### the distributor who considers that a vehicle , system , component or separate technical unit that he has made available on the market is not in conformity with this regulation , shall inform the manufacturer or the importer to ensure that the appropriate measures necessary to bring that vehicle , system , component or separate technical unit into conformity , to withdraw it from the market or to recall it , as appropriate , are taken in accordance with article 12 or article 15 . ### the distributor who considers that a vehicle , system , component or separate technical unit that he has made available on the market is not in conformity with this regulation , shall inform the commission , the manufacturer or the importer to ensure that the appropriate measures necessary to bring that vehicle , system , component or separate technical unit into conformity , to withdraw it from the market or to recall it , as appropriate , are taken in accordance with article 12 or article 15 .


### the commission shall investigate all cases where concerns have been brought to its attention regarding the competence of a technical service or the continued compliance by a technical service with the requirements and responsibilities to which it is subject under this regulation . it may also commence such investigations on its own initiative . ### the commission , working in conjunction with the type - approval authority of the member state concerned , shall investigate all cases where concerns have been brought to its attention regarding the competence of a technical service or the continued compliance by a technical service with the requirements and responsibilities to which it is subject under this regulation . it may also commence such investigations on its own initiative .


### the member states shall draw up the annual plan for the peer - review , ensuring an appropriate rotation in respect of reviewing and reviewed type - approval authorities , and submit it to the commission . ### the forum established in article 10 shall draw up a working plan for the peer - review , ensuring an appropriate rotation in respect of reviewing and reviewed type - approval authorities .


### market surveillance authorities of one member state that have taken action pursuant to article 20 of regulation no 765 / 2008 and article 8 of this regulation , or that have sufficient reason to believe that a vehicle , system , component or separate technical unit covered by this regulation presents a serious risk to the health or safety of persons or to other aspects of the protection of public interests covered by this regulation , shall inform without delay the approval authority that granted the approval about its findings . ### market surveillance authorities of one member state that have taken action pursuant to article 20 of regulation no 765 / 2008 and article 8 of this regulation , or that have sufficient reason to believe that a vehicle , system , component or separate technical unit covered by this regulation presents a serious risk to the safety of persons , the environment or persons ' health or to other aspects of the protection of public interests covered by this regulation , shall inform without delay the approval authority that granted the approval about its findings .


### the commission may adopt implementing acts to lay down the criteria for setting out the scale , scope and frequency with which the compliance verification checks of samples taken referred to in paragraph 1 have to be performed . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 87 . ### the commission shall lay down in delegated acts the criteria for setting out the scale , scope and frequency with which the compliance verification checks of samples taken referred to in paragraph 1 have to be performed . those delegated acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### the power to adopt delegated acts referred to in article 4 , article 5 , article 10 , article 22 , article 24 , article 25 , article 26 , article 28 , article 29 , article 34 , article 55 and , article 56 , article 60 , article 65 , article 76 and article 90 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation . ### the power to adopt delegated acts referred to in article 4 , article 5 , article 10 , article 22 , article 24 , article 25 , article 26 , article 28 , article 29 , article 34 , article 55 and , article 56 , article 60 , article 65 and article 65 , article 76 and article 90 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation .


### where information society service providers store and provide access to the public to copyright protected works or other subject - matter uploaded by their users , thereby going beyond the mere provision of physical facilities and performing an act of communication to the public , they are obliged to conclude licensing agreements with rightholders , unless they are eligible for the liability exemption provided in article 14 of directive 2000 / 31 / ec of the european parliament and of the council34 . __________________ 34 directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market . ### where information society service providers offer users content storage services and provide the public with access to content and where such activity constitutes an act of communication to the public and is not of a merely technical , automatic and passive nature , they should be obliged to conclude licensing agreements with rightholders as regards copyright protected works or other subject - matter , unless they are eligible for the liability exemptions provided in directive 2000 / 31 / ec of the european parliament and of the council34 . __________________ 34 directive 2000 / 31 / ec of the european parliament and of the council of 8 june 2000 on certain legal aspects of information society services , in particular electronic commerce , in the internal market .


### in order to ensure the functioning of any licensing agreement , information society service providers storing and providing access to the public to large amounts of copyright protected works or other subject - matter uploaded by their users should take appropriate and proportionate measures to ensure protection of works or other subject - matter , such as implementing effective technologies . this obligation should also apply when the information society service providers are eligible for the liability exemption provided in article 14 of directive 2000 / 31 / ec . ### in order to ensure the functioning of any licensing agreement , information society service providers actively and directly involved in allowing users to upload , making works available and promoting works to the public should take appropriate and proportionate measures to ensure protection of works or other subject - matter . such measures should respect the charter of fundamental rights of the european union and should not impose a general obligation on information society service providers to monitor the information which they transmit or store as referred to in article 15 of directive 2000 / 31 / ec .


### member states shall ensure that the service providers referred to in paragraph 1 put in place complaints and redress mechanisms that are available to users in case of disputes over the application of the measures referred to in paragraph 1 . ### member states shall ensure that the service providers referred to in paragraph 1 in cooperation with rightholders put in place complaints mechanisms that are available to users in case of disputes over the implementation of the licensing agreements referred to in paragraph 1 .


### certain uses of protected content by online services ### certain uses of protected content online


### member states shall facilitate , where appropriate , the cooperation between the information society service providers and rightholders through stakeholder dialogues to define best practices , such as appropriate and proportionate content recognition technologies , taking into account , among others , the nature of the services , the availability of the technologies and their effectiveness in light of technological developments . ### member states shall facilitate , where appropriate , the cooperation between the information society service providers referred to in paragraph 1 , user representatives and rightholders through stakeholder dialogues to define best practices for the implementation of paragraph 1 . the measures undertaken shall be appropriate and proportionate and shall take into account , among others , the nature of the services , the availability of the technologies and their effectiveness in light of technological developments .


### use of protected content by information society service providers storing and giving access to large amounts of works and other subject - matter uploaded by their users ### use of protected content by information society service providers storing and giving access to works and other subject - matter uploaded by their users


### information society service providers that store and provide to the public access to large amounts of works or other subject - matter uploaded by their users shall , in cooperation with rightholders , take measures to ensure the functioning of agreements concluded with rightholders for the use of their works or other subject - matter or to prevent the availability on their services of works or other subject - matter identified by rightholders through the cooperation with the service providers . those measures , such as the use of effective content recognition technologies , shall be appropriate and proportionate . the service providers shall provide rightholders with adequate information on the functioning and the deployment of the measures , as well as , when relevant , adequate reporting on the recognition and use of the works and other subject - matter . ### where information society service providers offer users content storage services and provide the public with access to content and where such activity is not eligible for the liability exemptions provided for in directive 2000 / 31 / ec , they shall take appropriate and proportionate measures to ensure the functioning of licensing agreements concluded with rightholders . the implementation of such agreements shall respect the fundamental rights of users and shall not impose a general obligation on information society service providers to monitor the information which they transmit or store , in accordance with article 15 of directive 2000 / 31 / ec .


### during the negotiations the commission should have the possibility to advice on how to avoid incompatibility with union law . in particular , the commission could develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions . ### during the negotiations the commission should have the possibility to advice the member state on how to avoid incompatibility with union law . in particular , the commission could develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions .


### a permanent exchange of information on intergovernmental agreements at union level should enable best practices to be developed . on the basis of those best practices , the commission , where appropriate in cooperation with the european external action service as regards the union’s external policies , should develop optional model clauses to be used in intergovernmental agreements between member states and third countries . the use of such model clauses should aim to avoid conflicts of intergovernmental agreements with union law , in particular internal energy market rules and competition law , and conflicts with international agreements concluded by the union . their use should be optional , and it should be possible to adapt their content to any particular circumstance . ### a permanent exchange of information on intergovernmental agreements at union level should enable best practices to be developed . on the basis of those best practices , the commission , in cooperation with member states and where appropriate in cooperation with the european external action service as regards the union’s external policies , should develop optional model clauses and guidance to be used in intergovernmental agreements between member states and third countries . the use of such model clauses should aim to avoid conflicts of intergovernmental agreements with union law , in particular internal energy market rules and competition law , and conflicts with international agreements concluded by the union . their use should be optional , and it should be possible to adapt their content to any particular circumstance .


### during the negotiations the commission should have the possibility to advice on how to avoid incompatibility with union law . in particular , the commission could develop , together with member states , optional model clauses or guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions . ### during the negotiations the commission should have the possibility to advice on how to avoid incompatibility with union law . in particular , the commission should develop , together with member states , optional model clauses and guidelines . the commission should have the possibility to draw attention to the union’s energy policy objectives and the principle of solidarity between member states and union policy positions adopted in council or european council conclusions .


### 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 each making is to take place and the certificate - holder at its address for service in the relevant member state are notified by each person doing the making of the information listed in paragraph 3 no later than 3 months before the earliest start date of making or any related act that is strictly necessary for that making in that member state ;


### 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 and of the product resulting from such making , which is protected by a certificate in the territory of a member state , for the exclusive purpose of export of that product or of a medicinal product containing that product 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 possession , supply and import of active ingredients for the purpose of making a medicinal product containing that product , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations .


### 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 .


### 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 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 apply to certificates for which the basic patent expired on or after 1 january 2023 . the date specified takes into account the need to provide for a transitional period sufficiently long to ensure that holders of supplementary protection certificates are not deprived of their acquired rights . that date should also 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 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 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 particular acts against which the basic patent conferred protection if , with respect to those particular acts , the following conditions are met :


### 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 , 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 . the exception should apply to products to be placed on the market as medicinal products , as well as to products which are active ingredients of a medicinal product or combinations thereof , protected by the relevant supplementary protection certificate .


### 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 . ### effective and proportionate 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 .


### 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 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 .


### 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 , this regulation should impose a 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 each making is to take place . the information should be provided before the making or before other acts that are related for that making are 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 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 , 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 , this regulation should impose a 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 . a standard form should be used for the purpose of communicating such information . the information should be provided before the making is intended to start for the first time in that member state , and before any related act prior to that making , and should be updated as appropriate . 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 and has informed the holder of the supplementary protection certificate granted in that member state as regards the making . only the making should be notified , not the related acts . should making take place in more than one member state , a notification should be required in each of those member states . the authority should be required to publish certain elements of that information , in the interests of transparency . certain confidential or commercially sensitive information notified to the authority should not be published . only a court or other competent authority should be able to request such information .


### 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 referred to in point of paragraph 2 of the information listed in paragraph 3 no later than three months before the start date of making in that member state and in advance of any related act prior to that making that would otherwise be prohibited owing to the protection conferred by that 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 promote the competitiveness of generics and biosimilars producers in the union , enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions . this will help those producers to compete effectively in third country markets where protection does not exist or has expired . it should also complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products or active ingredients . indirectly , it should put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate .


### 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 . at the same time the safeguards should also ensure the necessary confidentiality and protection of commercially sensitive information of the applicant .


### 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 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 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 , i . e . their re - export from third countries to the 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 , 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 or placing the product on the market after the expiry of the certificate , 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 placing the product on the market subsequently to the certificate’s expiry 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 , temporary storage of the product or advertising for the exclusive purpose of export or stocking the product to prepare for entry to the market after the expiry of the certificate .


### this regulation does not affect the application of union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights , including directive 2004 / 48 / ec of the european parliament and of the council41 and regulation no 608 / 2013 of the european parliament and of the council42 . _________________ 41 directive 2004 / 48 / ec of the european parliament and of the council of 29 april 2004 on the enforcement of intellectual property rights . 42 regulation no 608 / 2013 of the european parliament and of the council of 12 june 2013 concerning customs enforcement of intellectual property rights . ### this regulation does not affect the application of union measures that aim to prevent infringements and facilitate enforcement of intellectual property rights , including directive 2004 / 48 / ec of the european parliament and of the council41 and regulation no 608 / 2013 of the european parliament and of the council42 . furthermore , this regulation does not affect the rules on the unique identifier provided for in commission delegated regulation 2016 / 1611a . . _________________ 41 directive 2004 / 48 / ec of the european parliament and of the council of 29 april 2004 on the enforcement of intellectual property rights . 42 regulation no 608 / 2013 of the european parliament and of the council of 12 june 2013 concerning customs enforcement of intellectual property rights . 1a commission delegated regulation 2016 / 161 of 2 october 2015 supplementing directive 2001 / 83 / ec of the european parliament and of the council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use .


### 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 on 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 .


### 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 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 purposes 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 .


### 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


### 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 , and to ensure the entry of generics and biosimilar medicines onto the union market from day - 1 after the expiry of the relevant supplementary protection certificate , thus fostering access to medicines . 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 and thereby help to prevent shortages of certain medicines , 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 , and / or day - 1 entry , as well as any upstream or downstream acts , 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 or 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 , or 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 and of the product resulting from such making , which is protected by a certificate in the territory of a member state , for the exclusive purpose of export of that product or of a medicinal product containing that product 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 possession , supply and import of active ingredients for the purpose of making a medicinal product containing that product , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations .


### 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 certificate granted in the relevant member state , and identification of the product , by reference to its international non - proprietary name , if available ;


### 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 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 authority referred to in article 9 of the relevant member state shall publish the information listed in points and of article 4 . it shall also publish any changes to that information that are notified in accordance with the first sentence of point of article 4 .


### the maker ensures that a logo , in the form set out in annex - i , is affixed to the outer packaging of the product or , if there is no outer packaging , to its immediate packaging ; ### the maker ensures that a logo , in the form set out in annex - i , is affixed to the outer packaging of the medicinal product and to its immediate packaging ; the maker ensures that the medicinal product manufactured under paragraph 2does not bear a unique identifier as per articles 3 and 4 of commission delegated regulation 2016 / 161 / eu . where appropriate , competent authorities shall have access to the data in the repositories mandated by directive 2011 / 62 / eu and delegated regulation 2016 / 161 / eu to ensure that the maker complies with its obligations .


### 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 and be as follows


### 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 apply to certificates for which the basic patent expired on or after 1 january 2023 . the date specified takes into account the need to provide for a transitional period sufficiently long to ensure that holders of supplementary protection certificates are not deprived of their acquired rights . that date should also 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 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 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 point of article 4 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 authority referred to in article 9 shall keep the notification referred to in point of article 4 and the information listed in paragraph 3 confidential and shall take appropriate measures to preserve such confidentiality . the authority shall only disclose the notification and the information it contains if such disclosure is ordered by a court having competence under national law to hear an infringement action based on the certificate . a court shall only order such disclose if at least the following conditions are met : the person requesting the disclosure is the holder of the certificate the maker is given the opportunity to attend the proceedings and to be heard before the court ; the holder of the certificate has provided evidence rendering plausible that the maker did not comply with the conditions set out in article 4 ; the holder of the certificate and the court have taken appropriate measures to keep the notification and the information it contains confidential and avoid their disclosure to 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 . at the same time the safeguards should also ensure the necessary confidentiality and protection of commercially sensitive information of the applicant .


### 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 within the union from manufacturing , with a view to enter the union market immediately after expiry of the certificate and / or export to countries outside the union in which 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 .


### the maker ensures that a logo , in the form set out in annex - i , is affixed to the outer packaging of the product or , if there is no outer packaging , to its immediate packaging ; ### in the case of products made for the exclusive purpose of export to third countries , the maker ensures that a logo , in the form set out in annex - i , is affixed to the outer packaging of the product or , if there is no outer packaging , to its immediate packaging ;


### 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 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 . in this regard , the commission’s study1a states that “neither the production for export , nor the production for stockpiling purposes run counter to the legal objectives of the spc system” , and “arguably the only effect of prohibiting stockpiling would be to boost the business opportunities of non - eu companies to the disadvantage of generic manufacturers established here . ”


### 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 ensure that the rights of holders of supplementary protection certificates are not unduly restricted , the exception provided for in this regulation should only apply to certificates that are applied for after the entry into force of this regulation , as well as to certificates that enter into effect two years after the entry into force of this regulation , irrespective of when these certificates were granted . it is necessary to ensure a timely entry into force of this regulation , given that , as from 2020 , patents will expire in third countries for many high - turnover medicinal products that are protected by certificates in the union , thus opening up considerable new opportunities in global markets that makers of generics and biosimilars established in the union should be able to seize . at the same time , these timing arrangements should allow a reasonable time for certificate holders to adjust to the changed legal context and to make appropriate investment decisions in a timely way , while ensuring that the economic benefits of the exception can be effectively reaped by makers of generics and biosimilars .


### 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 , and by imposing certain conditions on the application of the exception , this regulation also ensures respect for the freedom to conduct a business for manufacturers of generics and biosimilars established in the eu and facilitates access by union citizens to more accessible healthcare and medicines .


### the maker shall ensure , through appropriate means , that persons in a contractual relationship with the maker who perform acts falling within paragraph 2 are fully informed and aware of the following : ### the maker shall ensure , through appropriate and documented means , that persons in a contractual relationship with the maker who perform acts falling within paragraph 2 are fully informed and aware of the following :


### 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 . ### the scope of the exception is limited to making for day - 1 entry and for the purpose of export outside the union and to acts strictly necessary for such making or for the actual export itself , and therefore 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 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 those particular acts , the following conditions are met :


### the information for the purposes of paragraph 2 shall be as follows : the name and address of the maker ; the address , or addresses , of the premises where the making is to take place in the relevant member state ; 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 authorisation granted in accordance with article 40 of directive 2001 / 83 / ec or article 44 of directive 2001 / 82 / ec for the manufacture of the corresponding medicinal product or , in the absence of such authorisation , a valid certificate of good manufacturing practice as referred to in article 111 of directive 2001 / 83 / ec or article 80 of directive 2001 / 82 / ec covering the premises where the making is to take place ; the intended start date of making in the relevant member state ; an indicative list of the intended third country or third countries to which the product is to be exported . ### the information for the purposes of paragraph 2 shall be treated as strictly confidential and be as follows : the name and address of the maker ; the relevant member state where the making is to take place ; 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 start date of making in the relevant member state ;


### 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 , ### the cjeu has confirmed on numerous occasions that the objective pursued by regulation no 469 / 2009 is not to compensate the holder fully for the delay to the marketing of his invention . moreover , the protection granted by the spc relates to exclusivity on the eu market which does not fall within the scope of the waiver introduced by this regulation in respect of the fundamental rights and principles recognized by the charter of fundamental rights of the european union . in particular , this regulation aims at ensuring full respect for the right to property guaranteed by article 17 of the charter by maintaining the core rights of the supplementary protection certificate holder . by the introduction of this exception , the union adopts a solution in the pharmaceutical sector which is essential to promote public interest . the exception should be considered in the light of the principle of proportionality , measuring it up with the protection of values such as health protection , which is a special emanation of the general concept of public interest . facilitating the wide - ranging availability of medicinal products constitutes an important goal of health policy , including the one pursued at the eu level in accordance with article 35 of the charter of fundamental rights of the european union . any unjustified delay of lawful price competition in the pharmaceutical sector means that both state budgets and patients are forced to bear excessive pharmacotherapy costs , which is in conflict with the public interest . the provisions establishing supplementary protection certificate aim at compensating the holder of the basic patent for the period prior to the granting of a marketing authorization when they cannot enjoy the market exclusivity conferred by the basic patent . this compensation consists of a specific extension of patent protection for the purpose of ensuring market exclusivity lasting 15 years from the first marketing authorization of the medicinal product . such an extension , however , does not grant an absolute right to the holder of the certificate and therefore may be subject to certain restrictions , as long as the essential compensation function of the extension is safeguarded , notably that adequate market exclusivity is ensured for the duration of the certificate . in order to reap the full benefits of the exception introduced by this regulation with due regard to the protection of legitimate expectations and without unduly curtailing acquired rights , the exception should be operational in the case of certificates that enter into effect two years after the entry into force of this regulation , irrespective of when these certificates were granted . this solution ensures an appropriate transitional period but also makes the exception apply across the board from the specified date , allowing for a timely and transparent introduction of the new regime . from the point of view of public interest , it is most beneficial to introduce the waiver as soon as possible . however , postponing its application guarantees predictability to applicants and other stakeholders . in addition , it is ensured that legal continuity is maintained to the extent that it is necessary for the planned systemic change . it needs to be underlined that it is not possible to achieve the desired goal by other means . the legitimate expectations of holders of certificates granted before the specified date remains fully respected , as the exception does not alter their factual status on the markets on which they enjoy the extension of patent protection in any economically relevant manner . they will continue to enjoy market exclusivity for the same amount of time , as their competitors will only be able to lawfully enter the market in territories where no such exclusivity exists .


### the maker ensures that a logo , in the form set out in annex - i , is affixed to the outer packaging of the product or , if there is no outer packaging , to its immediate packaging ; ### the maker ensures that a logo , in the form set out in annex - ii , is affixed to the outer packaging of the product referred to in point of paragraph 2 or , if there is no outer packaging , to its immediate packaging ;


### ‘ 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 an authority as referred to in article 4 shall be published by that authority within 15 days of receipt of the notification . ’ the same provisions shall apply , where appropriate , to the updated notification in accordance with the provisions of article 4 . the published notification or , where applicable , updated notification shall not contain any confidential or commercially sensitive information .


### 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 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 should 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 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 . ### the scope of the exception is limited to making for the purpose of export outside the union and acts strictly necessary for such making or for the actual export 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 . ### keeping in mind that the spc regulation in the eu provides for uniform solution of the protection and for the free movement of medicinal products , the aim of this regulation is to enhance further balance between the interests of the originators , generic and biosimilar makers and public health by following the principle of proportionality . the regulation will promote the competitiveness of makers of generics and biosimilar producers established in the union , enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions . this will help these makers to compete effectively in markets where intellectual property protection does not exist or has expired . it should also complement the efforts of the union’s trade policy to ensure open markets for union - based makers of medicinal products or active ingredients , and it will ensure that neither member states’ health systems nor the patients are forced to bear excessive pharmacotherapy costs which would be in direct conflict with the public interest .


### this puts manufacturers of generics and biosimilars established in the union at a significant competitive disadvantage compared with manufacturers based in third countries that offer less or no protection . ### this puts manufacturers of generics and biosimilars established in the union at a significant competitive disadvantage compared with manufacturers based in third countries that offer less or no protection or where protection has expired . the european union must therefore strike a balance between , on the one hand , ensuring a level playing field between production activities on its territory and in third countries and , on the other , ensuring that the exclusive rights of the certificate holders are guaranteed in relation to the union market .


### 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 promote the competitiveness of generics and biosimilars producers in the union , enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions . this will help those producers to compete effectively in third country markets where protection does not exist or has expired . it should also complement the efforts of the union’s trade policy to ensure open markets for union - based manufacturers of medicinal products or active ingredients . indirectly , it should put those manufacturers in a better position to enter the union market immediately after expiry of the relevant supplementary protection certificate .


### 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 and be as follows


### the maker ensures that a logo , in the form set out in annex - i , is affixed to the outer packaging of the product or , if there is no outer packaging , to its immediate packaging ; ### the maker ensures that a logo , in the form set out in annex - i , is affixed to the outer packaging of the medicinal product and to its immediate packaging ; the maker ensures that the medicinal product manufactured under paragraph 2does not bear a unique identifier as per articles 3 and 4 of commission delegated regulation 2016 / 161 / eu . where appropriate , competent authorities shall have access to the data in the repositories mandated by directive 2011 / 62 / eu and delegated regulation 2016 / 161 / eu to ensure that the maker complies with its obligations .


### 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 and of the product resulting from such making , which is protected by a certificate in the territory of a member state , for the exclusive purpose of export of that product or of a medicinal product containing that product 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 possession , supply and import of active ingredients for the purpose of making a medicinal product containing that product , or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations .


### the act comprises : ### the act is :


### 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 certificate granted in the relevant member state , and identification of the product , by reference to its international non - proprietary name , if available ;


### 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 responsible for the making , or any person acting on its behalf , of the information listed in paragraph 3 no later than 28 days before the intended start date of making


### 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 each making is to take place and the certificate - holder at its address for service in the relevant member state are notified by each person doing the making of the information listed in paragraph 3 no later than 3 months before the earliest start date of making or any related act that is strictly necessary for that making in that member state ;


### 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 and / or 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 or 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 , or temporary storage of the product or medicinal product or other activities necessary for the purpose of export 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 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 products or medicinal products , into the union merely for the purposes of repackaging and re - exporting .


### 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 an authority as referred to in article 4 shall be published by that authority within 5 days of receipt of the notification . ' ;


### 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 , ### the cjeu has confirmed on numerous occasions that the objective pursued by regulation no 469 / 2009 is not to compensate the holder fully for the delay to the marketing of his invention . moreover , the protection granted by the spc relates to exclusivity on the eu market which does not fall within the scope of the waiver introduced by this regulation in respect of the fundamental rights and principles recognized by the charter of fundamental rights of the european union . in particular , this regulation aims at ensuring full respect for the right to property guaranteed by article 17 of the charter by maintaining the core rights of the supplementary protection certificate holder . by the introduction of this exception , the union adopts a solution in the pharmaceutical sector which is essential to promote public interest . the exception should be considered in the light of the principle of proportionality , measuring it up with the protection of values such as health protection , which is a special emanation of the general concept of public interest . facilitating the wide - ranging availability of medicinal products constitutes an important goal of health policy , including the one pursued at the eu level in accordance with article 35 of the charter of fundamental rights of the european union . any unjustified delay of lawful price competition in the pharmaceutical sector means that both state budgets and patients are forced to bear excessive pharmacotherapy costs , which is in conflict with the public interest . the provisions establishing supplementary protection certificate aim at compensating the holder of the basic patent for the period prior to the granting of a marketing authorization when they cannot enjoy the market exclusivity conferred by the basic patent . this compensation consists of a specific extension of patent protection for the purpose of ensuring market exclusivity lasting 15 years from the first marketing authorization of the medicinal product . such an extension , however , does not grant an absolute right to the holder of the certificate and therefore may be subject to certain restrictions , as long as the essential compensation function of the extension is safeguarded , notably that adequate market exclusivity is ensured for the duration of the certificate . in order to reap the full benefits of the exception introduced by this regulation with due regard to the protection of legitimate expectations and without unduly curtailing acquired rights , the exception should be operational in the case of certificates that enter into effect two years after the entry into force of this regulation , irrespective of when these certificates were granted . this solution ensures an appropriate transitional period but also makes the exception apply across the board from the specified date , allowing for a timely and transparent introduction of the new regime . from the point of view of public interest , it is most beneficial to introduce the waiver as soon as possible . however , postponing its application guarantees predictability to applicants and other stakeholders . in addition , it is ensured that legal continuity is maintained to the extent that it is necessary for the planned systemic change . it needs to be underlined that it is not possible to achieve the desired goal by other means . the legitimate expectations of holders of certificates granted before the specified date remains fully respected , as the exception does not alter their factual status on the markets on which they enjoy the extension of patent protection in any economically relevant manner . they will continue to enjoy market exclusivity for the same amount of time , as their competitors will only be able to lawfully enter the market in territories where no such exclusivity exists .


### the commission shall inform regularly the european parliament and the council about the activities of the platform . ### the platform shall inform regularly the commission , the european parliament and the council about its activities .


### tasks for the execution of its mission , the platform shall in particular carry out the following tasks : improve the knowledge of undeclared work by means of common concepts , measurement tools and promotion of joint comparative analysis and related relevant indicators , develop the analysis of effectiveness of different policy measures in curbing the incidence of undeclared work , including preventive and punitive as well as deterrence measures in general , establish tools , for instance a knowledge bank of different practices / measures , including bilateral agreements used in the member states to deter and prevent undeclared work , adopt non - binding guidelines for inspectors , handbooks of good practice and common principles of inspections to tackle undeclared work , develop forms of cooperation increasing the technical capacity to tackle cross - border aspects of undeclared work by adopting a common framework for joint operations for inspections and exchange of staff , examine ways to improve data sharing in compliance with the union data protection rules , including exploring possibilities to use of the internal market information system and the electronic exchange of social security information . develop permanent training capacity for enforcement authorities and adopt a common framework for carrying out joint trainings , organise peer reviews to follow member states progress when fighting undeclared work , including support for the implementation of country - specific recommendations related to fight or prevent undeclared work issued by the council . increase awareness of the problem by carrying out common activities such as european campaigns and adopting regional or eu wide strategies , including sectoral approaches . in carrying out its tasks , the platform will make use of all relevant sources of information , including studies and multilateral cooperation projects and take into account relevant union instruments and structures , as well the experience of relevant bilateral agreements . it will establish appropriate cooperation with eurofound and eu - osha . ### tasks for the execution of its mission , the platform shall in particular carry out the following tasks : improve the knowledge of all forms of undeclared work , also with regard to causes and regional differences , by means of common concepts , including comprehensive definitions of existing and new forms of undeclared work , indicators and methodologies for data collection , measurement tools and promotion of joint comparative analysis and research , improve the knowledge and mutual understanding of different national labour inspection systems and practices to tackle undeclared work , the consequences of undeclared work , including cross - border undeclared work , with regard to unfair competition and market distortions , as well as the precarious working conditions endured by persons in undeclared work , analyse the effectiveness and consequences of different policy measures , such as prevention and deterrence as well as enabling measures encouraging and promoting declared work , in curbing the incidence of undeclared work , establish efficient tools , for instance an interactive knowledge bank of different practices / measures based on the application in different labour market models , including bilateral and multilateral agreements used in the member states , to tackle undeclared work , develop guidelines for enforcement , handbooks of good practice and common principles of inspections to tackle undeclared work and monitor progress made on the implementation of guidelines , develop close cooperation in order to improve the capability of national labour inspection systems regarding controls and tackling cross - border aspects of undeclared work by means of actions such as joint operations , relevant databases and staff exchanges , draw up and publish information to facilitate the activities of national labour inspection systems , develop a reliable and efficient system of rapid information exchange and improve data sharing in compliance with the union data protection rules , including exploring possibilities to make use of the internal market information system established by regulation no 1024 / 2012 of the european parliament and of the council1a and the electronic exchange of social security information , contribute to the identification of areas related to undeclared work where union legislation is not achieving its intended objectives . develop and improve the permanent training capacity for enforcement authorities and adopt a common framework for carrying out joint trainings . put forward suggestions to the commission , the european parliament and the council for inclusion in the country - specific recommendations of appropriate action addressing the particular aspects of tackling undeclared work as well as the effects of non - action in the member states concerned . organise peer reviews to follow member states progress when fighting undeclared work , including support for the implementation of country - specific recommendations related to fight or prevent undeclared work issued by the council and promote appropriate action , give opinions and suggestions to the commission , the european parliament or the council on issues relating to better regulation and the enforcement of union legislation on working conditions and social protection in member states related to the tackling of undeclared work as well as relating to the effects of non - action , encourage active cooperation between the enforcement authorities of member states and non - eu countries , where relevant , in order to resolve problems related to undeclared work involving these countries , increase awareness of the problem by carrying out common activities such as european campaigns and adopting regional or eu wide strategies , including sectoral approaches . encourage national authorities and other bodies to provide counselling and information for workers victimised by practices of undeclared work , in carrying out its tasks , the platform shall make use of all relevant sources of information , including studies and multilateral cooperation projects and take into account relevant union instruments and structures , as well the experience of relevant bilateral agreements . the platform shall establish appropriate cooperation with eurofound as well as with eu - osha . 1a regulation no 1024 / 2012 of the european parliament and of the council of 25 october 2012 on administrative cooperation through the internal market information system and repealing commission decision 2008 / 49 / ec


### the platform , as set out in article 1 , shall contribute to better enforcement of eu and national law , to the reduction of undeclared work and the emergence of formal jobs , hence avoiding the deterioration of quality of work , and to promote integration in the labour market and social inclusion by : ### the platform , as set out in article 1 , shall contribute to better enforcement of eu and national law , to the reduction of undeclared work and to the emergence of formal jobs . it shall thus help to embed the europe 2020 strategy and its employment objectives , providing a more effective european framework for employment and workplace health and safety . avoiding thereby the deterioration of quality of work , it shall promote integration in the labour market and social inclusion by :


### the commission shall inform regularly the european parliament and the council about the activities of the platform . ### after each meeting of the platform , the commission shall , within a reasonable time , forward a report on the discussions and the decisions taken to the european parliament and the council .


### three different national enforcement authorities are mainly involved with undeclared work : labour inspectorates , social security inspectorates and tax authorities . in some cases , migration authorities and employment services as well as customs authorities , the police , the public prosecutor ' s office and the social partners are also involved . ### often several different national enforcement authorities are mainly involved with curbing undeclared work : including labour inspectorates , social security inspectorates , health and safety inspectorates and tax authorities . in some cases , migration authorities and employment services as well as customs authorities , the police , the public prosecutor ' s office and the social partners are also involved . together with better enforcement of existing legislation , the authorities concerned should increasingly put in place incentives enabling the regularisation of jobs .


### a two - year work programme of the platform setting out , inter alia , its detailed tasks and regular reports of the platform in every two years , ### adopt an annual as well as a multiannual work programme of the platform setting out , inter alia , its detailed tasks of the platform and taking into account the evaluation of the activities undertaken in the previous year ,


### at european level undeclared work is defined as ‘ any paid activities that are lawful as regards their nature but not declared to public authorities , taking into account differences in the regulatory systems of the member states’ , thus excluding all illegal activities . __________________ 28 communication from the commission ‘ stepping up the fight against undeclared work’ com 628 of 24 october 2007 http : / / eur - lex . europa . eu / lexuriserv / lexuriserv . do ? uri=celex : 52007dc0628 : en : html ### at european level undeclared work is defined as ‘ any paid activities that are lawful as regards their nature but not declared to public authorities , taking account differences in the regulatory systems of the member states’28 , thus excluding all illegal activities . it should be noted that definitions vary between the member states and that undeclared work exists in many different forms . __________________ 28 communication from the commission ‘ stepping up the fight against undeclared work’ com 628 of 24 october 2007 http : / / eur - lex . europa . eu / lexuriserv / lexuriserv . do ? uri=celex : 52007dc0628 : en : html


### four years after its entry into force , the commission shall submit a report on the application of this decision to the european parliament , the council , the european economic and social committee and the committee of the regions . the report shall in particular assess to what extent the platform has contributed to the achievement of the objectives set out in article 2 and fulfilled the tasks as set out in article 3 and in work programmes of the platform . ### four years after its entry into force , the commission shall submit a report on the application and the added value of this decision to the european parliament , the council , the european economic and social committee and the committee of the region , and propose , where appropriate , necessary amendments and modifications or withdrawal of this decision . the report shall in particular assess to what extent the platform has contributed to the achievement of the objectives set out in article 2 and carried out the initiatives as set out in article 4 and addressed the priorities as set out in its work programmes .


### the strengthening of cooperation among member states at eu level is necessary to help member states to prevent and deter undeclared work more efficiently and effectively . ### the strengthening of cooperation among member states at eu level is necessary to help member states to prevent and deter undeclared work more efficiently and effectively , while respecting the freedom to provide services , the free movement of workers and the principle of non - discrimination .