### member states shall carry out checks at regular intervals to ascertain whether producer organisations and inter - branch organisations comply with the conditions for recognition laid down in articles 17 and 18 and shall , where appropriate , withdraw recognition of producer organisations or inter - branch organisations . ### member states shall carry out checks at regular intervals to ascertain whether producer organisations , associations of producer organisations and inter - branch organisations comply with the conditions for recognition laid down in articles 17 and 18 and shall , where appropriate , withdraw recognition of producer organisations , associations of producer organisations or inter - branch organisations .


### member states whose nationals are members of a producer organisation or inter - branch organisation established in the territory of another member state and those member states hosting the official headquarters of an association of producer organisations recognised in different member states shall set up , in collaboration with the relevant member states , the administrative cooperation needed to carry out checks on the activities of the organisation or the association concerned . ### member states whose nationals are members of a producer organisation , association of producer organisations or inter - branch organisation established in the territory of another member state and those member states hosting the official headquarters of an association of producer organisations recognised in different member states shall set up , in collaboration with the relevant member states , the administrative cooperation needed to carry out checks on the activities of the organisation or the association concerned .


### member states shall communicate to the commission by electronic means any decision to grant or withdraw the recognition . ### the commission shall publish at the beginning of every year the list of producer organisations recognised in the preceding year and organisations whose recognition was withdrawn during that year .


### in order to ensure that the conditions for recognition of producer organisations or inter - branch organisations laid down in articles 17 and 18 are complied with , the commission may carry out checks and may , where appropriate , request that member states withdraw the recognition of producer organisations or inter - branch organisations . ### in order to ensure that the conditions for recognition of producer organisations , operator organisations , associations of producer organisations or inter - branch organisations laid down in articles 17 and 18 are complied with , the commission may carry out checks and may , where appropriate , request that member states withdraw the recognition of producer organisations , associations of producer organisations or organisations .


### extension of rules of producer organisations ### extension of rules of producer organisations and associations of producer organisations


### a member state may make the rules agreed within a producer organisation binding on producers who are not members of the organisation and who market any of the products within the area in which the producer organisation is representative on condition that : ### a member state may make the rules agreed within a producer organisation or association of producer organisations binding on producers who are not members of the organisation or association and who market any of the products within the area in which the producer organisation or association of producer organisations is representative on condition that :


### the producer organisation is considered to be representative of production and marketing in one member state and makes an application to the competent national authorities ; ### the producer organisation or association of producer organisations is considered to be representative of production and marketing in one member state and makes an application to the competent national authorities ;


### the producer organisation is considered to be representative of production and marketing in one member state and makes an application to the competent national authorities ; ### the producer organisation is considered to be representative of production and marketing in one member state , including small scale and artisanal fisheries , and makes an application to the competent national authorities ;


### 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 or association of producer organisations 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 .


### member states shall notify the commission of the rules which they intend to make binding on all producers or operators in a specific area or in specific areas pursuant to articles 26 and 27 . ### member states shall notify the commission of the rules which they decide to make binding on all producers or operators in a specific area or in specific areas pursuant to articles 26 and 27 .


### producer organisations may finance the storage of fishery products listed in annex ii to this regulation , provided that : ### producer organisations may fully or partly finance the storage of fishery products listed in annex ii to this regulation , along with other products to be determined by the member states , provided that :


### before the beginning of each year , each producer organisation may individually make a proposal for a price triggering the storage mechanism referred to in article 35 for fishery products listed in annex ii . ### before the beginning of each year , each producer organisation may individually make a proposal for a price triggering the storage mechanism referred to in article 35 for fishery products listed in annex ii , as well as for aquaculture products .


### common marketing standards may be laid down for the products listed in annex i intended for human consumption . ### common marketing standards may be laid down for the products listed in annex i , regardless of their origin intended for human consumption .


### minimum marketing sizes taking into account the best available scientific advice and in conformity with conservation reference sizes for fishery products as referred to in article 15 of the regulation on the common fisheries policy ; ### minimum conservation reference sizes taking into account the best available scientific advice and in conformity with conservation reference sizes for fishery products as referred to in article 15 of the regulation on the common fisheries policy ;


### the products for which marketing standards have been laid down may be marketed for human consumption in the union only in accordance with those standards . ### the products for which marketing standards have been laid down may be marketed in the union only in accordance with those standards .


### fishery and aquaculture products referred to in parts and of annex i , which are marketed within the union , irrespective of their origin , may only be offered for retail to the final consumer where appropriate marking or labelling indicates : : ### fishery and aquaculture products referred to in parts and of annex i , which are marketed within the union , irrespective of their origin , with the exception of prepared or canned products covered by regulation no 1169 / 2011 , may only be offered for retail to the final consumer where appropriate marking or labelling indicates : :


### the area where the product was caught or farmed ; ### the area where the product was caught or farmed , including its coastal and geographical denomination , expressed in terms understandable to consumers


### in addition to the information referred to in paragraph 1 , operators may indicate a more precise catch or production area . ### in addition to the information referred to in paragraph 1 , operators may indicate a more precise catch or production area , without prejudice to regulation no 510 / 2006 .


### it shall apply from 1 january 2013 with the exception of articles 32 , 35 and 36 , which shall apply from 1 january 2014 . ### it shall apply from 1 january 2013 with the exception of articles 32 , 35 and 36 , which shall apply from 1 january 2014 , and of article 42 , which shall apply on the dates on which the measures on consumer information shall become applicable , as indicated in regulation no 1169 / 2011 .


### viable food production , with a focus on agricultural income , agricultural productivity and price stability ; ### viable food production , with a focus on farmer ' s income , price margins , agricultural productivity and price stability ;


### 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 most crime , and particularly cross - border organised crime , including mafia - type criminal organization , is financial gain . in order to be effective , appropriate competent authorities should be given the means to trace , freeze , manage and confiscate the proceeds of crime . however , effective prevention of and fight against organized crime should not be limited to the neutralization of the proceeds of crime but should be extended , in some cases , even to property in any way related to such criminal associations . it is not enough , therefore , merely to ensure mutual recognition in the eu of seizure and confiscation of proceeds of crime . an effective fight against economic crime would also require the mutual recognition of measures taken in a different field from that of criminal law or otherwise adopted in the absence of a criminal conviction and that they have as their object , more broadly , any possible asset or income attributable to a criminal organization or to a person with a criminal conduct or suspected to belong to a criminal organization .


### confiscation of instrumentalities and proceeds following a final decision of a court and of property of equivalent value to those proceeds should therefore refer to this broadened concept for the criminal offences covered by this directive . framework decision 2001 / 500 / jha required member states to enable the confiscation of instrumentalities and proceeds of crime following a final conviction and to enable the confiscation of property of equivalent value to the proceeds of crime . such obligations should be maintained for the criminal offences not covered by this directive . ### confiscation of instrumentalities and proceeds following a final decision of a court and of property of equivalent value to those proceeds should therefore refer to this broadened concept for the criminal offences covered by this directive . framework decision 2001 / 500 / jha required member states to enable the confiscation of instrumentalities and proceeds of crime following a final conviction and to enable the confiscation of property of equivalent value to the proceeds of crime . such obligations should be maintained for the criminal offences not covered by this directive and the concept of proceeds as defined in this directive should be extended also for the criminal offences not covered by this directive .


### the practice by a suspected or accused person of transferring property to a knowing third party with a view to avoiding confiscation is common and increasingly widespread . the current union legal framework does not contain binding rules on the confiscation of property transferred to third parties . therefore it is becoming increasingly necessary to allow for confiscation of property transferred to third parties , which should normally take place when an accused person does not have property that can be confiscated . it is appropriate to provide for third party confiscation , under certain conditions , following an assessment , based on specific facts , that the confiscation of property of the convicted , suspected or accused person is unlikely to succeed , or in situations where unique objects must be restored to their rightful owner . furthermore , to protect the interests of bona fide third parties , such confiscation should only be possible if the third party knew or should have known that property was the proceeds of crime or was transferred in order to avoid confiscation and was given for free or transferred in exchange for an amount lower than its market value . ### the practice by a suspected or accused person of transferring property to a knowing third party with a view to avoiding confiscation is common and increasingly widespread . the current union legal framework does not contain binding rules on the confiscation of property transferred to third parties . therefore it is becoming increasingly necessary to allow for confiscation of property transferred to or acquired by third parties . to protect the interests of bona fide third parties , such confiscation should only be possible if the third party knew or should have been known that property was the instrumentalities or the proceeds of crime or was transferred in order to avoid confiscation or if it was given for free or transferred in exchange for an amount significantly lower than its market value .


### the practice by a suspected or accused person of transferring property to a knowing third party with a view to avoiding confiscation is common and increasingly widespread . the current union legal framework does not contain binding rules on the confiscation of property transferred to third parties . therefore it is becoming increasingly necessary to allow for confiscation of property transferred to third parties , which should normally take place when an accused person does not have property that can be confiscated . it is appropriate to provide for third party confiscation , under certain conditions , following an assessment , based on specific facts , that the confiscation of property of the convicted , suspected or accused person is unlikely to succeed , or in situations where unique objects must be restored to their rightful owner . furthermore , to protect the interests of bona fide third parties , such confiscation should only be possible if the third party knew or should have known that property was the proceeds of crime or was transferred in order to avoid confiscation and was given for free or transferred in exchange for an amount lower than its market value . ### the practice by a suspected or accused person of transferring property to a knowing third party with a view to avoiding confiscation is common and increasingly widespread . the current union legal framework does not contain binding rules on the confiscation of property transferred to third parties . therefore it is becoming increasingly necessary to allow for confiscation of property transferred to third parties , which should normally take place when an accused person does not have property that can be confiscated . it is appropriate to provide for third party confiscation , under certain conditions , following an assessment , based on specific facts , that the confiscation of property of the convicted , suspected or accused person is unlikely to succeed , or in situations where unique objects must be restored to their rightful owner . furthermore , to protect the interests of bona fide third parties , such confiscation should only be possible if the third party knew or should have known that property was the proceeds of crime or was transferred in order to avoid confiscation and was given for free or transferred in exchange for an amount lower than its market value . third party confiscation should also be possible where the acting suspect or accused person was acting for another natural or legal person from the outset .


### suspected or accused persons often hide property throughout the entire duration of criminal proceedings . as a result confiscation orders cannot be executed , leaving those subject to confiscations orders to benefit from their property once they have served their sentence . it is accordingly necessary to enable the determination of the precise extent of the property to be confiscated even after a final conviction for a criminal offence , in order to permit the full execution of confiscation orders when no property or insufficient property was initially discovered and the confiscation order remains unexecuted . given the limitation of the right to property by freezing orders , such provisional measures should not be maintained longer than necessary to preserve the availability of the property with a view of possible future confiscation . this may require a regular review by the court in order to ensure that their purpose of preventing the dissipation of property remains valid . ### suspected or accused persons often hide property throughout the entire duration of criminal proceedings . as a result confiscation orders cannot be executed , leaving those subject to confiscations orders to benefit from their property once they have served their sentence . it is accordingly necessary to enable the determination of the precise extent of the property to be confiscated even after a final conviction for a criminal offence , in order to permit the full execution of confiscation orders when no property or insufficient property was initially discovered and the confiscation order remains unexecuted . given the limitation of the right to property by freezing orders , such provisional measures should not be maintained longer than necessary to preserve the availability of the property with a view of possible future confiscation . this may require , where necessary , a review by the court in order to ensure that their purpose of preventing the dissipation of property remains valid .


### reliable data sources on the freezing and confiscation of the proceeds of crime are scarce . in order to allow for the evaluation of this directive , it is necessary to collect a comparable minimum set of appropriate statistical data on asset tracing , judicial and asset disposal activities . ### reliable data sources on the freezing and confiscation of the proceeds of crime are scarce . in order to allow for the evaluation of this directive , it is necessary to collect a comparable minimum set of appropriate statistical data on asset tracing , judicial and asset management and disposal activities .


### since the objective of this directive , namely facilitating confiscation of property in criminal matters , cannot be sufficiently achieved by the member states and can be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective . ### since the objective of this directive , namely facilitating confiscation of property , cannot be sufficiently achieved by the member states and can be better achieved at union level , the union may adopt measures , in accordance with the principle of subsidiarity as set out in article 5 of the treaty on european union . in accordance with the principle of proportionality , as set out in that article , this directive does not go beyond what is necessary in order to achieve that objective .


### this directive establishes minimum rules on the freezing of property with a view to possible later confiscation and on the confiscation of property in criminal matters . ### this directive establishes minimum rules on the seizure or freezing of property with a view to possible later confiscation , on the confiscation of property in criminal matters and without a criminal conviction and on the management and disposal of confiscated property .


### ' proceeds ' means any economic advantage derived from a criminal offence ; it may consist of any form of property and includes any subsequent reinvestment or transformation of direct proceeds by a suspected or accused person and any valuable benefits ; ### ' proceeds ' means any economic advantage directly or indirectly derived from a criminal offence ; it may consist of any form of property and includes any subsequent reinvestment or transformation of direct proceeds by a suspected or accused person and any valuable benefits ;


### 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 judicial authorities to confiscate , either wholly or in part , instrumentalities and proceeds or property the value of which corresponds to such instrumentalities and proceeds , subject to a final conviction for a criminal offence .


### 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 competent authorities to confiscate , either wholly or in part , property belonging to a person convicted of a criminal offence where , based on specific facts such as that the value of property is disproportionate to the lawful income of the convicted person , a court finds it on the balance of probabilities that the property in question has been acquired unlawfully .


### other property of the convicted person , which was transferred to third parties in order to avoid confiscation of property the value of which corresponds to the proceeds . ### other property which was transferred to or acquired by third parties in order to avoid confiscation of property the value of which corresponds to the proceeds .


### the proceeds or property were transferred for free or in exchange for an amount lower than their market value when the third party : ### the proceeds or property were transferred for free or in exchange for an amount significantly lower than their market value ;


### each member state shall ensure that the measures referred to in paragraph 1 optimise the economic value of such property , and shall include the sale or transfer of property which is liable to decline in value . ### each member state shall ensure that the measures referred to in paragraph 1 to frozen property optimise the economic value of such property , and shall include , only if necessary , the sale or transfer of property which is liable to decline in value . each member state shall take all the necessary measures to prevent any criminal infiltration in this phase .


### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need , including fragile states and states with high vulnerability , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance . ### union assistance should focus where it has more impact , having regard to its capacity to act on a global scale and respond to global challenges such as poverty eradication , sustainable and inclusive development and worldwide promotion of democracy , good governance , human rights and the rule of law , its long - term and predictable commitment to development assistance and its role in coordinating with its member states . to ensure such impact , the principle of differentiation should be applied not only at the level of funds allocation , but also at the level of programming , to ensure that bilateral development cooperation targets partner countries most in need including fragile states , states with high vulnerability , states with high levels of inequalities , and with limited capacity to have access to other sources of financing for supporting their own development , having regard to the potential impact of the union assistance in partner countries . as a consequence , bilateral programming would target such countries , pursuant to the application of objective criteria based on the needs and capacities of these countries , as well as the impact of eu assistance .


### commission communication ‘ increasing the impact of eu development policy : an agenda for change’ envisages continued support for social inclusion and human development through at least 20% of the union ' s development aid . to contribute to that end , at least 20% of the global public goods and challenges programme should support that area of development . ### commission communication ‘ increasing the impact of eu development policy : an agenda for change’ envisages continued support for social inclusion and human development through at least 20% of the union ' s development aid . the priority ' social inclusion and human development ' is to be understood as encompassing basic social services including health and education . to contribute to that end , at least 20% of the global public goods and challenges programme should support that area of development .


### without prejudice to point , at least 90 % of the expenditure foreseen under the pan - african and thematic programmes shall fulfil the criteria for oda established by the oecd / dac . ### 100 % of the expenditure foreseen under the pan - african and thematic programmes shall fulfil the criteria for oda established by the oecd / dac .


### the financial reference amount for the implementation of this regulation over the period 2014 - 2020 is eur 23 294 700 000 . ### the financial reference as defined in point [ 17 ] of the interinstitutional agreement of xx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management for the implementation of this regulation over the period 2014 - 2020 is eur 23 294 700 000 .


### the indicative minimum amounts allocated to each programme referred to in articles 5 to 9 for the period 2014 - 2020 are laid down in annex vii . the amounts may be reallocated between programmes by a delegated act in accordance with article 18 . the amounts within the global public goods and challenges programme may be reallocated between subheadings by commission decision which shall be communicated to the european parliament and to the council within one month of its adoption . ### the indicative minimum amounts allocated to each programme referred to in articles 5 to 9 for the period 2014 - 2020 are laid down in annex vii . the indicative amounts may be reallocated between programmes by a delegated act in accordance with article 18 . the indicative amounts within the global public goods and challenges programme may be reallocated between subheadings by commission decision which shall be communicated to the european parliament and to the council within one month of its adoption . annual appropriations shall be authorised by the budgetary authority without prejudice to the provisions of the regulation laying down the multiannual financial framework for the years 2014 - 2020 and the interinstitutional agreement of xxx / 201z between the european parliament , the council and the commission on cooperation in budgetary matters and sound financial management .


### member states shall ensure that when an offer binding on the creditor is provided to the consumer , it shall be accompanied by an esis . in such circumstances , member states shall ensure that the credit agreement cannot be concluded until the consumer has had sufficient time to compare the offers , assess their implications and take an informed decision on whether to accept an offer , regardless of the means of conclusion of the contract . ### member states shall ensure that the creditor provides the consumer with a standardised offer in the form of an esis . member states shall ensure that the credit agreement cannot be concluded until the consumer has had sufficient time to compare the offers , assess their implications and take an informed decision on whether to accept an offer , regardless of the means of conclusion of the contract .


### credit intermediaries who are not tied shall , at the consumer’s request , provide information on the variation in levels of commission payable by the different creditors providing the credit agreements being offered to the consumer . the consumer shall be informed that he has the right to request such information . ### credit intermediaries who are not tied shall provide the consumer with information on the variation in levels of commission payable by the different creditors providing the credit agreements being offered to the consumer .


### member&#160 ; states shall ensure that , before the conclusion of the credit agreement , a&#160 ; thorough assessment of the consumer ' s creditworthiness is conducted by the creditor , based on criteria including the consumer ' s income , savings , debts and other financial commitments . that assessment shall be carried out on the basis of the necessary information , obtained by the creditor or , where applicable , credit intermediary from the consumer and from relevant internal or external sources and shall respect the requirements with regard to necessity and proportionality set out in article 6 of directive 95 / 46 / ec . member&#160 ; states shall ensure that creditors establish appropriate processes to assess the creditworthiness of the consumer . these processes shall be reviewed at regular intervals and up - to - date records of those processes shall be maintained . ### member&#160 ; states shall ensure that , before the conclusion of the credit agreement , a&#160 ; thorough assessment of the consumer ' s creditworthiness is conducted by the creditor , based on criteria including the consumer ' s income , savings , debts and other financial commitments . that assessment shall be carried out on the basis of the necessary information , obtained by the creditor or , where applicable , credit intermediary from the consumer and from relevant internal or external sources and shall respect the requirements with regard to necessity and proportionality set out in article 6 of directive 95 / 46 / ec . positive data such as details of income , savings and assets may be requested only from the consumer . member&#160 ; states shall ensure that creditors establish appropriate processes to assess the creditworthiness of the consumer . these processes shall be reviewed at regular intervals and up - to - date records of those processes shall be maintained .


### each member state shall ensure non - discriminatory access for all creditors to databases used in that member&#160 ; state for assessing the creditworthiness of consumers and for monitoring consumers ' compliance with the credit obligations over the life of the credit agreement . such databases comprise databases operated by private credit bureaux or credit reference agencies and public credit registers . ### each member state shall ensure non - discriminatory access for all creditors , in the event of a consumer ' s non - compliance with the credit agreement , to databases used in that member&#160 ; state for assessing the creditworthiness of consumers . such databases comprise databases operated by private credit bureaux or credit reference agencies and public credit registers .


### this document was produced on the basis of the information that you have provided so far and on the current financial market conditions . the information below remains valid until [ validity date ] . after that date , it may change in line with market conditions . ### this document was produced on the basis of the information that you have provided so far and on the current financial market conditions . this document and the information below remain valid until [ validity date ] . after that date , it may change in line with market conditions . this document is an offer binding / non - binding on the creditor . delete as appropriate .


### the procedure should be flexible and efficient , in order to avoid administrative delays for starting a clinical trial . ### the procedure should be flexible and efficient , in order to avoid administrative delays in starting a clinical trial . the rights , safety and well - being of the individual research subject should prevail over all other interests .


### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval . ### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to the best current proven intervention . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval .


### 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 , which includes ensuring that the group of subjects participating in the trial represents the population to be treated , and 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 . in order to ensure that the clinical trial is relevant , the sponsor should , where possible , provide a systematic review of the existing data on the investigational medicinal products .


### the sponsor should be allowed to withdraw the application for authorisation of a clinical trial . to ensure the reliable functioning of the assessment procedure , however , an application for authorisation of a clinical trial should be withdrawn only for the entire clinical trial . it should be possible for the sponsor to submit a new application for authorisation of a clinical trial following the withdrawal of an application . ### the sponsor should be allowed to withdraw the application for authorisation of a clinical trial . to ensure the reliable functioning of the assessment procedure , however , an application for authorisation of a clinical trial should be withdrawn only for the entire clinical trial . the reasons for withdrawal should be communicated via the eu portal . it should be possible for the sponsor to submit a new application for authorisation of a clinical trial following the withdrawal of an application provided that the new application contains explanations regarding any previous withdrawals .


### in order to increase transparency in the area of clinical trials , clinical trial data submitted in support of a clinical trial application should be based only on clinical trials recorded in a publicly accessible database . ### in order to increase transparency in the area of clinical trials , clinical trial data submitted in support of a clinical trial application should be based on clinical trials recorded in a publicly accessible database . clinical trial data based on clinical trials conducted before the date of application of the present regulation should be registered in a public register which is a primary or partnered registry of the international clinical trials registry platform of the world health organisation .


### in order to streamline and facilitate the flow of information between sponsors and member states as well as between member states , the commission should set up and maintain a database , accessed through a portal . ### in order to streamline and facilitate the flow of information between sponsors and member states as well as between member states , the european medicines agency , on behalf of the commission , should set up and maintain a database , accessed through a portal .


### ‘ low - intervention clinical trial’ : a clinical trial which fulfils all of the following conditions : ### ‘ low - intervention clinical study’ : a clinical trial which fulfils all of the following conditions :


### ' informed consent ' : a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial , after having been informed of all aspects of the trial that are relevant to the subject ' s decision to participate ; ### ' informed consent ' : a process by which a subject freely and voluntarily confirms his or her willingness to participate in a particular trial , after having been informed of all aspects of the trial that are relevant to the subject ' s decision to participate ;


### – the data generated in the clinical trial are going to be reliable and robust . ### – the data generated in the clinical trial are going to be reliable , robust and relevant .


### 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 14 days , 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 .


### the anticipated therapeutic and public health benefits taking account of all of the following : ### the anticipated therapeutic and public health benefits , including the anticipated benefits for the subjects , taking account of all of the following :


### the anticipated therapeutic and public health benefits taking account of all of the following : ### the anticipated therapeutic , public health and quality of life benefits taking account of all of the following :


### the risk to subject health posed by the medical condition for which the investigational medicinal product is being investigated ; ### the risk to subject health or quality of life posed by the medical condition for which the investigational medicinal product is being investigated ;


### the reporting member state shall submit part i of the assessment report , including its conclusion , to the sponsor and to the other member states concerned within the following time periods : ### the reporting member state shall submit part i of the assessment report , including its conclusion , already comprising the views of the concerned ethics committee , to the sponsor and to the other member states concerned within the following time periods :


### the assessment of the aspects referred to in the first subparagraph shall constitute part ii of the assessment report . ### the assessment of the aspects referred to in the first subparagraph shall constitute part ii of the assessment report and shall be compiled into the assessment report by the reporting member state .


### each member state concerned shall complete its assessment within ten days from the validation date . it may request , with justified reasons , additional explanations from the sponsor regarding the aspects referred to in paragraph 1 only within that time period . ### each member state concerned shall complete its assessment within twenty days from the validation date . it may request , with justified reasons , additional explanations from the sponsor regarding the aspects referred to in paragraph 1 only within that time period .


### member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . ### member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . in addition , the views of the concerned ethics committee shall be taken into account .


### notification shall be done by way of one single decision within ten days from the assessment date . ### notification shall be done by way of one single decision , already comprising the views of the concerned ethics committee , within fifteen days from the assessment date .


### notification shall be done by way of one single decision within ten days from the validation date . ### notification shall be done by way of one single decision within ten days from the assessment date according to article 6 .


### notification shall be done by way of one single decision within ten days from the validation date . ### notification shall be done by way of one single decision , already comprising the views of the concerned ethics committee , within fifteen days from the validation date .


### each member state concerned shall assess , for its territory , the aspects of the substantial modification which are covered by part ii of the assessment report within ten days from the validation date . ### each member state concerned shall assess , for its territory , the aspects of the substantial modification which are covered by part ii of the assessment report within fifteen days from the validation date , according to the procedure referred to in article 7 , paragraph 1 .


### a clear description of the substantial modification ; ### a clear description of the nature of , reasons for and content of the substantial modification ;


### where reference is made in the application dossier to data generated in a clinical trial , that clinical trial shall have been conducted in accordance with this regulation . ### where reference is made in the application dossier to data generated in a clinical trial , that clinical trial shall have been conducted in accordance with this regulation or , if conducted prior to the date of application of this regulation , in accordance with directive 2001 / 20 / ec .


### where the clinical trial has been conducted outside the union , it shall comply with principles equivalent to those of this regulation as regards subject rights and safety and reliability and robustness of data generated in the clinical trial . ### where the clinical trial referred to in paragraph 4 has been conducted outside the union , it shall comply with this regulation and respect the ethical principles of the world medical association’s declaration of helsinki , and the international ethical guidelines for biomedical research involving human subjects by the council for international organizations of medical sciences , as regards subject rights , safety and well - being , and the reliability and robustness of data generated in the clinical trial .


### clinical trial data submitted in an application dossier shall be based on clinical trials which have been registered prior to their start in a public register which is a primary registry of the international clinical trials registry platform of the world health organisation . ### clinical trial data based on clinical trials conducted as from . . . [ date of application of this regulation ] and submitted in an application dossier shall be based on clinical trials which have been registered prior to their start in a public register which is a primary or partnered registry of the international clinical trials registry platform of the world health organisation .


### 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 a medical doctor who is 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 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 or other appropriate means of contact with the investigator , member of the investigating team or an appropriately qualified individual , 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 . during the prior interview or other appropriate contact referred to above , the potential subject shall also be informed of the right to refuse to participate in the clinical trial without any resulting detriment ;


### the rights , safety and well - being of the subjects shall prevail over the interests of science and society . ### the rights , safety and well - being of the subjects shall prevail over all other interests .


### 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 or his legal representative 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 .


### written information given to the subject and / or the legal representative for the purposes of obtaining his or her informed consent shall be kept concise , clear , relevant , and understandable to a lay person . it shall include both medical and legal information . it shall inform the subject about his or her right to revoke his or her informed consent . ### any written information given to the subject and / or the legal representative prior to obtaining his or her informed consent shall be concise , clear , relevant , and understandable to a layperson . special attention should be given to the information needs of individual subjects and specific patient populations , as well as to the methods used to give the information . it shall include both medical and legal information . it shall inform the subject about his or her right to revoke his or her informed consent at any time .


### the informed consent of the legal representative has been obtained , whereby consent shall represent the subject ' s presumed will ; ### the informed consent of the legal representative has been obtained ; consent shall represent the subject ' s presumed will and may be revoked at any time , without detriment to the subject ;


### the explicit wish of an incapacitated subject 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 considered by the investigator ; ### the investigator considers the explicit wish of an incapacitated subject 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 , without giving a reason and with no liability or prejudice whatsoever being incurred by the subject or their legal representative as a result ;


### the minor has received all relevant information in a way adapted to his or her age and maturity , from professionals trained or experienced in working with children , regarding the trial , the risks and the benefits ; ### the minor has received all relevant information in a way adapted to his or her age and maturity , from a medical doctor trained or experienced in working with children , regarding the trial , the risks and the benefits ;


### 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 investigator duly takes into consideration , in accordance with the age and maturity of the minor concerned , 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 , without giving a reason and with no liability or prejudice whatsoever being incurred by the minor concerned or their legal representative as a result ;


### the minor shall take part in the consent procedure in a manner adapted to his or her age and maturity . ### the minor shall take part in the consent procedure in a manner adapted to his or her age and maturity . minors who are 12 years old and over must also give their informed and express consent to participate in the trial .


### 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 . where a sponsor , due to lack of resources , &#160 ; is not able&#160 ; to&#160 ; inform the&#160 ; marketing authorisation holder , it may instead inform the agency .


### where the sponsor is aware , with respect to a clinical trial for which it is a sponsor , of a serious breach of this regulation or of the version of the protocol applicable at the time of the breach , it shall notify the member states concerned , through the eu portal , of that breach within seven days of becoming aware of that breach . ### where the sponsor is aware , with respect to a clinical trial for which it is a sponsor , of a serious breach of this regulation or of the version of the protocol applicable at the time of the breach , it shall notify the member states concerned , through the eu portal , of that breach as early as possible and no later than seven days after becoming aware of that breach .


### re - labelling , re - packaging or reconstitution prior to use or packaging , where those processes are carried out in hospitals , health centres or clinics , by pharmacists or other persons legally authorised in the member state to carry out such processes , and if the investigational medicinal products are intended to be used exclusively by those institutions ; ### labelling , re - labelling , packaging , re - packaging or reconstitution prior to use or packaging , where those processes are carried out in hospitals , health centres or clinics , by pharmacists or other persons legally authorised in the member state to carry out such processes , and if the investigational medicinal products are intended to be used exclusively by those institutions ;


### the preparation of medicinal products referred to in article 3 and of directive 2001 / 83 / ec . ### the preparation of medicinal products referred to in article 3 and of directive 2001 / 83 / ec or in accordance with the study plan provided by the sponsor .


### providing responses to all questions from subjects , investigators or any member state concerned regarding the clinical trial ; ### providing responses to all questions from subjects , investigators or any member state concerned regarding the clinical trial . in meeting this obligation the sponsor may delegate tasks as required , in accordance with the second paragraph of article 68 ;


### the commission shall set up and maintain a portal at union level as a single entry point for the submission of data and information relating to clinical trials in accordance with this regulation . ### the european medicines agency , on behalf of the commission , shall set up and maintain a portal at union level as a single entry point for the submission of data and information relating to clinical trials in accordance with this regulation .


### the commission shall set up and maintain a database at union level . the commission shall be considered controller of the database . ### the european medicines agency shall set up and maintain a database at union level , on behalf of the european commission . the european medicines agency shall be considered controller of the database .


### the commission shall set up and maintain a database at union level . the commission shall be considered controller of the database . ### the commission shall set up and maintain a database at union level . the commission shall be considered controller of the eu database and shall be responsible for avoiding unnecessary duplication between that database and the eudract and eudravigilance databases .


### the commission and member states shall ensure that the data subject may effectively exercise his or her rights to information , to access , to rectify and to object in accordance with regulation no 45 / 2001 and national data protection legislation implementing directive 95 / 46 / ec respectively . they shall ensure that the data subject may effectively exercise the right of access to data relating to him or her , and the right to have inaccurate or incomplete data corrected and erased . within their respective responsibilities , the commission and member states shall ensure that inaccurate and unlawfully processed data is deleted , in accordance with the applicable legislation . corrections and deletions shall be carried out as soon as possible , but no later than within 60 days after a request is made by a data subject . ### the commission , the european medicines agency and member states shall ensure that the data subject may effectively exercise his or her rights to information , to access , to rectify and to object in accordance with regulation no 45 / 2001 and national data protection legislation implementing directive 95 / 46 / ec respectively . they shall ensure that the data subject may effectively exercise the right of access to data relating to him or her , and the right to have inaccurate or incomplete data corrected and erased . within their respective responsibilities , the commission , european medicines agency and member states shall ensure that inaccurate and unlawfully processed data is deleted , in accordance with the applicable legislation . corrections and deletions shall be carried out as soon as possible , but no later than within 60 days after a request is made by a data subject .


### the commission and member states shall ensure that the data subject may effectively exercise his or her rights to information , to access , to rectify and to object in accordance with regulation no 45 / 2001 and national data protection laws implementing directive 95 / 46 / ec respectively . they shall ensure that the data subject may effectively exercise the right of access to data relating to him or her , and the right to have inaccurate or incomplete data corrected and erased . within their respective responsibilities , the commission and member states shall ensure that inaccurate and unlawfully processed data is deleted , in accordance with the applicable legislation . corrections and deletions shall be carried out as soon as possible , but no later than within 60 days after a request being made by a data subject . ### the commission and member states shall ensure that the data subject may effectively exercise his or her rights to information , to access , to rectify , to block and to object in accordance with regulation no 45 / 2001 and national data protection laws implementing directive 95 / 46 / ec respectively . they shall ensure that the data subject may effectively exercise the right of access to data relating to him or her , and the right to have inaccurate or incomplete data corrected , blocked and erased . within their respective responsibilities , the commission and member states shall ensure that inaccurate and unlawfully processed data is deleted , in accordance with the applicable legislation . corrections , blocking and deletions shall be carried out as soon as possible , but no later than within 60 days after a request being made by a data subject .


### a discussion of the relevance of the clinical trial and its design to allow assessment in accordance with article 6 ; ### a discussion of the relevance of the clinical trial and its design to allow assessment in accordance with article 6 , referencing all existing evidence , including systematic reviews and meta - analysis ;


### the authority shall act within the scope of directive 97 / 9 / ec , directive 98 / 26 / ec , directive 2001 / 34 / ec , directive 2002 / 47 / ec , directive&#160 ; 2002 / 87 / ec , directive 2003 / 6 / ec , directive 2003 / 71 / ec , directive 2004 / 25 / ec , directive 2004 / 39 / ec , directive 2004 / 109 / ec , directive 2005 / 60 / ec , directive 2009 / 65 / ec , directive 2002 / 65 / ec , directive 2006 / 49 / ec , directive &#8230 ; [ future aifm directive ] , and regulation &#8230 ; [ future cra regulation ] , including all directives , regulations , and decisions based on these acts , and of any further community act which confers tasks on the authority . ### the authority shall act within the scope of this regulation and of directive 2006 / 48 / ec , directive 2006 / 49 / ec , directive 2002 / 87 / ec , directive 2005 / 60 / ec , directive 2002 / 65 / ec and directive 94 / 19 / ec , including all directives , regulations , and decisions based on these acts , and of any further eu act which confers tasks on the authority


### contribute to a consistent application of community legislation , in particular by contributing to a common supervisory culture , ensuring consistent , efficient and effective application of the legislation referred to in article 1 , preventing regulatory arbitrage , mediating and settling disagreements between competent authorities , promoting a coherent functioning of colleges of supervisors and taking actions in emergency situations ; ### contribute to a consistent application of standards and legislation , in particular by contributing to a common supervisory culture , ensuring consistent , efficient and effective application of this regulation and the legislation referred to in article 1 , preventing regulatory arbitrage , mediating and settling disagreements between competent authorities , ensuring a coherent functioning of colleges of supervisors and taking action , inter alia in emergency situations ;


### the authority may develop technical standards in the areas specifically set out in the legislation referred to in article 1 . the authority shall submit its draft standards to the commission for endorsement . ### the authority shall develop technical standards in the areas specifically set out in this regulation and in the legislation referred to in article 1 , or at the request of the commission . technical standards shall not include policy choices and shall reflect the principle of proportionality . the authority shall submit its draft technical standards to the commission for adoption as delegated acts or endorsement as implementing acts in accordance with this regulation and with the legislation referred to in article 1 . the draft standards shall also be transmitted at the same time to the european parliament and the council .


### before submitting them to the commission , the authority shall , where appropriate , conduct open public consultations on technical standards and analyse the potential related costs and benefits . ### before submitting them to the commission , the authority shall conduct open public consultations with all stakeholders and analyse the potential related costs and benefits , unless such consultations and analyses are disproportionate to the scope and impact of the technical standards concerned or to the particular urgency of the matter . the authority shall also request an opinion or advice of the securities and markets stakeholder group referred to in article 22 .


### within three months of receipt of the draft standards , the commission shall decide whether to endorse the draft standards . the commission may extend that period by one month . the commission may endorse the draft standards only in part or with amendments where the community interest so requires . ### within three months of receipt of the draft technical standards , the commission shall endorse the draft supervisory standards if they comply with union legislation . within the same period , the commission may adopt the draft technical standards with amendments where they were drawn up as regulatory standards . in both cases , the commission may extend that period by one month .


### where a competent authority has not correctly applied the legislation referred to in article 1 , in particular by failing to ensure that a financial market participant satisfies the requirements laid down in that legislation , the authority shall have the powers set out in paragraphs 2 , 3 and 6 of this article . ### where a competent authority has not applied the legally binding acts and legislation referred to in article 1 or has applied them in a way which appears to be in breach of union law , in particular by failing to ensure that a financial institution satisfies the requirements laid down in that legislation , the authority shall have the powers set out in paragraphs 2 , 3 and 6 of this article .


### upon request from one or more competent authorities , from the commission or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged incorrect application of community law . ### upon request from one or more competent authorities from the european parliament , the council , the commission or the securities and markets stakeholder group , or on its own initiative and after having informed the competent authority concerned , the authority may investigate the alleged breach or non - application of union law .


### without prejudice to the powers of the commission under article 226 of the treaty , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non compliance by the competent authority in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial market participants , adopt an individual decision addressed to a financial market participant requiring the necessary action to comply with its obligations under community law including the cessation of any practice . ### without prejudice to the powers of the commission under article 258 of the treaty on the functioning of the european union , where a competent authority does not comply with the decision referred to in paragraph 4 of this article within the period of time specified therein , and where it is necessary to remedy in a timely manner the non - compliance in order to maintain or restore neutral conditions of competition in the market or ensure the orderly functioning and integrity of the financial system , the authority may , where the relevant requirements of the legislation referred to in article 1 are directly applicable to financial institutions , adopt an individual decision addressed to a financial institution requiring the necessary action to comply with its obligations under union law including the cessation of any practice .


### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the community , the commission , upon its own initiative or following a request by the authority , the council , or the esrb , may adopt a decision addressed to the authority , determining the existence of an emergency situation for the purposes of this regulation . ### in the case of adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the european union , the esrb , upon its own initiative or following a request by the authority , the european parliament or a member state , may issue a warning declaring the existence of an emergency situation for the purposes of this regulation .


### where the commission has adopted a decision pursuant to paragraph 1 , the authority may adopt individual decisions requiring competent authorities to take the necessary action in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial market participants and competent authorities satisfy the requirements laid down in that legislation . ### where the esrb has issued a warning pursuant to paragraph 1 , or where the commission or the council , upon its own initiative or following a request by the authority , the european parliament or a member state , adopts a decision determining the existence of similar or justified circumstances where coordinated action by national authorities is necessary in order to respond to adverse developments which may seriously jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system in the european union , the authority may , without having to comply with any further requirements , adopt individual decisions in accordance with the legislation referred to in article 1 to address any risks that may jeopardise the orderly functioning and integrity of financial markets or the stability of the whole or part of the financial system by ensuring that financial institutions and competent authorities satisfy the requirements laid down in that legislation .


### without prejudice to the competences of the community institutions , the authority may develop contacts with supervisory authorities from third countries . it may enter into administrative arrangements with international organisations and the administrations of third countries . ### without prejudice to the competences of the union institutions and member states , the authority may develop contacts and enter into administrative arrangements with supervisory authorities , international organisations and the administrations of third countries .


### the implementation phase shall last for a minimum of five years . during the implementation phase at least three calls for proposals shall be published with a view to funding projects which address the objectives of the bonus - 169 . these calls shall be targeted at multi - partner and trans - national projects , and include research , technological development , training and dissemination activities . projects shall be selected according to the principles of equal treatment , transparency , independent evaluation , co - financing , no - profit , financing not cumulated with other community sources , as well as the principle of non - retroactivity . ### the implementation phase shall last for a minimum of five years . during the implementation phase at least three calls for tender for research contracts shall be published with a view to funding projects which address the necessary scientific objectives . these calls shall be targeted at multi - partner and transnational projects ; at least two states from the south - east of the baltic sea region must participate in each project . the projects in question shall include research , technological development , training and dissemination activities . projects shall be selected in keeping with the main objectives of the strategic part , proceeding from the principles of equal treatment , transparency , independent evaluation by experts from all participating states , co - financing , no - profit , and financing not cumulated with other community sources , as well as the principle of non - retroactivity .


### the implementation phase shall last for a minimum of five years . during the implementation phase at least three calls for proposals shall be published with a view to funding projects which address the objectives of the bonus - 169 . these calls shall be targeted at multi - partner and trans - national projects , and include research , technological development , training and dissemination activities . projects shall be selected according to the principles of equal treatment , transparency , independent evaluation , co - financing , no - profit , financing not cumulated with other community sources , as well as the principle of non - retroactivity ### the implementation phase shall last for a minimum of five years . during the implementation phase at least three calls for proposals shall be published with a view to funding projects which address the objectives of the bonus - 169 . these calls shall be targeted at multi - partner and transnational projects , and include research , technological development , training and dissemination activities . projects shall be selected according to the principles of equal treatment , transparency , independent evaluation , no - profit , and financing not cumulated with other union sources , as well as the principle of non - retroactivity .


### developing a financing structure of funding bonus - 169 project based on a pool of funds consisting of cash contributions of the participating states and of the community ; ### developing a financing structure for funding projects based , having regard in particular to the selection phase and the preparation of the research infrastructure , on a pool of funds consisting of cash and in kind contributions of the participating states and of the community ;


### the community financial contribution and the cash contribution of the participating states to bonus - 169 shall be pooled and administered centrally by the bonus eeig . ### the community financial contribution and the cash and in kind contributions of the participating states to the bonus research programme shall be pooled and administered directly by the bonus eeig or administered by it indirectly , that is to say , virtually in those cases where a participating member state or third country assigns its cash and in kind contributions exclusively to national research projects connected with the implementation phase of joint projects under the research programme .


### in order to address the potentially detrimental effect of poorly designed remuneration structures on the sound management of risk and control of risk - taking behaviour by individuals , the requirements of directive 2006 / 48 / ec should be supplemented by an express obligation for credit institutions and investment firms to establish and maintain , for those categories of staff whose professional activities have a material impact on their risk profile , remuneration policies and practices that are consistent with effective risk management . ### in order to address the potentially detrimental effect of poorly designed remuneration structures on the sound management of risk and control of risk - taking behaviour by individuals , the requirements of directive 2006 / 48 / ec should be supplemented by an express obligation for credit institutions and investment firms to establish and maintain , for those categories of staff whose professional activities clearly have a material impact on their risk profile , remuneration policies and practices that are consistent with effective risk management . those categories of staff should include , at least , senior management , risk takers and control functions .


### because excessive and imprudent risk - taking may undermine the financial soundness of financial institutions and destabilise the banking system , it is important that the new obligation concerning remuneration policies and practices should be implemented in a consistent manner . it is therefore appropriate to specify core principles on sound remuneration to ensure that the structure of remuneration does not encourage excessive risk - taking by individuals and is aligned with the risk appetite , values and long - term interests of the institution . in order to ensure that the design of remuneration policies is integrated in the risk management of the financial institution , the management body of each credit institution or investment firm should establish the general principles to be applied , and the policies should be subject to at least annual independent internal review . ### because excessive and imprudent risk - taking may undermine the financial soundness of financial institutions and destabilise the banking system , it is important that the new obligation concerning remuneration policies and practices should be implemented in a consistent manner . it is therefore appropriate to specify clear principles on sound remuneration to ensure that the structure of remuneration does not encourage excessive risk - taking by individuals and is aligned with the risk appetite , values and long - term interests of the institution . in order to ensure that the design of remuneration policies is integrated in the risk management of the financial institution , the management body of each credit institution or investment firm should establish the general principles to be applied , and the policies should be subject to at least annual independent internal review . credit institutions and investment firms of significant size should set up independent remuneration committees as an integral part of their governance structure and organisation . remuneration committees should cooperate with the risk and compliance function in order to guard the incentives created for managing risk , capital and liquidity .


### remuneration policy should aim at aligning the personal objectives of staff members with the long - term interests of the credit institution or investment firm concerned . the assessment of the performance - based components of remuneration should be based on longer - term performance and take into account the outstanding risks associated with the performance . the assessment of performance should be set in a multi - year framework , for example of three to five years , in order to ensure that the assessment process is based on longer term performance and that the actual payment of performance - based components of remuneration is spread over the business cycle of the firm ### remuneration policy should aim at aligning the personal objectives of staff members with the long - term interests of the credit institution or investment firm concerned . the assessment of the performance - based components of remuneration should be based on longer - term performance and take into account the outstanding risks associated with the performance . the assessment of performance should be set in a multi - year framework , for example of three to five years , in order to ensure that the assessment process is based on longer term performance and that the actual payment of performance - based components of remuneration is spread over the business cycle of the firm . corporate social responsibility targets should be included in the assessment of longer - term performance justifying the payments of deferred variable remuneration .


### commission recommendation of 30 april 2009 on remuneration policies in the financial services sector also sets out principles on sound remuneration policies as to how firms might comply with this obligation , that are consistent with and complement the principles set out in this directive . ### the principles regarding sound remuneration policies set out in commission recommendation of 30 april 2009 on remuneration policies in the financial services sector are consistent with and complement the principles set out in this directive .


### since poorly designed remuneration policies and incentive schemes are capable of increasing to an unacceptable extent the risks to which credit institutions and investment firms are exposed , it is appropriate that competent authorities impose qualitative or quantitative measures on the relevant entities that are designed to address problems that have been identified in relation to remuneration policies in the pillar 2 supervisory review . qualitative measures available to competent authorities include requiring credit institutions or investment firms to reduce the risk inherent in their activities , products or systems , including structures of remuneration to the extent that they are inconsistent with effective risk management . quantitative measures include a requirement to hold additional own funds . ### since poorly designed remuneration policies and incentive schemes are capable of increasing to an unacceptable extent the risks to which credit institutions and investment firms are exposed , prompt remedial action and , if necessary , appropriate corrective measures should be taken . consequently , it is appropriate to ensure that competent authorities have the powers to impose qualitative or quantitative measures on the relevant entities that are designed to address problems that have been identified in relation to remuneration policies in the pillar 2 supervisory review . qualitative measures available to competent authorities include requiring credit institutions or investment firms to reduce the risk inherent in their activities , products or systems , including structures of remuneration to the extent that they are inconsistent with effective risk management . quantitative measures include a requirement to hold additional own funds .


### the committee of european banking supervisors shall ensure the existence of guidelines on sound remuneration policies which comply with the principles set out in point 22 of annex v . the committee of european securities regulators shall cooperate closely with the committee of european banking supervisors in ensuring the existence of guidelines on remuneration policies for categories of staff involved in the provision of investment services and activities meaning of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments . ### the committee of european banking supervisors shall ensure the existence of guidelines on sound remuneration policies which comply with the principles set out in point 22 of annex v . the guidelines shall take into account the principles on sound remuneration policies set out in the commission recommendation of 30 april 2009 on remuneration policies in the financial services sector . the committee of european securities regulators shall cooperate closely with the committee of european banking supervisors in ensuring the existence of guidelines on remuneration policies for categories of staff involved in the provision of investment services and activities within the meaning of point 2 of article 4 of directive 2004 / 39 / ec of the european parliament and of the council of 21 april 2004 on markets in financial instruments .


### for the purposes of determining the appropriate level of own funds in the supervisory review process carried out in accordance with article 124 , the competent authorities shall assess whether any imposition of a specific own funds requirement in excess of the minimum level is required to capture risks to which a credit institution might be exposed , taking into account the following : ### for the purposes of determining the appropriate level of own funds on the basis of the review and evaluation carried out in accordance with article 124 , the competent authorities shall assess whether any imposition of a specific own funds requirement in excess of the minimum level is required to capture risks to which a credit institution is or might be exposed , taking into account the following :


### the outcome of the supervisory review process carried out in accordance with article 124 . ### the outcome of the review and evaluation carried out in accordance with article 124 .


### when establishing and applying the remuneration policies for those categories of staff whose professional activities have a material impact on their risk profile , credit institutions shall comply with the following principles in a way that is appropriate to their size , internal organisation and the nature , the scope and the complexity of their activities : ### when establishing and applying the remuneration policies for those categories of staff whose professional activities clearly have a material impact on their risk profile , credit institutions shall comply with the following principles in a way that is appropriate to their size , internal organisation and the nature , the scope and the complexity of their activities :


### the management body of the credit institution establishes the general principles of the remuneration policy and is responsible for its implementation ; ### the management body of the credit institution adopts and periodically reviews the general principles of the remuneration policy and is responsible for its implementation ;


### the measurement of performance used to calculate bonuses or bonus pools includes an adjustment for current and future risks and takes into account the cost of the capital and the liquidity required ; ### the measurement of performance used to calculate variable remuneration components or pools of variable remuneration components includes an adjustment for all types of current and future risks and takes into account the cost of the capital and the liquidity required ;


### payment of the major part of a significant bonus is deferred for an appropriate period and is linked to the future performance of the firm . ### at least 40 % of the variable remuneration component , is deferred over a period of no less than three years and is correctly aligned with the nature of the business , its risks and the activities of the member of staff in question ; remuneration payable under deferral arrangements vests no faster than on a pro - rata basis ; in the case of a variable remuneration component of a particularly high amount , at least 60&#160 ; % of the amount is deferred .


### the following information shall be disclosed regarding the remuneration policy and practices of the credit institution for those categories of staff whose professional activities have a material impact on their risk profile : ### the following information , including regular updates , shall be disclosed to the public regarding the remuneration policy and practices of the credit institution for those categories of staff whose professional activities have a material impact on their risk profile :


### information concerning the decision - making process used for determining the remuneration policy , including if applicable , information about the composition and the mandate of a remuneration committee , the name of the external consultant whose services have been used for the determination of the remuneration policy and the role of the relevant stakeholders ; ### information concerning the decision - making process used for determining the remuneration policy , including if applicable , information about the composition and the mandate of a remuneration committee , the external consultant whose services have been used for the determination of the remuneration policy and the role of the relevant stakeholders ;


### information on the criteria used for performance measurement and the risk adjustment ; ### the most important design characteristics of the remuneration system , including information on the criteria used for performance measurement and the risk adjustment , deferral policy and vesting criteria ;


### the main parameters and rationale for any bonus scheme and any other non - cash benefits . ' ### the main parameters and rationale for any variable component scheme and any other non - cash benefits .


### directive 2008 / 68 / ec of the european parliament and of the council of 24 september 2008 on the inland transport of dangerous goods extended the application of the provisions of certain international agreements to cover national traffic in order to harmonise the conditions under which dangerous goods are transported by road , rail and inland waterways across the community . ### directive 2008 / 68 / ec of the european parliament and of the council of 24 september 2008 on the inland transport of dangerous goods extended the application of the provisions of certain international agreements to cover national traffic in order to harmonise the conditions under which dangerous goods are transported by road , rail and inland waterways across the union .


### periodic inspections and exceptional checks of transportable pressure equipment should be carried out in accordance with the annexes to directive 2008 / 68 / ec and with this directive to ensure continued compliance with their safety requirements . ### periodic inspections , intermediate inspections and exceptional checks of transportable pressure equipment should be carried out in accordance with the annexes to directive 2008 / 68 / ec and with this directive to ensure continued compliance with their safety requirements .


### existing transportable pressure equipment not previously assessed for conformity with directive 1999 / 36 / ec should be reassessed and marked according to the provisions of this directive in order to demonstrate its compliance with safety requirements and ensure free movement and use . ### if existing transportable pressure equipment not previously assessed for conformity with directive 1999 / 36 / ec is to benefit from free movement and free use , it should be subject to reassessment of conformity .


### member states should be able to take measures to limit or prohibit the placing on the market and use of equipment in cases where it presents a risk to safety in certain specified circumstances . ### member states should be able to take measures to limit or prohibit the placing on the market and use of equipment in cases where it presents a risk to safety in certain specified circumstances , including when the equipment is in compliance with directive 2008 / 68 / ec and this directive .


### in particular the commission should be empowered to adapt the annexes to scientific and technical progress . since those measures are of general scope and are designed to amend non - essential elements of this directive , inter alia , by supplementing it with new non - essential elements , they must be adopted in accordance with the regulatory procedure with scrutiny provided for in article 5a of decision 1999 / 468 / ec . ### the commission should be empowered to adopt delegated acts in accordance with article 290 of the tfeu in respect of certain adaptations of the annexes .


### transportable pressure equipment as defined in article 2 , bearing the conformity markings provided for in this directive or in directives 84 / 525 / eec , 84 / 526 / eec , 84 / 527 / eec or 99 / 36 / ec , for the purposes of their periodic inspections , exceptional checks and use ; ### transportable pressure equipment as defined in article 2 , bearing the conformity markings provided for in this directive or in directives 84 / 525 / eec , 84 / 526 / eec , 84 / 527 / eec or 99 / 36 / ec , for the purposes of their periodic inspections , intermediate inspections , exceptional checks and use ;


### all pressure receptacles , their valves and other accessories when appropriate , as defined in chapter 6 . 2 of the annexes to directive 2008 / 68 / ec , ### all pressure receptacles , their valves and other accessories when appropriate , as covered in chapter 6 . 2 of the annexes to directive 2008 / 68 / ec ,


### tanks , battery vehicles / wagons , multiple - element gas containers , their valves and other accessories when appropriate , as defined in chapter 6 . 8 of the annexes to directive 2008 / 68 / ec , when the equipment under or is used in accordance with those annexes for the transport of class 2 gases , excluding gases or articles with figures 6 and 7 in the classification code , and for the transport of the dangerous substances of other classes specified in annex i to this directive ; ### tanks , battery vehicles / wagons , multiple - element gas containers , their valves and other accessories when appropriate , as covered in chapter 6 . 8 of the annexes to directive 2008 / 68 / ec , when the equipment under or is used in accordance with those annexes for the transport of class 2 gases , excluding gases or articles with figures 6 and 7 in the classification code , and for the transport of the dangerous substances of other classes specified in annex i to this directive ; transportable pressure equipment shall be understood as including gas cartridges and excluding aerosols , open cryogenic receptacles , gas cylinders for breathing apparatus , fire extinguishers , transportable pressure equipment exempted according to 1 . 1 . 3 . 2 of the annexes to directive 2008 / 68 / ec and transportable pressure equipment exempted from the rules for construction and testing of packaging according to special provisions in 3 . 3 of the annexes to directive 2008 / 68 / ec .


### “economic operators” means the manufacturer , the authorised representative , the importer , the distributor , the owner or the operator acting in the course of a commercial activity , whether in return for payment or free of charge ; ### “economic operators” means the manufacturer , the authorised representative , the importer , the distributor , the owner or the operator acting in the course of a commercial or public service activity , whether in return for payment or free of charge ;


### ' reassessment of conformity ' means the procedure undertaken , at the request of the owner , for the subsequent assessment of the conformity of transportable pressure equipment manufactured and placed on the market before the date of implementation of directive 1999 / 36 / ec ; ### ' reassessment of conformity ' means the procedure undertaken , at the request of the owner or operator , for the subsequent assessment of the conformity of transportable pressure equipment manufactured and placed on the market before the date of implementation of directive 1999 / 36 / ec ;


### “accreditation” means an attestation by a national accreditation body that a notified body meets the requirements set out in the second paragraph of 1 . 8 . 6 . 4 of the annexes to directive 2008 / 68 / ec ; ### “accreditation” means an attestation by a national accreditation body that a notified body meets the requirements set out in the second paragraph of 1 . 8 . 6 . 8 of the annexes to directive 2008 / 68 / ec ;


### manufacturers who consider or have reason to believe that transportable pressure equipment which they have placed on the market is not in conformity with the annexes to directive 2008 / 68 / ec and with this directive shall immediately take the necessary corrective measures to bring the transportable pressure equipment into conformity , to withdraw it or to recall it , if appropriate . furthermore , where the transportable pressure equipment presents a risk , manufacturers shall immediately inform the competent national authorities of the member states in which they made the transportable pressure equipment available to that effect , giving details , in particular , of the non - compliance and of any corrective measures taken . ### manufacturers who consider or have reason to believe that transportable pressure equipment which they have placed on the market is not in conformity with the annexes to directive 2008 / 68 / ec or with this directive shall immediately take the necessary corrective measures to bring the transportable pressure equipment into conformity , to withdraw it or to recall it , if appropriate . furthermore , where the transportable pressure equipment presents a risk , manufacturers shall immediately inform the competent national authorities of the member states in which they made the transportable pressure equipment available to that effect , giving details , in particular , of the non - compliance and of any corrective measures taken .


### the obligations set out in article 4 and the drawing up of technical documentation shall not form part of the authorised representative ' s mandate . ### the obligations set out in article 4 and and the drawing up of technical documentation shall not form part of the authorised representative ' s mandate .


### keep the technical documentation at the disposal of national surveillance authorities for at least 20 years from the date of manufacture of the transportable pressure equipment ; ### keep the technical documentation at the disposal of national surveillance authorities for at least the period as specified in the annexes to directive 2008 / 68 / ec for manufacturers ;


### importers shall , for at least 20 years from the date of the manufacture of the transportable pressure equipment , keep a copy of the technical documentation at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request . ### importers shall , for at least the period as specified in the annexes to directive 2008 / 68 / ec for manufacturers , keep a copy of the technical documentation at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request .


### where a distributor considers or has reason to believe that transportable pressure equipment is not in conformity with the annexes to directive 2008 / 68 / ec or this directive , he shall not make the transportable pressure equipment available on the market until it has been brought into conformity . furthermore , where the transportable pressure equipment presents a risk , the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities . ### where a distributor considers or has reason to believe that transportable pressure equipment is not in conformity with the annexes to directive 2008 / 68 / ec or with this directive , he shall not make the transportable pressure equipment available on the market until it has been brought into conformity . furthermore , where the transportable pressure equipment presents a risk , the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities .


### economic operators shall , on request from the market surveillance authority , identify the following to it for the period specified in the annexes to directive 2008 / 68 / ec ### economic operators shall , on request from the market surveillance authority , identify the following to it for a period of at least 10 years .