natgillin/translations-raw huggingface dataset:
Jestliže výrobek / výrobky, na něž se vztahuje nucená licence, jsou patentovány v dovážejících členech WTO uvedených v žádosti, vyváží se výrobek / výrobky pouze tehdy, pokud tyto země vydaly nucenou licenci pro vývoz a prodej těchto výrobků.
If the product(s) covered by the compulsory licence are patented in the importing WTO members cited in the application, the product(s) shall only be exported if those countries have issued a compulsory licence for the import and sale of the products.
Jestliže výrobek / výrobky, na něž se vztahuje nucená licence, jsou patentovány v dovážejících zemích uvedených v žádosti, vyváží se výrobek / výrobky pouze tehdy, pokud tyto země vydaly nucenou licenci pro vývoz, prodej a distribuci těchto výrobků.
If the product(s) covered by the compulsory licence are patented in the importing countries cited in the application, the product(s) shall only be exported if those countries have issued a compulsory licence for the import , sale and/or distribution of the products.
The draft Regulation conditions exportation upon the prior granting of ‘a compulsory licence for the import and sale’ in the importing country.
The draft Regulation conditions exportation upon the prior granting of ‘a compulsory licence for the import and sale’ in the importing country.
However, in many cases the products subject to the compulsory licence may not be sold but distributed free of charge (e.g. by public hospitals or NGOs).
However, in many cases the products subject to the compulsory licence may not be sold but distributed free of charge (e.g. by public hospitals or NGOs).
Nabyvatel licence vede úplné a přesné knihy a záznamy o celém množství vyrobeného výrobku a o všech souvisejících obchodech.
The licensee shall keep complete and accurate books and records of all quantities of product manufactured and of all dealings therein.
Pouze pro účel kontroly, zda byly splněny podmínky licence, zejména podmínky spojené s konečným místem určení, zpřístupní nabyvatel licence tyto knihy a záznamy na požádání nezávislé osobě, na které se dohodly strany nebo která byla v ostatních případech jmenována příslušným orgánem.
The licensee shall make these books and records available on request to an independent person agreed by the parties, or otherwise appointed by the competent authority, for the sole purpose of checking whether the terms of the licence, and in particular those relating to the final destination of the products, have been met.
This paragraph obliges suppliers to keep complete and accurate books and to permit access thereto to authorised persons.
This paragraph obliges suppliers to keep complete and accurate books and to permit access thereto to authorised persons.
This condition is not imposed by the WTO Decision.
This condition is not imposed by the WTO Decision.
Given the various measures provided for in the draft Regulation to avoid diversion, this additional obligation seems redundant and may further discourage prospective suppliers unwilling to have direct State control over their commercial operations.
Given the various measures provided for in the draft Regulation to avoid diversion, this additional obligation seems redundant and may further discourage prospective suppliers unwilling to have direct State control over their commercial operations.
The patentee will always have the right to request the review of the compulsory licensee’s books to check his operations under the license.
The patentee will always have the right to request the review of the compulsory licensee’s books to check his operations under the license.
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, 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, and shall retain such records for at least three years.
Na požádání musí být tyto důkazy předloženy příslušnému orgánu.
Upon request these proofs must be supplied to the competent authority.
This paragraph requires the supplier to provide proof of exportation.
This paragraph requires the supplier to provide proof of exportation.
Nabyvatel licence odpovídá za uhrazení přiměřené odměny držiteli práva podle určení příslušného orgánu, přičemž se přihlédne k ekonomické hodnotě používání, k němuž byla/y předmětná dovážející země nebo předmětné dovážející země oprávněna / oprávněny 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 country or countries concerned.
Přitom je třeba přihlížet k humanitárním a nekomerčním důvodům, které jsou podkladem této licence.
In making this determination, the humanitarian and non-commercial reasons underlying the issue of the licence must be considered.
Výše přiměřené odměny má být stanovena v souladu s obecnými zásadami, které stanoví Komise.
The amount of the adequate remuneration shall be determined in accordance with guidelines to be established by the Commission.
Členské státy sdělí Komisi ve lhůtě šesti měsíců ode dne, kdy vstoupí toto nařízení v platnost, jaké licenční poplatky a jaký právní vzorec budou uplatňovat pro výpočet přiměřené odměny.
Member States shall communicate to the Commission within six months after the entry into force of this Regulation the royalty rates and the regulatory formula they will apply in the calculation of the adequate remuneration.
The lack of guidance about the remuneration to be paid creates considerable uncertainty for prospective users of the system (both potential producer companies and importers of pharmaceutical products) and may give rise to litigation as to whether the determined remuneration is adequate.
The lack of guidance about the remuneration to be paid creates considerable uncertainty for prospective users of the system (both potential producer companies and importers of pharmaceutical products) and may give rise to litigation as to whether the determined remuneration is adequate.
In order to enhance the predictability of the determinations to be made at national level, the draft Regulation should include guidance on what factors must be considered in determining adequate remuneration.
In order to enhance the predictability of the determinations to be made at national level, the draft Regulation should include guidance on what factors must be considered in determining adequate remuneration.
Před zamítnutím žádosti poskytne příslušný orgán žadateli příležitost k vyjádření jeho stanoviska a k nápravě situace.
Before refusing an application, the competent authority shall give the applicant an opportunity to rectify the situation and to be heard.
Amendment consistent with the amendment to Article 5(4).
Amendment consistent with the amendment to Article 5(4).
(e) délka platnosti licence
(e) the duration of the licence
(e) délka platnosti licence a podmínky jejího vydání;
(e) the duration of the licence and the conditions for its issue ;
In order to be consistent with Recital 7 which states that 'compulsory licences issued under this regulation should therefore impose clear conditions upon the licensee as regards the acts covered by the licence'.
In order to be consistent with Recital 7 which states that 'compulsory licences issued under this regulation should therefore impose clear conditions upon the licensee as regards the acts covered by the licence'.
Odstavec 1 se nepoužije v případě zpětného vývozu do dovážející země uvedené v žádosti a označené 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 této dovážející země .
Paragraph 1 shall not apply in the case of re-export to the importing country 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 country .
Therefore, the scope of the regulation should be extended to include also developing countries and least-developed countries.
Therefore, the scope of the regulation should be extended to include also developing countries and least-developed countries
Pozastavení nebo zadržení nepřekročí 10 pracovních dnů, ledaže vzniknou zvláštní okolnosti, pak lze dobu prodloužit o nejvýše 10 pracovních dnů.
The period of suspension or detention shall not exceed 10 working days unless special circumstances apply, in which case the period may be extended by a maximum of 10 working days.
Po uplynutí této lhůty se výrobky propustí za předpokladu, že byly splněny veškeré celní formality.
Upon expiry of that period, the products shall be released, provided that all customs formalities have been complied with.
Příslušný orgán je oprávněn z vlastní iniciativy nebo na odůvodněnou žádost držitele práva nebo nabyvatele licence prověřit, zda se v uvedeném případě jedná o dovoz.
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 importation is taking place.
The text inserted makes clear when the competent authority can act and brings Article 12 into line with Article 14.
The text inserted makes clear when the competent authority can act and brings Article 12 into line with Article 14.
The wording in the proposal for a regulation is too vague.
The wording in the proposal for a regulation is too vague.
The grounds on which the release of products may be suspended should be the same as the conditions specified for the granting of a compulsory licence.
The grounds on which the release of products may be suspended should be the same as the conditions specified for the granting of a compulsory licence.
Řádně se přihlédne k vnitrostátním ustanovením o ochraně osobních údajů, o obchodním a průmyslovém tajemství a o profesním tajemství.
Due account shall be taken of national provisions on the protection of personal data, commercial and industrial secrecy and professional and administrative confidentiality.
Dovozce, případně vývozce, dostane dostatečnou příležitost, aby příslušnému vnitrostátnímu orgánu poskytnul informace, které tento orgán považuje v souvislosti s výrobkem za náležité.
The importer, and where appropriate, the exporter, shall be given ample opportunity to supply the relevant national authority with the information which it deems appropriate regarding the products.
Příslušný orgán, držitel práva 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 , the right holder 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.
Řádně se přihlédne k vnitrostátním ustanovením o ochraně osobních údajů a o obchodním a průmyslovém tajemství a o profesním tajemství.
Due account shall be taken of national provisions on the protection of personal data and commercial and industrial secrecy and professional and administrative confidentiality.
Dovozce, případně vývozce, dostane dostatečnou příležitost, aby příslušnému orgánu poskytnul informace, které tento orgán považuje v souvislosti s výrobkem za náležité.
The importer, and where appropriate, the exporter, shall be given ample opportunity to supply the competent authority with the information which it deems appropriate regarding the products.
This amendment brings the terminology into line with the remaining text of the regulation, which refers only to the competent authority.
This amendment brings the terminology into line with the remaining text of the regulation, which refers only to the competent authority.
The rights holder is an interested party as it is possible that diverted products may have already entered the market.
The rights holder is an interested party as it is possible that diverted products may have already entered the market.
Příslušný orgán dotčeného členského státu zajistí, aby držitel práva byl bezodkladně informován o pozastaveném propouštění nebo o zadržení výrobků.
The right holder shall be informed without delay, by the competent authority of the Member State concerned, of the suspended release or detention of the products.
Zmíněnému orgánu může držitel práv předat veškeré informace, které bude v souvislosti s výrobky považovat za užitečné.
He may supply that authority with any information which he deems appropriate regarding the products.
Enabling the right holder to supply the relevant information could be extremely helpful for the national authority responsible for monitoring infringements of the ban on reimporting products into the Community.
Enabling the right holder to supply the relevant information could be extremely helpful for the national authority responsible for monitoring infringements of the ban on reimporting products into the Community.
Moreover, the right holder is directly damaged by any fraudulent use of the compulsory licence.
Moreover, the right holder is directly damaged by any fraudulent use of the compulsory licence.
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.
(See amendment to Article 12(4) (new))
(See amendment to Article 12(4) (new))
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.
Tato řízení se provádí na náklady dovozce.
These procedures are carried out at the expense of the importer.
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 these expenses from the importer, they may, in accordance with national legislation, be recovered from any other person responsible for the attempted illicit importation.
Products imported illegally into the European Union or one of its Member States may only be seized on the basis of confirmation of a breach of the provisions of this regulation.
Products imported illegally into the European Union or one of its Member States may only be seized on the basis of confirmation of a breach of the provisions of this regulation.
The provisions on payment of the expense occasioned by the seizure of products have been deleted solely in order to avoid unnecessary repetition in relation to the (amended) provisions contained in paragraph 3 of this Article.
The provisions on payment of the expense occasioned by the seizure of products have been deleted solely in order to avoid unnecessary repetition in relation to the (amended) provisions contained in paragraph 3 of this Article.
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.
See amendment to Article 12(3).
See amendment to Article 12(3).
The words “or seizure” have been added .
The words “or seizure” have been added.
The provisions contained in this paragraph are redundant, in the light of the provisions laid down in paragraph 1 of this Article.
The provisions contained in this paragraph are redundant, in the light of the provisions laid down in paragraph 1 of this Article.
Příslušný orgán sdělí Komisi jakákoliv rozhodnutí o zabavení nebo zničení, která byla přijata na základě tohoto nařízení.
The competent authority shall inform the Commission of any decisions on seizure or destruction which are adopted pursuant to this Regulation.
Vzhledem k přiměřené ochraně oprávněných zájmů nabyvatele licence lze rozhodnutím příslušného orgánu nebo jednoho ze subjektů, na které odkazuje článek 16, ukončit platnost nucené licence, která byla udělena na základě tohoto nařízení, v těchto případech:
Subject to adequate protection of the legitimate interests of the licensee, a compulsory licence granted pursuant to this Regulation may be terminated by a decision of the competent authority or by one of the bodies referred to under Article 16 in either of the following cases:
Vzhledem k přiměřené ochraně oprávněných zájmů nabyvatele licence lze rozhodnutím příslušného orgánu nebo jednoho ze subjektů, na které odkazuje článek 16, ukončit platnost nucené licence, která byla udělena na základě tohoto nařízení.
Subject to adequate protection of the legitimate interests of the licensee, a compulsory licence granted pursuant to this Regulation may be terminated by a decision of the competent authority or by one of the bodies referred to under Article 16 if the conditions of the licence are not respected by the licensee.
a) jestliže nabyvatel licence nedodržuje podmínky licence;
(a) if the conditions of the licence are not respected by the licensee ;
b) jestliže okolnosti, jež vedly k udělení licence, již neexistují a je nepravděpodobné, že znovu vzniknou .
(b) if and when the circumstances which led to the grant of the licence cease to exist and are unlikely to recur .
Příslušný orgán má pravomoc přezkoumat z vlastního podnětu nebo na základě zdůvodněné žádosti držitele práva nebo nabyvatele licence, zda se jedná o jednu z výše uvedených situací .
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 either of those situations applies.
Příslušný orgán má pravomoc přezkoumat na základě zdůvodněné žádosti držitele práva nebo nabyvatele licence, zda byly dodrženy podmínky licence .
The competent authority shall have the authority to review, upon reasoned request by the right holder or the licensee, whether the conditions of the licence have been respected .
Toto přezkoumání se má zakládat na hodnocení vypracovaném dovážející zemí.
This review shall be based on the assessment made in the importing country.
The possibility of terminating a compulsory licence means that a European government might substitute the government of the importing country in determining when a situation that justifies the application of the system subsists.
The possibility of terminating a compulsory licence means that a European government might substitute the government of the importing country in determining when a situation that justifies the application of the system subsists.
The decision to declare a situation of national emergency or other circumstances of extreme urgency, as well as of establishing the lack or insufficiency of manufacturing capacity, is the competence of the importing country, and not that of the exporting country.
The decision to declare a situation of national emergency or other circumstances of extreme urgency, as well as of establishing the lack or insufficiency of manufacturing capacity, is the competence of the importing country, and not that of the exporting country.
The Doha Declaration explicitly reinforced WTO Members’ right to autonomously determine what constitutes a national emergency or other circumstances of extreme urgency.
The Doha Declaration explicitly reinforced WTO Members’ right to autonomously determine what constitutes a national emergency or other circumstances of extreme urgency.
Therefore, a transfer of this judgement of emergency in the importing country to the authorities of the exporting country is not consistent with the Doha Declaration.
Therefore, a transfer of this judgement of emergency in the importing country to the authorities of the exporting country is not consistent with the Doha Declaration.
Po ukončení platnosti licence má příslušný orgán právo stanovit přiměřenou dobu, během níž nabyvatel licence zařídí, aby jakýkoliv výrobek v jeho vlastnictví, úschově nebo kontrolní pravomoci byl na jeho náklady zaslán zpět do zemí, které ho potřebují, nebo aby s ním bylo naloženo způsobem, který stanoví příslušný orgán po konzultaci s držitelem práva.
Following termination of the licence, the competent authority shall be entitled to establish a reasonable period of time within which the licensee shall arrange for any product in his possession, custody, power or control to be redirected at his expense to countries in need or otherwise as prescribed by the competent authority in consultation with the right holder.
Given that the competent authority is entitled to terminate a compulsory licence, it must also be able to determine the period of time within which the licensee shall arrange for any product in his possession, custody, power or control to be redirected.
Given that the competent authority is entitled to terminate a compulsory licence, it must also be able to determine the period of time within which the licensee shall arrange for any product in his possession, custody, power or control to be redirected.
Odvolání proti rozhodnutí příslušného orgánu a spory týkající se dodržení podmínek licence projednává příslušný orgán odpovědný podle vnitrostátního práva.
Appeals against any decision of the competent authority, and disputes concerning compliance with the conditions of the licence, shall be heard by the appropriate body responsible under national law.
Odvolání proti rozhodnutí o udělení nucené licence nemá ve vztahu k licenci odkladný účinek.
Appeals against a decision to grant a compulsory licence shall not have a suspensory effect in relation to the licence.
The draft Regulation permits appeals against any decision by the competent authority.
The draft Regulation permits appeals against any decision by the competent authority.
The system established by the draft Regulation will operate in a context of conflict or disagreement with the patentee, in a sector where litigation is extremely frequent.
The system established by the draft Regulation will operate in a context of conflict or disagreement with the patentee, in a sector where litigation is extremely frequent.
If the right to appeal is not appropriately regulated, the patentee may be able to obtain injunctive relief from the courts and block for a long time the supply of medicines.
If the right to appeal is not appropriately regulated, the patentee may be able to obtain injunctive relief from the courts and block for a long time the supply of medicines.
The possibility of obtaining this type of measures creates a high uncertainty for prospective suppliers and may further reduce the interest of potential suppliers to operate under the system.
The possibility of obtaining this type of measures creates a high uncertainty for prospective suppliers and may further reduce the interest of potential suppliers to operate under the system.
As established in many national regulations, an appeal by the patentee should not suspend the execution of the compulsory licence.
As established in many national regulations, an appeal by the patentee should not suspend the execution of the compulsory licence.