natgillin/translations-raw huggingface dataset:
In order to ensure deliveries, vehicle drivers should also receive permits to travel without restriction and access hospitals, pharmacies and other dispensing sites (especially in quarantined areas).
Da bi zagotovili dobavo, bi morali tudi vozniki vozil prejeti dovoljenja za potovanje brez omejitev in dostop do bolnišnic, lekarn in drugih mest za distribucijo zdravil (zlasti na območjih, ki so v karanteni).
Simplified control procedures could also be introduced for controlled substances that fall under international rules against the illicit traffic of drugs and psychotropic substances and that are used to manufacture many intensive care medicines.
Uvedejo se lahko tudi poenostavljeni postopki nadzora za nadzorovane snovi, ki sodijo v okvir mednarodnih pravil za preprečevanje nezakonitega prometa mamil in psihotropnih snovi ter se uporabljajo za proizvodnjo številnih zdravil za intenzivno nego.
Limitation of online sales of essential medicines may be temporarily considered to better control the supply of essential medicines to patients.
Omejitev spletne prodaje osnovnih zdravil se lahko obravnava kot začasni ukrep za boljši nadzor oskrbe bolnikov z osnovnimi zdravili.
These guidelines aim to protect public health and preserve the integrity of the single market, whilst ensuring that Europe has the supply of affordable medicines it needs during the COVID-19 outbreak.
Te smernice so namenjene varovanju javnega zdravja in ohranjanju celovitosti enotnega trga, hkrati pa zagotavljajo, da je Evropa med izbruhom COVID-19 oskrbljena s cenovno dostopnimi zdravili, ki jih potrebuje.
to request, facilitate and coordinate, as need be, joint industry efforts to find effective measures and resources to reduce shortages and meet the demand for COVID-19 medicines; and,
glede na potrebe zahtevati, olajševati in usklajevati skupna prizadevanja industrije za iskanje učinkovitih ukrepov in sredstev za zmanjšanje pomanjkanja in zadovoljitev povpraševanja po zdravilih za zdravljenje COVID-19 ter
In order to ensure adequate supply, and especially in case of urgent demand, the flexibilities outlined in the Commission guidance on using the public procurement framework in the emergency situation related to the COVID-19 crisis should be taken into account.
Da bi zagotovili ustrezno oskrbo, zlasti v primeru nujnega povpraševanja, bi bilo treba upoštevati prožnosti, opisane v smernicah Komisije o uporabi okvira za javno naročanje v izrednih razmerah zaradi krize v zvezi z boleznijo COVID-19 (11) .
Member States should also take account of communication by the European Medicines Agency.
Države članice bi morale upoštevati tudi sporočila Evropske agencije za zdravila.
Such protocols should be based on evidence and adapted following experiences in treating COVID-19 patients.
Takšni protokoli morajo temeljiti na dokazih in morajo biti prilagojeni v skladu z izkušnjami pri zdravljenju pacientov s COVID-19.
National authorities should monitor stocks and demand by organising an efficient reporting system that allows hospital pharmacies to communicate available and required stocks of essential medicines once or even several times per week.
Nacionalni organi bi morali spremljati zaloge in povpraševanje z organizacijo učinkovitega sistema poročanja, ki bi bolnišničnim lekarnam omogočil, da enkrat ali večkrat tedensko sporočajo razpoložljive in potrebne zaloge osnovnih zdravil.
They also cover any medicine at risk of shortage due to the COVID-19 pandemic.
Zajemajo tudi vsa zdravila, pri katerih obstaja tveganje pomanjkanja zaradi pandemije COVID-19.
Information received from industry should be shared at EU level via the SPOC network coordinated by EMA.
Informacije, prejete od industrije, bi bilo treba deliti na ravni EU prek mreže enotnih kontaktnih točk, ki jo usklajuje Evropska agencija za zdravila.
Decreased production capacity, closure of raw material/active pharmaceutical ingredients (API) suppliers, logistics issues in affected countries, as well as transportation barriers between countries also have a direct impact on the availability of medicines, as well as on the development of new treatments against COVID-19.
Zmanjšana proizvodna zmogljivost, zaprtje dobaviteljev surovin/aktivnih farmacevtskih učinkovin, logistične težave v prizadetih državah ter prometne ovire med državami neposredno vplivajo tudi na razpoložljivost zdravil in razvoj novih načinov zdravljenja COVID-19.
At a technical level, EMA chairs a regular exchange with Member States on shortages in the single point of contact network ('SPOC').
Evropska agencija za zdravila na tehnični ravni predseduje redni izmenjavi z državami članicami glede pomanjkanja prek mreže enotnih kontaktnih točk.
To ensure sufficient supply and optimise manufacturing capacity, it is recommended that Member States grant regulatory flexibility to the pharmaceutical industry in the context of variations to marketing authorisation according to the relevant guidance.
Da bi zagotovili zadostno oskrbo in optimizirali proizvodne zmogljivosti, je priporočljivo, da države članice farmacevtski industriji v okviru sprememb dovoljenja za promet z zdravili zagotovijo regulativno prožnost v skladu z ustreznimi smernicami.
Member States should ensure access to personal protective equipment (PPE) for actors in the pharmaceutical supply chain as they are not only required by applicable EU legislation on occupational safety and health but are also necessary to prevent cross contamination and ensure the quality of medicines.
države članice bi morale akterjem v farmacevtski dobavni verigi zagotoviti dostop do osebne zaščitne opreme, saj je ta obvezna ne le po veljavni zakonodaji EU o varnosti in zdravju pri delu, temveč je potrebna tudi za preprečevanje navzkrižne kontaminacije in zagotavljanje kakovosti zdravil;
They focus on the rational supply, allocation and use of medicines to treat COVID-19 patients.
Osredotočajo se na racionalno oskrbo, dodeljevanje in uporabo zdravil za zdravljenje bolnikov s COVID-19.
The SPOC network has been used to collect information on current or expected shortages of intensive care medicines.
Mreža enotnih kontaktnih točk se uporablja za zbiranje informacij o trenutnem ali pričakovanem pomanjkanju zdravil za intenzivno nego.
There are different ways to bridge the gap between supply and demand.
Vrzel med ponudbo in povpraševanjem je mogoče zapolniti na različne načine.
For medicines under development or medicines currently authorised for other diseases and used to treat COVID-19 patients outside their authorised indications ("off-label") used under national early access programmes or in clinical trials, it is important that a complete forecast can be made of the supplies needed taking into account the needs of patients using these medicines on-label.
Za zdravila v razvoju ali zdravila, ki so sicer trenutno odobrena za druge bolezni, vendar se poleg odobrenih indikacij uporabljajo („nenamensko") za zdravljenje bolnikov s COVID-19 v okviru nacionalnih programov za zgodnji dostop ali v fazi kliničnega preskušanja, je pomembno, da je mogoče natančno oceniti njihove potrebne zaloge ob upoštevanju potreb bolnikov, ki uporabljajo ta zdravila namensko.
In case of critical shortages of essential authorised human medicines, using equivalent medicines (the same active substance, strength and pharmaceutical form) authorised for veterinary use should also be considered.
V primeru kritičnega pomanjkanja odobrenih osnovnih zdravil za uporabo v humani medicini bi bilo treba preučiti tudi uporabo enakovrednih zdravil (ista zdravilna učinkovina, jakost in farmacevtska oblika), odobrenih za uporabo v veterinarski medicini.
Member States should ensure that wholesaler distributors, community pharmacies and hospitals receive their usual stocks of medicines.
Države članice bi morale zagotoviti, da bodo distributerji na debelo, lekarne in bolnišnice prejemali svoje običajne zaloge zdravil.
This information should be shared with the marketing authorisation holder and wholesalers, as appropriate, to facilitate their ability to supply alternative medicines in case of shortages of first-line treatments.
Te informacije bi bilo treba deliti z imetnikom dovoljenja za promet in po potrebi trgovcem na debelo, da se olajša njihova zmožnost dobave alternativnih zdravil v primeru pomanjkanja zdravil prve izbire.
The current confinement measures have led to a decrease in air freight capacity and price increases.
Zaradi trenutnih ukrepov za osamitev so se zmanjšale zmogljivosti in povišale cene zračnega tovornega prometa.
Member States should limit dispensing and sales of certain prescription and non-prescription medicines (for example only allowing a one-month supply of prescription medicines, or a maximum of one package per customer of non-prescription medicines).
Države članice bi morale omejiti izdajanje in prodajo nekaterih zdravil na recept in zdravil brez recepta (na primer, da se dovoli le enomesečna zaloga zdravil na recept ali največ ena škatlica zdravil brez recepta na stranko).
For patients in critical care who need intubation, a concomitant therapy with anaesthetics, antibiotics, muscle relaxants, resuscitation medicines and anti-diuretics is essential.
Pri pacientih na intenzivni negi, ki jih je potrebno intubirati, je nujno sočasno zdravljenje z anestetiki, antibiotiki, mišičnimi relaksanti, zdravili za reanimacijo in antidiuretiki.
Measures leading to requisitioning of medicines, intermediates or APIs, or their production, should not be considered as an option.
Ukrepi, ki privedejo do zasega zdravil, intermediatov ali aktivnih farmacevtskih učinkovin ali omejevanje njihove proizvodnje, se ne bi smeli obravnavati kot možnost.
a. Introducing measures to reassure persons reliant on medication
a. Uvedba ukrepov za pomiritev oseb, ki potrebujejo zdravila
to implement, as need be, demand support and procurement initiatives to encourage appropriate supply to patients (EU level tools such as RescEU and the EU joint procurement agreement can be considered, as well as the Emergency Support Instrument when approved by the budgetary authority).
glede na potrebe izvajati pobude za podporo povpraševanju in javna naročila, da se spodbudi ustrezna oskrba bolnikov (uporabijo se lahko orodja na ravni EU, kot so RescEU, sporazum o skupnem javnem naročanju v EU in instrument za zagotavljanje nujne pomoči, ko ga bo odobril proračunski organ).
a. Equitable distribution of available medicines
a. Pravična distribucija razpoložljivih zdravil
to request that actors in the supply chain monitor their stocks and production capacity, share information with authorities, report shortages and monitor any potential disruptions in the supply of essential medicines;
od akterjev v dobavni verigi zahtevati, naj spremljajo svoje zaloge in proizvodne zmogljivosti, izmenjujejo informacije z organi, poročajo o pomanjkanju in spremljajo morebitne motnje v oskrbi z osnovnimi zdravili;
While a certain level of stockpiling of essential medicines for emergency use is understandable, generally speaking, the more localised the stockpiling, the greater will be the tendency towards an unsustainable increase in aggregate anticipatory demand which, if supply cannot follow suit, will lead to shortages in places where needs have materialised.
Medtem ko je določena stopnja zalog osnovnih zdravil za nujno rabo na splošno sprejemljiva, bo zaradi lokaliziranega kopičenja zalog večje tveganje, da bo skupno pričakovano povpraševanje, če ga ne bo mogoče pokriti z oskrbo, zraslo do nevzdržne meje, ki bo privedla do pomanjkanja na tistih mestih, kjer se bodo potrebe uresničile.
Member States should also inform citizens of any European Medicines Agency recommendations.
Države članice bi morale državljane obveščati tudi o vseh priporočilih Evropske agencije za zdravila (13) .
Weekly meetings with the EU associations representing the different actors of the pharmaceutical supply chain aimed to encourage industry to share information, report shortages and anticipate any disruption in the supply of critical products.
Tedenska srečanja z združenji EU, ki zastopajo različne akterje v farmacevtski dobavni verigi, so namenjena spodbujanju industrije k izmenjavi informacij, poročanju o pomanjkanjih in predvidevanju motenj v oskrbi z osnovnimi zdravili.
Taking into account the current unprecedented crisis, the procedures for changes in suppliers of APIs, the designation of new manufacturing sites or the extension of expiry dates should be accelerated as long as quality is ensured.
Ker je sedanja kriza brez primere, bi bilo treba pospešiti postopke za spremembo dobaviteljev aktivnih farmacevtskih učinkovin, določitev novih proizvodnih obratov ali podaljšanje roka uporabnosti, če je zagotovljena kakovost.
(2) Communication to the European Parliament, the European Council, the Council, the European Central Bank, the European Investment Bank and the Eurogroup on coordinated economic response to the COVID-19 outbreak of 13.3.2020, COM(2020)112 final
(2) Sporočilo Komisije Evropskemu parlamentu, Evropskemu svetu, Svetu, Evropski centralni banki, Evropski investicijski banki in Euroskupini: Usklajen gospodarski odziv na izbruh virusa COVID-19 (COM(2020) 112 final z dne 13. marca 2020).
The supply of essential medicines to hospital pharmacies must be coordinated at the appropriate level that allows an efficient and equitable distribution of the available medicines, depending on Member State's organisation and structure.
Oskrba bolnišničnih lekarn z osnovnimi zdravili mora biti usklajena na ustrezni ravni, da se glede na organizacijo in strukturo države članice omogoči učinkovita in pravična distribucija razpoložljivih zdravil.
Optimisation of sales in community pharmacies to avoid hoarding
Optimizacija prodaje v lekarnah v izogib kopičenju
A similar process is in place to collect direct reports, from supply chain stakeholders, of actual and anticipated shortages of critical medicines used in context of COVID-19, both for centrally authorised and nationally authorised medicines.
Podoben postopek se izvaja za zbiranje neposrednih poročil zainteresiranih strani v dobavni verigi o dejanskem in pričakovanem pomanjkanju osnovnih zdravil, ki se uporabljajo za zdravljenje COVID-19, tako za zdravila, odobrena po centraliziranem postopku, kot za nacionalno odobrena zdravila.
National authorities should be able to reallocate stock between hospitals depending on needs.
Nacionalnim organom bi moralo biti omogočeno, da glede na potrebe prerazporedijo zaloge med bolnišnicami.
As much as possible, in order to increase efficiency, purchases for hospitals should be bundled and organised by central purchasing bodies active in the healthcare sector.
Da bi povečali učinkovitost, bi morali osrednji nabavni organi, ki delujejo v zdravstvenem sektorju, v največji možni meri združiti in organizirati nakupe za bolnišnice.
(4) Communication from the Commission on Amendment to the Temporary Framework for State aid measures to support the economy in the current COVID-19 outbreak of 3.4.2020, C(2020) 2215 final
(4) Sporočilo Komisije o spremembi Začasnega okvira za ukrepe državne pomoči v podporo gospodarstvu ob izbruhu COVID-19 z dne 3.4.2020, C(2020) 2215 final.
Member States should consider actions to ensure air cargo capacity for transport of medicines, APIs, intermediates and raw materials in line with Commission guidelines.
Države članice bi morale razmisliti o ukrepih za zagotovitev zmogljivosti zračnega prometa za prevoz zdravil, aktivnih farmacevtskih učinkovin, intermediatov in surovin v skladu s smernicami Komisije (9) .
(2) In order to achieve this objective, it is critically important that Member States lift export bans on medicines within the internal market.
Za dosego tega cilja je bistveno, da države članice odpravijo vse prepovedi izvoza zdravil na notranjem trgu.
c. Limiting online sales of products at risk
c. Omejevanje spletne prodaje zdravil, pri katerih obstaja tveganje
b. Introducing restrictions on sales in community pharmacies
b. Uvedba omejitev prodaje v lekarnah
Member States should share information with marketing authorisation holders (MAHs), wholesalers and hospital pharmacies, such as epidemiological forecasts (7) , that help them to better plan for increased demand and respond to that Member State's needs.
Države članice bi si morale izmenjevati informacije, kot so epidemiološke napovedi (7) , z imetniki dovoljenj za promet z zdravili, trgovci na debelo in bolnišničnimi lekarnami, da bi jim pomagale izboljšati načrt za večje povpraševanje in odzivanje na potrebe držav članic.
Marketing authorisation holders should be invited to request the extension of the expiry dates of batches of essential medicines where possible, based on stability data to the relevant national authorities.
Imetnike dovoljenj za promet z zdravili bi bilo treba pozvati, naj pri nacionalnih organih na podlagi podatkov o stabilnosti, kadar je mogoče, zahtevajo podaljšanje rokov uporabnosti serij osnovnih zdravil.
The elements outlined above all contribute to an increased risk of shortages of essential COVID-19 medicines (referred to here as essential medicines).
Vsi zgoraj navedeni elementi prispevajo k večjemu tveganju pomanjkanja osnovnih zdravil za zdravljenje COVID-19 (v nadaljnjem besedilu: osnovna zdravila).
A fortiori, more localised stockpiling can be even more harmful - Member States should therefore ensure that stockpiling by wholesalers and pharmacies (including by hospital pharmacies) is prevented.
Ker je bolj lokalizirano kopičenje zalog tako lahko celo škodljivo, bi morale države članice trgovcem na debelo in lekarnam (vključno z bolnišničnimi lekarnami) preprečiti kopičenje zalog.
(9) Member States should encourage cargo and express airlines to exceptionally reserve capacity for the supply of essential goods, in particular medical and emergency supplies, and to apply reasonable shipping rates for such supplies.
Države članice bi morale tovorne letalske prevoznike in letalske prevoznike za hitro dostavo spodbujati, da rezervirajo zmogljivosti za dostavo osnovnega blaga, zlasti zdravil in opreme za nujno pomoč, ter za take dostave zaračunavati razumne prevozne cene.
(10) In order to effectively facilitate transport, inland vessels travelling to manufacturing sites after or before pick-up must also be allowed to cross borders without delays.
Za učinkovito lajšanje prometa je treba tudi plovilom za celinsko plovbo, ki potujejo v proizvodne obrate pred prevzemom ali po njem, dovoliti prehod meje brez zamud.
(3) See also: Communication from the Commission on the Temporary Framework for assessing antitrust issues related to business cooperation in response to urgency situations related to the current COVID-19 pandemic of 8 April 2020, C(2020) 3200
(3) Glej tudi Sporočilo Komisije o začasnem okviru za ocenjevanje protimonopolnih vprašanj, povezanih s poslovnim sodelovanjem v odziv na izredne razmere zaradi trenutnega izbruha COVID-19 z dne 8. aprila 2020 C(2020) 3200
d. Extending the expiry dates of medicines
d. Podaljšanje roka uporabnosti zdravil
This should allow the reallocation of stocks to the hospitals most in need.
To bi moralo omogočiti prerazporeditev zalog tistim bolnišnicam, ki najbolj potrebujejo pomoč.
(8) In order to effectively facilitate transport, trucks travelling to/from manufacturing sites after or before pick-up must also be allowed to cross borders without delays.
Za učinkovito olajševanje prevoza je treba tudi tovornjakom, ki potujejo v proizvodne obrate ali iz njih pred prevzemom ali po njem, dovoliti prehod meje brez zamud.
Hospital pharmacies may have stocks of medicines close to or past their expiry dates.
Bolnišnične lekarne imajo morda zaloge zdravil, ki so tik pred iztekom roka uporabnosti ali pa je rok že potekel.
e. Considering the use of magistral preparations or veterinary medicines
e. Uporaba magistralnih zdravil ali zdravil za uporabo v veterinarski medicini
Additionally, respiratory and cardiac medicines, analgesics, anti-clotting medicines, medical nutrition and large-volume parenterals are needed for intensive and supportive care of those COVID-19 patients.
Poleg tega so za intenzivno in podporno zdravljenje pacientov s COVID-19 potrebni tudi respiratorna in srčna zdravila, analgetiki, zdravila proti strjevanju, medicinska prehrana in parenteralne raztopine z velikim volumnom.
Member States should therefore encourage alternative delivery measures to prevent excessive purchasing by citizens, at least limited to patients in risk groups (e.g. home delivery services set up by local community pharmacies).
Države članice bi zato morale spodbujati alternativne ukrepe dostave (npr. storitve dostave na dom, ki jih vzpostavijo lekarne), s katerimi bi preprečili, da bi jih prekomerno kupovali državljani, vsaj tisti iz ogroženih skupin.
f. Using medicines off label and in clinical trials
f. Nenamenska uporaba zdravil in uporaba zdravil v fazi kliničnega preskušanja
Particular flexibility should be granted to cross-border workers in line with Commission guidelines.
zaposlenim, ki delajo v proizvodnih obratih, bi moralo biti dovoljeno, da še naprej potujejo na delovno mesto; v skladu s smernicami Komisije bi bilo treba obmejnim delavcem zagotoviti posebno prožnost (6) .
There has also been stockpiling of non-prescription painkillers by citizens in reaction to the pandemic.
V odziv na pandemijo so državljani začeli kopičiti tudi zaloge zdravil proti bolečinam brez recepta.
The purpose of this Communication is to explain:
Namen tega sporočila je pojasniti:
This shock affects the whole economy through different channels and in different ways.
Ta šok vpliva na celotno gospodarstvo, in sicer prek različnih kanalov in na različne načine.
The Communication shall remain applicable until the Commission withdraws it (once it considers that the underlying exceptional circumstances are no longer present).
Sporočilo velja, dokler ga Komisija ne umakne (ko meni, da temeljne izjemne okoliščine niso več prisotne).
(2) Unless otherwise specified, references to medicines in the present Communication also cover medical equipment.
(2) Če ni določeno drugače, sklici na zdravila v tem sporočilu vključujejo tudi medicinsko opremo.
This system of self-assessment framed by the extensive guidance (4) provided by the Commission is now consolidated.
Ta sistem samoocene, ki temelji na obširnih usmeritvah (4) Komisije, je zdaj utrjen.
At the same time, the Commission underlines that in these exceptional circumstances, it is more important than ever that undertakings and consumers receive protection under competition law.
Komisija hkrati poudarja, da je v teh izjemnih okoliščinah bolj kot kdaj koli prej pomembno, da se podjetjem in potrošnikom zagotovi zaščita na podlagi konkurenčnega prava.
Undertakings should document all exchanges, and agreements between them and make them available to the Commission on request.
Podjetja bi morala dokumentirati vse medsebojne izmenjave in sporazume ter jih na zahtevo predložiti Komisiji.
Different measures may contribute to bridging the gap between demand and supply.
K premostitvi vrzeli med povpraševanjem in ponudbo lahko prispevajo različni ukrepi.
Work on a model to predict demand on a Member State level, and identifying supply gaps;
pripravi model za predvidevanje povpraševanja na ravni držav članic in opredelitev vrzeli v dobavi;
Such exchanges and coordination between undertakings are in normal circumstances problematic under EU competition rules.
Take izmenjave in usklajevanja med podjetji so v običajnih okoliščinah z vidika pravil EU o konkurenci sporna.
It might also require the reallocation of stocks, which would require that undertakings agree to exchange/communicate information on sales and stocks.
Prav tako se lahko zahteva prerazporeditev zalog, kar bi pomenilo, da se morajo podjetja strinjati z izmenjavo/posredovanjem informacij o prodaji in zalogah.
Based on recent experience, the Commission understands that cooperation in the health sector might for instance be limited to entrusting a trade association (or an independent advisor, or independent service provider, or a public body), to e.g.:
Komisija na podlagi nedavnih izkušenj razume, da bi lahko bilo sodelovanje v zdravstvenem sektorju recimo omejeno na pooblastilo panožnemu združenju (ali neodvisnemu svetovalcu ali neodvisnemu ponudniku storitev ali javnemu organu), da na primer: