natgillin/translations-raw huggingface dataset:
Nabyvatel licence se žádá, aby o vývozu výrobku předložil důkaz formou prohlášení o vývozu vystaveného příslušným celním orgánem a důkaz o dovozu nebo uvedení na trh ověřený orgánem dovážejícího člena WTO, nebo jiné potřebné země , přičemž tyto zápisy uchová alespoň tři roky.
The licensee shall be required to provide proof of exportation of the product, through a declaration of exportation certified by the customs authority concerned, and proof of importation or putting on the market certified by an authority of the importing WTO member or other country in need , and shall retain such records for at least three years.
Dotyčnému držiteli práva bude také na požádání poskytnut přístup ke spisům, nejpozději 14 dnů po uskutečnění vývozu.
The right holder concerned shall also be granted access to the files on request, at the latest 14 days after the export has taken place.
The group of LDCs has been enlarged beyond the circle of WTO members in line with Amendment 4.
The group of LDCs has been enlarged beyond the circle of WTO members in line with Amendment 4.
In order to improve checks on the manufacturing side as well, it would be useful to grant right holders access to the export and customs documents as well.
In order to improve checks on the manufacturing side as well, it would be useful to grant right holders access to the export and customs documents as well.
Nabyvatel licence odpovídá za uhrazení přiměřené odměny držiteli práva podle určení příslušného orgánu, přičemž se přihlédne k ekonomické hodnotě používání, k němuž byl/i předmětný dovážející člen / předmětní dovážející členové WTO nebo předmětná potřebná země nebo více uvedených zemí oprávněn / oprávněni na základě licence.
The licensee shall be responsible for the payment of adequate remuneration to the right holder as determined by the competent authority taking into account the economic value of the use that has been authorised under the licence to the importing WTO member(s) or country or countries in need concerned.
Při stanovení částky vezme příslušný orgán v úvahu také postavení, jaké dovážející člen WTO zaujímá v Indexu lidského rozvoje OSN (HDI).
When determining the amount, the competent authority shall also take account of the position occupied by the importing WTO member in the UN Human Development Index (HDI).
The reference to adequate remuneration is excessively vague.
The reference to adequate remuneration is excessively vague.
The reference to the HDI index will make it easier to predict the amount of remuneration and ensure greater legal certainty.
The reference to the HDI index will make it easier to predict the amount of remuneration and ensure greater legal certainty.
Notifying the distinguishing features to the Commission will increase transparency and help prevent trade diversion and reimporting.
Notifying the distinguishing features to the Commission will increase transparency and help prevent trade diversion and reimporting.
Za účelem výměny dat mezi příslušnými orgány, držiteli práv a žadateli zřídí Komise centrální webové stránky, na nichž budou potřebné údaje zveřejněny.
For the purpose of data exchange between the competent authorities, right holders and applicants, the Commission shall set up a central website on which the requisite data shall be published.
Odstavec 1 se nepoužije v případě zpětného vývozu do dovážejícího člena WTO uvedeného v žádosti a označeného na obalu a v dokumentaci k výrobku, nebo v případech tranzitního režimu nebo režimu uskladňování v celním skladu, umístění do svobodného celního pásma nebo svobodného celního skladu pro účely zpětného vývozu do tohoto člena WTO.
Paragraph 1 shall not apply in the case of re-export to the importing WTO member or other country in need cited in the application and identified in the packaging and documentation associated with the product, or placing under a transit or customs warehouse procedure or in a free zone or free warehouse for the purpose of re-export to that importing WTO member or other country in need .
Příslušný orgán je oprávněn z vlastní iniciativy nebo na odůvodněnou žádost držitele práva nebo nabyvatele licence prověřit, zda se v uvedeném případě jedná o podezřelou akci.
The competent authority shall have the authority to review, on its own initiative or upon reasoned request by the right holder or the licensee, whether such action is suspected.
Příslušný orgán a výrobce či vývozce předmětných výrobků jsou bezodkladně informováni o pozastaveném propouštění nebo zadržení výrobků a obdrží veškeré dostupné informace o předmětných výrobcích.
The competent authority and the manufacturer or exporter of the products concerned shall be informed without delay of the suspended release or detention of the products and shall receive all information available with respect to the products concerned.
Jestliže není možné uhradit tyto náklady dovozcem, mohou být uhrazeny, v souladu s vnitrostátními právními předpisy, jakoukoliv další osobou odpovědnou za pokus o nezákonný dovoz. .
If it is not possible to recover those expenses from the importer, they may, in accordance with national legislation, be recovered from any other person responsible for the attempted illicit importation.
Náklady na pozastavení, zadržení nebo zabavení výrobků jsou hrazeny dovozcem.
The suspension or detention or seizure procedure for the products is carried out at the expense of the importer.
Není-li možné, aby tyto náklady hradil dovozce, mohou být uhrazeny, v souladu s vnitrostátními právními předpisy, jakoukoli další osobou odpovědnou za pokus o nezákonný dovoz .
If it is not possible to recover those expenses from the importer, they may, in accordance with national legislation, be recovered from any other person responsible for the attempted illicit importation.
The provisions on payment of the expense occasioned by the - suspected or established -illegal importation of products have been transferred to paragraph 4a (new), so as to avoid the repetition of these provisions in paragraphs 3 and 4 of this Article.
The provisions on payment of the expense occasioned by the - suspected or established -illegal importation of products have been transferred to paragraph 4a (new), so as to avoid the repetition of these provisions in paragraphs 3 and 4 of this Article.
10 odst.
shall not apply.
1 směrnice 2001/83/ES se nežádá, aby žadatel předložil výsledky předklinických zkoušek a klinických hodnocení, pokud může doložit, že předmětný přípravek je generickým referenčním léčivým přípravkem, který je nebo byl registrován podle článku 6 uvedené směrnice nebo podle článku 3 nařízení (ES) č. 726/2004
For the purpose of the application of this paragraph, and by way of derogation from Article 10(1) of Directive 2001/83/EC, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the product concerned is a generic of a reference medicinal product which is or has been authorised under Article 6 of that Directive or under Article 3 of Regulation (EC) No 726/2004.
The Commission’s draft regulation seeks to prescribe rules governing marketing approval in the European Union in the context of compulsory licences.
The Commission’s draft regulation seeks to prescribe rules governing marketing approval in the European Union in the context of compulsory licences.
This is not only superfluous given that medicines produced in this way are exclusively intended for the market of selected LDCs, which is at the core of the regulation, but also conflicts with the rules laid down in Regulation (EC) No 726/2004, Article 58 of which is echoed in paragraph 2.
This is not only superfluous given that medicines produced in this way are exclusively intended for the market of selected LDCs, which is at the core of the regulation, but also conflicts with the rules laid down in Regulation (EC) No 726/2004, Article 58 of which is echoed in paragraph 2.
The absence of such a provision results in work on developing new generic products being done outside Europe, in countries which have such a provision.
The absence of such a provision results in work on developing new generic products being done outside Europe , in countries which have such a provision.
Tři roky po vstupu tohoto nařízení v platnost, a potom vždy za tři roky, předloží Komise Evropskému parlamentu, Radě a Hospodářskému a sociálnímu výboru zprávu o fungování tohoto nařízení a jeho přínosu k provádění režimu zavedeného rozhodnutím.
Three years after the entry into force of this Regulation, and thereafter every three years, the Commission shall present a report to the European Parliament, the Council, and the European Economic and Social Committee on the operation of this Regulation and the contribution it has made to the implementation of the system established by the Decision.
Bude-li to nezbytné, předloží návrhy změn tohoto nařízení.
Where necessary, it shall present proposals for amendments to this Regulation.
Komise také předloží Evropskému parlamentu a Radě všechny nezbytné návrhy na přezkoumání tohoto nařízení ve chvíli, kdy bude pozměněna dohoda TRIPS.
The Commission shall also present to the European Parliament and the Council any necessary proposals for revising this Regulation when the TRIPS Agreement has been amended.
Návrh nařízení Evropského parlamentu a Rady o nucených licencích na patenty týkající se výroby farmaceutických výrobků na vývoz do zemí s problémy v oblasti veřejného zdraví
Proposal for a regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
Anja Weisgerber 23.11.2004
Anja Weisgerber 23.11.2004
Adamos Adamou, Georgs Andrejevs, Irena Belohorská, Johannes Blokland, John Bowis, Hiltrud Breyer, Martin Callanan, Dorette Corbey, Avril Doyle, Mojca Drčar Murko, Jillian Evans, Anne Ferreira, Karl-Heinz Florenz, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Gyula Hegyi, Caroline Jackson, Dan Jørgensen, Christa Klaß, Holger Krahmer, Urszula Krupa, Aldis Kušķis, Peter Liese, Linda McAvan, Marios Matsakis, Riitta Myller, Péter Olajos, Dimitrios Papadimoulis, Vittorio Prodi, Guido Sacconi, Karin Scheele, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Jonas Sjöstedt, María Sornosa Martínez, Antonios Trakatellis, Thomas Ulmer, Anja Weisgerber a Åsa Westlund.
Adamos Adamou, Georgs Andrejevs, Irena Belohorská, Johannes Blokland, John Bowis, Hiltrud Breyer, Martin Callanan, Dorette Corbey, Avril Doyle, Mojca Drčar Murko, Jillian Evans, Anne Ferreira, Karl-Heinz Florenz, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Gyula Hegyi, Caroline Jackson, Dan Jørgensen, Christa Klaß, Holger Krahmer, Urszula Krupa, Aldis Kušķis, Peter Liese, Linda McAvan, Marios Matsakis, Riitta Myller, Péter Olajos, Dimitrios Papadimoulis, Vittorio Prodi, Guido Sacconi, Karin Scheele, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Jonas Sjöstedt, María Sornosa Martínez, Antonios Trakatellis, Thomas Ulmer, Anja Weisgerber and Åsa Westlund.
k návrhu nařízení Evropského parlamentu a Rady o nucených licencích na patenty týkající se výroby farmaceutických výrobků na vývoz do zemí s problémy v oblasti veřejného zdraví
on the proposal for a European Parliament and Council regulation on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
The aim of the regulation proposed by the Commission is to enable manufacturers of generic pharmaceutical products to produce and sell patented pharmaceutical products intended for export to countries in need of such products which either have no manufacturing capacity, or are not self-sufficient, in the relevant sector.
The aim of the regulation proposed by the Commission is to enable manufacturers of generic pharmaceutical products to produce and sell patented pharmaceutical products intended for export to countries in need of such products which either have no manufacturing capacity, or are not self-sufficient, in the relevant sector.
The regulation aims to implement at Community level the WTO General Council decision of 30 August 2003 on the implementation of paragraph 6 of the Declaration on the TRIPs agreement and public health.
The regulation aims to implement at Community level the WTO General Council decision of 30 August 2003 on the implementation of paragraph 6 of the Declaration on the TRIPs agreement and public health.
By waiving WTO members’ obligations under Article 31(f) of the WTO agreement on Trade Related Aspects of Intellectual Property Rights (the TRIPS agreement), this decision allows WTO members to grant compulsory licences for the production and sale of patented pharmaceutical products intended for export to third countries with insufficient or no manufacturing capacity in the pharmaceutical sector.
By waiving WTO members’ obligations under Article 31(f) of the WTO agreement on Trade Related Aspects of Intellectual Property Rights (the TRIPS agreement), this decision allows WTO members to grant compulsory licences for the production and sale of patented pharmaceutical products intended for export to third countries with insufficient or no manufacturing capacity in the pharmaceutical sector.
Uniform implementation of the decision within the Community is needed to ensure that the conditions for the granting of compulsory licences for export are the same in all EU Member States, to avoid distortion of competition for operators in the EU single market and to apply uniform rules to prevent re-importation into the territory of the European Union of pharmaceutical products manufactured under compulsory licences.
Uniform implementation of the decision within the Community is needed to ensure that the conditions for the granting of compulsory licences for export are the same in all EU Member States, to avoid distortion of competition for operators in the EU single market and to apply uniform rules to prevent re-importation into the territory of the European Union of pharmaceutical products manufactured under compulsory licences.
The European Union, therefore, proposes to take a stand as one of the international players with the greatest commitment to ensuring that the citizens of the most disadvantaged countries have access to pharmaceutical products at lower prices.
The European Union, therefore, proposes to take a stand as one of the international players with the greatest commitment to ensuring that the citizens of the most disadvantaged countries have access to pharmaceutical products at lower prices.
In view of the objectives set forth by the Commission, your rapporteur can only warmly welcome this proposal for a regulation.
In view of the objectives set forth by the Commission, your rapporteur can only warmly welcome this proposal for a regulation.
However, it should be remembered that the measures contained in the proposal in question constitute, objectively speaking, a reduction in the protection usually accorded to intellectual property rights through the TRIPS agreement.
However, it should be remembered that the measures contained in the proposal in question constitute, objectively speaking, a reduction in the protection usually accorded to intellectual property rights through the TRIPS agreement.
Consequently, while fully supporting the principle of solidarity with the disadvantaged which underlies the proposal, it is perfectly reasonable to allow patent holders the opportunity to be involved in the procedure laid down for the granting of compulsory licences for the manufacture and sale of pharmaceuticals intended for export to WTO countries with public health problems.
Consequently, while fully supporting the principle of solidarity with the disadvantaged which underlies the proposal, it is perfectly reasonable to allow patent holders the opportunity to be involved in the procedure laid down for the granting of compulsory licences for the manufacture and sale of pharmaceuticals intended for export to WTO countries with public health problems.
The amendments tabled by your rapporteur aim, therefore, to protect the legitimate economic, industrial and commercial interests of pharmaceutical patent holders.
The amendments tabled by your rapporteur aim, therefore, to protect the legitimate economic, industrial and commercial interests of pharmaceutical patent holders.
This would be achieved by giving them the right to submit comments to the competent national authority in order to ensure, by providing for both parties to have a say in the proceedings, that the decision taken minimises any loss of rights in relation to intellectual property.
This would be achieved by giving them the right to submit comments to the competent national authority in order to ensure, by providing for both parties to have a say in the proceedings, that the decision taken minimises any loss of rights in relation to intellectual property.
Provision is made also for the right holder to be involved in any proceedings to ascertain whether there has been an infringement of the ban on re-importing into the European market pharmaceutical products manufactured under a compulsory licence.
Provision is made also for the right holder to be involved in any proceedings to ascertain whether there has been an infringement of the ban on re-importing into the European market pharmaceutical products manufactured under a compulsory licence.
Finally, your rapporteur has sought to avoid giving manufacturers of generic pharmaceuticals under compulsory licences an unfair competitive advantage.
Finally, your rapporteur has sought to avoid giving manufacturers of generic pharmaceuticals under compulsory licences an unfair competitive advantage.
Article 16 of the proposal refers to two possible procedures which may be used to enable importing countries to control the quality of the pharmaceuticals exported: a marketing authorisation for the European market (under Article 6 of Directive 2001/83/EC) or the scientific opinion procedure (under Article 58 of Regulation (EC) No 726/2004).
Article 16 of the proposal refers to two possible procedures which may be used to enable importing countries to control the quality of the pharmaceuticals exported: a marketing authorisation for the European market (under Article 6 of Directive 2001/83/EC) or the scientific opinion procedure (under Article 58 of Regulation (EC) No 726/2004).
In both cases, provision is made for derogations from the usual data protection and caducity rules.
In both cases, provision is made for derogations from the usual data protection and caducity rules.
However, in the case of marketing authorisation, this procedure would allow the authorised person to enter the EU market on conditions in which he would not otherwise be allowed to do so.
However, in the case of marketing authorisation, this procedure would allow the authorised person to enter the EU market on conditions in which he would not otherwise be allowed to do so.
Even on the understanding that such authorisation was granted only for export purposes, it would have the effect of reducing legal certainty and creating an unfair advantage for manufacturers of generic pharmaceuticals who, at the end of the period laid down for the protection of data relating to the patented product, could obtain marketing authorisation for the EU market before they could otherwise expect to do so.
Even on the understanding that such authorisation was granted only for export purposes, it would have the effect of reducing legal certainty and creating an unfair advantage for manufacturers of generic pharmaceuticals who, at the end of the period laid down for the protection of data relating to the patented product, could obtain marketing authorisation for the EU market before they could otherwise expect to do so.
The solution proposed by your rapporteur, therefore, is to drop the marketing authorisation procedure, given that the scientific opinion procedure guarantees the possibility of controlling the quality of pharmaceutical products intended for export.
The solution proposed by your rapporteur, therefore, is to drop the marketing authorisation procedure, given that the scientific opinion procedure guarantees the possibility of controlling the quality of pharmaceutical products intended for export.
Výbor pro právní záležitosti vyzývá Výbor pro mezinárodní obchod jako příslušný výbor, aby do své zprávy začlenil tyto pozměňovací návrhy:
The Committee on Legal Affairs calls on the Committee on International Trade, as the committee responsible, to incorporate the following amendments in its report:
Příslušnému orgánu se sdělí internetová adresa.
The website address shall be communicated to the competent authority.
Příslušnému orgánu a držiteli práva se sdělí internetová adresa.
The website address shall be communicated to the competent authority and to the right holder .
The other party concerned, i.e. the right holder, should have access to this information.
The other party concerned, i.e. the right holder, should have access to this information.
Do jednoho měsíce po předložení žádosti o nucenou licenci příslušnému vnitrostátnímu orgánu informuje osoba, která o licenci žádá, o této žádosti držitele práva.
Within a month of applying to the competent national authority for a compulsory licence, the applicant shall notify the right holder of that application.
Žadatel zajistí, aby o tomto informování držitele práva byl zpraven i příslušný vnitrostátní orgán.
The notification shall be communicated to the competent authority by the applicant.
V případě, že držitel práva nebyl informován, proces vydání nucené licence bude zastaven.
If the applicant fails to notify the right holder, the procedure for granting the compulsory licence shall be suspended.
Držitel práva může do procesu vydání nucené licence zasáhnout, aby:
The right holder may intervene in the procedure for granting the compulsory licence in order to:
a) předložil své výhrady, při čemž se odvolá na existenci důkazů a okolností záležitosti specifikovaných v článku 7;
(a) submit his own comments concerning the existence of the evidence and the factual circumstances referred to in Article 7;
b) se vyjádřil k termínům a podmínkám vydání nucené licence;
(b) state his opinion on the terms and conditions governing the grant of the compulsory licence;
Granting a compulsory licence involves a significant curtailment of intellectual property rights.
Granting a compulsory licence involves a significant curtailment of intellectual property rights.
For that reason, it is essential to have a system that allows both sides to be heard and enables the right holder to participate in the procedure brought before the competent national authority.
For that reason, it is essential to have a system that allows both sides to be heard and enables the right holder to participate in the procedure brought before the competent national authority.
This will enable him to protect his legitimate rights by submitting his own observations on the terms and conditions for the grant of the compulsory licence.
This will enable him to protect his legitimate rights by submitting his own observations on the terms and conditions for the grant of the compulsory licence.
(e) délka platnosti licence a podmínky jejího vydání;
(e) the duration of the licence and the conditions for the issue thereof ;
The proposed provision aims to guarantee the quality of the products in question for the importing country.
The proposed provision aims to guarantee the quality of the products in question for the importing country.
However, allowing derogations from the rules on data protection and caducity in connection with the market authorisation procedure could give an unfair competitive advantage to manufacturers of generic pharmaceuticals on the European market.
However, allowing derogations from the rules on data protection and caducity in connection with the market authorisation procedure could give an unfair competitive advantage to manufacturers of generic pharmaceuticals on the European market.