natgillin/translations-raw huggingface dataset:
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.
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.
Predhodna pogajanja
Prior negotiation
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 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.
Pogoj iz odstavka 1 se ne uporablja v razmerah izrednega stanja na nacionalni ravni ali drugih skrajno nujnih okoliščinah, ali v primerih javne nekomercialne uporabe v skladu s točko (b) člena 31 Sporazuma TRIPS.
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.
Pogoji prisilne licence
Compulsory licence conditions
Podeljena licenca ni prenosljiva, razen za tisti del podjetja ali njegove poslovne dejavnosti, ki uporablja licenco, in ni izključna.
The licence granted shall be non-assignable, except with that part of the enterprise or goodwill which enjoys the licence, and non-exclusive.
Vsebuje posebne pogoje, določene v odstavkih 2 do 9, ki jih mora izpolniti pridobitelj licence.
It shall contain the specific conditions set out in paragraphs 2 to 9 to be fulfilled by the licensee.
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 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.
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.
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.
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.
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.
Izdelki, narejeni po licenci, so jasno opredeljeni s posebno označitvijo, iz katere je razvidno, 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.
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 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.
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.
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.
Podrobnosti o lastnostih izdelkov so na voljo carinskim organom držav članic.
Details of the product characteristics shall be made available to the customs authorities of the Member States.
Pred odpremo v državo ali države uvoznice, navedene v zahtevi, 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:
količine, dobavljene po licenci, in države uvoznice, katerim jih dobavlja;
the quantities being supplied under the licence and the importing countries to which they are supplied;
razpoznavne značilnosti zadevnega izdelka ali izdelkov.
the distinguishing features of the product or products concerned.
Naslov spletne strani se sporoči pristojnemu organu.
The website address shall be communicated to the competent authority.
Pristojni organ lahko na zahtevo imetnika pravice ali na lastno pobudo, če nacionalna zakonodaja pristojnemu organu dovoljuje ukrepanje na lastno pobudo, zahteva dostop do poslovnih knjig in evidenc, ki jih vodi pridobitelj licence, zgolj z namenom, da preveri, ali so bili izpolnjeni pogoji licence, predvsem tisti glede končnega namembnega kraja izdelkov.
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, request access to books and records kept by the licensee, 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.
Knjige in evidence vsebujejo dokazilo o izvozu izdelka z deklaracijo o izvozu, ki jo je overil zadevni carinski organ, in dokazilo o uvozu, ki ga je izdal eden od organov iz člena 6(3)(f).
The books and records shall include proof of exportation of the product, through a declaration of exportation certified by the customs authority concerned, and proof of importation from one of the bodies referred to in Article 6(3)(f).
Pridobitelj licence je odgovoren za plačilo primernega nadomestila imetniku pravice, kakor ga določi pristojni organ, in sicer:
The licensee shall be responsible for the payment of adequate remuneration to the rights-holder as determined by the competent authority as follows:
v primerih iz člena 9(2) je nadomestilo v višini največ 4 % celotne cene, ki jo plača država uvoznica ali se plača v njenem imenu;
in the cases referred to in Article 9(2), the remuneration shall be a maximum of 4% of the total price to be paid by the importing country or on its behalf;
v vseh drugih primerih se nadomestilo določi ob upoštevanju ekonomske vrednosti uporabe, ki je bila odobrena po licenci zadevni državi ali državam uvoznicam, kot tudi humanitarnih in nekomercialnih okoliščin pri podelitvi licence.
in all other cases, the remuneration shall be determined taking into account the economic value of the use authorised under the licence to the importing country or countries concerned, as well as humanitarian or non-commercial circumstances relating to the issue of the licence.
Pogoji licence ne posegajo v način distribucije v državi uvoznici.
The licence conditions are without prejudice to the method of distribution in the importing country.
Distribucijo lahko na primer izvaja kateri koli organ iz člena 6(3)(f) pod komercialnimi ali nekomercialnimi pogoji, tudi popolnoma brezplačno.
Distribution may be carried out for example by any of the bodies listed in Article 6(3)(f) and on commercial or non-commercial terms including completely without charge.
Zavrnitev zahteve
Refusal of the application
Pristojni organ zahtevo zavrne, če katerikoli od pogojev, določenih v členih 6 do 9, ni izpolnjen ali če zahteva ne vsebuje potrebnih sestavin, ki pristojnemu organu omogočajo podelitev licence v skladu s členom 10.
The competent authority shall refuse an application if any of the conditions set out in Articles 6 to 9 are not met, or if the application does not contain the elements necessary to allow the competent authority to grant the licence in accordance with Article 10.
Pred zavrnitvijo zahteve pristojni organ vložniku omogoči, da se o tem izjavi in popravi položaj.
Before refusing an application, the competent authority shall give the applicant an opportunity to rectify the situation and to be heard.
Ko je prisilna licenca podeljena, država članica s posredovanjem Komisije uradno obvesti Svet za TRIPS o podelitvi licence in posebnih pogojih v zvezi z njo.
When a compulsory licence has been granted, the Member State shall notify the Council for TRIPS through the intermediary of the Commission of the grant of the licence, and of the specific conditions attached to it.
Predloženi podatki vsebujejo naslednje podrobnosti o licenci:
The information provided shall include the following details of the licence:
ime in naslov pridobitelja licence;
the name and address of the licensee;
zadevni izdelek ali zadevne izdelke;
the product or products concerned;
količino, ki se bo dobavila;
the quantity to be supplied;
državo ali države, v katere se bodo izdelki izvozili;
the country or countries to which the product or products are to be exported;
trajanje licence;
the duration of the licence;
naslov spletne strani iz člena 10(6).
the address of the website referred to in Article 10(6).
Prepoved uvoza
Prohibition of importation
Izdelke, proizvedene po prisilni licenci, ki je bila podeljena v skladu s Sklepom in/ali to uredbo, je prepovedano uvažati v Skupnost za namene sprostitve v prosti promet, ponovnega izvoza, uvedbe odložnih postopkov ali vnosa v prosto cono ali prosto skladišče blaga.
The import into the Community of products manufactured under a compulsory licence granted pursuant to the Decision and/or this Regulation for the purposes of release for free circulation, re-export, placing under suspensive procedures or placing in a free zone or free warehouse shall be prohibited.
Odstavek 1 se ne uporablja v primeru ponovnega izvoza v državo uvoznico, navedeno v zahtevi ter opredeljeno na embalaži in spremljajoči dokumentaciji izdelka, ali v primeru uvedbe tranzitnega postopka ali postopka carinskega skladiščenja, vnosa v prosto cono ali prosto skladišče blaga za namene ponovnega izvoza v navedeno državo uvoznico.
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.
Ukrepi carinskih organov
Action by customs authorities
Države članice zagotovijo, da je za preverjanje ali tak uvoz poteka pristojen določen organ.
Member States shall ensure that a body has the authority to review whether such importation is taking place.
Ob izteku tega obdobja se izdelki sprostijo, pod pogojem, da so bile opravljene vse carinske formalnosti.
Upon expiry of that period, the products shall be released, provided that all customs formalities have been complied with.
Pristojni organ, imetnik pravice in proizvajalec ali izvoznik zadevnih izdelkov, so nemudoma obveščeni o prekinitvi sprostitve ali zadržanja izdelkov in prejmejo tudi vse razpoložljive podatke glede zadevnih izdelkov.
The competent authority, the rights-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 be given all information available with respect to the products concerned.
Ustrezno se upoštevajo nacionalne določbe o varstvu osebnih podatkov, poslovne in industrijske skrivnosti ter poklicne in upravne zaupnosti.
Due account shall be taken of national provisions on the protection of personal data and commercial and industrial secrecy and professional and administrative confidentiality.
Uvoznik, kadar je primerno tudi izvoznik, ima na voljo dovolj možnosti, da pristojnemu organu predloži podatke, ki se mu v zvezi z izdelki zdijo primerni.
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.
Če je potrjeno, da so bili izdelki, katerih sprostitev so carinski organi prekinili ali so jih zadržali, namenjeni uvozu v Skupnost v nasprotju s prepovedjo iz člena 13(1), pristojni organ zagotovi, da se ti izdelki zasežejo in odstranijo v skladu z nacionalno zakonodajo.
If it is confirmed that products suspended for release or detained by customs authorities were intended for import into the Community contrary to the prohibition in Article 13(1), the competent authority shall ensure that the products are seized and disposed of in accordance with national legislation.
Postopek prekinitve sprostitve, zadržanja ali zasega blaga se izvaja na stroške uvoznika.
The procedure of suspension or detention or seizure of the goods shall be carried out at the expense of the importer.
Če navedenih stroškov od uvoznika ni mogoče izterjati, se jih lahko v skladu z nacionalno zakonodajo izterja od katere koli druge osebe, odgovorne za poskus nezakonitega uvoza.
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.
Če se kasneje ugotovi, da izdelki, katerih sprostitev so carinski organi prekinili ali so jih zadržali, ne kršijo prepovedi iz člena 13(1), jih carinski organ sprosti in izroči prejemniku, pod pogojem, da so bile opravljene vse carinske formalnosti.
If the products suspended for release or detained by customs authorities are subsequently found not to violate the prohibition in Article 13(1), the customs authorities shall release the products to the consignee, provided that all customs formalities have been complied with.
Pristojni organ Komisijo obvesti o vsaki odločitvi glede zasega ali uničenja, sprejete v skladu s to uredbo.
The competent authority shall inform the Commission of any decisions on seizure or destruction adopted pursuant to this Regulation.
Izjema za osebno prtljago
Personal luggage exception
Člena 13 in 14 se ne uporabljata za blago nekomercialne narave, ki je v osebni prtljagi potnikov, ki ga ti uporabljajo za osebno rabo, v mejah, ki veljajo za oprostitev plačila carine.
Articles 13 and 14 shall not apply to goods of a non-commercial nature contained in travellers' personal luggage for personal use within the limits laid down in respect of relief from customs duty.
Preklic ali preverjanje licence
Termination or review of the licence
Ob upoštevanju zadostnega varstva zakonitih interesov pridobitelja licence se lahko prisilna licenca, ki je podeljena v skladu s to uredbo, prekliče z odločitvijo pristojnega organa ali enega izmed organov, omenjenih v členu 17, če pridobitelj licence ne spoštuje pogojev licence.
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 in Article 17 if the licence conditions are not respected by the licensee.
Pristojni organ je pooblaščen, da na utemeljeno zahtevo imetnika pravice ali pridobitelja licence preveri, ali se spoštujejo pogoji licence.
The competent authority shall have the authority to review, upon reasoned request by the rights-holder or the licensee, whether the licence conditions have been respected.
Preverjanje temelji na oceni, narejeni v državi uvoznici, kadar je to primerno.
This review shall be based on the assessment made in the importing country where appropriate.
O preklicu licence, podeljene po tej uredbi, se s posredovanjem Komisije uradno obvesti Svet za TRIPS.
Termination of a licence granted under this Regulation shall be notified to the Council for TRIPS through the intermediary of the Commission.
Po preklicu licence ima pristojni organ ali kateri koli drug organ, ki ga imenuje država članica, pravico do določitve razumnega časovnega obdobja, v katerem pridobitelj licence poskrbi, da je vsak izdelek, ki je v njegovi lasti, hrambi ali pod njegovo pristojnostjo ali nadzorom, na njegove stroške preusmerjen v države v stiski, kot je določeno v členu 4, ali drugače odstranjen, kot določi pristojni organ ali kateri drug organ, ki ga imenuje država članica, po posvetu z imetnikom pravice.
Following termination of the licence, the competent authority, or any other body appointed by the Member State, 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 as referred to in Article 4 or otherwise disposed of as prescribed by the competent authority, or by another body appointed by the Member State, in consultation with the rights-holder.
Ko država uvoznica uradno obvesti pristojni organ, da količina farmacevtskih izdelkov ne zadostuje več za zadovoljevanje njenih potreb, lahko pristojni organ na zahtevo pridobitelja licence spremeni pogoje licence ter dovoli proizvodnjo in izvoz dodatnih količin izdelka v obsegu, ki je potreben za izpolnjevanje potreb te države uvoznice.
When notified by the importing country that the amount of pharmaceutical product has become insufficient to meet its needs, the competent authority may, following an application by the licensee, modify the conditions of the licence permitting the manufacture and export of additional quantities of the product to the extent necessary to meet the needs of the importing country concerned.
V takih primerih se zahteva pridobitelja licence obravnava po poenostavljenem in pospešenem postopku, pri čemer podatki iz člena 6(3), točk (a) in (b) niso potrebni, če pridobitelj licence predloži izvirno prisilno licenco.
In such cases the licensee's application shall be processed in accordance with a simplified and accelerated procedure, whereby the information set out in Article 6(3), points (a) and (b), shall not be required provided that the original compulsory licence is identified by the licensee.
V primerih, za katere se uporablja člen 9(1), odstopanje iz člena 9(2) pa zanje ne velja, dodatna dokazila o pogajanjih z imetnikom pravice niso potrebna, če zahtevana dodatna količina ne presega 25 % količine, odobrene z izvirno licenco.
In situations where Article 9(1) applies but the derogation set out in Article 9(2) does not apply, no further evidence of negotiation with the rights-holder will be required, provided that the additional amount requested does not exceed 25% of the amount granted under the original licence.
V primerih, za katere se uporablja člen 9(2), dokazila o pogajanjih z imetnikom pravice niso potrebna.
In situations where Article 9(2) applies, no evidence of negotiation with the rights-holder will be required.
Pritožbe proti kateri koli odločitvi pristojnega organa in spori glede izpolnjevanja pogojev licence se predložijo ustreznemu organu, ki je po nacionalni zakonodaji za to odgovoren.
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.
Države članice zagotovijo, da lahko pristojni organ in/ali organ iz odstavka 1 odločijo, da ima pritožba na odločitev o podelitvi prisilne licence odložilni učinek.
Member States shall ensure that the competent authority and/or the body referred to in paragraph 1 have the power to rule that an appeal against a decision granting a compulsory licence shall have suspensory effect.
Varnost in učinkovitost zdravil
Safety and efficacy of medicinal products
Kadar zahteva za pridobitev prisilne licence zadeva zdravilo, lahko vložnik uporabi:
Where the application for a compulsory licence concerns a medicinal product, the applicant may avail himself of:
postopek za pridobitev znanstvenega mnenja, ki ga določa člen 58 Uredbe (ES) št. 726/2004, ali
the scientific opinion procedure as provided for under Article 58 of Regulation (EC) No 726/2004, or
katere koli podobne postopke v okviru nacionalne zakonodaje, kot so znanstveno mnenje ali izvozna potrdila, namenjena izključno za trge zunaj Skupnosti.
any similar procedures under national law, such as scientific opinions or export certificates intended exclusively for markets outside the Community.
Če zahteva za katerega od zgoraj navedenih postopkov zadeva zdravilo, ki je generik referenčnega zdravila, ki je ali je bilo odobreno v skladu s členom 6 Direktive 2001/83/ES, se ne uporabljajo obdobja za varstvo podatkov iz člena 14(11) Uredbe (ES) št. 726/2004 ter členov 10(1) in 10(5) Direktive 2001/83/ES..
If a request for any of the above procedures concerns a product which is a generic of a reference medicinal product which is or has been authorised under Article 6 of Directive 2001/83/EC, the protection periods set out in Article 14(11) of Regulation (EC) No 726/2004 and in Articles 10(1) and 10(5) of Directive 2001/83/EC shall not apply.
Komisija tri leta po začetku veljavnosti te uredbe in vsaka tri leta zatem Evropskemu parlamentu, Svetu in Evropskemu ekonomsko-socialnemu odboru predloži poročilo o izvajanju te uredbe, vključno z ustreznimi načrti sprememb.
Three years after the entry into force of this Regulation, and every three years thereafter, the Commission shall present a report to the European Parliament, the Council, and the European Economic and Social Committee on the operation of this Regulation including any appropriate plans for amendments.
Poročilo vsebuje zlasti:
The report shall cover, in particular:
uporabo člena 10(9) o določitvi nadomestila imetniku pravice;
the application of Article 10(9) on determining the remuneration of the rights-holder;
uporabo poenostavljenega in pospešenega postopka iz člena 16(4);
the application of the simplified and accelerated procedure referred to in Article 16(4);
zadostnost pogojev iz člena 10(5) za preprečitev preusmerjanja trgovine, in
the sufficiency of the requirements under Article 10(5) to prevent trade diversion, and
prispevek te uredbe k uveljavljanju sistema, vzpostavljenega s Sklepom.
the contribution this Regulation has made to the implementation of the system established by the Decision.
Zakonodajna resolucija Evropskega parlamenta o predlogu Direktive Sveta o ukrepih Skupnosti za nadzor aviarne influence ( KOM(2005)0171 – C6-0195/2005 – 2005/0062(CNS) )
European Parliament legislative resolution on the proposal for a Council directive on Community measures for the control of Avian Influenza ( COM(2005)0171 – C6-0195/2005 – 2005/0062(CNS) )