natgillin/translations-raw huggingface dataset:
Pristojni organ preveri, da količina izdelka, navedena v zahtevku, ne presega tiste, ki jo je (so jih) Svetovni trgovinski organizaciji sporočila (sporočile) članica STO uvoznica (članice STO uvoznice), in da je ob upoštevanju drugih prisilnih licenc, odrejenih v Skupnosti, skupna količina izdelka, ki je lahko proizveden za katero koli članico STO uvoznico, občutno ne presega količine, ki jo je Svetovni trgovinski organizaciji sporočila navedena članica.
The competent authority shall verify that the quantity of product cited in the application does not exceed that notified to the WTO by the importing WTO member(s), and that, taking into account other compulsory licences ordered in the Community, the total amount of product authorised to be produced for any importing WTO member does not significantly exceed the amount notified to the WTO by that member.
Pristojni organ preveri, da količina izdelka, navedena v zahtevku, ne presega tiste, ki jo je (so jih) Svetovni trgovinski organizaciji sporočila (sporočile) članica STO uvoznica (članice STO uvoznice), in da je ob upoštevanju drugih prisilnih licenc, odrejenih v Skupnosti, skupna količina izdelka, ki je lahko proizveden za katero koli članico STO uvoznico, ne presega količine, ki jo je Svetovni trgovinski organizaciji sporočila navedena članica.
The competent authority shall verify that the quantity of product cited in the application does not exceed that notified to the WTO by the importing WTO member(s), and that, taking into account other compulsory licences ordered in the Community, the total amount of product authorised to be produced for any importing WTO member does not exceed the amount notified to the WTO by that member.
To črtanje odpravlja nasprotje s členom 8(2).
The deletion removes a contradiction between this paragraph and Article 8(2).
Izdelki, proizvedeni v skladu s prisilno licenco, ne smejo preseči zahtevane potrebe, o kateri je bila obveščena STO.
The products manufactured under a compulsory licence must not exceed the amount needed as notified to the WTO.
Člen 6, odstavek 2a (novo)
Article 6, paragraph 2 a (new)
Prilagoditev je redakcijska sprememba glede na širši krog upravičenih držav in jasno izraža, da druge države v stiski nikakor ne morejo pridobiti prisilnih licenc pod drugačnimi pogoji kot članice STO.
The amendment adjusts the wording to reflect the expanded group of eligible countries and makes it clear that other countries in need should on no account be granted compulsory licences under different conditions from those applying to WTO members.
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 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 period of 30 days, except in situations of national emergency or other circumstances of extreme urgency or in cases of public non ‑commercial use pursuant to Article 31(b) of the TRIPS Agreement .
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.
Vpeljava točno določenega časovnega obdobja odpravlja pravno negotovost, povezano z določitvijo časovnega obdobja, glede na njegovo razumno trajanje.
Inserting a clearly specified period removes the legal uncertainty associated with defining what constitutes a reasonable period.
Časovno obdobje je za pogajanja za privolitev imetnika pravice razumno in preprečuje zamude pri podelitvi prisilne licence.
This is an appropriate time limit for negotiations with a view to authorisation from the right holder and avoids delays in the granting of a licence.
Količina patentiranega izdelka (patentiranih izdelkov) , ki ga (jih) je proizvedel po licenci, ne presega količine, ki je potrebna za izpolnitev potreb članice ali članic STO uvoznic ali drugih držav v stiski , 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 or other country or countries in need cited in the application .
Vsaka dodatna količina enakega patentiranega izdelka (enakih patentiranih izdelkov), proizvedenega (proizvedenih) v skladu z licenco, bo ponovno sporočena pristojnemu organu in STO;
Any additional amount of the same patented product(s) manufactured under the licence shall be the subject of renewed notification to the competent authority and the WTO .
Treba je predlagati le enostaven postopek in ne zahtevati novega postopka podeljevanja licenc za vsako rast količin enakega izdelka/enakih izdelkov.
Only a simple procedure, not a new licensing procedure, should be required in respect of any increase in the amount of identical product(s).
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 obsega vse stopnje, potrebne za uvoz, proizvodnjo in prodajo različnih sestavin zadevnega izdelka , vključno z aktivnimi sestavinami, da bi omogočili prodajo za izvoz članici ali članicam STO, navedenim v zahtevku, in v druge države v stiski .
The licence shall cover all of the stages necessary for the importation, manufacture and sale of the various ingredients of the product in question , including active ingredients, in order to enable the product to be sold for export to the WTO member or members or other country or countries in need cited in the application.
Državi, ki je prvotno naročila izdelek (izdelke), se v skladu z določili iz odstavka 6 Sklepa ponovni izvoz dovoli le, kadar gre za pogodbenico regionalnega trgovinskega sporazuma.
Re ‑export by the country that originally requested the product(s) shall be authorised in the case of parties to a regional trade agreement, pursuant to the provisions of paragraph 6 of the Decision .
Izrazje v izvirni uredbi ne omogoča uvoza vseh sestavin, potrebnih za proizvodnjo zdravil, ki jih obsega prisilna licenca.
The wording of the original regulation does not allow for the importing of all of the ingredients needed to manufacture medicines covered by a compulsory licence.
Brez podrobnosti je lahko Uredba neučinkovita.
Without this more precise wording, the regulation is likely to be ineffective.
Poleg tega sklep STO dovoljuje ponovni izvoz v države članice z regionalnim sporazumom.
Furthermore, the WTO Decision authorises re‑export to countries that are parties to a regional trade agreement.
S posebnim pakiranjem se izdelki razlikujejo od tistih, ki jih je proizvedel imetnik pravice, in/ali s posebnim barvanjem ali oblikovanjem izdelkov samih, če je takšno razlikovanje izvedljivo in nima vpliva ali skoraj nobenega vpliva na ceno .
The products shall be distinguished from those made by the right holder through special packaging and/or special colouring or shaping of the products themselves, provided that such distinction is feasible and has no, or almost no, impact on price .
To velja za vsa mesta, kjer se trži izdelek, proizveden po licenci.
This applies to all the places where the product made under the licence is marketed.
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 distribucijo v zadevno članico ali članice STO uvoznice ali drugo državo (države) v stiski.
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 WTO member or members or other country or countries in need concerned.
Treba je povzeti sestavo iz sklepa STO z dne 30. avgusta 2003 (člen 2(b)(ii)).
The wording contained in the WTO Decision of 30 August 2003 (Article 2(b)(ii)) should be used.
Ta predlog Komisije je veliko strožji in vzpostavlja dodatne zahteve, ki omejujejo pomoč sistema za prisilno licenciranje.
The wording proposed by the Commission is far more stringent and lays down additional requirements, which will limit the use of the compulsory licensing system.
Razen tega predloženi predlog spremembe upošteva dejstvo, da lahko vsaka opazna sprememba oblikovanja in/ali doziranja zdravila povzroči zmanjšanje, celo neučinkovitost zdravila, proizvedenega s prisilno licenco, kar je v nasprotju s ciljem za obravnavanje izrednih zdravstvenih razmer v državi uvoznici (državah uvoznicah).
Furthermore, the amendment proposed takes account of the fact that any significant change to the formulation and/or dose of a medicine could lead to a reduction in the effectiveness of, or even render ineffective, the medicine produced under a compulsory licence, contrary to the objective of dealing with an emergency health situation in the importing country or countries.
Treba je tudi nadomestiti izraz „prodaja“ z izrazom „distribucija“, da bi upoštevali javno uporabo zdravila s prisilno licenco za nekomercialne namene.
The word 'sale' should be replaced by 'distribution' in order to take account of public non-commercial use of the medicine under a compulsory licence.
Zaradi preprečevanja preusmerjanja trgovine je smiselno, da se farmacevtski izdelki, proizvedeni po licenci, jasno razlikujejo od farmacevtskih izdelkov imetnika pravice, in sicer povsod, kjer se tržijo.
In order to prevent trade diversion, it is advisable to differentiate clearly between products made under the licence and products made by the right holder wherever they are marketed.
Člen 8, odstavek 5, pododstavek 1, uvodni del
Article 8, paragraph 5, subparagraph 1, introductory part
Pred odpremo v članico ali članice STO uvoznice ali drugo državo (države) v stiski , navedene v zahtevku, pridobitelj licence na spletni strani objavi naslednje podatke:
Before shipment to the importing WTO member or members or other country or countries in need cited in the application, the licensee shall post on a website the following information:
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.
Člen 8, odstavek 5, pododstavek 1, točka a
Article 8, paragraph 5, subparagraph 1, 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 članice STO ali druge države v stiski, katerim jih dobavlja ;
(a) the quantities being supplied under the licence and the WTO members or other countries in need to which they are supplied
Člen 8, odstavek 5, pododstavek 2
Article 8, paragraph 5, subparagraph 2
Če je (so) izdelek (izdelki), ki ga (jih) pokriva prisilna licenca, patentiran (patentirani) v članicah STO uvoznicah ali drugih državah v stiski , navedenih v zahtevku, se izdelek (izdelki) lahko izvozi (izvozijo) le, če so te države podelile prisilno licenco za uvoz in distribucijo izdelkov.
If the product(s) covered by the compulsory licence are patented in the importing WTO members or other countries in need cited in the application, the product(s) shall only be exported if those countries have issued a compulsory licence for the import and distribution of the products.
Predlog spremembe za uskladitev s predlogom spremembe člena 8(4).
Amendment consistent with the amendment to Article 8(4).
Pridobitelj licence da na zahtevo na voljo vse poslovne knjige in evidence imetniku pravice in 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 the right holder and 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.
Zaradi spodbujanja preglednosti in možnosti nadzora je smiselno, da se dostop do vodenja knjig pridobitelja licence zagotovi na željo in po potrebi tudi podjetjem in proizvajalcem, ki imajo licenco.
In order to promote transparency and increase the possibilities for monitoring, it would be useful to make the licensee's accounting records available to the firms and manufacturers holding the licence as well, on request and where necessary.
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 ali druge države v stiski , 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 or other country in need , and shall retain such records for at least three years.
Najpozneje 14 dni po izvozu je treba na zahtevo zagotoviti vpogled v listine tudi zadevnemu imetniku pravice.
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.
V skladu s predlogom spremembe 4 se krog najmanj razvitih držav razširi čez meje STO.
The group of LDCs has been enlarged beyond the circle of WTO members in line with Amendment 4.
Da bi se izboljšal nadzor tudi, kar zadeva proizvajalce, je smiselno, da se vpogled v dokumente v zvezi z izvozom in carino zagotovi tudi imetnikom pravice.
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.
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 ali drugim državam v stiski .
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.
Pri določitvi pristojni organ upošteva tudi položaj, ki ga ima članica STO uvoznica po indeksu človekovega razvoja ZN (Human Development Index – 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).
Formulacija pravičnega nadomestila je preveč nedoločna.
The reference to adequate remuneration is excessively vague.
S sklicevanjem na indeks HDI se povečata predvidljivost in pravna varnost pri določitvi višine nadomestila.
The reference to the HDI index will make it easier to predict the amount of remuneration and ensure greater legal certainty.
Člen 10, odstavek 1, pododstavek 2, točka f a (novo)
Article 10, paragraph 1, subparagraph 2, point f a (new)
(fa) značilnosti iz člena 8(4), po katerih se razlikujejo izdelki, proizvedeni po licenci, od tistih, ki jih je proizvedel imetnik pravice.
( fa ) the features described in Article 8(4) which distinguish the products made under the licence from those made by the right holder.
Posredovanje značilnosti, po katerih se razlikujejo izdelki, Komisiji povečuje preglednost in pomaga pri preprečevanju preusmerjanja trgovine in ponovnega uvoza .
Notifying the distinguishing features to the Commission will increase transparency and help prevent trade diversion and reimporting.
Komisija pripravi za izmenjavo podatkov med pristojnimi organi, imetniki pravice in vlagatelji osrednjo spletno stran, na kateri se objavijo potrebni podatki.
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.
Odstavek 1 se ne uporablja v primeru ponovnega izvoza v članico STO uvoznico, navedeno v zahtevku ter opredeljeno na embalaži in dokumentaciji, povezani z izdelkom, ali v primeru uvedbe tranzitnega postopka ali postopka carinskega skladiščenja, vnosa v prosto cono ali prosto skladišče blaga za namene ponovnega izvoza v navedeno članico STO uvoznico.
Paragraph 1 shall not apply in the case of re-export to the importing WTO member 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.
Odstavek 1 se ne uporablja v primeru ponovnega izvoza v članico STO uvoznico ali drugo državo v stiski , navedeno v zahtevku ter opredeljeno na embalaži in dokumentaciji, povezani z izdelkom, ali v primeru uvedbe tranzitnega postopka ali postopka carinskega skladiščenja, vnosa v prosto cono ali prosto skladišče blaga za namene ponovnega izvoza v navedeno članico STO uvoznico ali drugo državo v stiski .
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 .
Kadar se upravičeno sumi, da se izdelki, za katere se uporablja prisilna licenca po tej uredbi, v nasprotju s členom 11(1) uvažajo v Skupnost, carinski organi prekinejo sprostitev zadevnih izdelkov ali jih zadržijo za toliko časa, kolikor je potrebno za pridobitev odločbe zadevnega nacionalnega organa o stanju blaga.
Where there is reason to suspect that, contrary to Article 11(1), products subject of a compulsory licence under this Regulation are being imported into the Community, customs authorities shall suspend the release of, or detain, the products concerned for the time necessary to obtain a decision of the relevant national authority on the character of the merchandise.
Kadar se upravičeno sumi, da se izdelki, za katere se uporablja prisilna licenca po tej uredbi, v nasprotju s členom 11(1) uvažajo v Skupnost, carinski organi prekinejo sprostitev zadevnih izdelkov ali jih zadržijo za toliko časa, kolikor je potrebno za pridobitev odločbe pristojnega organa o stanju blaga.
Where there is reason to suspect that, contrary to Article 11(1), products subject of a compulsory licence under this Regulation are being imported into the Community, customs authorities shall suspend the release of, or detain, the products concerned for the time necessary to obtain a decision of the competent authority on the character of the merchandise.
Pristojni organ ima pravico, da na lastno pobudo ali na utemeljeno zahtevo imetnika pravice ali pridobitelja licence preveri, ali obstaja tak sum.
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.
O prekinitvi sprostitve ali zadržanju izdelkov so takoj obveščeni pristojni organ in proizvajalec ali izvoznik zadevnih izdelkov, prejeti morajo tudi vse razpoložljive podatke glede zadevnih izdelkov.
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.
Določila v zvezi s prevzemom stroškov zaradi nezakonitega uvoza sumljivih ali potrjenih izdelkov so premeščena v odstavek 4 (a) (novo), da bi se izognili ponavljanju določil iz odstavkov 3 in 4 tega člena.
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.
Člen 12, odstavek 4 a (novo)
Article 12, paragraph 4 a (new)
Postopek prekinitve, zadržanja blaga ali zaplenitve se izvaja na stroške uvoznika.
The suspension or detention or seizure procedure for the products is carried out at the expense of the importer.
Določila v zvezi s prevzemom stroškov zaradi nezakonitega uvoza sumljivih ali potrjenih izdelkov so premeščena v odstavek 4 (a) (novo), da bi se izognili ponavljanju določil iz odstavkov 3 in 4 tega člena.
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.
Če se po nadaljnjem nadzoru pristojnega organa ugotovi, da izdelki, katerih sprostitev so carinski organi prekinili ali so jih zadržali, ne kršijo prepovedi iz člena 11(1), carinski organ te izdelke sprosti prejemniku pod pogojem, da so bile opravljene vse carinske formalnosti.
Where products suspended for release or detained by customs authorities subsequent to further control by the competent authority are found not to violate the prohibition in Article 11(1), the customs authority shall release the products to the consignee, provided that all customs formalities have been complied with.
Kadar zahtevek za prisilno licenco zadeva zdravilo, odobreno v skladu s členom 6 Direktive 2001/83/ES, se določbe člena 24(4) in (5) ter člena 14(4) in (5) Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta ne uporabljajo.
Where the application for a compulsory licence concerns a medicinal product authorised in accordance with Article 6 of Directive 2001/83/EC, the provisions of Article 24(4) and (5) and of Article 14(4) and (5) of Regulation (EC) No 726/2004 of the European Parliament and the Council
Obstoječi osnutek Komisije je poskus, da se določi ureditev za dostop na trg v Evropski uniji na področju prisilnega licenciranja.
The Commission’s draft regulation seeks to prescribe rules governing marketing approval in the European Union in the context of compulsory licences.