### they shall be informed in a language which they may reasonably be supposed to understand of the procedure to be followed and of their rights and obligations during the procedure and the possible consequences of not complying with their obligations and not cooperating with the authorities . they shall be informed of the time - frame , as well as the means at their disposal for fulfilling the obligation to submit the elements as referred to in article 4 of directive [ &#8230 ; . / . . / ec ] [ the qualification directive ] . this information shall be given in time to enable them to exercise the rights guaranteed in this directive and to comply with the obligations described in article 12 ; ### they shall be informed in a language which they understand of the procedure to be followed and of their rights and obligations during the procedure and the possible consequences of not complying with their obligations and not cooperating with the authorities . they shall be informed of the time - frame , as well as the means at their disposal for fulfilling the obligation to submit the elements as referred to in article 4 of directive [ &#8230 ; . / . . / ec ] [ the qualification directive ] . this information shall be given sufficiently in advance in order to enable them to exercise the rights guaranteed in this directive and to comply with the obligations described in article 12 ;


### before a decision is taken by the determining authority , the applicant shall be given the opportunity of a personal interview on his / her application for international protection with a person competent under national law to conduct such an interview . interviews on the substance of an application for international protection shall always be conducted by the personnel of the determining authority . ### before a decision is taken by the determining authority , the applicant shall be given the opportunity of a personal interview on his / her application for international protection in a language which he / she understands with a person competent under national law to conduct such an interview . interviews on the substance of an application for international protection shall always be conducted by the personnel of the determining authority .


### where the member state does not provide the applicant with the opportunity for a personal interview pursuant to point , or where applicable , to the dependant , reasonable efforts shall be made to allow the applicant or the dependant to submit further information . ### where the determining authority does not provide the applicant with the opportunity for a personal interview pursuant to point , or where applicable , to the dependant , the determining authority shall allow the applicant or the dependant to reschedule the personal interview and to submit further information .


### ensure that the person who conducts the interview is competent to take account of the personal or general circumstances surrounding the application , including the applicant ' s cultural origin , gender , or vulnerability ; ### ensure that the person who conducts the interview is qualified , trained and competent to take account of the personal and general circumstances surrounding the application , including the applicant ' s cultural origin , gender , sexual orientation or vulnerability ;


### select a competent interpreter who is able to ensure appropriate communication between the applicant and the person who conducts the interview . the communication need not necessarily take place in the language preferred by the applicant if there is another language which he / she understands and in which he / she is able to communicate clearly . wherever possible , member states shall provide an interpreter of the same sex if the applicant so requests ; ### select a qualified , trained and competent interpreter who is able to ensure appropriate communication between the applicant and the person who conducts the interview . the communication need not necessarily take place in the language preferred by the applicant if there is another language which he / she understands and in which he / she is able to communicate clearly . wherever possible , member states shall provide an interpreter of the same sex if the applicant so requests ;


### member states may allow non - governmental organisations to provide free legal assistance and / or representation to applicants for international protection in procedures provided for in chapter iii and / or chapter v . ### member states shall allow and facilitate the provision by non - governmental organisations of free legal assistance and / or representation to applicants for international protection in procedures provided for in chapter iii and chapter v .


### as soon as possible take measures to ensure that a representative represents and assists the unaccompanied minor with respect to the lodging and the examination of the application . the representative shall be impartial and have the necessary expertise in the field of childcare . this representative can also be the representative referred to in directive [ &#8230 ; / &#8230 ; / ec ] 17 [ the reception conditions directive ] ; ### immediately take measures to ensure that a representative represents and assists the unaccompanied minor with respect to the lodging and the examination of the application . the representative shall be impartial and have the necessary expertise in the field of childcare . this representative can also be the representative referred to in directive [ &#8230 ; / &#8230 ; / ec ] 17 [ the reception conditions directive ] ;


### ensure that the representative is given the opportunity to inform the unaccompanied minor about the meaning and possible consequences of the personal interview and , where appropriate , how to prepare himself / herself for the personal interview . member states shall ensure that a representative and / or a legal advisor or other counsellor admitted as such under national law are present at that interview and have an opportunity to ask questions or make comments , within the framework set by the person who conducts the interview . ### ensure that the representative informs the unaccompanied minor about the meaning and possible consequences of the personal interview and , where appropriate , how to prepare himself / herself for the personal interview . member states shall ensure that a representative and / or a legal advisor or other counsellor admitted as such under national law are present at that interview and have an opportunity to ask questions or make comments , within the framework set by the person who conducts the interview .


### member states may prioritise an examination of an application for international protection in accordance with the basic principles and guarantees of chapter ii : ### the determining authorities may prioritise an examination of an application for international protection in accordance with the basic principles and guarantees of chapter ii :


### member states shall ensure that a decision in the framework of the procedures provided for in paragraph 1 is taken within a reasonable time . when a decision has not been taken within four weeks , the applicant shall be granted entry to the territory of the member state in order for his / her application to be processed in accordance with the other provisions of this directive . ### member states shall ensure that a decision in the framework of the procedures provided for in paragraph 1 is taken within a reasonable time and as long as these third country nationals or stateless persons are accommodated normally at locations close to the border or transit zone . when a decision has not been taken within four weeks , the applicant shall be granted entry to the territory of the member state in order for his / her application to be processed in accordance with the other provisions of this directive .


### the erdf should contribute to the europe 2020 strategy , thus ensuring greater concentration of erdf support on the priorities of the union . according to the category of regions supported , the support from the erdf should be concentrated on research and innovation , small and medium - sized enterprises and climate change mitigation . the degree of concentration should take into account the level of development of the region as well as the specific needs of regions whose gdp per capita for the 2007 - 13 period was less than 75% of the average gdp of the eu - 25 for the reference period . ### the erdf should contribute to the europe 2020 strategy , thus ensuring greater concentration of erdf support on the priorities of the union . according to the category of regions supported , the support from the erdf should be concentrated on research and innovation , small and medium - sized enterprises , climate change mitigation and resource efficiency . the degree of concentration should take into account the level of development of the region as well as the specific needs of regions whose gdp per capita for the 2007 - 13 period was less than 75% of the average gdp of the eu - 25 for the reference period .


### productive investment , which contributes to creating and safeguarding sustainable jobs , through direct aid to investment in small and medium - sized enterprises ; ### tangible and intangible investments which contributes to creating and safeguarding sustainable jobs , through direct aid to investment exclusively in small and medium - sized enterprises ;


### in more developed regions , the erdf shall not support investments in infrastructure providing basic services to citizens in the areas of environment , transport , and ict . ### in more developed regions , the erdf shall not support investments in infrastructure providing basic services to citizens in the areas of environment , transport , and ict , but shall be open to innovative solutions in the fields of ecosystem services , biodiversity and green infrastructures , environmental friendly transport solutions and green ict .


### promoting business r&i investment , product and service development , technology transfer , social innovation and public service applications , demand stimulation , networking , clusters and open innovation through smart specialisation ; ### promoting business r&i investment , product and service development , technology transfer , eco - efficient innovation , social innovation and public service applications , demand stimulation , networking , clusters and open innovation through smart specialisation ;


### enhancing the competitiveness of smes : ### enhancing the competitiveness and sustainability of smes


### promoting low - carbon strategies for urban areas ; ### promoting efficient and renewable - based energy strategies for urban areas ;


### promoting sustainable transport and removing bottlenecks in key network infrastructures : ### promoting intermodal sustainable transport and mobility while focusing on removing bottlenecks and completing missing transborder links in sustainable and intermodal transport infrastructures :


### promoting employment and supporting labour mobility : ### promoting employment and the development in particular of green jobs , and supporting labour mobility :


### development of business incubators and investment support for self - employment and business creation ; ### development of business incubators and investment support for self - employment , micro - enterprises and business creation ;


### investing in infrastructure for public employment services ; ### investing in infrastructure for public employment services and vocational training centres ;


### economic and social partners ; and ### economic and social partners representing the general interest of industries or branches , employers and employees ; and


### the commission shall be empowered to adopt delegated acts in accordance with article 142 to provide for a european code of conduct that lays down objectives and criteria to support the implementation of partnership and to facilitate the sharing of information , experience , results and good practices among member states . ### the commission shall be empowered to adopt delegated acts in accordance with article 142 to provide for a european code of conduct that lays down objectives and criteria to guide the implementation of partnership and to facilitate the sharing of information , experience , results and good practices among member states in a manner that provides for the fullest possible transparency and access to information and participation in the partnership .


### the objectives of the csf funds shall be pursued in the framework of sustainable development and the union ' s promotion of the aim of protecting and improving the environment , as set out in article 11 of the treaty , taking into account the polluter pays principle . ### the objectives of the csf funds shall be pursued in the framework of sustainable development and the union ' s promotion of the aim of protecting and improving the environment , as set out in article 11 of the treaty , taking into account the polluter pays principle . this will be implemented through the integration of environmental acquis and the protection of biodiversity , through minimising future external costs to the environment or public health , and through the application of the precautionary principle in supporting measures under the funds .


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


### promoting climate change adaptation , risk prevention and management ; ### promoting ecosystem - based climate change adaptation , risk prevention and management ;


### the partnership contract shall be drawn up by member states in cooperation with the partners referred to in article 5 . the partnership contract shall be prepared in dialogue with the commission . ### the partnership contract shall be drawn up by member states in close cooperation with the partners referred to in article 5 . the partnership contract shall be prepared in dialogue with the commission .


### the partnership contract shall be drawn up by member states in cooperation with the partners referred to in article 5 . the partnership contract shall be prepared in dialogue with the commission . ### the partnership contract shall be drawn up by member states in cooperation with the partners referred to in article 5 , with a priority to address any non - implementation of eu acquis and taking into account cost - effective potential for greenhouse gas reductions outside the sectors covered by the ets directive . the partnership contract shall be prepared in dialogue with the commission .


### an analysis of disparities and development needs with reference to the thematic objectives and key actions defined in the common strategic framework and the targets set in the country - specific recommendations under article 121 of the treaty and the relevant council recommendations adopted under article 148 of the treaty ; ### an analysis of disparities and development needs with reference to the thematic objectives and key actions defined in the common strategic framework taking into account any gaps in implementing eu environmental legislation , and the relevant targets set in the country - specific recommendations under article 121 of the treaty and the relevant council recommendations adopted under article 148 of the treaty ;


### the arrangements to ensure an integrated approach to the use of the csf funds for the territorial development of urban , rural , coastal and fisheries areas and areas with particular territorial features , in particular the implementation arrangements for articles 28 , 29 and 99 accompanied , where appropriate , by a list of the cities to participate in the urban development platform referred to in article 8 of the erdf regulation ; ### the arrangements to ensure an integrated approach to the use of the csf funds for the sustainable territorial development of urban , rural , coastal and fisheries areas and areas with particular territorial features , in particular the implementation arrangements for articles 28 , 29 and 99 accompanied , where appropriate , by a list of the cities to participate in the urban development platform referred to in article 8 of the erdf regulation ;


### a description of specific actions to take into account environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management , in the selection of operations ; ### a description of specific actions to take into account environmental protection requirements , resource efficiency , biodiversity protection , ecosystem - based climate change mitigation and adaptation , disaster resilience and risk prevention and management , in the selection of operations ;


### an analysis of the environmental impact , taking into account climate change adaptation and mitigation needs , and disaster resilience ; ### an analysis of the environmental impact , taking into account biodiversity protection , resource efficiency , climate change adaptation and mitigation needs , and disaster resilience ;


### ‘ substantial modification’ : any change to any aspect of the clinical trial which is made after notification of the decision referred to in articles 8 , 14 , 19 , 20 and 23 and which is likely to have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial ; ### ' substantial modification ' : any change to any aspect of the clinical trial , including early termination of the clinical trial and change in number of subjects participating in the trial , which is made after notification of the decision referred to in articles 8 , 14 , 19 , 20 and 23 and which could have a substantial impact on the safety or rights of the subjects , or on the reliability and robustness of the data generated in the clinical trial , i . e . change the interpretation of the scientific documents used to support the conduct of the clinical trial , or if the modifications are otherwise significant .


### within one year from the end of a clinical trial , the sponsor shall submit to the eu database a summary of the results of the clinical trial . ### within one year from the end of a clinical trial , the sponsor shall submit to the eu database a summary of the results of the clinical trial and a clinical study report .


### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with article 1 , point by [ date ] . they shall forthwith communicate to the commission the text of those provisions . ### member states shall bring into force the laws , regulations and administrative provisions necessary to comply with article 1 , point by 12 months after the date of entry into force of this directive . they shall forthwith communicate to the commission the text of those provisions .


### article 3 of directive 2009 / 28 / ec on the promotion of the use of energy from renewable energy sources and amending and subsequently repealing directives 2001 / 777 / ec and 2003 / 30 / ec requires member states to ensure that the share of energy from renewable energy sources in all forms of transport in 2020 is at least 10% of their final energy consumption . the blending of biofuels is one of the methods available for member states to meet this target , and is expected to be the main contributor . ### given the negative climate impact linked to biofuels competing with agricultural land , the obligation under article 3 of directive 2009 / 28 / ec on the promotion of the use of energy from renewable energy sources and amending and subsequently repealing directives 2001 / 777 / ec and 2003 / 30 / ec should be replaced by a requirement on member states to ensure that the share of energy from advanced transport energy sources in all forms of transport in 2020 is at least 3% of their final energy consumption . the blending of advanced biofuels and renewable energy from non - biological origin is one of the methods available for member states to meet this target , and is expected to be the main contributor .


### in view of the union ' s objectives to further reduce greenhouse gas emissions and the significant contribution that road transport fuels make to those emissions , article 7a of directive 98 / 70 / ec relating to the quality of petrol and diesel fuels and amending council directive 93 / 12 / ec requires fuel suppliers to reduce by at least 6% by 31 december 2020 the life cycle greenhouse gas emissions per unit of energy of fuels used in the union by road vehicles , non - road mobile machinery , agricultural and forestry tractors and recreational craft when not at sea . the blending of biofuels is one of the methods available for fossil fuel suppliers to reduce the greenhouse gas intensity of the fossil fuels supplied . ### in view of the union ' s objectives to further reduce greenhouse gas emissions and the significant contribution that road transport fuels make to those emissions , article 7a of directive 98 / 70 / ec relating to the quality of petrol and diesel fuels and amending council directive 93 / 12 / ec [ 1 ] requires fuel suppliers to reduce by at least 6% by 31 december 2020 the life cycle greenhouse gas emissions per unit of energy of fuels used in the union by road vehicles , non - road mobile machinery , agricultural and forestry tractors and recreational craft when not at sea . the blending of zero or low greenhouse gas emissions biofuels and other fuels derived from unavoidable waste gas using carbon capture and utilisation for transport purposes are among the methods available for fossil fuel suppliers to reduce the greenhouse gas intensity of the fossil fuels supplied . in order to ensure investment security for such advanced transport fuels , the 2020 target should be complemented with a binding annual trajectory leading to 10% reductions in greenhouse gas intensity of fuels used in the union in 2025 .


### while considering that the responsibility for the control and surveillance of external borders lies with the member states , the agency shall facilitate and render more effective the application of existing and future european union measures relating to the management of external borders , in particular the schengen borders code , and in accordance with relevant union law , international law , obligations related to access to international protection , and fundamental rights . it shall do so by ensuring the coordination of member states ' actions in the implementation of those measures , thereby contributing to an efficient , high and uniform level of control on persons and surveillance of the external borders of the member states . ### while considering that the responsibility for the control and surveillance of external borders lies with the member states , the agency shall facilitate and render more effective the application of existing and future european union measures relating to the management of external borders , in particular the schengen borders code , as well as of the charter of fundamental rights of the european union and the geneva convention relating to the status of refugees of 1951 , and in accordance with relevant union law , international law , obligations related to access to international protection , and fundamental rights . it shall do so by ensuring the coordination of member states ' actions in the implementation of those measures , thereby contributing to an efficient , high and uniform level of control on persons and surveillance of the external borders of the member states while applying the provisions of the charter of fundamental rights with due regard to respect for and the protection of the human rights of migrants .


### carry out risk analyses , including the evaluation of the capacity of member states to face threats and pressure at the external borders ; ### carry out risk analyses , including the evaluation of the capacity of member states to face threats and pressure at the external borders and incorporate the findings of the un high commissioner for refugees , the un high commissioner for human rights and other non - governmental organisations with relevant expertise in the human rights situation of migrants in countries of transit , especially with regard to the situation of persons in need of international protection , and regularly report to the european parliament , the commission and the member states .


### all border guards and other personnel of the member states , as well as the staff of the agency shall , prior to their participation in operational activities organised by the agency , have received training in relevant eu and international law , including fundamental rights and access to international protection . ### all border guards and other personnel of the member states , as well as the staff of the agency and its liaison officers , shall , prior to their participation in operational activities organised by the agency or , in the case of liaison officers , to their deployment in a third country , have received training in relevant eu and international law , including fundamental rights and access to international protection .


### the agency shall evaluate the results of the joint operations and pilot projects and transmit the detailed evaluation reports within 60 days following the end of the activity to the management board . the agency shall make a comprehensive comparative analysis of those results with a view to enhancing the quality , coherence and efficiency of future operations and projects to be included in its general report provided for in article 20 . ### the agency shall evaluate the results of the joint operations and pilot projects and transmit the detailed evaluation reports within 60 days following the end of the activity to the management board . the agency shall make a comprehensive comparative analysis of those results with a view to enhancing the quality , coherence and efficiency of future operations and projects to be included in its general report provided for in article 20 . the evaluation reports shall cover compliance with fundamental rights of the joint operations and pilot projects , also on the basis of the monitoring carried out by independent observers .


### a reporting and evaluation scheme containing detailed provisions on incident reporting , benchmarks for the evaluation report and final date of submission of the final evaluation report in accordance with article 3 . ### a reporting and evaluation scheme containing detailed provisions on incident reporting , benchmarks for the evaluation report and final date of submission of the final evaluation report in accordance with article 3 . the incident reporting scheme shall include information concerning credible allegations of breaches of , in particular , this regulation or the schengen borders code , including fundamental rights , during joint operations and pilot projects and shall be transmitted by the agency to the relevant public authorities and to the management board .


### regarding sea operations , specific requirements regarding the applicable jurisdiction and maritime law provisions concerning the geographical area where the joint operation takes place . ### regarding sea operations , specific requirements regarding the applicable jurisdiction and maritime law provisions concerning the geographical area where the joint operation takes place . in particular , those requirements shall specify the place of disembarkation , as well as detailed measures regarding the provision of food , shelter , medical care and access to asylum and non - refoulement . they shall allow individuals to explain their circumstances during a personal interview and facilitate access to the asylum procedure through interpretation and legal advice if individuals wish to apply for asylum .


### the agency shall establish and further develop common core curricula for border guards ' training and provide training at european level for instructors of the national border guards of member states , including with regard to fundamental rights and access to international protection . member states shall integrate the common core curricula in the training of their national border guards . ### the agency shall establish and further develop common core curricula for border guards ' training and provide training at european level for instructors of the national border guards of member states , including with regard to fundamental rights and access to international protection . the european parliament shall have full access to the contents of the common core curricula . member states shall integrate the common core curricula in the training of their national border guards . in developing , implementing and evaluating the common core curricula , frontex should work closely with the fundamental rights agency , as well as with unhcr and non - governmental organisations with relevant expertise .


### the code of conduct will in particular pay attention to the obligation set out in article 8 of directive 2008 / 115 / ec to provide for an effective forced - return monitoring system . the monitoring of joint return operations should be carried out independently and should cover the whole joint return operation from the predeparture phase until the hand - over of the returnees in the country of return . furthermore , observations of the monitor , which shall cover the compliance with the code of conduct and in particular fundamental rights , shall be made available to the commission and form part of the internal final return operation report . in order to ensure transparency and a coherent evaluation of the forced - return operations , reports of the monitor shall be included in an annual reporting mechanism . ### the code of conduct will in particular pay attention to the obligation set out in article 8 of directive 2008 / 115 / ec to provide for an effective forced - return monitoring system . the monitoring of joint return operations should be carried out independently and should cover the whole joint return operation from the predeparture phase until the hand - over of the returnees in the country of return . monitors should have access to all relevant facilities , including detention centres and aircraft , and receive the necessary training to perform their duties . furthermore , observations of the monitor , which shall cover the compliance with the code of conduct and in particular fundamental rights , shall be made available to the commission and form part of the internal final return operation report . in order to ensure transparency and a coherent evaluation of the forced - return operations , reports of the monitor shall be included in an annual public reporting mechanism .


### the agency may cooperate with europol , the european asylum support office , the fundamental rights agency , other european union agencies and bodies , and the international organisations competent in matters covered by this regulation in the framework of working arrangements concluded with those bodies , in accordance with the relevant provisions of the treaty and the provisions on the competence of those bodies . ### the agency may cooperate with europol , the european asylum support office , the fundamental rights agency , other european union agencies and bodies , and the international organisations competent in matters covered by this regulation in the framework of working arrangements concluded with those bodies , in accordance with the relevant provisions of the treaty and the provisions on the competence of those bodies . the european parliament shall be informed of any such arrangements concluded by the agency .


### the agency may deploy liaison officers , which should enjoy the highest possible protection to carry out their duties , in third countries . they shall form part of the local or regional cooperation networks of member states ' liaison officers set up pursuant to council regulation no 377 / 2004 . liaison officers shall only be deployed to third countries in which border management practices respect minimum human rights standards . priority for deployment should be given to those third countries , which on the basis of risk analysis constitute a country of origin or transit regarding illegal migration . on a reciprocal basis the agency may receive liaison officers posted by those third countries also , for a limited period of time . the management board shall adopt , on a proposal of the executive director , the list of priorities on a yearly basis in accordance with the provisions of article 24 . . ### the agency may deploy liaison officers , which should enjoy the highest possible protection to carry out their duties , in third countries . they shall form part of the local or regional cooperation networks of member states ' liaison officers set up pursuant to council regulation no 377 / 2004 . liaison officers shall only be deployed to third countries in which border management practices respect fundamental rights and international protection obligations . priority for deployment should be given to those third countries , which on the basis of risk analysis constitute a country of origin or transit regarding illegal migration . on a reciprocal basis the agency may receive liaison officers posted by those third countries also , for a limited period of time . the management board shall adopt , on a proposal of the executive director , the list of priorities on a yearly basis in accordance with the provisions of article 24 .


### the tasks of the liaison officers shall include , in compliance with european union law and in accordance with fundamental rights , the establishment and maintaining of contacts with the competent authorities of the third country to which they are assigned to with a view to contribute to the prevention of and fight against illegal immigration and the return of illegal migrants . ### the tasks of the liaison officers shall include , in compliance with european union law and in accordance with fundamental rights , with special regard to the right of everyone to leave a country , including his or her own , and international protection obligations , with special regard to respect for the principle of non - refoulement , the establishment and maintaining of contacts with the competent authorities of the third country to which they are assigned with a view to contribute to the prevention of and fight against illegal immigration and the return of irregular migrants .


### the agency may benefit from union funding in accordance with the provisions of the relevant instruments supporting the union ' s external relations policy . it may launch and finance technical assistance projects in third countries regarding matters covered by this regulation . the agency may also invite representatives of third countries , other european union agencies and bodies or international organisations to participate in its activities referred to in articles 3 , 4 and 5 . these representatives shall receive the appropriate training from the agency prior to their participation . ### the agency may benefit from union funding in accordance with the provisions of the relevant instruments supporting the union ' s external relations policy . it may launch and finance technical assistance projects in third countries regarding matters covered by this regulation . the agency shall ensure that assistance to operations within the framework of these projects is not provided to third countries where there are reasons to believe that such operations could lead to violations of fundamental rights . the agency may also invite representatives of third countries , other european union agencies and bodies or international organisations to participate in its activities referred to in articles 3 , 4 and 5 . these representatives shall receive the appropriate training from the agency prior to their participation , in particular in relation to fundamental rights .


### when concluding bilateral agreements with third countries as referred to in article 2 member states shall , where appropriate , include provisions concerning the role and competencies of the agency , in particular regarding the exercise of executive powers by members of the teams deployed by the agency during the activities referred to in article 3 . ### when concluding bilateral agreements with third countries as referred to in article 2 member states shall , where appropriate , include provisions concerning the role and competencies of the agency , in particular regarding the exercise of executive powers by members of the teams deployed by the agency during the activities referred to in article 3 . the text of these bilateral agreements shall be transmitted to the european parliament and the commission .


### the agency may cooperate with the authorities of third countries competent in matters covered by this regulation in the framework of working arrangements concluded with these authorities , in accordance with the relevant provisions of the treaty . ### the agency may cooperate with the authorities of third countries competent in matters covered by this regulation in the framework of working arrangements concluded with these authorities , in accordance with the relevant provisions of the treaty and in particular of the charter of fundamental rights and international law , with special regard to respect for the non - refoulement principle . those arrangements shall guarantee compliance with international human rights and humanitarian law by third countries . a human rights assessment , including the right to seek asylum , shall be carried out prior to the conclusion of such working arrangements and shall be reported to the european parliament and the commission .


### the evaluation shall include a specific analysis on the way the charter of fundamental rights was respected pursuant to the application of the regulation . ### the evaluation shall include a specific analysis of the way in which the rights enshrined in the charter of fundamental rights were guaranteed pursuant to the application of this regulation . that analysis shall be carried out in cooperation with the fundamental rights agency , and include the participation of unhcr and non - governmental organisations with relevant expertise . an annual evaluation of that analysis shall be annexed to the general report of frontex .


### the planning of pharmacovigilance for each individual medicinal product by the marketing authorisation holder should take place in the context of a risk management system and should be proportionate to the identified risks , potential risks , and the need for additional information on the medicinal product . it should also be foreseen that any key measures contained in a risk management system are included in the marketing authorisation as conditions . ### the planning of pharmacovigilance for each individual medicinal product by the marketing authorisation holder should take place in the context of a risk management system and should be proportionate to the identified risks , potential risks , and the need for additional information on the medicinal product . it should also be foreseen that any key measures contained in a risk management system are included in the marketing authorisation as conditions . if the conditions included in the marketing authorisation are not fulfilled within the corresponding deadline , the competent authorities should have the power and appropriate resources to immediately suspend or revoke the marketing authorisation .


### where a medicinal product is authorized subject to the requirement to conduct a post - authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be intensively monitored on the market . patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products , and a publicly available list of such medicinal products should be maintained up to date by the european medicines agency established by regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency . ### where , in the case of an unmet medical need , a medicinal product is authorized subject to the requirement to conduct a post - authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product , the medicinal product should be intensively monitored on the market . patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products , which should be identified by a specific symbol on the outer packaging and by a corresponding explanatory sentence in the leaflet , and a publicly available list of such medicinal products should be maintained up to date by the european medicines agency established by regulation no 726 / 2004 of the european parliament and of the council of 31 march 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a european medicines agency .


### in order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use , the summary of the product characteristics and the package leaflet should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits . ### within five years of the entry into force of this directive , the commission shall , following consultations with patient and consumer organisations , health care professional organisations , member states and other interested parties , present to the european parliament and the council an assessment report regarding the readability of the summaries of product characteristics and the packaging leaflets . following an analysis of such data , the commission shall , if appropriate , put forward proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and health care professionals .


### to further increase the coordination of resources between the member states , member state should be authorised to delegate certain pharmacovigilance tasks to another member state . ### each member state should be responsible for the oversight of the adverse reactions occurring in its territory . to further increase the level of expertise in pharmacovigilance , member states should be encouraged to organise training and to regularly exchange information and expertise .


### in order to increase the level of transparency on the processes of pharmacovigilance , the member states should create and maintain medicines safety web - portals . to the same end , the marketing authorisation holders should provide the authorities with prior warning about safety announcements and the authorities should provide each other with such a warning . ### in order to increase the level of transparency on the processes of pharmacovigilance , the member states should create and maintain medicines safety web - portals . the marketing authorisation holders should be required to submit to the authorities the safety announcements which they plan to disseminate for prior authorisation . without delay following such a request , the authorities should provide each other with a prior warning about these safety announcements .


### in order to protect public health , there should be adequate funding of activities related to pharmacovigilance by the national competent authorities . it should be possible to ensure adequate funding for pharmacovigilance activities through the collection of fees . however , the management of those collected funds should be under the permanent control of the national competent authorities in order to guarantee their independence . ### in order to protect public health , there should be adequate funding of activities related to pharmacovigilance by the national competent authorities .


### post - authorisation safety study : any study with an authorised medicinal product conducted with the aim of identifying , characterising or quantifying a safety hazard , confirming the safety profile of the medicinal product , or of measuring the effectiveness of risk management measures . ” ; ### post - authorisation pharmacovigilance study : any study with a medicinal product authorised early for reasons of public health in the absence of a therapeutic alternative , or carried out at the request of the health authorities once a medicinal product has been placed on the market , with the aim of identifying , characterising or quantifying an adverse reaction risk or of assessing the adverse reaction profile of the medicinal product and its risk / benefit balance , or of measuring the effectiveness of risk management measures ;


### risk management system : a set of pharmacovigilance activities and interventions designed to identify , characterise , prevent or minimise risks relating to a medicinal product , including the assessment of the effectiveness of those interventions . ### risk management system : a set of specific pharmacovigilance activities and interventions designed to quantify or prevent risks relating to a medicinal product , including the assessment of the effectiveness of those interventions , or to ensure early identification of new risks .


### pharmacovigilance system : a system utilized by marketing authorisation holders and by member states to fulfil the tasks and responsibilities listed in title ix and designed to monitor the safety of authorised medicinal products and detect any change to their risk - benefit balance . ### pharmacovigilance system : a system allowing marketing authorisation holders and member states , with a view to fulfilling the tasks and responsibilities listed in title ix : to collect information useful in the surveillance of medicinal products , with particular reference to adverse reactions in human beings , including misuse and abuse of medicinal products and medication errors ; and to evaluate such information scientifically in order to detect any change to the benefit - risk balance of authorised medicinal products .


### for the purposes of point of the first subparagraph , for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the summary shall include the statement : “this medicinal product is under intensive monitoring . all suspected adverse reactions should be reported to . &#8221 ; ### for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the leaflet shall include the statement : “this newly authorised medicinal product is under intensive monitoring in order to increase knowledge on its adverse reactions . all suspected adverse reactions should be reported to &#8221 ; . the statement shall be accompanied by an inverted black triangle &#61553 ; . the black triangle shall also appear on the outer packaging .


### the national competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre - clinical tests , the clinical trials and the risk management system and the pharmacovigilance system of the medicinal product concerned . the assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality , safety or efficacy of the medicinal product concerned . ### the national competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre - clinical tests , the clinical trials and the risk management system and the pharmacovigilance system of the medicinal product concerned . the assessment report shall detail the natural development of the disease , existing treatments for the indication requested , where appropriate , and whether the medicinal product produces tangible therapeutic progress in comparison with existing treatments . the assessment report shall be updated whenever new information becomes available which is of importance for the evaluation of the quality , safety or efficacy of the medicinal product concerned .


### a marketing authorisation may be granted subject to one or more of the following conditions : to take certain measures for the safe use of the medicinal product contained in the risk management system ; to conduct post - authorisation safety studies ; to comply with requirements on adverse reaction recording or reporting which are stricter than those referred to in title ix ; any other conditions or restrictions with regard to the safe and effective use of the medicinal product . the marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary . ### if the medicinal product responds to unmet medical needs and if its risk - benefit balance may be considered positive , a marketing authorisation may be granted subject to one or more of the following conditions : to take certain measures for the safe use of the medicinal product contained in the risk management system ; to conduct post - authorisation safety studies ; to comply with requirements on adverse reaction recording or reporting which are stricter than those referred to in title ix ; any other conditions or restrictions with regard to the safe and effective use of the medicinal product . the marketing authorisation shall lay down deadlines for the fulfilment of the conditions where necessary . if the conditions included in the marketing authorisation are not fulfilled within the corresponding deadline , the competent authorities shall have the power and appropriate resources to immediately suspend or revoke the marketing authorisation .


### in order that the risk - benefit balance may be continuously assessed , the national competent authority may at any time ask the holder of the marketing authorisation to forward data demonstrating that the risk - benefit balance remains favourable . ### in order that the risk - benefit balance may be continuously assessed , the national competent authority may at any time ask the holder of the marketing authorisation and its pharmacovigilance system to forward the data necessary for a reassessment of the risk - benefit balance .


### a coordination group shall be set up for the following purposes : the examination of any question relating to a marketing authorisation of a medicinal product in two or more member states in accordance with the procedures laid down in chapter 4 ; the examination of questions related to the pharmacovigilance of medicinal products authorised by the member states , in accordance with articles 107c , 107e , 107g , 107l and 107r ; the examination of questions related to the variations to the terms of marketing authorisations granted by the member states , in accordance with article 35 . the agency shall provide the secretariat of this coordination group . for the fulfilment of its pharmacovigilance tasks , the coordination group shall be assisted by the pharmacovigilance risk assessment advisory committee referred to in article 56 of regulation no 726 / 2004 . ### two coordination groups shall be set up : a coordination group for mutual recognition and decentralised procedures shall be responsible for the following tasks : the examination of any question relating to a marketing authorisation of a medicinal product in two or more member states in accordance with the procedures laid down in chapter 4 ; the examination of questions related to the variations to the terms of marketing authorisations granted by the member states , in accordance with article 35 , with the exception of all questions relating to pharmacovigilance . for the fulfilment of its tasks , the coordination group for mutual recognition and decentralised procedures shall be assisted by the committee for medicinal products for human use referred to in article 5 of regulation no 726 / 2004 . a coordination group for pharmacovigilance risk assessment shall be responsible for the following tasks : the examination of questions related to the pharmacovigilance of medicinal products authorised by the member states , in accordance with articles 107c , 107e , 107g , 107l and 107r ; ii ) the examination of questions related to the variations to the terms of marketing authorisations granted by the member states , in accordance with article 35 , for all questions relating to pharmacovigilance . for the fulfilment of its pharmacovigilance tasks , the coordination group for pharmacovigilance risk assessment shall be assisted by the european pharmacovigilance committee referred to in article 56 of regulation no 726 / 2004 . the agency shall provide the secretariat for these coordination groups .


### for the fulfilment of its pharmacovigilance tasks , the coordination group shall be assisted by the pharmacovigilance risk assessment advisory committee referred to in article 56 of regulation no 726 / 2004 . ### for the fulfilment of its pharmacovigilance tasks , the coordination group shall be assisted by the pharmacovigilance committee referred to in article 56 of regulation no 726 / 2004 .


### members of the coordination group and experts shall , for the fulfilment of their tasks , rely on the scientific and regulatory resources available to national marketing authorisation bodies . each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts . article 63 of regulation no 726 / 2004 shall apply to the coordination group as regards the transparency and independence of its members . ### members of the coordination groups and experts shall , for the fulfilment of their tasks , rely on the scientific and regulatory resources available to the national bodies responsible for , respectively , issuing marketing authorisations and pharmacovigilance . each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts . article 63 of regulation no 726 / 2004 shall apply to the coordination groups as regards the transparency and independence of their members . a member of a coordination group can only be a member of one of these groups at a time . the members of the coordination group for pharmacovigilance risk assessment shall be hierarchically independent of the national marketing authorisation bodies .


### the information referred to in point of the first subparagraph shall be presented in a box surrounded by a black border . any new or amended text shall for a period of 1 - year be presented in bold text and preceded by the following symbol and text ' new information ' . for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the following additional statement shall be included “this medicinal product is under intensive monitoring . all suspected adverse reactions should be reported to ' . ### new important safety warnings shall for a period of 1 - year be presented in bold text and preceded by the following symbol and the following text ' new important safety warnings ' . for medicinal products included on the list referred to in article 23 of regulation no 726 / 2004 , the following additional statement shall be included “this newly authorised medicinal product is under intensive monitoring in order to increase knowledge of its adverse reactions . all suspected adverse reactions should be reported to . &#8221 ; the statement shall be accompanied by an inverted black triangle . the black triangle shall also appear on the outer packaging .


### the member states shall : take all appropriate measures to encourage doctors , pharmacists and other health - care professionals to report suspected adverse reactions to the national competent authority or the marketing authorisation holder ; ensure that adverse reaction reports contain the highest quality information possible ; through the methods of collecting information and where necessary through the follow up of adverse reaction reports , ensure that any biological medicinal product prescribed , dispensed , or sold in their territory which is the subject of an adverse reaction report is identifiable ; take the necessary measures to ensure that a marketing authorisation holder who fails to discharge the obligations laid down in this title is subject to effective , proportionate and dissuasive penalties . for the purposes of point of the first paragraph the member states may impose specific requirements on doctors , pharmacists and other health - care professionals in respect of the reporting of suspected serious or unexpected adverse reactions . ### the member states shall : take all appropriate measures to encourage doctors , pharmacists and other health - care professionals to report suspected adverse reactions to the national competent authority and the marketing authorisation holder ; conduct public awareness campaigns on the importance of reporting adverse reactions ; ensure that adverse reaction reports and the databases contain the highest quality information possible ; through the methods of collecting information and where necessary through the follow up of adverse reaction reports , ensure that any biological medicinal product prescribed , dispensed , or sold in their territory which is the subject of an adverse reaction report is identifiable ; ensure that the public is given important information in good time on pharmacovigilance concerns relating to the use of a medicinal product and has permanent access to the data ; take the necessary measures to ensure that a marketing authorisation holder who fails to discharge the obligations laid down in this title is subject to effective , proportionate and dissuasive penalties . for the purposes of point of the first paragraph the member states may impose specific requirements on doctors , pharmacists and other health - care professionals in respect of the reporting of suspected serious or unexpected adverse reactions .


### each member state shall set up and maintain a national medicines safety web - portal which shall be linked to the european medicines safety web - portal established in accordance with article 26 of regulation no 726 / 2004 . by means of the national medicines safety web - portals , the member states shall make public at least the following : risk management systems for medicinal products authorised in accordance with this directive ; the list of medicinal products under intensive monitoring referred to in article 23 of regulation no 726 / 2004 ; web - based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in article 25 of regulation no 726 / 2004 . ### each member state shall set up and maintain a national medicines web - portal , including a dedicated medicine safety web page , which shall be linked to the european medicines safety web - portal established in accordance with article 26 of regulation no 726 / 2004 . by means of the national medicines web - portals , the member states shall make public at least the following : the leaflets for the medicines available on the national market in the national language ; the summary of the product characteristics and any conditions established in accordance with articles 21a , 22 and 22a , together with any deadlines for their fulfilment , for each medicinal product which they have authorised ; the assessment reports together with the periodic safety update reports submitted by marketing authorisation holders to the health authorities ; detailed descriptions of risk management systems , and detailed protocols for post - authorisation studies for medicinal products authorised in accordance with this directive ; the list of medicinal products under intensive monitoring referred to in article 23 of regulation no 726 / 2004 ; web - based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in article 25 of regulation no 726 / 2004 ; agendas for meetings of the pharmacovigilance committee and of the coordination group and records of their meetings , accompanied by the decisions taken and by details and explanations of the votes , including minority opinions ; requests from the national competent authority to the marketing authorisation holder to operate a risk management system or to conduct a post - authorisation study , together with the explanations provided by the marketing authorisation holder to the national competent authority where necessary , and the final decision of the competent authority .


### marketing authorisation holders shall be required to record all suspected adverse reactions in the community or in third countries which are brought to their attention , whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post - authorisation safety study . marketing authorisation holders shall be required to ensure that those reports are accessible at a single point within the community . by way of derogation to the first subparagraph , suspected adverse reactions occurring in the context of a clinical trial shall be recorded and reported in accordance with directive 2001 / 20 / ec . 2 . the marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically from patients and health - care professionals . 3 . marketing authorisation holders shall be required to submit electronically to the database and data - processing network referred to in article 24 of regulation no 726 / 2004 information on all serious suspected adverse reactions that occur in the community and in third countries within 15 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . marketing authorisation holders shall be required to submit electronically to the eudravigilance database information on all non - serious suspected adverse reactions that occur in the community , within 90 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . for medicinal products containing the active substances referred to in the list of publications monitored by the agency pursuant to article 27 of regulation no 726 / 2004 , marketing authorisation holders shall not be required to report to the eudravigilance database the suspected adverse reactions recorded in the listed medical literature , but they shall monitor all other medical literature and report any suspected adverse reactions . 4 . member states shall access reports on adverse reactions through the eudravigilance database and shall assess the quality of the data received from marketing authorisation holders . they shall , as appropriate , involve patients and health - care professionals in the follow up of any reports they receive and request follow up of such reports to be conducted by the marketing authorisation holders . the marketing authorisation holders shall be required to report any follow up information received to the eudravigilance database . ### marketing authorisation holders shall be required to record all suspected adverse reactions in the community or in third countries which are brought to their attention , whether reported spontaneously by patients or healthcare professionals or occurring in the context of a clinical trial or a post - authorisation safety study . suspected adverse reactions occurring in the context of a clinical trial shall also be recorded and reported in accordance with directive 2001 / 20 / ec . 2 . the marketing authorisation holder shall forward to the national competent authorities any reports of suspected adverse reactions received from patients and health - care professionals within 7 days of receiving the reports . the marketing authorization holder shall inform the patient and healthcare professional that their report has been forwarded to the competent authorities who will be in charge of following it up . the national competent authorities may not refuse any reports of suspected adverse reactions received by post , telephone , facsimile transmission or in electronic format from patients and healthcare professionals . 3 . marketing authorisation holders shall be required to submit electronically to the national competent authorities information on all serious suspected adverse reactions that occur in the community and in third countries within 15 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . marketing authorisation holders shall be required to submit electronically to the national competent authorities information on all non - serious suspected adverse reactions that occur on the markets in which they operate , within 45 days following the receipt of the report or , in the absence of a report , following the day on which the holder concerned gained knowledge of the event . for medicinal products containing the active substances referred to in the list of publications monitored by the agency pursuant to article 27 of regulation no 726 / 2004 , marketing authorisation holders shall not be required to report to the eudravigilance database the suspected adverse reactions recorded in the listed medical literature , but they shall monitor all other medical literature and report any suspected adverse reactions . 4 . member states shall assess the quality of the data received from marketing authorisation holders . they shall , as appropriate , involve patients and health - care professionals in the follow up of any reports they receive .


### the member states shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals and patients . member states shall ensure that reports of such reactions are submitted by means of the national medicines safety web - portals . 2 . member states shall , within 15 days following the receipt of the reports referred to in paragraph 1 , submit the reports electronically to the eudravigilance database . marketing authorisation holders shall access those reports through the eudravigilance database . 3 . the member states shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the eudravigilance database and to any authorities responsible for patient safety within that member state . they shall also ensure that the authorities responsible for medicinal products within that member state are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that member state . ### the member states shall record all suspected adverse reactions that occur in their territory which are brought to their attention by healthcare professionals , patients , marketing authorisation holders and programmes for the reporting and prevention of medication errors . member states shall ensure that reports of such reactions can be submitted by means of the national medicines safety web - portals , as well as by mail , telephone and fax . 2 . member states shall , within 15 days following the receipt of the reports referred to in paragraph 1 , submit electronically to the database and data - processing network referred to in article 24 of regulation no 726 / 2004 information on all adverse reactions that occur within their territory within 15 days following the receipt of the report or , in the absence of a report , following the day on which the competent authority gained knowledge of the event . marketing authorisation holders , healthcare professionals and the public shall access those reports through the eudravigilance database , which must be permanently accessible without delay . 3 . the member states shall ensure that reports of medication errors brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the eudravigilance database , to any authorities responsible for patient safety within that member state and to independent programmes for the reporting and prevention of medication errors . they shall also ensure that the authorities responsible for medicinal products within that member state are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that member state .


### following consultation with the agency , member states and interested parties , the commission shall adopt and make public guidelines on good pharmacovigilance practice for medicinal products authorised in accordance with article 6 in the following areas : the establishment and operation of the pharmacovigilance system by the marketing authorisation holder and the content and maintenance of the pharmacovigilance system master file ; quality assurance and quality control by the marketing authorisation holder , the national competent authorities and the agency of their performance of pharmacovigilance activities . the use of internationally agreed terminologies , formats and standards for the conduct of pharmacovigilance ; the methodology for the monitoring of data in the eudravigilance database to determine whether there are new or changed risks ; the format of electronic reporting of adverse reactions by member states and marketing authorisation holders ; the format of electronic periodic safety update reports ; the format of protocols , abstracts and final study reports for the post - authorisation safety studies ; the procedures and formats for pharmacovigilance communications . those guidelines shall take account of international harmonisation work carried out in the field of pharmacovigilance and shall where necessary be revised to take account of technical and scientific progress . ### following consultation with the agency , member states and interested parties , the commission shall adopt and make public guidelines on good pharmacovigilance practice for medicinal products authorised in accordance with article 6 in the following areas : the establishment and operation of the pharmacovigilance system by the marketing authorisation holder and the content and maintenance of the pharmacovigilance system master file ; quality assurance and quality control by the marketing authorisation holder , the national competent authorities and the agency of their performance of pharmacovigilance activities . the use of internationally agreed terminologies , formats and standards for the conduct of pharmacovigilance allowing the clinical significance of reported case to be preserved ; the methodology for the monitoring of data in the eudravigilance database to determine whether there are new or changed risks ; the format of electronic reporting of adverse reactions by member states and marketing authorisation holders ; the format of electronic periodic safety update reports ; the format of protocols , abstracts and final study reports for the post - authorisation safety studies ; the procedures and formats for pharmacovigilance communications . those guidelines shall be based on patient needs from a scientific perspective , shall take account of international harmonisation work carried out in the field of pharmacovigilance and shall where necessary be revised to take account of technical and scientific progress .


### with regard to the requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectively in the summary of the product characteristics and the package leaflet provided for in point 3a of article 11 and in point of article 59 of directive 2001 / 83 / ec as amended by this directive , the member states shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of article 3 of this directive from renewal of that authorisation or from the expiry of a period of three years starting from that date , whichever is the earliest . ### with regard to the requirement for the inclusion of the medicinal product ' s adverse reaction profile in the summary of the product characteristics and the package leaflet provided for in point 3a of article 11 and in point of article 59 of directive 2001 / 83 / ec as amended by this directive , the member states shall ensure that the requirement applies to a marketing authorisation granted before the date set out in the second subparagraph of article 3 of this directive from renewal of that authorisation or from the expiry of a period of three years starting from that date , whichever is the earliest .


### subject to the agreement of the competent authorities concerned and of the notifier , the information and documents listed in paragraph 1 may be submitted and exchanged by means of electronic data interchange with electronic signature or electronic authentication in accordance with directive 1999 / 93 / ec of the european parliament and of the council of 13 december 1999 on a community framework for electronic signatures* , or a comparable electronic authentication system which provides the same level of security . in such cases , organisational arrangements concerning the flow of electronic data interchange may be made . _____________ * oj l 13 , 19 . 1 . 2000 , p . 12 . ### article 26 , paragraph 4 is replaced by the following : ' 4 . subject to the agreement of the competent authorities concerned and of the notifier , the information and documents listed in paragraph 1 may be submitted and exchanged by means of electronic data interchange with electronic signature or electronic authentication in accordance with directive 1999 / 93 / ec of the european parliament and of the council* , or a comparable electronic authentication system which provides the same level of security . in such cases , organisational arrangements concerning the flow of electronic data interchange may be made . as soon as the technical and organisational requirements for the practical implementation of the electronic data interchange have been adopted pursuant to article 26 , the information and documents listed in paragraph 1 shall be submitted and exchanged by means of electronic data interchange with electronic signature or electronic authentication in accordance with directive 1999 / 93 / ec , or a comparable electronic authentication system which provides the same level of security . _______________ * directive 1999 / 93 / ec of the european parliament and of the council of 13 december 1999 on a community framework for electronic signatures '


### the commission shall be empowered to adopt delegated acts in accordance with article 59 concerning technical and organisational requirements for the practical implementation of electronic data interchange for the submission of documents and information . ### the commission shall adopt delegated acts in accordance with article 59 concerning technical and organisational requirements for the practical implementation of electronic data interchange for the submission of documents and information no later than . . . * . the commission shall be empowered to adopt delegated acts in accordance with article 59 concerning the update of these technical and organisational requirements . __________ * oj : please insert the date : 18 months after the entry into force of this regulation


### ' 5 . member states shall cooperate , bilaterally or multilaterally , with one another in order to facilitate the prevention and detection of illegal shipments . ' ### paragraph 5 is replaced by the following : ' 5 . member states shall cooperate , bilaterally and multilaterally , with one another in order to facilitate the prevention and detection of illegal shipments . they shall exchange information on waste shipments , waste flows , operators and facilities and share experience and knowledge on enforcement measures , including the names of illegal operators , establishments and undertakings . the commission shall create a common platform that includes all member states for these purposes . '


### ' information on spot checks on shipments of waste or on the related recovery or disposal number of checks on shipments of waste or on the related recovery or disposal : number of supposed illegal shipments ascertained during these checks : additional remarks : ' ### in annex ix , the description of the information to be provided pursuant to article 50 shall be replaced by the following : ' information on inspections number of inspections of establishments and undertakings , shipments of waste , related actors and the related recovery or disposal , respectively : number of physical checks of establishments and undertakings , shipments of waste , related actors and related recovery or disposal , respectively : number of establishments and undertakings that did not act in accordance with this regulation , illegal shipments of waste , illegal activities by related actors and illegal related recovery or disposal , respectively : additional remarks : '


### the implementation plan agreed by the world summit on sustainable development at johannesburg in 2002 states that all commercial stocks should be restored to levels that can produce maximum sustainable yield by 2015 . ices deems that for the baltic salmon river stocks this level corresponds to a smolt production level between 60% and 75 % of the potential smolt production capacity for the different wild salmon rivers . such scientific advice should constitute the basis for setting the objectives and targets of the multiannual plan . ### the implementation plan agreed by the world summit on sustainable development at johannesburg in 2002 states that all commercial stocks should be restored to levels that can produce maximum sustainable yield by 2015 . this has been a legal requirement under united nations convention on the law of the sea since 1994 . ices deems that for the baltic salmon river stocks this level corresponds to a smolt production level between 60% and 75 % of the potential smolt production capacity for the different wild salmon rivers . such scientific advice should constitute the basis for setting the objectives and targets of the multiannual plan .


### recent scientific advice indicates that recreational salmon fisheries at sea have a significant impact on the salmon stocks , even though the data quality in this regard is not at a high precision level . in particular , recreational fisheries carried out from vessels operated by undertakings offering their services for profit can potentially account for an important part of catches of baltic salmon . hence , it is appropriate for the functioning of the multiannual plan to introduce certain specific management measures to control such activities . ### recent scientific advice indicates that recreational salmon fisheries have a significant impact on the salmon stocks , even though the data quality in this regard is not at a high precision level . hence , it is appropriate for the functioning of the multiannual plan to introduce certain specific management measures to control such recreational fishing activities .


### recreational fisheries of salmon in the baltic sea where such fisheries are conducted by service vessels . ### recreational fisheries of salmon in the baltic sea and in the member states concerned .


### for wild salmon rivers which have not reached 50 % of the potential smolt production capacity by the time of the entry into force of this regulation , the wild smolt production shall reach 50% of the potential smolt production capacity for each river in five years and 75 % in ten years after the entry into force of this regulation . ### for wild salmon rivers which have not reached 50 % of the potential smolt production capacity by the time of the entry into force of this regulation , the wild smolt production shall reach 50 % of the potential smolt production capacity for each river in five years and 80 % in ten years after the entry into force of this regulation .


### stocking of salmon may only be conducted in wild salmon river . the number of released smolts in each river shall not exceed the estimated potential smolt production capacity of the river . ### stocking of salmon may only be conducted in wild salmon rivers when required to prevent the extermination of the local stock .


### by way of derogation from article 14 of regulation 1224 / 2009 masters of european union fishing vessels of all length holding a fishing authorisation for salmon shall keep a logbook of their operations in accordance with the rules set in article 14 of regulation no 1224 / 2009 . ### by way of derogation from article 14 of regulation 1224 / 2009 masters of european union fishing vessels of all lengths holding a fishing authorisation for salmon , as well as masters of european union service vessels , shall keep a logbook of their operations in accordance with the rules set in article 14 of regulation no 1224 / 2009 .


### by way of derogation from the introductory sentence of article 17 of regulation 1224 / 2009 , masters of european union fishing vessels of all length retaining salmon and / or sea trout on board shall notify the competent authorities of their flag member state immediately after the completion of the fishing operation of the information listed in article 17 of regulation 1224 / 2009 . ### by way of derogation from the introductory sentence of article 17 of regulation 1224 / 2009 , masters of european union fishing vessels of all length , as well as masters of european union service vessels , retaining salmon and / or sea trout on board shall notify the competent authorities of their flag member state immediately after the completion of the fishing operation of the information listed in article 17 of regulation 1224 / 2009 .


### where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be the person entitled to submit an application , no action shall be taken by the customs authorities . the decision granting the application shall be revoked or amended accordingly by the customs authorities that granted the decision . ### where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be the person entitled to submit an application , the applicant shall notify the customs authorities thereof and no further action shall be taken by the customs authorities . the decision granting the application shall be revoked or amended accordingly by the customs authorities that granted the decision .


### where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be the person entitled to submit an application , no action shall be taken by the customs authorities . the decision granting the extension shall be revoked or amended accordingly by the customs authorities that granted the decision . ### where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be the person entitled to submit an application , the applicant shall notify the customs authorities thereof and no further action shall be taken by the customs authorities . the decision granting the extension shall be revoked or amended accordingly by the customs authorities that granted the decision .


### when charging for the cost of noise effects is allowed by union legislation for road freight transport , the infrastructure charges shall be modified to take account of the cost of noise effects caused by the operation of the train in accordance with annex viii , point 2 . ### infrastructure charges shall be modified to take account of the cost of noise effects caused by the operation of the train in accordance with annex viii , point 2 . these modifications shall be revenue neutral as long as the member state of the infrastructure in question does not apply noise charging for the road sector .


### the commission and representatives of the regulatory bodies , which co - operate according to article 57 , shall be informed of and invited to attend as observers all meetings at which common principles and practices for the allocation of infrastructure are developed . in the case of it - based allocation systems , the regulatory bodies shall receive sufficient information from these systems to allow them to perform their regulatory supervision in accordance with the provisions of article 56 . ### the commission and representatives of the regulatory bodies , which co - operate according to article 57 , shall be informed of common principles and practices for the allocation of infrastructure . in the case of it - based allocation systems , the regulatory bodies shall receive sufficient information from these systems to allow them to perform their regulatory supervision in accordance with the provisions of article 56 .


### the strategic planning and harmonisation of spectrum use at union level should enhance the single market for wireless electronic communications services and equipment as well as other union policies requiring spectrum use , thus creating new opportunities for innovation and contributing to economic recovery and social integration across the union , while at the same time respecting the important social , cultural and economic value of spectrum . to this end , the union therefore needs a policy programme that covers the internal market in all union policy areas involving the use of spectrum such as electronic communications , research and development , transport and energy . ### the strategic planning and harmonisation of spectrum use at union level should enhance the single market for wireless electronic communications services and equipment as well as other union policies requiring spectrum use , thus creating new opportunities for innovation and contributing to economic recovery and social integration across the union , while at the same time respecting the important social , cultural and economic value of spectrum . the harmonisation of spectrum use is also essential to ensure the quality of the services provided by electronic communications and to create economies of scale lowering both the cost of deploying wireless networks and the cost of wireless devices for consumers . to this end , the union therefore needs a policy programme that covers the internal market in all union policy areas involving the use of spectrum such as electronic communications , research and development , transport and energy .


### optimal and efficient spectrum use requires continuous monitoring of developments , and up - to - date transparent information on spectrum use throughout the union . while commission decision 2007 / 344 / ec on harmonised availability of information regarding spectrum use within the community6 requires member states to publish information on usage rights , a detailed inventory of existing spectrum use together with an effective review and assessment methodology are necessary in the union to improve the efficiency of spectrum and radio equipment use , in particular between 300 mhz and 3 ghz . this would help to identify inefficient technologies and usages in both the commercial and public sectors , as well as unused assignments and sharing opportunities , and to evaluate future consumer and business needs . ### optimal and efficient spectrum use requires continuous monitoring of developments , and up - to - date transparent information on spectrum use throughout the union . while commission decision 2007 / 344 / ec on harmonised availability of information regarding spectrum use within the community6 requires member states to publish information on usage rights , a detailed inventory of existing spectrum use and the efficiency thereof , following a common review and assessment methodology , is necessary in the union to improve the efficiency of spectrum and radio equipment use , in particular between 300 mhz and 3 ghz . the inventory should be sufficiently detailed to identify inefficient technologies and usages in both the commercial and public sectors , as well as unused assignments and sharing opportunities , and to evaluate future consumer and business needs .


### protection of public health against electromagnetic fields is essential for citizens ‘ well - being and for a coherent approach to spectrum authorisation in the union ; while subject to council recommendation 1999 / 519 / ec on the limitation of exposure of the general public to electromagnetic fields , it is essential to ensure constant monitoring of the ionising and non - ionising effects of spectrum use on health , including the real - life cumulative effects of spectrum use in various frequencies by an increasing number of equipment types . ### protection of public health against electromagnetic fields is essential for citizens ' wellbeing and for a coherent approach to spectrum authorisation in the union ; while subject to council recommendation 1999 / 519 / ec on the limitation of exposure of the general public to electromagnetic fields , it is essential to attain a better understanding of the responses of living organisms to electromagnetic fields and to ensure constant monitoring of the ionising and non - ionising effects of spectrum use on health , including the real - life cumulative effects of spectrum use in various frequencies by an increasing number of equipment types .


### member states and the commission shall cooperate to develop and harmonise standards for radio equipment and telecommunications terminals as well as for electric and electronic equipment and networks based where necessary upon standardisation mandates from the commission to the relevant standardisation bodies ### member states and the commission shall cooperate to develop and harmonise standards for radio equipment and telecommunications terminals as well as for electric and electronic equipment and networks based where necessary upon standardisation mandates from the commission to the relevant standardisation bodies . special attention shall also be given to standards for equipment to be used by disabled people , without depriving them of the right to use non - standardised equipment if that is their preference .


### this regulation does not address issues of protection of fundamental rights and freedoms or the free flow of data related to activities which fall outside the scope of union law , nor does it cover the processing of personal data by the union institutions , bodies , offices and agencies , which are subject to regulation no 45 / 2001 , or the processing of personal data by the member states when carrying out activities in relation to the common foreign and security policy of the union . ### this regulation does not address issues of protection of fundamental rights and freedoms or the free flow of data related to activities which fall outside the scope of union law , nor does it cover the processing of personal data by the union institutions , bodies , offices and agencies , which are subject to regulation no 45 / 2001 of the european parliament and of the council of 18 december 2000 on the protection of individuals with regard to the processing of personal data by the community institutions and bodies and on the free movement of such data , or the processing of personal data by the member states when carrying out activities in relation to the common foreign and security policy of the union . in order to ensure a coherent data protection framework , regulation no 45 / 2001 should be brought into line with this regulation .


### this regulation should not apply to processing of personal data by a natural person , which are exclusively personal or domestic , such as correspondence and the holding of addresses , and without any gainful interest and thus without any connection with a professional or commercial activity . the exemption should also not apply to controllers or processors which provide the means for processing personal data for such personal or domestic activities . ### this regulation should not apply to processing of personal data by a natural person , which is exclusively personal or domestic , such as correspondence , the holding of addresses or the personal use of certain electronic services . the exemption should not apply where the processing of personal data is done in pursuit of a professional or commercial objective . the nature of the personal data processed and whether it is available to a definite or indefinite number of persons shall be taken into account in determining whether the processing falls within the exemption . the exemption should also not apply to controllers or processors which provide the means for processing personal data for such personal or domestic activities .


### this regulation allows the principle of public access to official documents to be taken into account when applying the provisions set out in this regulation . ### this regulation allows the principle of public access to official documents to be taken into account when applying the provisions set out in this regulation . personal data in documents held by a public authority or public body may be disclosed by that authority or body in accordance with union or member state law regarding public access to official documents , if it is necessary for reconciling the right to data protection with the right of public access to official documents and constitutes a fair balance of the various interests involved .


### in order to ensure that individuals are not deprived of the protection to which they are entitled under this regulation , the processing of personal data of data subjects residing in the union by a controller not established in the union should be subject to this regulation where the processing activities are related to the offering of goods or services to such data subjects , or to the monitoring of the behaviour of such data subjects . ### in order to ensure that individuals are not deprived of the protection to which they are entitled under this regulation , the processing of personal data of data subjects residing in the union by a controller not established in the union should be subject to this regulation where the processing activities are related to the offering of goods or services , including services offered free of charge , to such data subjects , or to the monitoring of such data subjects .


### in order to determine whether a processing activity can be considered to ‘ monitor the behaviour’ of data subjects , it should be ascertained whether individuals are tracked on the internet with data processing techniques which consist of applying a ‘ profile’ to an individual , particularly in order to take decisions concerning her or him or for analysing or predicting her or his personal preferences , behaviours and attitudes . ### in order to determine whether a processing activity can be considered to ‘ monitor’ data subjects , it should be ascertained whether individuals are tracked on the internet or through other means , or if other data about them is collected , including from public registers and announcements in the union that are accessible from outside of the union , including with the intention to use , or potential of subsequent use of data processing techniques which consist of applying a ‘ profile’ , particularly in order to take decisions concerning her or him or for analysing or predicting her or his personal preferences , behaviours and attitudes .


### the principles of protection should apply to any information concerning an identified or identifiable person . to determine whether a person is identifiable , account should be taken of all the means likely reasonably to be used either by the controller or by any other person to identify the individual . the principles of data protection should not apply to data rendered anonymous in such a way that the data subject is no longer identifiable . ### the principles of protection should apply to any information concerning an identified or identifiable person . to determine whether a person is identifiable , account should be taken of all the means likely reasonably to be used either by the controller or by any other person to identify the individual . this regulation should not apply to anonymous data , meaning any data that can not be related , directly or indirectly , alone or in combination with associated data , to a natural person or where establishing such a relation would require a disproportionate amount of time , expense , and effort , taking into account the state of the art in technology at the time of the processing and the possibilities for development during the period for which the data will be processed .