natgillin/translations-raw huggingface dataset:
-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.
These APAs will specify a number of details with respect to expected payments (such as payment amounts, schedule and financial structure), delivery details of the vaccine if and when successful (such as price per person vaccinated, quantity of vaccines and delivery timeline after approval) and any other relevant conditions (such as production capacity in the EU, possible availability of production facilities for the manufacturing of other vaccines or medicines in case of failure, or liability arrangements).
V sporazumih za vnaprejšnji nakup bodo določene podrobnosti glede pričakovanih plačil (kot so zneski plačil, časovni okvir in finančna struktura), podrobnosti o dobavi cepiva, če in ko bo cepivo uspešno (kot so cena cepiva na osebo, količina cepiv in časovni okvir dobave po odobritvi), in vsi drugi zadevni pogoji (kot so proizvodne zmogljivosti v EU, morebitna razpoložljivost proizvodnih zmogljivosti za proizvodnjo drugih cepiv ali zdravil v primeru neuspeha ter ureditve glede odgovornosti).
In response to the WHO's call for global action on 24 April, the Commission launched a Global Coronavirus Response to mobilise resources and join forces among countries and global health organisations to accelerate the development and deployment of diagnostics, therapeutics and vaccines wherever they are needed.
V odgovor na poziv STO 24. aprila k ukrepanju na svetovni ravni je Komisija organizirala vrh o globalnem odzivu na koronavirus, da bi mobilizirala vire in združila moči med državami in zdravstvenimi organizacijami po svetu, da bi pospešila razvoj in uvajanje diagnostike, zdravljenja in cepiv, kjer koli so potrebni.
The Commission stands ready to enter into negotiations with all vaccine producers, which have either started or have firm plans to start clinical trials still in 2020 and which have the potential to deliver doses at the necessary scale and within the necessary timelines.
Komisija je pripravljena začeti pogajanja z vsemi proizvajalci cepiv, ki so se že začeli klinična preskušanja ali imajo zanje trdne načrte še v letu 2020, in ki bi lahko zagotovili odmerke v potrebnem obsegu in v potrebnih časovnih okvirih.
The Commission will implement the EU strategy for COVID-19 vaccines together with the Member States, thus increasing the likelihood that all who need vaccines will have equitable and affordable access to the supplies of these vaccines in the shortest possible time frame.
Komisija bo strategijo EU za cepiva proti COVID-19 izvajala skupaj z državami članicami, s čimer bo povečala verjetnost, da bodo imeli vsi, ki cepiva potrebujejo, pravičen in cenovno dostopen dostop do zalog teh cepiv v najkrajšem možnem časovnem okviru.
To this end, the EU is leading the global effort for universal testing, treatment and vaccination by mobilising resources through international pledging and by joining forces with countries and global health organisations through the Access to Covid-19 Tools (ACT) Accelerator collaborative framework 1 .
V ta namen EU vodi globalna prizadevanja za univerzalno testiranje, zdravljenje in cepljenje z mobilizacijo sredstev prek mednarodnih donacij ter z združevanjem moči z državami in svetovnimi zdravstvenimi organizacijami prek okvira sodelovanja Pospeševalnik ACT (za dostop do orodij COVID-19) 1 .
When any of the vaccines becomes available, Member States can use the results of the procurement carried out by the Commission to acquire vaccines directly from the producer, without the need to carry out an additional national procurement procedure.
Ko bo katero od cepiv na voljo, lahko države članice uporabijo rezultate javnega naročila, ki ga izvede Komisija, za nakup cepiv neposredno od proizvajalca, ne da bi jim bilo pri tem treba izvesti dodaten nacionalni postopek javnega naročanja.
Through the ETF, it provides rapid scientific advice and feedback on development plans, offers scientific support to facilitate clinical trials conducted in the EU and a rolling review of incoming scientific data from clinical trials to allow for an accelerated assessment of the final data after completion of the clinical trials.
Prek te projektne skupine zagotavlja hitro znanstveno svetovanje in povratne informacije o načrtih razvoja ter nudi znanstveno podporo za olajšanje kliničnih preskušanj, ki se izvajajo v EU, in redno pregledovanje vhodnih znanstvenih podatkov iz kliničnih preskušanj, da se omogoči pospešeno ocenjevanje končnih podatkov po zaključku kliničnih preskušanj.
As per the requirements of the ESI Regulation, the Member States and the Commission would agree in the above-mentioned agreement that the Commission carries out the procurement on behalf of the Member States including the terms applicable to such procurement.
V skladu z zahtevami iz uredbe o ESI bi se države članice in Komisija v navedenem sporazumu strinjale, da Komisija izvede javno naročilo v imenu držav članic, vključno z določitvijo pogojev, ki se uporabijo za tako javno naročilo.
In addition, the Commission has adopted alongside the present Communication a proposal for a Regulation to adjust and clarify certain legal requirements for the environmental risk assessment for COVID-19 vaccines that contain or consist of genetically modified organisms that could otherwise slow down the conduct of clinical trials with these vaccines in the EU and their administration, where appropriate, to specific populations that could benefit from early access.
Poleg tega je Komisija skupaj s tem sporočilom sprejela predlog uredbe za prilagoditev in pojasnitev določenih pravnih zahtev za oceno tveganja za okolje za cepiva proti COVID-19, ki vsebujejo gensko spremenjene organizme ali so iz njih sestavljena, ki bi lahko drugače upočasnile izvajanje kliničnih preskušanj s temi cepivi v EU ter njihovo uporabo, kadar je to primerno, za določeno skupino prebivalstva, ki bi lahko imela koristi od zgodnjega dostopa.
The Commission will propose to Member States to alleviate the language requirements and to ensure the acceptability of multi-dose presentations for COVID-19 vaccines to facilitate more rapid deployment of a new vaccine and more even distribution of the doses between Member States.
Komisija bo državam članicam predlagala, naj ublažijo jezikovne zahteve in zagotovijo sprejemljivost pakiranja z večkratnimi odmerki za cepiva proti COVID-19, da bi se omogočilo hitrejše uvajanje novega cepiva in enakomernejša distribucija odmerkov med državami članicami.
Delivering such an undertaking within such a compressed timeframe requires running clinical trials in parallel with investing in production capacity and securing raw materials so that production can start as soon as those trials are concluded, or even earlier.
Da bi to dosegli v tako omejenem časovnem okviru, je treba klinična preskušanja izvajati vzporedno z naložbami v proizvodne zmogljivosti in zagotavljanjem surovin, da se bo proizvodnja lahko začela takoj, ko se bodo navedena preskušanja zaključila, ali celo prej.
In the light of the experience it will gain with the present strategy, and building on existing international procurement initiatives, the Commission is ready to support the development and operation of an inclusive international COVID-19 procurement mechanism that facilitates early and affordable access to vaccines and other tools for all who need it across the world.
Komisija je glede na izkušnje, ki jih bo pridobila s to strategijo, in na podlagi obstoječih mednarodnih pobud za javna naročila pripravljena podpreti razvoj in delovanje vključujočega mednarodnega mehanizma za javna naročila v zvezi s COVID-19, ki bi omogočil zgodnji in cenovno dostopen dostop do cepiv in drugih orodij za vse, ki jih potrebujejo, po vsem svetu.
This alliance was formed to pool the national resources of those countries and secure fair access to vaccine supplies for the European population.
Njegov namen je združiti nacionalna sredstva navedenih držav in zagotoviti pravičen dostop evropskega prebivalstva do zalog cepiva.
If additional funds are needed, Member States will have the possibility to top-up the ESI to make up any financing gap in order to finance more offers.
Če bodo potrebna dodatna sredstva, bodo imele države članice možnost, da za zapolnitev morebitne finančne vrzeli namenijo dodatna finančna sredstva v instrument ESI za financiranje več ponudb.
This is particularly the case for the Horizon 2020 InnovFin Infectious Disease Finance Facility (H2020 InnovFin IDFF), a debt facility guaranteed at 100% by the Commission, which provides support from clinical studies to scaled-up manufacturing.
To zlasti velja za finančni instrument za nalezljive bolezni v programu InnovFin v okviru programa Obzorje 2020 (H2020 InnovFin IDFF), ki je dolžniška shema, za katero Komisija jamči 100 %, ki zagotavlja podporo od kliničnih študij do proizvodnje v velikem obsegu.
Under normal circumstances, companies make investments in production capacity dependent on the probability of obtaining a successful vaccine from the development phase that will meet the strict standards of quality, safety and efficacy needed to be authorised, and that will be viable according to the demand projections available.
V običajnih okoliščinah podjetja od razvojne faze dalje vlagajo v proizvodne zmogljivosti glede na verjetnost pridobitve uspešnega cepiva, ki izpolnjuje stroge standarde kakovosti, varnosti in učinkovitosti, potrebne za njegovo odobritev, in ki bo poslovno vzdržno glede na razpoložljive projekcije povpraševanja.
Supporting and accelerating clinical trials and de-risking simultaneous investments in production capacity will significantly increase the potential for the world to have access to an affordable vaccine sooner than would otherwise be the case.
S podpiranjem in pospeševanjem kliničnih preskušanj in zmanjševanjem tveganja sočasnih naložb v proizvodne zmogljivosti se bodo znatno povečale možnosti, da dobi svet dostop do cenovno dostopnega cepiva prej, kot bi ga sicer.