natgillin/translations-raw huggingface dataset:
Where an applicant for a marketing authorisation for a veterinary medicinal product or for a variation to the terms of the marketing authorisation submits an application in accordance with Regulation (EC) No 470/2009 for the establishment of a maximum residue limit, together with clinical trials during the application procedure, other applicants shall not use those trials for a period of 5 years from the granting of the marketing authorisation for which they were carried out, unless the other applicant has obtained written agreement in the form of a letter of access with regard to those trials.
Kadar predlagatelj za pridobitev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini ali za spremembo pogojev dovoljenja za promet predloži vlogo v skladu z Uredbo (ES) št. 470/2009 za določitev mejne vrednosti ostankov skupaj s kliničnimi preskušanji med postopkom obravnavanja vloge, drugi predlagatelji ne uporabljajo navedenih preskušanj za obdobje 5 let od izdaje dovoljenja za promet, za katerega so bili izvedena, razen če je drugi predlagatelj pridobil pisno soglasje v obliki izjave o dostopnosti podatkov v zvezi z navedenimi preskušanji.
Where an applicant lodges a further appeal against a first or a subsequent appeal decision, he or she shall, in principle, not have a right to remain on the territory of Member States (Article 54(5)).
Kadar prosilec vloži pravno sredstvo zoper prvo ali poznejšo odločitev v pritožbenem postopku, načeloma nima pravice ostati na ozemlju držav članic (člen 54(5)).
Where an applicant refuses to approve the content of the report, the reasons for this refusal shall be entered into the applicant's file.
Če prosilec odkloni potrditev vsebine zapisnika, se razlogi za odklonitev zabeležijo v njegovem spisu.
Where an applicant refuses to cooperate by not providing the details necessary for the examination of the application and by not providing his or her fingerprints and facial image, and the responsible authorities have properly informed that person of his or her obligations and has ensured that that person has had an effective opportunity to comply with those obligations, his or her application shall be rejected as abandoned in accordance with the procedure referred to in Article 39.
Če prosilec odklanja sodelovanje in ne zagotovi potrebnih podrobnosti za obravnavo prošnje ter svojih prstnih odtisov in podobe obraza, odgovorni organi pa so navedeno osebo ustrezno obvestili o njenih obveznostih ter zagotovili, da je imela dejansko možnost navedene obveznosti izpolniti, se prošnja zavrže zaradi odstopa v skladu s postopkom iz člena 39.
Where an application for a marketing authorisation is submitted in respect of a medicinal product designated as an orphan medicinal product pursuant to Regulation (EC) No 141/2000 and that application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, and the statement referred to in Article 29(3) of this Regulation is subsequently included in the marketing authorisation granted, the ten-year period referred to in Article 8(1) of Regulation (EC) No 141/2000 shall be extended to twelve years.
Če je predložena vloga za dovoljenje za promet za zdravilo, določeno kot zdravilo sirota v skladu z Uredbo (ES) št. 141/2000, in ta vloga vsebuje rezultate vseh študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, in je izjava iz člena 29(3) te uredbe posledično vsebovana v odobrenem dovoljenju za promet, se desetletno obdobje iz člena 8(1) Uredbe (ES) št. 141/2000 podaljša na dvanajst let.
Where an application for an EAPO is made prior to the initiation of proceedings on the substance, the claimant shall initiate such proceedings within 30 days of the date of issue of the order or within any shorter time period set by the issuing court, failing which the order shall be revocable in accordance with point (b) of Article 34(1) or Article 35(2).
Če je vloga za izdajo ENZBR vložena pred začetkom postopka v glavni stvari, tožnik tak postopek začne v roku 30 dni od dneva izdaje naloga ali v krajšem roku, ki ga določi sodišče, ki je nalog izdalo; če ti roki niso upoštevani, se nalog v skladu s točko (b) člena 34(1) ali členom 35(2) lahko prekliče.
Where an application is lodged with the authorities of that Member State, the circumstances of paragraph 4a apply, i.e. that Member State becomes responsible for examining that application.
Če prošnjo vloži pri organih navedene države članice, se uporabi odstavek 4a, kar pomeni, da je za obravnavo vloge odgovorna navedena država članica.
Where an application or a request is deemed inadmissible, the Commission shall, by means of implementing acts without the assistance of the Committee referred to in Article 323(1), decide to reject it as inadmissible.
Če se šteje, da je vloga ali zahtevek nedopusten, Komisija z izvedbenimi akti brez pomoči odbora iz člena 323(1) odloči, da ga zavrne kot nedopustnega.
Where an application or a request submitted under this Chapter is deemed inadmissible, the Commission shall, by means of implementing acts without the assistance of the Committee referred to in Article 36, decide to reject it as inadmissible.
Če se šteje, da je vloga ali zahtevek, predložen v skladu s tem poglavjem, nedopusten, Komisija z izvedbenimi akti brez pomoči odbora iz člena 36 odloči, da ga zavrne kot nedopustnega.
Where an application under Articles 8 or 9 includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Articles 13(1) and 13(2) of Regulation (EEC) No 1768/92.
Če vloga v skladu s členom 8 ali 9 vsebuje rezultate vseh študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, je imetnik patenta ali dodatnega varstvenega certifikata upravičen do šestmesečnega podaljšanja obdobja iz členov 13(1) in 13(2) Uredbe (EGS) št. 1768/92.
Where an appropriate authority makes a determination referred to in paragraph 1, it shall immediately notify the resolution authority responsible for the institution in question, if different.
Če ustrezen organ sprejme ugotovitev iz odstavka 1, o tem nemudoma obvesti organ za reševanje, pristojen za zadevno institucijo, če ne gre za isti organ.
Where an approval authority considers that the restrictive measures taken by the approval authority that granted the EU type-approval pursuant to article 58(1) are not sufficient or timely enough, .it shall inform the Commission thereof and it may take appropriate restrictive measures to prohibit or restrict the making available on the market, registration or entry into service of the concerned non-compliant vehicles, systems, components or separate technical units on their national market, or to withdraw them from that market or to recall them.
Če homologacijski organ meni, da omejevalni ukrepi, ki jih je sprejel homologacijski organ, ki je podelil EU-homologacijo v skladu s členom 58(1), niso zadostni ali pravočasni, o tem obvesti Komisijo, ter lahko sprejme vse ustrezne omejevalne ukrepe, s katerimi prepove ali omeji dajanje na trg, registracijo ali začetek uporabe neskladnih vozil, sistemov, sestavnih delov ali samostojnih tehničnih enot na nacionalnem trgu, jih s tega trga umakne ali odpokliče.
Where an approval authority is informed in accordance with Articles 8(5), 9(5), 52(4) or 54, it shall take all necessary measures to review the approval granted and, where appropriate, correct or withdraw the approval depending on the reasons and the seriousness of the deviations demonstrated.
Kadar je homologacijski organ obveščen v skladu s členom 8(5), 9(5), 52(4) ali 54, sprejme vse potrebne ukrepe za proučitev podeljene homologacije ter po potrebi popravi ali prekliče homologacijo glede na razloge in resnost dokazanih odstopanj.
Where an approval authority or market surveillance authority finds that vehicles, systems, components or separate technical units are not in conformity with this Regulation or that the type-approval has been granted on the basis of incorrect data or that vehicles, systems, components or separate technical units accompanied by a certificate of conformity or bearing an approval mark do not conform to the approved type, it may take all appropriate restrictive measures in accordance with Article 53(1).
Če homologacijski organ ali organ za nadzor trga ugotovi, da vozila, sistemi, sestavni deli ali samostojne tehnične enote niso skladni s to uredbo ali da je bila homologacija podeljena na podlagi nepravilnih podatkov ali da vozila, sistemi, sestavni deli ali samostojne tehnične enote, ki jim je priloženo potrdilo o skladnosti ali ki nosijo homologacijsko oznako, niso skladni s homologiranim tipom, lahko sprejme vse ustrezne omejevalne ukrepe v skladu s členom 53(1).
Where an approval authority or the Commission considers that the remedies referred to in Article 57(3) are insufficient or are not implemented quickly enough, they shall notify their concern to the approval authority that granted the EU type-approval and the Commission without delay.
Kadar homologacijski organ ali Komisija meni, da so popravni ukrepi iz člena 57(3) nezadostni ali da niso bili izvedeni dovolj hitro, o svojih pomislekih takoj obvesti homologacijski organ, ki je podelil EU-homologacijo, in Komisijo.
Where an asterisk appears in the tables, the division is required to be of steel or other equivalent material but is not required to be of ‘A’ class standard.
Kjer se v tabelah pojavlja zvezdica, mora biti pregrada iz jekla ali drugega enakovrednega materiala, ne zahteva pa se, da ustreza standardu razreda «A».
Where an audit firm generates more than one third of its annual audit revenues from large PIEs and belongs to a network whose members have combined annual audit revenues which exceed EUR 1 500 million within the European Union, it shall comply with the following conditions:
Kadar revizijsko podjetje ustvari več kot eno tretjino svojih letnih prihodkov od revizije z revizijo velikih subjektov javnega interesa in je del mreže, katere člani na leto skupaj ustvarijo več kot 1 500 milijonov EUR prihodkov od revizije v Evropski uniji, izpolnjuje naslednje pogoje:
Where an audit firm generates more than one third of its annual audit revenues from large public-interest entities and belongs to a network whose members have combined annual audit revenues which exceed EUR 1 500 million within the European Union, it shall comply with the following conditions:
Kadar revizijsko podjetje ustvari več kot eno tretjino svojih letnih prihodkov od revizije z revizijo velikih subjektov javnega interesa in je del mreže, katere člani na leto skupaj ustvarijo več kot 1 500 milijonov EUR prihodkov od revizije v Evropski uniji, izpolnjuje naslednje pogoje:
Where an e-gate is used, the corresponding registration of the entry/exit record and the linking of that record to the concerned individual file pursuant to Article 13 of [Regulation establishing the Entry/Exit System (EES)] shall be carried out when performing the border crossing through the e-gate.
Če se uporabi elektronski izhod, se ustrezno evidentiranje podatkov o vstopu/izstopu in povezovanje te evidence z zadevno individualno dokumentacijo v skladu s členom 13 [Uredbe o vzpostavitvi sistema vstopa/izstopa (SVI)] izvedeta ob prehajanju skozi elektronski izhod.
Where an EBA beneficiary country no longer fulfils the conditions referred to in paragraph 1, it shall be removed by Commission decision from the list of EBA beneficiary countries following a transitional period of three years as from the date of the adoption of the Commission decision.
Če država upravičenka do EBA ne izpolnjuje več pogojev iz odstavka 1, Komisija sprejme sklep o izločitvi zadevne države s seznama držav upravičenk do EBA, ki se izvrši po triletnem prehodnem obdobju od datuma sprejetja sklepa Komisije.
Where an economic operator has advised the contracting authority or has otherwise been involved in the preparation of the procurement procedure, the contracting authority shall take appropriate measures as set out in Article 137 to ensure that competition is not distorted by the participation of that economic operator.
15.2. Kadar je gospodarski subjekt svetoval javnemu naročniku ali bil kako drugače vključen v pripravo postopka javnega naročanja, javni naročnik z ustreznimi ukrepi iz člena 137 zagotovi, da se zaradi sodelovanja zadevnega gospodarskega subjekta konkurenca ne izkrivlja.
Where an entity or permanent establishment is treated as a controlled foreign company under paragraph 1, non-distributed income of the entity or permanent establishment shall be subject to tax to the extent that it is derived from the following categories:
Če se subjekt ali stalna poslovna enota obravnava kot nadzorovana tuja družba v skladu z odstavkom 1, je nerazdeljeni dohodek subjekta ali stalne poslovne enote obdavčen, če izhaja iz naslednjih kategorij:
Where an EU parent credit institution and its subsidiaries or an EU parent financial institution and its subsidiaries use an Advanced Measurement Approach on a unified basis for the parent and its subsidiaries, the competent authorities may allow the qualifying criteria set out in Annex X, Part 3 to be met by the parent and its subsidiaries considered together.
Če matična kreditna institucija EU in njena hčerinska podjetja ali matična finančna institucija EU in njena hčerinska podjetja uporabljajo napredni pristop za merjenje operativnega tveganja na enotni osnovi za matično podjetje in za hčerinska podjetja, lahko pristojni organi dovolijo, da matično podjetje in njegova hčerinska podjetja skupaj izpolnjujejo kvalifikacijske kriterije iz dela 3 Priloge X.
Where an EU parent credit institution and its subsidiaries or an EU parent financial institution and its subsidiaries use the IRB Approach on a unified basis for the parent and its subsidiaries, the competent authorities may allow minimum requirements of Annex VII, Part 4 to be met by the parent and its subsidiaries considered together.
Če matična kreditna institucija EU in njena hčerinska podjetja ali matična finančna institucija EU in njena hčerinska podjetja uporabljajo pristop IRB na enotni osnovi za matično podjetje in hčerinska podjetja, lahko pristojni organi dovolijo, da matično podjetje in njegova hčerinska podjetja skupaj izpolnjujejo minimalne zahteve iz dela 4 Priloge VII.
where an exceptional event has occurred during a movement of excise goods within the Union, which is not defined in the provisions of Directive 2008/118/EC and which may affect the calculation of liability to excise duty of an economic operator.
kadar se med gibanjem trošarinskega blaga v Uniji zgodi izredni dogodek, ki ni opredeljen v določbah Direktive 2008/118/ES in bi lahko vplival na izračun trošarin, ki jih mora plačati gospodarski subjekt.
Where an exemption under Article 38 relates to a UNECE regulation, the Commission shall propose an amendment to the UNECE regulation in accordance with the procedure applicable under the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions54.
Kadar se izjema skladno s členom 38 nanaša na pravilnik UN/ECE, Komisija predlaga spremembo pravilnika UN/ECE po postopku, ki se uporablja v skladu s Sporazumom Gospodarske komisije Združenih narodov za Evropo o sprejetju enotnih tehničnih predpisov za cestna vozila, opremo in dele, ki se lahko vgradijo v cestna vozila in/ali uporabijo na njih, in o pogojih za vzajemno priznanje homologacij, dodeljenih na podlagi teh predpisov54.
Where an importer considers or has reason to believe that a CE marked fertilising product is not in conformity with the applicable requirements set out in Annex I, Annex II or Annex III, he or she shall not place the fertilising product on the market until it has been brought into conformity.
Kadar uvoznik meni ali upravičeno domneva, da gnojilni proizvod z oznako CE ni skladen z ustreznimi zahtevami iz Priloge I, Priloge II ali Priloge III, da gnojilni proizvod na trg šele po tem, ko je skladen z zahtevami.
Where an importer considers or has reason to believe that a safety component for lifts is not in conformity with the essential health and safety requirements set out in Annex I, he shall not place the safety component for lifts on the market until it has been brought into conformity.
Kadar uvoznik meni ali ima razlog, da domneva, da varnostni sestavni del za dvigala ni skladen z bistvenimi zdravstvenimi in varnostnimi zahtevami iz Priloge I, da varnostni sestavni del za dvigala na trg šele po tem, ko je bil usklajen.
Where an importer considers or has reason to believe that a subsystem or a safety component is not in conformity with the essential requirements set out in Annex II, he shall not place the subsystem or the safety component on the market until it has been brought into conformity.
Če uvoznik meni ali ima razlog za domnevo, da podsistem ali varnostni element ni skladen z bistvenimi zahtevami iz Priloge II, da podsistem ali varnostni element na trg šele po tem, ko je usklajen.
Where an independent operator or a trade association representing independent operators files a complaint to the approval authority on the failure of the manufacturer to comply with Articles 65 to 70, the approval authority shall carry out an audit in order to verify compliance by the manufacturer.
Če neodvisni izvajalec ali poslovno združenje, ki zastopa neodvisne izvajalce, pri homologacijskem organu vloži pritožbo o tem, da proizvajalec ne izpolnjuje zahtev iz členov od 65 do 70, homologacijski organ izvede presojo, s katero preveri to neizpolnjevanje zahtev proizvajalca.
Where an indirect action is supported which is of high relevance to several of the priorities set out in Article 5(2) or to several specific objectives within those priorities, the financial amount for that action may be combined from the amounts allocated to respectively each priority or specific objective concerned.
Če je podprt posreden ukrep, ki je zelo pomemben za več prednostnih nalog iz člena 5(2) ali več posebnih ciljev v okviru teh prednostnih nalog, se lahko finančni znesek za ta ukrep združi iz zneskov, dodeljenih za vsako zadevno prednostno nalogo oziroma posebni cilj.
Where an institution does not know the delinquency status for 5% or less of underlying exposures in the pool, the institution may use the SEC-SA subject to the following adjustment in the calculation KA:
Če institucija ne pozna statusa delinkventnosti za 5 % ali manj osnovnih izpostavljenosti v skupini, institucija lahko uporabi pristop SEC-S, ob upoštevanju naslednje prilagoditve pri izračunu KA:
Where an institution does not meet or is likely to breach the requirements of Directive 2006/48/EC, Member States shall ensure that competent authorities, , have at their disposal, in addition to the measures referred to in Article 136 of Directive 2006/48/EC where applicable, in particular, the following measures:
Če institucija ne izpolnjuje ali bo verjetno kršila zahteve Direktive 2006/48/ES, države članice zagotovijo, da imajo pristojni organi poleg ukrepov iz člena 136 Direktive 2006/48/ES po potrebi na voljo zlasti naslednje ukrepe:
Where an institution makes use of this option, outstanding securitisations should continue to be subject to the regulatory capital requirements set out in Regulation (EU) No 575/2013 in the version that applied prior to the date of application of this Regulation.
Če institucija uporabi to možnost, bi se morale za neporavnano listinjenje še naprej uporabljati regulativne kapitalske zahteve, določene v Uredbi (EU) št. 575/2013, v različici, ki se je uporabljala pred datumom začetka uporabe te uredbe
Where an institution meets the conditions for resolution and the resolution authority decides to apply a resolution tool to that institution, the resolution authority shall comply with the requirement set out in Article 51(1) before applying the resolution tool.
Kadar institucija izpolnjuje pogoje za reševanje in se organ za reševanje odloči, da bo za zadevno institucijo uporabil instrument za reševanje, organ za reševanje pred uporabo instrumenta za reševanje izpolni zahtevo iz člena 51(1).
Where an insurance or reinsurance undertaking and either a credit institution as defined in Directive 2006/48/EC or an investment firm as defined in Council Directive 2004/39/EC, or both, are directly or indirectly related or have a common participating undertaking, the supervisory authorities concerned and the authorities responsible for the supervision of those other undertakings shall cooperate closely.
Če sta zavarovalnica ali pozavarovalnica in bodisi kreditna institucija, kot je opredeljena v Direktivi 2006/48/ES, bodisi investicijska družba, kot je opredeljena v Direktivi Sveta 2004/39/ES, bodisi obe neposredno ali posredno povezani ali imata skupno udeleženo podjetje, morajo zadevni nadzorni organi in organi, ki so odgovorni za nadzor teh drugih podjetij, tesno sodelovati.
Where an internal hedge has been conducted in accordance with the first subparagraph and the requirements in Sub-section 2 have been met, institutions shall apply the rules set out in Sections 4 to 6 for the calculation of risk-weighted exposure amounts and expected loss amounts where they acquire unfunded credit protection.
Če je bilo izvedeno notranje varovanje v skladu s prvim pododstavkom in so bile izpolnjene zahteve iz pododdelka 2, institucije uporabijo pravila iz oddelkov 4 do 6 za izračun zneskov tveganju prilagojenih izpostavljenosti in zneskov pričakovanih izgub, kadar pridobijo osebno kreditno zavarovanje.
Where an investment product manufacturer has produced a key information document which does not comply with the requirements of Articles 6, 7 and 8 on which a retail investor has relied when making an investment decision, such a retail investor may claim from the investment product manufacturer damages for any loss caused to that retail investor through the use of the key information document.
Kadar proizvajalec naložbenega produkta pripravi dokument s ključnimi informacijami, ki ni v skladu z zahtevami iz členov 6, 7 in 8 ter na katerega se je mali vlagatelj zanašal pri sprejetju naložbene odločitve, lahko mali vlagatelj od proizvajalca naložbenega produkta zahteva povrnitev škode za kakršno koli izgubo, ki jo je utrpel zaradi uporabe dokumenta s ključnimi informacijami.
where an invoice is not issued, or is issued late, no later than on the 15th day of the month following that in which the chargeable event occurs."
kadar se račun ne izda ali je izdan pozneje, najpozneje 15. dan v mesecu, ki sledi mesecu, v katerem nastane obdavčljivi dogodek.“
Where an objection is upheld pursuant to paragraphs 1 and 2, the controller shall no longer use or otherwise process the personal data concerned.
Če je podan ugovor v skladu z odstavkoma 1 in 2, upravljavec zadevnih osebnih podatkov ne sme več uporabljati ali kako drugače obdelovati.
Where an OCT becomes independent and accedes to the ACP-EU Partnership Agreement, the amount indicated in paragraph 1 shall be reduced and the amounts indicated in Article 2(a)(i) correspondingly increased by a decision of the Council acting unanimously on a proposal from the Commission.
Kadar ČDO postane neodvisna in pristopi k Sporazumu o partnerstvu AKP-EU, se s sklepom Sveta, sprejetim soglasno na podlagi predloga Komisije, znesek iz odstavka 1 zniža, zneski iz člena 2(a)(i) pa ustrezno zvišajo.
Where an offer of securities to the public or an admission of securities to trading on a regulated market is outside the scope of this Regulation as defined in Article 1, an issuer, an offeror or a person asking for admission to trading on a regulated market shall be entitled to voluntarily draw up a prospectus in accordance with this Regulation.
Če je javna ponudba vrednostnih papirjev ali sprejem vrednostnih papirjev v trgovanje na reguliranem trgu zunaj področja uporabe te uredbe, kot je opredeljeno v členu 1, je izdajatelj, ponudnik ali oseba, ki prosi za sprejem v trgovanje na reguliranem trgu, upravičena do prostovoljne priprave prospekta v skladu s to uredbo.