qanastek/ELRC-Medical-V2 huggingface dataset:
English: (f) its scientific studies in accordance with Articles 32 and 32e;
Translation (en-sl): (f) svoje znanstvene študije v skladu s členoma 32 in 32e;
English: The results of all consultation activities are summarised in the synopsis report.
Translation (en-sl): Rezultati vseh posvetovanj so povzeti v zbirnem poročilu.
English: N° of documents (or parts of) subject to claims of confidentiality;
Translation (en-sl): Št. dokumentov (ali njihovih delov), ki so predmet zahtev za zaupnost;
English: Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be made public:
Translation (en-sl): Ne glede na odstavka 2 in 3 se naslednje informacije kljub temu objavijo:
English: XX is the policy area or budget title concerned.
Translation (en-sl): XX je zadevno področje ali naslov.
English: Description of the calculation of cost for FTE units should be included in the Annex V, section 3.
Translation (en-sl): Opis izračuna stroškov za enote EPDČ mora biti vključen v oddelek 3 Priloge V.
English: […] [XX.YY.YY.YY] […] […] YES/
Translation (en-sl): […] [XX YY YY YY] […] […] DA/
English: (15) It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise.
Translation (en-sl): (15) Bistveno je, da se zagotovi učinkovito delovanje Agencije in izboljša trajnost njenega strokovnega znanja.
English: - the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation;
Translation (en-sl): - poenostavitev pravil za upravičenost stroškov v skladu z določbami finančne uredbe;
English: Since duly justified confidential information is protected, incentives for innovation should remain unchanged.
Translation (en-sl): Ker so informacije, ustrezno utemeljene kot zaupne, zaščitene, bi morale spodbude za inovacije ostati nespremenjene.
English: 1) improve and clarify the rules on transparency
Translation (en-sl): 1) Izboljšati in pojasniti pravila o preglednosti
English: "Unless otherwise provided, the Management Board shall act by a majority of its members.
Translation (en-sl): „Če ni drugače določeno, upravni odbor odloča z večino svojih članov.
English: Fundamental rights
Translation (en-sl): Temeljne pravice
English: The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings.
Translation (en-sl): Komisija Evropskemu parlamentu, Svetu in upravnemu odboru poroča o ugotovitvah ocene.
English: Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.
Translation (en-sl): Navedena pooblastila bi bilo treba izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta.
English: (f) ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain.
Translation (en-sl): (f) zagotavljanje primerne izmenjave informacij z zainteresiranimi stranmi v zvezi s tveganji, povezanimi z agroživilsko verigo.
English: It is proportionate to harmonise these rules while preserving, where needed, the specific balance of interests in sectoral legislations.
Translation (en-sl): Ta pravila je sorazmerno uskladiti, hkrati pa po potrebi ohranjati specifično ravnovesje interesov v sektorski zakonodaji.
English: Please indicate the planned recruitment date and adapt the amount accordingly (if recruitment occurs in July, only 50 % of the average cost is taken into account) and provide further explanations in an annex.
Translation (en-sl): Navedite predvideni datum zaposlitve in ustrezno prilagodite znesek (če pride do zaposlitve v juliju, se upošteva samo 50 % povprečnih stroškov) ter navedite dodatna pojasnila v prilogi.
English: (17) Provisions exist on the content of applications for authorisations.
Translation (en-sl): (17) Obstajajo določbe o vsebini vlog za odobritev.
English: However, issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance.
Translation (en-sl): Vendar se v nekaterih primerih lahko pojavijo težave glede skladnosti z veljavnimi standardi, zato so vzpostavljeni nacionalni sistemi za preverjanje te skladnosti.
English: Information systems
Translation (en-sl): Informacijski sistemi
English: X Indirect management by entrusting budget implementation tasks to:
Translation (en-sl): X Posredno upravljanje s poverjanjem nalog izvrševanja proračuna:
English: Access to the information for renewal
Translation (en-sl): Dostop do informacij za obnovitev
English: That section shall be publicly available and easily accessible.
Translation (en-sl): Navedeni razdelek je na voljo javnosti in je zlahka dostopen.
English: Consistency with other Union policies
Translation (en-sl): Skladnost z drugimi politikami Unije
English: (b) breeding patterns and strategies.
Translation (en-sl): (b) vzorcev in strategij žlahtnjenja.
English: (c) four members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations.
Translation (en-sl): (c) štirje člani z glasovalno pravico, ki predstavljajo civilno družbo in interese prehranske verige, in sicer en član iz združenja potrošnikov, eden iz okoljske nevladne organizacije, eden iz organizacije kmetov in eden iz industrijske organizacije.
English: X The proposal is compatible with the current multiannual financial framework and may entail the use of special instruments as defined in Council Regulation (EU, Euratom) No 1311/2013.
Translation (en-sl): X Predlog je v skladu z veljavnim večletnim finančnim okvirom in lahko vključuje uporabo posebnih instrumentov, kot so opredeljeni v Uredbi Sveta (EU, Euratom) št. 1311/2013.
English: The evaluation shall address the possible need to modify the mandate of the Authority, and the financial implications of any such modification.
Translation (en-sl): Pri oceni se obravnavajo morebitna potreba po spremembi pooblastil agencije in finančne posledice kakršnih koli tovrstnih sprememb.
English: (h) requests from the European Parliament, the Commission or a Member State for scientific opinions which have been refused or modified and the justifications for the refusal or modification.
Translation (en-sl): (h) zaprosila Evropskega parlamenta, Komisije ali države članice za znanstvena mnenja, ki so bila zavrnjena ali spremenjena, in utemeljitev za zavrnitev ali spremembo;
English: (a) the name and address of the applicant;
Translation (en-sl): (a) ime in naslov vlagatelja,
English: It shall forthwith transmit this opinion to the Commission, the authorisation-holder and the Member States.
Translation (en-sl): To mnenje nemudoma pošlje Komisiji, imetniku odobritve in državam članicam.
English: (19) In the case of applications to request the renewal of an authorisation, the authorised substance or product has already been on the market for several years.
Translation (en-sl): (19) V primeru vlog za obnovitev odobritve je odobrena snov ali izdelek na trgu že več let.
English: X bodies referred to in Articles 208 and 209;
Translation (en-sl): X organom iz členov 208 in 209,
English: In parallel, the Commission's Scientific Advice Mechanism has been asked to prepare an opinion on the authorisation process of plant protection products.
Translation (en-sl): Vzporedno s tem je bil mehanizem Komisije za znanstveno svetovanje zaprošen, da pripravi mnenje o postopku registracije fitofarmacevtskih sredstev.
English: The consultation carried out demonstrates an overall support of stakeholders to the initiative.
Translation (en-sl): Pri posvetovanju se je pokazalo, da zainteresirane strani na splošno podpirajo pobudo.
English: The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents.
Translation (en-sl): Seznam, ki ga sestavi Komisija, se posreduje Evropskemu parlamentu skupaj s zadevnimi referenčnimi dokumenti.
English: For the purposes of this point ‘added value of Union involvement' is the value resulting from Union intervention which is additional to the value that would have been otherwise created by Member States alone.
Translation (en-sl): Za namene te točke je „dodana vrednost ukrepanja Unije" vrednost, ki izhaja iz ukrepanja Unije in predstavlja dodatno vrednost poleg tiste, ki bi jo sicer ustvarile države članice same.
English: The reasons underlying differences in the assessments and conclusions of scientific bodies should be better communicated to the public in order to facilitate their understanding.
Translation (en-sl): O razlogih za razlike med ocenami in ugotovitvami znanstvenih organov bi bilo treba bolje obveščati javnost, da bi se olajšalo njihovo razumevanje.
English: In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels.
Translation (en-sl): Zlasti se je zmanjšalo število kandidatov, ki se prijavljajo za člane znanstvenih svetov.
English: Alternate members shall represent the member in his absence and vote on his behalf.
Translation (en-sl): Nadomestni člani predstavljajo člane v njihovi odsotnosti in glasujejo v njihovem imenu.
English: Risk communication is an essential part of the risk analysis process.
Translation (en-sl): Obveščanje o tveganju je bistven del postopka analize tveganja.
English: (4) the following Articles 32a, 32b, 32c, 32d and 32e are inserted:
Translation (en-sl): (4) vstavijo se naslednji členi 32a, 32b, 32c, 32d in 32e:
English: N° of requests for access to documents addressed to EFSA and the Commission.
Translation (en-sl): št. prošenj za dostop do dokumentov, naslovljenih na agencijo EFSA in Komisijo.
English: In particular EFSA will be able to cross-check the information on the studies performed (the laboratories being an external source of information).
Translation (en-sl): EFSA bo lahko zlasti navzkrižno preverila informacije o izvedenih študijah (laboratoriji so zunanji vir informacij).
English: The main objectives of this initiative are to update the GFL Regulation so as to:
Translation (en-sl): Glavni cilj te pobude je bil posodobiti uredbo o splošni živilski zakonodaji z namenom:
English: This should have a positive impact since experience from other Union agencies demonstrates that this model ensures efficient supervision of the functioning of agencies and coordinated views between the Union and national level.
Translation (en-sl): To naj bi imelo pozitiven učinek, saj izkušnje z drugimi agencijami Unije kažejo, da ta model zagotavlja učinkovit nadzor nad delovanjem agencij in usklajena stališča na ravni Unije in na nacionalni ravni.
English: To address these issues, the Commission has come up with a wide ranging and ambitious proposal requiring a significant increase in the resources available to the EFSA to enable it to discharge its existing and proposed new responsibilities.
Translation (en-sl): Za obravnavo teh vprašanj je Komisija pripravila obsežen in ambiciozen predlog, ki zahteva znatno povečanje virov agencije EFSA, da bo lahko izpolnila svoje obstoječe in predlagane nove naloge.
English: [Body]: <EFSA.> Year
Translation (en-sl): [Organ]: <EFSA.> Leto
English: The proposal also stipulates that personal data be protected taking into account the applicable Union legislative framework on the processing of such data.
Translation (en-sl): Predlog tudi določa varstvo osebnih podatkov in pri tem upošteva veljavni zakonodajni okvir Unije za obdelavo takih podatkov.
English: Implementation with a start-up period from 2020 to 2022
Translation (en-sl): izvajanje z obdobjem uvajanja med letoma 2020 in 2022,
English: A public consultation on the initiative in all Union official languages was launched on 23 January 2018 and ran until 20 March 2018; 471 replies were received (318 from individuals and 153 from organisations).
Translation (en-sl): 23. januarja 2018 se je začelo javno posvetovanje o pobudi v vseh uradnih jezikih Unije, ki je trajalo do 20. marca 2018; prejetih je bilo 471 odgovorov (od tega 318 odgovorov posameznikov in 153 odgovorov organizacij).
English: The fourth measure provides for controls and audits by Commission inspectors in relation to studies.
Translation (en-sl): Četrti ukrep določa nadzor in presoje, ki jih izvajajo inšpektorji Komisije v zvezi s študijami.
English: It has also strengthened the cooperation with national and international scientific bodies as well as the exchange of information between Member States, the Commission and EFSA itself.
Translation (en-sl): Prav tako je okrepila sodelovanje z nacionalnimi in mednarodnimi znanstvenimi organi ter izmenjavo informacij med državami članicami, Komisijo in agencijo EFSA.
English: This paved the way for a complete overhaul of the regulatory framework, with the focus on the GFL Regulation in 2002.
Translation (en-sl): To je utrlo pot popolni prenovi regulativnega okvira s poudarkom na uredbi o splošni živilski zakonodaji v letu 2002.
English: There are no negative impacts in the duration of authorisation procedures since this is a parallel activity.
Translation (en-sl): Ni negativnih učinkov na trajanje odobritvenih postopkov, ker gre za vzporedno dejavnost.
English: [4: C(2017) 8414 final.]
Translation (en-sl): [4: COM(2017) 8414 final.]
English: They also seriously undermined public confidence in the Union food safety regulatory framework.
Translation (en-sl): Prav tako so te krize resno omajale zaupanje javnosti v regulativni okvir Unije za varnost hrane.
English: The notification obligation under paragraph 1, also applies to Union laboratories carrying out those studies.
Translation (en-sl): Obveznost uradnega obveščanja iz odstavka 1 velja tudi za laboratorije Unije, ki izvajajo navedene študije.
English: In addition to monitoring compliance, DG SANTE identifies and disseminates good practices in collaboration with the agencies.
Translation (en-sl): GD SANTE poleg spremljanja skladnosti tudi opredeljuje in razširja dobre prakse v sodelovanju z agencijami.
English: (a) the study plan for studies demonstrating the efficacy of a feed additive in terms of the aims of its intended use as defined in Article 6(1) and Annex I to this Regulation; and,
Translation (en-sl): (a) načrtov študij, ki dokazujejo učinkovitost krmnega dodatka glede na cilje njegove nameravane uporabe, kakor je opredeljena v členu 6(1) in Prilogi I k tej uredbi; ter
English: Expected generated Union added value (ex-post)
Translation (en-sl): Pričakovana ustvarjena dodana vrednost Unije (naknadno)
English: Their interplay can impact on the acceptability of the risk assessment by the general public.
Translation (en-sl): Njihovo medsebojno učinkovanje lahko vpliva na sprejemljivost ocene tveganja za splošno javnost.
English: The Commission shall make the application available to the Member States without delay.
Translation (en-sl): Komisija brez odlašanja da vlogo na voljo državam članicam.
English: (c) any other information deemed confidential within the specific procedural rules referred to in Article 5(1)(n) of this Regulation.
Translation (en-sl): (c) vseh drugih informacij, ki veljajo za zaupne v posebnih postopkovnih pravilih iz člena 5(1)(n) te uredbe.
English: (a) ensure that accurate, appropriate and timely information is interactively exchanged, based on the principles of transparency, openness, and responsiveness;
Translation (en-sl): (a) zagotavljati interaktivno izmenjavo točnih, ustreznih in pravočasnih informacij na podlagi načel preglednosti, odprtosti in odzivnosti;
English: (a) to any intellectual property right which may exist over documents or their content; and,
Translation (en-sl): (a) katero koli pravico intelektualne lastnine, ki lahko obstaja na dokumentih ali njihovi vsebini; ter
English: Its primary mission is to provide scientific advice at the request of the Commission, Member States and the European Parliament and on its own motion.
Translation (en-sl): Njena glavna naloga je zagotavljati znanstveno svetovanje na zahtevo Komisije, držav članic in Evropskega parlamenta ter tudi na lastno pobudo.
English: Where the Commission considers that the continuation of the Authority is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.
Translation (en-sl): Če Komisija meni, da nadaljnji obstoj agencije glede na zastavljene cilje, pooblastila in naloge ni več upravičen, lahko predlaga ustrezno spremembo ali razveljavitev zadevnih določb te uredbe.
English: Setting up the EFSA has given Union measures a sounder scientific basis.
Translation (en-sl): Z ustanovitvijo agencije EFSA so ukrepi Unije dobili trdnejšo znanstveno podlago.
English: [41: OJ L 123, 12.5.2016, p.
Translation (en-sl): [41: UL L 123, 12.5.2016, str.
English: [42: As referred to in Article 54(2)(a) or (b) of the Financial Regulation.]
Translation (en-sl): [42: Po členu 54(2)(a) oz. (b) finančne uredbe.]
English: Each Member State shall nominate a member and an alternate member to the Management Board.
Translation (en-sl): Vsaka država članica predlaga člana in nadomestnega člana upravnega odbora.
English: Protection of personal data
Translation (en-sl): Varstvo osebnih podatkov
English: The EFSA also regularly fine-tunes and strengthens its strict policies on independence, transparency and openness.
Translation (en-sl): EFSA prav tako redno prilagaja in krepi svoje stroge politike neodvisnosti, preglednosti in odprtosti.
English: The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and experience gained.
Translation (en-sl): Komisija sprejme splošni načrt obveščanja o tveganju v [dveh letih od začetka uporabe te uredbe] in ga redno posodablja, pri čemer se upoštevajo tehnični in znanstveni napredek ter pridobljene izkušnje.
English: (20) There are certain public concerns about the Authority's assessment in the area of authorisation being primarily based on industry studies.
Translation (en-sl): (20) Obstajajo nekateri pomisleki javnosti, da ocena Agencije v zvezi z odobritvijo temelji predvsem na študijah industrije.
English: Member States that provide the EFSA with expertise also need to receive more compensation.
Translation (en-sl): Države članice, ki agenciji EFSA zagotavljajo strokovno znanje, morajo prav tako prejeti višja nadomestila.
English: The involvement of the EFSA Executive Director in the selection process is an additional guarantee that the independence criteria will be met.
Translation (en-sl): Vključenost izvršnega direktorja agencije EFSA v izbirni postopek je dodatno jamstvo, da bodo izpolnjena merila glede neodvisnosti.
English: Transparency and confidentiality rules currently vary depending on the sub-area of regulation concerned.
Translation (en-sl): Pravila o preglednosti in zaupnosti se trenutno razlikujejo glede na zadevno podpodročje urejanja.
English: With regard to the reliability and robustness of studies submitted by industry in the context of authorisation procedures, the following impacts were in particular considered:
Translation (en-sl): Kar zadeva zanesljivost in trdnost študij, ki jih predloži industrija v okviru odobritvenih postopkov, so bili zlasti upoštevani naslednji učinki:
English: Provisions in relation to the nomination, selection and appointment of experts include strict criteria on independence, thus providing appropriate safeguards.
Translation (en-sl): Določbe v zvezi s predlaganjem, izbiro in imenovanjem strokovnjakov vključujejo stroga merila glede neodvisnosti, kar zagotavlja ustrezne zaščitne ukrepe.
English: Estimate to be expressed in full amounts (or at most to one decimal place)
Translation (en-sl): ocena, izražena v celih številkah (ali na največ eno decimalno mesto natančno)
English: As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Translation (en-sl): Kakor hitro je mogoče in v treh mesecih od uradnega obvestila, lahko Evropski parlament predloži svoje mnenje v presojo Svetu, ki potem imenuje navedene člane.
English: Impact on the European Food Safety Authority (EFSA)
Translation (en-sl): Posledice za Evropsko agencijo za varnost hrane (EFSA)
English: Although in principle a revision of Regulation (EC) No 178/2002 could be used as an opportunity to set up a more comprehensive monitoring system of the implementation of Union food law, the targeted scope of this proposal is too limited to accommodate the establishment of such a system.
Translation (en-sl): Čeprav bi načeloma lahko revizijo Uredbe (ES) št. 178/2002 izkoristili kot priložnost za vzpostavitev celovitejšega sistema za spremljanje izvajanja živilske zakonodaje Unije, je ciljno področje uporabe tega predloga preveč omejeno, da bi omogočalo vzpostavitev takega sistema.
English: The proposal also provides for a better organisation of the Panels' work.
Translation (en-sl): Predlog prav tako zagotavlja boljšo organizacijo dela znanstvenih svetov.
English: [43: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
Translation (en-sl): [43: Pojasnila o načinih upravljanja in sklici na finančno uredbo so na voljo na spletišču BudgWeb: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
English: (d) facilitate understanding and dialogue amongst all interested parties; and,
Translation (en-sl): (d) olajšati razumevanje in dialog med vsemi zainteresiranimi stranmi ter
English: Problems in relation to safety have a huge impact on consumers' confidence and consequently on market stability, trade flows and the climate for innovation.
Translation (en-sl): Težave v zvezi z varnostjo močno vplivajo na zaupanje potrošnikov in posledično na stabilnost trga, trgovinske tokove in okolje za inovacije.
English: A delegated act adopted pursuant to Article 8(c) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Translation (en-sl): Delegirani akt, sprejet na podlagi člena 8(c), začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.
English: The impact on the timing of authorisation is minimal as detailed for each measure.
Translation (en-sl): Učinek na časovni potek odobritve je minimalen, kot je podrobno opisano za vsak ukrep.
English: It shall in particular make public without delay:
Translation (en-sl): Brez odlašanja objavi zlasti:
English: (25) It is therefore necessary to strengthen the transparency of the risk assessment process in a proactive manner.
Translation (en-sl): (25) Zato je treba proaktivno okrepiti preglednost postopka ocenjevanja tveganja.
English: Type[47: Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).]
Translation (en-sl): vrsta[47: Realizacije so dobavljeni proizvodi in opravljene storitve (npr. število financiranih izmenjav študentov, število kilometrov novozgrajenih cest itd.).]
English: The delegation of power referred to in Article 8(c) may be revoked at any time by the European Parliament or by the Council.
Translation (en-sl): Prenos pooblastila iz člena 8(c) lahko kadar koli prekliče Evropski parlament ali Svet.
English: Indeed, the notification of planned studies represents a relatively small burden for the applicant.
Translation (en-sl): Dejansko predstavlja obveščanje o načrtovanih študijah razmeroma majhno breme za vlagatelja.