natgillin/translations-raw huggingface dataset:
In addition, the Commission will reduce the time needed to complete the authorisation procedure, by shortening the period for consulting Member States, and allowing translation of the documents into the full set of languages after the authorisation, rather than before. 
Poleg tega bo Komisija skrajšala čas, ki je potreben za dokončanje postopka za pridobitev dovoljenja, tako da bo skrajšala obdobje za posvetovanje z državami članicami in omogočila prevajanje dokumentov v vse jezike po pridobitvi dovoljenja namesto prej.
This means that the initial authorisation is based on less comprehensive data than would normally be the case (though nonetheless with a positive benefit-risk balance), and with obligations on the marketing authorisation holders for the data to be completed afterwards. 
To pomeni, da prvotno dovoljenje temelji na manj celovitih podatkih, kot bi bili običajno (vendar kljub temu s pozitivnim razmerjem med tveganji in koristmi), imetniki dovoljenja za promet pa morajo podatke dopolniti naknadno.
Usually, the authorisation procedure starts when the applicant is in a position to present the relevant data package in the form of an application for marketing authorisation. 
Postopek za odobritev se običajno začne, ko vložnik lahko predloži zadevni sveženj podatkov v obliki vloge za pridobitev dovoljenja za promet.
However, the value of earlier access to a vaccine is enormous, in terms of lives saved and economic damage avoided. 
Vendar je vrednost hitrejšega dostopa do cepiva izjemna z vidika rešenih življenj in preprečene gospodarske škode.
Additional financing and other forms of support can be made available on top of such agreements. 
Poleg takih sporazumov je mogoče zagotoviti dodatna finančna sredstva in druge oblike podpore,
Only very swift and unified action by the EU and its Member States will ensure sufficient and speedy supplies of a safe and effective vaccine. 
Zgolj z zelo hitrim in enotnim ukrepanjem EU in njenih držav članic bomo zagotovili zadostno in hitro preskrbo z varnim in učinkovitim cepivom.
While the EU remains fully committed to international trade and to the development of global supply chains, it should also aim to attract production capacity for vaccines to its territory in order to mitigate disruptions to such supply chains. 
Čeprav EU ostaja v celoti zavezana mednarodni trgovini in razvoju svetovnih dobavnih verig, bi si morala prizadevati tudi, da privabi proizvodne zmogljivosti za cepiva na svoje ozemlje, da bi se zmanjšale motnje v takih dobavnih verigah.
But an effective and safe vaccine against COVID-19 is generally considered the most likely lasting solution to the ongoing pandemic. 
Vendar učinkovito in varno cepivo proti COVID-19 na splošno velja za najbolj verjetno trajno rešitev trenutne pandemije.
-Risk sharing: benefits offered in return for the financing provided in the two cases where there either (a) is a successful vaccine or (b) no vaccine (e.g. potential flexibilities in the use of manufacturing capacity). 
-delitev tveganja: koristi, ponujene v zameno za finančna sredstva, ki se zagotovijo v dveh primerih, in sicer (a) kadar je cepivo uspešno ali (b) kadar cepiva ni (na primer morebitna prožnost pri uporabi proizvodnih zmogljivosti).
EMA also ensures close cooperation with relevant European and international organisations and third countries regulators, including with the World Health Organization on clinical trial protocols for vaccines. 
EMA prav tako zagotavlja tesno sodelovanje z ustreznimi evropskimi in mednarodnimi organizacijami ter regulatorji iz tretjih držav, vključno s Svetovno zdravstveno organizacijo, v zvezi s protokoli kliničnega preskušanja za cepiva.
2.2.Advance Purchase Agreements via the Emergency Support Instrument 
2.2.Sporazumi za vnaprejšnji nakup v okviru instrumenta za nujno pomoč
This proposed framework is therefore an insurance policy, which transfers some of the risk from industry to the public authorities in return for assuring Member States equitable and affordable access to a vaccine, should one become available. 
Ta predlagani okvir je torej zavarovalna polica, pri kateri se nekatera tveganja prenesejo z industrije na javne organe v zameno za zagotovitev pravičnega in cenovno dostopnega dostopa do cepiva za države članice, če bi se to razvilo.
In addition, once a successful COVID-19 vaccine is available, hundreds of millions, or even billions, of doses will need to be produced in order to cover global needs, without compromising the production of other essential vaccines. 
Ko bo uspešno cepivo proti COVID-19 na voljo, bo treba proizvesti na stotine milijonov ali celo milijard odmerkov, da bi pokrili globalne potrebe, ne da bi pri tem ogrozili proizvodnjo drugih osnovnih cepiv.
With sufficient scale and scope, such international mechanism could become the world's insurance policy against pandemics. 
Tak mednarodni mehanizem bi z zadostnim obsegom in razponom lahko postal svetovna zavarovalna polica proti pandemijam.
They will be invited to contribute their expertise on potential vaccine candidates as well as provide additional financing (should financing under ESI be insufficient), and will be closely associated with the negotiations. 
Pozvane bodo, da prispevajo svoje strokovno znanje o možnih kandidatih za cepivo in zagotovijo dodatna finančna sredstva (če bi bilo financiranje v okviru instrumenta ESI nezadostno), in bodo tesno vključene v pogajanja.
-Speed of delivery at scale: progress in clinical trials and the ability to deliver sufficient quantities of the vaccine in 2020 and 2021. 
-hitrost dobave v ustreznem obsegu: napredek pri kliničnih preskušanjih in zmožnost zagotavljanja zadostnih količin cepiva v letih 2020 in 2021,
The contracts with companies may be concluded through a procurement process run by the Commission on behalf of all participating Member States. 
Pogodbe s podjetji se lahko sklenejo prek postopka javnega naročanja, ki ga vodi Komisija v imenu vseh sodelujočih držav članic.
·Adapting the EU's regulatory framework to the current urgency and making use of existing regulatory flexibility to accelerate the development, authorisation and availability of vaccines while maintaining the standards for vaccine quality, safety and efficacy. 
·prilagoditi regulativni okvir EU sedanjim izrednim razmeram in izkoristiti obstoječo regulativno prožnost za pospešitev razvoja, odobritve in razpoložljivosti cepiv ob ohranjanju standardov za kakovost, varnost in učinkovitost cepiv.
As stipulated in the ESI Regulation, the procurement procedure is carried out in conformity with the requirements of the Financial Regulation 3 , which contains rules which are equivalent to those of the Procurement Directives of the Union and therefore also to national procurement rules. 
Kot je določeno v uredbi o ESI, se postopek javnega naročanja izvaja v skladu z zahtevami iz finančne uredbe 3 , ki vsebuje pravila, enakovredna pravilom iz direktiv Unije o javnem naročanju in torej enakovredna tudi nacionalnim pravilom o javnem naročanju.
Joint EU action within a global framework greatly enhances the potential for universal vaccination against COVID-19 and returning economic and social life to normality across the world. 
Skupno ukrepanje EU znotraj svetovnega okvira močno povečuje možnosti za univerzalno cepljenje proti COVID-19 ter za vračanje gospodarskega in družbenega življenja v normalne vode po vsem svetu.
In particular, all EU Member States will be able to benefit from an option to purchase vaccines via a single procurement action. 
Zlasti bodo vse države članice EU lahko izkoristile možnost nakupa cepiv prek enotnega javnega naročila.
However, requirements in relation to labelling and packaging may slow down the rapid deployment of the COVID-19 vaccines. 
Vendar lahko zahteve glede označevanja in pakiranja upočasnijo hitro uvajanje cepiv proti COVID-19.
Though steps will be taken to mitigate the risk - for example, by investing in a portfolio of companies covering different technologies - the failure rate of vaccine development is high. 
Čeprav bodo sprejeti ukrepi za zmanjšanje tveganja (na primer z vlaganjem v nabor podjetij, ki zajema različne tehnologije), je stopnja neuspeha pri razvoju cepiva visoka.
The EU regulatory system contains significant flexibility when it comes to authorisation procedures, which will facilitate access to a vaccine. 
Regulativni sistem EU omogoča znatno prožnost pri postopkih za pridobitev dovoljenja, kar bo olajšalo dostop do cepiva.
While an initial list of candidates would need to be established quickly to start negotiations, the list will be updated as additional information becomes available, in particular from the clinical trials. 
Začetni seznam kandidatov bi bilo sicer treba hitro oblikovati, da se pogajanja lahko začnejo, vendar se bo seznam posodabljal, ko bodo na voljo dodatne informacije, zlasti glede kliničnih preskušanj.
All participating Member States will be represented in a steering board, which will assist the Commission on all aspects of the APA contract before signature. 
Vse sodelujoče države članice bodo zastopane v usmerjevalnem odboru, ki bo Komisiji v pomoč pred podpisom za vse vidike pogodbe v zvezi s sporazumom za vnaprejšnji nakup.
In return for the right to buy a specified number of vaccine doses in a given timeframe and at a given price, part of the upfront costs faced by vaccines producers will be financed from the ESI. 
V zameno za pravico do nakupa določenega števila odmerkov cepiva v določenem časovnem okviru in po določeni ceni se bo del začetnih stroškov, s katerimi se soočajo proizvajalci cepiva, financiral iz ESI.
As the ultimate acquirers of the vaccines, Member States will participate in the process from the start. 
Države članice bodo kot končni kupci cepiv sodelovale v postopku od samega začetka.
-Soundness of scientific approach and technology used, including drawing on any evidence related to quality, safety and efficacy already generated from the development phases, where available. 
-tehtnost znanstvenega pristopa in uporabljene tehnologije, vključno z uporabo kakršnih koli dokazov v zvezi s kakovostjo, varnostjo in učinkovitostjo, ki so že bili zbrani v razvojnih fazah, če so na voljo,
Member States can also provide earlier access, based on their assessment of risk and need and taking into account harmonised advice by EMA. 
Države članice lahko na podlagi svoje ocene tveganja in potreb ter ob upoštevanju usklajenega nasveta agencije EMA zagotovijo tudi zgodnejši dostop.
As part of the effort to help protect people everywhere and EU citizens in particular, the Commission is proposing an EU strategy to accelerate the development, manufacturing, and deployment of vaccines against COVID-19. 
Komisija v okviru prizadevanj, da bi prispevala k zaščiti ljudi povsod in zlasti državljanov EU, predlaga strategijo EU za pospeševanje razvoja, proizvodnje in uvajanja cepiv proti COVID-19.
As announced in the context of the Coronavirus Global Response Pledge Conference hosted by President von der Leyen, the Commission has allocated an additional budget of EUR 400 million in 2020 to this facility, which now covers COVID-19 projects exclusively. 
Kot je bilo napovedano na donatorski konferenci o globalnem odzivu na koronavirus, ki jo je gostila predsednica Komisije von der Leyen, je Komisija leta 2020 temu instrumentu dodelila dodatni proračun v višini 400 milijonov EUR, ki zdaj zajema izključno projekte COVID-19.
This results in long development and production timelines. 
Zato so časovni okviri za razvoj in proizvodnjo dolgi.
·Ensuring equitable access for all in the EU to an affordable vaccine as early as possible. 
·čim prej zagotoviti pravičen dostop do cenovno dostopnega cepiva za vse v EU.
-Capacity to supply through development of production capacity within the EU: the COVID-19 crisis has demonstrated the advantage of diversified sources of supply and having parts of the supply chains of essential goods within the EU. 
-zmogljivosti dobave prek razvoja proizvodnih zmogljivosti v EU: kriza COVID-19 je pokazala na prednosti raznolikih virov dobave in tega, da so deli dobavnih verig osnovnega blaga znotraj EU.
-Engagement at an early stage with EU regulators with the intention to apply for an EU marketing authorisation for the candidate vaccine(s). 
-sodelovanje z regulatorji EU v zgodnji fazi z namenom, da se zaprosi za dovoljenje EU za promet s kandidati za cepivo(-a).
The Commission is committed to universal, equitable and affordable access to COVID-19 vaccines, and has taken a number of steps to promote this. 
Komisija je zavezana univerzalnemu, pravičnemu in cenovno dostopnemu dostopu do cepiv proti COVID-19 in je za spodbujanje tega sprejela številne ukrepe.
This will be done in the form of advance purchase agreements (APAs). 
To se bo izvedlo v obliki sporazumov za vnaprejšnji nakup.
Funding provided will be considered as a down-payment on the vaccines that will actually be purchased by the Member States, and will be reflected in the conditions for final purchase of the vaccines. 
Zagotovljena sredstva se bodo štela kot polog za cepiva, ki jih bodo države članice dejansko kupile, in se bodo odražala v pogojih za končni nakup cepiv,
Companies with a promising vaccine candidate, already in or close to starting clinical trials, are invited to contact the Commission via the following email address: EC-VACCINES@ec.europa.eu 
Podjetja z obetavnimi kandidati za cepivo, ki so že v postopku kliničnega preskušanja ali blizu začetka tega preskušanja, vabimo, da stopijo v stik s Komisijo prek naslednjega elektronskega naslova: EC-VACCINES@ec.europa.eu .
These are precisely the kind of clinical trials needed to ensure representativeness of the populations for whom the vaccines are intended and to generate robust and conclusive data on COVID-19 vaccines. 
To so ravno taka klinična preskušanja, ki so potrebna za zagotavljanje reprezentativnosti skupin prebivalstva, za katere so cepiva namenjena, ter za ustvarjanje trdnih in prepričljivih podatkov o cepivih proti COVID-19.
EMA has set up a Task Force (ETF) to interact with developers of COVID-19 vaccines and offer scientific support from the early stages of development. 
EMA je ustanovila projektno skupino (ETF) za sodelovanje z razvijalci cepiv proti COVID-19 in nudenje znanstvene podpore od zgodnjih faz razvoja naprej.
This proposed derogation will apply to the operations necessary for the clinical trial phase and for compassionate or emergency use in the context of COVID-19. 
To predlagano odstopanje se bo uporabljalo za operacije, potrebne za fazo kliničnega preskušanja ter za sočutno ali nujno uporabo v okviru COVID-19.
A common strategy allows better hedging of bets, sharing of risks and pooling investments to achieve economies of scale, scope and speed. 
Skupna strategija omogoča boljše varovanje pred izgubami, delitev tveganj in združevanje naložb za doseganje ekonomije obsega, razpona in hitrosti.
These products, ranging from debt to equity-type financing, are already supporting key players developing innovative COVID-19 vaccine candidates. 
Ti produkti, ki segajo od dolžniških instrumentov do kapitalskih naložb, že podpirajo ključne akterje, ki razvijajo inovativne kandidate za cepivo proti COVID-19.
·Securing sufficient production of vaccines in the EU and thereby sufficient supplies for its Member States through Advance Purchase Agreements (APAs) with vaccine producers via the Emergency Support Instrument (ESI 2 ). 
·zagotoviti zadostno proizvodnjo cepiv v EU in s tem zadostne zaloge za njene države članice prek sporazumov za vnaprejšnji nakup s proizvajalci cepiv v okviru instrumenta za nujno pomoč (v nadaljnjem besedilu: ESI 2 ).
Whilst the need for a vaccine is urgent, it is essential that any regulatory decision concerning its authorisation is underpinned by sufficiently robust data to ensure patient safety and vaccine efficacy. 
Cepivo sicer nujno potrebujemo, vendar je bistveno, da vse regulativne odločitve o odobritvi temeljijo na dovolj trdnih podatkih, da se zagotovita varnost bolnikov in učinkovitost cepiva.
The EU can also promote global access through a scientific review provided by EMA combined with the epidemiology and disease expertise of WHO, and experts and national regulators in the target countries, to promote the development of high-priority medicines for markets outside the EU. 
EU lahko dostop na svetovni ravni spodbuja tudi prek znanstvenega pregleda, ki ga zagotovi EMA, skupaj s strokovnim znanjem SZO na področju epidemiologije in bolezni, ter s strokovnjaki in nacionalnimi regulatorji v ciljnih državah, da bi spodbudili razvoj visoko prednostnih zdravil za trge zunaj EU.
The conditions of the contract will reflect the balance between the prospect of the producer providing a safe and effective vaccine quickly and the investment needed to deploy the vaccine on the European market. 
Pogoji iz pogodbe bodo odražali ravnotežje med možnostjo, da proizvajalec hitro zagotovi varno in učinkovito cepivo, in naložbami, potrebnimi za uvajanje cepiva na evropskem trgu.
This is also the case for some of the vaccines in development against COVID-19. 
To velja tudi za nekatera cepiva proti COVID-19, ki so v razvoju.
The EU regulatory system is designed to accommodate this situation by providing for a conditional authorisation system. 
Regulativni sistem EU je zasnovan tako, da se lahko prilagodi tem razmeram z določitvijo sistema pogojnih dovoljenj.
This Communication has noted the benefits of a joined-up EU approach in speeding up vaccine development, de-risking investment, ensuring access to a broader portfolio of candidates, and avoiding competition between countries. 
To sporočilo izpostavlja prednosti skupnega pristopa EU pri pospeševanju razvoja cepiv, zmanjšanju tveganja naložb, zagotavljanju dostopa do širšega nabora kandidatov in preprečevanju konkurence med državami.
An important step towards joint action between Member States has already been taken in the formation of an inclusive vaccine Alliance by France, Germany, Italy, and the Netherlands. 
Pomemben korak k skupnemu ukrepanju držav članic so že pokazale Francija, Nemčija, Italija in Nizozemska z oblikovanjem vključujočega zavezništva za cepivo.
The Commission is therefore proposing a Regulation to derogate temporarily - only for the period during which COVID-19 is regarded as a public health emergency - from certain provisions of the GMO Directive for clinical trials with COVID-19 vaccines (and also COVID-19 treatments) that contain or consist of GMOs. 
Komisija zato predlaga uredbo o začasnem odstopanju (samo za obdobje, v katerem COVID-19 velja za izredne razmere v javnem zdravju) od nekaterih določb direktive o GSO za klinična preskušanja cepiv proti COVID-19 (in tudi za zdravila proti COVID-19), ki vsebujejo GSO ali so iz njih sestavljena.
Allocation of access to vaccine doses between Member States would be according to a population-based distribution key. 
Dodelitev dostopa do odmerkov cepiva med državami članicami bo potekala po ključu za dodelitev glede na prebivalstvo.
The Commission also supports voluntary pooling and licensing of intellectual property related to COVID-19 therapeutics and vaccines, in line with the recent resolution of the World Health Assembly 6 , to promote equitable global access as well as a fair return on investments. 
Komisija podpira tudi prostovoljno združevanje in licenciranje intelektualne lastnine v zvezi z zdravili in cepivi proti COVID-19, v skladu z nedavno resolucijo Generalne skupščine Svetovne zdravstvene organizacije 6 , za spodbujanje pravičnega globalnega dostopa in razumne donosnosti naložb.
The Commission stands ready to commit a significant proportion of those funds to the activities described here in order to maximise chances of arriving at a viable vaccine for the EU and the world in the shortest time possible. 
Komisija je pripravljena nameniti velik delež navedenih sredstev dejavnostim, opisanim v tem dokumentu, da bi čim bolj povečala možnosti za razvoj učinkovitega cepiva za EU in svet v najkrajšem možnem času.
In particular, the Commission is currently providing guarantees to the European Investment Bank (EIB) under its financial instruments, such as Horizon 2020 InnovFin, the European Fund for Strategic Investments (EFSI) and the forthcoming InvestEU 5 . 
Komisija trenutno zlasti zagotavlja jamstva Evropski investicijski banki (EIB) v okviru finančnih instrumentov, kot so finančna sredstva EU za inovatorje (InnovFin) v okviru programa Obzorje 2020 (Horizon 2020 InnovFin), Evropski sklad za strateške naložbe (EFSI) in prihodnji program InvestEU 5 .
Together with the Member States and the European Medicines Agency (EMA), the Commission will make the greatest use of these existing flexibilities to accelerate the authorisation and availability of successful vaccines against COVID-19. 
Komisija bo skupaj z državami članicami in Evropsko agencijo za zdravila (EMA) čim bolj izkoristila to obstoječo prožnost, da bi pospešila odobritev in razpoložljivost uspešnih cepiv proti COVID-19.
As part of the ACT-Accelerator, the WHO is leading work with many other actors on developing a global immunisation strategy and a policy on product allocation, which will enable vaccines to reach priority groups as quickly as possible. 
STO v okviru Pospeševalnika ACT vodi sodelovanje s številnimi drugimi akterji za razvoj globalne strategije za imunizacijo in politike o dodeljevanju proizvodov, da bodo lahko prednostne skupine čim prej prišle do cepiv.
Among the frontrunners of vaccine candidates having already entered the clinical trial stage, an EU based biotechnology company which is a leader in mRNA technology is receiving support through these financial products for the development and upscaling of manufacturing capacities: on 11 June, BioNTech SE signed an agreement with the EIB for EUR 100 million financing guaranteed jointly by EFSI and Horizon 2020 InnovFin. 
Med vodilnimi kandidati za cepivo, ki so že v fazi kliničnega preskušanja, biotehnološko podjetje s sedežem v EU, ki ima vodilno vlogo v tehnologiji na osnovi informacijske ribonukleinske kisline, prejema podporo prek teh finančnih produktov za razvoj in povečanje proizvodnih zmogljivosti: podjetje BioNTech SE je 11. junija podpisalo sporazum z EIB za financiranje v višini 100 milijonov EUR, za katero skupaj jamčita EFSI in Horizon 2020 InnovFin.
In order to support companies in the swift development and production of a vaccine, the Commission will enter into agreements with individual vaccine producers on behalf of Member States. 
Komisija bo podjetja podprla pri hitrem razvoju in proizvodnji cepiva tako, da bo v imenu držav članic sklenila sporazume s posameznimi proizvajalci cepiv.
The EU's regulatory framework, which offers a high degree of protection, contains regulatory flexibilities to cater for urgency. 
Regulativni okvir EU, ki zagotavlja visoko stopnjo varovanja, omogoča regulativno prožnost v izrednih razmerah.
In a pandemic situation, clinical trials will be carried out within a remarkably compressed timeframe, thus limiting the data available for reviewing the market authorisation request. 
V teh razmerah pandemije se bodo klinična preskušanja izvajala v izjemno skrajšanem časovnem okviru, zaradi česar bodo razpoložljivi podatki za pregled vloge za pridobitev dovoljenja za promet omejeni.
A large share of vaccine candidates fail during clinical trials. 
Med kliničnim preskušanjem odpade velik delež kandidatov za cepivo.
By the end of May 2020, the pledging campaign the Commission initiated had raised EUR 9.8 billion euro, to which it had contributed EUR 1.4 billion (of which 1 billion from its Horizon 2020 research and innovation framework programme), with the aim of providing universal access to affordable coronavirus vaccination, treatment and testing. 
V donatorski kampanji, ki jo je organizirala Komisija, je bilo do konca maja 2020 zbrane 9,8 milijarde EUR, od tega je Komisija prispevala 1,4 milijarde EUR (1 milijardo EUR iz okvirnega programa za raziskave in inovacije Obzorje 2020), da bi zagotovila univerzalen dostop do cenovno dostopnega cepljenja, zdravljenja in testiranja v zvezi s koronavirusom.