natgillin/translations-raw huggingface dataset:
Vlagatelj mora pristojnemu organu zadovoljivo predložiti dokazila, da si je prizadeval za pridobitev pooblastila od imetnika pravice pod razumnimi komercialnimi pogoji in da v razumnem časovnem obdobju takšno prizadevanje ni bilo uspešno.
The applicant shall provide evidence to satisfy the competent authority that he has made efforts to obtain authorisation from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time .
Vlagatelj pristojnemu organu predloži dokazila, da si je prizadeval za pridobitev pooblastila od imetnika pravice pod razumnimi komercialnimi pogoji in da takšno prizadevanje ni bilo uspešno v obdobju 30 dni, razen v primeru izrednega stanja na nacionalni ravni, drugih okoliščin skrajne nuje ali v primeru javne uporabe za nekomercialne namene v skladu s točko (b) člena 31 Sporazuma TRIP.
The applicant shall provide evidence to satisfy the competent authority that he has made efforts to obtain authorisation from the right holder and that such efforts have not been successful within a period of thirty days before submitting the application, except 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.
Vlagatelj si mora prizadevati, da pridobi pooblastilo „pod razumnimi komercialnimi pogoji“.
Efforts by the applicant are required to obtain authorisation on “reasonable commercial terms and conditions”.
Čeprav se bodo v primeru podjetij, ki želijo dobavljati zahtevane izdelke, pojavile poslovne koristi, lahko obstajajo tudi primeri, v katerih se lahko izvozna licenca uporablja za nepridobitne namene.
Although commercial interest will be present in the case of companies willing to supply required products, there might be cases in which the license for export may be used for non-profit purposes.
„ Razumno časovno obdobje“ za prejšnja pogajanja z imetnikom patenta ni določeno .
The ‘reasonable period of time’ for the prior negotiation with a patentee is not specified.
Negotovost, ki jo ohranja ta določba, bo mogoče sprožila dolga pogajanja in sodne postopke za določitev, ali je razumno časovno obdobje poteklo pred zahtevkom prisilne licence.
The uncertainty left by this provision will possibly invite drawn-out negotiations and court proceedings to determine whether a reasonable period of time has elapsed before requesting a compulsory licence.
To lahko zelo odvrača morebitne uporabnike sistema.
This may constitute a significant disincentive to prospective users of the system.
Dejanska opredelitev lahko ima pozitivne učinke na zagotavljanje večje pravne varnosti.
A concrete specification could have positive effects by providing more legal certainty.
Točka b) člena 31 Sporazuma o TRIP v nekaterih pogojih dovoljuje kršenje obveznosti, da bi se pridobilo predhodno dovoljenje za imetnika patenta (patentov) ali dodatnega certifikata (dodatnih certifikatov).
Article 31(b) of the TRIPS Agreement authorises, under certain conditions, waiving the requirement to obtain prior authorisation from the holder of the patent(s) or supplementary certificate(s).
Uredba Skupnosti v zvezi z podeljevanjem prisilnih licenc ne sme prekoračiti določil, sprejetih na ravni STO, s tveganjem, da se na ravni Skupnosti in v Evropski uniji onemogoči pomoč sistema za prisilno licenciranje .
The Community rules on compulsory licensing should not go beyond the provisions adopted and accepted at the WTO level; otherwise there is a risk that it will become impossible at the Community level and within the European Union to use the compulsory licensing system.
Podeljena licenca je neizključna in neprenosljiva.
The licence granted shall be non-exclusive and non-assignable.
Vsebuje posebne pogoje, določene v odstavkih 2 do 8 , ki jih mora izpolniti pridobitelj licence.
It shall contain the specific conditions set out in paragraphs 2 to 8 to be fulfilled by the licensee.
Vsebuje posebne pogoje, določene v odstavkih 2 do 6 , ki jih mora izpolniti pridobitelj licence.
It shall contain the specific conditions set out in paragraphs 2 to 6 to be fulfilled by the licensee.
Glej predloga spremembe 32 in 33.
See amendments 32 and 33.
Količina patentiranega (patentiranih) izdelka (izdelkov), ki ga (jih) je proizvedel po licenci, ne presega količine, ki je potrebna za izpolnitev potreb članice ali članic STO uvoznic, navedenih v zahtevku.
The amount of patented product(s) manufactured under the licence shall not exceed what is necessary to meet the needs of the importing WTO member or members cited in the application.
Količina patentiranega (patentiranih) izdelka (izdelkov), proizvedenega (proizvedenih) po licenci, ne presega količine, ki je potrebna za izpolnitev potreb države ali držav uvoznic, navedenih v zahtevku ; pristojni organ odobri dovoljenje za proizvodnjo dodatne količine istega izdelka (izdelkov) po licenci v roku 8 dni po vložitvi zahtevka z utemeljitvijo, zakaj so potrebne dodatne količine izdelka.
The amount of patented 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 ; authorisation to produce any additional amount of the same patented product(s) manufactured under the licence shall be granted within 8 days by the competent authority on submission of an application stating the reasons for which additional production is necessary.
Kakršna koli dodatna količina istega patentiranega (patentiranih) izdelka (izdelkov), proizvedenega (proizvedenih) po licenci se ponovno sporoči pristojnemu organu, Komisiji in STO.
Any additional amount of the same patented product(s) manufactured under the licence shall be notified to the competent authority, the Commission and the WTO .
Licenca je strogo omejena na dejanja proizvodnje zadevnega izdelka in prodaje za izvoz članici ali članicam STO , navedenim v zahtevku.
The licence shall be strictly limited to the acts of manufacturing the product in question and selling for export to the WTO member or members cited in the application.
Noben izdelek, narejen po prisilni licenci se ne ponudi za prodajo ali da na trg v kateri koli drugi državi razen v članici (članicah) STO, ki je (so) navedena (navedene) v zahtevku.
No product made under the compulsory licence shall be offered for sale or put on the market in any country other than the WTO member(s) cited in the application .
Licenca je strogo omejena na vsa dejanja, ki so potrebna za namene proizvodnje in distribucije farmacevtskega izdelka in njegov izvoz državi ali državam uvoznicam, navedenim v zahtevku , ali državi v razvoju ali najmanj razviti državi, ki je članica regionalnega trgovinskega sporazuma, če najmanj polovico sedanjih članic sestavljajo države, ki so uvrščene na seznam najmanj razvitih držav Združenih narodov, v obsegu, ki je potreben za zagotavljanje, da se farmacevtski izdelek, ki se proizvaja ali uvaža v skladu s prisilno licenco v navedeni državi, izvaža na trge drugih držav v razvoju ali najmanj razvitih držav, ki so članice regionalnega trgovinskega sporazuma, ki se ukvarjajo z zadevnimi težavami v zvezi z zdravjem .
The licence shall be strictly limited to all acts necessary for the purposes of production and distribution of a pharmaceutical product and its export to the importing country or countries cited in the application or to a developing or least-developed country party to a regional trade agreement, at least half of the current membership of which is made up of countries presently on the United Nations list of least-developed countries, to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that country to be exported to the markets of those other developing or least ‑developed country parties to the regional trade agreement that share the health problem in question .
Osnutek Uredbe dosledno omeji obseg licence na proizvodnjo in prodajo.
The draft Regulation limits the scope of the licence strictly to the acts of manufacturing and selling.
Sklep STO je širši, ker se odpoveduje obvezi iz člena 31(f) TRIP „v obsegu, ki je potreben za namene proizvodnje farmacevtskega izdelka/farmacevtskih izdelkov in njen izvoz [...]“.
The WTO Decision is broader, as it waives TRIPS Article 31(f) obligation ‘to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export [...]’.
Proizvodnja farmacevtskih izdelkov lahko zahteva uvoz farmacevtskih učinkovin (API).
The production of a pharmaceutical product may require the importation of active pharmaceutical ingredients (APIs).
Dejansko je farmacevtska industrija EU odvisna od velikega obsega farmacevtskih učinkovin, ki se proizvajajo zunaj EU in se uvažajo tja za opredelitev farmacevtskih izdelkov.
In fact, the EU pharmaceutical industry depends to a significant extent on APIs produced outside the EU and imported therein for the formulation of pharmaceutical products.
Odstavek 6 Sklepa STO dovoljuje ponovni izvoz izdelkov, ki se uvažajo v skladu s sistemom, drugim članicam regionalnega trgovinskega sporazuma, najmanj polovico članstva katerih sestavljajo najmanj razvite države.
Paragraph 6 of the WTO Decision permits the re-exportation of products imported under the system to other members of a regional trade agreement at least half of the membership of which is made up of LDCs .
V teh primerih držav, v katere se ponovno izvažajo izdelki, ni treba omeniti v obvestilu države uvoznice.
In these cases, the countries to which re-exportation takes place need not to have been mentioned in the notification made by the importing country.
Izdelki, narejeni po licenci, so jasno prepoznavni s posebnim označevanjem, ki nakazuje, da so bili proizvedeni v skladu s to uredbo.
Products made under the licence shall be clearly identified, through specific labelling or marking, as being produced pursuant to this Regulation.
S posebnim pakiranjem se izdelki razlikujejo od tistih, ki jih je proizvedel imetnik pravice.
The products shall be distinguished from those made by the right holder through special packaging.
Embalaža in katera koli povezana literatura mora označevati, da velja za izdelek prisilna licenca po tej uredbi, navajati ime pristojnega organa in identifikacijsko referenčno številko ter jasno navajati, da je izdelek namenjen izključno za izvoz in prodajo v zadevno članico ali članice STO uvoznice.
The packaging and any associated literature shall bear an indication that the product is subject of 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 sale in the importing WTO member or members concerned.
Razen če vlagatelj dokaže, da takšno razlikovanje ni izvedljivo ali ima pomemben vpliv na ceno, se zahtevata tudi posebno barvanje ali oblikovanje izdelkov samih.
Unless the applicant proves that such distinction is not feasible or has a significant impact on price, special colouring or shaping of the products themselves shall also be required.
S posebnim pakiranjem in/ali posebnim barvanjem/oblikovanjem, pod pogojem, da je takšno razlikovanje izvedljivo in nima pomembnega vpliva na ceno, se izdelki razlikujejo od tistih, ki jih je proizvedel imetnik pravice.
The products shall be distinguished from those made by the right holder through special packaging and/or special colouring/shaping, provided that such distinction is feasible and does not have a significant impact on price .
Embalaža in katera koli povezana literatura mora označevati, da velja za izdelek prisilna licenca po tej uredbi, navajati ime pristojnega organa in identifikacijsko referenčno številko ter jasno navajati, da je izdelek namenjen izključno za izvoz in prodajo v zadevno držav o ali države uvoznice.
The packaging and any associated literature shall bear an indication that the product is subject of 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.
Carinskim organom države članice so na voljo podrobnosti o lastnostih izdelka.
Details of the product characteristics shall be made available to the customs authorities of the Member States.
Sklep STO zahteva, da dobavitelji ločujejo izdelke „s posebnim pakiranjem in/ali posebnim barvanjem/oblikovanjem, pod pogojem, da je takšno razlikovanje izvedljivo in nima pomembnega vpliva na ceno“.
The WTO Decision requires suppliers to distinguish their products ‘through special packaging and/or special colouring/shaping of the products themselves, provided that such distinction is feasible and does not have a significant impact on price’.
To pomeni, da je razlikovanje mogoče s posebnim pakiranjem ali posebnim barvanjem/oblikovanjem, po izbiri dobavitelja, pod pogojem, da je izvedljivo in nima pomembnega vpliva na ceno.
This means that differentiation can be satisfied through special packaging or special colouring/shaping, at the option of the supplier, provided it is feasible and does not have a significant impact on price.
Osnutek Uredbe zahteva posebno barvanje ali oblikovanje, „razen če vlagatelj dokaže, da takšno razlikovanje ni izvedljivo ali ima pomemben vpliv na ceno“.
The draft Regulation makes special colouring or shaping mandatory ‘unless the applicant proves that such distinction is not feasible or has a significant impact on price’.
Ta določba jasno presega Sklep STO, ker bo obveznost dobavitelja, da dokaže, da spreminjanje barve ali oblike ni izvedljivo ali ima pomemben vpliv na ceno.
This provision clearly goes beyond the WTO Decision, as the supplier will be obliged to prove that changing colour or shape is not feasible or has a significant impact on price.
S pomočjo teh podatkov bodo carinski organi prepoznali izdelke, ki so predmet kršitve.
This will aid Customs officials in identifying infringing products.
Člen 8, odstavek 5, uvodni del
Article 8, paragraph 5, introductory part
Pred odpremo v članico ali članice STO uvoznice, navedene v zahtevku, pridobitelj licence na spletni strani objavi naslednje podatke:
Before shipment to the importing WTO member or members cited in the application, the licensee shall post on a website the following information:
Pred odpremo v državo ali države uvoznice, navedene v zahtevku, pridobitelj licence na spletni strani objavi naslednje podatke:
Before shipment to the importing country or countries cited in the application, the licensee shall post on a website the following information:
Člen 8, odstavek 5, točka (a)
Article 8, paragraph 5, point (a)
(a) količine, dobavljene po licenci, in članice STO , katerim jih dobavlja
(a) the quantities being supplied under the licence and the WTO members to which they are supplied
(a) količine, dobavljene po licenci, in države uvoznice , katerim jih dobavlja
(a) the quantities being supplied under the licence and the importing countries to which they are supplied;
Člen 8, odstavek 5, pododstavek 4
Article 8, paragraph 5, subparagraph 4
Naslov spletne strani mora biti sporočen pristojnemu organu.
The website address shall be communicated to the competent authority.
Naslov spletne strani mora biti posredovan pristojnemu organu, Komisiji in imetnikom pravice .
The website address shall be communicated to the competent authority , the Commission and the right holder.
Komisija objavi naslov na svoji osrednji spletni strani.
The Commission shall post the address on its central website .
Prilagoditev je redakcijska sprememba glede na razširjen krog upravičenih držav.
This amendment adjusts the wording to reflect the expanded group of eligible countries.
Zaradi spodbujanja preglednosti in nadzora uporabe prisilnih licenc je smiselno, da se o spletni strani, na kateri so objavljeni podatki, obvesti tudi imetnika pravice in da se naslov objavi na osrednji strani Komisije.
In order to promote transparency and checks on the use of compulsory licences, it would be useful to notify the right holder of the website containing the information to be made public, and to post the address on the central Commission web page.
Če je (so) izdelek (izdelki), ki ga (jih) pokriva prisilna licenca, patentiran (patentirani) v članicah STO uvoznicah, navedenih v zahtevku, se izdelek (izdelki) lahko izvozi (izvozijo) le, če so te države podelile prisilno licenco za uvoz in prodajo izdelkov.
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.
Če je (so) izdelek (izdelki), ki ga (jih) pokriva prisilna licenca, patentiran (patentirani) v državah uvoznicah, navedenih v zahtevku, se izdelek (izdelki) lahko izvozi (izvozijo) le, če so te države podelile prisilno licenco za uvoz , prodajo in/ali razdeljevanje izdelkov.
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.
Osnutek Uredbe pogojuje izvažanje s predhodno odobritvijo „prisilne licence za uvoz in prodajo“ v državi uvoznici.
The draft Regulation conditions exportation upon the prior granting of ‘a compulsory licence for the import and sale’ in the importing country.
Vseeno se v več primerih izdelki, ki so predmet prisilne licence, ne prodajajo, ampak brezplačno razdelijo (npr. javne bolnišnice ali nevladne organizacije).
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).
Člen 8, odstavek 7
Article 8, paragraph 7
Pridobitelj licence vodi popolne in natančne poslovne knjige ter evidenco vseh količin proizvedenega izdelka in vseh poslov, ki se pri tem opravijo.
The licensee shall keep complete and accurate books and records of all quantities of product manufactured and of all dealings therein.
Pridobitelj licence da na zahtevo na voljo vse poslovne knjige in evidence neodvisni osebi, o kateri sta se sporazumeli stranki ali jo je drugače imenoval pristojni organ, z edinim namenom, da preveri, ali so bili izpolnjeni pogoji licence, predvsem tisti glede končnega namembnega kraja izdelkov.
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.
Ta odstavek obvezuje dobavitelje, da vodijo popolne in natančne poslovne knjige ter pristojnim osebam dovolijo dostop do njih.
This paragraph obliges suppliers to keep complete and accurate books and to permit access thereto to authorised persons.
Sklep STO ne predpisuje tega pogoja.
This condition is not imposed by the WTO Decision.
Ob upoštevanju različnih ukrepov v osnutku Uredbe je ta dodatna obveznost nepotrebna in lahko dodatno odvrne morebitne dobavitelje, ki ne želijo neposrednega nadzorovanja svojih komercialnih poslov s strani države.
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.
Imetnik patenta ima vedno pravico zahtevati revizijo knjig prisilne licence, da preveri posle na podlagi licence.
The patentee will always have the right to request the review of the compulsory licensee’s books to check his operations under the license.
Pridobitelj licence zagotovi dokazilo o izvozu izdelka z deklaracijo o izvozu, ki jo je overil zadevni pristojni organ, in dokazilo o uvozu ali dajanju na trg, ki ga je overil organ članice STO uvoznice, in hraniti takšno evidenco vsaj tri leta.
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 zahtevo mora ta dokazila predložiti pristojnemu organu.
Upon request these proofs must be supplied to the competent authority.
Ta odstavek zahteva, da dobavitelj zagotovi dokazilo o izvozu.
This paragraph requires the supplier to provide proof of exportation.
Pridobitelj licence je odgovoren za plačilo pravičnega nadomestila imetniku pravice, kot ga določi pristojni organ ob upoštevanju ekonomske vrednosti uporabe, ki je bila odobrena po licenci zadevni članici ali članicam STO uvoznicam.
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) concerned.
Pridobitelj licence je odgovoren za plačilo pravičnega nadomestila imetniku pravice, kot ga določi pristojni organ ob upoštevanju ekonomske vrednosti uporabe, ki je bila odobrena po licenci zadevni državi ali državam uvoznicam.
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.
Pri določanju tega je treba upoštevati človekoljubne in nekomercialne vzroke, ki so temelj za izdajo licence.
In making this determination, the humanitarian and non-commercial reasons underlying the issue of the licence must be considered.
Znesek primernega nadomestila se določi v skladu s smernicami Komisije.
The amount of the adequate remuneration shall be determined in accordance with guidelines to be established by the Commission.
Države članice Komisiji v šestih mesecih po začetku veljavnosti te uredbe sporočijo stopnje nadomestil in predpisano formulo, ki jo bodo uporabili pri izračunu primernega nadomestila.
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.
Pomanjkanje navodil v zvezi z nadomestili, ki jih je treba plačati, ustvarja pomembno negotovost za morebitne uporabnike sistema (možne proizvodne družbe in uvoznike farmacevtskih izdelkov) in lahko poveča število sodnih postopkov glede na to, ali je določeno nadomestilo primerno.
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.
Da se izboljša predvidljivost določitev na nacionalni ravni, mora osnutek Uredbe vključevati navodila, katere dejavnike je treba upoštevati pri določanju primernega nadomestila.
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.
Če kateri koli od pogojev, določenih v členu 5(3) in (4) ter členih 6, 7 in 8, ni izpolnjen, pristojni organ zahtevek zavrne.
The competent authority shall refuse an application if any of the conditions set out in Article 5 (3) and (4) and Articles 6, 7 and 8 is not met.
Pred zavrnitvijo zahtevka nudi pristojni organ vlagatelju možnost, da je zaslišan in da položaj popravi.
Before refusing an application, the competent authority shall give the applicant an opportunity to rectify the situation and to be heard.
Če kateri koli od pogojev, določenih v členu 5(3) in členih 6, 7 in 8, ni izpolnjen, pristojni organ zahtevek zavrne.
The competent authority shall refuse an application if any of the conditions set out in Article 5 (3) and Articles 6, 7 and 8 is not met.