natgillin/translations-raw huggingface dataset:
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 a paediatric use marketing authorisation is submitted in accordance with the procedure laid down in Regulation (EC) No 726/2004, the amount of the reduced fees for the examination of the application and the maintenance of the marketing authorisation shall be fixed in accordance with Article 70 of Regulation (EC) No 726/2004.
Če je vloga za dovoljenje za promet za pediatrično uporabo vložena v skladu s postopkom, določenim v Uredbi (ES) št. 726/2004, se znesek znižane pristojbine za pregled vloge in ohranitev dovoljenja za promet določi v skladu s členom 70 Uredbe (ES) št. 726/2004.
Where an application for access to provide port services under this Directive is rejected, the applicant(s) shall be informed of the reasons for not having been authorised or selected.
Če je prošnja za opravljanje pristaniških storitev po tej direktivi zavrnjena , mora/-ajo biti prosilec/-lci obveščen/-ni o razlogih, zaradi katerih ni/niso bil/-li izbran/-ni oziroma ni/niso prejel/-li dovoljenja.
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 for refund has not been expressly refused, but payment of the refund has not been made before the end of the three-month period laid down in the first subparagraph of Article 7(1), or in the second subparagraph of Article 7(4), as appropriate, interest of 1% per month, calculated from the date on which the refund should have been made to the date on which the refund was actually made, shall be due by the Member State on the amount of the refund to be made.
Kadar zahtevek za izplačilo ni bil izrecno zavrnjen, vendar vračilo ni bilo izplačano v trimesečnem roku iz prvega pododstavka člena 7(1) oziroma drugega pododstavka člena 7(4), je država članica na znesek vračila dolžna plačati mesečne obresti v višini 1 % od dneva, ko bi moralo biti izvedeno vračilo, do dneva dejanskega plačila.
where an application for remission of duty is made in accordance with Article 90;
kadar je v skladu s členom 90 vložen zahtevek za odpust dajatev;
Where an application has been lodged after [the first day following the entry into force of this Regulation] the date mentioned in the second paragraph of Article 49, the events that are likely to entail the responsibility of a Member State under this Regulation shall be taken into consideration, even if they precede that date, with the exception of the events mentioned in Article 13(2).
Kadar je prošnja vložena po [prvem dnevu, ki sledi začetku veljavnosti te uredbe] datumu iz drugega odstavka člena 49, se dogodki, katerih posledica je zelo verjetno odgovornost države članice po tej uredbi, upoštevajo tudi, če se zgodijo pred tem datumom, z izjemo dogodkov iz člena 13(2).
Where an application is explicitly withdrawn by the applicant, the determining authority shall take a decision to reject the application as explicitly withdrawn or as unfounded where the determining authority has, at the stage that the application is explicitly withdrawn, already found that the applicant does not qualify for international protection pursuant to Regulation (EU) No XXX/XXX (Qualification Regulation).
Kadar prosilec prošnjo izrecno umakne, organ za presojo odloči, da se prošnja zavrže kot izrecno umaknjena ali neutemeljena, če je organ za presojo že pred fazo postopka, v kateri je prošnja izrecno umaknjena, ugotovil, da prosilec ne izpolnjuje pogojev za mednarodno zaščito v skladu z Uredbo (EU) XXX/XXX (uredba o pogojih za azil).
Where an application is implicitly withdrawn, the determining authority shall take a decision to reject the application as abandoned or as unfounded where the determining authority has, at the stage that the application is implicitly withdrawn, already found that the applicant does not qualify for international protection pursuant to Regulation (EU) No XXX/XXX (Qualification Regulation).
Kadar je prošnja implicitno umaknjena, organ za presojo sprejme odločitev, s katero prošnjo zavrže zaradi odstopa ali kot neutemeljeno, če je organ za presojo že pred fazo postopka, v kateri je prošnja implicitno umaknjena, ugotovil, da prosilec ne izpolnjuje pogojev za mednarodno zaščito v skladu z Uredbo (EU) XXX/XXX (uredba o pogojih za azil).
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 is not made in writing, the time elapsing between the statement of intention and the preparation of a report should be as short as possible.
Če prošnja ni pisna, mora biti čas med izjavo o nameri in pripravo poročila čim krajši.
Where an application is rejected as inadmissible in application of the concept of the first country of asylum, the determining authority shall:
Kadar se prošnja zavrže kot nedopustna zaradi uporabe koncepta prve države azila, organ za presojo:
Where an application is rejected as inadmissible in application of the concept of the safe third country, the determining authority shall:
Kadar se prošnja zavrže kot nedopustna zaradi uporabe koncepta varne tretje države, organ za presojo:
Where an application is rejected as inadmissible, as unfounded with regard to refugee status or subsidiary protection status, as explicitly withdrawn or as abandoned, the reasons in fact and in law shall be stated in the decision.
Kadar se prošnja zavrže kot nedopustna, zavrne kot neutemeljena v zvezi s statusom begunca ali statusom subsidiarne zaščite ali zavrže kot izrecno umaknjena ali zaradi odstopa, se v odločitvi navedejo dejanski in pravni razlogi.
Where an application is subject to the procedure laid down in Regulation (EU) No XXX/XXX (Dublin Regulation), the time-limit referred to in paragraph 2 shall start to run from the moment the Member State responsible is determined in accordance with that Regulation, the applicant is on the territory of that Member State and he or she has been taken in charge in accordance with Regulation (EU) No XXX/XXX (Dublin Regulation).
Kadar se prošnja obravnava po postopku, določenem v Uredbi (EU) XXX/XXX (dublinska uredba), rok iz odstavka 2 začne teči v trenutku, ko se v skladu z navedeno uredbo določi odgovorna država članica, prosilec pa je na ozemlju navedene države članice in pod njenim nadzorom v skladu z Uredbo (EU) XXX/XXX (dublinska uredba).
Where an application is subject to the procedure laid down in Regulation (EU) No XXX/XXX (Dublin Regulation), the time-limits referred to in paragraph 2 shall start to run from the moment the Member State responsible is determined in accordance with that Regulation, the applicant is on the territory of that Member State and he or she has been taken in charge in accordance with Regulation (EU) No XXX/XXX (Dublin Regulation).
Kadar se prošnja obravnava po postopku, določenem v Uredbi (EU) XXX/XXX (dublinska uredba), roki iz odstavka 2 začnejo teči od trenutka, ko se v skladu z navedeno uredbo določi odgovorna država članica, prosilec pa je na ozemlju navedene države članice in pod njenim nadzorom v skladu z Uredbo (EU) XXX/XXX (dublinska uredba).
Where an application meets the requirements of this Regulation and where no notice of opposition has been given within the period referred to in Article 41(1) or where opposition has been rejected by a definitive decision, the trade mark shall be registered as a Community trade mark, provided that the registration fee has been paid within the period prescribed.
Če prijava ustreza zahtevam te uredbe in če v roku iz člena 41(1) nihče ni vložil pisnega ugovora ali če je bil ugovor zavrnjen z dokončno odločbo, se blagovna znamka registrira kot blagovna znamka Skupnosti, pod pogojem, da je bila pristojbina za registracijo plačana v določenem roku.
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 finds that the manufacturer has failed to comply with his obligations regarding access to vehicle OBD and vehicle repair and maintenance information, the approval authority that granted the relevant type-approval shall take appropriate measures to remedy the situation.
Če homologacijski organ ugotovi, da proizvajalec ne izpolnjuje svojih obveznosti glede dostopa do informacij o OBD vozila ter popravilu in vzdrževanju vozil, homologacijski organ, ki je podelil ustrezno homologacijo, sprejme vse ustrezne ukrepe za izboljšanje stanja.
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 area is at risk from different concurrent soil degradation processes, Member States may adopt a single programme in which appropriate risk reduction targets are to be set for all the risks identified together with the appropriate measures for reaching those targets.
Če območje hkrati ogrožajo različni procesi degradacije, lahko države članice sprejmejo posamezen program, v katerem opredelijo ustrezne cilje glede zmanjševanja tveganja za vse ugotovljene nevarnosti in ustrezne ukrepe za dosego teh ciljev.
Where an asset is disposed of, voluntarily or involuntarily, during a tax year, its value for tax purposes and the value for tax purposes of any improvement costs incurred in relation to the asset shall be deducted from the tax base in that year.
Kadar je sredstvo prostovoljno ali neprostovoljno odtujeno med davčnim letom, se njegova vrednost za davčne namene in vrednost za davčne namene kakršnih koli stroškov izboljšav, ki nastanejo v zvezi s sredstvom, odbijeta od davčne osnove v navedenem letu.
Where an asset is transferred from a MS which allows transfer at book value to a MS which would usually value the transferred asset at market value, MSs should take appropriate measures to avoid double non-taxation of the difference between the book value of the asset and its market value at the moment of transfer.
Če je sredstvo preneseno iz države članice, ki dovoli prenos po knjigovodski vrednosti, v državo članico, ki bi ponavadi vrednotila preneseno sredstvo po tržni ceni, morajo države članice sprejeti primerne ukrepe, da bi se izognile dvojnemu neobdavčevanju razlike med knjigovodsko vrednostjo sredstva in njegovo tržno vrednostjo pri prenosu.
Where an asset manager casts votes on behalf of an institutional investor, the institutional investor shall make a reference as to where such voting information has been published by the asset manager.
Če upravljavec premoženja glasuje v imenu institucionalnega vlagatelja, institucionalni vlagatelj navede sklic na mesto objave takih informacij o glasovanju s strani upravljavca premoženja.
Where an asset manager invests on behalf of an institutional investor, either on a discretionary client-by-client basis or through a collective investment undertaking, the institutional investor shall annually disclose to the public the main elements of the arrangement with the asset manager with regard to the following issues:
Če upravljavec premoženja vlaga v imenu institucionalnega vlagatelja, bodisi po lastni presoji za vsako stranko posebej bodisi prek kolektivnih naložbenih podjemov, institucionalni vlagatelj javnosti vsako leto razkrije glavne elemente dogovora z upravljavcem premoženja v zvezi z naslednjimi vprašanji:
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 asylum seeker is held in detention he/she should be able to have effective access to the necessary procedural guarantees such as judicial remedy before a national court.
Prosilcem za azil bi morala biti ob pridržanju dana dejanska možnost uveljavljanja potrebnih procesnih jamstev, kot je na primer pravno sredstvo pred nacionalnim sodiščem.
Where an asylum seeker is held in detention he/she should have a right to a judicial remedy before national court.
Ko je prosilec za azil pridržan, bi moral imeti pravico do pravnega sredstva pred nacionalnim sodiščem.
Where an audit based on internationally accepted standards providing reasonable assurance has been conducted by an independent auditor on the financial statements and reports setting out the use of the Union contribution, that audit shall form the basis of the overall assurance, as futher specified, where appropriate, in sector specific rules.
Če revizijo, temelječo na mednarodno sprejetih standardih, ki zagotavljajo razumno zagotovilo, v zvezi z računovodskimi izkazi in poročili, v katerih je opredeljena uporaba prispevka Unije, izvede neodvisen revizor, je ta revizija osnova za splošno zagotovilo, ki je po potrebi podrobneje določeno v pravilih za posamezni sektor.
Where an audit firm carries out the statutory audit, the additional report to the audit committee shall be signed by at least the statutory auditor(s) carrying out the statutory audit on behalf of the audit firm.
Kadar revizijsko podjetje izvaja obvezno revizijo, podpišejo dodatno poročilo revizijski komisiji vsaj zakoniti revizorji, ki izvajajo obvezno revizijo v imenu revizijskega podjetja.
Where an audit firm carries out the statutory audit, the audit report shall be signed by at least the statutory auditor(s) carrying out the statutory audit on behalf of the audit firm.
Kadar revizijsko podjetje izvaja obvezno revizijo, podpišejo revizijsko poročilo vsaj zakoniti revizorji, ki izvajajo obvezno revizijo v imenu revizijskega podjetja.
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 audit firm generates more than one third of its annual audit revenues from large public-interest entities, it shall make public a corporate governance statement.
Kadar revizijsko podjetje ustvari več kot eno tretjino svojih letnih prihodkov od revizije z revizijo subjektov javnega interesa, objavi izjavo o upravljanju.
Where an authorisation is granted to a mollusc farming area in accordance with Article 4(2), the data required under point 1(a) of this Part shall be recorded for all aquaculture production businesses which operate inside the mollusc farming area.
Kjer se območju gojenja mehkužcev odobri pooblastilo v skladu s členom 4(2), se zahtevani podatki iz točke 1 (a) tega dela zabeležijo za vse dejavnosti ribogojne proizvodnje, ki delujejo znotraj območja gojenja mehkužcev.
Where an authorised AIFM intends to market to professional investors the units or shares of an AIF it manages in another Member State, it shall submit the following documents to the competent authorities of its home Member State:
Če namerava UAIS, ki ima dovoljenje, profesionalnim vlagateljem tržiti enote ali deleže AIS, ki ga upravlja v drugi državi članici, pristojnim organom v matični državi članici predloži naslednje dokumente:
Where an authority of a Member State considers the placement of a child in a foster family or in an institution in another Member State, a consultation procedure through the Central Authorities of both Member States concerned should be carried out prior to the placement.
Kadar organ države članice razmišlja o namestitvi otroka v oskrbo rejniške družine ali zavoda v drugi državi članici, bi bilo treba pred namestitvijo izvesti postopek posvetovanja prek osrednjih organov obeh zadevnih držav članic.
Where an authority of a Member State has already given a decision in matters of parental responsibility or is contemplating such a decision and the implementation is to take place in another Member State, the authority may request that the authorities of that other Member State assist in the implementation of the decision.
Kadar je organ države članice že izdal odločbo v sporu v zvezi s starševsko odgovornostjo ali razmišlja o taki odločbi, ki naj bi se izvrševala v drugi državi članici, lahko zaprosi organe navedene druge države članice za pomoč pri njenem izvrševanju.
Where an automatic monitoring system has been installed, the Member States shall ensure that the hydrocarbon capture efficiency is tested at least once every three years.
Če je sistem za samodejno spremljanje nameščen, države članice zagotovijo, da se učinkovitost zajetja ogljikovodika preskusi vsaj enkrat na tri leta.
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.