### the evidence referred to in paragraph 1 shall be presented or transmitted upon the request of the authorised inspecting officer of the member state where the check is carried out . in case of road side checks , it shall be presented within the duration of such check . it shall be in an official language of that member state or in english . during a roadside check , the driver shall be allowed to contact the head office , the transport manager or any other person or entity which may support him in providing the evidence referred to paragraph 2 . ### the evidence referred to in paragraph 1 shall be presented or transmitted upon the request of the authorised inspecting officer of the member state where the check is carried out . in case of road side checks , it shall be presented within the duration of such check , within a maximum of 45 minutes . it shall be in an official language of that member state or in english . during a roadside check , the driver shall be allowed to contact the head office , the transport manager or any other person or entity which may support him in providing the evidence referred to paragraph 2 .


### reducing the negative impact of transport activities remains one of the main goals of the union ' s transport policy . council directive 92 / 106 / eec21 which establishes measures to encourage the development of combined transport , is the only legislative act of the union to directly incentivise the shift from road freight to lower emission transport modes such as inland waterways , maritime and rail . _________________ 21 council directive 92 / 106 / eec of 7 december 1992 on the establishment of common rules for certain types of combined transport of goods between member states . ### reducing the negative impact of transport activities remains one of the main goals of the union ' s transport policy . council directive 92 / 106 / eec21 which establishes measures to encourage the development of combined transport , is the only legislative act of the union to directly incentivise the shift from road freight to lower emission transport modes such as inland waterways , maritime and rail . in order to further reduce the negative externalities of road freight , research into , and the sharing of best practices between member states on solutions to better routing , network optimisation , increases in load efficiency and the possibilities for the charging of external costs should be encouraged . _________________ 21 council directive 92 / 106 / eec of 7 december 1992 on the establishment of common rules for certain types of combined transport of goods between member states .


### member states shall take the measures necessary to ensure that the taxes listed in paragraph 3 which are applicable to road vehicles when routed in combined transport are reduced or reimbursed either by a standard amount , or in proportion to the journeys that such vehicles undertake by rail , within limits and in accordance with conditions and rules they fix after consultation with the commission . ### in article 6 , paragraph 1 is replaced by the following : ' 1 . member states shall take the measures necessary to ensure that the taxes listed in paragraph 3 which are applicable to road vehicles when routed in combined transport are reduced or reimbursed either by a standard amount , or in proportion to the journeys that such vehicles undertake by rail or inland waterway transport , within limits and in accordance with conditions and rules they fix after consultation with the commission . '


### member states should implement additional economic support measures in addition to the existing ones , targeting the various legs of a combined transport operation , in order to reduce the road freight and to encourage the use of other modes of transport such as rail , inland waterways and maritime transport , thereby reducing air pollution , greenhouse gas emissions , road traffic accidents , noise and congestion . such measures may include the reduction of certain taxes or transport fees , grants for intermodal load units effectively transported in combined transport operations , or the partial reimbursement of transhipments cost . ### member states should stimulate competition and reduce protectionist measures within the rail sector , in order to reduce the road freight and to encourage the use of other modes of transport such as rail , inland waterways and maritime transport , thereby reducing air pollution , greenhouse gas emissions , road traffic accidents , noise and congestion . additional measures may include the reduction of certain taxes or transport fees , grants for intermodal load units effectively transported in combined transport operations .


### member states shall coordinate with neighbouring member states and with the commission and ensure that , when such measures are implemented , priority is given to ensuring a balanced and sufficient geographical distribution of suitable facilities in the union , and notably on the ten - t core and comprehensive networks , allowing that any location in the union is not situated at a distance farther than 150 km from such terminal . ### member states shall coordinate with neighbouring member states and with the commission and ensure that , when such measures are implemented , priority is given to ensuring a balanced and sufficient geographical distribution of suitable facilities in the union , and notably on the ten - t core and comprehensive networks , allowing that any location in the union is not situated at a distance farther than 150 km as the crow flies from such terminal . in addition , member states shall take due account of the need to : reduce congestion , in particular near urban and sub - urban areas or in areas with natural constraints ; improve cross - border connections ; improve accessibility and connectivity in particular as regards the access infrastructure to transhipment terminals ; and accelerate the shift to digitalisation ;


### member states shall take the measures necessary to ensure that the taxes listed in paragraph 3 which are applicable to road vehicles when routed in combined transport are reduced or reimbursed either by a standard amount , or in proportion to the journeys that such vehicles undertake by rail , within limits and in accordance with conditions and rules they fix after consultation with the commission . ### in article 6 , paragraph 1 is replaced by the following : ' 1 . member states shall take the measures necessary to ensure that the taxes listed in paragraph 3 which are applicable to road vehicles when routed in combined transport are reduced or reimbursed either by a standard amount , or in proportion to the journeys that such vehicles undertake by rail , inland waterway or maritime transport , within limits and in accordance with conditions and rules they fix after consultation with the commission . the reductions of reimbursements referred to in the first paragraph shall be granted by the member state in which the vehicles are registered , on the basis of the rail , inland waterway or maritime transport journeys effected within that state . member states may , however , grant these reductions or reimbursements on the basis of the rail , inland waterway or maritime transport journeys which take place partially or wholly outside the member state in which the vehicles are registered . '


### the road leg distance limit may be exceeded for combined road / rail transport operations , when authorised by the member state or member states on whose territory the road leg takes place , in order to reach the geographically nearest transport terminal which has the necessary operational transhipment capability for loading or unloading in terms of transhipment equipment , terminal capacity and appropriate rail freight services . ### exceeding the road leg distance limit specified in this paragraph for combined road / rail transport operations shall be allowed by the member state or member states on whose territory the road leg takes place , in order to reach the geographically nearest transhipment terminal which has the necessary operational transhipment capability for loading or unloading in terms of transhipment equipment , terminal capacity , terminal opening times and appropriate rail freight services , in the absence of a transhipment terminal fulfilling all of these conditions within the distance limit .


### member states may take additional measures , to improve the competitiveness of combined transport operations as compared to equivalent alternative road transport operations . ### by 31 december 2021 , member states shall take at least one additional measure of an economic and legislative nature , to improve - also through the use of technologies - the competitiveness of combined transport operations as compared to equivalent alternative road transport operations , in particular with a view to reducing the time and costs involved in transhipment operations .


### the goal of reaching 30% of road freight over 300 km shifted to other modes of transport such as rail or waterborne transport by 2030 , and more than 50% by 2050 , in order to optimise the performance of multimodal logistic chains , including by making greater use of more energy - efficient modes , has been slower than expected and according to the current projections , will not be reached . ### the goal of reaching 30% of road freight over 300 km shifted to other modes of transport such as rail or waterborne transport by 2030 , and more than 50% by 2050 , has to be achieved via efficiency gains and infrastructure improvements within the rail and waterborne sector .


### during the past years , member states have notified an increasing number of new psychoactive substances via the mechanism for rapid exchange of information which was established by joint action 97 / 396 / jha adopted by the council on the basis of article k . 3 of the treaty on european union concerning the information exchange , risk assessment and the control of new synthetic drugs13 and was further strengthened by council decision 2005 / 387 / jha14 . __________________ 13 council joint action 97 / 396 / jha of 16 june 1997 concerning the information exchange , risk assessment and control of new synthetic drugs . 14 council decision 2005 / 387 / jha of 10 may 2005 on the information exchange , risk assessment and control of new psychoactive substances . ### during the past years , member states have notified an increasing number of new psychoactive substances via the mechanism for rapid exchange of information which was established by joint action 97 / 396 / jha adopted by the council on the basis of article k . 3 of the treaty on european union concerning the information exchange , risk assessment and the control of new synthetic drugs13 and was further strengthened by council decision 2005 / 387 / jha14 . according to the european medicine centre for drugs and drug addiction , member states notified 101 new psychoactive substances , which had not been reported previously , via that mechanism during the year 2014 . __________________ 13 council joint action 97 / 396 / jha of 16 june 1997 concerning the information exchange , risk assessment and control of new synthetic drugs . 14 council decision 2005 / 387 / jha of 10 may 2005 on the information exchange , risk assessment and control of new psychoactive substances .


### new psychoactive substances can pose serious cross border threats to health which makes necessary to enhance monitoring , early warning and combating of those threats . ### new psychoactive substances can pose serious cross border threats to health , in particular due to their diversity and the speed with which they have been appearing , which makes necessary to enhance monitoring , early warning and combating of those threats .


### where a member state intends to apply higher external - cost charges than the reference values specified in annex iiib , the member state or , where appropriate , an independent authority shall calculate the chargeable cost of traffic–based noise pollution by applying the following formulae : ### where a member state intends to apply higher external - cost charges than the minimum values specified in annex iiib , the member state or , where appropriate , an independent authority shall calculate the chargeable cost of traffic–based noise pollution by applying the following formulae :


### the variation of infrastructure charges according to euro emission class has contributed to the use of cleaner vehicles . however , with the renewal of vehicle fleets , the variation of charges on this basis on the inter - urban network is expected to become obsolete by the end of 2020 and should therefore be phased out by that time . from the same point in time , external - cost charging should be applied more systematically , as a targeted means to recover external cost in respect of situations in which it matters most . ### the variation of infrastructure charges according to euro emission class has contributed to the use of cleaner vehicles . however , with the renewal of vehicle fleets , the variation of charges on this basis on the inter - urban network is expected to become obsolete by the end of 2020 and should therefore be phased out by that time . from the same point in time , external - cost charging must be applied as a targeted means to recover external cost in respect of situations in which it matters most .


### it is necessary to ensure that external - cost charges continue to reflect the cost of air pollution and noise generated by heavy duty vehicles as accurately as possible without rendering the charging scheme excessively complex , to incentivise the use of the most fuel - efficient vehicles , and to keep the incentives effective and the differentiation of road charges up - to - date . therefore , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission for the purpose of adapting the reference values for external cost charging to scientific progress , defining the modalities for the revenue - neutral variation of infrastructure charges according to the co2 emissions from heavy duty vehicles , and adapting the modalities of the variation of infrastructure charges for light duty vehicles to technical progress . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 201621 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . __________________ 21 oj l 123 , 12 . 5 . 2016 , p . 1 . ### it is necessary to ensure that external - cost charges continue to reflect the cost of air pollution and noise generated by heavy duty vehicles as accurately as possible without rendering the charging scheme excessively complex , to incentivise the use of the most fuel - efficient vehicles , and to keep the incentives effective and the differentiation of road charges up - to - date . therefore , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission for the purpose of adapting the minimum values for external cost charging to scientific progress , defining the modalities for the revenue - neutral variation of infrastructure charges according to the co2 emissions from heavy duty vehicles , and adapting the modalities of the variation of infrastructure charges for light duty vehicles to technical progress . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement on better law - making of 13 april 201621 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states ' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts . __________________ 21 oj l 123 , 12 . 5 . 2016 , p . 1 .


### road charges can mobilise resources that contribute to the financing of the maintenance and development of high quality transport infrastructure . it is therefore appropriate to incentivise member states to use revenues from road charges accordingly and , to this end , to require that they adequately report on the use of such revenues . that should in particular help identifying possible financing gaps , and raising the public acceptance of road charging . ### road charges mobilise resources that contribute to the financing of the maintenance and development of high quality transport infrastructure , reducing road transport pollution at source and facilitating the production and taking up of zero - emission vehicles . it is therefore appropriate for member states to use revenues from road charges accordingly and , to this end , to require that they adequately report on the use of such revenues . that should in particular help identifying possible financing gaps , and raising the public acceptance of distance - based road charging .


### this section shall apply where a member state intends to apply higher external cost charges than the reference values specified in annex iiib . ### this section shall apply where a member state intends to apply higher external cost charges than the minimum values specified in annex iiib .


### for heavy duty vehicles , the external - cost charge shall vary and be set in accordance with the minimum requirements and the methods referred to in annex iiia and shall respect the reference values set out in annex iiib . ### for heavy duty vehicles and vans intended for the carriage of goods , the external - cost charge shall vary and be set in accordance with the minimum requirements and the methods referred to in annex iiia and shall respect at least the minimum values set out in annex iiib .


### where a member state intends to apply higher external - cost charges than the reference values specified in annex iiib , it shall notify the commission of the classification of vehicles according to which the external - cost charge shall vary . it shall also notify the commission of the location of roads subject to higher external - cost charges ’ ) , and of roads subject to lower external - cost charges ’ ) . ### where a member state intends to apply higher external - cost charges than the minimum values specified in annex iiib , it shall notify the commission of the classification of vehicles according to which the external - cost charge shall vary . it shall also notify the commission of the location of roads subject to higher external - cost charges ’ ) , and of roads subject to minimum external - cost charges ’ ) .


### pursuant to directive 1999 / 62 / ec , an external - cost charge may be imposed at a level close to the social marginal cost of the usage of the vehicle in question . that method has proven to be the fairest and most efficient way to take account of negative environmental and health impacts of air pollution and noise generated by heavy duty vehicles , and would ensure a fair contribution from heavy duty vehicles to meeting eu air quality standards17 and any applicable noise limits or targets . the application of such charges should therefore be facilitated . _________________ 17 directive 2008 / 50 / ec of the european parliament and of the council of 21 may 2008 on ambient air quality and cleaner air for europe , oj l 152 , 11 . 06 . 2008 , p . 1 - 44 . ### pursuant to directive 1999 / 62 / ec , an external - cost charge must be imposed at a level close to the social marginal cost of the usage of the vehicle in question . that method has proven to be the fairest and most efficient way to take account of negative environmental and health impacts of air pollution and noise generated by heavy duty vehicles , and would ensure a fair contribution from heavy duty vehicles to meeting eu air quality standards17 and any applicable noise limits or targets . the application of such charges should therefore be facilitated . _________________ 17 directive 2008 / 50 / ec of the european parliament and of the council of 21 may 2008 on ambient air quality and cleaner air for europe , oj l 152 , 11 . 06 . 2008 , p . 1 - 44 .


### to this effect , the maximum weighted average external - cost charges should be replaced by readily applicable reference values updated in light of inflation , the scientific progress made in estimating the external costs of road transport and the evolution of the fleet composition . ### to this effect , the maximum weighted average external - cost charges should be replaced by readily applicable minimum values updated in light of inflation , the scientific progress made in estimating the external costs of road transport and the evolution of the fleet composition .


### ‘ light duty vehicle’ means a passenger car , a minibus or van ; ### ‘ light duty vehicle’ means a passenger car , a minibus , a van , or a van intended for the carriage of goods ;


### this annex sets out reference values of the external - cost charge , including the cost of air pollution and noise . ### this annex sets out minimum values of the external - cost charge , including the cost of air pollution and noise .


### reference values of the external - cost charge ### minimum values of the external - cost charge


### within one year from the entry into force of the delegated act , member states shall vary the infrastructure charge taking into account the reference co2 emission values and the relevant vehicle categorisation . charges shall be varied in such a way that no infrastructure charge is more than 100% above the same charge for equivalent vehicles having the lowest , but not zero , co2 emissions . zero - emission vehicles shall benefit from infrastructure charges reduced by 75% compared to the highest rate . ### within two years from the entry into force of the delegated act , member states shall vary the infrastructure charge taking into account the reference co2 emission values and the relevant vehicle categorisation . charges shall be varied in such a way that no infrastructure charge is more than 100% above the same charge for equivalent vehicles having the lowest , but not zero , co2 emissions . zero - emission vehicles shall benefit from infrastructure charges reduced by 75% compared to the highest rate .


### road congestion , to which all motor vehicles contribute in different proportions , represents a cost of about 1% of gdp . a significant part of this cost can be attributed to interurban congestion . a specific congestion charge should therefore be allowed , on condition that it is applied to all vehicle categories . in order to be effective and proportionate , the charge should be calculated on the basis of the marginal congestion cost and differentiated according to location , time and vehicle category . in order to maximise the positive effect of congestion charges , corresponding revenues should be allocated to projects addressing the sources of the problem . ### road congestion , to which all motor vehicles contribute in different proportions , represents a cost of about 1% of gdp . a significant part of this cost can be attributed to interurban congestion . a specific congestion charge should therefore be allowed , on condition that it is applied to all vehicle categories . in order to be effective and proportionate , the charge should be calculated on the basis of the marginal congestion cost and differentiated according to location , time and vehicle category . in order to maximise the positive effect of congestion charges , corresponding revenues should be allocated to projects addressing the sources of the problem . in case of new collection infrastructure , the method of collection of congestion charges should itself not contribute to creation or further development of the congestion .


### the mark - up does not exceed 15 % of the weighted average infrastructure charge calculated in accordance with article 7b and article 7e , except where the revenue generated is invested in cross - border sections of core network corridors , in which case the mark - up may not exceed 25 % ; ### the mark - up does not exceed 15 % of the weighted average infrastructure charge calculated in accordance with article 7b and article 7e , except where the revenue generated is invested in cross - border sections of core network corridors , in which case the mark - up may not exceed 50 % ;


### table 1 : reference values of the external - cost charge for heavy goods vehicles ### table 1 : minimum values of the external - cost charge for heavy goods vehicles


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union’s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export or for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in those specific and limited circumstances , it is appropriate to eliminate the aforementioned , unintended side effects of the supplementary protection certificate so as to enable a level - playing field between union - based manufacturers and those in third countries . this would enable making exclusively for export to third countries and entry onto the union market immediately after expiry of the relevant supplementary protection certificate , as well as any related acts strictly necessary for that making or for the actual export or that entry onto the union market itself .


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the certificate holder is notified at its registered address , by the person responsible for the making ) , or any person acting on its behalf , of the information listed in paragraph 3 , prior to the intended start date of making .


### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate , and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union . ### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules enabling the making of the product in question during the term of the certificate . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to countries where no supplementary protection certificate is in place and to prepare for the entry in the union ' s market on the first day after patent expiration , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export , for the actual export itself or for the entry in the union ' s market on the first day after patent expiration . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to country destinations where no supplementary protection certificate is in place or the entry in the union ' s market on the first day after patent expiration .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in those specific and limited circumstances , it is appropriate to eliminate the aforementioned , unintended side effects of the supplementary protection certificate so as to enable a level - playing field between union - based manufacturers and those in third countries . this would enable making exclusively for : export to third countries and entry onto the union market immediately after expiry of the relevant supplementary protection certificate , as well as any related acts strictly necessary for that making or for the actual export or that entry onto the union market itself .


### an indicative list of the intended third country or third countries to which the product is to be exported . ### a list of the third country or third countries to which the product is to be exported . if , after this list is provided , the maker intends to export to further countries , it shall provide a further notification within the time period specified in art 4 .


### any related act that is strictly necessary for that making or for the actual export itself ; ### any related act that is strictly necessary for that making , for the export , and / or for effectively entering the market of member states immediately after expiry of the certificate in those member states .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purpose of export or for the entry in the union ' s market on the first day after patent expiration in the member state where a supplementary protection certificate is in force , nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting .


### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . ### by limiting the scope of the exception to making for the purposes of day - 1 entry and of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not conflict with normal exploitation of the product or medicinal product in the member state where the certificate is in force , nor prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties .


### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , even for the exclusive purpose of exporting to third country markets in which such protection does not exist or has expired . a further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the union market immediately after expiry of the certificate , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired . ### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , even for the exclusive purpose of exporting to country markets in which such protection does not exist or has expired . a further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the union market immediately after expiry of the certificate , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired .


### in addition , this regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate . the maker should be required to inform persons within its supply chain , through appropriate means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate . ### in addition , this regulation should impose certain due diligence requirements on a maker as a condition for the exception to operate . each maker should be required to inform persons within its supply chain , through appropriate and documented means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate .


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the authority referred to in article 9 of the member state where that making is to take place and the certificate holder are notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ;


### any related act that is strictly necessary for that making or for the actual export itself ; ### any related act that is strictly necessary for that making , for the export and / or for effectively entering the market of the member states immediately after expiry of the certificate in those member states ;


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product , protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union ' s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export or for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union’s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export , for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredient for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### in order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights , the exception provided for in this regulation should only apply to certificates that are granted on or after a specified date after entry into force , irrespective of when the application for the certificate was first lodged . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make , and should take due account of pending applications for certificates . ### the exception provided for in this regulation should only become applicable following period of 1 year after the entry into force of this regulation . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way .


### in order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights , the exception provided for in this regulation should only apply to certificates that are granted on or after a specified date after entry into force , irrespective of when the application for the certificate was first lodged . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make , and should take due account of pending applications for certificates . ### in order to abolish segmentation among eu and non eu undertakings , and ensure equal treatment , the exception provided for in this regulation should apply immediately after this regulation comes in force . this regulation should apply to certificates that are valid at entry into force . such solution shall not interfere with legal rights of holders of supplementary protection certificates arising from this legal instrument . holders of supplementary protection certificates already in force shall not be deprived of their acquired rights , if the exception provided for in this regulation should apply to certificates that are valid and in force at the date of entry into force of this regulation .


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the authority referred to in article 9 of the member state where that making is to take place and all titular holders of the supplementary protection certificate are notified at their official address by the person doing the making , or any person authorised to act on their behalf , of the information listed in paragraph 3 no later than 90 days before the intended start date of making ;


### the certificate referred to in paragraph 1 shall not confer protection against a particular act against which the basic patent conferred protection if , with respect to that particular act , the following conditions are met : ### the certificate referred to in paragraph 1 shall not confer protection against certain acts against which the basic patent conferred protection if , with respect to that particular act , the following conditions are met :


### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . ### by limiting the scope of the exception to making for the purposes of entry in the union ' s market on the first day after patent expiration and export to countries where no supplementary protection certificate is in place as well as to prepare for the acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not conflict with normal exploitation of the product or medicinal product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties .


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than three months before the intended start date of making in that member state and in advance of any related act prior to that making that would otherwise be prohibited by the protection conferred by a certificate ; ;


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate , namely the day - 1 entry . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union’s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export or for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in those specific and limited circumstances , it is appropriate to eliminate the aforementioned , unintended side effects of the supplementary protection certificate so as to enable a level - playing field between union - based manufacturers and those in third countries . this would enable making exclusively for : export to third countries and entry onto the union market immediately after expiry of the relevant supplementary protection certificate , as well as any related acts strictly necessary for that making or for the actual export or that entry onto the union market itself .


### the notification sent to an authority as referred to in article 4 shall be published by that authority within 15 days of receipt of the notification . ; ### the notification sent to the spc holder as referred to in article 2 shall be treated as strictly confidential by the holder of the certificate and shall not be used by the holder of the certificate for any other purpose than ensuring that the maker has complied with the scope and conditions of the exception ;


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate .


### in order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights , the exception provided for in this regulation should only apply to certificates that are granted on or after a specified date after entry into force , irrespective of when the application for the certificate was first lodged . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make , and should take due account of pending applications for certificates . ### the exception provided for in this regulation should apply to all certificates following a specified transition period after entry into force , irrespective of when the application for the certificate was first lodged . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish the uniform notifications of the intention to make , and should take due account of pending applications for certificates .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purposes of export and day 1 entry on the market in a member state where a supplementary protection certificate is in force , nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting .


### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . ### by limiting the scope of the exception to making for the purposes of export outside the union or day - 1 entry and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties .


### safeguards should accompany the exception in order to increase transparency , to help the holder of a supplementary protection certificate to enforce its protection in the union and to reduce the risk of illicit diversion onto the union market during the term of the certificate . ### reasonable and proportionate safeguards should accompany the exception , for the exclusive purpose of helping the holder of a supplementary protection certificate to check compliance with the conditions set out hereunder . those safeguards should not negatively affect competition among companies and should allow the exception to work effectively with no disruption on the main objectives of the exception .


### by providing for a period of supplementary protection of up to five years , regulation no 469 / 2009 seeks to promote , within the union , the research and innovation that is necessary to develop medicinal products , and to contribute to preventing the relocation of pharmaceutical research outside the union to countries that may offer greater protection . ### regulation no 469 / 2009 provided a uniform solution at community level to prevent a heterogeneous evolution of national legislation creating new disparities , which could hinder the free movement of medicines within the community and thus directly affect the functioning of the internal market . however , the medicines system in the eu has evolved in recent decades with the introduction of generic and biosimilar medicines which improve competitiveness , the sustainability of health systems and european citizens’ access to medicines , while the exception intended by the proposed amendment of this regulation provides an opportunity to improve the parameters referred to above , which are now under threat .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing the product made for the exclusive purposes of export or day - 1 entry on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purpose of export and day 1 entry on the market in a member state where a supplementary protection certificate is in force nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting .


### the information for the purposes of paragraph 2 shall be as follows : ### the information for the purposes of paragraph 2 shall be treated as strictly confidential by the holder of the certificate and be as follows :


### this regulation respects fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union . in particular , this regulation seeks to ensure full respect for the right to property in article 17 of the charter by maintaining the core rights of the supplementary protection certificate , by confining the exception to certificates granted on or after a specified date after entry into force of this regulation and by imposing certain conditions on the application of the exception , ### this regulation respects fundamental rights and observes the principles recognised by the charter of fundamental rights of the european union . in particular , this regulation seeks to ensure full respect for the right to property in article 17 of the charter by maintaining the core rights of the supplementary protection certificate , the right to healthcare in article 35 of the charter by making medicines more accessible to eu patients , the principle of proportionality in article 52 of the charter , point of the article 6 tfeu on the right to health protection for european citizens .


### the number of the certificate granted in the relevant member state , and identification of the product , by reference to the proprietary name used by the holder of that certificate ; ### the number of the relevant certificate , and identification of the product , by reference to the proprietary name used by the holder of the certificate ;


### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules restricting the exclusive right of a supplementary protection certificate holder to make the product in question during the term of the certificate , and also to impose certain information and labelling obligations on makers wishing to take advantage of those rules . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union . ### it is necessary and appropriate for the achievement of the basic objective , of providing a level playing field for generic and biosimilar manufacturers with their competitors in third country markets where protection does not exist or has expired , to lay down rules enabling the making of the product in question during the term of the certificate . this regulation complies with the principle of proportionality , and does not go beyond what is necessary in order to achieve the objectives pursued , in accordance with article 5 of the treaty on european union .


### in addition , this regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate . the maker should be required to inform persons within its supply chain , through appropriate means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate . ### in addition , this regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate . the maker should be required to inform persons within its supply chain , through appropriate means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purposes of export and day - 1 entry . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate .


### in addition , this regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate . the maker should be required to inform persons within its supply chain , through appropriate means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate . ### in addition , this regulation should impose certain due diligence requirements on a maker as a condition for the exception to operate . each maker should be required to inform persons within its supply chain , through appropriate and documented means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate .


### in addition , this regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate . the maker should be required to inform persons within its supply chain , through appropriate means , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate . ### in addition , this regulation should impose certain due diligence requirements on the maker as a condition for the exception to operate . the maker should be required to inform persons within its supply chain , in particular contractual means , that the product is covered by the exception introduced by this regulation and is intended for the exclusive purpose of export and / or day - 1 entry . a maker who failed to comply with these due diligence requirements would not benefit from the exception , nor would any third party performing a related act in the same or a different member state where a certificate conferring protection for the product was in force , and the holder of the relevant certificate would therefore be entitled to enforce its rights under the certificate .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union’s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export or for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union’s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export , for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredient for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### making for the exclusive purpose of export to third countries ; or ### making for the exclusive purpose of export to third countries ; and / or entry onto the market of member states immediately after expiry of the certificate in those member states ; and / or


### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , even for the exclusive purpose of exporting to third country markets in which such protection does not exist or has expired . a further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the union market immediately after expiry of the certificate , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired . ### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , even for the exclusive purpose of exporting to third country markets in which protection does not exist or has expired . a further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the union market immediately after expiry of the certificate , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in those specific and limited circumstances , it is appropriate to eliminate the aforementioned , unintended side effects of the supplementary protection certificate so as to enable a level - playing field between union - based manufacturers and those in third countries . this would enable making exclusively for : export to third countries and entry onto the union market immediately after expiry of the relevant supplementary protection certificate , as well as any related acts strictly necessary for that making or for the actual export or that entry onto the union market itself .


### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . indirectly , it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate . ### the aim of this regulation is to ensure that manufacturers established in the union are able to compete effectively in those third country markets where supplementary protection does not exist or has expired . it is intended to complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products . it is also intended to put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate , namely the day - 1 entry . it would also help to serve the aim of fostering access to medicines in the union by helping to ensure a swifter entry of generic and biosimilar medicines onto the market after expiry of the relevant certificate .


### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , even for the exclusive purpose of exporting to third country markets in which such protection does not exist or has expired . a further unintended consequence is that the protection conferred by the certificate makes it more difficult for those manufacturers to enter the union market immediately after expiry of the certificate , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired . ### the absence of any exception in regulation no 469 / 2009 to the protection conferred by a supplementary protection certificate has had the unintended consequence of preventing manufacturers of generics and biosimilars established in the union from manufacturing , with a view to enter the union market immediately after expiry of the certificate and / or export to countries in which such protection does not exist or has expired , given that they are not in a position to build up production capacity until the protection provided by the certificate has lapsed , by contrast with manufacturers located in third countries where protection does not exist or has expired .


### to this end , this regulation should impose a once - off duty on the person making the product for the exclusive purpose of export , requiring that person to provide certain information to the authority which granted the supplementary protection certificate in the member state where the making is to take place . the information should be provided before the making is intended to start for the first time in that member state . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , should only fall within the scope of the exception where the maker has sent this notification to the competent industrial property authority of the member state of making . the once - off duty to provide information to the authority should apply in each member state where making is to take place , both as regards the making in that member state , and as regards related acts , whether performed in that or another member state , related to that making . the authority should be required to publish that information , in the interests of transparency and for the purpose of informing the holder of the certificate of the maker’s intention . ### to this end , and to the extent it intends to rely on the exception , the person responsible for the making , or any person acting on its behalf , should provide certain information to the registered holder of the certificate , at its registered address on a confidentiality basis . the information should be provided before the making is intended to start for the first time . the making and related acts , including those performed in member states other than the one of making in cases where the product is protected by a certificate in those other member states too , would altogether fall within the scope of the exception , provided that the maker has sent this notification to the holder of the certificate . the notification should be without prejudice to any defences otherwise available to the maker and any other persons conducting the related acts referred to in recital 9 against a claim from the holder of the certificate in relation to an alleged infringement or threat of infringement of the certificate , and should not be construed as an acknowledgment by the maker that the certificate or the basic patent is valid and / or that the making or any of the related acts referred to in recital 9 would otherwise infringe the certificate and / or the basic patent .


### in order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights , the exception provided for in this regulation should only apply to certificates that are granted on or after a specified date after entry into force , irrespective of when the application for the certificate was first lodged . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make , and should take due account of pending applications for certificates . ### in order to abolish segmentation among eu and non eu undertakings , and ensure equal treatment , the exception provided for in this regulation should apply immediately after this regulation comes in force . this regulation should apply to certificates that are valid at entry into force . such solution shall not interfere with legal rights of holders of supplementary protection certificates arising from this legal instrument . holders of supplementary protection certificates already in force shall not be deprived of their acquired rights , if the exception provided for in this regulation should apply to certificates that are valid and in force at the date of entry into force of this regulation .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product , protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to third countries or countries where no supplementary protection certificate is in place and to prepare for day - 1 entry on the union ' s market , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export or for the actual export itself and for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to third country destinations or day - 1 entry .


### the exception should not cover placing the product made for the exclusive purpose of export on the market in the member state where a supplementary protection certificate is in force , either directly or indirectly after export , nor should it cover re - importation of the product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting . ### the exception should not cover placing a medicinal product made for the exclusive purpose of export and day - 1 entry on the market in a member state where a supplementary protection certificate is in force , nor should it cover re - importation of the medicinal product to the market of a member state in which a certificate is in force . moreover , it should not cover any act or activity for the purpose of import of medicinal products , or parts of medicinal products , into the union merely for the purposes of repackaging and re - exporting .


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the certificate holder is notified at its registered address , by the person responsible for the making , or any person acting on its behalf , of the information listed in paragraph 3 , prior to the intended start date of making ;


### in order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights , the exception provided for in this regulation should only apply to certificates that are granted on or after a specified date after entry into force , irrespective of when the application for the certificate was first lodged . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make , and should take due account of pending applications for certificates . ### the exception provided for in this regulation should apply to all certificates following a specified transition period after entry into force , irrespective of when the application for the certificate was first lodged . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish the uniform notifications of the intention to make , and should take due account of pending applications for certificates .


### by limiting the scope of the exception to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not unreasonably conflict with normal exploitation of the product in the member state where the certificate is in force , nor unreasonably prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties . ### by limiting the scope of the exception to making for the purposes of day - 1 entry and of export outside the union and acts strictly necessary for such making or for the actual export itself , the exception introduced by this regulation will not conflict with normal exploitation of the product or medicinal product in the member state where the certificate is in force , nor prejudice the legitimate interests of the certificate - holder , taking account of the legitimate interests of third parties .


### the notification sent to an authority as referred to in article 4 shall be published by that authority within 15 days of receipt of the notification . ; ### the notification sent to the spc holder as referred to in article 2 shall be treated as strictly confidential by the holder of the certificate and shall not be used by the holder of the certificate for any other purpose than ensuring that the maker has complied with the scope and conditions of the exception ;


### making for the exclusive purpose of export to third countries ; or ### making for the exclusive purposes of export to third countries or entry onto the union market immediately after expiry of the certificate ; or


### the authority referred to in article 9 of the member state where that making is to take place is notified by the person doing the making of the information listed in paragraph 3 no later than 28 days before the intended start date of making in that member state ; ### the authority referred to in article 9 of the member state where that making is to take place and all titular holders of the supplementary protection certificate are notified at their official address by the person doing the making , or any person authorised to act on their behalf , of the information listed in paragraph 3 no later than 90 days before the intended start date of making ;


### in order to ensure that holders of supplementary protection certificates already in force are not deprived of their acquired rights , the exception provided for in this regulation should only apply to certificates that are granted on or after a specified date after entry into force , irrespective of when the application for the certificate was first lodged . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way . the date should also allow sufficient time for public authorities to put in place appropriate arrangements to receive and publish notifications of the intention to make , and should take due account of pending applications for certificates . ### the exception provided for in this regulation should only become applicable following period of 1 year after the entry into force of this regulation . the date specified should allow a reasonable time for applicants and other relevant market players to adjust to the changed legal context and to make appropriate investment and manufacturing location decisions in a timely way .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries or day - 1 entry , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export , for the actual export itself or for day - 1 entry . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the purpose of export to third country destinations or day - 1 entry .


### that exception should cover the making of the product , including the product which corresponds to the medicinal product protected by a supplementary protection certificate in the territory of a member state , for the exclusive purpose of export to third countries , as well as any upstream or downstream acts by the maker or by third parties in a contractual relationship with the maker , where such acts would otherwise require the consent of the certificate - holder , and are strictly necessary for making for the purpose of export or for the actual export itself . for instance , such acts may include the supply and import of active ingredients for the purpose of making the medicinal product to which the product covered by the certificate corresponds , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations . ### that exception should cover the making of the product protected by a supplementary protection certificate , including the making of the corresponding medicinal product , in the territory of a member state , for the exclusive purpose of export to countries where no supplementary protection certificate is in place and to prepare for the entry in the union ' s market on the first day after patent expiration , as well as any upstream or downstream acts , where such acts would otherwise require the consent of the certificate - holder , and are necessary for making for the purpose of export , for the actual export itself or for the entry in the union ' s market on the first day after patent expiration . for instance , such acts may include the supply and import of active ingredients for the purpose of making the corresponding medicinal product , temporary storage of the product or medicinal product , advertising or other activities necessary for the purpose of actually exporting to country destinations where no supplementary protection certificate is in place or the entry in the union ' s market on the first day after patent expiration .


### in those specific and limited circumstances , and in order to create a level playing field between union - based manufacturers and third country manufacturers , it is appropriate to restrict the protection conferred by a supplementary protection certificate so as to allow making for the exclusive purpose of export to third countries and any related acts strictly necessary for making or for the actual export itself . ### in these specific and limited circumstances , it is appropriate to eliminate the aforementioned , unintended side effects of the supplementary protection certificate so as to enable a level - playing field between union - based manufacturers and those in third countries . this would enable making exclusively for : export to third countries , and entry onto the union market immediately after expiry of the relevant supplementary protection certificate , as well as any related acts strictly necessary for that making or for the actual export itself or that entry onto the union market .


### the number of the certificate granted in the relevant member state , and identification of the product , by reference to the proprietary name used by the holder of that certificate ; ### the number of the relevant certificate , and identification of the product , by reference to the proprietary name used by the holder of the certificate ;