natgillin/translations-raw huggingface dataset:
The aid is granted for the construction or upgrade of testing and upscaling infrastructures required to develop, test and upscale, up to first industrial deployment prior to mass production, COVID-19 relevant medicinal products (including vaccines) and treatments, their intermediates, active pharmaceutical ingredients and raw materials; medical devices, hospital and medical equipment (including ventilators and protective clothing and equipment as well as diagnostic tools) and necessary raw materials; disinfectants and their intermediary products and raw chemical materials necessary for their production; as well as data collection/processing tools;
pomoč se odobri za gradnjo ali nadgradnjo infrastruktur za preskušanje in prenos v proizvodnjo, ki je do prve industrijske uvedbe pred njihovo serijsko proizvodnjo potrebna za razvoj, preskušanje in prenos v proizvodnjo zdravil (vključno s cepivi) in zdravljenj v zvezi s COVID-19, njihovih vmesnih izdelkov, aktivnih farmacevtskih učinkovin in surovin; medicinskih pripomočkov ter bolnišnične in medicinske opreme (vključno z ventilatorji in zaščitnimi oblačili ter opremo in diagnostičnimi orodji) in potrebnih surovin; razkužil in njihovih vmesnih izdelkov ter kemičnih surovin, ki so potrebne za njihovo proizvodnjo; ter orodij za zbiranje/obdelavo podatkov;
The investment aid is granted for the production of COVID-19 relevant products, such as medicinal products (including vaccines) and treatments, their intermediates, active pharmaceutical ingredients and raw materials; medical devices, hospital and medical equipment (including ventilators, protective clothing and equipment as well as diagnostic tools) and necessary raw materials; disinfectants and their intermediary products and raw chemical materials necessary for their production; data collection/processing tools;
pomoč za naložbe se odobri za proizvodnjo izdelkov v zvezi s COVID-19, kot so ustrezna zdravila (vključno s cepivi) in zdravljenja, njihovi vmesni izdelki, aktivne farmacevtske učinkovine in surovine; medicinski pripomočki, bolnišnična in medicinska oprema (vključno z ventilatorji, zaščitnimi oblačili ter opremo in diagnostičnimi orodji) in potrebne surovine; razkužila in njihove vmesne izdelke ter kemične surovine, ki so potrebne za njihovo proizvodnjo; orodja za zbiranje/obdelavo podatkov;
The Commission has been closely monitoring the situation since the onset of the crisis.
Komisija od začetka krize pozorno spremlja razmere.
Member States should encourage exchange of those experiences.
Države članice bi morale spodbujati izmenjavo teh izkušenj.
Showing solidarity
Izkazovanje solidarnosti
The current crisis requires a significant increase of production.
Sedanja kriza zahteva znatno povečanje proizvodnje.
c. Implementing regulatory flexibility
c. Izvajanje regulativne prožnosti
It has become apparent that protectionist measures are affecting the global pharmaceutical supply chain.
Postalo je jasno, da protekcionistični ukrepi vplivajo na svetovno farmacevtsko dobavno verigo.
d. Monitoring available stocks at national level
d. Spremljanje razpoložljivih zalog na nacionalni ravni
In some cases, administrative procedures slow down movement of these substances cross-border within the EU.
Upravni postopki v nekaterih primerih upočasnjujejo čezmejno gibanje teh snovi znotraj EU.
These guidelines have been developed based on best practices in the Member States shared with the Commission.
Te smernice so bile oblikovane na podlagi najboljših praks v državah članicah, ki so jih delile s Komisijo.
g. Facilitating air freight and other forms of transport
g. Olajševanje zračnega tovornega prometa in drugih oblik prometa
a. Increasing and reorganising production
a. Povečanje in reorganizacija proizvodnje
This has resulted in a considerable surge in the demand for these medicines and medical oxygen.
To je povzročilo velik porast povpraševanja po teh zdravilih in medicinskem kisiku.
The guidelines outlined below are addressed to the EU Member States and are also relevant for European Economic Area (EEA) countries.
V nadaljevanju opisane smernice so namenjene državam članicam EU in so uporabne tudi za države Evropskega gospodarskega prostora (EGP).
Contacts between national authorities and industry should be organised via a single contact point.
Stike med nacionalnimi organi in industrijo bi bilo treba organizirati prek enotne kontaktne točke.
Export bans and national stockpiling, within and outside the EU, can easily lead to inequitable supply and shortages in the EU and worldwide.
Prepovedi izvoza in nacionalno kopičenje zalog znotraj in zunaj EU lahko zlahka privedejo do nepravične oskrbe in pomanjkanja v EU in po svetu.
Total export bans for medicines are not in line with the Treaty and impede the functioning of the single market.
Popolna prepoved izvoza zdravil ni v skladu s Pogodbo in ovira delovanje enotnega trga.
c. Avoiding that misinformation leads to improper use and unnecessary stockpiling
c. Preprečevanje, da napačne informacije privedejo do nepravilne uporabe in nepotrebnega kopičenja zalog
They have also collected information on overall demand from Member States and the potential impact of third country export bans.
Zbrala je tudi informacije o skupnem povpraševanju držav članic in morebitnem učinku prepovedi izvoza tretjih držav.
Additionally, the following measures are fundamental to ensure that production capacity can function optimally:
Poleg tega so za zagotovitev optimalnega delovanja proizvodne zmogljivosti bistveni naslednji ukrepi:
The Member States, with the support of the Commission and the European Medicines Agency should continue:
Države članice bi morale ob podpori Komisije in Evropske agencije za zdravila še naprej:
The COVID-19 pandemic affects all Member States.
Pandemija COVID-19 vpliva na vse države članice.
Optimal use of medicines in hospitals
Optimalna uporaba zdravil v bolnišnicah
b. Ensuring manufacturing continues at full capacity
b. Zagotavljanje, da se proizvodnja nadaljuje s polno zmogljivostjo
Pharmaceutical production and distribution is multinational and vulnerable to border control delays.
Farmacevtska proizvodnja in distribucija sta večnacionalni in ranljivi zaradi zamud pri mejnih kontrolah.
In particular, manufacturing of essential medicines should be increased, where possible or at least maintained at their current level.
Zlasti je treba, kadar je to mogoče, povečati proizvodnjo osnovnih zdravil ali jo vsaj ohraniti na trenutni ravni.
The pharmaceutical industry relies mainly on small volume shipments by air.
Farmacevtska industrija se v glavnem zanaša na pošiljke majhnih količin po zraku.
c. Considering alternative medicines on the basis of hospital protocols and national guidelines
c. Preučitev alternativnih zdravil na podlagi bolnišničnih protokolov in nacionalnih smernic
The European Commission should be directly informed of any supply issues due to third country export bans that require political outreach.
Evropska komisija bi morala biti neposredno obveščena o vseh vprašanjih oskrbe zaradi prepovedi izvoza tretjih držav, ki zahtevajo politično ukrepanje.
Substitution should always be carefully assessed and authorised by the appropriate national authority taking into account the possible specificities of the veterinary sector.
Nadomestitev bi moral ustrezni nacionalni organ vedno pozorno oceniti in odobriti, pri čemer bi bilo treba upoštevati morebitne posebnosti veterinarskega sektorja.
Member States are expected to protect public health in a spirit of European solidarity.
Države članice naj bi varovale javno zdravje v duhu evropske solidarnosti (2) .
Whilst it is understandable that countries wish to ensure the availability of essential medicines nationally, export bans are detrimental to the availability of medicines for European patients even when they are legally justifiable.
Čeprav je razumljivo, da države želijo zagotoviti razpoložljivost osnovnih zdravil na nacionalni ravni, prepoved izvoza škodljivo vpliva na razpoložljivost zdravil za evropske bolnike, čeprav je pravno upravičena.
Medicines wholesalers are responsible for distributing medicines within the EU/EEA.
Trgovci z zdravili na debelo so odgovorni za distribucijo zdravil v EU/EGP.
In EU/EEA countries with available data, around 30% of diagnosed COVID-19 patients are hospitalised (1) , many of them needing oxygen therapy.
V državah EU/EGP z razpoložljivimi podatki je približno 30 % diagnosticiranih bolnikov s COVID-19 hospitaliziranih (1) , od katerih jih veliko potrebuje terapijo s kisikom.
Magistral preparations should be used to replace unavailable medicines.
Za nadomestitev zdravil, ki niso na voljo, bi bilo treba uporabiti magistralna zdravila.
Preventive stockpiling by Member States puts supply at risk for all countries.
Zaradi preventivnega kopičenja zalog v državah članicah je ogrožena oskrba v vseh državah.
e. Ensuring necessary support to the wholesale sector
e. Zagotavljanje potrebne podpore za veleprodajni sektor
Pharmaceutical manufacturing (including all necessary raw materials and components) should be designated as an essential activity and allowed to continue operating.
Proizvodnja zdravil (vključno z vsemi potrebnimi surovinami in sestavinami) bi morala biti določena kot bistvena dejavnost, ki bi se morala še naprej izvajati.
h. Ensuring fair distribution of supply
h. Zagotavljanje pravične porazdelitve oskrbe
The unprecedented nature of the outbreak may require Member States to take exceptional measures to protect public health.
Zaradi neprimerljive narave izbruha lahko države članice sprejmejo izredne ukrepe za varovanje javnega zdravja.
The Commission has formally called on the pharmaceutical industry to increase production capacity for all medicines for which there is an increased demand as a result of COVID-19, and in particular for those for which there is a risk of supply shortages.
Komisija je farmacevtsko industrijo uradno pozvala, naj poveča proizvodno zmogljivost za vsa zdravila, po katerih se je povečalo povpraševanje zaradi COVID-19, in zlasti za tista, za katera obstaja tveganje pomanjkanja oskrbe.
It should be stressed that they rely on the EU pharmaceutical industry acting responsibly and with solidarity.
Poudariti je treba, da se opirajo na odgovorno ravnanje farmacevtske industrije EU in solidarnost.
It is recommended that procurement is organised regularly at short intervals to avoid shortages and prevent stockpiling.
Priporoča se, da se javno naročanje redno organizira v kratkih časovnih presledkih, da se prepreči pomanjkanje in kopičenje zalog.
It might also require to re-organise supply chains and production lines and tap on existing stocks to increase output as quickly as possible.
Prav tako bo morda treba ponovno organizirati dobavne verige in proizvodne linije ter čim prej izkoristiti obstoječe zaloge za povečanje proizvodnje.
Where regular sources are exhausted, essential medicines should be allowed to be sourced outside the EU/EEA under the supervision of national authorities or the European Medicines Agency.
Kadar se običajni viri izčrpajo, bi bilo treba omogočiti, da se osnovna zdravila nabavljajo zunaj EU/EGP pod nadzorom nacionalnih organov ali Evropske agencije za zdravila.
a. Lifting export bans and restrictions
a. Odprava prepovedi in omejitev izvoza
Supplementary demand (voluntary stockpiles) must be justified according to the number of COVID-19 patients in the affected area.
Dodatno povpraševanje (npr. za prostovoljne zaloge) je treba utemeljiti glede na število bolnikov s COVID-19 na prizadetem območju.
They must ensure that essential medicines are available in the hospitals and pharmacies that need them most, regardless of their location.
Zagotoviti morajo, da so osnovna zdravila na voljo v bolnišnicah in lekarnah, ki jih najbolj potrebujejo, ne glede na njihovo lokacijo.
Member States should promote the rational use of medicines and reassure the public of the availability and safe use of medicines.
Države članice bi morale spodbujati racionalno uporabo zdravil ter pomiriti javnost glede razpoložljivosti in varne uporabe zdravil.
They must be allowed to continue operating at full capacity and supply medicinal product to hospitals and pharmacies.
Omogočiti jim je treba, da še naprej poslujejo s polno zmogljivostjo in dobavljajo zdravila bolnišnicam in lekarnam.
Special attention should be given to ensure appropriate dosing and additional reporting of adverse reactions.
Posebno pozornost bi bilo treba nameniti zagotavljanju ustreznega odmerjanja in dodatnemu poročanju o neželenih učinkih.
b. Exchanging hospital protocols to treat patients
b. Izmenjava bolnišničnih protokolov za zdravljenje bolnikov
It is therefore critical to optimise and rationalise supply, allocation and use to ensure the optimal availability of the essential medicines needed to respond to the pandemic.
Zato je nujno optimizirati in racionalizirati oskrbo, dodeljevanje in uporabo, da se zagotovi optimalna razpoložljivost osnovnih zdravil, potrebnih za odziv na pandemijo.
Coordinated or aggregated purchasing also helps to allocate supplies depending on hospital needs.
Usklajena ali skupna nabava prav tako pomaga pri dodeljevanju materiala glede na potrebe bolnišnic.
Member States should apply these limits for medicines at risk of shortages or subject to increased demand.
Države članice bi morale te omejitve uvesti za zdravila, pri katerih obstaja tveganje pomanjkanja ali povečano povpraševanje.
The Commission, with the support of the European Medicines Agency (EMA), has been collecting data to monitor, assess and anticipate EU level shortages, notably in hospital settings.
Komisija ob podpori Evropske agencije za zdravila zbira podatke za spremljanje, ocenjevanje in predvidevanje pomanjkanja na ravni EU, zlasti v bolnišnicah.
The current crisis has highlighted many challenges in ensuring the supply of medicines needed in the EU during the COVID-19 outbreak.
Sedanja kriza je izpostavila številne izzive pri zagotavljanju oskrbe z zdravili, ki so potrebna v EU med izbruhom COVID-19.
In situations of high demand, national coordination between authorities, procurers and industry should be put in place to guarantee an equitable distribution of medicines.
V razmerah velikega povpraševanja je treba vzpostaviti nacionalno usklajevanje med organi, naročniki in industrijo, da se zagotovi pravična distribucija zdravil.
(4) It is of utmost importance to ensure that products considered essential to protect public health remain available at competitive prices.
Najbolj pomembno je zagotoviti, da so proizvodi, ki se štejejo za osnovne za varovanje javnega zdravja, še naprej dostopni po konkurenčnih cenah (5) .
The guidelines recognise the competency of Member States to organise the delivery of healthcare and retail sales of medicinal products.
Smernice priznavajo pristojnost držav članic, da organizirajo zagotavljanje zdravstvenega varstva in prodajo zdravil na drobno.
The European Commission is calling on all Member States to lift unjustified export bans for medicines within the internal market.
Evropska komisija poziva vse države članice, naj odpravijo neupravičene prepovedi izvoza zdravil na notranjem trg.
(5) Joint statement by the European Competition Network (ECN) on application of competition law during the Corona crisis of 23 March 2020 (https://ec.europa.eu/competition/ecn/202003_joint-statement_ecn_corona-crisis.pdf)
(5) Skupna izjava Evropske mreže za konkurenco o uporabi konkurenčnega prava med krizo zaradi koronavirusa z dne 23. marca 2020 (https://ec.europa.eu/competition/ecn/202003_joint-statement_ecn_corona-crisis.pdf)
Member States should support industry increasing their manufacturing capacity, in particular through fiscal incentives and State aid.
Države članice bi morale podpirati industrijo, da poveča svoje proizvodne zmogljivosti, zlasti s fiskalnimi spodbudami in državno pomočjo (4) .
It is important to acknowledge that no country is self-sufficient in the raw materials, intermediates, APIs and finished medicines required to ensure a well-functioning healthcare system.
Pomembno je priznati, da nobena država ni samozadostna pri surovinah, intermediatih, aktivnih farmacevtskih učinkovinah in končnih zdravilih, ki so potrebna za zagotovitev dobro delujočega zdravstvenega sistema.
The increase in demand for medicines to treat COVID-19 can also, in some cases, threaten their availability for patients using them to manage their chronic and/or rare diseases.
Povečanje povpraševanja po zdravilih za zdravljenje COVID-19 lahko v nekaterih primerih ogrozi njihovo razpoložljivost za bolnike, ki jih potrebujejo za zdravljenje svojih kroničnih in/ali redkih bolezni.
Patients may be tempted to hoard medicines to avoid visiting pharmacies and being exposed to coronavirus during the pandemic.
Bolniki bodo morda v skušnjavi, da kopičijo zdravila, da bi se izognili obiskom lekarn in izpostavljenosti koronavirusu med pandemijo.
Where such temporary measures of pharmaceutical companies require cooperation or coordination with other companies in order to ensure continued care for COVID-19 patients, the Commission is ready to provide guidance and legal certainty to these companies on their compliance with EU competition rules.
Kadar taki začasni ukrepi farmacevtskih družb zahtevajo sodelovanje ali usklajevanje z drugimi podjetji za zagotavljanje stalne oskrbe bolnikov s COVID-19, je Komisija pripravljena tem podjetjem zagotoviti smernice in pravno varnost glede njihove skladnosti s pravili EU o konkurenci (3) .
Hospitals may benefit from the COVID-19 Clinicians network (12) established by the Commission to adjust their protocols for better clinical outcomes and in order to optimise the use of medicines.
Bolnišnice lahko izkoristijo mrežo kliničnih zdravnikov pri COVID-19 (12) , ki jo je ustanovila Komisija, da bi prilagodile svoje protokole za boljše klinične rezultate in optimizirale uporabo zdravil.
The COVID-19 pandemic has led to a significant increase in the demand for certain medicines.
Zaradi pandemije COVID-19 se je znatno povečalo povpraševanje po nekaterih zdravilih.
Members States should also consider strengthening information regarding the common EU logo that identifies legally operating on-line retailers to avoid that patients buy falsified medicines from unauthorised sellers.
Države članice bi morale razmisliti tudi o krepitvi informacij glede skupnega logotipa EU, s katerim bi bile identificirane zakonito delujoče spletne trgovine na drobno, za preprečitev, da bi bolniki kupovali ponarejena zdravila pri nepooblaščenih prodajalcih.
In case of confirmed medicines shortages, hospitals should adapt their existing protocols or establish new validated protocols that identify the optimal alternative.
V primeru potrjenega pomanjkanja zdravil bi morale bolnišnice prilagoditi svoje obstoječe protokole ali oblikovati nove potrjene protokole, ki bi opredelili najboljšo možno alternativo.
Member States should inform citizens of the actions taken to address actual and potential problems of availability and correct any misinformation concerning shortages.
Države članice bi morale državljane obveščati o ukrepih, sprejetih za obravnavanje dejanskih in morebitnih težav glede razpoložljivosti in popravo morebitnih napačnih informacij v zvezi s pomanjkanjem.
Worldwide confinement measures have led to disruptions and increased prices for air freight and shipping.
Ukrepi za osamitev na svetovni ravni so privedli do motenj in višjih cen v zračnem tovornem prometu in pomorskem prometu.
Stockpiling at EU level (e.g. through RescEU) is therefore the optimal solution for all Member States, and any stockpiling by Member States should be at national level and for moderate quantities based on epidemiological indications.
Kopičenje zalog na ravni EU (npr. prek RescEU) je zato optimalna rešitev za vse države članice, vsako kopičenje zalog v državah članicah pa bi bilo treba izvajati na nacionalni ravni in v zmernih količinah glede na epidemiološko situacijo.
On their side, marketing authorisation holders should ensure that Member States authorities are promptly informed of any potential or expected shortages and other relevant information.
Imetniki dovoljenja za promet pa bi morali zagotoviti, da so organi držav članic nemudoma obveščeni o vsakem morebitnem ali pričakovanem pomanjkanju in drugih pomembnih informacijah.
It is important to fully implement green lanes, established to facilitate transport of all goods, as they will allow for smooth transport of not only medicinal products, but also raw materials, intermediates, APIs, substances of human origin (e.g. plasma), and related materials such as packaging.
Pomembno je, da se v celoti uveljavljajo zeleni vozni pasovi, ki so bili vzpostavljeni za lažji prevoz vsega blaga, saj bodo omogočali nemoten prevoz ne le zdravil, ampak tudi surovin, intermediatov, aktivnih farmacevtskih učinkovin, snovi človeškega izvora (npr. plazme) in povezanih materialov, kot je embalaža (8) .
(1) ECDC report: Coronavirus disease 2019 (COVID-19) pandemic: increased transmission in the EU/EEA and the UK - seventh update of 25.3.2020
(1) Poročilo ECDC: Pandemija koronavirusne bolezni 2019 (COVID-19): hitrejši prenos v EU/EGP in Združenem kraljestvu - sedma posodobitev z dne 25.3.2020
f. Fully enforcing the green lanes
f. Celovito uveljavljanje zelenih voznih pasov
Stockpiling practices in anticipation of possible shortages can further contribute to the actual appearance of such shortages.
Kopičenje zalog v pričakovanju morebitnega pomanjkanja lahko dodatno prispeva k dejanskemu pomanjkanju.
Their employees should have access to the necessary PPE.
Njihovi zaposleni bi morali imeti dostop do potrebne osebne zaščitne opreme.
Preference needs to be given to setting up large, as much as possible European, clinical trials as these are necessary to generate the robust data required to establish evidence of their efficacy and thus to provide appropriate advice to healthcare professionals and patients and enable regulatory decision-making.
Prednost je treba dati vzpostavitvi obsežnih, v največji možni meri kliničnih preskušanj na evropski ravni, saj so ta potrebna za pridobitev zanesljivih podatkov, potrebnih za dokaz njihove učinkovitosti, s tem pa za zagotavljanje ustreznega svetovanja zdravstvenim delavcem in bolnikom ter za omogočanje sprejemanja regulativnih odločitev.
These measures, especially as far as they are applied to APIs or intermediates, endanger supply since they lead to a slowdown in industry output.
Ti ukrepi, zlasti če se uporabljajo za aktivne farmacevtske učinkovine ali intermediate, ogrožajo oskrbo, saj vodijo do upočasnitve proizvodnje v industriji.
Similarly, maritime cargo services need to run smoothly and without unnecessary delays to ensure the continuity of supply chains.
Podobno morajo storitve pomorskega tovornega prometa potekati nemoteno in brez nepotrebnih zamud, da se zagotovi kontinuiteta dobavnih verig (10) .
The processing of import permits should, therefore, be accelerated and facilitating the movement of medicines containing controlled substances across Member States should be considered in compliance with International Narcotic Control Board advice.
Zato bi bilo treba postopek izdaje uvoznih dovoljenj pospešiti, pretok zdravil, ki vsebujejo nadzorovane snovi, pa bi bilo treba olajšati v vseh državah članicah v skladu z nasveti Mednarodne uprave za kontrolo narkotikov.
Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak
Smernice o optimalni in racionalni oskrbi z zdravili za preprečevanje pomanjkanja med izbruhom COVID-19
Optimised protocols with confirmed outcomes should be made available to share between hospitals EU wide.
Optimizirani protokoli s potrjenimi rezultati bi morali biti na voljo za izmenjavo med bolnišnicami v EU.
The use of the medicines in the hospitals should follow validated hospital protocols that optimise the amount of medicines used to treat patients.
Uporaba zdravil v bolnišnicah bi morala slediti potrjenim bolnišničnim protokolom, ki optimizirajo količino zdravil, ki se uporabljajo za zdravljenje bolnikov.