qanastek/ELRC-Medical-V2 huggingface dataset:
English: Combining the implementation of all three pillars, where possible, is probably the most effective way to minimise risks.
Translation (en-sl): Združevanje izvajanja vseh treh stebrov, kadar je to mogoče, je verjetno najučinkovitejši način za zmanjšanje tveganj na najnižjo mogočo raven.
English: No problems were reported regarding the implementation of the provisions related to data protection.
Translation (en-sl): V zvezi z izvajanjem določb o varstvu podatkov niso bile sporočene nobene težave.
English: The Commission is required to transmit these national reports to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
Translation (en-sl): Komisija mora ta nacionalna poročila poslati Evropskemu parlamentu, Svetu, Ekonomsko-socialnemu odboru in Odboru regij.
English: Views vary on whether such cross-border donations are desirable.
Translation (en-sl): Mnenja o tem, ali so taka čezmejna darovanja zaželena, se razlikujejo.
English: Significant progress has been made in many areas, often through the active support of Commission funded projects and other initiatives.
Translation (en-sl): Na številnih področjih je napredek znaten, pogosto zaradi dejavne podpore projektov, ki jih financira Komisija, in drugih pobud.
English: [7: Links to be added once published]
Translation (en-sl): [7: Povezave bodo dodane, ko bosta objavljena.]
English: There are a small number of international companies that supply the majority of countries.
Translation (en-sl): Majhno število mednarodnih družb dobavlja večini držav.
English: Several Member States expressed interest in applying instead a risk-based prioritisation planning for inspections.
Translation (en-sl): Več držav članic je izrazilo zanimanje, da se namesto tega uporabi prednostno načrtovanje inšpekcijskih pregledov na podlagi tveganja.
English: Some Member States called for more common procedures for authorisation across the Union.
Translation (en-sl): Nekatere države članice so pozvale k enotnejšim postopkom odobritve po vsej Uniji.
English: In 2012, 22 countries reported having performed 760 on-site inspections.
Translation (en-sl): Leta 2012 je 22 držav poročalo, da je bilo opravljenih 760 inšpekcijskih pregledov na kraju samem.
English: All Member States replied to the transposition questionnaire.
Translation (en-sl): Vse države članice so odgovorile na vprašalnik o prenosu.
English: Irrespective of the organisational set-up, it is important that authorities have appropriate resources at their disposal to enable them to carry out the required duties, as well as to ensure their independence from economic operators in the sector and from other influences.
Translation (en-sl): Ne glede na organizacijsko strukturo je pomembno, da imajo organi na voljo ustrezne vire, ki jim omogočajo opravljanje zahtevanih nalog ter zagotavljajo njihovo neodvisnost od gospodarskih subjektov v sektorju in od drugih vplivov.
English: Voluntary and unpaid donation (VUD)
Translation (en-sl): Prostovoljno in brezplačno darovanje (PBD)
English: One national competent authority has taken the lead on developing such an initiative within the network of national competent authorities.
Translation (en-sl): Eden od nacionalnih pristojnih organov je prevzel vodilno vlogo pri razvoju take pobude znotraj mreže nacionalnih pristojnih organov.
English: All Member States have appointed competent authorities for blood.
Translation (en-sl): Vse države članice so imenovale pristojne organe za kri.
English: In some Member States, donors receive a fixed payment that is not directly related to actual costs incurred.
Translation (en-sl): V nekaterih državah članicah darovalci prejmejo fiksno plačilo, ki ni neposredno povezano z dejanskimi stroški.
English: VUD is a factor which is not only ethical in nature, but which might also contribute to higher safety standards and, therefore, be important for the protection of human health.
Translation (en-sl): PBD je dejavnik, ki ni zgolj etičen, temveč lahko prispeva tudi k višjim varnostnim standardom ter je zato lahko pomemben za varstvo zdravja ljudi.
English: These authorisations also cover 731 mobile sites, 534 satellite sites and 253 plasma collection centres.
Translation (en-sl): Te odobritve vključujejo tudi 731 mobilnih enot, 534 satelitskih enot in 253 centrov za zbiranje krvne plazme.
English: The Commission will consider the need for an evaluation in order to assess the relevance, effectiveness, efficiency, coherence and the EU added value of Directive 2002/98/EC and its implementing Directives.
Translation (en-sl): Komisija bo razmislila o potrebi po ocenjevanju za ovrednotenje ustreznosti, učinkovitosti, uspešnosti, skladnosti in dodane vrednosti EU Direktive 2002/98/ES in njenih izvedbenih direktiv.
English: Inspections and control measures.
Translation (en-sl): Inšpekcijski pregledi in kontrolni ukrepi.
English: Fig. 4: Countries reporting regular shortages
Translation (en-sl): Slika 4: Države, ki poročajo o rednem pomanjkanju
English: Testing and inactivation technologies.
Translation (en-sl): Testiranje in tehnologije inaktivacije.
English: However, some difficulties in interpretation, implementation and enforcement of the legislation were identified, in some cases due to technological and scientific advances since its adoption.
Translation (en-sl): Vendar je bilo ugotovljenih nekaj težav pri razlagi, izvajanju in izvrševanju zakonodaje, v nekaterih primerih zaradi tehnološkega in znanstvenega napredka od njenega sprejetja.
English: In almost every country, donation promotion activities are the main actions taken to increase supply.
Translation (en-sl): V skoraj vseh državah so dejavnosti spodbujanja darovanja glavni ukrepi za povečanje dobave.
English: Quality and safety of blood and blood components
Translation (en-sl): Kakovost in varnost krvi in komponent krvi
English: Less than half of the countries reported having national guiding principles to define what form of compensation or other practice is allowed and under which circumstances.
Translation (en-sl): Manj kot polovica držav je poročala, da imajo nacionalna vodilna načela za opredelitev, katera oblika nadomestila ali druga praksa je dovoljena in v kakšnih okoliščinah.
English: This topic is intrinsically linked with the promotion and success of the principle of VUD, as highlighted in recital 23 of Directive 2002/98/EC.
Translation (en-sl): Ta tema je neločljivo povezana s spodbujanjem in uspehom načela PBD, kot je poudarjeno v uvodni izjavi 23 Direktive 2002/98/ES.
English: The implementation survey confirmed that this core responsibility of national competent authorities is well developed across the Union.
Translation (en-sl): Anketa o izvajanju je potrdila, da je ta ključna odgovornost nacionalnih pristojnih organov dobro razvita po vsej Uniji.
English: There are differences between Member States in relation to the duration and terms of renewal of the individual authorisations.
Translation (en-sl): Med državami članicami obstajajo razlike glede trajanja in pogojev obnove posameznih odobritev.
English: The UK and Ireland apply this policy as part of their risk mitigation strategy for transmission of variant Creutzfeldt Jacob disease.
Translation (en-sl): Združeno kraljestvo in Irska to politiko uporabljata kot del strategije za blažitev tveganj prenosa različice Creutzfeldt-Jacobove bolezni.
English: In order to address shortages, countries can put in place policies to increase supply and to optimise usage.
Translation (en-sl): Za reševanje težav s pomanjkanjem lahko države vzpostavijo politike za povečanje dobave in optimizacijo uporabe.
English: The ways in which EU Member States have implemented the principle of VUD are difficult to assess in a comprehensive manner.
Translation (en-sl): Načine, kako države članice EU izvajajo načelo PBD, je težko celovito oceniti.
English: Reimbursement of travel costs can cover the actual costs or be a standard lump sum.
Translation (en-sl): Povračilo potnih stroškov lahko krije dejanske stroške ali pa je izplačano v obliki standardnega pavšalnega zneska.
English: Almost all countries report that a donor identification system was implemented in their country, in the majority of countries at national level.
Translation (en-sl): Skoraj vse države poročajo, da je bil v njihovi državi vzpostavljen sistem identifikacije darovalcev, v večini držav na nacionalni ravni.
English: A verification of the completeness of transposition into national legislation of the EU blood legislation, carried out by the Commission, demonstrated that it is fully transposed in all but one Member State.
Translation (en-sl): Preverjanje popolnosti prenosa zakonodaje EU o krvi v nacionalno zakonodajo, ki ga je izvedla Komisija, je pokazalo, da je v celoti prenesena v vseh državah članicah, razen v eni.
English: There appears to be a good interconnectivity with other health-related vigilance systems, in particular on medical devices and communicable diseases.
Translation (en-sl): Videti je, da obstaja dobra medsebojna povezanost z drugimi sistemi vigilance v zvezi z zdravjem, zlasti glede medicinskih pripomočkov in nalezljivih bolezni.
English: Accreditation, designation, authorisation or licensing of blood establishments.
Translation (en-sl): Akreditacija, imenovanje, odobritev ali izdajanje dovoljenj transfuzijskim ustanovam.
English: Other challenges to the principle of (self-) sufficiency are outlined below.
Translation (en-sl): Spodaj so prikazane še druge težave v zvezi z načelom (samo)zadostnosti.
English: Wherever different oversight activities (authorisation, inspection, haemovigilance) are undertaken by different authorities, good communication and coordination between respective authorities needs to be ensured.
Translation (en-sl): Kadar različne nadzorne dejavnosti (odobritev, inšpekcija, hemovigilanca) izvajajo različni organi, je treba zagotoviti dobro komunikacijo in usklajevanje med zadevnimi organi.
English: Since 2003, a number of projects have been funded under the multi-annual programmes for Union action in the field of health addressing the area of blood and blood components.
Translation (en-sl): Od leta 2003 je bilo financiranih več projektov v okviru večletnih programov za ukrepanje Unije na področju zdravja, ki so se nanašali na kri in komponente krvi.
English: The debate on possible compensation and incentives for donors plays an important role in supply management (see below).
Translation (en-sl): Razprava o morebitnem nadomestilu in spodbudah za darovalce ima pomembno vlogo pri upravljanju dobave (glej spodaj).
English: The VUD survey addressed questions on the balance between supply and demand, and the measures taken to achieve sufficiency.
Translation (en-sl): Anketa o PBD se je nanašala na vprašanja ravnotežja med ponudbo in povpraševanjem ter ukrepe, sprejete za zagotovitev zadostnosti.
English: Finally, the Commission developed, in close cooperation with the Member States, a Rapid Alert Platform for Blood (RAB) which facilitates web-based communications between Member States in case of alerts with relevance in two or more Member States.
Translation (en-sl): Nazadnje, Komisija je v tesnem sodelovanju z državami članicami razvila platformo za hitro obveščanje o krvi (RAB), ki olajšuje spletno komuniciranje med državami članicami v primeru opozoril, ki se nanašajo na dve ali več držav članic.
English: Member States also highlight the need for good validation of testing technologies, and also pathogen inactivation technologies, in order to achieve an effective level of safety and quality.
Translation (en-sl): Države članice poudarjajo tudi potrebo po dobri validaciji tehnologij testiranja in tehnologij inaktivacije patogenov za dosego učinkovite stopnje varnosti in kakovosti.
English: They reported conducting additional tests for syphilis, malaria, hepatitis A, hepatitis E and Parvovirus B19.
Translation (en-sl): Poročale so o izvajanju dodatnih testov za sifilis, malarijo, hepatitis A, hepatitis E in parvovirus B19.
English: While most cross-border donations seem to be individual initiatives, Hungary and Slovakia reported organised transport for their citizens to travel to Austria for plasma donation.
Translation (en-sl): Medtem ko je za večino čezmejnih darovanj videti, da gre za individualno pobudo, sta Madžarska in Slovaška poročali o organiziranem prevozu državljanov, ki potujejo v Avstrijo darovat krvno plazmo.
English: In a system allowing donor payment, some individuals may find the monetary remuneration so important that they might not disclose relevant medical and/or behavioural information.
Translation (en-sl): V sistemu, ki bi dovoljeval plačevanje darovalcem, bi lahko bila denarna nagrada za nekatere tako pomembna, da ne bi razkrili bistvenih zdravstvenih in/ali vedenjskih informacij.
English: Article 26 of Directive 2002/98/EC requires Member States to submit to the European Commission, before 31 December 2003 and every three years thereafter, a report on the activities carried out in relation to the provisions of the Directive, including an account of the measures taken in relation to inspection and control.
Translation (en-sl): V skladu s členom 26 Direktive 2002/98/ES morajo države članice pred 31. decembrom 2003 in nato vsaka tri leta Evropski komisiji predložiti poročilo o dejavnostih, ki se izvajajo v zvezi z določbami navedene direktive, skupaj s poročilom o ukrepih, sprejetih v zvezi z inšpekcijskim pregledom in kontrolo.
English: On the basis of these national reports, the Commission is required to inform the European Parliament and the Council of any necessary further measures in relation to VUD it intends to take at Union level.
Translation (en-sl): Komisija mora na podlagi teh nacionalnih poročil Evropski parlament in Svet obvestiti o morebitnih nadaljnjih potrebnih ukrepih v zvezi s PBD, ki jih namerava sprejeti na ravni Unije.
English: 3.2 Obligations of blood competent authorities
Translation (en-sl): 3.2 Obveznosti pristojnih organov za kri
English: The European Commission has been supporting the implementation of the legislation by the Member States by encouraging the active participation of national Competent Authorities in a series of actions, from bi-annual expert meetings to EU-funded projects.
Translation (en-sl): Evropska komisija podpira izvajanje zakonodaje s strani držav članic s spodbujanjem dejavnega sodelovanja nacionalnih pristojnih organov v več dejavnostih, od dveletnih strokovnih srečanj do projektov, ki jih financira EU.
English: Many countries reported financially supporting blood establishments and local players in the organisation of such promotion activities (although the financial support in many of these countries also relates to collection, processing, storage and distribution activities).
Translation (en-sl): Številne države so poročale, da finančno podpirajo transfuzijske ustanove in lokalne akterje pri organizaciji takih dejavnosti spodbujanja (čeprav se finančna podpora v številnih od teh držav nanaša tudi na dejavnosti zbiranja, predelave, shranjevanja in razdeljevanja).
English: While two of these latter six countries also report regular shortages in national supply, the information provided was not sufficient to establish a causal link between these shortages and the cross-border movement of donors.
Translation (en-sl): Čeprav sta dve od teh zadnjih šestih držav poročali tudi o rednem pomanjkanju v nacionalni dobavi, poslane informacije niso bile zadostne, da bi lahko sklepali o vzročni povezavi med tem pomanjkanjem in čezmejnim gibanjem darovalcev.
English: The maximum reported values of compensation and incentives are around EUR 25-30 per donation while the reported values of refreshments and small tokens are between EUR 1 and EUR 10 per donation.
Translation (en-sl): Najvišja sporočena vrednost nadomestil in spodbud je približno 25 EUR-30 EUR na darovanje, medtem ko je sporočena vrednost okrepčil in majhnih daril med 1 EUR in 10 EUR na darovanje.
English: Several Member States mentioned the limited role of authorities at federal/national level and pointed to the important tasks attributed to/carried out by regional competent authorities.
Translation (en-sl): Več držav članic je omenilo omejeno vlogo organov na zvezni/nacionalni ravni in opozorilo na pomembne naloge, ki so dodeljene regionalnim pristojnim organom/jih regionalni pristojni organi izvajajo.
English: While all countries report having recall procedures in place, only 14 reported recalls (1867 in total).
Translation (en-sl): Medtem ko vse države poročajo, da imajo vzpostavljene postopke za odpoklic, jih je o odpoklicih poročalo samo 14 (skupaj 1 867 primerov).
English: The Commission is also required to provide them with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and control.
Translation (en-sl): Predložiti jim mora tudi pregledno poročilo o izvajanju zahtev Direktive, zlasti glede inšpekcijske in kontrolnih ukrepov.
English: As the legislation in question does not provide a basis for full harmonisation and as Directives allow the Member States a certain degree of discretion as to how to ensure their implementation, there are accordingly many differences between Member States in the approaches they have taken to implementation.
Translation (en-sl): Ker zadevna zakonodaja ne daje podlage za popolno uskladitev in ker direktive državam članicam dopuščajo določeno stopnjo proste presoje glede tega, kako zagotoviti njihovo izvajanje, med državami članicami obstajajo številne razlike v pristopih k izvajanju.
English: To facilitate good regulatory communication between Member States, as well as to comply with the annual reporting requirements to the Commission, a well-informed national coordinating contact point is essential, even where competent authority responsibilities are shared among multiple organisations or regions.
Translation (en-sl): Za dobro regulativno komunikacijo med državami članicami in izpolnjevanje zahtev po letnem poročanju Komisiji je bistvena dobro obveščena nacionalna usklajevalna kontaktna točka, tudi če so odgovornosti pristojnih organov razdeljene na več organizacij ali regij.
English: Every change in deferral, testing or pathogen inactivation policy has a possible impact not only on safety and quality, but also on the economics and on the volume of donations and supply.
Translation (en-sl): Vsaka sprememba politike glede odklona, testiranja ali inaktivacije patogenov lahko vpliva tako na varnost in kakovost kot tudi na ekonomičnost ter količino darovanj in dobave.
English: It is important to note that the hyperlinks contain the original replies of Member States, whilst the report reflects the updated information provided by Member States.
Translation (en-sl): Opozoriti je treba, da povezave vsebujejo prvotne odgovore držav članic, medtem ko so v poročilu upoštevane posodobljene informacije, ki so jih poslale države članice.
English: These policies involve players at multiple levels, national competent authorities as well as local clinicians.
Translation (en-sl): Te politike vključujejo akterje na več ravneh, nacionalne pristojne organe in lokalne klinične zdravnike.
English: These actions brought improvements in areas of common interest such as quality management and inspection and donor selection and included training courses for Member States Competent Authorities and their inspectors.
Translation (en-sl): Ti ukrepi so prinesli izboljšanja na področjih, ki so v splošnem interesu, kot so upravljanje kakovosti, inšpekcija in izbira darovalcev, ter so vključevali usposabljanja za pristojne organe držav članic in njihove inšpektorje.
English: The service contract aims to develop best practices, which could allow for a significant reduction of blood demand for many treatments.
Translation (en-sl): Namen naročila storitev je razviti dobre prakse, ki bi lahko omogočile znatno zmanjšanje potrebe po krvi pri številnih zdravljenjih.
English: From an EU perspective, the relevant question is whether blood collected from these donors might have a different safety and quality profile (see below).
Translation (en-sl): Z vidika EU je pomembno vprašanje, ali ima lahko kri, zbrana od teh darovalcev, drugačne lastnosti glede varnosti in kakovost (glej spodaj).
English: These shortages often occur in summer/holiday seasons when the number of donors is reduced and the risk of epidemiological outbreaks, such as West Nile Virus, can temporarily reduce the number of eligible donors.
Translation (en-sl): Do takega pomanjkanja pogosto pride poleti / med počitnicami, ko je število darovalcev manjše in lahko nevarnost epidemioloških izbruhov, kot je izbruh virusa zahodnega Nila, začasno zmanjša število ustreznih darovalcev.
English: In almost all countries, the inspections of blood establishments overlap with inspections in other areas.
Translation (en-sl): Skoraj v vseh državah se inšpekcijski pregledi transfuzijskih ustanov prekrivajo z inšpekcijskimi pregledi na drugih področjih.
English: A limited number of countries report surpluses for some blood components which indicates the potential for cross-border agreements.
Translation (en-sl): Omejeno število držav poroča o presežku nekaterih komponent krvi, kar kaže na možnost čezmejnih sporazumov.
English: Policies towards them vary, from prohibition to seeing replacement donations as an opportunity to contribute to national self-sufficiency by converting them into regular donors.
Translation (en-sl): Politike v odnosu do njih so različne, od prepovedi do razumevanja nadomestnega darovanja kot priložnosti za prispevanje k nacionalni samozadostnosti, tako da postanejo redni darovalci.
English: The value of international projects, at EU level and organised by the Council of Europe, are clearly appreciated by most of the national competent authorities as a means to help maintain an adequate level of training and know-how within the group of inspectors and to help ensure a uniform level of compliance verification throughout the EU.
Translation (en-sl): Večina nacionalnih pristojnih organov očitno ceni mednarodne projekte, tiste na ravni EU in tiste, ki jih organizira Svet Evrope, kot pomoč pri vzdrževanju ustrezne ravni usposabljanja in strokovnega znanja v skupini inšpektorjev ter pomoč pri zagotavljanju enotne ravni preverjanja skladnosti po vsej EU.
English: Overall, the implementation of the EU blood legislation by Member States is considered adequate and the legislation has resulted in the establishment of a network of competent authorities that oversee the field through authorisation, inspection, and vigilance.
Translation (en-sl): Na splošno se izvajanje zakonodaje EU o krvi šteje za ustrezno, zaradi zakonodaje pa je bila vzpostavljena mreža pristojnih organov, ki to področje nadzorujejo z odobritvami, inšpekcijo in vigilanco.
English: In contrast, 47-48% considered that receiving refreshments, free blood testing or a free physical check-up were acceptable.
Translation (en-sl): Nasprotno jih je 47 %-48 % menilo, da je sprejemljivo prejetje okrepčil, brezplačno testiranje krvi ali brezplačen zdravniški pregled.
English: The practical application of the VUD principle varies across the Union.
Translation (en-sl): Praktična uporaba načela PBD se po Uniji razlikuje.
English: Although the large majority of the responding countries (26) reported that the principle of VUD is mandatory at national level, their legislations often refer to an "encouragement" or to a "strong recommendation".
Translation (en-sl): Čeprav je velika večina držav, ki so se odzvale (26), poročala, da je načelo PBD obvezno na nacionalni ravni, njihove zakonodaje pogosto govorijo o „spodbujanju" ali „močno priporočljivem" ravnanju.
English: Most countries have additional supportive measures in place, primarily focused on promoting VUD or defining compensation and incentives (see below).
Translation (en-sl): Večina držav je sprejela dodatne podporne ukrepe, ki so osredotočeni predvsem na spodbujanje PBD ali opredelitev nadomestil in spodbud (glej spodaj).