natgillin/translations-raw huggingface dataset:
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.
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 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).
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 licensee shall be responsible for the payment of adequate remuneration to the rights-holder as determined by the competent authority as follows:
Pridobitelj licence je odgovoren za plačilo primernega nadomestila imetniku pravice, kakor ga določi pristojni organ, in sicer:
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 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 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.
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.
The licence conditions are without prejudice to the method of distribution in the importing country.
Pogoji licence ne posegajo v način distribucije v državi uvoznici.
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.
Distribucijo lahko na primer izvaja kateri koli organ iz člena 6(3)(f) pod komercialnimi ali nekomercialnimi pogoji, tudi popolnoma brezplačno.
Refusal of the application
Zavrnitev zahteve
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.
Pristojni organ zahtevo zavrne, če kateri koli 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.
Before refusing an application, the competent authority shall give the applicant an opportunity to rectify the situation and to be heard.
Pred zavrnitvijo zahteve pristojni organ vložniku omogoči, da se o tem izjavi in popravi položaj.
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.
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.
The information provided shall include the following details of the licence:
Predloženi podatki vsebujejo naslednje podrobnosti o licenci:
the name and address of the licensee;
ime in naslov pridobitelja licence;
the product or products concerned;
zadevni izdelek ali zadevne izdelke;
the quantity to be supplied;
količino, ki se bo dobavila;
the country or countries to which the product or products are to be exported;
državo ali države, v katere se bodo izdelki izvozili;
the duration of the licence;
trajanje licence;
the address of the website referred to in Article 10(6).
naslov spletne strani iz člena 10(6).
Prohibition of importation
Prepoved uvoza
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.
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.
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.
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.
Action by customs authorities
Ukrepi carinskih organov
If there are sufficient grounds for suspecting that products manufactured under a compulsory licence granted pursuant to the Decision and/or this Regulation are being imported into the Community contrary to Article 13(1), 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.
Če obstaja dovolj razlogov za sum, da se izdelki, proizvedeni po prisilni licenci, podeljeni v skladu s Sklepom in/ali to uredbo, uvažajo v Skupnost v nasprotju s členom 13(1), carinski organi prekinejo sprostitev zadevnih izdelkov ali jih zadržijo za toliko časa, kolikor je potrebno za pridobitev odločbe pristojnega organa o naravi blaga.
Member States shall ensure that a body has the authority to review whether such importation is taking place.
Države članice zagotovijo, da je za preverjanje obstoja takšnega uvoza pristojen določen organ.
The period of suspension or detention shall not exceed 10 working days unless special circumstances apply, in which case the period may be extended by a maximum of 10 working days.
Obdobje prekinitve ali zadržanja ne presega 10 delovnih dni, razen v primeru posebnih okoliščin, ko se lahko to obdobje podaljša za največ 10 delovnih dni.
Upon expiry of that period, the products shall be released, provided that all customs formalities have been complied with.
Ob izteku tega obdobja se izdelki sprostijo, pod pogojem, da so bile opravljene vse carinske formalnosti.
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.
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.
Due account shall be taken of national provisions on the protection of personal data and commercial and industrial secrecy and professional and administrative confidentiality.
Ustrezno se upoštevajo nacionalne določbe o varstvu osebnih podatkov, poslovne in industrijske skrivnosti ter poklicne in uradne skrivnosti.
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.
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.
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.
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.
The procedure of suspension or detention or seizure of the goods shall be carried out at the expense of the importer.
Postopek prekinitve sprostitve, zadržanja ali zasega blaga se izvaja na stroške uvoznika.
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 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 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.
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.
The competent authority shall inform the Commission of any decisions on seizure or destruction adopted pursuant to this Regulation.
Pristojni organ obvesti Komisijo o vsaki odločitvi glede zasega ali uničenja, sprejeti v skladu s to uredbo.
Personal luggage exception
Izjema za osebno prtljago
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.
Člena 13 in 14 se ne uporabljata za blago nekomercialne narave, ki je v osebni prtljagi potnikov in ga ti uporabljajo za osebno rabo, v mejah, ki veljajo za oprostitev plačila carine.
Termination or review of the licence
Preklic ali preverjanje 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.
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.
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.
Pristojni organ je pooblaščen, da na utemeljeno zahtevo imetnika pravice ali pridobitelja licence preveri, ali se spoštujejo pogoji licence.
This review shall be based on the assessment made in the importing country where appropriate.
Preverjanje temelji na oceni, narejeni v državi uvoznici, kadar je to primerno.
Termination of a licence granted under this Regulation shall be notified to the Council for TRIPS through the intermediary of the Commission.
O preklicu licence, podeljene po tej uredbi, se s posredovanjem Komisije uradno obvesti Svet za TRIPS.
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.
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.
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.
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.
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 takih primerih se zahteva pridobitelja licence obravnava po poenostavljenem in pospešenem postopku, pri čemer podatki iz člena 6(3), točki (a) in (b), niso potrebni, če pridobitelj licence predloži izvirno prisilno 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(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(2) applies, no evidence of negotiation with the rights-holder will be required.
V primerih, za katere se uporablja člen 9(2), dokazila o pogajanjih z imetnikom pravice niso potrebna.
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.
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.
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.
Države članice zagotovijo, da lahko pristojni organ in/ali organ iz odstavka 1 odloči(-ta), da ima pritožba na odločitev o podelitvi prisilne licence odložilni učinek.
Safety and efficacy of medicinal products
Varnost in učinkovitost zdravil
Where the application for a compulsory licence concerns a medicinal product, the applicant may avail himself of:
Kadar zahteva za pridobitev prisilne licence zadeva zdravilo, lahko vložnik uporabi:
the scientific opinion procedure as provided for under Article 58 of Regulation (EC) No 726/2004, or
postopek za pridobitev znanstvenega mnenja, ki ga določa člen 58 Uredbe (ES) št. 726/2004; ali
any similar procedures under national law, such as scientific opinions or export certificates intended exclusively for markets outside the Community.
katere koli podobne postopke v okviru nacionalne zakonodaje, kot so znanstveno mnenje ali izvozna potrdila, namenjena izključno za trge zunaj Skupnosti.
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.
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.
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.
Komisija tri leta po začetku veljavnosti te uredbe in nadalje vsaka tri leta Evropskemu parlamentu, Svetu in Evropskemu ekonomsko-socialnemu odboru predloži poročilo o izvajanju te uredbe, vključno z ustreznimi načrti sprememb.
The report shall cover, in particular:
Poročilo vsebuje zlasti:
the application of Article 10(9) on determining the remuneration of the rights-holder;
uporabo člena 10(9) o določitvi nadomestila imetniku pravice;
the application of the simplified and accelerated procedure referred to in Article 16(4);
uporabo poenostavljenega in pospešenega postopka iz člena 16(4);
the sufficiency of the requirements under Article 10(5) to prevent trade diversion, and
zadostnost pogojev iz člena 10(5) za preprečitev preusmerjanja trgovine; in
the contribution this Regulation has made to the implementation of the system established by the Decision.
prispevek te uredbe k uveljavljanju sistema, vzpostavljenega s Sklepom.
OJ C 286, 17.11.2005, p. 4.
UL C 286, 17.11.2005, str. 4.
Opinion of the European Parliament of 1.12.2005 (not yet published in the Official Journal), and Council Decision of 28 April 2006.
Mnenje Evropskega parlamenta z dne 1. decembra 2005 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 28. aprila 2006.
Council Regulation (EC) No 817/2006
Uredba Sveta (ES) št. 817/2006
renewing the restrictive measures in respect of Burma/Myanmar and repealing Regulation (EC) No 798/2004
o obnovitvi omejevalnih ukrepov v zvezi z Burmo/Mjanmarom in o razveljavitvi Uredbe (ES) št. 798/2004
Having regard to Council Common Position 2006/318/CFSP of 27 April 2006 renewing restrictive measures in respect of Burma/Myanmar [1],
ob upoštevanju Skupnega stališča Sveta 2006/318/SZVP z dne 27. aprila 2006 o podaljšanju omejevalnih ukrepov proti Burmi/Mjanmaru [1],
On 28 October 1996, the Council, concerned at the absence of progress towards democratisation and at the continuing violation of human rights in Burma/Myanmar, imposed certain restrictive measures against Burma/Myanmar by Common Position 1996/635/CFSP [2].
Zaradi zaskrbljenosti nad pomanjkanjem napredka v smeri demokratizacije in zaradi nenehnega kršenja človekovih pravic v Burmi/Mjanmaru je Svet 28. oktobra 1996 s Skupnim stališčem 1996/635/SZVP [2] sprejel nekatere omejevalne ukrepe proti Burmi/Mjanmaru.
These measures were subsequently extended and amended by Common Position 2000/346/CFSP [3], repealed by Common Position 2003/297/CFSP [4], and then renewed by Common Position 2004/423/CFSP [5], reinforced by Common Position 2004/730/CFSP [6], amended by Common Position 2005/149/CFSP [7] and extended and amended by Common Position 2005/340/CFSP [8].
Ti ukrepi so bili nato podaljšani in spremenjeni s Skupnim stališčem 2000/346/SZVP [3] in Skupnim stališčem 2003/297/SZVP [4] ter nato obnovljeni s Skupnim stališčem 2004/423/SZVP [5], okrepljeni s Skupnim stališčem 2004/730/SZVP [6], spremenjeni s Skupnim stališčem 2005/149/SZVP [7] ter podaljšani in spremenjeni s Skupnim stališčem 2005/340/SZVP [8].
Some of the restrictive measures imposed against Burma/Myanmar were implemented at Community level by Council Regulation (EC) No 798/2004 of 26 April 2004 renewing the restrictive measures in respect of Burma/Myanmar and repealing Regulation (EC) No 1081/2000 [9].
Nekateri omejevalni ukrepi proti Burmi/Mjanmaru so bili na ravni Skupnosti izvedeni z Uredbo Sveta (ES) št. 798/2004 z dne 26. aprila 2004 o podaljšanju omejitvenih ukrepov proti Burmi/Mjanmaru in o razveljavitvi Uredbe (ES) št. 1081/2000 [9].
In view of the current political situation in Burma/Myanmar, as witnessed by:
Glede na trenutne politične razmere v Burmi/Mjanmaru, o katerih pričajo naslednja dejstva:
the failure of the military authorities to enter into substantive discussions with the democratic movement concerning a process leading to national reconciliation, respect for human rights and democracy,
vojaške oblasti niso začele pogovorov z demokratičnim gibanjem o bistvenih vprašanjih procesa, katerega cilj so narodna sprava, spoštovanje človekovih pravic in demokracija;
the failure to allow a genuine and open National Convention,
pristen in odprt narodni zbor ni bil omogočen;
the continuing detention of Daw Aung San Suu Kyi, other members of the National League for Democracy (NLD) and other political detainees,
Daw Aung San Suu Kyi, drugi člani Narodne lige za demokracijo in drugi politični zaporniki so še vedno v priporu;
the continued harassment of the NLD and other organised political movements,
nenehni pritiski na Narodno ligo za demokracijo in na druga organizirana politična gibanja;
the continuing serious violations of human rights, including the failure to take action to eradicate the use of forced labour in accordance with the recommendations of the International Labour Organisation's High-Level Team report of 2001 and recommendations and proposals of subsequent ILO missions; and
nenehne hude kršitve človekovih pravic, vključno z nesprejetjem ukrepov za odpravo prisilnega dela v skladu s priporočili iz poročila skupine visokih uradnikov Mednarodne organizacije dela iz leta 2001 ter priporočili in predlogi nadaljnjih misij Mednarodne organizacije dela; in
recent developments such as increasing restrictions on the operation of international organisations and non-governmental organisations,
nedavni dogodki, kot je čedalje več omejitev pri delovanju mednarodnih organizacij in nevladnih organizacij,
Common Position 2006/318/CFSP provides for the maintenance of the restrictive measures against the military regime in Burma/Myanmar, those who benefit most from its misrule and those who actively frustrate the process of national reconciliation, respect for human rights and democracy.
Skupno stališče 2006/318/SZVP določa ohranitev omejevalnih ukrepov proti vojaškemu režimu v Burmi/Mjanmaru, in sicer proti tistim, ki imajo največ koristi zaradi njegove zlorabe oblasti, in tistim, ki dejavno ovirajo proces narodne sprave, spoštovanje človekovih pravic in demokracijo.