall furthermore be empowered to adopt , by means of delegated acts in accordance with the procedure referred to in article 37 , interim harmonised requirements and testing standards for that specific item of marine equipment in order to remove the threat to safety or to the environment pending the modification of the testing standard concerned by the relevant international organisation . ### where the non - compliance of the marine equipment is attributed to shortcomings in the testing standards referred to in article 4 , the commission may , in order to fulfil the objective of this directive , confirm , modify or revoke the said measure by means of implementing acts . implementing powers shall be conferred upon the commission in order to adopt interim harmonised requirements and testing standards for that specific item of marine equipment in order to remove the threat to safety or to the environment pending the modification of the testing standard concerned by the relevant international organisation and in accordance with the criteria identified in article 8 .


### the eu declaration of conformity shall have the model structure set out in annex iii of decision no 768 / 2008 / ec , shall contain the elements specified in the relevant modules set out in annex ii to this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the measuring instrument is placed or made available . ### the eu declaration of conformity shall have the model structure set out in annex iii of decision no 768 / 2008 / ec , shall contain the elements specified in the relevant modules set out in annex ii to this directive and shall be continuously updated . it may be translated , upon request , into the language or languages required by the member state in which market the measuring instrument is placed or made available .


### member states shall adopt and publish by [ insert date – 2 years after adoption ] at the latest the laws , regulations and administrative provisions necessary to comply with articles 4 to , 8 , 9 , 10 , 11 , 13 , 14 , [ 15 ] , 20 , 22 , 23 , 23 , 23 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 49 , 50 and annex ii . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive . ### member states shall adopt and publish by [ insert date – three years after adoption ] at the latest the laws , regulations and administrative provisions necessary to comply with articles 4 to , 8 , 9 , 10 , 11 , 13 , 14 , [ 15 ] , 20 , 22 , 23 , 23 , 23 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 49 , 50 and annex ii . they shall forthwith communicate to the commission the text of those provisions and a correlation table between those provisions and this directive .


### the constant rise of infringements of intellectual property rights constitutes a genuine threat not only to the union economy , but also health and safety of union consumers . therefore , effective , immediate and coordinated actions at european and global levels are needed to successfully combat this phenomenon . ### the constant rise of infringements of intellectual property rights constitutes a genuine threat to the union economy , especially as it negatively affects the competitiveness of small and medium - sized enterprises . moreover , an exponential increase in counterfeit products used in the daily lives of union consumers threatens their health and safety . therefore , effective , immediate and coordinated actions at european and global levels are needed to successfully combat this phenomenon .


### the european parliament , in its resolution of 22 september 2010 on enforcement of intellectual property rights in the internal market , called on the member states and the commission to extend the cooperation between the office and national intellectual property offices to also include the fight against infringements of intellectual property rights . ### the european parliament , in its resolution of 22 september 2010 on enforcement of intellectual property rights in the internal market , called on the member states and the commission to extend the cooperation between the office and national intellectual property offices to also include the fight against infringements of intellectual property rights ; moreover , it expressed its wish that the observatory should inter alia compile scientific research on counterfeiting and the regulation of intellectual property rights .


### improving the understanding on the scope and impact of infringements of intellectual property rights , protected under european union law or the national laws of the member states , including industrial property rights , copyright and rights related to copyright ; ### improving the understanding on the scope , scale , value and impact of infringements of intellectual property rights , protected under european union law or the national laws of the member states , including industrial property rights , copyright and rights related to copyright ;


### enhancing the knowledge on technical tools to prevent and combat counterfeiting and piracy , including tracking and tracing systems ; ### enhancing the knowledge on , and promoting , technical tools to prevent and combat counterfeiting and piracy , including tracking and tracing systems ;


### establishing a methodology for the collection , analysis and reporting of independent , objective , comparable and reliable data related to infringements of intellectual property rights ; ### establishing a methodology for the regular collection , analysis and reporting of independent , objective , comparable , robust and reliable data related to infringements of intellectual property rights ;


### collecting , analysing and disseminating relevant objective , comparable and reliable data regarding infringements of intellectual property rights ; ### regularly collecting , analysing and disseminating relevant independent , objective , comparable , robust and reliable data regarding infringements of intellectual property rights ;


### collecting , analysing and disseminating relevant objective , comparable and reliable data regarding the economic value of intellectual property and its contribution to economic growth , welfare , innovation , creativity , cultural diversity , the creation of high quality jobs and the development of high quality products and services within the union ; ### regularly collecting , analysing and disseminating relevant independent , objective , comparable , robust and reliable data regarding the economic value of intellectual property and its contribution to economic growth , welfare , innovation , creativity , cultural diversity , the creation of high quality jobs and the development of high quality products and services within the union ;


### providing regular assessments and specific reports by economic sector , geographic area and type of intellectual property right infringed , which evaluate , inter alia , the impact of intellectual property rights infringements on society , economy , health , environment , safety and security , and the relation of such infringements with organized crime and terrorism ; ### providing regular assessments and specific reports by economic sector , geographic area and type of intellectual property right infringed , which evaluate , inter alia , the impact of intellectual property rights infringements on society , economy , especially small and medium - sized enterprises , health , environment , safety and security , and the relation of such infringements with organized crime and terrorism ;


### the office shall at all times ensure that the activities entrusted to it by this regulation are carried out by making use of its own budgetary means . ### the office shall at all times ensure that the activities entrusted to it by this regulation are carried out by making use of its own budgetary means and that appropriate financial resources are allocated so that those activities can be carried out properly .


### the names of the representatives , the agenda and the minutes of the meetings shall be published on the office ' s website . ### the names of the representatives , the agenda , the minutes , other relevant information and related documentation of the meetings shall be published on the office ' s website .


### an overview of the activities that the office intends to undertake in the future ; ### an overview of the activities that the office intends to undertake in the future , taking into consideration the activities carried out in the member states so as to avoid unnecessary duplication ;


### the commission shall , when preparing the evaluation report , consult the representatives meeting as the observatory on the issues set out in paragraph 2 . ### the commission shall , when preparing the evaluation report , consult the representatives meeting as the observatory on the issues set out in paragraph 2 . the commission shall also consider the possible involvement of any other interested parties in the process of evaluation .


### eur 89 million to equal the contributions of any other member state or any other country associated to horizon 2020 framework programme participating in the edctp2 programme in accordance with article 1 . 2 . ### eur 89 million to equal the contributions , be they in kind or financial contributions , of any other member state or any other country associated to horizon 2020 framework programme participating in the edctp2 programme in accordance with article 1 . 2 .


### the contribution shall be paid from the appropriations in the general budget of the union allocated to the relevant parts of the specific programme implementing horizon 2020 framework programme , established by decision … / 2013 / eu in accordance with article 58 and articles 60 and 61 of regulation no 966 / 2012 . ### the contribution shall be paid from the appropriations in the general budget of the union allocated to the relevant parts of the horizon 2020 framework programme , and in particular from the appropriations under the specific objective ' health , demographic change and wellbeing ' in accordance with article 58 and articles 60 and 61 of regulation no 966 / 2012 .


### activities may include national programme activities of participating states and new activities , including calls for proposals managed by the edctp2 - is . ### activities may include activities undertaken by public or private not - for - profit research organisations included in the national programme activities of participating states and new activities , including calls for proposals managed by the edctp2 - is .


### where such an activity is included in the workplan , edctp2 - is may launch joint calls with third countries or their scientific and technological organisations and agencies , with international organisations or with other third parties , in particular non - governmental organisations , in accordance with the rules developed based on article 11 of regulation no … [ rules for the participation and dissemination in horizon 2020 ] . ### where such an activity is included in the workplan , edctp2 - is may launch joint calls with third countries or their scientific and technological organisations and agencies , with international organisations or with other third parties , in particular non - governmental organisations and product development organisations , in accordance with the rules developed based on article 11 of regulation no … [ rules for the participation and dissemination in horizon 2020 ] .


### the commission may decide to carry out the audits referred to in paragraph 1 itself . ### without prejudice to the independence or the role of the court of auditors of the european union , the commission may , in duly reasoned cases and in consultation with the participating states , decide to carry out the audits referred to in paragraph 1 itself .


### an increased number of new or improved medical interventions for hiv / aids , tuberculosis , malaria and other poverty - related diseases , and by the end of the programme to have delivered at least one new medical intervention ; to have issued at least 30 guidelines for improved or extended use of existing medical interventions ; and to have progressed the clinical development of at least 20 candidate medical interventions ; ### an increased number of new or improved medical interventions for hiv / aids , tuberculosis , malaria and other poverty - related diseases , and by the end of the programme to have delivered at least one new medical intervention ; to have issued [ xx ] new guidelines for improved or extended use of existing medical interventions ; and to have progressed the clinical development of [ xx ] candidate medical interventions ;


### operational objectives in order to reach the specific objectives set out in point 2 , the following operational objectives , including indicative targets , shall be met by the end of the edctp2 programme in 2024 : ### operational indicators in order to reach the specific objectives set out in point 2 , the following indicators shall be monitored during the course of the edctp2 programme .


### target : increase the number of supported clinical trials to at least 150 compared to 88 under edctp1 . ### indicator : increase the number of supported clinical trials that lead to new products , processes , methodologies , diagnostics , treatments or preventions .


### target : sustain or increase the proportion of clinical trials funded by the edctp2 - is with african leadership to at least 50 % . ### indicator : sustain or increase the proportion of clinical trials funded by the edctp2 - is with african leadership .


### target : increase the number of peer - reviewed scientific articles published to at least 1000 . ### indicator : aim to increase the number of peer - reviewed scientific articles published to three times that of edctp1 .


### target : sustain or increase the number of sub - saharan african countries supported by the edctp2 to at least 30 . ### indicator : aim to sustain or increase the participation of sub - saharan african countries in the edctp2 .


### target : increase the number of capacity - building activities supported for conducting clinical trials in sub - saharan africa to at least 150 compared to 74 under edctp1 . ### indicator : increase the number of capacity - building activities supported for conducting clinical trials in sub - saharan africa .


### develop a common research agenda , criteria for priority setting and common evaluation : ### develop a research agenda for edctp2 that includes common criteria for priority setting and common evaluation whilst recognising that contributions from national programmes and edctp may differ , for example national programmes may contribute in kind whereas edctp may not .


### target : administrative costs are below 5 % of the edctp2 - is budget . ### indicator : administrative costs below 5 % of the edctp2 - is budget .


### target : increase the contributions received from developing countries to at least eur 30 million compared to eur 14 million under edctp1 . ### indicator : an increase in the contributions received from developing countries of at least eur 30 million compared to eur 14 million under edctp1 .


### promoting networking , coordination , alignment , cooperation and integration of national research programmes and activities on poverty - related infectious diseases at scientific , management and financial level ; ### promoting networking , coordination , alignment , collaboration and cooperation and integration of national research programmes and activities on poverty - related diseases at scientific , management and financial level ;


### fostering capacity development for clinical trials and related research in developing countries through grants for : career development of junior / senior fellows , promoting mobility , staff exchange grants , research training networks , strengthening ethics and regulatory bodies , mentoring and partnerships at individual or institutional level ; ### fostering capacity development for clinical trials and related research in developing countries through grants for : career development of junior / senior fellows , promoting mobility , staff exchange grants , research training networks , strengthening ethics and regulatory bodies , mentoring and partnerships at individual or institutional or regional level ;


### the annual work plan shall identify topics and activities to be implemented , including calls for proposals to be launched by edctp - is to select and fund indirect actions , as well as the budgets and edctp2 funding for those topics and activities . ### the annual work plan shall identify topics and activities to be implemented , in coordination , where appropriate , with national programmes , including calls for proposals to be launched by edctp - is to select and fund indirect actions , as well as the budgets and edctp2 funding for those topics and activities . edctp2 should seek scientific coordination and , where relevant , exchange of information with relevant public or private initiatives including those under horizon 2020 such as the innovative medicines initiative and the strategic panel for health .


### the ga shall decide by consensus . failing consensus , the ga shall take its decisions by a majority of at least 75 % of the votes . ### the ga shall take its decisions by a majority of at least 75 % of the votes .


### the ga shall appoint a management board that shall supervise the secretariat of the edctp2 - is established by the ga as the executive body of the edctp2 programme . sec shall have the following tasks : ### the ga shall appoint a management board that shall supervise the secretariat of the edctp2 - is established by the ga as the executive body of the edctp2 programme . sec shall have at least the following tasks :


### represent the edctp2 - is ; ### execute the annual work plan


### a scientific advisory committee shall advise the ga on the strategic priorities of the edctp2 programme . ### a strategic advisory committee shall provide strategic and scientific advice to the ga , the board and the sec .


### review and advise the ga on the content , scope and dimension of the edctp2 draft annual work plan , including diseases covered and approaches to be adopted , from a scientific and technical standpoint ### advise the ga on the content , scope and dimension of the edctp2 draft annual work plan , including diseases covered and approaches to be adopted , from a scientific and technical standpoint


### at the time of the entry into force of the treaty of lisbon , member states of the union maintained a significant number of bilateral agreements with third countries relating to investment . the treaty does not contain any explicit transitional provisions for such agreements which have now come under exclusive union competence . furthermore , some of those agreements may include provisions affecting the common rules on capital movements laid down in part three chapter 4 of title iv of the treaty . ### at the time of the entry into force of the treaty of lisbon , member states of the union maintained a significant number of bilateral agreements with third countries relating to foreign direct investment . the treaty does not contain any explicit transitional provisions for such agreements . furthermore , some of those agreements may include provisions affecting the common rules on capital movements laid down in part three chapter 4 of title iv of the treaty .


### although bilateral agreements remain binding on the member states under public international law and will be progressively replaced by future agreements of the union relating to the same subject matter , the conditions for their continuing existence and their relationship with the union ' s policies relating to investment , including in particular the common commercial policy , require appropriate management . that relationship will develop further as the union exercises its competence . ### although bilateral agreements remain binding on the member states under public international law and will be progressively replaced by future agreements of the union relating to the same subject matter , the conditions for their continuing existence and their relationship with the union ' s policies relating to foreign direct investment , including in particular the common commercial policy , require appropriate management and legal certainty . that relationship will develop further as the union exercises its competence in common commercial policy .


### the authorisation to amend or conclude agreements provided for by this regulation notably allows member states to address any incompatibilities between their international agreements relating to investment and the law of the union , other than incompatibilities arising from the allocation of competences between the union and its member states , which are addressed in this regulation . ### the authorisation to amend or conclude foreign direct agreements provided for by this regulation notably allows member states to address any incompatibilities between their international agreements relating to foreign direct investment and the law of the union , other than incompatibilities arising from the allocation of competences between the union and its member states , which are addressed in this regulation .


### no later than five years after the entry into force of this regulation , the commission should present to the european parliament and the council a report on the application of chapters ii and iii of this regulation . this report should , inter alia , review the need for the continued application of these chapters . where the report recommends to discontinue the application of the provisions of these chapters or where it would propose to modify these provisions , it should be accompanied by an appropriate legislative proposal . unless replaced by an agreement of the union concerning investment , or otherwise terminated , bilateral agreements concluded by member states with third countries remain binding on the parties under public international law . ### no later than five years after the entry into force of this regulation , the commission should present to the european parliament and the council a report on the application of chapters ii and iii of this regulation . this report should , inter alia , review the need for the continued application of these chapters . where the report recommends discontinuing the application of the provisions of these chapters or where it would propose to modify these provisions , it should be accompanied by an appropriate legislative proposal . unless replaced by an agreement of the union concerning foreign direct investment , or otherwise terminated , bilateral foreign direct agreements concluded by member states with third countries remain binding on the parties under public international law .


### subject to the conditions laid down in articles 8 to12 , a member state shall be authorised to enter into negotiations to amend an existing or to conclude a new agreement relating to investment with a third country . ### subject to the conditions laid down in articles 8 to12 , a member state shall be authorised to enter into negotiations to amend an existing or to conclude a new agreement relating to foreign direct investment with a third country .


### jordan ' s economy has been significantly affected by domestic events related to the events in the southern mediterranean since the end of 2010 , known as the ' arab spring ' , and by the ongoing regional unrest , notably in neighbouring egypt and syria . combined with a weaker global environment , the repeated disruptions to the flow of natural gas from egypt , which have forced jordan to replace gas imports from egypt with more expensive fuels for electricity generation , and the important inflow of refugees from syria have resulted in important external and budgetary financial gaps . ### jordan ' s economy has been significantly affected by domestic events related to the events in the southern mediterranean since the end of 2010 , known as the ' arab spring ' , and by the ongoing regional unrest , notably in neighbouring egypt and syria . combined with a weaker global environment , the repeated disruptions to the flow of natural gas from egypt , which have forced jordan to replace gas imports from egypt with more expensive fuels for electricity generation , and the important inflow of refugees from syria have resulted in important external and budgetary financial gaps and become a cause of social unrest .


### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their reproduction and dissemination . ### where charges are made for the re - use of documents , the total amount charged by public sector bodies shall be limited to the marginal costs incurred for their collection , production , reproduction and dissemination .


### directive 2001 / 83 / ec provides that certain types of information are subject to control by the member states ' national competent authorities prior to their dissemination . this concerns information about non - interventional scientific studies , or accompanying measures to prevention and medical treatment , or information which presents the medicinal product in the context of the condition to be prevented or treated . in the case of medicinal products for human use authorised pursuant to title ii of regulation no 726 / 2004 , provision should also be made for certain types of information to be subject to prior vetting by the european medicines agency . ### directive 2001 / 83 / ec provides that certain types of information are subject to control by the member states ' national competent authorities prior to their dissemination . this concerns information about non - interventional scientific studies based on experimental observation , or accompanying measures to prevention and medical treatment , or information which presents the medicinal product in the context of the condition to be prevented or treated . in the case of medicinal products for human use authorised pursuant to title ii of regulation no 726 / 2004 , provision should also be made for certain types of information to be subject to prior vetting by the european medicines agency , unless the content of that information had already been vetted by a competent national authority , and for the agency , or a competent national body , to monitor the measures to be taken by the manufacturer following a report of adverse reactions , and the consequent immediate updating of the literature .


### by way of derogation from article 100g of directive 2001 / 83 / ec , medicinal product - related information referred to in article 100b of that directive shall be subject to vetting by the agency prior to its dissemination . ### by way of derogation from article 100g of directive 2001 / 83 / ec , medicinal product - related information referred to in article 100b of that directive shall be subject to vetting by the agency or a competent national authority prior to its dissemination .


### in order to ensure transparency , in particular for data subjects , the union acts for which imi is to be used should be listed in annex i to this regulation . areas of possible further expansion should be set out in annex ii . it is appropriate to identify in annex ii , a set of union acts where it is necessary to evaluate the technical feasibility ; cost efficiency , user friendliness and the overall impact on the system , before it is decided to use imi for such acts . ### in order to ensure transparency , in particular for data subjects , the union acts for which imi is to be used should be listed in annex i to this regulation .


### while imi is in essence a communication tool for public authorities , not open to the general public , technical means may need to be developed to allow external actors such as citizens , enterprises and organisations to interact with the competent authorities in order to supply information and retrieve data , or to exercise their rights as data subjects . such technical means should include appropriate safeguards for data protection . ### while imi is in essence a communication tool for public authorities , it is not open to the general public .


### this regulation lays down rules for the use of an internal market information system , hereinafter ‘ imi’ , for administrative cooperation , including processing of personal data , among competent authorities in the member states and the commission . ### the purpose of this regulation is to lay down rules governing the operation of an internal market information system , hereinafter ‘ imi’ , for exchange of information necessary for administrative cooperation , including processing of personal data , among competent authorities in the member states and the commission .


### each member state shall appoint one national imi coordinator whose tasks shall include : ### each member state shall appoint one national imi coordinator whose responsibilities shall include :


### when cooperating by means of imi , the competent authorities shall ensure that an adequate response is provided within the shortest possible period of time or within the deadline set by the applicable union act , acting through imi users in accordance with administrative cooperation procedures . ### when cooperating by means of imi , the competent authorities shall ensure that a response is provided without delay , subject to the provisions of , and within the deadline set by , the applicable union act , acting through imi users in accordance with administrative cooperation procedures .


### the commission shall ensure the security , availability , maintenance and development of the software and it infrastructure for imi . it shall provide a multilingual system , training in cooperation with the member states , and a helpdesk to assist member states in the use of imi . 2 . the commission may participate in administrative cooperation procedures involving the processing of personal data where required by a union act listed in annex i . 3 . the commission shall register the national imi coordinators and shall grant them access to imi . 4 . the commission shall perform processing operations on personal data in imi where provided for in this regulation . 5 . for the purposes of performing its tasks under this article and for producing reports and statistics , the commission shall have access to the necessary information relating to the processing operations performed in imi . ### the commission shall be responsible for carrying out the following tasks : to ensure the security , availability , maintenance and development of the software and it infrastructure for imi . it shall , in particular , provide translation functionalities , training in cooperation with the member states , and a helpdesk to assist member states in the use of imi ; to participate in administrative cooperation procedures involving the processing of personal data where required by a union act listed in annex i ; to register the national imi coordinators and shall grant them access to imi ; to perform processing operations on personal data in imi where provided for in this regulation in accordance with the purposes determined by the applicable union acts set out in annex i ; to monitor the application of this regulation and report back in accordance with article 26 . 5 . for the purposes of performing its tasks under this article and for producing reports and statistics , the commission shall have access to the necessary information relating to the processing operations performed in imi .


### imi actors shall ensure that requests of other imi actors for confidential treatment of information exchanged by means of imi are complied with by imi users working under their authority . ### imi actors shall ensure that requests of other imi actors for confidential treatment of information exchanged by means of imi are complied with by imi users working under their authority . such requests shall be explicitly transmitted through imi together with the information to which those requests apply .


### imi shall be based on administrative cooperation procedures developed and updated for that purpose by the commission , in close cooperation with the member states . ### imi shall be based on administrative cooperation procedures defined , developed and updated for that purpose by the commission in close cooperation with the member states .


### imi actors shall ensure that data subjects are informed about processing of their personal data in imi and that they have access to a privacy notice explaining their rights and how to exercise them , in accordance with articles 10 or 11 of directive 1995 / 46 / ec and national legislation which is in accordance with that directive . ### imi actors in contact with data subjects shall ensure that data subjects are informed about processing of their personal data in imi and that they have access to a privacy notice explaining their rights and how to exercise them , in accordance with articles 10 or 11 of directive 95 / 46 / ec and national legislation which is in accordance with that directive .


### “baile átha cliath / dublin / corcaigh / cork – zeebrugge / antwerpen / rotterdam . ### “shannon foynes / baile átha cliath / dublin / corcaigh / cork – zeebrugge / terneuzen / gent / antwerpen / rotterdam / amsterdam


### any additional conditions set by the competent authority in the relevant permit pursuant to points and of article 7 , as regards water quality . ### any well - founded additional conditions set by the competent authority in the relevant permit pursuant to points and of article 7 , as regards water quality .


### in the event of non - compliance , the competent authority shall require the reclamation plant operator to take any necessary measures to restore compliance without delay . ### in the event of non - compliance detected after issue of a permit , the competent authority shall require the reclamation plant operator to halt the supply of reclaimed water until the necessary measures to restore compliance have been taken .


### member states should conduct their economic policies and should coordinate them in such a way as to attain the objective of strengthening economic , social , and territorial cohesion . ### member states should , with regards to their fiscal limits as set out in the treaties , conduct their economic policies and should optimize them for their own country , but always try to learn from others .


### the eisf shall provide financial assistance in the form of loans and interest rate subsidies for public investment to a member state which is experiencing a large asymmetric shock . ### the eisf shall provide financial assistance in the form of loans and interest rate subsidies for public investment to a member state which is experiencing a large asymmetric shock . an asymmetric shock is a negative economic development that affects one region or one country within a currency area more than other regions or countries in the same currency area . an asymmetric schock will usually affect the economic structure of a country and can not simply be overcome by temporarily increased fiscal spending . it can be overcome by a focus on education and entrepreneurship and by becoming competitive in order to attract new private investment and new industries . a common currency area will lead to increased specialization and its countries and regions will be more susceptible to asymmetric shocks .


### the unprecedented financial crisis and economic downturn that hit the world and the euro area has shown that in the euro area available instruments such as the single monetary policy , automatic fiscal stabilisers and discretionary fiscal policy measures at national level are insufficient to absorb large asymmetric shocks . ### the unprecedented financial crisis and economic downturn that hit the world and the euro area has shown that in the euro area available instruments such as the single monetary policy , automatic fiscal stabilisers and discretionary fiscal policy measures at national level are insufficient in multiple countries to absorb large asymmetric shocks .


### a member state shall be considered to experience a large asymmetric shock if the following activation criteria are simultaneously fulfilled : ### a member state shall be considered to experience a large asymmetric shock if its economy suffer a significant&#160 ; downturn in comparison to other member states of the euro system :


### unless otherwise provided for in an international agreement concluded by the union , one of the following conditions is fulfilled ### unless otherwise provided for in an international agreement on wet - lease signed by the union based on an existing air transport agreement which has been signed before 1 january 2008 , one of the following conditions is fulfilled :


### existing electronic toll systems which use technologies other than those listed in annex iv shall comply with those technologies if substantial technological improvements are carried out ### existing electronic toll systems which use technologies other than those listed in the first subparagraph shall comply with those technologies if substantial technological improvements are carried out .


### article 8 data protection the provisions of regulation 2016 / 679 and the national laws , regulations or administrative provisions transposing directive 2016 / 680 shall apply to personal data processed under this directive . 2 . member states shall ensure that personal data processed under this directive are , within an appropriate time period , rectified if inaccurate , or erased or restricted , and that a time limit for the storage of data is established in accordance with regulation 2016 / 679 and the national laws , regulations or administrative provisions transposing directive 2016 / 680 . member states shall ensure that all personal data processed under this directive are only used for the purpose of facilitating the cross - border exchange of information on failures to pay road fees , and that the data subjects have the same rights to information , access , rectification , erasure and blocking , compensation and judicial redress as provided for in regulation 2016 / 679 and the national laws , regulations or administrative provisions transposing directive 2016 / 680 . 3 . any person concerned shall have the right to obtain information on which personal data recorded in the member state of registration were transmitted to the member state in which there was a failure to pay a road fee , including the date of the request and the competent authority of the member state in whose territory there was a failure to pay a road fee . ### article 8 data protection regulation 2016 / 679 and directive 2002 / 58 / ec shall apply to personal data processed under this directive . directive 2016 / 680 shall only apply to personal data processed under this directive when the failure to pay a road fee is a criminal offence in the member state where the payment is due . 2 . member states shall ensure that the processing of personal data for the purposes of article 5 is limited to the types of data listed in annex ii . member states shall also ensure that data subjects have the right to update , rectify or erase personal data processed without undue delay if inaccurate . member states shall establish a time limit for the storage of personal data in accordance with regulation 2016 / 679 and , where applicable , directive 2016 / 680 . ) member states shall ensure that personal data processed under this directive are processed for the sole purpose of facilitating the cross - border exchange of information on failures to pay road fees and shall not be further processed for any other purpose . member states shall also ensure that the data subjects have the same rights of information , access , rectification , erasure and restriction of processing , to lodge a complaint with a data protection supervisory authority , compensation and an effective judicial remedy as provided for in regulation 2016 / 679 and , where applicable , directive 2016 / 680 . member states shall ensure that access to personal data is only granted to the designated competent authorities for the exchange of vehicle registration . 3 . any person concerned shall have the right to obtain , without undue delay , information on which personal data recorded in the member state of registration were transmitted to the member state in which there was a failure to pay a road fee , including the date of the request and the competent authority of the member state in whose territory there was a failure to pay a road fee .


### the introduction of electronic toll systems will entail the processing of personal data . such processing needs to be carried out in accordance with union rules , as set out , inter alia , in regulation 2016 / 679 of the european parliament and of the council19 , directive 2016 / 680 of the european parliament and of the council20 and directive 2002 / 58 / ec of the european parliament and of the council21 . the right to protection of personal data is explicitly recognised by article 8 of the charter of fundamental rights of the european union . __________________ 19 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec , 20 directive 2016 / 680 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , and on the free movement of such data , and repealing council framework decision 2008 / 977 / jha . 21 directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector . ### the introduction of electronic toll systems entails the processing of personal data . the right to protection of personal data is explicitly recognised by article 8 of the charter and article 16 of the treaty on the functioning of the european union . such processing needs to be carried out in accordance with union rules , as set out , inter alia , in regulation 2016 / 679 of the european parliament and of the council19 , and directive 2002 / 58 / ec of the european parliament and of the council20 , and , where the failure to pay a road fee is a criminal offence in the member state where the payment is due , by directive 2016 / 680 of the european parliament and of the council . 21 __________________ 19 regulation 2016 / 679 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data , and repealing directive 95 / 46 / ec , 20 directive 2002 / 58 / ec of the european parliament and of the council of 12 july 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector . 21 directive 2016 / 680 of the european parliament and of the council of 27 april 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention , investigation , detection or prosecution of criminal offences or the execution of criminal penalties , and on the free movement of such data , and repealing council framework decision 2008 / 977 / jha .


### electronic tolling and co - operative its applications use similar technologies and neighbouring frequency bands for short range vehicle - to - vehicle and vehicle - to - infrastructure communication . in the future , the potential for merging electronic tolling with c - its in the 5 . 9 ghz band , currently used by c - its , should be explored , after a thorough assessment of the costs , benefits , technical barriers and possible solutions thereto . ### electronic tolling and co - operative its applications use similar technologies and neighbouring frequency bands for short range vehicle - to - vehicle and vehicle - to - infrastructure communication .


### this directive lays down the conditions necessary to ensure the interoperability of electronic road toll systems and to facilitate the cross - border exchange of information on the failure to pay road fees in the union . it applies to the electronic collection of all types of road fees , on the entire union road network , urban and interurban , motorways , major and minor roads , and various structures such as tunnels , bridges and ferries . ### this directive lays down the conditions necessary to ensure the interoperability of electronic road toll systems in the union . it applies to the electronic collection of all types of road fees , on the entire union road network , urban and interurban , motorways , major and minor roads , and various structures such as tunnels , bridges and ferries .


### the commission’s proposal for a directive of the european parliament and of the council34 includes accessibility requirements for a specific set of public sector bodies’ websites . in addition , it proposes to establish the basis for a monitoring and reporting methodology of the compliance of the relevant websites with the requirements listed in that directive . both the accessibility requirements and the monitoring and reporting methodology included in that directive are to apply to the public sector bodies ' websites . with the purpose of , notably , ensuring that relevant authorities implement the same accessibility requirements independently of the type of regulated website , the accessibility requirements set out in this directive should be aligned to those of the proposed directive on the accessibility of public sector bodies’ websites . activities of ecommerce of public sector websites not covered by that directive , fall under the scope of this proposal , in order to ensure that the online sale of products and services is accessible for persons with disabilities and older persons , irrespective of their public or private sale . __________________ 34 proposal for a directive of the european parliament and of the council on the accessibility of public sector bodies ' websites com 721 . ### directive 2016 / 2102 of the european parliament and of the council34 includes accessibility requirements for all public sector bodies ' websites . in addition , it establishes the basis for a monitoring and reporting methodology of the compliance of the relevant websites and mobile applications with the requirements listed in that directive . both the accessibility requirements and the monitoring and reporting methodology included in that directive apply to the public sector bodies ' websites and mobile applications . with the purpose of , notably , ensuring that relevant authorities implement the same accessibility requirements independently of the type of regulated website and mobile applications , the accessibility requirements set out in this directive should be aligned to those of directive 2016 / 2102 . activities of ecommerce of public sector websites and mobile applications which are not covered by directive 2016 / 2102 fall within the scope of this directive , in order to ensure that the online sale of products and services is accessible for persons with disabilities , irrespective of their public or private sale . __________________ 34 directive 2016 / 2102 of the european parliament and of the council of 26 october 2016 on the accessibility of the websites and mobile applications of public sector bodies .


### service providers shall prepare the necessary information in accordance with annex iii explaining how the services meet the accessibility requirements referred to in article 3 . the information shall be made available to the public in written and oral format , including in a manner which is accessible to persons with functional limitations and persons with disabilities . service providers shall keep the information as long as the service is in operation . ### service providers shall prepare the necessary information in accordance with annex iii explaining how the services meet the accessibility requirements referred to in article 3 . the information shall be made available to the public in a manner which is accessible to persons with disabilities . service providers shall keep the information as long as the service is in operation .


### public contracts and concessions which are subject to directive 2014 / 23 / eu42 directive 2014 / 24 / eu and directive 2014 / 25 / eu . __________________ 42 directive 2014 / 23 / eu of the european parliament and of the council of 26 february 2014 on the award of concession contracts ### subject to paragraph 3a of this article , public contracts , including mixed contracts , the object of which is intended for use by natural persons , whether general public or staff of the contracting authority or contracting entity , and that are subject to directive 2014 / 24 / eu and directive 2014 / 25 / eu , where technical specifications are drawn up in accordance with those directives so as to take into account , except in duly justified cases , accessibility criteria for persons with disabilities or design for all users .


### member states may decide , in the light of national conditions , that the built environment used by clients of passenger transport services including the environment that is managed by service providers and by infrastructure operators as well as the built environment used by clients of banking services , and customer services centres and shops under the scope of telephony operators shall comply with the accessibility requirements of annex i , section x , in order to maximise their use by persons with functional limitations , including persons with disabilities . ### member states may decide , in the light of national conditions , that the built environment used by clients of passenger transport services including the environment that is managed by service providers and by infrastructure operators as well as the built environment used by clients of banking services , and customer services centres and shops under the scope of telephony operators shall comply with the accessibility requirements of annex i , section x , in order to maximise their use by persons with disabilities .


### the provision of services in order to maximise their foreseeable use by persons with functional limitations , including persons with disabilities , shall be achieved by : ensuring the accessibility of the products they use in the provision of the service , in accordance with the rules laid down in point b on ' related terminal equipment with advance computing capability used by consumers ' providing information about the functioning of the service and about its accessibility characteristics and facilities as follows : the information content shall be available in text formats that can be used to generate alternative assistive formats to be presented in different ways by the users and via more than one sensory channel , alternatives to non - text content shall be provided ; the electronic information , including the related online applications needed in the provision of the service shall be provided in accordance with point . making websites accessible in a consistent and adequate way for users’ perception , operation and understanding , including the adaptability of content presentation and interaction , when necessary providing an accessible electronic alternative ; and in a way which facilitates interoperability with a variety of user agents and assistive technologies available at union and international level ; providing accessible information to facilitate complementarities with assistive services ; including functions , practices , policies and procedures and alterations in the operation of the service targeted to address the needs of persons with functional limitations . ### the provision of services in order to maximise their reasonably foreseeable use by persons with disabilities shall be achieved by meeting the functional performance requirements set out in point ba , and shall include : the products the service providers use in the provision of the service concerned , in accordance with the rules laid down in point b on ' related terminal equipment used by consumers ' ; information about the functioning of the service and about its accessibility characteristics and facilities ; electronic information , including the related websites and online applications needed in the provision of the service ; information to facilitate complementarities with assistive services ; functions , practices , policies , procedures and alterations in the operation of the service targeted to address the needs of persons with disabilities .


### the commission’s report shall take into account the viewpoints of the economic stakeholders and relevant non - governmental organisations , including organisations of persons with disabilities and those representing older persons . ### the commission’s report shall take into account the viewpoints of the economic stakeholders and relevant non - governmental organisations , including organisations of persons with disabilities .


### in some situations , common accessibility requirements of the built environment would facilitate the free movement of the related services and of persons with disabilities . therefore , this directive enables member states to include the built environment used in the provision of the services under the scope of this directive , ensuring compliance with the accessibility requirements set in annex x . ### in some situations , common accessibility requirements related to the built environment including transport infrastructure used by passengers would facilitate the free movement of the related services and of persons with disabilities . therefore , this directive enables member states to include the built environment used in the provision of the services under the scope of this directive where no other union legal acts on built environment exists . where member state decide to apply accessibility requirements to the built environment used in the provision of services covered by this directive , they may adopt all or some of the accessibility requirements set out in section v of annex i . however , member states should not be required to amend or introduce national rules on accessibility of the built environment , if they do not decide to apply accessibility requirements provided for in this directive related to the built environment used in the provision of the services under the scope of this directive .