### the commission shall implement the programme by establishing annual work programmes setting out the elements provided in the financial regulation and in particular : the priorities and the actions to be undertaken , including the allocation of financial resources ; detailed eligibility criteria for the beneficiaries in compliance with article 8 ; the criteria for the percentage of the financial contribution of the union , including criteria for assessing whether or not exceptional utility applies , and the applicable rate of the co - financing ; the essential selection and award criteria to be used to select the proposals receiving financial contributions ; the time schedule of the planned calls for the tenders and calls for proposals ; where appropriate , the authorisation to use lump sums , standard scales of unit costs or flat - rate financing in line with the financial regulation ; the actions co - financed by international organisations active in the area of health without previous call for proposal duly justified . 2 . the working programme referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in article 16 . 3 . in implementing the programme , the commission , together with the member states , shall ensure compliance with all relevant legal provisions regarding personal data protection and , where appropriate , the introduction of mechanisms to ensure the confidentiality and safety of such data . ### the commission shall be empowered to adopt delegated acts in accordance with article 16a in the form of annual work programmes setting out the elements provided in the financial regulation and in particular : the annual priorities and the actions to be undertaken , including the allocation of financial resources ; detailed eligibility criteria for the beneficiaries in compliance with article 8 ; the criteria for the percentage of the financial contribution of the union , including criteria for assessing whether or not exceptional utility applies , and the applicable rate of the co - financing ; the essential selection and award criteria to be used to select the proposals receiving financial contributions ; the actions co - financed by international organisations active in the area of health without previous call for proposal duly justified . 2 . the commission shall implement the annual work programmes by setting out : the time schedule of the planned calls for tenders and calls for proposals ; where appropriate , the authorisation to use lump sums , standard scales of unit costs or flat - rate financing in line with the financial regulation ; 2a . the measures referred to in paragraph 2 shall be adopted in accordance with the examination procedure referred to in article 16 . 3 . in implementing the programme , the commission , together with the member states , shall ensure compliance with all relevant legal provisions regarding personal data protection and , where appropriate , the introduction of mechanisms to ensure the confidentiality and safety of such data .


### the programme should be implemented in full respect of the principle of transparency and with a reasonable balance between its different objectives . appropriate actions covered by the programme ' s specific objectives and with a clear eu added value should be selected and funded by the programme . the annual work programmes should set out , in particular , the essential selection criteria applicable to the potential beneficiaries , in accordance with the financial regulation , in order to ensure they have the financial and operational capacity to undertake activities financed under the programme , and , where appropriate , the evidence required to demonstrate their independence . ### the programme should be implemented in full respect of the principle of transparency . budgetary resources should be shared out between objectives in a manner proportionate to their probable advantages for eu citizens’ health . there should not , therefore , be a set order of priority for objectives . appropriate actions covered by the programme ' s specific objectives and with a clear eu added value should be selected and funded by the programme . the annual work programmes should set out , in particular , the essential selection criteria applicable to the potential beneficiaries , in accordance with the financial regulation , in order to ensure they have the financial and operational capacity to undertake activities financed under the programme , and , where appropriate , the evidence required to demonstrate their independence .


### to develop common tools and mechanisms at eu level to address shortages of resources , both human and financial , and to facilitate up - take of innovation in healthcare in order to contribute to innovative and sustainable health systems . ### to develop common tools and mechanisms at eu level to address shortages of resources , both human and financial , and to facilitate voluntary up - take of innovation in healthcare in order to contribute to innovative , efficient and sustainable health systems .


### this regulation lays down the conditions under which member states should be authorised to maintain in force or to permit to enter into force international agreements relating to investment . ### this regulation lays down a notification procedure in order to provide transparency on all bilateral agreements of the member states that are maintained in force . the notification may be withdrawn by a member state if the respective agreement is terminated .


### this regulation lays down the conditions under which member states should be authorised to maintain in force or to permit to enter into force international agreements relating to investment . ### this regulation lays down the conditions under which member states should be authorised to maintain in force or to permit to enter into force international agreements relating to foreign direct investment .


### within thirty days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to investment concluded before the entry into force of this regulation that they either wish to maintain in force or permit to enter into force under this chapter . the notification shall include a copy of those bilateral agreements . ### within thirty days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to investment concluded before the entry into force of this regulation that they either wish to maintain in force or permit to enter into force under this chapter . the notification shall include a copy of those bilateral agreements . member states shall also notify the commission of all future changes to the status of these agreements .


### in the interest of eu investors and their investments in third countries , and of member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of investment should be maintained in force . ### in the interest of eu investors and their investments in third countries and of member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of foreign direct investment remain binding under public international law without prejudice to the right of the commission to replace progressively existing direct foreign investment agreements with new agreements offering equal or better conditions to member states .


### the commission should be able to withdraw the authorisation if an agreement conflicts with the law of the union other than the incompatibilities arising from the allocation of competence between the union and its member states . the authorisation may also be withdrawn if an agreement of the union in force with a third country contains investment provisions similar to those of a member state agreement . in order to ensure that agreements of member states do not undermine the development and implementation of the union ' s policies relating to investment , including in particular of autonomous measures of common commercial policy , authorisation may be withdrawn . finally , should the council not take a decision on the authorisation to open negotiations concerning investment within one year of the submission of a recommendation by the commission pursuant to article 218 of the treaty , the possibility would exist to withdraw the authorisation . ### the commission should be able to withdraw the authorisation if a foreign direct investment agreement conflicts with the law of the union , including respect for the protection of human rights and social and environmental legislation , save where the incompatibilities arise from the allocation of competence between the union and its member states . such authorisations should be withdrawn only following a request by the commission for the member state to renegotiate the foreign direct investment agreement with which the member state has failed to comply . it should also be possible to withdraw the authorisation if a foreign direct investment agreement of the union in force with a third country contains investment provisions that are equivalent in substance to those of a member state foreign direct investment agreement . in order to ensure that agreements of member states do not undermine the development and implementation of the union ' s policies relating to investment , including in particular of autonomous measures of common commercial policy , authorisation may be withdrawn . finally , should the council not take a decision on the authorisation to open negotiations concerning investment within one year of the submission of a recommendation by the commission pursuant to article 218 of the treaty , the possibility would exist to withdraw the authorisation .


### agreements authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to investment , in particular common commercial policy . ### agreements on foreign direct investment authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to foreign direct investment , in particular common commercial policy .


### agreements between member states relating to investment should not be covered by this regulation . ### agreements between member states relating to investment are not covered by this regulation .


### although bilateral agreements remain binding on the member states under public international law and will be progressively replaced by future agreements of the union relating to the same subject matter , the conditions for their continuing existence and their relationship with the union ' s policies relating to investment , including in particular the common commercial policy , require appropriate management . that relationship will develop further as the union exercises its competence . ### although bilateral agreements remain binding on the member states under public international law and will be progressively replaced by future agreements of the union relating to the same subject matter , the conditions for their continuing existence and their relationship with the union ' s policies relating to investment , including in particular the common commercial policy , require appropriate management . that relationship will develop further as the union exercises its competence in common investment policy with the main goal to create the best possible investment protection system for all member states investors , equally and equal investing conditions on third markets . as the new investment policy will be developed in view of transitional validity of bilateral investment agreements concluded by member states , it should acknowledge the rights of investors whose investments fall into the scope of those agreements and should grant their legal certainty .


### the notification referred to in paragraph 1 shall be transmitted at least five calendar months before formal negotiations are to commence with the third country concerned . ### the notification referred to in paragraph 1 shall be transmitted at least two calendar months before formal negotiations are to commence with the third country concerned .


### as the authorisation to maintain , amend or conclude agreements covered by this regulation is granted in an area of exclusive union competence , it must be regarded as an exceptional measure . the authorisation is without prejudice to the application of article 258 of the treaty with respect to failures of member states to fulfil obligations under the treaties other than those concerning incompatibilities arising from the allocation of competences between the union and its member states . ### as the authorisation to maintain , amend or conclude foreign direct investment agreements covered by this regulation is granted in an area of exclusive union competence , it must be regarded as an exceptional measure . the authorisation is without prejudice to the application of article 258 of the treaty with respect to failures of member states to fulfil obligations under the treaties other than those concerning incompatibilities arising from the allocation of competences between the union and its member states .


### constitute an obstacle to the development and the implementation of the union ' s policies relating to investment , including in particular the common commercial policy . ### constitute an obstacle to the development and the implementation of the union ' s policies relating to fdi , including in particular the common commercial policy ;


### within thirty days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to investment concluded before the entry into force of this regulation that they either wish to maintain in force or permit to enter into force under this chapter . the notification shall include a copy of those bilateral agreements . ### within 30 days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to fdi concluded before the entry into force of this regulation that will either remain in force or be permitted to enter into force under this chapter . the notification shall include a copy of those bilateral agreements .


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


### where a member state intends to enter into negotiations in order to amend an existing or to conclude a new agreement with a third country relating to investment , it shall notify the commission of its intentions in writing . ### where a member state intends to enter into negotiations in order to amend an existing agreement or to conclude a new agreement falling within the scope of this regulation , it shall notify the commission in writing of its intention at the earliest possible moment before the opening of formal negotiations is envisaged .


### notwithstanding the union ' s competences relating to investment and without prejudice to other obligations of member states under the law of the union , member states are authorised in accordance with article 2 of the treaty to maintain in force bilateral agreements relating to investment that have been notified in accordance with article 2 of this regulation . ### notwithstanding the union ' s competences relating to fdi and without prejudice to other obligations of member states under the law of the union , member states are authorised in accordance with article 2 of the treaty to maintain in force bilateral agreements relating to fdi that have been notified in accordance with article 2 of this regulation .


### where a member state intends to enter into negotiations in order to amend an existing or to conclude a new agreement with a third country relating to investment , it shall notify the commission of its intentions in writing . ### where a member state intends to enter into negotiations in order to amend an existing or to conclude a new agreement with a third country relating to fdi , it shall notify the commission of its intentions in writing .


### this regulation establishes the terms , conditions and the procedure under which member states are authorised to maintain in force , amend or conclude bilateral agreements with third countries relating to investment . ### this regulation establishes the terms , conditions and the procedure under which member states are authorised to maintain in force , amend or conclude bilateral agreements with third countries relating to foreign direct investment . fdi includes any foreign investment which serves to establish lasting and direct links with an undertaking to which capital is made available in order to carry out an economic activity . where fdi takes the form of a shareholding , those lasting and direct links are the ability of the shareholder to participate effectively in the management or control of the undertaking concerned . fdi does not include foreign investments where there is no intention to influence the management or control of an undertaking . such investments which are often of a more short - term , and sometimes of a more speculative , nature , are commonly referred to as portfolio investments .


### decisions pursuant to paragraphs 4 and 5 shall be taken in accordance with the procedure referred to in article 15 . the commission shall take the decision within 90 days of receipt of the notifications referred to in paragraphs 1 and 2 . where additional information is needed to take the decision , the 90 days shall run from the date of receipt of the additional information . ### decisions pursuant to paragraphs 4 and 5 shall be taken in accordance with the procedure referred to in article 15 . the commission shall take the decision within 60 working days of receipt of the notifications referred to in paragraphs 1 and 2 . where additional information is needed to take the decision , the 60 working days shall run from the date of receipt of the additional information .


### in the interest of eu investors and their investments in third countries , and of member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of investment should be maintained in force . ### in the interest of eu investors and their investments and third countries , member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of investment should be maintained in force and remain binding on the parties under public international law unless replaced by new agreements that provide for at least the same level of investor protection . this will be applied not only to bits already in force but also to bits concluded and / or signed by the time of the entering in to force of this regulation .


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


### agreements authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to investment , in particular common commercial policy . ### authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union’s policies relating to investment .


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


### where the consultations referred to in paragraph 2 fail to resolve the matter , the commission shall withdraw the authorisation for the agreement concerned . the commission shall take a decision on the withdrawal of the authorisation in accordance with the procedure referred to in article 15 . it shall include a requirement that the member state takes appropriate action , and where necessary terminate the relevant agreement . ### where the consultations referred to in paragraph 2 fail to resolve the matter , the commission may withdraw the authorisation for the agreement concerned . the commission shall take a decision on the withdrawal of the authorisation in accordance with the procedure referred to in article 15 . it shall include a requirement that the member state takes appropriate action , and where necessary terminate the relevant agreement .


### this regulation establishes the terms , conditions and the procedure under which member states are authorised to maintain in force , amend or conclude bilateral agreements with third countries relating to investment . ### this regulation declares the maintenance in force of existing and concluded bilateral agreements with third countries relating to investment as well as establishes the terms , conditions and the procedure under which member states are authorised to amend or conclude such agreements . this procedure is without prejudice to the respective competencies of the european union and of the member states .


### in the interest of eu investors and their investments in third countries , and of member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of investment should be maintained in force . ### in the interest of eu investors and their investments in third countries and of member states hosting foreign investors and investments , bilateral agreements that specify and guarantee the conditions of foreign direct investment remain binding under public international law without prejudice to the right of the commission to replace progressively existing direct foreign investment agreements with new agreements offering equal or better conditions to member states .


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


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


### agreements authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to investment , in particular common commercial policy . ### agreements on foreign direct investment authorised under this regulation or authorisations to open negotiations to amend an existing or to conclude a new bilateral agreement with a third country should not in any case be allowed to constitute an obstacle to the implementation of the union ' s policies relating to foreign direct investment , in particular common commercial policy .


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


### within thirty days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to investment concluded before the entry into force of this regulation that they either wish to maintain in force or permit to enter into force under this chapter . the notification shall include a copy of those bilateral agreements . ### within thirty days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to investment concluded and / or signed before the entry into force of this regulation that they either wish to maintain in force or permit to enter into force under this chapter . the notification shall include a copy of those bilateral agreements . member states shall also notify the commission on future changes to the status of these agreements .


### this regulation establishes the terms , conditions and the procedure under which member states are authorised to maintain in force , amend or conclude bilateral agreements with third countries relating to investment . ### this regulation declares the maintenance in force of concluded bilateral investment agreements with third countries relating to direct investment as well as establishes the terms , conditions and the procedure under which member states are authorised to amend or conclude such agreements .


### notwithstanding the union ' s competences relating to investment and without prejudice to other obligations of member states under the law of the union , member states are authorised in accordance with article 2 of the treaty to maintain in force bilateral agreements relating to investment that have been notified in accordance with article 2 of this regulation . ### notwithstanding the union ' s competences relating to fdi and without prejudice to other obligations of member states under the law of the union , member states are authorised in accordance with article 2 of the treaty to maintain in force bilateral agreements relating to fdi that have been notified in accordance with article 2 of this regulation .


### as the authorisation to maintain , amend or conclude agreements covered by this regulation is granted in an area of exclusive union competence , it must be regarded as an exceptional measure . the authorisation is without prejudice to the application of article 258 of the treaty with respect to failures of member states to fulfil obligations under the treaties other than those concerning incompatibilities arising from the allocation of competences between the union and its member states . ### as the authorisation to maintain , amend or conclude agreements covered by this regulation is granted in an area of exclusive union competence , it must be regarded as a transitional measure . the authorisation is without prejudice to the application of article 258 of the treaty with respect to failures of member states to fulfil obligations under the treaties other than those concerning incompatibilities arising from the allocation of competences between the union and its member states .


### this regulation lays down the conditions under which member states are empowered to amend or conclude international agreements relating to investment . ### this regulation lays down the conditions under which member states are empowered to maintain , amend or conclude international agreements relating to foreign direct investment .


### where a member state intends to enter into negotiations in order to amend an existing or to conclude a new agreement with a third country relating to investment , it shall notify the commission of its intentions in writing . ### where a member state intends to enter into negotiations in order to amend an existing agreement or to conclude a new agreement falling within the scope of this regulation , it shall notify the commission in writing of its intention at the earliest possible moment before the opening of formal negotiations is envisaged .


### decisions on the authorisation referred to in paragraph 1 shall be taken in accordance with the procedure referred to in article 15 . the commission shall take its decision within 90 days of receipt of the notification referred to in article 8 . where additional information is needed to take a decision , the 90 days shall run from the date of receipt of the additional information . ### decisions on the authorisation referred to in paragraph 1 shall be taken in accordance with the procedure referred to in article 15 . the commission shall take its decision within 35 days of receipt of the notification referred to in article 8 . where additional information is needed to take a decision , the 35 days shall run from the date of receipt of the additional information .


### this regulation establishes the terms , conditions and the procedure under which member states are authorised to maintain in force , amend or conclude bilateral agreements with third countries relating to investment . ### this regulation establishes the terms , conditions and the procedure under which member states are authorised to maintain in force , amend or conclude bilateral agreements with third countries relating to foreign direct investment . fdi includes any foreign investment which serves to establish lasting and direct links with an undertaking to which capital is made available in order to carry out an economic activity . where fdi takes the form of a shareholding , those lasting and direct links are the ability of the shareholder to participate effectively in the management or control of the undertaking concerned . fdi does not include foreign investments where there is no intention to influence the management or control of an undertaking . such investments which are often of a more short - term , and sometimes of a more speculative , nature , are commonly referred to as portfolio investments .


### within thirty days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to investment concluded before the entry into force of this regulation that they either wish to maintain in force or permit to enter into force under this chapter . the notification shall include a copy of those bilateral agreements . ### within 30 days from the entry into force of this regulation , the member states shall notify the commission of all bilateral agreements with third countries relating to fdi concluded before the entry into force of this regulation that will either remain in force or be permitted to enter into force under this chapter . the notification shall include a copy of those bilateral agreements .


### the commission shall be kept informed of the progress and results throughout the different stages of negotiations and may request to participate in the negotiations between the member state and the third country concerning investment . ### the commission shall be kept informed of the progress and results throughout the different stages of negotiations and may request to participate in the negotiations between the member state and the third country concerning fdi .


### where the consultations referred to in paragraph 2 fail to resolve the matter , the commission shall withdraw the authorisation for the agreement concerned . the commission shall take a decision on the withdrawal of the authorisation in accordance with the procedure referred to in article 15 . it shall include a requirement that the member state takes appropriate action , and where necessary terminate the relevant agreement . ### where the consultations referred to in paragraph 2 fail to resolve the matter , the commission shall withdraw the authorisation for the agreement concerned . such a withdrawal of authorisation shall not occur until at least one year has elapsed from the date of delivery of the reasoned opinion referred to in paragraph 2 . the commission shall take a decision on the withdrawal of the authorisation in accordance with the procedure referred to in article 15 . it shall include a requirement that the member state takes appropriate action , and where necessary terminate the relevant agreement .


### this regulation lays down the conditions under which member states are empowered to amend or conclude international agreements relating to investment . ### this regulation lays down the conditions under which member states are empowered to amend or conclude international agreements relating to foreign direct investment .


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


### the existing exemption for that use should continue to apply until 31 december 2015 in order to enable industry to further adapt the relevant technologies . ### the existing exemption for that use should continue to apply until 31 december 2016 in order to enable producers , the recycling industry and consumers along the whole value chain to further adapt the relevant substitute technologies across all the regions of the union in a uniform manner .


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred in the process of meeting a given request for re - use . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should always lie with the public sector body charging for the re - use of documents . those charges should be set according to objective , transparent and verifiable criteria .


### in article 13 the date of 1 july 2008 is replaced by [ 3 years after the transposition date ] and the following paragraph is added : ‘ member states shall submit a yearly report to the commission on the extent of the re - use of public sector information , the conditions under which it is made available and the work of the independent authority referred to in article 4 . ’ ### in article 13 the date of 1 july 2008 is replaced by [ 3 years after the transposition date ] .


### ' machine - readable ' means that digital documents are sufficiently structured for software applications to identify reliably individual statements of fact and their internal structure . ’ ### ' machine - readable ' means that digital documents are structured so that software applications can , in a technology - neutral manner , extract individual data which are of interest . ’


### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata . ' . ### paragraph 1 is replaced by the following : ‘ 1 . public sector bodies shall make their documents available in the pre - existing formats or languages and , where possible and appropriate , in technology - neutral , machine - readable format and together with their metadata . this shall not imply an obligation for public sector bodies to create , digitise or adapt documents or render them machine - readable in a technology - neutral manner in order to comply with the request , nor shall it imply an obligation to provide extracts from documents where this would involve disproportionate effort , going beyond a simple operation . ’


### in exceptional cases , in particular where public sector bodies generate a substantial part of their operating costs relating to the performance of their public service tasks from the exploitation of their intellectual property rights , public sector bodies may be allowed to charge for the re - use of documents over and above the marginal costs , according to objective , transparent and verifiable criteria , provided this is in the public interest and subject to the approval of the independent authority referred to in article 4 , and without prejudice to paragraphs 3 and 4 of this article . ### paragraph 1 shall not apply to the following : public sector bodies that are required to generate revenue to cover a substantial part of the costs of collection , production , reproduction and dissemination of documents . libraries , museums and archives .


### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . ### member states shall make practical arrangements to facilitate searches for documents available for re - use throughout the union , such as asset lists of main documents with relevant metadata , accessible preferably in technology - neutral , machine - readable format , and portal sites that are linked to asset lists .


### public sector bodies may allow re - use without conditions or may impose conditions , such as indication of source , where appropriate through a licence . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . ### ' 1 . public sector bodies may allow re - use without conditions for non - commercial use or may impose conditions , such as indication of source , where appropriate through a licence . when used for commercial purposes , a minimum condition of the indication of source shall be required . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . '


### it is necessary to ensure that the member states report to the commission on the extent of the re - use of public sector information , the conditions under which it is made available , and the work of the independent authority . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### it is necessary to ensure that the member states report to the commission on the extent of the re - use of public sector information , the conditions under which it is made available , and the work of the impartial body . to ensure consistency between approaches at union level , coordination between the impartial bodies should be encouraged , particularly through exchange of information on best practices and data re - use policies .


### for documents for which libraries , museums and archives have intellectual property rights , member states shall ensure that , where the re - use of documents is allowed , these documents shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv . ### for documents for which libraries , museums and archives have intellectual property rights , member states shall ensure that , where the re - use of documents is allowed , these documents shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv , provided that the documents concerned are of types classified as accessible under the rules which exist in the member states regarding access to public - sector information . where possible , these documents shall be disseminated in technology - neutral , machine - readable form .


### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . ### member states shall facilitate that practical arrangements for the cross - lingual search for documents available for re - use , such as asset lists of main documents with relevant metadata , accessible preferably in technology - neutral , machine - readable format , and portal sites that are linked to asset lists


### ' documents held by educational and research establishments , such as research facilities , including , where relevant , organisations established for the transfer of research results , schools and universities and ; ’ ### ' documents held by educational and research establishments , including organisations established for the transfer of research results , schools and universities and ; ’


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for supplying and allowing the re - use of documents , they should in principle be limited to the marginal costs . however , the necessity of not hindering the normal running of public sector bodies that are required to cover a substantial part of their costs relating to the performance of their public task as well as the normal running of libraries , museums and archives should notably be taken into consideration . those public sector bodies should be allowed to charge higher charges for re - use . such charges above marginal costs should be set according to objective , transparent and verifiable criteria and the total income from supplying and allowing re - use of documents should not exceed the cost of collection , production , reproduction and dissemination , together with a reasonable return on investment . the burden of proving that charges are cost - oriented and comply with relevant criteria should lie with the public sector body charging for the re - use of documents .


### directive 2003 / 98 / ec does not contain an obligation to allow re - use of documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , so that all generally accessible documents are re - usable . in other member states , the link between the two sets of rules is less clear and this is a source of legal uncertainty . ### directive 2003 / 98 / ec does not contain an obligation for member states to allow access to , and re - use of , public - sector documents . the decision whether or not to authorise re - use remains with the member states or the public sector body concerned . the directive only harmonises the conditions subject to which documents are made available for re - use . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , whereas other member states have legally separated the right of re - use from national rules on access to information and freedom of information .


### subject to paragraph member states shall ensure that documents referred to in article 1 shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv . ### subject to paragraph member states shall ensure that documents of public sector bodies referred to in article 1 shall be re - usable for commercial or non - commercial purposes in accordance with the conditions set out in chapters iii and iv , provided that the documents concerned are of types classified as accessible under the rules which exist in the member states regarding access to public sector information . where possible , these documents shall be disseminated in technology - neutral , machine - readable form .


### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require supervision by independent authorities competent on the re - use of public sector information . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require supervision by independent authorities competent on the re - use of public sector information . member states have a responsibility to make appropriate national authorities responsible for supervision . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . where implementation results in conflict , recourse can be made to national ombudsmen systems or the european ombudsman .


### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata . ' . ### paragraph 1 is replaced by the following : ' 1 . ' public sector bodies shall make their documents available in the pre - existing formats or languages and , where possible and appropriate , in technology - neutral , machine - readable format and together with their metadata . this shall not imply an obligation for public sector bodies to create , digitise or adapt documents or render them machine - readable in a technology - neutral manner in order to comply with the request , nor shall it imply an obligation to provide extracts from documents where this would involve disproportionate effort , going beyond a simple operation . '


### directive 2003 / 98 / ec does not contain an obligation to allow re - use of documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , so that all generally accessible documents are re - usable . in other member states , the link between the two sets of rules is less clear and this is a source of legal uncertainty . ### directive 2003 / 98 / ec does not justify an obligation for member states to allow access to , and re - use of , public - sector documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . the directive only harmonises the conditions subject to which documents are made available for re - use . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , whereas other member states have legally separated the right of re - use from national rules on access to information and freedom of information .


### in article 13 the date of 1 july 2008 is replaced by [ 3 years after the transposition date ] and the following paragraph is added : ### in article 13 the date of 1 july 2008 is replaced by [ 5 years after the date of entry into force ] and the following paragraph is added :


### in exceptional cases , in particular where public sector bodies generate a substantial part of their operating costs relating to the performance of their public service tasks from the exploitation of their intellectual property rights , public sector bodies may be allowed to charge for the re - use of documents over and above the marginal costs , according to objective , transparent and verifiable criteria , provided this is in the public interest and subject to the approval of the independent authority referred to in article 4 , and without prejudice to paragraphs 3 and 4 of this article . ### in exceptional cases , in particular where public sector bodies generate a substantial part of their operating costs relating to the performance of their public service tasks from the exploitation of their intellectual property rights , public sector bodies may be allowed to charge for the re - use of documents over and above the marginal costs , according to objective , transparent and verifiable criteria , provided this is in the public interest and subject to the approval of the impartial body referred to in article 4 , and without prejudice to paragraphs 3 and 4 of this article .


### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , may also play an important role in this respect . therefore , member states should encourage the use of open government licences . ### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible , preferably limiting them to the indication of source . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , should play an important role in this respect . therefore , member states should encourage the use of open licences that in time should become standardised across the union .


### the commission should assist the member states in implementing the directive in a consistent way by giving guidance , particularly on charging and calculation of costs , on recommended licensing conditions and on formats , after consulting interested parties . ### the commission should assist the member states in implementing the directive in a consistent way by making proposals and laying down guidelines , particularly on charging and calculation of costs , on recommended licensing conditions and on formats , after consulting interested parties .


### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . ### member states shall adopt practical arrangements facilitating the cross - lingual search for documents available for re - use , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable and technology - neutral format , and portal sites that are linked to decentralised asset lists .


### the means of redress shall include the possibility of review by an independent authority that is vested with specific regulatory powers regarding the re - use of public sector information and whose decisions are binding upon the public sector body concerned . ### the means of redress shall include a reference to the possibility of review by an authority in the member states .


### directive 2003 / 98 / ec should therefore lay down a clear obligation for member states to make all generally available documents re - usable . as it constitutes a limitation to the intellectual property rights hold by the authors of the documents , the scope of such a link between the right of access and the right of use should be narrowed to what is strictly necessary to reach the objectives pursued by its introduction . in this respect , taking into account the union legislation and member states ' and union ' s international obligations , notably under the berne convention for the protection of literary and artistic works and the agreement on trade - related aspects of intellectual property rights , documents on which third parties hold intellectual property rights should be excluded from the scope of directive 2003 / 98 / ec . if a third party was the initial owner of a document held by libraries , museums and archives that is still protected by intellectual property rights , that document should , for the purpose of this directive , be considered as a document for which third parties hold intellectual property rights . ### directive 2003 / 98 / ec limits the intellectual property rights held by the authors of the documents . the scope of such a link between the right of access and the right of use should therefore be narrowed to what is strictly necessary to reach the objectives pursued by its introduction . in this respect , taking into account the union legislation and member states ' and union ' s international obligations , notably under the berne convention for the protection of literary and artistic works and the agreement on trade - related aspects of intellectual property rights , documents on which third parties hold intellectual property rights should be excluded from the scope of directive 2003 / 98 / ec . if a third party was the initial owner of a document held by libraries , museums and archives that is still protected by intellectual property rights , that document should , for the purpose of this directive , be considered as a document for which third parties hold intellectual property rights .


### directive 2003 / 98 / ec should therefore lay down a clear obligation for member states to make all generally available documents re - usable . as it constitutes a limitation to the intellectual property rights hold by the authors of the documents , the scope of such a link between the right of access and the right of use should be narrowed to what is strictly necessary to reach the objectives pursued by its introduction . in this respect , taking into account the union legislation and member states ' and union ' s international obligations , notably under the berne convention for the protection of literary and artistic works and the agreement on trade - related aspects of intellectual property rights , documents on which third parties hold intellectual property rights should be excluded from the scope of directive 2003 / 98 / ec . if a third party was the initial owner of a document held by libraries , museums and archives that is still protected by intellectual property rights , that document should , for the purpose of this directive , be considered as a document for which third parties hold intellectual property rights . ### directive 2003 / 98 / ec should therefore lay down a clear obligation for member states to make all generally available documents re - usable . this obligation should not apply to documents which , in accordance with existing access rules in the member states , are not accessible , or which are covered by the exceptions provided for in this directive .


### “machine - readable” means that digital documents are sufficiently structured for software applications to identify reliably individual statements of fact and their internal structure . ### “document in a machine - readable format” means a digital document in a file format which allows software applications to easily identify , recognise and extract data of interest from that document in a technologically neutral way .


### ' machine - readable ' means that digital documents are sufficiently structured for software applications to identify reliably individual statements of fact and their internal structure . ’ ### ' machine - readable ' means that digital documents are structured so that software applications can , in a technology - neutral manner , extract individual data which are of interest . ’


### in article 7 , the words ‘ over and above the marginal costs or’ are inserted after ‘ calculation of charges’ . ### in article 7 , the third sentence is replaced by the following : ‘ the public sector body in question shall also indicate which factors will be taken into account in the calculation of charges as referred to in article 6 . ’


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for supplying and allowing the re - use of documents , they should in principle be limited to the marginal costs . however , the necessity of not hindering the normal running of public sector bodies that are required to cover a substantial part of their costs relating to the performance of their public task as well as the normal running of libraries , museums and archives should notably be taken into consideration . those public sector bodies should be allowed to charge higher charges for re - use . such charges above marginal costs should be set according to objective , transparent and verifiable criteria and the total income from supplying and allowing re - use of documents should not exceed the cost of collection , production , reproduction and dissemination , together with a reasonable return on investment . the burden of proving that charges are cost - oriented and comply with relevant criteria should lie with the public sector body charging for the re - use of documents .


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


### public sector bodies may allow re - use without conditions or may impose conditions , such as indication of source , where appropriate through a licence . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . ### public sector bodies may allow re - use of documents without conditions or may impose conditions , such as indication of source , where appropriate through a licence dealing with relevant issues . these conditions shall be made available through electronic means and shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition .


### in paragraph 1 , the words ' through electronic means ' are replaced by ' in machine - readable format and together with their metadata . ' . ### paragraph 1 is replaced by the following : ‘ 1 . public sector bodies shall make their documents available in the pre - existing formats or languages and , where possible and appropriate , in technology - neutral , machine - readable format and together with their metadata . this shall not imply an obligation for public sector bodies to create , digitise or adapt documents or render them machine - readable in a technology - neutral manner in order to comply with the request , nor shall it imply an obligation to provide extracts from documents where this would involve disproportionate effort , going beyond a simple operation . ’


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for the re - use of documents , they should be set according to objective , transparent and verifiable criteria that ensure equal treatment . they should in principle be limited to the marginal costs involved in reproducing documents and making them available . however , the fact that some public bodies may generate revenue to cover a substantial part of their costs relating to the performance of their public tasks from the exploitation of their intellectual property rights should notably be taken into consideration . those bodies and also libraries , museums and archives , should be able to levy charges that exceed the marginal costs involved in reproducing documents and making them available and provide a reasonable return on investment . the charges should be set according to objective , transparent and verifiable criteria that ensure equal treatment . the burden of proving that charges are cost oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents .


### to facilitate re - use , public sector bodies should make documents available through machine readable formats and together with their metadata where possible and appropriate , in a format that ensures interoperability , e . g . by processing them in a way consistent with the principles governing the compatibility and usability requirements for spatial information under directive 2007 / 2 / ec of the european parliament and of the council of 14 march 2007 establishing an infrastructure for spatial information in the european community ### to facilitate re - use , public sector bodies should make documents available through technology - neutral machine readable formats and together with their metadata where possible and appropriate , in a format that ensures interoperability , e . g . by processing them in a way consistent with the principles governing the compatibility and usability requirements for spatial information under directive 2007 / 2 / ec of the european parliament and of the council of 14 march 2007 establishing an infrastructure for spatial information in the european community .


### at the end of paragraph 4 , the following wording is added : ‘ the means of redress shall include the possibility of review by an independent authority that is vested with specific regulatory powers regarding the re - use of public sector information and whose decisions are binding upon the public sector body concerned . ’ ### paragraph 4 is replaced by the following : ‘ 4 . any negative decision shall contain a reference to the means of redress in case the applicant wishes to appeal the decision . the means of redress shall include a reference to the possibility of review by an authority in the member states . ’


### member states shall ensure that practical arrangements facilitating the cross - lingual search for documents available for re - use are in place , such as asset lists of main documents with relevant metadata , accessible preferably online and in machine - readable format , and portal sites that are linked to decentralised asset lists . ### member states shall make practical arrangements to facilitate searches for documents available for re - use throughout the union , such as asset lists of main documents with relevant metadata , accessible preferably in technology - neutral , machine - readable format , and portal sites that are linked to asset lists .


### in article 13 the date of 1 july 2008 is replaced by [ 3 years after the transposition date ] and the following paragraph is added : ### in article 13 the date of 1 july 2008 is replaced by [ 5 years after the date of entry into force ] and the following paragraph is added :


### ‘ public sector bodies may allow re - use without conditions or may impose conditions , such as indication of source , where appropriate through a licence . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . ’ ### public sector bodies may allow re - use of documents without conditions or may impose conditions , where appropriate through a licence dealing with relevant issues . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition .


### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , may also play an important role in this respect . therefore , member states should encourage the use of open government licences . ### in relation to any re - use that is made of the document , public sector bodies shall , where practicable , impose conditions on the re - user , such as acknowledgment of source . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , may also play an important role in this respect . therefore , member states should encourage the use of open government licences .


### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require supervision by independent authorities competent on the re - use of public sector information . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require supervision by a competent impartial body , entitled to review any public sector body ' s decision on re - use . to ensure consistency between approaches at union level , coordination between these bodies should be encouraged , particularly through exchange of information on best practices and data re - use policies .


### directive 2003 / 98 / ec does not contain an obligation to allow re - use of documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , so that all generally accessible documents are re - usable . in other member states , the link between the two sets of rules is less clear and this is a source of legal uncertainty . ### directive 2003 / 98 / ec does not justify an obligation for member states to allow access to , and re - use of , public - sector documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . the directive only harmonises the conditions subject to which documents are made available for re - use . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , whereas other member states have legally separated the right of re - use from national rules on access to information and freedom of information .


### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require supervision by independent authorities competent on the re - use of public sector information . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies . ### proper implementation of some of the features of this directive , such as means of redress , compliance with charging principles and reporting obligations require review by authorities competent on the re - use of public sector information . member states have a responsibility to make appropriate national authorities responsible for this review . to ensure consistency between approaches at union level , coordination between the independent authorities should be encouraged , particularly through exchange of information on best practices and data re - use policies .


### directive 2003 / 98 / ec does not contain an obligation to allow re - use of documents . the decision whether or not to authorise re - use remains with the member sates or the public sector body concerned . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , so that all generally accessible documents are re - usable . in other member states , the link between the two sets of rules is less clear and this is a source of legal uncertainty . ### directive 2003 / 98 / ec does not contain an obligation for member states to allow access to , and re - use of , public - sector documents . the decision whether or not to authorise re - use remains with the member states or the public sector body concerned . the directive only harmonises the conditions subject to which documents are made available for re - use . at the same time , the directive builds on national rules on access to documents . some member states have expressly linked the right of re - use to this right of access , whereas other member states have legally separated the right of re - use from national rules on access to information and freedom of information .


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction , provision and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration .


### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , may also play an important role in this respect . therefore , member states should encourage the use of open government licences . ### in relation to any re - use that is made of the document , public sector bodies may , where practicable , impose conditions on the re - user , such as acknowledgment of source . any licences for the re - use of public sector information should in any case place as few restrictions on re - use as possible , preferably limiting them to the indication of source . open licences available online , which grant wider re - use rights without technological , financial or geographical limitations and relying on open data formats , should play an important role in this respect . therefore , member states should encourage the use of open licences that in time should become standardised across the union .


### where charges are made for the re - use of documents , they should in principle be limited to the marginal costs incurred for their reproduction and dissemination , unless exceptionally justified according to objective , transparent and verifiable criteria . the necessity of not hindering the normal running of public sector bodies covering a substantial part of the operating cost relating to the performance of their public task from the exploitation of their intellectual property rights should notably be taken into consideration . the burden of proving that charges are cost - oriented and comply with relevant limits should lie with the public sector body charging for the re - use of documents . ### where charges are made for supplying and allowing the re - use of documents , they should in principle be limited to the marginal costs . however , the necessity of not hindering the normal running of public sector bodies that are required to cover a substantial part of their costs relating to the performance of their public task as well as the normal running of libraries , museums and archives should notably be taken into consideration . those public sector bodies should be allowed to charge higher charges for re - use . such charges above marginal costs should be set according to objective , transparent and verifiable criteria and the total income from supplying and allowing re - use of documents should not exceed the cost of collection , production , reproduction and dissemination , together with a reasonable return on investment . the burden of proving that charges are cost - oriented and comply with relevant criteria should lie with the public sector body charging for the re - use of documents .


### public sector bodies may allow re - use without conditions or may impose conditions , such as indication of source , where appropriate through a licence . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . ### ' 1 . public sector bodies may allow re - use without conditions for non - commercial use or may impose conditions , such as indication of source , where appropriate through a licence . when used for commercial purposes , a minimum condition of the indication of source shall be required . these conditions shall not unnecessarily restrict possibilities for re - use and shall not be used to restrict competition . '


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


### member states , in cooperation with the commission , shall designate the imi coordinators and competent authorities and the internal market areas in which they have competence . ### member states shall designate the imi coordinators and competent authorities and the internal market areas in which they have competence . the commission may play a consultative role in this process .


### while imi is in essence a communication tool for public authorities , not open to the general public , technical means may need to be developed to allow external actors such as citizens , enterprises and organisations to interact with the competent authorities in order to supply information and retrieve data , or to exercise their rights as data subjects . such technical means should include appropriate safeguards for data protection . ### while imi is in essence a communication tool for public authorities , not open to the general public , technical means may need to be developed to allow external actors such as citizens , enterprises and organisations to interact with the competent authorities in order to supply information and retrieve data , or to exercise their rights as data subjects . such technical means should include appropriate safeguards for data protection . in order to ensure a high level of security , any such public interface should be developed as technically separate from the imi application to which only imi users should have access .


### imi actors 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 unlawfully processed data deleted , in accordance with national legislation . the correction and deletion shall be carried out within 60 days by the imi actor responsible . ### imi actors 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 unlawfully processed data deleted , in accordance with national legislation . the correction and deletion shall be carried out as soon as possible and not later than within&#160 ; 30 days by the imi actor responsible .


### measures to stimulate in particular disadvantaged or older workers to remain in or return to the labour market . ### measures to stimulate in particular disadvantaged workers and those who are at higher risk of poverty , such as women – especially single mothers – or older workers to remain in or return to the labour market .


### this regulation respects the fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union , notably the right to life , human dignity , prohibition of torture and of inhuman or degrading treatment or punishment , right to liberty and security , non - refoulement , non - discrimination , the right to an effective remedy , the right to asylum and the rights of the child . ### this regulation respects the fundamental rights and observes the principles recognised by articles 2 and 6 of the treaty on european union and by the charter of fundamental rights of the european union , in particular respect for human dignity , the right to life , the prohibition of torture and of inhuman or degrading treatment or punishment , the prohibition of trafficking in human beings , the right to liberty and security , the right to the protection of personal data , the right to asylum and to protection against removal and expulsion , non - refoulement , non - discrimination , the right to an effective remedy and the rights of the child . this regulation should be applied by member states and the agency in accordance with those rights and principles .


### border guards participating in a sea operation shall be trained with regard to relevant provisions of fundamental rights , refugee law and the international legal regime of search and rescue . ### border guards participating in a sea operation shall be trained with regard to relevant provisions of fundamental rights , refugee law and the international legal regime of search and rescue . each participating unit shall include at least one person with basic medical training .


### the participating units shall communicate information about any ship suspected of being engaged in illegal activities at sea outside the scope of a sea operation to the international coordination centre , which shall convey this information to the national coordination centre of the member state or member states concerned . ### the participating units shall communicate information about any ship suspected of being engaged in illegal activities at sea , which are outside the scope of the sea operation , to the international coordination centre , which shall convey this information to the national coordination centre of the member state or member states concerned .


### the participating units shall inform the international coordination centre of the presence of any persons within the meaning of article 4 , and the international coordination centre shall convey that information to the competent national authorities . on the basis of that information , the operational plan should determine which follow - up measures may be taken . ### the participating units shall inform the international coordination centre of the presence of any persons within the meaning of article 4 , and the international coordination centre shall convey that information to the competent national authorities . on the basis of that information , the operational plan shall determine which follow - up measures may be taken .


### conducting the ship or persons on board to the host member state or to another member state participating in the operation , or to the coastal member state . ### conducting the ship or persons on board to the coastal member state .


### in the zone contiguous to the territorial sea of a member state , which is a host member state or a participating member state , the measures laid down in article 6 shall be taken in accordance with article 6 . ### in the formally proclaimed zone contiguous to the territorial sea of a member state , which is a host member state or a participating member state , the measures laid down in article&#160 ; 6 shall be taken in accordance with article&#160 ; 6 .


### in case of disembarkation in a third country , the participating units shall identify the intercepted or rescued persons and assess their personal circumstances to the extent possible before disembarkation . they shall inform the intercepted or rescued persons of the place of disembarkation in an appropriate way and they shall give them an opportunity to express any reasons for believing that disembarkation in the proposed place would be in violation of the principle of non - refoulement . ### if disembarkation in a third country is considered , the participating units shall identify the intercepted or rescued persons and assess their personal circumstances , including their medical conditions and other circumstances that might make them vulnerable , before a decision is made . they shall inform the intercepted or rescued persons of the place of disembarkation in a language which those persons understand or may reasonably be presumed to understand and they shall give them an opportunity to express any reasons for believing that disembarkation in the proposed place would be in violation of the principle of non - refoulement .


### pursuant to regulation no 2007 / 2004 , border surveillance operations coordinated by the agency are conducted in accordance with an operational plan . accordingly , as regards sea operations , the operational plan should include specific information on the application of the relevant jurisdiction and legislation in the geographical area where the joint operation or pilot project takes place , including references to international and union law , regarding interception , rescue at sea and disembarkation . in turn , this regulation governs the issues of interception , rescue at sea and disembarkation in the context of sea border surveillance operations coordinated by the agency . ### pursuant to regulation no 2007 / 2004 , border surveillance operations coordinated by the agency are conducted in accordance with an operational plan . accordingly , as regards sea operations , the operational plan should include specific information on the application of the relevant jurisdiction and legislation in the geographical area where the joint operation , pilot project or rapid intervention takes place , including references to international and union law , regarding interception , rescue at sea , disembarkation and rules and procedures which ensure that persons with international protection needs , victims of human trafficking , unaccompanied minors and other vulnerable persons are identified during the operation and provided with appropriate assistance , including access to international protection . in turn , this regulation governs the issues of interception , rescue at sea and disembarkation in the context of sea border surveillance operations coordinated by the agency .


### conducting the ship or persons on board to the host member state or to another member state participating in the operation , or to the coastal member state . ### conducting the ship or persons on board to the host member state or to another member state participating in the operation , or to the coastal member state , in accordance with the operational plan .


### where there are reasonable grounds to suspect that a ship without nationality or one that may be assimilated to a ship without nationality is carrying persons intending to circumvent the checks at border crossing points or is engaged in the smuggling of migrants by sea , the host member state or the participating member state in whose territorial sea the stateless ship is intercepted shall authorise and instruct the participating unit to stop it and to take any of the measures laid down in paragraph 1 . ### where there are reasonable grounds to suspect that a stateless ship is carrying persons intending to circumvent the checks at border crossing points or is engaged in the smuggling of migrants by sea , the host member state or the participating member state in whose territorial sea the stateless ship is intercepted shall authorise and instruct the participating unit to stop it and to take any of the measures laid down in paragraph 1 .


### before deciding on disembarkation in a third country , the participating units shall take into account the general situation in that third country and intercepted or rescued persons shall not be disembarked in that third country when the host member state or the participating member states are aware or ought to be aware that this third country is engaged in practices as described in paragraph 1 . ### before and while a sea operation is taking place , the host member state and the participating member states shall examine the general situation in the neighbouring third countries . intercepted or rescued persons shall not be disembarked in a third country when the host member state or the participating member states are aware or ought to be aware that this third country is engaged in practices as described in paragraph 1 . those member states shall provide that information to the participating units . for that purpose , they may use the information prepared by the european asylum support office , the agency and the united nations high commissioner for refugees .


### making persons on board aware that they may not be authorised to cross the border and that persons directing the craft may face penalties for facilitating the voyage ; ### making persons on board aware that they may not be authorised to cross the border and that persons directing the ship may face penalties for facilitating the voyage ;


### in accordance with regulation no 562 / 2006 of the european parliament and of the council of 15 march 2006 establishing a community code on the rules governing the movement of persons across borders and general principles of union law , any measure taken in the course of a surveillance operation should be proportionate to the objectives pursued , non - discriminatory and it should fully respect human dignity , fundamental rights and the rights of refugees and asylum seekers , including the principle of non - refoulement . member states and the agency are bound by the provisions of the asylum acquis , and in particular of council directive 2005 / 85 / ec of 1 december 2005 on minimum standards on procedures in member states for granting and withdrawing refugee status with regard to applications for asylum made in the territory , including at the border or in the transit zones of member states . ### in accordance with regulation no 562 / 2006 of the european parliament and of the council of 15 march 2006 establishing a community code on the rules governing the movement of persons across borders and general principles of union law , any measure taken in the course of a surveillance operation should be proportionate to the objectives pursued , non - discriminatory and it should fully respect human dignity , fundamental rights , the rights of refugees and asylum seekers and the principle of non - refoulement . member states and the agency are bound by the provisions of the asylum acquis , and in particular of directive 2013 / 32 / eu of the european parliament and of the council1 with regard to applications for international protection made in the territory , including at the border , in the territorial waters or in the transit zones of member states . _________________ 1 directive 2013 / 32 / eu of the european parliament and of the council of 26 june 2013 on common procedures for granting and withdrawing international protection .


### in the case of search and rescue situations as laid down in article 9 , the participating units shall cooperate with the responsible rescue coordination centre to provide a suitable port or place of safety for the rescued persons and to ensure their rapid and effective disembarkation . ### subject to the application of article 4 , in the case of search and rescue situations as laid down in article 9 , the participating units shall cooperate with the responsible rescue coordination centre to provide a suitable port or place of safety for the rescued persons and to ensure their rapid and effective disembarkation .