### as demonstrated by the sovereign debt crisis , and in particular by the need to put in place common financial backstops , member states whose currency is the euro share enhanced spillovers from their budgetary policy . each of the member states whose currency is the euro should consult the commission and other member states whose currency is the euro before the adoption of any major fiscal policy reform plans with potential spillover effects , so as to give the possibility for an assessment of possible impact for the euro area as a whole . they should consider their budgetary plans to be of common concern and submit them to the commission for monitoring purposes in advance of the plans becoming binding . the commission should be in a position , if necessary , to adopt an opinion on the draft budgetary plan , that the member state and in particular budgetary authorities should be invited to take into account in the process of the budget law adoption . such an opinion should ensure that union ' s policy guidance in the budgetary area is appropriately integrated in the national budgetary preparations . in particular , this opinion should include an assessment of whether or not the budgetary plans appropriately address the recommendations issued in the context of the european semester in the budgetary area . the commission should stand ready to present this opinion to the parliament of the member state concerned at its request . the extent to which this opinion has been taken into account should be part of the assessment , if and when the conditions are met , leading to the decision to place the concerned member state in excessive deficit procedure , where no follow - up to the early guidance from the commission should be considered as an aggravating factor . also , based on an overall assessment of the plans by the commission , the eurogroup should discuss the budgetary situation and prospects for the euro area . ### as demonstrated by the sovereign debt crisis , and in particular by the need to put in place common financial backstops , member states whose currency is the euro share enhanced spill - overs from their budgetary policy . each of the member states whose currency is the euro should consult the commission and other member states before the adoption of any major fiscal policy reform plans with potential spill - over effects , so as to give the possibility for an assessment of possible impact for all member states . they should consider their budgetary plans to be of common concern and submit them to the commission for monitoring purposes in advance of the plans becoming binding . the commission should be in a position , if necessary , to adopt an opinion on the draft budgetary plan , that the member state and in particular budgetary authorities should be invited to take into account in the process of the budget law adoption . such an opinion should ensure that union ' s policy guidance in the budgetary area is appropriately integrated in the national budgetary preparations . in particular , this opinion should include an assessment of whether or not the budgetary plans appropriately address the recommendations issued in the context of the european semester in the budgetary area . the commission should stand ready to present this opinion to the parliament of the member state concerned at its request . the extent to which this opinion has been taken into account should be part of the assessment , if and when the conditions are met , leading to the decision to place the concerned member state in excessive deficit procedure , where no follow - up to the early guidance from the commission should be considered as an aggravating factor . also , based on an overall assessment of the plans by the commission , the eurogroup should discuss the budgetary situation and prospects for the euro area .


### as demonstrated by the sovereign debt crisis , and in particular by the need to put in place common financial backstops , member states whose currency is the euro share enhanced spillovers from their budgetary policy . each of the member states whose currency is the euro should consult the commission and other member states whose currency is the euro before the adoption of any major fiscal policy reform plans with potential spillover effects , so as to give the possibility for an assessment of possible impact for the euro area as a whole . they should consider their budgetary plans to be of common concern and submit them to the commission for monitoring purposes in advance of the plans becoming binding . the commission should be in a position , if necessary , to adopt an opinion on the draft budgetary plan , that the member state and in particular budgetary authorities should be invited to take into account in the process of the budget law adoption . such an opinion should ensure that union ' s policy guidance in the budgetary area is appropriately integrated in the national budgetary preparations . in particular , this opinion should include an assessment of whether or not the budgetary plans appropriately address the recommendations issued in the context of the european semester in the budgetary area . the commission should stand ready to present this opinion to the parliament of the member state concerned at its request . the extent to which this opinion has been taken into account should be part of the assessment , if and when the conditions are met , leading to the decision to place the concerned member state in excessive deficit procedure , where no follow - up to the early guidance from the commission should be considered as an aggravating factor . also , based on an overall assessment of the plans by the commission , the eurogroup should discuss the budgetary situation and prospects for the euro area . ### as demonstrated by the sovereign debt crisis , and in particular by the need to put in place common financial backstops , member states whose currency is the euro share enhanced spill - overs from their budgetary and economic policies . each of the member states whose currency is the euro should consult the commission and other member states whose currency is the euro before the adoption of any major fiscal policy reform plans with potential spill - over effects , so as to give the possibility for an assessment of possible impact for the euro area as a whole . they should consider their budgetary plans to be of common concern and submit them to the commission for monitoring purposes in advance of the plans becoming binding . the commission should be in a position , if necessary , to adopt as soon as possible and no later than 15 november an opinion on the draft budgetary plan , that the member state and in particular budgetary authorities should be invited to take into account in the process of the budget law adoption . such an opinion should ensure that union ' s policy guidance in the budgetary area is appropriately integrated in the national budgetary preparations . in particular , this opinion should include an assessment of whether or not the budgetary plans appropriately address the recommendations issued in the context of the european semester in the budgetary area . the commission should stand ready to present this opinion without delay to the parliament of the member state concerned at its request . the extent to which this opinion has been taken into account should be part of the assessment , if and when the conditions are met , leading to the decision to place the concerned member state in excessive deficit procedure , where no follow - up to the early guidance from the commission should be considered as an aggravating factor . also , based on an overall assessment of the plans by the commission , the eurogroup and the competent committee of the european parliament should discuss the budgetary situation and prospects for the euro area .


### member states shall have in place numerical fiscal rules on the budget balance that implement in the national budgetary processes their medium - term budgetary objective as defined in article 2a of regulation no 1466 / 97 . such rules shall cover the general government as a whole and be of binding , preferably constitutional , nature . ### member states shall have in place numerical fiscal rules on the budget balance that implement in the national budgetary processes their medium - term budgetary objective as defined in article 2a of regulation no 1466 / 97 ; these rules may also include details concerning exceptional occurrences or severe economic downturns , in accordance with articles 5 and 6 of regulation no 1466 / 97 . such rules shall cover the general government as a whole and be of binding , preferably constitutional , nature .


### the commission opinion shall be made public and , at the request of the parliament of the member state concerned , shall be presented by the commission to the parliament concerned . ### the commission opinion shall be made public in its entirety unless the commission after consulting the eurogroup , decides otherwise . at the request of the parliament of the member state concerned , the commission shall present the published opinion to the parliament of the member state concerned and justify all its recommendations for adjustments of the proposed national budget before the parliament of the member state concerned takes a simple majority vote on this opinion to adopt it or reject it .


### member states shall make public annually their medium - term fiscal plans in accordance with their medium - term budgetary framework based on independent macroeconomic forecast together with their stability programmes , no later than 15 april . ### member states shall , in the context of the european semester defined in article 2 - a of regulation no 1466 / 97 make public , preferably by 30 april each year , their national medium - term fiscal plans in accordance with their medium - term budgetary framework , based on credible and independent macroeconomic forecasts . such plans shall be presented together with the nrps and scps and shall be fully compatible with the policy orientations based on the annual growth survey and the annual reports under the macroeconomic imbalances procedure as established in regulation no 1174 / 2011 and regulation no 1176 / 2011 .


### the commission opinion shall be made public and , at the request of the parliament of the member state concerned , shall be presented by the commission to the parliament concerned . ### the commission opinion shall be made public . at the request of the parliament of the member state concerned , the commission shall present it to the parliament concerned , giving detailed reasons for the measures called for .


### when the council decides in accordance with article 126 of the treaty that an excessive deficit exists in a member state , the member state concerned shall be subject to paragraphs 2 to 5 of this article , until the abrogation of its excessive deficit procedure . ### when the council decides in accordance with article 126 tfeu that an excessive deficit exists in a member state after the entry into force of this regulation , the member state concerned shall be subject to paragraphs 2 to 5 of this article , until the abrogation of its excessive deficit procedure .


### in case of risks of non - compliance with the deadline to correct the excessive deficit , the commission shall address a recommendation to the member state concerned for adoption of further measures within a timeframe consistent with the deadline for the correction of its excessive deficit referred to in paragraph 1 . the recommendation by the commission shall be made public , and , at the request of the parliament of the member state concerned , shall be presented by the commission to the parliament concerned . ### in case of risks of non - compliance with the deadline to correct the excessive deficit , the commission shall address a recommendation to the member state concerned for adoption of further measures within a timeframe consistent with the deadline for the correction of its excessive deficit referred to in paragraph 1 . the commission opinion shall be made public and presented to the eurogroup . at the request of the parliament of the member state concerned , it shall be presented by the commission to the parliament concerned .


### member states shall make public annually their medium - term fiscal plans in accordance with their medium - term budgetary framework based on independent macroeconomic forecast together with their stability programmes , no later than 15 april . ### member states shall make public annually their medium - term fiscal plans in accordance with their medium - term budgetary framework based on independent macroeconomic forecast together with their stability programmes , no later than 30 april .


### budget laws for the general government shall be adopted and made public annually no later than 31 december . ### the budget for the central government shall be adopted and made public annually no later than 31 december . member states shall have in place reversionary budget procedures in case that the budget is not adopted by 31 december .


### this gradually strengthened surveillance will further complement the existing provisions of the stability and growth pact and strengthen the surveillance of budgetary discipline in member states whose currency is the euro . a gradually enhanced monitoring procedure should contribute to better budgetary outcomes to the benefit of all member states whose currency is the euro . as part of a gradually strengthened procedure , a closer monitoring is particularly valuable to member states that are subject to an excessive deficit procedure . ### this gradually strengthened surveillance and coordination will further complete the european semester for economic policy coordination , complement the existing provisions of the stability and growth pact and strengthen the surveillance of budgetary soundness and economic convergence in member states whose currency is the euro . a gradually enhanced monitoring procedure should contribute to better budgetary and economic outcomes to the benefit of all member states whose currency is the euro . as part of a gradually strengthened procedure , a closer monitoring is particularly valuable to member states that are subject to an excessive deficit procedure .


### setting - up a common budgetary timeline for member states whose currency is the euro should better synchronize the key steps in the preparation of national budgets , thus contributing to the effectiveness of the european semester for budgetary policy coordination . adopting a common budgetary timeline should lead to stronger synergies by facilitating policy coordination among member states whose currency is the euro and ensure that the council and commission recommendations are appropriately integrated in the national process for budget adoption . ### setting - up a common budgetary timeline for member states whose currency is the euro should better synchronize the key steps in the preparation of national budgets , thus contributing to the effectiveness of the european semester for economic and budgetary policy coordination . adopting a common budgetary timeline should lead to stronger synergies by facilitating policy coordination among member states whose currency is the euro and ensure that the country - specific policy recommendations and the national reform programmes and stability and convergence programmes , as well as the recommendations based on the macroeconomic imbalances analysis are appropriately integrated in the national process for budget adoption .


### the amendments to the stability and growth pact increase both the guidance , and , for the member states whose currency is the euro , incentives for the setting and the implementation of a prudent budgetary policy , while avoiding excessive government deficits . these provisions have created a more robust framework at the level of the union for the surveillance of national economic policies . ### the amendments to the stability and growth pact increase both the guidance , and , for the member states whose currency is the euro , incentives for the setting and the implementation of a prudent budgetary policy , while avoiding excessive government deficits . these provisions have created a more robust framework at the level of the union for the surveillance of national economic policies . an enhanced surveillance of social policies linked with job creation should be added to these provisions .


### the commission shall , if necessary , adopt an opinion on the draft budgetary plan by 30 november . ### the commission shall , if necessary , adopt an opinion on the draft budgetary plan as soon as possible and no later than 15 november


### as demonstrated by the sovereign debt crisis , and in particular by the need to put in place common financial backstops , member states whose currency is the euro share enhanced spillovers from their budgetary policy . each of the member states whose currency is the euro should consult the commission and other member states whose currency is the euro before the adoption of any major fiscal policy reform plans with potential spillover effects , so as to give the possibility for an assessment of possible impact for the euro area as a whole . they should consider their budgetary plans to be of common concern and submit them to the commission for monitoring purposes in advance of the plans becoming binding . the commission should be in a position , if necessary , to adopt an opinion on the draft budgetary plan , that the member state and in particular budgetary authorities should be invited to take into account in the process of the budget law adoption . such an opinion should ensure that union ' s policy guidance in the budgetary area is appropriately integrated in the national budgetary preparations . in particular , this opinion should include an assessment of whether or not the budgetary plans appropriately address the recommendations issued in the context of the european semester in the budgetary area . the commission should stand ready to present this opinion to the parliament of the member state concerned at its request . the extent to which this opinion has been taken into account should be part of the assessment , if and when the conditions are met , leading to the decision to place the concerned member state in excessive deficit procedure , where no follow - up to the early guidance from the commission should be considered as an aggravating factor . also , based on an overall assessment of the plans by the commission , the eurogroup should discuss the budgetary situation and prospects for the euro area . ### as demonstrated by the sovereign debt crisis , and in particular by the need to put in place common financial backstops , member states whose currency is the euro share enhanced spillovers from their budgetary and macroeconomic policy . each of the member states whose currency is the euro should consult the commission and other member states whose currency is the euro before the adoption of any major fiscal policy reform plans with potential spillover effects , so as to give the possibility for an assessment of possible impact for the euro area as a whole , including social and environmental impact . they should consider their budgetary plans to be of common concern and submit them to the commission for monitoring purposes in advance of the plans becoming binding . the commission should be in a position , if necessary , to adopt an opinion on the draft budgetary plan , that the member state and in particular budgetary authorities should be invited to take into account in the process of the budget law adoption . such an opinion should ensure that union ' s policy guidance given in the european semester is appropriately integrated in the national budgetary preparations . in particular , this opinion should include an assessment of whether or not the budgetary plans appropriately address the ' eu 2020 ' growth , employment and social targets as well as the recommendations issued in the context of the european semester . the commission should stand ready to present this opinion to the parliament of the member state concerned at its request . the extent to which this opinion has been taken into account should be part of the assessment , if and when the conditions are met , leading to the decision to place the concerned member state in excessive deficit procedure , where no follow - up to the early guidance from the commission should be considered as an aggravating factor . also , based on an overall assessment of the plans by the commission , the eurogroup should discuss the budgetary situation and prospects for the euro area .


### member states shall have in place numerical fiscal rules on the budget balance that implement in the national budgetary processes their medium - term budgetary objective as defined in article 2a of regulation no 1466 / 97 . such rules shall cover the general government as a whole and be of binding , preferably constitutional , nature . ### member states shall have in place numerical fiscal rules on the budget balance that implement in the national budgetary processes their medium - term budgetary objective as defined in article 2a of regulation no 1466 / 97 . such rules shall cover the general government as a whole and be of binding force and permanent character , preferably constitutional , or otherwise guaranteed to be fully respected and complied with throughout the national budgetary processes .


### member state shall report regularly to the commission and to the economic and financial committee or any sub - committee it will designate for that purpose , for the general government and its sub - sectors , the in - year budgetary execution , the budgetary impact of discretionary measures taken on both the expenditure and the revenue side , targets for the government expenditure and revenues , as well as information on the measures adopted and the nature of those envisaged to achieve the targets . the report shall be made public . ### the member state shall report regularly to the commission and to the economic and financial committee or any sub - committee it will designate for that purpose , for the general government and its sub - sectors , the in - year budgetary execution , the budgetary impact of discretionary measures taken on both the expenditure and the revenue side , targets for the government expenditure and revenues , as well as information on the measures adopted and the nature of those envisaged to achieve the targets . the member state shall also report on the implementation of the budgetary and economic partnership programme and the structural reforms necessary to ensure an effective and durable correction of its excessive debt . the report shall be made public .


### as demonstrated by the sovereign debt crisis , and in particular by the need to put in place common financial backstops , member states whose currency is the euro share enhanced spillovers from their budgetary policy . each of the member states whose currency is the euro should consult the commission and other member states whose currency is the euro before the adoption of any major fiscal policy reform plans with potential spillover effects , so as to give the possibility for an assessment of possible impact for the euro area as a whole . they should consider their budgetary plans to be of common concern and submit them to the commission for monitoring purposes in advance of the plans becoming binding . the commission should be in a position , if necessary , to adopt an opinion on the draft budgetary plan , that the member state and in particular budgetary authorities should be invited to take into account in the process of the budget law adoption . such an opinion should ensure that union ' s policy guidance in the budgetary area is appropriately integrated in the national budgetary preparations . in particular , this opinion should include an assessment of whether or not the budgetary plans appropriately address the recommendations issued in the context of the european semester in the budgetary area . the commission should stand ready to present this opinion to the parliament of the member state concerned at its request . the extent to which this opinion has been taken into account should be part of the assessment , if and when the conditions are met , leading to the decision to place the concerned member state in excessive deficit procedure , where no follow - up to the early guidance from the commission should be considered as an aggravating factor . also , based on an overall assessment of the plans by the commission , the eurogroup should discuss the budgetary situation and prospects for the euro area . ### member states whose currency is the euro share enhanced spillovers from their budgetary and economic policies . each of the member states whose currency is the euro should consult the commission and other member states whose currency is the euro before the adoption of any major economic and fiscal policy reform plans with potential spillover effects , so as to give the possibility for an assessment of possible impact for the euro area as a whole . they should consider their budgetary and economic plans to be of common concern and submit them to the commission for monitoring purposes in advance of the plans becoming binding . the commission should be in a position , if necessary , to adopt an opinion on the draft budgetary plan , that the member state should be invited to take into account in the process of the budget law adoption . such an opinion should ensure that union ' s policy guidance in the economic and budgetary area is appropriately integrated in the national budgetary preparations . in particular , this opinion should include an assessment of whether or not the budgetary plans appropriately address the recommendations issued in the context of the european semester in the economic and budgetary area . in the same context , the commission should ensure that member states ' commitments within the framework of their national reform programmes , commitments made within the framework of economic partnership programmes , and any council recommendations within the macroeconomic imbalances procedure , are appropriately reflected in the draft national budget . the commission should stand ready to present this opinion to the parliament of the member state concerned at its request . the extent to which this opinion has been taken into account should be part of the assessment , if and when the conditions are met , leading to the decision to place the concerned member state in excessive deficit procedure , where no follow - up to the early guidance from the commission should be considered as an aggravating factor . also , based on an overall assessment of the plans by the commission , the eurogroup should discuss the budgetary situation and prospects for the euro area .


### carry out and report on a comprehensive independent audit of the accounts of the general government conducted in coordination with national supreme audit institutions , aiming at assessing the reliability , completeness and accuracy of these public accounts for the purposes of the excessive defiocit procedure . in this context , the commission shall assess the quality of data reported by the member state concerned in accordance with regulation no 679 / 20103 ; ### carry out and report on a comprehensive independent audit of the accounts of the general government and its subsectors conducted in coordination with national supreme audit institutions , aiming at assessing the reliability , completeness and accuracy of these public accounts for the purposes of the excessive deficit procedure . in this context , the commission shall assess the quality of data reported by the member state concerned in accordance with regulation no 679 / 20103 ;


### member state shall report regularly to the commission and to the economic and financial committee or any sub - committee it will designate for that purpose , for the general government and its sub - sectors , the in - year budgetary execution , the budgetary impact of discretionary measures taken on both the expenditure and the revenue side , targets for the government expenditure and revenues , as well as information on the measures adopted and the nature of those envisaged to achieve the targets . the report shall be made public . ### the member state subject to closer monitoring shall report regularly to the commission and to the economic and financial committee or any sub - committee it will designate for that purpose , for the general government and its sub - sectors , the in - year budgetary execution , the budgetary impact of discretionary measures taken on both the expenditure and the revenue side , targets for the government expenditure and revenues , as well as information on the measures adopted and the nature of those envisaged to achieve the targets . the report shall be made public .


### article 103o of council regulation no 1234 / 2007 of 22 september 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products provides for a possibility for the member states to grant decoupled aid under the single payment scheme to vine - growers . several member states have used this possibility , which shows the utility of that measure . ### article 103o of council regulation no 1234 / 2007 of 22 september 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products provides for a possibility for the member states to grant decoupled aid under the single payment scheme to vine - growers . those member states which have used this possibility may continue to do so .


### article 103o of council regulation no 1234 / 2007 of 22 september 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products provides for a possibility for the member states to grant decoupled aid under the single payment scheme to vine - growers . several member states have used this possibility which shows the utility of that measure . ### article 103o of council regulation no 1234 / 2007 of 22 september 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products provides for a possibility for the member states to grant decoupled aid under the single payment scheme to vine - growers . several member states have used this possibility .


### the financial envelope for implementing the community activities referred to in this decision for the period from 1 january 2007 to 31 december 2013 is hereby set at eur 643 250 000 . ### the financial envelope for implementing the community activities referred to in this decision for the period from 1 january 2007 to 31 december 2013 is hereby set at eur 743 250 000 .


### member states shall ensure that , in the case of a cartel infringement , it shall be presumed that the infringement caused harm . the infringing undertaking shall have the right to rebut this presumption . ### member states shall provide that national courts be granted the power to establish the existence , and estimate the amount , of harm taking into account the presentation of evidence by the parties .


### unless a different agreement has been concluded with the buyer of the vehicle , the certificate of conformity shall be drawn up in the official language of the member state where the vehicle is purchased . ### the certificate of conformity shall be drawn up in one of the official languages of the union . any member state may request the certificate of conformity to be translated into its own language or languages .


### the euro 5 emission limits referred to in annex vi and the obd thresholds in annex vi ; ### the euro 5 emission limits referred to in annex v , annex vi and the obd thresholds in annex vi ;


### the commission shall lay down the specific requirements regarding the measures referred to in paragraph 2 by means of a delegated act adopted in accordance with articles 76 , 77 and 78 . ### the commission shall lay down the specific technical requirements and specifications regarding the measures referred to in paragraph 2 by means of a delegated act in accordance with article 76 .


### manufacturers shall provide unrestricted access to vehicle repair and maintenance information to independent operators through websites using a standardised format in a readily accessible and prompt manner . in particular , this access shall be granted in a manner which is non - discriminatory compared to the access granted to authorised dealers and repairers . ### manufacturers shall provide unrestricted access to vehicle repair and maintenance information to independent operators through websites using a standardised format in a readily accessible and prompt manner . in particular , this information shall be made available in a manner which is non - discriminatory compared to the repair and maintenance information provided to authorised dealers and repairers .


### powers are conferred on the commission to adopt , in accordance with article 76 , 77 and 78 a delegated act laying down the detailed technical requirements related to on - board diagnostics , including functional obd requirements and test procedures for the subjects listed in paragraphs 1 to 5 in order to ensure a high level of functional safety , environmental protection and the same standardised level of access to repair and maintenance information for all vehicle repairers . ### the commission shall , by means of a delegated act in accordance with article 76 , lay down the detailed technical requirements related to obd , including functional requirements and test procedures in order to ensure a high level of functional safety , environmental protection and the same standardised level of access to repair and maintenance information for all vehicle repairers .


### based on the findings of the environmental effect study the commission shall confirm : ### the commission shall report to the european parliament and to the council on the findings of the environmental effect study and proposed definitive policy measures as regards :


### where distributors consider or have reason to believe that a vehicle , system , component or separate technical unit is not in conformity with the requirements of this regulation , they shall not sell or register the vehicle , system , component or separate technical unit and shall prevent its entry into service until it has been brought into conformity . ### where distributors consider or have reason to believe that a vehicle , system , component or separate technical unit is not in conformity with the requirements of this regulation , they shall contact the competent authorities and shall not sell or register the vehicle , system , component or separate technical unit until they have received confirmation from the competent authorities that it is in conformity with this regulation and shall prevent its entry into service until it has been brought into conformity .


### paragraph 1 shall not apply to systems , components or separate technical units produced for vehicles intended exclusively for racing on roads . if systems , components or separate technical units on a list in a delegated act to this regulation have a dual use , for vehicles intended exclusively for racing on roads and for vehicles intended for use on public roads , they may not be sold or offered for sale to consumers . ### paragraph 1 shall not apply to systems , components or separate technical units produced for vehicles intended exclusively for sport activities not taking place on the public road . if systems , components or separate technical units on a list in a delegated act to this regulation have a dual use , for vehicles intended exclusively for those sport activities and for vehicles intended for use on public roads , they may not be sold or offered for sale to consumers .


### l - category vehicles shall be equipped with designated measures to prevent tampering of a vehicle ' s powertrain , to be laid down in a delegated act by means of a series of technical requirements and specifications with the aim : ### l - category vehicles shall be equipped with designated measures to prevent tampering of a vehicle ' s powertrain with the aim :


### this regulation aims to lay down harmonised rules for the approval of l - category vehicles , with a view to ensuring the functioning of the internal market . l - category vehicles are two - , three - or four - wheel vehicles such as powered two - wheel vehicles , tricycles , on - road quads and mini - cars . in addition , the objectives are to simplify the current legal framework , to contribute to a lower , more proportionate share in overall road transport emissions , to increase the overall level of safety , to adapt to technical progress and to strengthen the rules on market surveillance . ### this regulation aims to lay down harmonised rules for the approval of l - category vehicles , with a view to ensuring the functioning of the internal market . l - category vehicles are two - , three - or four - wheel vehicles such as powered two - wheel vehicles , tricycles , on - road quads , all - terrain vehicles and mini - cars . in addition , the objectives are to simplify the current legal framework , to contribute to a lower , more proportionate share in overall road transport emissions , to increase the overall level of safety , to adapt to technical progress and to strengthen the rules on market surveillance .


### by 1 january 2016 at the latest , the commission shall carry out a comprehensive environmental effect study . the study shall evaluate the air quality and the share of pollutants contributed by l - category vehicles and shall cover the requirements of test types i , iv , v , vii and viii listed in annex v . it shall collate and evaluate the latest scientific data , scientific research findings , modelling and cost efficiency with a view to establishing definitive policy measures by confirmation of the euro 5 enforcement dates laid down in annex iv and the euro 5 environmental requirements laid down in annexes v , vi , vi , vi and annex vii concerning euro 5 durability mileages and deterioration factors . ### by 1 january 2016 the commission shall carry out a comprehensive environmental effect study . the study shall evaluate the air quality and the share of pollutants contributed by l - category vehicles and shall cover the requirements of test types i , iv , v , vii and viii listed in annex v . it shall collate and evaluate the latest scientific data , scientific research findings , modelling and cost efficiency with a view to establishing definitive policy measures on issues referred to in paragraph 5 .


### an individual approval shall apply to a particular vehicle , whether it is unique or not . ### an individual approval shall apply to a particular vehicle , whether it is unique or not . unique amateur built vehicles shall benefit from simplified and affordable application to individual approval .


### the amount of end - of - series vehicle shall not exceed 10 % of the number of vehicles registered in the two preceding years or 10 vehicles per member state , whatever is the highest . ### the amount of end - of - series vehicle shall not exceed 10 % of the number of vehicles registered in the two preceding years or 50 vehicles per member state , whatever is the highest .


### where importers consider or have reason to believe that a vehicle , system , component or separate technical unit is not in conformity with the requirements of this regulation , in particular does not correspond to its type - approval , they shall not sell or register the vehicle , system , component or separate technical unit until it has been brought into conformity . furthermore , where they consider or have reason to believe that the vehicle , system , component or separate technical unit presents a risk , they shall inform the manufacturer , the market surveillance and approval authorities to that effect . ### where importers consider or have reason to believe that a vehicle , system , component or separate technical unit is not in conformity with the requirements of this regulation , in particular does not correspond to its type - approval , they shall contact the competent authorities and shall not sell or register the vehicle , system , component or separate technical unit until they have received confirmation from the competent authorities that it is in conformity with this regulation . furthermore , where they consider or have reason to believe that the vehicle , system , component or separate technical unit presents a risk , they shall inform the manufacturer , the market surveillance and approval authorities to that effect .


### member states shall provide the commission with data on the population as referred to in article 2 and at the reference time . where the circumstances described in article 2 i . or ii . cannot be established , member states shall provide the commission with data on population at their place of legal or registered residence at the reference time ; in this case , they shall undertake proportionate efforts to compute data which are the closest possible approximation to the population referred to in article 2 and . ### member states shall provide the commission with statistical data on the population as referred to in article&#160 ; 2 and at the reference time . where the circumstances described in article&#160 ; 2 or cannot be established , member states shall provide the commission with statistical data on population at their place of legal or registered residence at the reference time ; in this case , they shall undertake proportionate efforts to compute data which are the closest possible approximation to the statistical data of the population referred to in article&#160 ; 2 and .


### ‘ usually resident population’ means all persons having their usual residence in a member state at the reference time ; ### ‘ european citizens’ means all persons having their citizenship of a member state at the reference time ;


### member states shall use the same population definition for all national and regional levels as defined in article 2 and . ### member states shall use the same population definition for all national levels as defined in article 2 and local levels .


### for the purposes of qualified majority voting in the council , member states shall provide the commission with data on the total population at national level at the reference time , as referred to in article 2 , within 8 months from the end of the reference year . for the purposes of this article , member states shall not provide data on population at their place of legal or registered residence at the reference time . ### for the purposes of qualified majority voting in the council , member states shall provide the commission with data on the total population at national level at the reference time , as referred to in article 2 , within 8 months from the end of the reference year .


### pursuant to article 175 of the treaty on the functioning of the european union , the commission submits every three years a report to the european parliament , the council , the economic and social committee and the committee of the regions on the progress made towards achieving economic , social and territorial cohesion . the preparation of these reports and the regular monitoring of demographic developments and of possible future demographic challenges in the eu regions , including different types of regions such as cross - border regions , metropolitan regions , rural regions , mountain and island regions , require annual regional data at nuts 3 regional level . since demographic ageing displays strong regional differences , eurostat is requested to prepare regional projections on a regular basis in order to complement the demographic picture of the nuts 2 regions in the european union . ### pursuant to article 175 of the treaty on the functioning of the european union , the commission submits every three years a report to the european parliament , the council , the economic and social committee and the committee of the regions on the progress made towards achieving economic , social and territorial cohesion . the preparation of these reports and the regular monitoring of demographic developments and of possible future demographic challenges in the eu regions , require annual regional data at nuts 3 regional level . since demographic ageing displays strong regional differences , eurostat is requested to prepare regional projections on a regular basis in order to complement the demographic picture of the nuts 2 regions in the european union .


### for the purposes of qualified majority voting in the council , member states shall provide the commission with data on the total population at national level at the reference time , as referred to in article 2 , within 8 months from the end of the reference year . for the purposes of this article , member states shall not provide data on population at their place of legal or registered residence at the reference time . ### for the purposes of qualified majority voting in the council , member states shall provide the commission with data on the population of their citizens at the reference time . for the purposes of this article , member states shall provide data on population at the place of their permanent residence at the reference time .


### for the purposes of qualified majority voting in the council , member states shall provide the commission with data on the total population at national level at the reference time , as referred to in article 2 , within 8 months from the end of the reference year . for the purposes of this article , member states shall not provide data on population at their place of legal or registered residence at the reference time . ### for the purposes of qualified majority voting in the council , member states shall provide the commission with data on the number of their citizens at the reference time . for the purposes of this article , member states shall provide data on population at the place of permanent residence at the reference time .


### ' usual residence ' means the same as in article 2 first paragraph of regulation no 763 / 2008 . the following persons alone shall be considered to be usual residents of the geographical area in question : ### ' permanent residence ' means the same as ' usual residence ' as that term is defined in the first paragraph of article 2 of regulation no 763 / 2008 . the following persons alone shall be considered to be permanent residents of the geographical area in question :


### member states shall provide the commission with data on vital events at the reference time , regardless of the place where the events occurred . member states shall use the same population definition as for the data referred to in paragraph . ### member states shall provide the commission with data on vital events at the reference time .


### ‘ usual residence’ means the same as in article 2 first paragraph of regulation no 763 / 2008 . the following persons alone shall be considered to be usual residents of the geographical area in question : ### ‘ usual residence’ shall mean the place where a person normally spends the daily period of rest , regardless of temporary absences for purposes of recreation , holidays , visits to friends and relatives , business , medical treatment or religious pilgrimage . the following persons alone shall be considered to be usual residents of the geographical area in question :


### member states shall provide the commission with data on the population as referred to in article 2 and at the reference time . where the circumstances described in article 2 i . or ii . cannot be established , member states shall provide the commission with data on population at their place of legal or registered residence at the reference time ; in this case , they shall undertake proportionate efforts to compute data which are the closest possible approximation to the population referred to in article 2 and . ### member states shall provide the commission with data on their citizens at the reference time . where the circumstances described in article 2 i . or ii . cannot be established , member states shall provide the commission with data on population at their place of permanent residence at the reference time .


### telecommunications networks and services are increasingly becoming internet - based infrastructures , with broadband networks and digital services closely interrelated . the internet is becoming the dominant platform for communication , services , and doing business . therefore , the trans - european availability of fast internet access and digital services in the public interest is essential for economic growth and the single market . ### telecommunications networks and services are increasingly becoming internet - based infrastructures , with broadband networks and digital services closely interrelated . the internet is becoming the dominant platform for communication , services , education , participating in the social and political life , and doing business . therefore , the trans - european availability of fast internet access and digital services in the public interest is essential for social and economic growth and the single market .


### actions funded from additional ring - fenced contributions provided in accordance with article 15 . 2 of regulation no xxxx / 2012 [ cef regulation ] shall bring significant new capabilities to the market in terms of broadband service availability , speeds and capacity . projects which provide speeds of data transmission of less than 30 mbps should ensure the increase of speeds to at least 30 mbps over time . ### actions funded from additional ring - fenced contributions provided in accordance with article 15 . 2 of regulation no xxxx / 2012 [ cef regulation ] shall bring significant new capabilities to the market in terms of broadband service availability , speeds and capacity . projects which provide speeds of data transmission of less than 100 mbps should ensure the increase of speeds to at least 100 mbps over time .


### telecommunications networks and services are increasingly becoming internet - based infrastructures , with broadband networks and digital services closely interrelated . the internet is becoming the dominant platform for communication , services , and business . therefore , the trans - european availability of fast internet access and digital services in the public interest is essential for economic growth and the single market . ### digital networks and services are increasingly becoming internet - based infrastructures , with broadband networks and digital services closely interrelated . the internet is becoming the dominant platform for communication , services , and business . therefore , the trans - european availability of fast internet access and digital services in the public interest is essential for economic growth and the single market .


### telecommunications networks and services are increasingly becoming internet - based infrastructures , with broadband networks and digital services closely interrelated . the internet is becoming the dominant platform for communication , services , and doing business . therefore , the trans - european availability of fast internet access and digital services in the public interest is essential for economic growth and the single market . ### digital networks and services are increasingly becoming internet - based infrastructures , with broadband networks and digital services closely interrelated . the internet is becoming the dominant platform for communication , services , education , participating in social and political life , and business . therefore , the trans - european availability of widespread , fast , secure internet access and digital services in the public interest is essential for social and economic growth , competitiveness , social inclusion and the single market .


### contribute to improvements in daily life for citizens , businesses and governments through the promotion of the interconnection and interoperability of national telecommunication networks as well as access to such networks . ### contribute to improvements in daily life for citizens , businesses and governments through the promotion of the interconnection and interoperability of national , regional and local telecommunication networks as well as access to such networks .


### ' telecommunications networks ' means broadband networks and digital service infrastructures . ### ' digital networks ' means broadband networks and digital service infrastructures .


### the expert group may also consider any other issue relating to the development of the trans - european telecommunications networks . ### the expert group may also consider any other issue relating to the development of the trans - european digital networks .


### where the amounts due to rightholders cannot be distributed , after five years from the end of the financial year in which the collection of the rights revenue occurred , and provided that the collecting society has taken all necessary measures to identify and locate the rightholders , the collecting society shall decide on the use of the amounts concerned in accordance with article 7 , without prejudice to the right of the rightholder to claim such amounts from the collecting society . ### where the amounts due to rightholders cannot be distributed , after five years from the end of the financial year in which the collection of the rights revenue occurred , and provided that the collective management organisation has taken all necessary measures to identify and locate the rightholders , the collective management organisation shall decide on the use of the amounts concerned in accordance with article 7 , provided that the collective management organisation ensures that the revenue is distributed in proportion to the revenues received by rightholders for the relevant financial year . collective management organisations may distribute amounts due to rightholders who cannot be identified before the expiration of the five - year period if allowed under national law . where , under national law , the prescription period is longer than five years , collective management organisations shall make adequate provisions for future claims without prejudice to the right of the rightholder to claim such amounts from the collective management organisation .


### rightholders shall have the right to authorise a collecting society of their choice to manage the rights , categories of rights or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collecting society or the rightholder . ### rightholders shall have the right to authorise a collective management organisation of their choice to manage the rights , categories of rights or types of works and other subject matter of their choice , for the member states of their choice , irrespective of the member state of residence or of establishment or the nationality of either the collective management organisation or the rightholder . collective management organisations shall have the right to require the exclusive assignment of the rights in all works of their members .


### 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 collective management organisations . to this end , collective management organisations should establish a supervisory function appropriate to their organisational structure and allow members , representing different categories of rightholders , to be represented in the body that exercises this 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 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 collective management organisations . to this end , collective management organisations should establish a supervisory function appropriate to their organisational structure and allow the different categories of members to be represented in fair and balanced manner 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 .


### tariffs for exclusive rights shall reflect the economic value of the rights in trade and of the service provided by the collecting society . ### tariffs for exclusive rights and rights to equitable remuneration shall reflect the economic value of the rights in trade and the economic benefit that users derive from the collective management of rights .


### activities dependent on the passing of the seasons are typically to be found in sectors such as agriculture , during the planting or harvesting period , or tourism , during the holiday period . ### activities dependent on the passing of the seasons are to be found in the agriculture and horticulture sectors , for example during the planting or harvesting periods , and in the tourism sector , for example during the holiday periods . there should be the possibility for member states to decide , with the involvement of the social partners and in consultation with them , to consider additional activities dependent on the passing of seasons as seasonal activities , for the purposes of this directive .


### member states shall ensure that third parties which have , in accordance with the criteria laid down by their national law , a legitimate interest in ensuring compliance with this directive , may engage either on behalf of or in support of a seasonal worker , with his / her approval , in any administrative or civil proceedings provided for with the objective of implementing this directive . ### member states shall ensure that third parties which have , in accordance with the criteria laid down by their national law , a legitimate interest in ensuring compliance with this directive , may engage either on behalf of or in support of a seasonal worker , with his / her approval and after providing clear and comprehensible information , in any administrative or civil proceedings provided for with the objective of implementing this directive .


### member states shall require employers of seasonal workers to provide evidence that the seasonal worker will benefit from accommodation that ensures an adequate standard of living . if seasonal workers are required to pay rent for such accommodation , its cost shall not be excessive in relation to their remuneration . ### member states shall require employers of seasonal workers to provide evidence that the seasonal worker will benefit from adequate accommodation , pursuant to national legislation and practice , that ensures a decent standard of living . as a minimum , such accommodation shall provide the inhabitants with adequate space , shall protect them from the elements and other threats to health , shall be safe and well maintained , and shall provide the facilities essential for health , security , comfort and nutrition , such as safe drinking water , systems for cooking , heating and lighting , sanitation and washing facilities , means of food storage and refuse disposal . the accommodation shall allow access to basic services .


### member states may verify whether the vacancy concerned could not be filled by national or eu , or by third - country nationals lawfully residing in the member state and already forming part of its labour market by virtue of eu or national law and reject the application . ### before taking the decision on an application for seasonal employment , member states shall examine the situation of their labour market and shall verify whether the vacancy concerned could not be filled by national or eu , or by third - country nationals lawfully residing in the member state and already forming part of its labour market by virtue of eu or national law and reject the application . member states shall reject an application for seasonal employment in labour market sectors to which access to workers from other member states is restricted on the basis of the transitional arrangements set out in the acts of accession of 16 april 2003 and 25 april 2005 .


### in order to ensure open choice for customers and fair competition , as well as encourage innovation and boost the competitiveness of the union’s information technology industry on the global market , the ecall in - vehicle system should be accessible free of charge and without discrimination to all independent operators and based on an interoperable and open - access platform for possible future in - vehicle applications or services . ### in order to ensure open choice for customers and fair competition , as well as encourage innovation and boost the competitiveness of the union’s information technology industry on the global market , the ecall in - vehicle system should be accessible free of charge and without discrimination to all independent operators and based on an interoperable , open - access and secured platform for possible future in - vehicle applications or services .


### in order to ensure open choice for customers and fair competition , as well as encourage innovation and boost the competitiveness of the union’s information technology industry on the global market , the ecall in - vehicle system should be accessible free of charge and without discrimination to all independent operators and based on an interoperable and open - access platform for possible future in - vehicle applications or services . ### in order to ensure open choice for customers and fair competition , as well as encourage innovation and boost the competitiveness of the union’s information technology industry on the global market , the 112 - based ecall in - vehicle system should be accessible free of charge in a standardised form and without discrimination to all independent operators and based on an interoperable and open - access platform for possible future in - vehicle applications or services .


### making the best use of unwanted catches of commercial stocks by : ### assisting their members to develop and implement measures to minimise and avoid unwanted catches of commercial stocks


### aquaculture producer organisations make use of the following measures to achieve the objectives referred to in article 10 : ### aquaculture producer organisations may make use , inter alia , of the following measures to achieve the objectives referred to in article 10 :


### the date of catch of fishery products or harvest of aquaculture products ; ### the date of landing of fishery products , except for frozen products under point a ) of annex i , or the date of harvest of aquaculture products ;


### promoting viable fishing activities of their members in full compliance with the conservation policy laid down in the regulation on the common fisheries policy and environmental legislation ; ### promoting viable and sustainable fishing activities of their members in full compliance with the conservation policy laid down in the regulation on the common fisheries policy and environmental legislation ;


### within two months of receipt of the notification , the commission shall take a decision authorising or refusing to authorise the extension of rules and shall inform the member states . where the commission has not taken a decision within the two - month period , the extension of rules shall be deemed to have been authorised by the commission . ### within 15 days of receipt of the notification , the commission shall take a decision authorising or refusing to authorise the extension of rules and shall inform the member states . where the commission has not taken a decision within the 15 - day period , the extension of rules shall be deemed to have been authorised by the commission .


### the date of catch of fishery products or harvest of aquaculture products ; ### for products which are to be sold fresh , the date of landing of fishery products or harvest of aquaculture products ;


### producer organisations may create a collective fund to finance the production and marketing plans and the storage mechanism . ### producer organisations shall be allocated community financial assistance under the european maritime and fisheries fund to finance the production and marketing plans and the storage mechanism .


### the common market organisation shall be guided by the principles of good governance laid down in article 4 of the regulation on the common fisheries policy . ### the common market organisation shall be guided by the principles of good governance , clearly defining responsibilities at the union , national , regional and local levels , with a long - term perspective , the broad involvement of stakeholders , the responsibility of the flag state , and consistency with the integrated maritime policy , the trade policy and other union policies .


### they comply with the competition rules laid down in chapter vi ; ### they comply with the competition rules laid down in chapter v ;


### the scientific name for each species according to the fishbase information system ; ### the scientific name for each species ;


### for the purposes of paragraph 1 a fishery producer organisation is deemed representative where it accounts for at least 65 % of the quantities marketed of the relevant product during the previous year in the area where it is proposed to extend the rules . ### for the purposes of paragraph 1 a fishery producer organisation is deemed representative where it accounts for at least 30 % of the quantities marketed of the relevant product during the previous year in the area where it is proposed to extend the rules


### whether the product is fresh or has been defrosted ; ### whether the product is being sold as fresh when it has previously been defrosted ;


### in order to be able to supplement or amend the conditions and requirements for recognition of producers organisations , supplement or amend the content of the production and marketing plan , define and amend the common marketing standards , supplement or amend mandatory information and set minimum criteria for information voluntarily provided by operators to the consumers , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of articles 24 , 33 , 41 and 46 . ### in order to be able to establish rules that may concern the internal functioning of producer organisations , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of article 24 .


### each producer organisation shall submit a production and marketing plan to their competent national authorities to fulfil the objectives laid down in article 3 . ### each producer organisation shall submit a production and marketing plan to their competent national authorities to fulfil the objectives laid down in articles 3 , 7 and 10 .


### the rules to be extended to non - members shall apply for a period between 90 days and 12 months . ### the rules to be extended to non - members shall apply for a period between 30 days and 12 months .


### the common market organisation shall contribute to the achievement of the objectives laid down in articles 2 and 3 of the regulation on the common fisheries policy . ### the common market organisation shall contribute to the achievement of the objectives laid down in the regulation on the common fisheries policy and , in particular to improving market incentives to support sustainable production practices , the market position of eu production , producers’ market strategies to adapt eu production to structural market changes and short term fluctuations and to enhance the market potential of eu products .


### promotion of responsible and sustainable aquaculture , notably in terms of environment protection , animal health and animal welfare ; ### promotion of responsible , extensive and sustainable aquaculture , notably in terms of environment protection , animal health and animal welfare ;


### each producer organisation may create a collective fund , which shall be used only to finance the following measures : ### the european maritime and fisheries fund shall be used only to finance the following measures :


### the common market organisation shall be guided by the principles of good governance laid down in article 4 of the regulation on the common fisheries policy . ### the common market organisation shall be guided by the principles of good governance , by means of a clear definition of responsibilities at the union , national , regional and local levels , a long - term perspective , the broad involvement of operators , the responsibility of the flag state , and consistency with the integrated maritime policy , the trade policy and other union policies .


### the common market organisation shall apply to the fishery and aquaculture products listed in annex i to this regulation , which are marketed in the union . ### the common market organisation shall apply to the fishery and aquaculture products listed in annex i to this regulation , which are produced or marketed in the union .


### aquaculture producer organisations make use of the following measures to achieve the objectives referred to in article 10 : ### aquaculture producer organisations may make use , inter alia , of the following measures to achieve the objectives referred to in article 10 :


### fishery producer organisations may make use of the following measures to achieve the objectives set out in article 7 : ### fishery producer organisations may make use , inter alia , of the following measures to achieve the objectives set out in article 7 :


### management of frozen property ### management of frozen and confiscated property


### each member state shall adopt the necessary measures to enable it to confiscate , either wholly or in part , property belonging to a person convicted of a criminal offence where , based on specific facts , a court finds it substantially more probable that the property in question has been derived by the convicted person from similar criminal activities than from other activities . ### each member state shall adopt the necessary measures to enable it to confiscate , either wholly or in part , property belonging to a person convicted of a criminal offence where , based on specific facts , a court finds it substantially more probable that the property belonging to the convicted person is of illegal origin .


### the main motive for cross - border organised crime is financial gain . in order to be effective , law enforcement and judicial authorities should be given the means to trace , freeze , manage and confiscate the proceeds of crime . ### the main motive for organised crime , and particularly cross - border crime , is financial gain . in order to be effective , law enforcement and judicial authorities should be given the means to trace , freeze , manage and confiscate the proceeds of crime .


### each member state shall adopt the necessary measures to enable it to confiscate , either wholly or in part , property belonging to a person convicted of a criminal offence where , based on specific facts , a court finds it substantially more probable that the property in question has been derived by the convicted person from similar criminal activities than from other activities . ### each member state shall adopt the necessary measures to enable it to confiscate , either wholly or in part , property belonging to a person convicted of a criminal offence where , based on specific facts and after full utilization of all evidence a court is convinced that the property in question has been derived by the convicted person from similar criminal activities than from other activities .


### each member state shall take the necessary measures to enable it to confiscate , either wholly or in part , instrumentalities and proceeds following a final conviction for a criminal offence . ### each member state shall take the necessary measures to enable only judicial authorities to confiscate , either wholly or in part , instrumentalities and proceeds following a final conviction for a criminal offence .


### the confiscation of proceeds or property referred to in paragraph 1 shall be possible where the property is subject to restitution or where ### the confiscation of proceeds or property referred to in paragraph 1 shall be possible where


### the issuance of confiscation orders generally requires a criminal conviction . in some cases , even where a criminal conviction cannot be achieved , it should still be possible to confiscate assets in order to disrupt criminal activities and ensure that profits resulting from criminal activities are not reinvested into the licit economy . some member states allow confiscation where there is insufficient evidence for a criminal prosecution , if a court considers on the balance of probabilities that the property is of illicit origin , and also in situations where a suspect or accused person becomes a fugitive to avoid prosecution , is unable to stand trial for other reasons or died before the end of criminal proceedings . this is referred to as non - conviction based confiscation . provision should be made to enable non - conviction based confiscation in at least the latter , limited , circumstances in all member states . this is in line with article 54 . 1 . c ) of the united nations convention against corruption , which provides that each state party is to consider taking the necessary measures to allow confiscation of illicitly acquired property without a criminal conviction , including in cases in which the offender cannot be prosecuted by reason of death , flight or absence . ### the issuance of confiscation orders generally requires a criminal conviction . in some cases non - conviction based confiscation should be possible in order to disrupt criminal activities and ensure that profits resulting from criminal activities are not reinvested into the licit economy .


### the union and the member states should improve the consistency and the complementarity of their respective policies on development cooperation , in particular by responding to partner countries ' and regions ' priorities at country and regional level . to ensure that the union ' s development cooperation policy and that of the member states complement and reinforce each other , it is appropriate to provide for joint programming procedures which should be implemented whenever possible and relevant . ### the union and the member states should improve the consistency , coordination and the complementarity of their respective policies on development cooperation , in particular by responding to partner countries ' and regions ' priorities at country and regional level . to ensure that the union ' s development cooperation policy and that of the member states complement and reinforce each other , it is appropriate to provide for joint programming procedures which should be implemented whenever possible and relevant .


### draft legislative resolution ### points out that the financial envelope specified in the legislative proposal constitutes only an indication to the legislative authority and cannot be fixed until agreement is reached on the proposal for a regulation laying down the multiannual financial framework for the years 2014 - 2020 ;


### some direct benefit for the group of patients is obtained from the clinical trial . ### some direct benefit for the category of patients concerned by the trial may be obtained from the clinical trial .


### the database should contain all relevant information as regards the clinical trial . no personal data of data subjects participating in a clinical trial should be recorded in the database . the information in the database should be public , unless specific reasons require that a piece of information should not be published , in order to protect the right of the individual to private life and the right to the protection of personal data , recognised by articles 7 and 8 of the charter of fundamental rights of the european union . ### the database should contain all relevant information as regards the clinical trial . all clinical trials should be registered in the database prior to being started . the start and end dates of the recruitment of subjects should also be published in the database . it should be possible for sponsors to enter this information directly into the database without the need to further notify member states . no personal data of data subjects participating in a clinical trial should be recorded in the database . the information in the database should be public , unless specific reasons require that a piece of information should not be published , in order to protect the right of the individual to private life and the right to the protection of personal data , recognised by articles 7 and 8 of the charter of fundamental rights of the european union .


### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a medium - risk or low - risk clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state .


### regarding authorised medicinal products which , according to the protocol , are used in accordance with the terms of the marketing authorisation , the sponsor shall inform annually the marketing authorisation holder of all suspected serious adverse reactions . ### regarding authorised medicinal products which , according to the protocol , are used in accordance with the terms of the marketing authorisation , the sponsor shall inform annually the marketing authorisation holder of all suspected serious adverse reactions , including , where relevant , those reactions concerning a specific gender or age group .


### apart from the reporting of suspected unexpected serious adverse reactions , there may be other events which are relevant in terms of benefit - risk balance and which should be reported in a timely manner to the member states concerned . ### apart from the reporting of suspected unexpected serious adverse reactions , there may be other events which are relevant in terms of benefit - risk balance and which should be reported in a timely manner to the competent bodies of the member states concerned , including those responsible for the assessment of ethical aspects .


### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . this decision is a matter of internal organisation of each member state . member states , when determining the appropriate body or bodies , should ensure the involvement of lay persons and patients . they should also ensure that the necessary expertise is available . in any case , however , and in accordance with international guidelines , the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . the persons assessing the application should be independent from the sponsor , the institution of the trial site , and the investigators involved , as well as free of any other undue influence . ### it should be left to the member state concerned to determine the appropriate body or bodies to be involved in this assessment . this decision is a matter of internal organisation of each member state . however , irrespective of the organisation of the assessment process and the bodies involved , member states should make sure that the assessment is entirely completed within the deadlines provided for in this regulation and that no further assessment can prevent the sponsor from starting the clinical trial after the notification of the decision granting the authorisation .


### within one year from the end of a clinical trial , the sponsor shall submit to the eu database a summary of the results of the clinical trial . ### within one year from the end of a clinical trial , the sponsor shall submit to the eu database all the results of that trial , both positive and negative . the results of clinical trials that have been withdrawn or suspended shall also be provided , along with the reasons why they were withdrawn or suspended .


### the incapacitated subject has received adequate information in relation to his or her capacity for understanding regarding the trial , the risks and the benefits ; ### the incapacitated subject has received adequate information in relation to his or her capacity for understanding regarding the trial , the risks and the benefits from the investigator or his / her representative , in accordance with the legislation of the member state concerned ;


### such research relates directly to a life - threatening or debilitating medical condition from which the subject suffers ; ### such research relates directly to a medical condition from which the person concerned suffers ;


### the assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits and the risk and inconveniences for the subject . regarding the relevance , numerous aspects should be taken into account , including whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products . ### the assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits and the risk and inconveniences for the subject . regarding the relevance , numerous aspects should be taken into account , such as the subpopulations to be studied and the potential differences in efficacy and / or safety for specific subpopulations notably gender and age differences , or whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products .


### within six days following submission of the application dossier , the proposed reporting member state shall notify the sponsor through the eu portal of the following : ### within three calendar days following its appointment , the reporting member state shall notify the sponsor through the eu portal of the following :


### the subject or , where the subject is not able to give informed consent , his or her legal representative has had the opportunity , in a prior interview with the investigator or a member of the investigating team , to understand the objectives , risks and inconveniences of the clinical trial , and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment ; ### the subject or , where the subject is not able to give informed consent , his or her legal representative has had the opportunity , in a prior interview with the investigator or his / her representative , to understand the objectives , risks and inconveniences of the clinical trial , and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment ;


### the sponsor shall adequately monitor the conduct of a clinical trial . the extent and nature of the monitoring shall be determined by the sponsor on the basis of all characteristics of the clinical trial , including the following characteristics : ### the sponsor shall adequately monitor the conduct of a clinical trial . the extent and nature of the monitoring shall be determined by the sponsor on the basis of a risk assessment covering all the risk determinants of the clinical trial . the risk assessment shall determine the quality management and trial monitoring , taking into account the following characteristics :


### in order to allow for independent control as to whether these principles are adhered to , a clinical trial should be subject to prior authorisation . ### in order to allow for independent control as to whether these principles are adhered to , a clinical trial should be subject to prior authorisation . this authorisation should include scientific , ethical and administrative aspects .


### for clinical trials other than low - intervention clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator . ### for clinical trials other than low - intervention clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator , including compensation by means of insurance , is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator . where damage compensation is provided by means of insurance , a sponsor may use a single insurance policy to cover one or more clinical trials within the same member state .


### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator in accordance with his or her age and maturity ; ### the explicit wish of a minor to refuse participation in , or to be withdrawn from , the clinical trial at any time , is respected , irrespective of the position of his or her legal representative , no matter what the age or maturity of the minor may be ;


### regarding incapacitated subjects and minors , the informed consent referred to in paragraph 1 shall be obtained as soon as possible from the legal representative and the information referred to in paragraph 1 shall be given as soon as possible to the subject ; ### regarding incapacitated subjects and minors , the informed consent referred to in paragraph 1 shall be obtained as soon as possible from the legal representative and the information referred to in paragraph 1 shall be given as soon as possible to the subject by the investigator or his / her representative ;


### the clinical trial poses a minimal risk to , and imposes a minimal burden on , the subject . ### there are grounds for expecting that the benefits of participating in the clinical trial are proportional to the risks for the subject or that it involves a minimal risk only and it doesn ' t impose a disproportionate burden on the subject .


### the member states concerned should cooperate in assessing a request for authorisation of a clinical trial . this cooperation should not include aspects of an intrinsically national nature , nor ethical aspects of a clinical trial , such as informed consent . ### the member states concerned should cooperate in assessing a request for authorisation of a clinical trial . this cooperation may exclude aspects of an intrinsically national nature .


### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator in accordance with his or her age and maturity ; ### the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in , or to be withdrawn from , the clinical trial at any time , is duly taken into consideration by the investigator


### any subject may , without any resulting detriment , withdraw from the clinical trial at any time by revoking his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal . ### any subject may , without any resulting detriment , withdraw from the clinical trial at any time by revoking his or her informed consent . the withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal . the data collected between the date on which the subject gave his or her informed consent and the date on which consent was withdrawn may be used in the context of the trial , unless the person concerned objects .


### the investigational medicinal products are not authorised ; ### the investigational medicinal products are not authorised for marketing ;


### authorised investigational medicinal products and authorised auxiliary medicinal products shall be labelled ### authorised investigational medicinal products and authorised auxiliary medicinal products shall not carry any additional labelling .


### the application may be submitted only after the notification date of the initial authorisation decision . ### the application may be submitted only after the notification date of the initial authorisation decision in any member state .


### within four days following submission of the application dossier , the reporting member state shall notify the sponsor through the eu portal of the following : ### within ten days following submission of the application dossier , the reporting member state shall notify the sponsor through the eu portal of the following :


### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a low - intervention clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state . ### where the proposed reporting member state has not notified the sponsor within the time period referred to in paragraph 2 , the clinical trial applied for shall be considered as falling within the scope of this regulation , the application shall be considered complete , the clinical trial shall be considered a medium - risk or low - risk clinical trial if this is claimed by the sponsor , and the proposed reporting member state shall be the reporting member state .


### the sponsor shall report electronically and without delay to the electronic database referred to in article 36 all relevant information about suspected unexpected serious adverse reactions to investigational medicinal products insofar as the suspected unexpected serious adverse reaction occurred in a clinical trial conducted by the sponsor , or occurred in a clinical trial related to the sponsor . ### the sponsor shall report electronically and within the time limits specified in points 2 . 4 and 2 . 5 of annex iii to the electronic database referred to in article 36 all relevant information about suspected unexpected serious adverse reactions to investigational medicinal products insofar as the suspected unexpected serious adverse reaction occurred in a clinical trial conducted by the sponsor , or occurred in a clinical trial related to the sponsor .


### directive 2001 / 20 / ec aimed to simplify and harmonise the administrative provisions governing clinical trials in the european union . however , experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved . this makes it in particular difficult to perform a clinical trial in several member states . scientific development however , suggests that future clinical trials will target more specific patient populations , such as subgroups identified through genomic information . in order to include a sufficient number of patients for such trials it may be necessary to involve many , or all , member states . the new procedures for the authorisation of clinical trials should stimulate the inclusion of as many member states as possible . therefore , in order to simplify submission procedures , the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier through a single submission portal to all the member states concerned . ### directive 2001 / 20 / ec aimed to simplify and harmonise the administrative provisions governing clinical trials in the european union . however , experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved . this makes it in particular difficult to perform a clinical trial in several member states . scientific development however , suggests that future clinical trials will target more specific patient populations , such as subgroups identified through genomic information . in order to include a sufficient number of patients for such trials it may be necessary to involve many , or all , member states . the new procedures for the authorisation of clinical trials should stimulate the inclusion of as many member states as possible . therefore , in order to simplify submission procedures , the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier through a single submission portal to all the member states concerned . the application dossier related to a clinical trial conducted in a single member state should also be submitted through that single submission portal .


### within one year from the end of a clinical trial , the sponsor shall submit to the eu database a summary of the results of the clinical trial . ### within two years from the end of a clinical trial , the sponsor shall submit to the eu database a summary of the results of the clinical trial containing the elements laid down in annex iiia of this regulation . additionally , the sponsor shall also submit a summary with the same content which shall be understandable to a layperson . where the clinical trial is intended , at the time of submission of the application for authorisation , to be used for obtaining a marketing authorisation for a medicinal product , the summary of the results referred to in subparagraph 1 shall be made public within 30 days after the marketing authorisation date or , where applicable , within one year from the decision to discontinue the development of a medicinal product .


### the agency shall , by electronic means , forward to the relevant member states the information reported in accordance with article 38 and 39 . ### the agency shall , by electronic means , forward to the relevant member states the information reported in accordance with article 38 , 39 and 41 .


### the investigational medicinal products are authorised ; ### the investigational medicinal products are authorised and tested in accordance with their marketing authorisation .


### the information generated in the clinical trial should be recorded , handled and stored adequately for the purpose of ensuring subject rights and safety , the robustness and reliability of the data generated in the clinical trial , accurate reporting and interpretation , effective monitoring by the sponsor and effective inspection by member states or the commission . ### the information generated in the clinical trial should be recorded , handled and stored adequately for the purpose of ensuring subject rights , safety and well - being , the robustness and reliability of the data generated in the clinical trial , accurate reporting and interpretation , effective monitoring by the sponsor and effective inspection by member states or the commission .


### ‘ incapacitated subject’ : a subject who is , for other reasons than the age of legal competence to give informed consent , legally incapable of giving informed consent according to the laws of the member state concerned ; ### ‘ incapacitated subject’ : a subject who is , legally or de facto , incapable of giving informed consent according to the laws of the member state concerned ;


### the conduct of a clinical trial should be adequately monitored by the sponsor in order to ensure the reliability and robustness of the results . monitoring may also contribute to subject safety , taking into account the characteristics of the clinical trial and respect for fundamental rights of subjects . when establishing the extent of monitoring , the characteristics of the clinical trial should be taken into account . ### the conduct of a clinical trial should be adequately monitored by the sponsor in order to ensure the reliability and robustness of the results . monitoring may also contribute to subject safety , taking into account the characteristics of the clinical trial and respect for fundamental rights of subjects . monitoring should be adapted to the nature of the trial and focus on mitigating the key risks .