natgillin/translations-raw huggingface dataset:
Competent authorities shall evaluate all adverse events reported to them by healthcare professionals and animal holders, manage risks and take the measures referred to in Articles 130 to 135 concerning marketing authorisations where necessary.
Pristojni organi ocenijo vse neželene dogodke, o katerih so jim poročali zdravstveni delavci in imetniki živali, obvladujejo tveganja in po potrebi sprejmejo ukrepe v zvezi z dovoljenji za promet iz členov 130 do 135.
Competent authorities shall evaluate dose response data generated in trials (which must include an untreated control) involving dose rates lower than the recommended rate, in order to assess if the recommended dose is the minimum necessary to achieve the desired effect.
Pristojni organi ocenijo v preskusih pridobljene podatke o odzivu na odmerke (preskus mora vključevati tudi netretiran kontrolni predmet), ter odzive na odmerke, ki so manjši od priporočenih, da bi ocenili, ali je priporočeni odmerek resnično najmanjši potreben odmerek za doseganje želenega učinka.
Competent authorities shall examine the institution's capability to perform back-testing on both actual and hypothetical changes in the portfolio's value.
Pristojni organi preverijo sposobnost institucije, da izvaja testiranje za nazaj za dejanske in hipotetične spremembe vrednosti portfelja.
Competent authorities shall exchange information regarding the studies submitted and their implications for any marketing authorisations concerned.
Pristojni organi si izmenjajo informacije glede predloženih študij in njihovih vplivov na katero koli dovoljenje za promet.
Competent authorities shall exchange information regarding the studies submitted and their implications for any marketing authorisations concerned.
Pristojni organi si izmenjajo informacije glede predloženih študij in njihovih vplivov na zadevno dovoljenje za promet.
Competent authorities shall exercise the powers to impose administrative sanctions and remedial measures referred to in Article 17 of this Regulation in accordance with their national legal frameworks:
Pristojni organi pooblastila za nalaganje upravnih sankcij in popravnih ukrepov iz člena 17 te uredbe izvajajo v skladu s svojim nacionalnim pravnim okvirom:
Competent authorities shall exercise their functions and powers, referred to in paragraph 1, in any of the following ways:
Pristojni organi izvajajo funkcije in pooblastila iz odstavka 1 na katerega koli od naslednjih načinov:
Competent authorities shall facilitate full access to the procedures mentioned in paragraph 1 to those beneficiaries of international protection who cannot provide documentary evidence of their qualifications without prejudice to Articles 2(2) and 3(3) of Directive 2005/36/EC of the European Parliament and of the Council46.
Pristojni organi olajšajo popoln dostop do postopkov v iz odstavka 1 za navedene upravičence do mednarodne zaščite, ki ne morejo predložiti dokumentarnih dokazil o svojih kvalifikacijah, brez poseganja v člen 2(2) in člen 3(3) Direktive 2005/36/ES Evropskega parlamenta in Sveta46.
Competent authorities shall facilitate the transfer or lease of rights of use for radio spectrum by giving timely consideration to any request to adapt the conditions attached to the right and by ensuring that the rights or the radio spectrum attached thereto may to the best extent be partitioned or disaggregated.
Pristojni organi olajšajo prenos ali dajanje v zakup pravic do uporabe radiofrekvenčneg spektra, tako da pravočasno obravnavajo vsako zahtevo za spremembo pogojev, vezanih na pravico, in zagotovijo, da je mogoče pravice ali radiofrekvenčni spekter, povezan z njimi, v največji možni meri razdeliti ali razčleniti.
Competent authorities shall grant permission for an institution to use the internal models approach set out in Article 150(4) provided the institution meets the requirements set out in Sub-section 4 of Section 6.
Pristojni organi instituciji izdajo dovoljenje za uporabo pristopa notranjih modelov iz člena 150(4), če institucija izpolnjuje zahteve iz pododdelka 4 oddelka 6.
Competent authorities shall grant such authorisations to self-handlers in an efficient and expedient manner.
Pristojni organ mora takšna dovoljenja samoizvajalcev izdati na učinkovit in prikladen način.
Competent authorities shall grant such permission only if they verify that the model properly captures the effects of margining when estimating EE.
Pristojni organi to dovolijo, samo če potrdijo, da model ustrezno zajame učinke oblikovanja kritja pri ocenjevanju EE.
Competent authorities shall have the power to request an EU parent, that is not a regulated entity but that has at least one subsidiary which is a regulated entity, to ensure that its regulated subsidiaries comply with this Regulation.
Pristojni organi imajo pooblastilo, da od obvladujočega podjetja v EU, ki ni reguliran subjekt, a ima vsaj eno odvisno podjetje, ki je reguliran subjekt, zahteva, da zagotovi, da njegova regulirana odvisna podjetja zagotavljajo skladnost s to uredbo.
Competent authorities shall in that case determine one of the institutions subject to the waiver to meet Article 401on the basis of the consolidated situation of all institutions of the single liquidity sub-group.
Pristojni organi v tem primeru določijo eno od institucij, za katero velja opustitev uporabe člena 401 na podlagi konsolidiranega stanja vseh institucij ene likvidnostne podskupine.
Competent authorities shall inform each other accordingly.
Pristojni organi se v skladu s tem med sabo obveščajo.
Competent authorities shall inform ESMA of all administrative sanctions or measures imposed but not published in accordance with Article 40(2)(c) including any appeal in relation thereto and the outcome thereof.
Pristojni organi obvestijo ESMA o vseh upravnih sankcijah ali ukrepih, ki so bili naloženi, vendar niso bili objavljeni v skladu s členom 40(2)(c), vključno z vsako pritožbo v zvezi z njimi in njenim rezultatom.
Competent authorities shall inform ESMA, EBA and EIOPA of all administrative sanctions and remedial measures imposed, including, where appropriate, any appeal in relation thereto and the outcome thereof.
Pristojni organi obvestijo EBA, EIOPA in ESMA o vseh naloženih upravnih sankcijah in popravnih ukrepih in, kadar je to primerno, o morebitnih pritožbah v zvezi z njimi ter o izidu takih pritožb.
Competent authorities shall inform ESMA, without undue delay, of any sanction or measure adopted for breach of this Regulation.
Pristojni organi o vsaki sankciji ali ukrepu, ki se sprejme zaradi kršitve te uredbe, takoj obvestijo ESMA.
Competent authorities shall inform immediately the European Securities and Markets Authority of any extension granted to any compensation schemes and the circumstances justifying such extension.
Pristojni organi o vsakem podaljšanju, odobrenem za katero koli odškodninsko shemo, in okoliščinah, ki tako podaljšanje upravičujejo, takoj obvestijo Evropski organ za vrednostne papirje in trge.
Competent authorities shall inform the Authority of delegation agreements they intend to enter into.
Pristojni organi obvestijo organ o sporazumih o prenosu pooblastil, ki jih nameravajo skleniti.
Competent authorities shall inform the relevant resolution authorities of any measures they require an institution to take under Article 22 of this Directive or Article 136(1) of Directive 2006/48/EC.
Pristojni organi obvestijo ustrezne organe za reševanje o katerih koli ukrepih, za katere zahtevajo, da jih mora institucija sprejeti v skladu s členom 22 te direktive ali členom 136(1) Direktive 2006/48/ES.
Competent authorities shall issue travel documents with the minimum security features and biometrics outlined in Regulation (EC) No 2252/2004 to beneficiaries of subsidiary protection status who are unable to obtain a national passport.
Pristojni organi izdajo potne listine z minimalnimi varnostnimi značilnostmi in biometričnimi podatki, določenimi v Uredbi (ES) št. 2252/2004, upravičencem do statusa subsidiarne zaščite, ki ne morejo pridobiti nacionalnega potnega lista.
Competent authorities shall keep an updated list containing the names and addresses of operators and groups of operators that have notified their activities in accordance with paragraph 1 and shall make that list public, together with the information relating to their organic certificates as referred to in Article 25(1).
Pristojni organi vodijo posodobljen seznam z imeni in naslovi izvajalcev dejavnosti in skupin izvajalcev dejavnosti, ki so priglasili svoje dejavnosti v skladu z odstavkom 1, ter objavijo navedeni seznam skupaj z informacijami v zvezi s potrdilom o ekološki pridelavi iz člena 25(1).
Competent authorities shall keep records of the checks referred to in Article 7(1), indicating in particular their nature and results, including any corrective measures requested to be taken.
Pristojni organi hranijo evidence pregledov iz člena 7(1), v katerih so navedeni zlasti njihova vrsta in rezultati, vključno z vsemi zahtevanimi korektivnimi ukrepi.
Competent authorities shall make public the appointment of a special manager.
Pristojni organi javno objavijo imenovanje posebnega upravitelja.
Competent authorities shall make public, for the general information of the sectors concerned in the Community the authorisations which are going to expire, at least six months before their date of expiry.
Pristojni organ za splošno informacijo zadevnih sektorjev v Skupnosti javno objavi dovoljenja, ki jim bo potekla veljavnost, najmanj šest mesecev pred potekom.
Competent authorities shall make publicly available an explanation of the recognition process, and a list of eligible ECAIs.
Pristojni organi javno objavijo razlago procesa priznanja in seznam primernih ECAI.
Competent authorities shall make the assessment report publicly available, after deleting any commercially confidential information.
Pristojni organi poročilo o oceni objavijo po izbrisu vseh poslovno zaupnih informacij.
competent authorities shall means the national authorities which are empowered by law or regulation to supervise investment firms
pristojni organi pomenijo nacionalne organe, ki so z zakonom ali podzakonskim aktom pooblaščeni za nadzorovanje investicijskih družb,
Competent authorities shall not make use of the powers provided for in paragraph 1 and Article 22 before communicating a motivated draft decision to CESR.
Pristojni organi ne uporabijo pooblastil, predvidenih v odstavku 1 in členu 22, preden ne posredujejo CESR utemeljenega osnutka odločitve.
Competent authorities shall notify the Commission within two months of any decision to grant, refuse or withdraw recognition to a monitoring organisation.
Pristojni organi v dveh mesecih uradno obvestijo Komisijo o vsaki odločitvi o odobritvi, zavrnitvi ali preklicu priznanja nadzorne organizacije.
Competent authorities shall oversee that operators meet this obligation.
Pristojni organi nadzorujejo, ali izvajalci to obveznost izpolnjujejo.
Competent authorities shall perform controls of manufacturers, importers, marketing authorisation holders, wholesale distributors and suppliers of the veterinary medicinal products regularly, on a risk-basis, in order to verify that the requirements as set out in this Regulation are complied with.
Pristojni organi izvajajo redne kontrole proizvajalcev, uvoznikov, imetnikov dovoljenj za promet, prodajaln na debelo in dobaviteljev zdravil za uporabo v veterinarski medicini na podlagi tveganja, da se preveri, ali so zahteve iz te uredbe izpolnjene.
Competent authorities shall provide each other with all relevant information, in particular in the case of infringements or suspected infringements by a branch, a tied agent or a subsidiary.
Pristojni organi si med seboj zagotovijo vse ustrezne informacije, zlasti v primeru kršitev ali domnevnih kršitev s strani podružnice, vezanega zastopnika ali hčerinske družbe.
Competent authorities shall provide ESMA and one another with the information required for the purposes of carrying out their duties under this Regulation.
Pristojni organi med sabo in z organom ESMA izmenjujejo informacije, potrebne za opravljanje dolžnosti, ki jih imajo po tej uredbi.
Competent authorities shall provide information in summary form to ESMA on a quarterly basis on net short positions relating to shares or sovereign debt, and uncovered positions relating to credit default swaps, for which it is the relevant competent authority and receives notifications under Articles 5 to 8.
Pristojni organi vsako četrtletje organu ESMA predložijo povzetek informacij o neto kratkih pozicijah v delnicah ali državnih dolžniških instrumentih ter nekritih pozicijah v zamenjavah kreditnega tveganj, katerih zadevni pristojni organ so in prejemajo priglasitve v skladu s členi 5 do 8.
Competent authorities shall provide on their websites guidance on the scrutiny and approval process in order to facilitate efficient and timely approval of prospectuses.
Pristojni organi na svojih spletnih mestih zagotovijo smernice o postopku pregleda in odobritve, da se zagotovi pravočasna odobritev prospektov.
Competent authorities shall publish and maintain the list of those other eligible providers of unfunded credit protection, or the guiding criteria for identifying such other eligible providers of unfunded credit protection, together with a description of the applicable prudential requirements, and share their list with other competent authorities in accordance with Article 112 of Directive [inserted by OP].
Pristojni organi objavijo in vzdržujejo seznam navedenih primernih dajalcev osebnega kreditnega zavarovanja ali smernice za določanje takšnih primernih dajalcev osebnega kreditnega zavarovanja skupaj z opisom veljavnih zahtev glede varnega in skrbnega poslovanja ter svoj seznam delijo z drugimi pristojnimi organi v skladu s členom 112 Direktive [vstavi OP].
Competent authorities shall recognise an ECAI as eligible for the purposes of Article 80 only if they are satisfied that its assessment methodology complies with the requirements of objectivity, independence, ongoing review and transparency, and that the resulting credit assessments meet the requirements of credibility and transparency.
Pristojni organi priznajo ECAI kot primerno za namene člena 80 le, če se prepričajo, da njena metodologija za ocenjevanje izpolnjuje zahteve po objektivnosti, neodvisnosti, nenehnem preverjanju in preglednosti, ter da bonitetna ocena, ki jo izdela, izpolnjuje zahteve po verodostojnosti in preglednosti.
Competent authorities shall recognise monitoring organisations which apply for such recognition, if the monitoring organisation complies with the following requirements:
Pristojni organi priznajo nadzorno organizacijo, ki vloži zahtevek za takšno priznanje, če izpolnjuje naslednje zahteve:
Competent authorities shall record in the manufacturing and wholesale distribution database information on authorisations and certificates granted in accordance with Articles 93, 103 and 105 together with information on the veterinary medicinal products covered by the authorisations, using the format referred to in paragraph 3.
Pristojni organi v zbirki podatkov o proizvodnji in prodaji na debelo z uporabo obrazca iz odstavka 3 evidentirajo informacije o dovoljenjih in potrdilih, izdanih v skladu s členi 93, 103 in 105, skupaj z informacijami o zdravilih za uporabo v veterinarski medicini, za katera so bila izdana dovoljenja.
Competent authorities shall record in the pharmacovigilance database all adverse events which were reported to them by healthcare professionals and animal holders and that occurred in the territory of their Member State, within 30 days following the receipt of the adverse event report.
Pristojni organi v 30 dneh od prejema poročila o neželenem dogodku v zbirki podatkov o farmakovigilanci evidentirajo vse neželene dogodke, o katerih so poročali zdravstveni delavci in imetniki živali in ki so se zgodili na ozemlju njihove države članice.
Competent authorities shall regularly monitor compliance of the recipient with the criteria referred to in paragraph 2, and with any condition attached to the certificates referred to in paragraph 4.
Pristojni organi redno spremljajo skladnost prejemnika z merili iz odstavka 2 in s katerimi koli pogoji, dodanimi dovoljenjem iz odstavka 4.
Competent authorities shall regularly report to the Gas Coordination Group on the progress achieved on the preparation and adoption of the preventive action plans and the emergency plans.
Pristojni organi koordinacijski skupini za plin redno poročajo o napredku, doseženem pri pripravi in sprejetju preventivnih načrtov ukrepov in načrtov za izredne razmere.
Competent authorities shall report to the Gas Coordination Group on the agreed cooperation mechanism for conducting the risk assessment 18 months before the deadline for the adoption of the risk assessment and the updates of the risk assessment.
Pristojni organi koordinacijski skupini za plin poročajo o dogovorjenem mehanizmu sodelovanja za izvajanje ocene tveganja 18 mesecev pred iztekom roka za sprejetje ocene tveganja in posodobitve ocene tveganja.
Competent authorities shall require credit institutions to hold own funds against operational risk in accordance with the approaches set out in Articles 103, 104 and 105.
Pristojni organi od kreditnih institucij zahtevajo, da vzdržujejo lastne vire sredstev za operativna tveganja v skladu s pristopi iz členov 103, 104 in 105.
Competent authorities shall require institutions to take appropriate measures to improve their back-testing programme if deemed deficient.
Pristojni organi od institucij zahtevajo, da sprejmejo potrebne ukrepe za izboljšanje svojih programov testiranja za nazaj, če so ti pomanjkljivi.
Competent authorities shall require subsidiary credit institutions to apply the requirements laid down in Articles 75, 120, 123 and Section 5 on a sub-consolidated basis if those credit institutions, or the parent undertaking where it is a financial holding company, have a credit institution or a financial institution or an asset management company as defined in Article 2(5) of Directive 2002/87/EC as a subsidiary in a third country, or hold a participation in such an undertaking.
Pristojni organi zahtevajo, da hčerinske kreditne institucije izpolnjujejo zahteve iz členov 75, 120, 123 in oddelka 5 na podkonsolidirani osnovi, če imajo navedene kreditne institucije, ali matično podjetje v primerih, kadar je to finančni holding, v tretji državi hčerinsko podjetje, ki je kreditna institucija ali finančna institucija ali družba za upravljanje s premoženjem, kakor je opredeljeno v členu 2(5) Direktive 2002/87/ES, ali če so udeležene v takem podjetju.
Competent authorities shall require that every investment firm, as well as meeting the requirements in Article 13 of Directive 2004/39/EC, shall meet the requirements in Articles 22 and 123 of Directive [2000/12/EC].
Pristojni organi zahtevajo, da vsaka investicijska družba poleg zahtev iz člena 13 Direktive 2004/39/ES izpolni zahteve iz členov 22 in 123 Direktive [2000/12/ES].
Competent authorities shall require the institutions to calculate overshootings consistently on the basis of back-testing either on actual or on hypothetical changes in the portfolio's value.
Pristojni organi zahtevajo, da institucije dosledno izračunavajo ta preseganja s testiranjem za nazaj bodisi dejanskih ali hipotetičnih sprememb vrednosti portfelja.
Competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the product into compliance, the withdrawal of the product from the market or its recall within a given reasonable time limit, commensurate with the nature of the risk, where there is non compliance with any of the following:
Pristojni organi od pristojne osebe zahtevajo, da sprejme vse ustrezne ukrepe, vključno s korektivnimi ukrepi za vzpostavitev skladnosti izdelka, umik izdelka s trga, ali odpoklic v razumnem roku, sorazmerno z naravo tveganja, kadar niso izpolnjene naslednje zahteve:
Competent authorities shall review compliance with the previous sentence at least yearly.
Pristojni organi najmanj enkrat letno preverijo skladnost s prejšnjim stavkom.
Competent authorities shall review the relative volatility of loss rates across the qualifying revolving retail sub-portfolios, as well the aggregate qualifying revolving retail portfolio, and shall share information on the typical characteristics of qualifying revolving retail loss rates across Member States.
Pristojni organi pregledajo relativno nestanovitnost stopenj izgub v podportfeljih kvalificiranih obnavljajočih se izpostavljenosti do neprofesionalnih strank in skupni podportfelj kvalificiranih obnavljajočih se izpostavljenosti do neprofesionalnih strank ter si izmenjujejo informacije o tipičnih značilnostih stopenj izgub kvalificiranih obnavljajočih se izpostavljenosti do neprofesionalnih strank v državah članicah.
Competent authorities shall take all appropriate measures to encourage the reporting of adverse events by healthcare professionals and animal holders.
Pristojni organi sprejmejo vse ustrezne ukrepe za spodbujanje poročanja zdravstvenih delavcev in imetnikov živali o neželenih dogodkih.
Competent authorities shall take into account such information received, as well as applicable European and international standards, in making their own decisions with regard to the exemption of corresponding practices.
Pristojni organi upoštevajo prejete informacije ter veljavne evropske in mednarodne standarde pri sprejemanju odločitev v zvezi z izvzetjem zadevnih dejavnosti.
Competent authorities shall take measures to ensure effective cooperation at Union level in respect of quality assurance reviews.
Pristojni organi sprejmejo ukrepe za zagotovitev uspešnega sodelovanja na ravni Unije v zvezi s pregledi zagotavljanja kakovosti.
Competent authorities shall take the necessary arrangements for biocidal products which have been placed on the market on their own or incorporated in treated materials to be monitored to establish whether they comply with the requirements of this Regulation.
Pristojni organi uredijo vse potrebno za nadzor biocidnih pripravkov, ki so bili dani v promet sami ali kot del tretirane snovi, da se ugotovi, ali izpolnjujejo zahteve te uredbe.
Competent authorities shall timely consult and inform interested parties regarding conditions attached to individual usage rights and general authorisations in advance of their imposition.
Pristojni organi se pravočasno posvetujejo z zainteresiranimi stranmi in jih obveščajo o pogojih, vezanih na individualne pravice do uporabe in splošne odobritve, še pred njihovo uvedbo.
Competent authorities shall update in the Community Register for Biocidal Products the information relating to biocidal products which have been authorised within their territory or for which a national authorisation has been refused, amended, renewed or cancelled.
Pristojni organi posodabljajo v Registru biocidnih pripravkov Skupnosti informacije o biocidnih pripravkih, ki so dovoljeni na njihovem ozemlju ali za katere je bilo nacionalno dovoljenje zavrnjeno, spremenjeno, obnovljeno ali preklicano.
Competent authorities shall use their powers for the purpose of co-operation, even in cases where the conduct under investigation does not constitute an infringement of any regulation in force in that Member State.
Pristojni organi lahko uporabijo svoja pooblastila za namen sodelovanja tudi v primerih, ko preiskovano ravnanje ne predstavlja kršitve katere koli od določb, ki veljajo v zadevni državi članici.
Competent authorities shall use their powers for the purpose of cooperation, even in cases where the conduct under investigation does not constitute an infringement of any regulation in force in that Member State.
Pristojni organi uporabijo svoja pooblastila za namen sodelovanja tudi v primerih, ko preiskovano ravnanje ne predstavlja kršitve nobene od določb, ki veljajo v zadevni državi članici.
Competent authorities shall verify by means of inspections referred to in Article 125 that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this Section.
Pristojni organi z inšpekcijskimi pregledi iz člena 125 preverijo, ali imetniki dovoljenj za promet izpolnjujejo zahteve glede farmakovigilance, določene v tem oddelku.