natgillin/translations-raw huggingface dataset:
The Paediatric Committee shall review these changes and adopt an opinion proposing their refusal or acceptance.
Odbor za pediatrijo pregleda te spremembe in sprejme mnenje, s katerim predlaga njihovo zavrnitev ali odobritev.
The Paediatric Committee shall take into account any information available to it, including any opinions, decisions or advice given by the competent authorities of third countries.”
Odbor za pediatrijo upošteva kakršne koli podatke, ki jih ima na voljo, vključno z vsemi mnenji, odločitvami ali nasveti pristojnih organov tretjih držav.“
The Paediatric Committee should be primarily responsible for the assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof, and it should also be central to various support measures contained in this Regulation.
Odbor za pediatrijo bi moral biti primarno odgovoren za presojo in dogovor o načrtih pediatričnih preiskav ter za sistem opustitev in odlogov ter biti tudi središče za različne podporne ukrepe, ki so vsebovani v tej uredbi.
The Paediatric Committee should be primarily responsible for the assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof.
Odbor za pediatrijo bi moral biti primarno odgovoren za presojo in dogovor o načrtih pediatričnih preiskav ter za sistem opustitev in odlogov.
The Paediatric Committee should follow existing Community requirements, including Directive 2001/20/EC, as well as International Conference on Harmonisation (ICH) guideline E11 on the development of medicines for children, and it should avoid any delay in the authorisation of medicines for other populations as a result of the requirements for studies in children.”
Odbor za pediatrijo bi moral slediti obstoječim zahtevam Skupnosti, vključno z Direktivo 2001/20/ES kot tudi smernico E11 Mednarodne konference o usklajevanju (ICH) o razvoju zdravil za otroke ter se izogniti vsaki zamudi pri odobritvi zdravil za druge populacije, ki je lahko posledica zahtev za študije pri otrocih.“
The Paediatric Committee will be responsible primarily for the assessment and agreement of paediatric investigation plans and requests for waivers and deferrals described below.
Odbor za pediatrijo bo primarno odgovoren za presojo in dogovor o načrtih pediatričnih preiskav ter za zahtevke za opustitve in odloge, ki so opisani v nadaljevanju.
The Paediatric Committee will start work as soon as it is set up, on lists of waivers of specific medicinal products and classes of medicinal product.
Odbor za pediatrijo bo začel z delom na seznamu opustitev za posebna zdravila in razrede zdravil takoj, ko bo vzpostavljen.
The Paediatric Committee’s general criteria for approving the paediatric investigation plan (PIP) should take account of the recommendations of the relevant International Conference on Harmonisation6, and should comply with directive 2001/20/EC on clinical trials in order to ensure compliance with the ethical conditions for the trials themselves.
Za zagotovitev spoštovanja etičnih vrednot pri preskusih bi morala splošna merila Odbora za pediatrijo za odobritev načrta pediatričnih preiskav (PIP) upoštevati priporočila ustrezne Mednarodne konference o usklajevanju (ICH)6 in se uskladiti z Direktivo 2001/20/ES o kliničnih preskusih.
The paediatric investigation plan shall specify the timing and the measures proposed to assess the quality, safety and efficacy of the medicinal product in all subsets of the paediatric population that may be concerned.
Načrt pediatričnih preiskav določi časovnost in ukrepe, predlagane za presojo kvalitete, varnosti in učinkovitosti zdravila pri vseh delih pediatrične populacije, ki so lahko udeleženi.
The paediatric investigation plan should be the basis upon which compliance with that requirement is judged.
Načrt pediatričnih preiskav bi moral biti podlaga za presojo skladnosti s to zahtevo.
The paediatric investigation plan should include details of the timing and the measures proposed to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population.
Načrt pediatričnih preiskav bi moral vključevati podrobnosti glede časovnega poteka in predlaganih ukrepov za dokazovanje kvalitete, varnosti in učinkovitosti zdravil pri pediatrični populaciji.
The paediatric investigation plan will be the basis upon which compliance with this requirement is judged.
Načrt pediatričnih preiskav bo osnova za presojo skladnosti s to zahtevo.
The paediatric investigation plan will be the document upon which the studies in children are based and will have to be agreed by the Paediatric Committee.
Načrt pediatričnih preiskav bo dokument, na katerem bodo temeljile študije pri otrocih in ki bo moral biti dogovorjen z Odborom za pediatrijo.
The paediatric population is a vulnerable group that differs from the adult population because of its specific developmental, physiological and psychological characteristics, which makes age and development related research of medicines particularly important.
Pediatrična populacija je ranljiva skupina, ki se razvojno, fizično in psihično razlikuje od odrasle populacije, zaradi česar so raziskave zdravil v povezavi s starostjo in razvojem še posebno pomembne.
The paediatric population is a vulnerable group with developmental, physiological and psychological differences from adults, which makes age and development related research of medicines particularly important.
Pediatrična populacija je ranljiva skupina, ki se razvojno, fizično in psihično razlikuje od odraslih, zaradi česar so raziskave zdravil v povezavi s starostjo in razvojem posebej pomembne.
The paediatric regulation aims to ensure that children throughout the EU are provided with safe and effective medicines, and this is achieved through the requirement that an extension of the supplementary protection certificate is available only if the product is authorised in all Member States.
Uredba o pediatriji želi zagotoviti, da so otrokom v EU na voljo varna in učinkovita zdravila, to pa je doseženo z zahtevo, da je podaljšanje veljavnosti dodatnega varstvenega certifikata mogoče le, če je proizvod odobren v vseh državah članicah.
The Paediatric Use Marketing Authorisation (PUMA)
Dovoljenje za promet za pediatrično uporabo (PUMA – Pediatric Use Marketing Authorisation)
The pages of this section should be clearly branded with the Network's logo.
Strani tega razdelka bi morale biti jasno označene z logotipom mreže.
The paid-in capital of the EIF is currently EUR 600 million (i.e. 20 % of subscribed capital).
Vplačani kapital EIS znaša trenutno 600 milijonov EUR (tj. 20 % vpisanega kapitala).
the paid-up share capital or, in the case of a mutual assurance undertaking, the effective initial fund plus any members' accounts which meet all the following criteria:
vplačani osnovni kapital ali, če gre za družbo za vzajemno zavarovanje, dejanski ustanovni kapital plus računi katerega koli družbenika, ki izpolnjujejo naslednja merila:
The Palace of Justice, a major infrastructure project in support to the improvement of the rule of law in Kosovo, was completed at the end of 2014.
Pravosodna palača, obsežen infrastrukturni projekt za podporo izboljšanju pravne države na Kosovu, je bila končana konec leta 2014.
The palm oil produced is destined for export.
Olje je namenjeno izvozu.
The palpable uncertainty regarding the legal situation in cross-border services must be countered with an information strategy at national and EU level.
Proti ugotovljeni negotovosti glede pravnega stanja pri čezmejnih storitvah se je treba bojevati z informacijsko strategijo na nacionalni ravni in ravni EU.
The palpable uncertainty regarding the legal situation in cross-border services must be countered with an information strategy at national and EU level.
Proti ugotovljeni negotovosti glede zakonodajnih predpisov s področja čezmejnih storitev se je treba bojevati z informacijsko strategijo na nacionalni ravni in ravni EU.
The pan European dimension of eGovernment and the concept of interoperability
Vseevropska razsežnost e-uprave in koncept interoperabilnosti
The Pan-African programme in the DCI will support the implementation of the Africa-EU Strategic Partnership in complementarity with other instruments for cooperation with African countries and regions.
vseafriški program v okviru DCI bo namenjen podpori izvajanja strateškega partnerstva med EU in Afriko, pri čemer bo dopolnjen z drugimi instrumenti za sodelovanje z afriškimi državami in regijami.
The Pan-African programme shall support the objectives and general principles of the Joint Africa-EU Strategy, in particular:
Vseafriški program podpira cilje in splošna načela skupne strategije Afrika-EU, zlasti:
The Pan-African programme will further promote complementarity and consistency with other financial instruments of the Union's external action, notably the European Development Fund and the European Neighbourhood Instrument.
Vseafriški program bo nadalje spodbujal dopolnjevanje in skladnost z drugimi finančnimi instrumenti zunanjega ukrepanja Unije, predvsem z Evropskim razvojnim skladom in evropskim sosedskim instrumentom.
The Pan-African Programme will work in close cooperation/concertation with other instruments, and will concentrate on specific initiatives agreed in the framework of JAES and its Action Plans for which no alternative source of funding can be mobilised, thus ensuring the necessary coherence and synergy and preventing duplications and overlappings.
Vseafriški program bo deloval v tesnem sodelovanju/usklajevanju z drugimi instrumenti ter se osredotočal na specifične pobude, dogovorjene v okviru skupne strategije Afrika-EU in njenih akcijskih načrtov, za katere ni mogoče mobilizirati nobenega drugega vira financiranja, s čimer bo zagotovil potrebno usklajenost in sinergije ter preprečil podvajanje in prekrivanje.
The pan-Euromed zone offers huge potential for the textiles and clothing sector: turnover of US$ 250 bn in 2001, seven million direct jobs and manifest skills - from machine textiles in the Czech Republic to sleeve presses in Hungary and Poland, from lingerie to jeans and sportswear in Morocco and Tunisia.
Vseevropsko sredozemsko območje nudi velike možnosti za tekstilno in oblačilno industrijo: promet, ki je v letu 2001 znašal 250 milijard ameriških dolarjev, sedem milijonov neposrednih delovnih mest ter dokazano znanje in spretnosti - od tekstilnih strojev v Češki republiki do stiskalnic za rokave na Madžarskem in Poljskem, od ženskega spodnjega perila do kavbojk in športnih oblačil v Maroku in Tuniziji.
The pan-European aviation landscape and the role of aviation organisations in Europe is changing.
Vseevropsko letalsko prizorišče in vloga letalskih organizacij v Evropi se spreminjata.
The pan-European blackout of 4 November 2006 demonstrated the vulnerability of electricity supply in Europe.
Vseevropski popolni izpad električne energije 4. novembra 2006 je pokazal ranljivost oskrbe z električno energijo v Evropi.
The Pan-European Conference also requested UNECE, the European Commission, the two River Commissions and the ECMT to cooperate closely with a view to identifying, by the end of 2002, the legal obstacles standing in the way of the establishment of a harmonised and competitive pan-European inland waterway transport market and to considering how this problem could be resolved.
Poleg tega vabi UNECE, Evropsko komisijo, obe rečni komisiji in EKMP, da v tesnem sodelovanju še pred koncem leta 2002 ugotovijo, kje so zakonodajne ovire za vzpostavitev usklajenega in konkurenčnega vseevropskega trga za prevoz po celinskih plovnih poteh, in poiščejo ustrezne rešitve.
The Pan-European Corridors and Areas5 (PEC) were developed during two Ministerial Conferences in Crete (1994) and in Helsinki (1997) with the aim of connecting the EU-15 with the then neighbouring countries.
Panevropski koridorji in območja5 (PEC) so bili razviti v okviru dveh ministrskih konferenc na Kreti (1994) in v Helsinkih (1997) z namenom, da se EU-15 poveže s takratnimi sosednjimi državami.
The pan-European data available are not adapted for an application of the criteria at a detailed territorial scale and for an assessment of its impact at such detailed scale.
Razpoložljivi vseevropski podatki niso prilagojeni za uporabo meril na podrobni teritorialni ravni in za oceno njihovega učinka na takšni podrobni ravni.
The pan-European dimension and coherence of the activities, the establishment of SICs in all Member States, and the close cooperation between different stakeholders have contributed to the successful implementation consolidation and collaboration at EU level, across services, and between programme beneficiaries
Vseevropska razsežnost in skladnost dejavnosti, vzpostavitev centrov za varnejši internet v vseh državah članicah in tesno sodelovanje med različnimi deležniki so prispevali k uspešnemu izvajanju, združevanju in sodelovanju na ravni EU, med službami in upravičenci programa.
The pan-European dimension of e-government is hampered by various factors, some relating to institutional, cultural, legal and political differences between Member States, others to the lack of pan-European approach to common issues.
Vseevropsko razsežnost e-uprave ovirajo različni dejavniki, od katerih se nekateri nanašajo na institucionalne, kulturne, pravne in politične razlike med državami članicami, drugi pa na pomanjkanje vseevropskega pristopa k skupnim vprašanjem.
The pan-European dimension of the activities, the establishment of Safer Internet Centres (SICs) in all Member States, and the close cooperation between different stakeholders are some of the key success factors.
Med ključnimi dejavniki uspeha so vseevropska razsežnost dejavnosti, vzpostavitev centrov za varnejši internet v vseh državah članicah in tesno sodelovanje med različnimi deležniki.
The pan-european eGovernment action, as provided for in Decision 2004/387/EC, requires measures to increase the efficiency of the organisation of customs controls and to ensure the seamless flow of data in order to make customs clearance more efficient, to reduce the administrative burden, to help to combat fraud, organised crime and terrorism, to serve fiscal interests, to protect intellectual property and cultural heritage, to increase the safety of goods and the security of international trade and to enhance health and environmental protection.
Vseevropske e-vladne storitve, kot so opredeljene v Sklepu 2004/387/ES, zahtevajo ukrepe za povečanje učinkovitosti carinske kontrole in zagotovitev neprekinjenega pretoka podatkov, kar bi omogočilo učinkovitejše carinjenje, zmanjšanje upravne obremenitve, boj proti goljufijam, organiziranemu kriminalu in terorizmu, varovanje davčnih interesov, večjo varnost intelektualne lastnine in kulturne dediščine, večjo varnost blaga in mednarodne trgovine ter boljšo zaščito zdravja in okolja.
The pan-European in-vehicle emergency call, eCall, is estimated to have the potential to save up to 2.500 fatalities annually in EU-25 when fully deployed, and furthermore to reduce the severity of injuries, to bring significant savings to the society in healthcare and other costs and to reduce human suffering4.
Ocenjuje se, da bi lahko s popolno uveljavitvijo vseevropskega avtomobilskega klica v sili (eCall) v EU‑25 preprečili do 2 500 smrtnih žrtev letno, poleg tega pa bi lahko zmanjšali resnost poškodb, družbi omogočili občutne prihranke pri stroških zdravstvene oskrbe in drugih stroških ter zmanjšali trpljenje ljudi4.
The pan-European in-vehicle emergency call, ‘eCall’, is estimated to have the potential to save up to 2 500 fatalities annually in EU-27 when fully deployed, to reduce the severity of injuries, bring significant savings to society in healthcare and other costs and reduce human suffering.4
Ocenjuje se, da bi lahko s popolno uveljavitvijo vseevropskega avtomobilskega klica v sili „eCall“ v EU-27 preprečili do 2 500 smrtnih žrtev letno, poleg tega pa bi lahko zmanjšali resnost poškodb, družbi omogočili občutne prihranke pri stroških zdravstvene oskrbe in drugih stroških ter zmanjšali trpljenje ljudi4.
The pan-European in-vehicle emergency call: how it works
Vseevropski avtomobilski klic v sili: kako deluje
The pan-European schemes are designed and implemented by the European Payments Council (EPC), a coordination and decision making body set up by the European banking sector.
Vseevropske sheme oblikuje in izvaja Evropski svet za plačila (EPC – European Payments Council), organ odločanja in koordiniranja, ki ga je ustanovil evropski bančni sektor.
The Pancretan Cooperative Bank also targets new borrowers with a viable business plan who cannot provide sufficient collateral.
Tudi banka Pancretan Cooperative Bank se obrača na najemnike mikrokreditov z izvedljivim poslovnim načrtom, ki pa ne morejo zagotoviti zadostnega zavarovanja s premoženjem.
The pane of glass to be tested must not be rigidly secured; it may however be fastened on an identical glass pane by means of adhesive tape applied all round the edge.
Preskušana steklena plošča ne sme biti trdno vpeta, lahko pa je z lepilnim trakom po celotnem obodu pritrjena na drugo enako stekleno ploščo.
The Panel acknowledges the value of the adopted system of 16 internal control standards and considers this a robust system for an efficient and effective management.
KNS priznava pomen sprejetega sistema 16 standardov notranje kontrole in meni, da je ta sistem dovolj trden za učinkovito in uspešno upravljanje.
The Panel agreed.
Komisija je predlog sprejela.
The panel also addressed the EESC's powers of representation, and the potential difficulties posed by the concept of "external relations" and the REX section in Rule 12(4).
Sledila je razprava o zastopanju EESO ter o pooblastilih za zastopanje, kakor tudi o težavi, ki lahko nastane zaradi pojma "zunanji odnosi", navedenega v členu 12(4), v povezavi s strokovno skupino REX.
The Panel and Appellate Body reports in European Communities — Measures Concerning Meat and Meat Products (Hormones)1, adopted by the World Trade Organization (WTO) Dispute Settlement Body (DSB) on 13 February 1998, found that the Community ban on imports of meat and meat products from cattle treated with certain hormones for growth promotion purposes was inconsistent with the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement).
Iz poročil sodnega senata in pritožbenega senata v sporu Evropske skupnosti – Ukrepi v zvezi z mesom in mesnimi izdelki (hormoni)1, ki jih je 13. februarja 1998 sprejel Senat za poravnavo sporov (SPS) Svetovne trgovinske organizacije (STO), je razvidno, da je bila prepoved uvoza govejega mesa in mesnih izdelkov iz mesa goveda, ki je dobivalo nekatere hormone, na ravni Skupnosti v nasprotju s Sporazumom o uporabi sanitarnih in fitosanitarnih ukrepov (Sporazum SPS).
The Panel and its concrete activities will facilitate the exchange of information and best practices on effective delivery of justice with a view to promoting adherence of the partner countries to international standards, in particular those formulated in the relevant conventions of the Council of Europe and the UN.
Z njo in njenimi konkretnimi dejavnostmi bo poenostavljena izmenjava informacij o dejanskem delovanju sodnih sistemov in najboljših praks na tem področju, da bi tako partnerske države spodbudili k spoštovanju mednarodnih standardov, še zlasti tistih iz upoštevnih konvencij Sveta Evrope in ZN.
The Panel appreciates that Clean Sky does not require a consortium as a condition for participation to calls for proposals, single entities can apply, and that there are a number of mono-beneficiaries also amongst SMEs.
KNS odobrava dejstvo, da pri Čistem nebu delovanje v konzorciju ni pogoj za sodelovanje v razpisih za zbiranje predlogov, saj se lahko prijavijo posamični subjekti, in da je tudi med MSP veliko posamičnih upravičencev.
The Panel appreciates that in the evaluation period ex-post audits of financial statements of CS JU beneficiaries have been implemented and recommends that the efforts undertaken to reduce the error rates are continued.
KNS z zadovoljstvom ugotavlja, da so bile v ocenjevalnem obdobju opravljene naknadne revizije računovodskih izkazov upravičencev do sredstev CS JU, in priporoča, da se nadaljujejo prizadevanja za zmanjšanje stopnje napak.
The Panel appreciates that monitoring and control tools are mature and implemented and recommends harmonized progress activity reports and technical evaluation reports across the ITDs.
KNS z zadovoljstvom ugotavlja, da so orodja za spremljanje in nadzor zrela in vpeljana, ter priporoča pripravo harmoniziranih poročil o napredku pri posameznih dejavnostih in tehničnih poročil o oceni za vse ITD.
The Panel appreciates that the JU has put efforts into improving its ex-ante validation process and has provided guidance to its beneficiaries concerning the eligibility of costs for the Clean Sky projects.
Z zadovoljstvom tudi ugotavlja, da si skupno podjetje prizadeva za izboljšanje svojega postopka predhodnega potrjevanja ter da je upravičencem svetovalo v zvezi z upravičenostjo stroškov pri projektih Čistega neba.
The Panel appreciates that there is a satisfactory alignment of strategic and annual planning and recommends its systematic implementation.
Izraža tudi zadovoljstvo nad tem, da sta strateško in letno načrtovanje dovolj dobro usklajena, ter predlaga, da se sistematično izvajata.
The Panel appreciates the effort on the part of the Executive Office to communicate call topics and disseminate the Clean Sky initiatives via publications.
KNS se zaveda prizadevanj izvršnega urada, da bi prek publikacij obveščal o temah razpisov in širil informacije o pobudah Čistega neba.
The Panel believes that information exchange between the JU and NSRG is very important and recommends that the NSRG continues to play a crucial role in ensuring the coherence of national programmes with Clean Sky.
KNS meni, da je izmenjava informacij med skupnim podjetjem in skupino nacionalnih predstavnikov (NSRG) zelo pomembna, in priporoča, da ima NSRG še naprej ključno vlogo pri zagotavljanju skladnosti nacionalnih programov s Čistim nebom.
The Panel believes that raising the profile of Clean Sky should be a key aspect of the CS Communication objectives.
KNS meni, da bi morala biti večja prepoznavnost Čistega neba ključni vidik njegovih komunikacijskih ciljev.
The Panel believes this recommendation is applicable to all large ITDs.
KNS meni, da to priporočilo velja za vse velike ITD.
The panel calls for a strategic re-focusing of the two JTIs, involving all stakeholders and moving further towards a truly joint effort.
Odbor poziva k strateški preusmeritvi obeh STP, ki bo zajemala vse zainteresirane strani in se še bolj približala resničnemu skupnemu delu.
The Panel commends that Clean Sky has been successful in attracting a high level of interest from companies, well above the average participation of industrial entities in collaborative projects in FP7.
KNS pozdravlja dejstvo, da Čisto nebo pri gospodarskih družbah uspešno vzbuja veliko zanimanja, ki je precej nad povprečno udeležbo industrijskih subjektov v skupnih projektih 7. OP.
The Panel concluded30 that there is an urgent need to improve data availability and the breadth and quality of indicators to measure and monitor innovation performance, ranging from technological innovation to other forms of innovation (e.g. public sector innovation).
Delovna skupina je sklenila30, da je treba nujno izboljšati dostopnost podatkov ter obseg in kakovost kazalnikov za merjenje in spremljanje uspešnosti inovacij, od tehnoloških inovacij do drugih oblik inovacij (npr. inovacije v javnem sektorju).
The Panel concludes that the EU Research Framework Programmes have played an important role in developing the European knowledge base over the period of the review (1999-2003).
Strokovna skupina ugotavlja, da so okvirni raziskovalni programi EU v obdobju preverjanja (1999–2003) igrali pomembno vlogo pri razvijanju evropske baze znanja.
The panel confirmed at the second assessment that recommendations were met.
Svet je pri drugi presoji potrdil, da so bila priporočila upoštevana.
The panel considered this proposal to be valid.
Komisija meni, da je ta predlog primeren.