natgillin/translations-raw huggingface dataset:
Since the objectives of this Regulation, in particular the establishment of harmonised procedures for the granting of compulsory licences which contribute to the effective implementation of the system set up by the Decision, cannot be sufficiently achieved by the Member States because of the options available to exporting countries under the Decision and can therefore, by reason of the potential effects on operators in the internal market, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
Ker ciljev te uredbe, ki jih je treba sprejeti, in sicer uvedbe usklajenih postopkov za podelitev prisilnih licenc, ki prispevajo k učinkovitemu izvajanju sistema, vzpostavljenega s Sklepom, države članice ne morejo zadovoljivo doseči zaradi možnosti, ki so po Sklepu na voljo državam izvoznicam, in se lahko zato zaradi možnih vplivov na gospodarske subjekte na notranjem trgu lažje dosežejo na ravni Skupnosti, lahko Skupnost sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Skladno z načelom sorazmernosti iz navedenega člena ta uredba ne presega tistega, kar je potrebno za doseganje navedenih ciljev.
The Community recognises the utmost desirability of promoting the transfer of technology and capacity-building to countries with insufficient or no manufacturing capacity in the pharmaceutical sector, in order to facilitate and increase the production of pharmaceutical products by those countries.
Skupnost priznava, da je nadvse zaželeno, da se podpira prenos tehnologije in vzpostavljanje zmogljivosti v državah, ki imajo nezadostne proizvodne zmogljivosti v farmacevtskem sektorju ali jih sploh nimajo, in se tako spodbuja in povečuje lastna proizvodnja farmacevtskih izdelkov v teh državah.
In order to ensure the efficient processing of applications for compulsory licences under this Regulation, Member States should have the ability to prescribe purely formal or administrative requirements, such as rules on the language of the application, the form to be used, the identification of the patent(s) and/or supplementary protection certificate(s) in respect of which a compulsory licence is sought, and rules on applications made in electronic form.
Za zagotovitev učinkovite obdelave zahtev za pridobitev prisilne licence v skladu s to uredbo bi morale imeti države članice možnost predpisati izključno formalne ali upravne pogoje, kot so pravila glede jezika zahteve, obrazca, ki se mora uporabljati, opredelitve patentov in/ali dodatnih varstvenih certifikatov, v zvezi s katerimi se zahteva prisilna licenca, in pravila o zahtevah v elektronski obliki.
The simple formula for setting remuneration is intended to accelerate the process of granting a compulsory licence in cases of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use under Article 31(b) of the TRIPS Agreement.
Namen preproste formule za določitev nadomestila je pospešiti postopek podelitve prisilnih licenc v primeru izrednih razmer v državi ali v drugih skrajno nujnih okoliščinah ali v primerih javne nekomercialne uporabe v skladu s členom 31(b) Sporazuma TRIPS.
The figure of 4 % could be used as a reference point for deliberations on adequate remuneration in circumstances other than those listed above,
Delež 4 % bi se lahko uporabil kot referenčna točka za razprave o ustreznem nadomestilu v okoliščinah, ki so drugačne od zgoraj navedenih —
This Regulation establishes a procedure for the grant of compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products, when such products are intended for export to eligible importing countries in need of such products in order to address public health problems.
Ta uredba uvaja postopek za podelitev prisilnih licenc v zvezi s patenti in dodatnimi varstvenimi certifikati za proizvodnjo in prodajo farmacevtskih izdelkov, kadar so takšni izdelki namenjeni izvozu v upravičene države uvoznice, ki potrebujejo takšne izdelke za reševanje težav v zvezi z javnim zdravjem.
Member States shall grant a compulsory licence to any person making an application in accordance with Article 6 and subject to the conditions set out in Articles 6 to 10.
Države članice podelijo prisilno licenco vsaki osebi, ki vloži zahtevo v skladu s členom 6 in ob upoštevanju pogojev, določenih v členih 6 do 10.
‘pharmaceutical product’ means any product of the pharmaceutical sector, including medicinal products as defined in Article 1(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [4], active ingredients and diagnostic kits ex vivo;
„farmacevtski izdelek“ pomeni kateri koli izdelek v farmacevtskem sektorju, vključno z zdravili, kot so določena v členu 1(2) Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [4], učinkovinami in opremo za diagnosticiranje ex vivo;
‘rights-holder’ means the holder of any patent or supplementary protection certificate in relation to which a compulsory licence has been applied for under this Regulation;
„imetnik pravice“ pomeni imetnika katerega koli patenta ali dodatnega varstvenega certifikata, v zvezi s katerim je bila vložena zahteva za pridobitev prisilne licence v skladu s to uredbo;
‘importing country’ means the country to which the pharmaceutical product is to be exported;
„država uvoznica“ pomeni državo, v katero se bo izvažal farmacevtski izdelek;
‘competent authority’ for the purposes of Articles 1 to 11, 16 and 17 means any national authority having competence to grant compulsory licences under this Regulation in a given Member State.
„pristojni organ“ pomeni za namene členov 1 do 11, 16 in 17 kateri koli nacionalni organ, ki je pristojen za podelitev prisilnih licenc v skladu s to uredbo v posamezni državi članici.
The competent authority as defined in Article 2(4) shall be that which has competence for the granting of compulsory licences under national patent law, unless the Member State determines otherwise.
Pristojni organ, kakor je opredeljen v členu 2(4), je tisti, ki je pristojen za podelitev prisilnih licenc po nacionalnem patentnem pravu, razen če zadevna država članica določi drugače.
Member States shall notify the Commission of the designated competent authority as defined in Article 2(4).
Države članice o imenovanem pristojnem organu iz člena 2(4) uradno obvestijo Komisijo.
Notifications shall be published in the Official Journal of the European Union.
Uradna obvestila se objavijo v Uradnem listu Evropske unije.
Eligible importing countries
Upravičene države uvoznice
The following are eligible importing countries:
Upravičene države uvoznice so naslednje:
any least-developed country appearing as such in the United Nations list;
vsaka najmanj razvita država, ki je kot taka navedena na seznamu Združenih narodov;
any member of the WTO, other than the least-developed country members referred to in point (a), that has made a notification to the Council for TRIPs of its intention to use the system as an importer, including whether it will use the system in whole or in a limited way;
vsaka članica STO, ki ni najmanj razvita država članica iz točke (a), ki je Svet za TRIPS obvestila o svoji nameri, da bo uporabila sistem kot uvoznica, vključno s tem, ali bo sistem uporabljala v celoti ali omejeno;
any country that is not a member of the WTO, but is listed in the OECD Development Assistance Committee's list of low-income countries with a gross national product per capita of less than USD 745, and has made a notification to the Commission of its intention to use the system as an importer, including whether it will use the system in whole or in a limited way.
vsaka država, ki ni članica STO, vendar je na seznamu Odbora OECD za razvojno pomoč med državami z nizkim dohodkom, katerih bruto nacionalni proizvod na prebivalca znaša manj kot 745 USD, in ki je Komisijo uradno obvestila o svoji nameri, da bo uporabila sistem kot uvoznica, vključno s tem, ali bo sistem uporabljala v celoti ali omejeno.
However, any WTO member that has made a declaration to the WTO that it will not use the system as an importing WTO member is not an eligible importing country.
Vendar vsaka članica STO, ki je STO podala izjavo, da sistema ne bo uporabljala kot članica STO uvoznica, ni upravičena država uvoznica.
Extension to least-developed and developing countries which are not members of the WTO
Razširitev na najmanj razvite države in države v razvoju, ki niso članice STO
The following provisions shall apply to importing countries eligible under Article 4 which are not WTO members:
Naslednje določbe se uporabljajo za upravičene države uvoznice po členu 4, ki niso članice STO:
the importing country shall make the notification referred to in Article 8(1) directly to the Commission;
država uvoznica pošlje uradno obvestilo iz člena 8(1) neposredno Komisiji;
the importing country shall, in the notification referred to in Article 8(1), state that it will use the system to address public health problems and not as an instrument to pursue industrial or commercial policy objectives and that it will adopt the measures referred to in paragraph 4 of the Decision;
država uvoznica v uradnem obvestilu iz člena 8(1) izjavi, da bo sistem uporabljala za reševanje problemov javnega zdravja in ne kot instrument za doseganje ciljev industrijske ali trgovinske politike ter da bo sprejela ukrepe iz odstavka 4 Sklepa;
the competent authority may, at the request of the rights-holder, or on its own initiative if national law allows the competent authority to act on its own initiative, terminate a compulsory licence granted pursuant to this Article if the importing country has failed to honour its obligations referred to in point (b).
pristojni organ lahko na zahtevo imetnika pravice ali na lastno pobudo, če nacionalna zakonodaja pristojnemu organu dovoljuje delovanje na lastno pobudo, prekliče prisilno licenco, podeljeno v skladu s tem členom, če država uvoznica ni izpolnila svojih obveznost iz točke (b).
Before terminating a compulsory licence, the competent authority shall take into account any views expressed by the bodies referred to in Article 6(3)(f).
Pred preklicem prisilne licence pristojni organ upošteva vsa mnenja, ki jih izrazijo organi iz člena 6(3)(f).
Application for a compulsory licence
Zahteva za prisilno licenco
Any person may submit an application for a compulsory licence under this Regulation to a competent authority in the Member State or States where patents or supplementary protection certificates have effect and cover his intended activities of manufacture and sale for export.
Vsaka oseba lahko vloži zahtevo za pridobitev prisilne licence po tej uredbi pri pristojnem organu v državi članici ali članicah, kjer patenti ali dodatni varstveni certifikati veljajo in obsegajo njene načrtovane dejavnosti proizvodnje in prodaje za izvoz.
If the person applying for a compulsory licence is submitting applications to authorities in more than one country for the same product, he shall indicate that fact in each application, together with details of the quantities and importing countries concerned.
Oseba, ki vloži zahtevo za pridobitev prisilne licence pri organih več kot ene države za isti izdelek, to v vseh svojih zahtevah navede skupaj s podatki o količinah in zadevnih državah uvoznicah.
The application pursuant to paragraph 1 shall set out the following:
Zahteva iz odstavka 1 vsebuje:
the name and contact details of the applicant and of any agent or representative whom the applicant has appointed to act for him before the competent authority;
ime in kontaktne podatke vložnika ter vsakega zastopnika, ki ga je vložnik pooblastil, da deluje v njegovem imenu pred pristojnim organom;
the non-proprietary name of the pharmaceutical product or products which the applicant intends to manufacture and sell for export under the compulsory licence;
nevarovano ime farmacevtskega izdelka ali izdelkov, ki jih namerava vložnik proizvajati in prodajati za izvoz v skladu s prisilno licenco;
the amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;
količino farmacevtskega izdelka, ki jo namerava vložnik proizvesti v skladu s prisilno licenco;
the importing country or countries;
državo ali države uvoznice;
where applicable, evidence of prior negotiation with the rights-holder pursuant to Article 9;
dokazila o prejšnjih pogajanjih z imetnikom pravice v skladu s členom 9, kjer je to potrebno;
evidence of a specific request from:
dokazila o posebni zahtevi:
authorised representatives of the importing country or countries; or
pooblaščenih zastopnikov države ali držav uvoznic; ali
a non-governmental organisation acting with the formal authorisation of one or more importing countries; or
nevladne organizacije s formalnim pooblastilom ene ali več držav uvoznic; ali
UN bodies or other international health organisations acting with the formal authorisation of one or more importing countries,
organov OZN ali drugih mednarodnih zdravstvenih organizacij s formalnim pooblastilom ene ali več držav uvoznic,
indicating the quantity of product required.
z navedbo zahtevane količine izdelka.
Purely formal or administrative requirements necessary for the efficient processing of the application may be prescribed under national law.
Nacionalna zakonodaja lahko predpiše zgolj formalne ali upravne pogoje, potrebne za učinkovito obravnavo zahteve.
Such requirements shall not add unnecessarily to the costs or burdens placed upon the applicant and, in any event, shall not render the procedure for granting compulsory licences under this Regulation more burdensome than the procedure for the granting of other compulsory licences under national law.
Takšni pogoji po nepotrebnem ne povečajo stroškov ali bremen vložnika, v vsakem primeru pa zaradi njih postopek za podelitev prisilne licence po tej uredbi ni bolj otežen, kot je postopek za podelitev drugih prisilnih licenc po nacionalni zakonodaji.
Rights of the rights-holder
Pravice imetnika pravice
The competent authority shall notify the rights-holder without delay of the application for a compulsory licence.
Pristojni organ nemudoma uradno obvesti imetnika pravice o zahtevi za pridobitev prisilne licence.
Before the grant of the compulsory licence, the competent authority shall give the rights-holder an opportunity to comment on the application and to provide the competent authority with any relevant information regarding the application.
Pred podelitvijo prisilne licence da pristojni organ imetniku pravice možnost, da poda pripombe k zahtevi in da pristojnemu organu sporoči kakršne koli pomembne informacije v zvezi z zahtevo.
The competent authority shall verify that:
Pristojni organ preveri:
each importing country cited in the application which is a WTO member has made a notification to the WTO pursuant to the Decision,
da je vsaka država uvoznica, navedena v zahtevi, ki je članica STO, v skladu s Sklepom uradno obvestila STO;
each importing country cited in the application which is not a WTO member has made a notification to the Commission pursuant to this Regulation in respect of each of the products covered by the application that:
da je vsaka država uvoznica, navedena v zahtevi, ki ni članica STO, glede vsakega izdelka iz zahteve, v skladu s to uredbo poslala Komisiji uradno obvestilo, ki:
specifies the names and expected quantities of the product(s) needed;
natančno navaja naziv in pričakovano količino potrebnega izdelka;
unless the importing country is a least-developed country, confirms that the country has established that it had insufficient or no manufacturing capacity in the pharmaceutical sector in relation to a particular product or products in one of the ways set out in the Annex to the Decision;
potrjuje, da je država na enega od načinov, določenih v Prilogi k Sklepu, ugotovila, da ima v farmacevtskem sektorju v zvezi z določenim izdelkom ali izdelki nezadostne proizvodne zmogljivosti ali pa jih sploh nima, razen če je država uvoznica ena od najmanj razvitih držav;
confirms that where a pharmaceutical product is patented in the territory of the importing country, that importing country has granted or intends to grant a compulsory licence for import of the product concerned in accordance with Article 31 of the TRIPS Agreement and the provisions of the Decision.
potrjuje, da je v primerih, ko je farmacevtski izdelek patentiran na ozemlju države uvoznice, ta država uvoznica podelila ali namerava podeliti prisilno licenco za uvoz zadevnega izdelka v skladu s členom 31 Sporazuma TRIPS in določbami Sklepa.
This paragraph is without prejudice to the flexibility that least-developed countries have under the Decision of the Council for TRIPS of 27 June 2002.
Ta odstavek ne posega v prožnost, ki jo imajo najmanj razvite države po Sklepu Sveta za TRIPS z dne 27. junija 2002.
The competent authority shall verify that the quantity of product cited in the application does not exceed that notified to the WTO by an importing country which is a WTO member, or to the Commission by an importing country which is not a WTO member, and that, taking into account other compulsory licences granted elsewhere, the total amount of product authorised to be produced for any importing country does not significantly exceed the amount notified by that country to the WTO, in the case of importing countries which are WTO members, or to the Commission, in the case of importing countries which are not WTO members.
Pristojni organ preveri, da količina izdelka, navedena v zahtevi, ne presega tiste, o kateri je država uvoznica, ki je članica STO, uradno obvestila STO, ali tiste, o kateri je država uvoznica, ki ni članica STO, uradno obvestila Komisijo, in da ob upoštevanju drugih prisilnih licenc, podeljenih drugje, skupna količina izdelka, ki se lahko proizvede za katero koli državo uvoznico, znatno ne presega količine, o kateri je ta država uradno obvestila STO v primeru držav uvoznic, članic STO, oziroma Komisijo v primeru držav uvoznic, ki niso članice STO.
Prior negotiation
Predhodna pogajanja
The applicant shall provide evidence to satisfy the competent authority that he has made efforts to obtain authorisation from the rights-holder and that such efforts have not been successful within a period of thirty days before submitting the application.
Vložnik pristojnemu organu predloži dokazila, da si je prizadeval za pridobitev pooblastila od imetnika pravice in da v obdobju tridesetih dni pred vložitvijo zahteve takšno prizadevanje ni bilo uspešno.
The requirement in paragraph 1 shall not apply in situations of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use under Article 31(b) of the TRIPS Agreement.
Pogoj iz odstavka 1 se ne uporablja v razmerah izrednega stanja na nacionalni ravni, drugih skrajno nujnih okoliščinah ali v primerih javne nekomercialne uporabe v skladu s členom 31(b) Sporazuma TRIPS.
Compulsory licence conditions
Pogoji prisilne licence
The licence granted shall be non-assignable, except with that part of the enterprise or goodwill which enjoys the licence, and non-exclusive.
Podeljena licenca ni prenosljiva, razen za tisti del podjetja ali njegove poslovne dejavnosti, ki uporablja licenco, in ni izključna.
It shall contain the specific conditions set out in paragraphs 2 to 9 to be fulfilled by the licensee.
Vsebuje posebne pogoje, določene v odstavkih 2 do 9, ki jih mora izpolniti pridobitelj licence.
The amount of product(s) manufactured under the licence shall not exceed what is necessary to meet the needs of the importing country or countries cited in the application, taking into account the amount of product(s) manufactured under other compulsory licences granted elsewhere.
Količina izdelka, proizvedenega po licenci, ne presega količine, ki jo potrebuje(-jo) za izpolnitev potreb država ali države uvoznice, navedene v zahtevi, ob upoštevanju količine izdelka, proizvedenega po drugih prisilnih licencah, ki so bile podeljene drugje.
The duration of the licence shall be indicated.
Trajanje licence je navedeno.
The licence shall be strictly limited to all acts necessary for the purpose of manufacturing the product in question for export and distribution in the country or countries cited in the application.
Licenca je strogo omejena na vsa dejanja, potrebna za proizvodnjo zadevnega izdelka za izvoz v državo ali države, navedene v zahtevi, in distribucijo v njih.
No product made or imported under the compulsory licence shall be offered for sale or put on the market in any country other than that cited in the application, except where an importing country avails itself of the possibilities under subparagraph 6(i) of the Decision to export to fellow members of a regional trade agreement that share the health problem in question.
Noben izdelek, narejen ali uvožen po prisilni licenci, se ne ponudi za prodajo ali da na trg v kateri koli drugi državi, razen tisti, ki je navedena v zahtevi, razen če država uvoznica uporabi možnosti iz pododstavka 6(i) Sklepa za izvoz v tiste države sopogodbenice regionalnega trgovinskega sporazuma, ki se soočajo z istim zdravstvenim problemom.
Products made under the licence shall be clearly identified, through specific labelling or marking, as being produced pursuant to this Regulation.
Izdelki, narejeni po licenci, so jasno opredeljeni s posebno označitvijo, iz katere je razvidno, da so bili proizvedeni v skladu s to uredbo.
The products shall be distinguished from those made by the rights-holder through special packaging and/or special colouring/shaping, provided that such distinction is feasible and does not have a significant impact on price.
Izdelki se morajo razlikovati od tistih, ki jih je proizvedel imetnik pravice po posebnem pakiranju in/ali barvanju/oblikovanju, če je tako razlikovanje izvedljivo in če nima pomembnega vpliva na ceno.
The packaging and any associated literature shall bear an indication that the product is subject to a compulsory licence under this Regulation, giving the name of the competent authority and any identifying reference number, and specifying clearly that the product is exclusively for export to and distribution in the importing country or countries concerned.
Embalaža in katera koli z izdelkom povezana dokumentacija vsebuje označbo, da je izdelek predmet prisilne licence po tej uredbi, navaja ime pristojnega organa in identifikacijsko referenčno številko ter jasno označuje, da je izdelek namenjen izključno za izvoz in distribucijo v zadevno državo ali države uvoznice.
Details of the product characteristics shall be made available to the customs authorities of the Member States.
Podrobnosti o lastnostih izdelkov so na voljo carinskim organom držav članic.
Before shipment to the importing country or countries cited in the application, the licensee shall post on a website the following information:
Pred odpremo v državo ali države uvoznice, navedene v zahtevi, pridobitelj licence na spletni strani objavi naslednje podatke:
the quantities being supplied under the licence and the importing countries to which they are supplied;
količine, dobavljene po licenci, in države uvoznice, katerim jih dobavlja;
the distinguishing features of the product or products concerned.
razpoznavne značilnosti zadevnega izdelka ali izdelkov.
The website address shall be communicated to the competent authority.
Naslov spletne strani se sporoči pristojnemu organu.
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.
Če so izdelki, ki jih pokriva prisilna licenca, patentirani v državah uvoznicah, navedenih v zahtevi, se izdelki lahko izvozijo le, če so te države podelile prisilno licenco za uvoz, prodajo in/ali distribucijo teh izdelkov.