### – there are still uncertainties surrounding the human health and environmental implications of endocrine disruptors , mixtures , chemicals in products and nanomaterials . filling these gaps can accelerate decision - making and enable the further development of the chemicals acquis to better target areas of concern , while stimulating more sustainable use of chemicals . an improved understanding of the environmental factors affecting human health would allow preventive policy actions to be taken . ### – while there are still uncertainties surrounding the full implications for human health and the environment of endocrine disrupters , mixtures , chemicals in products and nanomaterials , the latest research indicates that endocrine disrupters cause adverse health effects , especially regarding pregnant women and the development of children . this fully warrants precautionary action . in addition , concerns exist regarding the potential environment and health implications of the combined effects of chemicals in products , nanomaterials and similar advanced materials . implementing existing knowledge , supplemented with a continued effort to fill the remaining knowledge gaps including , inter alia , via the use of biomonitoring and environmental monitoring , can accelerate decision - making and enable the further development of the chemicals acquis to better target areas of concern , and also help to stimulate a more sustainable approach to the use of chemicals . an improved understanding of the environmental factors and the levels of exposure affecting human health and the environment would allow preventive policy actions to be taken .


### this transformation requires the full integration of environment issues into other policies , such as energy , transport , agriculture , fisheries , economy and industry , research and innovation , employment and social policy so as to create a coherent , joined - up approach . action within the eu should also be complemented by enhanced global action and cooperation with neighbouring countries to tackle common challenges . ### this transformation requires the full integration of environment issues into other policies , such as energy , transport , agriculture , fisheries , economy and industry , research and innovation , employment , trade , development , foreign affairs and security , and social policy so as to create a coherent , joined - up approach . action within the eu should also be complemented by enhanced global action and cooperation with neighbouring countries to tackle common challenges


### the eu’s economic prosperity and well - being is underpinned by its natural capital , which includes ecosystems that provide essential goods and services , from fertile soil and multi - functional forests to productive land and seas , from fresh water and clean air to pollination , flood control and climate regulation and protection against natural disasters . a substantial body of eu legislation seeks to protect , conserve and enhance natural capital , including the water framework directive , the marine strategy framework directive , the air quality and related directives and the habitats and birds directives . legislation to tackle climate change , chemicals , industrial emissions and waste also contribute to easing the pressures on biodiversity , including ecosystems , species and habitats . ### the eu’s economic prosperity and well - being is underpinned by its natural capital , i . e . its biodiversity , including ecosystems that provide essential goods and services , from fertile soil and multi - functional forests to productive land and seas , from fresh water and clean air to pollination , flood control and climate regulation and protection against natural disasters . a substantial body of eu legislation seeks to protect , conserve and enhance natural capital , including the water framework directive , the urban wastewater directive1 , the nitrates directive2 , the marine strategy framework directive , the air quality and related directives and the habitats and birds directives . legislation to tackle climate change , chemicals , industrial emissions and waste also contribute to easing the pressures on biodiversity , including ecosystems , soil and species and habitats . __________________ 1 directive 91 / 271 / eec . 2 directive 91 / 676 / eec .


### there is also considerable potential for improving waste management in the eu to make better use of resources , open up new markets , create new jobs and reduce dependence on imports of raw materials , while having lower impacts on the environment . each year in the eu , 2 . 7 billion tonnes of waste are produced , of which 98 million tonnes is hazardous . on average , only 40 % of solid waste is re - used or recycled . the rest goes to landfill or incineration . in some member states , more than 70 % of waste is recycled , showing how waste could be used as one of the eu ' s key resources . at the same time , many member states landfill over 75 % of their municipal waste . ### there is also considerable potential for improving waste management in the eu to make better use of resources and secondary raw materials , open up new markets , create new jobs and reduce dependence on imports of raw materials , while having lower impacts on the environment . each year in the eu , 2 . 7 billion tonnes of waste are produced , of which 98 million tonnes is hazardous . on average , only 40 % of solid waste is re - used or recycled . the rest goes to landfill or incineration . in some member states , more than 70 % of waste is recycled , showing how waste could be used as one of the eu ' s key resources . at the same time , many member states landfill over 75 % of their municipal waste .


### innovation to improve resource efficiency is required across the economy to improve competitiveness in the context of rising resource prices , scarcity and supply constraints . the business sector is the prime driver of innovation , including eco - innovation . however , markets will not deliver on their own . government action , at union and member state level , is essential to provide the right framework conditions for eco - innovation , stimulating the development of sustainable business or technological solutions to environmental challenges . ### innovation to improve resource efficiency and reduce the overall resource use is required across the economy to improve competitiveness in the context of rising resource prices , import dependency , scarcity and supply constraints . as a contribution to secure raw materials supply , innovation partnerships between the industry and waste management sector as well as research for the recyclability of important technology raw materials need to be reinforced . the business sector , in response to regulatory signals coming from ambitious environmental legislation , is the prime driver of innovation , including eco - innovation . however , markets will not deliver on their own . government action , at union and member state level , is essential to provide the right legal framework conditions for investments and eco - innovation , stimulating the development of sustainable business or technological solutions to environmental challenges .


### simplifying , streamlining and modernising environmental and climate change data and information collection , management and sharing . ### simplifying , streamlining and modernising environmental and climate change data and information collection , management and sharing – including the development and implementation of a european shared environmental information system .


### to reduce the most significant man - made pressures on land , soil and other ecosystems in europe , action will be taken to ensure that decisions relating to land use at all relevant levels give proper consideration to environmental as well as social and economic impacts . the rio + 20 summit outcome called for a ‘ land degradation neutral world’ . the eu and member states should reflect on how best to make such a commitment operational within their respective competencies as well as to address soil quality issues within a binding legal framework . targets will also be set for sustainable land use and soil . ### to reduce the most significant man - made pressures on land , soil and other ecosystems in europe , action will be taken to ensure that decisions relating to land use at all relevant levels give proper consideration to environmental as well as social and economic impacts . the rio + 20 summit outcome , recognizing the economic and social significance of good land management , called for a ‘ land degradation neutral world’ . the eu and member states should reflect on how best to make such a commitment operational within their respective competencies as well as how to address soil quality issues using a risk - based approach within a binding legal framework drawing on relevant aspects of the commission’s proposal for a directive establishing a framework for the protection of soil and amending directive 2004 / 35 / ec . targets should also be set for sustainable land use and soil .


### union environment policy should continue to draw on a sound evidence base . ### union environment policy should continue to draw on a sound knowledge and evidence base and be responsive to new scientific findings .


### the degradation , fragmentation and unsustainable use of land in the eu is jeopardising the provision of several key ecosystem services , threatening biodiversity and increasing europe’s vulnerability to climate change and natural disasters . it is also driving soil degradation . more than 25% of the eu’s territory is affected by soil erosion by water , which compromises soil functions and affects the quality of freshwater . soil contamination and sealing are also persistent problems . more than half a million sites across the eu are thought to be contaminated and until they are identified and assessed , they continue to pose potentially serious environmental and health risks . every year more than 1 000 km² of land are taken for housing , industry , transport or recreational purposes . these long - term changes are difficult or costly to reverse , and nearly always involve trade - offs between various social , economic and environmental needs . member states’ planning decisions relating to land use should be made more sustainable . ### the degradation , fragmentation and unsustainable use of land in the eu is jeopardising the provision of several key ecosystem services , threatening biodiversity and increasing europe’s vulnerability to climate change and natural disasters . it is also driving soil degradation and desertification . more than 25% of the eu’s territory is affected by soil erosion by water , which compromises soil functions and affects the quality of freshwater . soil contamination and sealing are also persistent problems . more than half a million sites across the eu are thought to be contaminated and until they are identified and assessed , they continue to pose potentially serious environmental , economic and social risks , including health risks . every year more than 1 000 km² of land are taken for housing , industry , transport or recreational purposes . these long - term changes are difficult or costly to reverse , and nearly always involve trade - offs between various social , economic and environmental needs . member states’ planning decisions relating to land use should be made more sustainable , especially taking biodiversity conservation and water protection into account .


### all sectors of the economy will need to contribute to reducing ghg emissions for the eu to deliver its fair share of global efforts . the eu needs to agree the next steps for its climate and energy framework beyond 2020 in order to prepare itself for international negotiations on a new legally binding agreement , but also to provide member states and industry with a clear framework to make the medium - term investments needed . hence the eu needs to consider policy options for delivering the reductions set out in the low - carbon economy roadmap for the period beyond 2020 . the 2050 energy roadmap and the white paper on transport need to be underpinned by strong policy frameworks . moreover , member states need to develop and put in place long - term , cost - effective low - carbon development strategies aimed at achieving the eu objective of reducing ghg emissions by 80% to 95% by mid - century , compared to 1990 , as part of a global effort to limit average temperature increase to below 2°c . the eu emissions trading system will continue to be a central pillar of eu climate policy beyond 2020 . ### all sectors of the economy will need to contribute to reducing ghg emissions for the eu to deliver on its commitments and reach the objective of reducing ghg emissions by 80 - 95% by 2050 . the eu urgently needs to agree the next steps towards a new climate and energy framework beyond 2020 with three legally binding targets for emission reduction , energy efficiency and renewable energy in order to prepare itself for an active engagement in international negotiations on a new legally binding agreement by 2015 , but also to provide member states and industry with a clear legal framework to make the medium - and long - term investments needed . hence the eu needs to consider policy options for delivering the reductions set out in the low - carbon economy roadmap for the period beyond 2020 in line with the proposed milestones and latest science . the 2050 energy roadmap and the white paper on transport need to be underpinned by strong policy frameworks , milestones and targets for the years 2030 , 2040 and 2050 . moreover , member states need to develop and put in place long - term , cost - effective low - carbon development strategies aimed at achieving the eu objective of decarbonization by mid - century , compared to 1990 , as part of a global effort to limit average temperature increase to below 2°c . the eu emissions trading system will continue to be a central pillar of eu climate policy beyond 2020 and needs to be structurally reformed to incentivise investments in low - carbon and sustainable technologies . in order to fulfil its international commitments , the eu needs to substantially supported developing countries in their efforts to mitigate climate change through capacity - building , financial aid and technology transfer .


### however , the pace of current developments and uncertainties surrounding likely future trends requires further steps to maintain and strengthen this evidence base to ensure policy in the eu continues to draw on a sound understanding of the state of the environment , possible response options and their consequences . ### however , the pace of current developments and uncertainties surrounding likely future trends requires further steps to maintain and strengthen this knowledge and evidence base to ensure policy in the eu continues to draw on a sound understanding of the state of the environment , possible response options and their consequences .


### the loss of biodiversity and the degradation of ecosystem services are halted and ecosystems and their services are maintained and enhanced . ### the loss of biodiversity and the degradation of ecosystem services are halted and ecosystems and their services are maintained , restored and enhanced , in particular through the full implementation and effective conservation of the natura 2000 network supported by prioritized action frameworks , and the implementation of the ' no nett loss principle ' .


### working towards a more effective un structure for sustainable development through strengthening unep in line with the outcome of rio + 20 , while continuing to strive for an upgrade of unep ' s status to that of un agency , and supporting ongoing efforts to enhance synergies between multilateral environmental agreements ; ### working towards a more effective un structure for sustainable development , in particular its environmental dimension through : further strengthening the united nations environment programme in line with the outcome of rio + 20 , building on the decision by the unep governing council to establish a un environment assembly , while continuing to strive for an upgrade of unep ' s status to that of a specialised agency ; supporting efforts to enhance synergies between multilateral environmental agreements , in particular in the chemicals and waste and the biodiversity clusters ; and c ) contributing to ensuring a strong and authoritative voice for the environment in the work of the high level political forum on sustainable development .


### developing an eu strategy for a non - toxic environment , supported by a comprehensive chemical exposure and toxicity knowledge base and conducive to innovation of sustainable substitutes . ### developing by 2018 an eu strategy for a non - toxic environment building on horizontal measures to be undertaken by 2015 to ensure by specific provisions in all relevant laws 1 ) the safety of nanomaterials and similar advanced materials ; 2 ) the minimisation of exposure to endrocrine disrupters ; 3 ) appropriate regulatory approaches to address combination effects of chemicals and 4 ) the minimisation of exposure to chemicals in products , including inter alia imported products , with a view to promoting non - toxic material cycles and reducing indoor exposure to harmful substances . this should be supported by a comprehensive chemical exposure and toxicity knowledge base , which would accelerate efficient decision - making and promote innovation and the development of sustainable substitutes .


### environmental sustainability is key to reducing poverty and ensuring quality of life and economic growth . at rio + 20 , world leaders renewed their commitment to sustainable development and recognised the inclusive green economy as an important tool for achieving sustainable development , and the crucial role of a healthy environment in ensuring food security and reducing poverty . in the light of a growing population in an increasingly urbanised world , these challenges will include the need for action on water , oceans , sustainable land and ecosystems , resource efficiency , sustainable energy and climate change , including through the phase out of fossil fuel subsidies . they will need to be addressed through tailor - made approaches at local , national or union level , as well as committed engagement in international efforts to develop the solutions needed to ensure sustainable development globally . ### ensuring sustainability is one of the most pressing challenges facing the world today and is key to ending poverty and ensuring prosperity and wellbeing for all . at rio + 20 , world leaders renewed their commitment to sustainable development and to ensuring the promotion of an economically , socially and environmentally sustainable future for the planet , for present and future generations . they also recognised that the inclusive green economy is an important tool for achieving sustainable development , and the crucial role of a healthy environment in ensuring food security and reducing poverty . in the light of a growing population in an increasingly urbanised world , these challenges will include the need for international action in a number of areas such as water , oceans , sustainable land and ecosystems , resource efficiency , sustainable energy and climate change , including through the phase out of environmentally harmful subsidies , including fossil fuel subsidies . in addition to translating these commitments into action at the local , national and eu level , the eu will engage proactively in international efforts to develop the solutions needed to ensure sustainable development globally .


### horizontal chemicals legislation provides baseline protection for human health and the environment and promotes the uptake of evolving non - animal testing methods . however , there is still uncertainty about the impacts on human health and the environment from the combined effects of different chemicals , nanomaterials , chemicals that interfere with the endocrine system and chemicals in products . in recent years , more information has come to light on the need for action to deal with these challenges , especially if the eu is to attain the goal agreed at the world summit on sustainable development in 2002 , and reaffirmed at the rio + 20 summit , to have ensured ‘ the minimisation of significant adverse effects’ of chemicals on human health and the environment by 2020 and to respond to new and emerging issues and challenges in an effective , efficient , coherent and coordinated manner . the eu will further develop and implement approaches to address combination effects of chemicals and safety concerns related to endocrine disruptors and set out a comprehensive approach for minimising adverse effects of hazardous substances , including chemicals in products , supported by a comprehensive chemical exposure and toxicity knowledge base . the safety and sustainable management of nanomaterials will be ensured as part of a comprehensive approach involving risk assessment and management , information and monitoring . together these approaches will increase the chemical knowledge base and provide a predictable framework driving the development of more sustainable solutions . ### horizontal chemicals legislation provides baseline protection for human health and the environment and promotes the uptake of evolving non - animal testing methods . however , there is still uncertainty about the full impacts on human health and the environment from the combined effects of different chemicals , nanomaterials , chemicals that interfere with the endocrine system and chemicals in products . in recent years , more information has come to light on the need for action to deal with these challenges , especially if the eu is to attain the goal agreed at the world summit on sustainable development in 2002 , and reaffirmed at the rio + 20 summit , to have ensured the minimisation of exposure to chemicals on human health and the environment by 2020 and to respond to new and emerging issues and challenges in an effective , efficient , coherent and coordinated manner . the eu will further develop and implement approaches including provisions for industry to address combination effects of chemicals and safety concerns related to endocrine disruptors and set out a comprehensive approach for minimising adverse effects of hazardous substances across all relevant eu legislation , including chemicals in products , supported by a comprehensive chemical exposure and toxicity knowledge base taking into account the precautionary principle to protect in particular vulnerable groups from exposure . the safety and sustainable management of nanomaterials will be ensured as part of a comprehensive approach involving risk assessment and management , information and monitoring . together these approaches will increase the chemical knowledge base and provide a predictable framework driving the development of more sustainable solutions .


### strengthening efforts to reach full compliance with eu air quality legislation and defining strategic targets and actions beyond 2020 . ### reaching full compliance with eu air quality legislation and defining strategic targets and actions beyond 2020 .


### progressively phasing out environmentally harmful subsidies , increasing the use of market - based instruments , including taxation , pricing and charging , and expanding markets for environmental goods and services , with due regard to any adverse social impacts . ### the commission and the member states to adopt , without delay and by 2014 , concrete plans based on the definition in point annex i , paragraph 82 , point a for progressively phasing out all environmentally harmful subsidies by 2020 , including subsidies that incentivise inefficient use of renewable resources , and to report on progress through the national reform programmes ; increasing the use of market - based instruments , including a minimum ten per cent shift from labour to environmental taxation , pricing and charging , and expanding markets for environmental goods and services , with due regard to any adverse social impacts .


### fully implementing the eu climate and energy package is essential to reach the milestones identified for 2020 and for building a competitive , low - carbon economy by 2050 . whereas the eu is currently on track to reduce domestic ghg emissions 20 % below 1990 levels by 2020 , meeting the 20 % energy efficiency target will require far more rapid efficiency improvements . this is also important in the light of still - growing demand for energy and the on - going debate on conflicts between land use for food and for bio - energy . the new energy efficiency directive is expected to make a significant contribution in this regard . ### fully implementing the eu climate and energy package is essential to reach the three targets set for 2020 and for building a competitive , sustainable , low - carbon economy based on a high renewable energy supply by 2050 . whereas the eu is currently on track to reduce domestic ghg emissions 20 % below 1990 levels by 2020 and might be able to achieve even more , meeting the 20 % energy efficiency target will require far more rapid efficiency improvements at all scales . this is also important in the light of still - growing demand for energy and the increasing competition for land for food and energy purposes . it is therefore important to ensure that biomass used for energy is limited in volume to what can be sustainably supplied respecting the ' cascading use ' principle . whereas the new energy efficiency directive is expected to make a significant contribution in this regard , it should be complemented by setting requirements for the energy use of all energy related products entering the eu market .


### – there are still uncertainties surrounding the human health and environmental implications of endocrine disruptors , mixtures , chemicals in products and nanomaterials . filling these gaps can accelerate decision - making and enable the further development of the chemicals acquis to better target areas of concern , while stimulating more sustainable use of chemicals . an improved understanding of the environmental factors affecting human health would allow preventive policy actions to be taken . ### – while there are still uncertainties surrounding the full implications for human health and the environment of endocrine disrupters , mixtures , chemicals in products and nanomaterials , the latest research indicates that endocrine disrupters cause adverse health effects , especially regarding pregnant women and the development of children . this fully warrants precautionary action . in addition , concerns exist regarding the potential environment and health implications of the combined effects of chemicals in products , nanomaterials and similar advanced materials . implementing existing knowledge , supplemented with a continued effort to fill the remaining knowledge gaps including , inter alia , via the use of biomonitoring and environmental monitoring , can accelerate decision - making and enable the further development of the chemicals acquis to better target areas of concern , and also help to stimulate a more sustainable approach to the use of chemicals . an improved understanding of the environmental factors and the levels of exposure affecting human health and the environment would allow preventive policy actions to be taken .


### promoting the development of maritime transport and providing efficient and cost - effective shipping routes across europe , including port accessibility and transport safety ; ### promoting the development of maritime transport outside marine protected areas , respecting sensitive ecosystems and providing efficient and cost - effective shipping routes across europe , including port accessibility and transport safety ;


### sea farming sites ; ### aquaculture sites ;


### the original data and information produced from space - borne observations , as well as from available in - situ data shall be accurate and reliable , supplied on a long term and sustainable basis and respond to the requirements of copernicus user communities . the access to those data shall be full , open and free of charge , subject to the conditions defined in or on the basis of this regulation . ### the original data and information produced from space - borne observations , as well as from available in - situ measurement and remote sensing data shall be accurate and reliable , supplied on a long term and sustainable basis and respond to the requirements of copernicus user communities . the access to those data shall be full , easy - to - access , open and free of charge , subject to the conditions defined in or on the basis of this regulation .


### recent events highlighted the risks of offshore oil and gas exploration and production activities to maritime transport and the marine environment . the use of the agency ' s response capabilities should be explicitly extended to cover response to pollution originating from such activities . in addition , the agency should assist the commission in analysing the safety of mobile offshore gas and oil installations , in order to identify possible weaknesses , basing its contribution on the expertise it has developed with regard to maritime safety , maritime security , the prevention of pollution caused by ships and response to marine pollution . ### recent events highlighted the risks of offshore oil and gas exploration and production activities to maritime transport and the marine environment . the use of the agency ' s capabilities should be explicitly extended to cover pollution originating from such activities . in addition , the agency should assist the commission in analysing the safety of offshore gas and oil installations , in order to identify possible weaknesses , basing its contribution on the expertise it has developed with regard to maritime safety , maritime security , the prevention of pollution caused by ships and response to marine pollution . this additional role , which offers european added value by making use of the agency ' s existing knowledge and expertise , should be accompanied by appropriate financial and staff resources .


### to contribute to enhancing the exercise of rights deriving from the citizenship of the union ; ### to contribute to enhancing the exercise of rights deriving from the citizenship of the union and the promotion of active citizenship ;


### in order to determine whether the economic equilibrium of a public service contract would be compromised , the relevant regulatory body or bodies referred to in article 55 shall make an objective economic analysis and base its decision on pre - determined criteria . they shall determine this after a request from any of the following , submitted within one month from the information on the intended passenger service referred to in article 38 : ### in order to determine whether the economic equilibrium and the availability and quality of a public service contract would be compromised , the relevant regulatory body or bodies referred to in article 55 shall make an objective economic , social and environmental analysis , including an analysis of the employment conditions , and base its decision on pre - determined criteria . they shall determine this after a request from any of the following , submitted within one month from the information on the intended passenger service referred to in article 38 :


### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . ### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development , conservation of the environment , climate change mitigation and adaptation , worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . to ensure the greatest impact of union assistance in the world , the implementation of this regulation should be strictly coordinated with programmes and actions funded under other regulations establishing external financing instruments , namely regulation no [ . . . / . . . ] of the european parliament and of the council establishing an instrument for stability and regulation no [ . . . / . . . ] of the european parliament and of the council establishing a financing instrument for the promotion of democracy and human rights worldwide and regulation no [ . . . / . . . ] of the european parliament and of the council establishing a partnership instrument for cooperation with third countries .


### the commission shall be empowered to adopt a delegated act in accordance with article 29 of this regulation to specify the requirements for the monitoring and reporting of co2 emissions from maritime transport relating to marine vessels calling at member states ' seaports . the monitoring and reporting requirements adopted shall be consistent with requirements agreed at the unfccc and , to the extent possible , with requirements applied to vessels in the context of the imo or through union legislation addressing ghg emissions from maritime transport . to the extent possible , monitoring and reporting requirements shall minimise member states ' workload including through the use of centralised data collection and maintenance . ### the commission shall adopt a delegated act in accordance with article 29 of this regulation by [ 30 january 2013 ] to specify requirements for the monitoring and reporting of climate - relevant information relating to maritime transport relating to marine vessels calling at member states ' seaports . the climate - relevant information required to be monitored and reported on shall include : - co2 , black carbon and nox emissions data ; - average speed when travelling between ports ; and - from 2015 , performance in reference to the imo energy efficiency design index , performance in reference to the imo energy efficiency operational index , and the effects of applying the ship energy efficiency management plan . the monitoring and reporting requirements adopted shall be consistent with methodologies agreed at the unfccc and , to the extent possible , with methodologies applied to vessels in the context of the imo or requirements through union legislation addressing ghg emissions from maritime transport . to the extent possible , monitoring and reporting requirements shall minimise member states ' workload including through the use of centralised data collection , maintenance and publication . the requirements shall cover ships responsible for significant emissions , including at least the categories of tankers , bulker , general cargo and container ships , ferries , cruise ships , vehicle ships and any ships carrying bulk fossil fuels , subject to appropriate de minimis size and traffic thresholds .


### where an act has been adopted pursuant to paragraph 1 , member states shall determine and report to the commission by 15 january each year for the year x - 2 , the co2 emissions from maritime transport pursuant to that act . ### following the adoption of a delegated act pursuant to paragraph 1 , member states shall determine and gather to the commission and the european maritime safety agency by 15 january each year for the year x - 2 , the climate - relevant information relating to maritime transport , and shall make that information available to the public . that information shall be made available in a manner that is useful to the charterers or users of such ships .


### information referred to in point of article 6 of decision no 406 / 2009 / ec and information on how their purchasing policy enhances the achievement of an international agreement on climate change . ### information referred to in point of article 6 of decision no 406 / 2009 / ec and evidence of compliance with article 11b of 2003 / 87 / ec as regards hydroelectric power production project activities with a generating capacity exceeding 20 mw and information on how their purchasing policy enhances the achievement of an international agreement on climate change ;


### information on activities by the member state related to technology transfer to developing countries under the unfccc and on technologies transferred for the year x - 1 , information on planned activities related to technology transfer to developing countries under the unfccc and on technologies to be transferred for the year x and subsequent years . it should include information on whether the technology transferred was used for mitigating or adapting to the effects of climate change , recipient country , amount of support provided , and type of technology transferred . ### information on activities by the member state related to technology transfer to developing countries in accordance with the unfccc and on technologies transferred for the year x - 1 , information on planned activities related to technology transfer to developing countries and on technologies to be transferred for the year x and subsequent years . it should include information on whether the technology transferred was used for mitigating or adapting to the effects of climate change , recipient country , amount of support provided , type of technology transferred .


### reporting co2 emissions from maritime transport ; ### reporting co2 emissions , black carbon emissions , and nox emissions from maritime transport ;


### information on any financial resources allocated by the member state related to the implementation of the unfccc by type of channel such as bilateral , regional or other multilateral channels ; ### information on any financial resources allocated by the member state in accordance with the unfccc by type of channel such as bilateral , regional or other multilateral channels or funds , specifying the share of loans and grants , including return flows from earlier climate - related loans ;


### set out monitoring and reporting requirements on lulucf , in accordance with any new international agreement or a legislative act adopted in accordance with article 9 of decision no 406 / 2009 / ec . ### set out monitoring and reporting requirements on lulucf , in accordance with any new international agreement or a legislative act adopted in accordance with article 9 of decision no 406 / 2009 / ec with a view to ensuring the environmental integrity of the sector ' s contribution to emission reductions in the union ;


### member states shall , based on the best data available , report to the commission by 15 march each year : ### member states shall , based on the best data available and using a common template , report to the commission by 15 march each year :


### the general arrangement should be granted to all those developing countries which share a common developing need and are in a similar stage of economic development . countries which are classified by the world bank as high - income or upper - middle income countries have per capita income levels allowing them to attain higher levels of diversification without the scheme ' s tariff preferences and include economies which have successfully completed their transition from centralised to market economies . those countries do not share the same development , trade and financial needs as the remaining developing countries ; they are at a different stage of economic development , i . e they are not similarly - situated as the more vulnerable developing countries ; and , so as to prevent unjustified discrimination , they need to be treated differently . furthermore , the use of tariff preferences provided under the scheme by high - income or upper - middle income countries increases the competitive pressure on exports from poorer , more vulnerable countries and therefore could impose unjustifiable burden on those more vulnerable developing countries . the general arrangement takes account of the fact that the development , financial and trade needs are subject to change and assures that the arrangement remains open if the situation of a country changes . ### the general arrangement should be granted to all those developing countries which share a common developing need and are in a similar stage of economic development . countries which are classified by the world bank as high - income or upper - middle income countries have per capita income levels allowing them to attain higher levels of diversification without the scheme ' s tariff preferences and include economies which have successfully completed their transition from centralised to market economies . some countries which are classified by the world bank as upper - middle income countries however , are still vulnerable due to the lack of diversification and their insufficient integration in the world economy . high - income countries and non - vulnerable upper - middle income countries do not share the same development , trade and financial needs as the remaining developing countries ; they are at a different stage of economic development , i . e they are not similarly - situated as the more vulnerable developing countries ; and , so as to prevent unjustified discrimination , they need to be treated differently . furthermore , the use of tariff preferences provided under the scheme by high - income or non - vulnerable upper - middle income countries increases the competitive pressure on exports from poorer , more vulnerable countries and therefore could impose unjustifiable burden on those more vulnerable developing countries . the general arrangement takes account of the fact that the development , financial and trade needs are subject to change and assures that the arrangement remains open if the situation of a country changes .


### the intermediary payment service provider shall have effective procedures in place in order to detect whether the following information on the payer and the payee is missing : ### the intermediary payment service provider shall have effective procedures in place in order to detect whether the following information on the payer and the payee is missing or incomplete :


### the payment service provider of the payer and the payment service provider of the payee shall keep records of the information referred to in articles 4 , 5 , 6 and 7 for five years . in the cases referred to in article 14 and , the intermediary payment service provider must keep records of all information received for five years . upon expiry of this period , personal data must be deleted , unless otherwise provided for by national law , which shall determine under which circumstances payment service providers may or shall further retain data . member states may allow or require further retention only if necessary for the prevention , detection or investigation of money laundering and terrorist financing . the maximum retention period following carrying - out of the transfer of funds shall not exceed ten years . ### the payment service provider of the payer and the payment service provider of the payee shall keep records of the information referred to in articles 4 , 5 , 6 and 7 for five years . in the cases referred to in article 14 and , the intermediary payment service provider must keep records of all information received for five years . upon expiry of this period , personal data must be deleted , unless otherwise provided for by national law , which shall determine under which circumstances payment service providers may or shall further retain data . member states may allow or require further retention only if necessary for the prevention , detection or investigation of money laundering and terrorist financing . the maximum retention period following carrying - out of the transfer of funds shall not exceed ten years and the storage of personal data shall comply with national law implementing directive 95 / 46 / ec


### cooperation obligations ### cooperation obligations and equivalence


### by way of derogation from article 4 and , where the payment service provider of both the payer and the payee are established in the union , only the account number of the payer or his unique transaction identifier shall be provided at the time of the transfer of funds . ### by way of derogation from article 4 and , where the payment service provider of both the payer and the payee are established in the union , only the full name of the principal and the account number of the payer or his unique identifier shall be provided at the time of the transfer of funds .


### however , this regulation shall apply when a credit or debit card , or a mobile telephone , or any other digital or it device is used in order to effect a person - to - person transfer of funds . ### however , this regulation shall apply when a credit or debit card , or a mobile telephone , or any other digital or it prepaid or postpaid device is used in order to affect a person - to - person transfer of funds .


### in order to facilitate their criminal activities , money launderers and terrorist financers could try to take advantage of the freedom of capital movements entailed by the integrated financial area , unless certain coordinating measures are adopted at union level . by its scale , union action should ensure that recommendation 16 on wire transfers of the financial action task force , adopted in february 2012 is transposed uniformly throughout the union , and , in particular , that there is no discrimination between national payments within a member state and cross border payments between member states . uncoordinated action by member states alone in the field of cross border transfers of funds could have a significant impact on the smooth functioning of payment systems at union level and therefore damage the internal market in the field of financial services . ### in order to facilitate their criminal activities , money launderers and terrorist financers are taking advantage of the freedom of capital movements entailed by the integrated financial area , unless certain coordinating measures are adopted at union level . by its scale , union action should ensure that recommendation 16 on wire transfers of the financial action task force , adopted in february 2012 is transposed uniformly throughout the union , and , in particular , that there is no discrimination and discrepancies between national payments within a member state and cross border payments between member states . uncoordinated action by member states alone in the field of cross border transfers of funds could have a significant impact on the smooth functioning of payment systems at the union level and therefore damage the internal market in the field of financial services .


### flows of dirty money through transfers of funds can damage the stability and reputation of the financial sector and threaten the internal market . terrorism shakes the very foundations of our society . the soundness , integrity and stability of the system of transfers of funds and confidence in the financial system as a whole could be seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to transfer funds for terrorist purposes . ### massive flows of illicit money damage the structure , stability and reputation of the financial sector and threaten the single market as well as international development , and terrorism shakes the very foundations of our society . crucial facilitators of illicit money flows are complex corporate structures operating in and through secrecy jurisdiction , often also referred to as tax havens . the soundness , integrity and stability of the system of transfers of funds and confidence in the financial system as a whole is being seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to transfer funds for terrorist purposes .


### before transferring the funds , the payment service provider of the payer shall verify the accuracy of the information referred in paragraph 1 on the basis of documents , data or information obtained from a reliable and independent source . ### before transferring the funds , the payment service provider of the payer shall verify the accuracy of the complete information referred in paragraph 1 on the basis of documents , data or information obtained from a reliable and independent source .


### flows of dirty money through transfers of funds can damage the stability and reputation of the financial sector and threaten the internal market . terrorism shakes the very foundations of our society . the soundness , integrity and stability of the system of transfers of funds and confidence in the financial system as a whole could be seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to transfer funds for terrorist purposes . ### massive flows of illicit money damage the stability and reputation of the financial sector and threaten the single market as well as international development , and terrorism shakes the very foundations of our society . crucial facilitators of illicit money flows are secretive corporate structures operating in and through secrecy jurisdictions , often also referred to as tax havens . the soundness , integrity and stability of the system of transfers of funds and confidence in the financial system as a whole is being seriously jeopardised by the efforts of criminals and their associates either to disguise the origin of criminal proceeds or to transfer funds for terrorist purposes .


### the provisions on transfers of funds where information on the payer or the payee is missing or incomplete apply without prejudice to any obligations on payment service providers and the intermediary payment service providers to suspend and / or reject transfers of funds which violate provisions of civil , administrative or criminal law . ### the provisions on transfers of funds where information on the payer or the payee is missing or incomplete apply without prejudice to any obligations on payment service providers and the intermediary payment service providers to suspend and / or reject transfers of funds which violate provisions of civil , administrative or criminal law . the need for identity information on payer or the payee of individuals , legal persons , trusts , foundations , mutual societies , holdings and other similar existing or future legal arrangements is a key factor in tracing criminals who might otherwise hide their identity behind corporate structure .


### appropriate protection for persons who report potential or actual breaches ; ### appropriate protection for whistleblowers and persons who report potential or actual breaches ;


### by way of derogation from article 4 and , where the payment service provider of both the payer and the payee are established in the union , only the account number of the payer or his unique transaction identifier shall be provided at the time of the transfer of funds . ### by way of derogation from article 4 and , where the payment service provider of both the payer and the payee are established in the union , the name and account number of the payer or his unique identifier shall be provided at the time of the transfer of funds .


### the full traceability of transfers of funds can be a particularly important and valuable tool in the prevention , investigation and detection of money laundering or terrorist financing . it is therefore appropriate , in order to ensure the transmission of information throughout the payment chain , to provide for a system imposing the obligation on payment service providers to have transfers of funds accompanied by information on the payer and the payee . ### the full traceability of transfers of funds can be a particularly important and valuable tool in the prevention , investigation and detection of money laundering or terrorist financing . it is therefore appropriate , in order to ensure the transmission of information throughout the payment chain channelled through the financial system , to provide for a system imposing the obligation on payment service providers to report identity information on transfer of funds conceded on behalf of their clients , and to have transfers of funds accompanied by information to the competent authorities on the payer and the payee to prevent their financial services being misused for money laundering and terrorist financing .


### the intermediary payment service provider shall establish effective risk - based procedures for determining when to execute , reject or suspend a transfer of funds lacking the required payer and payee information and the appropriate follow up action . ### the intermediary payment service provider shall establish effective risk - based procedures for determining when to execute , reject or suspend a transfer that are incomplete or transfer of funds lacking the required payer and payee information and have in place the appropriate follow up action .


### administrative sanctions and measures imposed in the cases referred to in articles 17 and 18 shall be published without undue delay including information on the type and nature of the breach and the identity of persons responsible for it , unless such publication would seriously jeopardise the stability of financial markets . ### the competent authorities shall publish administrative sanctions and measures imposed in the cases referred to in articles 17 and 18 without undue delay including information on the type and nature of the breach and the identity of persons responsible for it .


### administrative sanctions and measures imposed in the cases referred to in articles 17 and 18 shall be published without undue delay including information on the type and nature of the breach and the identity of persons responsible for it , unless such publication would seriously jeopardise the stability of financial markets . ### the competent authorities shall publish administrative sanctions and measures imposed in the cases referred to in articles 17 and 18 shall be published without undue delay including information on the type and nature of the breach and the identity of persons responsible for it , unless such publication would seriously jeopardise the stability of financial markets if necessary and proportionate after a case by case evaluation .


### in providing this information , companies may rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and international frameworks such as the united nations global compact , the guiding principles on business and human rights implementing the un ‘ protect , respect and remedy’ framework , the organisation for economic co - operation and development guidelines for multinational enterprises , the international organisation for standardisation 26000 , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative . ### in providing information on their compliance with rights and values protected by norms of international law , companies shall apply the guiding principles on business and human rights implementing the un ' protect , respect and remedy ' framework and the oecd guidelines for multinational enterprises , companies may also rely on eu - based frameworks such as the eco - management and audit scheme , and other international frameworks such as the united nations global compact , the international organisation for standardisation 26000 standard , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative .


### in providing this information , companies may rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and international frameworks such as the united nations global compact , the guiding principles on business and human rights implementing the un “protect , respect and remedy” framework , the organisation for economic co - operation and development guidelines for multinational enterprises , the international organisation for standardisation 26000 , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative . ### in providing information on their compliance with rights and values protected by norms of international law , companies shall apply the guiding principles on business and human rights implementing the un “protect , respect and remedy” framework and the oecd guidelines for multinational enterprises , companies may also rely on national frameworks , eu - based frameworks such as the eco - management and audit scheme , and other international frameworks such as the united nations global compact , the international organisation for standardisation 26000 standard , the international labour organization tripartite declaration of principles concerning multinational enterprises and social policy , and the global reporting initiative or on a set of quantifiable , sector - specific social criteria endorsed by the european union under , for example , a ‘ social labelling’ scheme .


### information provided to rightholders , members , other collecting societies and users on request ### information provided to rightholders , members , other collecting societies and users


### the requested collecting society shall accept such a request if it is already granting or offering to grant multi - territorial licences for the same category of online rights in musical works in the repertoire of one or more other collecting societies . ### the requested collecting society shall accept such a request within a reasonable time if it is already granting or offering to grant multi - territorial licences for the same category of online rights in musical works in the repertoire of one or more other collecting societies .


### member states shall ensure that the collecting society regularly and diligently distributes and pays amounts due to all rightholders it represents . the collecting society shall carry out such distribution and payments no later than 12 months from the end of the financial year in which the rights revenue was collected , unless objective reasons related in particular to reporting by users , the identification of rights , rightholders or to the matching of information on works and other subject matter with rightholders prevent the collecting society from respecting this deadline . the collecting society shall carry out such distribution and payments accurately , ensuring equal treatment of all categories of rightholders . ### member states shall ensure that the collective management organisations regularly and diligently distributes and pays amounts due to all rightholders it represents . the collective management organisation shall carry out such distribution and payments without undue delay and no later than three months after the rights revenue was collected , unless objective reasons related in particular to reporting by users , the identification of rights , rightholders or to the matching of information on works and other subject matter with rightholders prevent the collective management organisation from respecting this deadline . the collective management organisation shall carry out such distribution and payments accurately , ensuring equal treatment of all categories of rightholders .


### collecting societies collect , manage and distribute revenue from the exploitation of the rights entrusted to them by rightholders . this revenue is ultimately due to rightholders who may be members of that society , or another society . it is therefore important that collecting societies exercise the utmost diligence in collecting , managing and distributing that revenue . accurate distribution is only possible where collecting societies maintain proper records of membership , licences and use of works and other subject matter . where appropriate , data should also be provided by rightholders and users and verified by the collecting societies . amounts collected and due to rightholders should be managed separately from any own assets of the collecting society and , if they are invested , pending their distribution to rightholders , this should be carried out in accordance with the investment policy decided by the collecting societies ' general meeting . in order to maintain a high level of protection for the rights of rightholders and to ensure that any income which may be derived from exploitation of their rights accrues for the benefit of rightholders , the investments made and held by the collecting society should be managed in accordance with criteria which would oblige the collecting society to act prudently , while allowing the collecting society to decide on the most secure and efficient investment policy . this should allow the colleting society to opt for an asset allocation that suits the precise nature and duration of any exposure to risk of any rights revenue invested and which does not unduly prejudice any rights revenue owed to rightholders . moreover , in order to ensure that the amounts due to rightholders are appropriately and effectively distributed , it is necessary to require collecting societies to undertake diligent and good faith reasonable measures to identify and locate the relevant rightholders . it is also appropriate to provide for the approval by members of collecting societies of the rules governing any situation where , due to the lack of identified or located rightholders , amounts collected cannot be distributed . ### collective management organisations collect , manage and distribute revenue from the exploitation of the rights entrusted to them by rightholders . this revenue is ultimately due to rightholders who may be members of that society , or another society . it is therefore important that collective management organisations exercise the utmost diligence in collecting , managing and distributing that revenue . accurate distribution is only possible where collective management organisations maintain proper records of membership , licences and use of works and other subject matter . where appropriate , data should also be provided by rightholders and users and verified by the collective management organisations . amounts collected and due to rightholders should be managed separately from any own assets of the collective management organisation and , if they are invested , pending their distribution to rightholders , this should be carried out in accordance with the investment policy decided by the collective management organisations ' general meeting . in order to maintain a high level of protection for the rights of rightholders and to ensure that any income which may be derived from exploitation of their rights accrues for the benefit of rightholders , the investments made and held by the collective management organisation should be managed in accordance with criteria which would oblige the collective management organisation to act prudently , while allowing the collective management organisation to decide on the most secure and efficient investment policy . this should allow the collective management organisation to opt for a secure and profitable asset allocation that prevents exposure to risk of any rights revenue invested and which does not unduly prejudice any rights revenue owed to rightholders . moreover , in order to ensure that the amounts due to rightholders are appropriately and effectively distributed , it is necessary to require collective management organisations to undertake diligent and good faith reasonable measures to identify and locate the relevant rightholders . it is also appropriate to provide for the approval by members of collective management organisations of the rules governing any situation where , due to the lack of identified or located rightholders , amounts collected cannot be distributed .


### ‘ rights revenue’ means income collected by a collecting society on behalf of rightholders , whether from an exclusive right , a right to remuneration or a right to compensation ; ### ‘ rights revenue’ means income collected by a collective management organisation on behalf of its members , whether from an exclusive right or a right to remuneration and including any income derived from the investments of rights revenue ;


### member states shall ensure that a collecting society makes the following information available at the request of any rightholder whose rights it represents , any collecting society on whose behalf it manages rights under a representation agreement or any user , by electronic means , without undue delay : ### member states shall ensure that a collecting society makes the following information available to any rightholder whose rights it represents , any collecting society on whose behalf it manages rights under a representation agreement or any user , by electronic means , without undue delay :


### members should be allowed to take part in monitoring the management of collecting societies . to this end , collecting societies should establish a supervisory function appropriate to their organisational structure and allow members to be represented in the body that exercises this function . to avoid imposing excessive burden on smaller collecting societies and to make the obligations arising from this directive proportionate , member states should be able to , if they consider this to be necessary , exclude the smallest collecting societies from having to organise such a supervisory function . ### members should be allowed to take part in monitoring the management of collecting societies . to this end , collecting societies should establish a supervisory function appropriate to their organisational structure and allow all categories of members to be represented in the body that exercises this function .


### for reasons of sound management , a collecting society ' s senior management must be independent . managers and executive directors should be required to declare annually to the collecting society whether there are conflicts between their interests and those of the society . ### for reasons of sound management , a collective management organisation ' s senior management must be independent . managers and executive directors should be required to declare before taking up their duties and thereafter annually to the collective management organisation whether there are conflicts between their interests and those of the organisation .


### in addition , a collecting society shall make available at the request of any rightholder or any collecting society , any information on works for which one or more rightholders have not been identified including , where available , the title of the work , the name of the author , the name of the publisher and any other relevant information available which could be necessary to identify the rightholders . ### in addition , a collective management organisation shall make publicly available any information on works for which one or more rightholders have not been identified including , where available , the title of the work , the name of the author , the name of the publisher and any other relevant information available which could be necessary to identify the rightholders .


### to ensure that rightholders are in a position to monitor the performance of their collecting societies and compare their respective performance , collecting societies should make public an annual transparency report comprising comparable audited financial information specific to the activities of collecting societies . collecting societies should also make public an annual special report on the use of amounts dedicated to social , cultural and educational services . to avoid imposing excessive burden on smaller collecting societies and to make the obligations arising from this directive proportionate , member states should be able to , if they consider this to be necessary , exclude the smallest collecting societies from certain transparency obligations . ### to ensure that rightholders are in a position to monitor the performance of their collecting societies and compare their respective performance , collecting societies should make public an annual transparency report comprising comparable audited financial information specific to the activities of collecting societies . collecting societies should also make public an annual special report on the use of amounts dedicated to social , cultural and educational services .


### there are significant differences in the national rules governing the functioning of collecting societies , in particular as regards their transparency and accountability towards their members and rightholders . beyond the difficulties non - domestic rightholders face when exercising their rights and the too often poor financial management of the revenues collected , problems with the functioning of collecting societies lead to inefficiencies in the exploitation of copyright and related rights across the internal market to the detriment of the members of collecting societies , rightholders and users alike . these difficulties do not arise in the functioning of independent rights management service providers who act as agents for rightholders for the management of their rights on a commercial basis and in which rightholders do not exercise membership rights . ### there are significant differences in the national rules governing the functioning of collecting societies , in particular as regards their transparency and accountability towards their members , rightholders and users . beyond the difficulties non - domestic rightholders face when exercising their rights and the too often poor financial management of the revenues collected , problems with the functioning of collecting societies lead to inefficiencies in the exploitation of copyright and related rights across the internal market to the detriment of the members of collecting societies , rightholders and users alike .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall notify the applicant within 10 days of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### member states shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of the application . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . if the derogation is granted , the competent authorities shall forthwith publish an announcement of the price increase allowed . ### member states shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 90 days of the receipt of the application . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information . if the derogation is granted , the competent authorities shall forthwith publish an announcement of the price increase allowed .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be in all events 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 90 days of receipt of this additional information . with respect to generic medicinal products , that time limit shall be in all events 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product is essentially similar , within the meaning of directive 2001 / 83 / ec of 6 november 2001 , and has already been included in the public health insurance system .


### irrespective of the organisation of their internal procedures , member states shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this article and the price approval procedure set out in article 3 does not exceed 120 days . however , with respect to the medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall not exceed 180 days . with respect to generic medicinal products , that time limit shall not exceed 30 days , provided that the reference medicinal product has already been included in the public health insurance system . those time - limits may be extended in accordance with paragraph 5 of this article or article 3 . ### irrespective of the organisation of their internal procedures , member states shall ensure that the overall period of time taken by the inclusion procedure set out in paragraph 5 of this article and the price approval procedure set out in article 3 does not exceed 180 days . with respect to generic medicinal products , that time limit shall not exceed 180 days , provided that the reference medicinal product has already been included in the public health insurance system . those time - limits may be extended in accordance with paragraph 5 of this article or article 3 or suspended in accordance with the provisions of the preceding paragraph .


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a reasoned and objectively justified decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted or , where appropriate , of the formal receipt of the marketing authorisation , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 90 days of receipt of this additional information . with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time limit shall likewise be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### by 31 january of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 31 january and 1 july of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information : ### by 31 january of [ &#8230 ; ] [ insert a date - the year following the date referred to in the first subparagraph of article 18 ] , and by 31 january of every year thereafter , member states shall communicate to the commission and publish in an appropriate publication a detailed report providing the following information :


### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 60 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the price of the reference medicinal product has been approved by the competent authorities . ### member states shall ensure that a decision on the price which may be charged for the medicinal product concerned is adopted and communicated to the applicant within 90 days of the receipt of an application submitted , in accordance with the requirements laid down in the member state concerned , by the holder of a marketing authorisation . with respect to generic medicinal products , that time limit shall be 45 days , provided that the price of the reference medicinal product has been approved by the competent authorities .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt or , where appropriate , of the formal receipt of the marketing authorisation . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system .


### the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines . ### the applicant shall furnish the competent authorities with adequate information , including details of those events intervening since the price of the medicinal product was last determined which in his opinion justify the price increase requested . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 90 days of receipt of this additional information . member states shall not request any additional information which is not explicitly required under national legislation or administrative guidelines .


### member states shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### member states shall ensure that an application to approve the price of the product can be introduced by the marketing authorisation holder . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder at any point in time . the competent authorities shall provide the applicant with an official acknowledgement of receipt . ### marketing authorisation holders may apply for a derogation from a price freeze or price reduction if this is justified by particular reasons . these reasons must be drawn from a pre - defined list determined and published in an appropriate publication by the member state . the application shall contain an adequate statement of reasons . member states shall ensure that applications for a derogation can be introduced by the marketing authorisation holder . the competent authorities shall provide the applicant with an official acknowledgement of receipt .


### member states shall ensure that a decision on an application submitted in accordance with the requirements laid down in the member state concerned , by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 60 days of its receipt . ### member states shall ensure that a decision on an application submitted in accordance with the requirements laid down in the member state concerned , by a marketing authorisation holder to increase the price of a medicinal product is adopted and communicated to the applicant within 90 days of its receipt .


### the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , are ascertained in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### proof of the quality , safety and efficacy of medicinal products , including the bioequivalence of generic medicinal products with the reference product , is verified in the framework of marketing authorisation procedures . in the framework of pricing and reimbursement procedures , member states should therefore not re - assess the essential elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . however , member states must be guaranteed full access to the data used by the authorities responsible for granting the marketing authorisation so that they can assess the relative safety , efficiency and efficacy of a medicinal product in the context of its inclusion in the scope of the mandatory health insurance system . the competent authorities should also be able to include or generate additional relevant data for the purposes of assessing medicinal products .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicinal products for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 90 days of its receipt . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product has already been included in the public health insurance system .


### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 60 days of its receipt . however , with respect to medicines for which member states use health technology assessment as part of their decision - making process , the time - limit shall be 90 days . with respect to generic medicinal products , that time limit shall be 15 days , provided that the reference medicinal product has already been included in the public health insurance system . ### member states shall ensure that a decision on an application to include a medicinal product in the scope of the public health insurance system , submitted by the marketing authorisation holder in accordance with the requirements laid down in the member state concerned , is adopted and communicated to the applicant within 90 days of its receipt . with respect to generic medicinal products , that time limit shall be 30 days , provided that the reference medicinal product is essentially similar , within the meaning of directive 2001 / 83 / ec , and has already been included in the public health insurance system . if generic medicinal products display differences by comparison with the reference medicinal product , for example as regards their packaging or their therapeutic indications , member states may provide for their re - assessment .


### member states shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 60 days of the receipt of the application . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of the detailed additional information required and take their final decision within 60 days of receipt of this additional information . if the derogation is granted , the competent authorities shall forthwith publish an announcement of the price increase allowed . ### member states shall ensure that a reasoned decision on an application referred to in paragraph 2 is adopted and communicated to the applicant within 90 days of the receipt of the application . if the information supporting the application is inadequate , the competent authorities shall forthwith notify the applicant of what detailed additional information is required and take their final decision within 90 days of receipt of this additional information . if the derogation is granted , the competent authorities shall forthwith publish an announcement of the price increase allowed .


### in the framework of pricing and reimbursement decisions , member states shall not re - assess the elements on which the marketing authorisation is based , including the quality , safety , efficacy or bioequivalence of the medicinal product . ### in the framework of pricing and reimbursement decisions , member states should not be seeking to re - assess the essential elements on which the marketing authorisation is based . however , member states must be guaranteed full access to the data used by the authorities responsible for granting the marketing authorisation so that they can assess the relative safety , efficacy and efficiency of a medicinal product in the context of its inclusion in the scope of the mandatory health insurance system . the competent authorities should also be able to include or generate additional relevant data for the purposes of assessing medicinal products .