natgillin/translations-raw huggingface dataset:
National rules for export often limit or place conditions on export of blood and blood components, e.g. only in situations of emergency, which is seen by many countries as part of their national policy to ensure self-sufficiency (see below). 
Nacionalna pravila o izvozu pogosto omejujejo izvoz krvi in komponent krvi ali zanj postavljajo pogoje, na primer samo v nujnih primerih, kar številne države razumejo kot del svoje nacionalne politike za zagotavljanje samozadostnosti (glej spodaj).
Besides complying with the legal obligations, the current report sets out how Directive 2002/98/EC and its implementing Directives 2004/33/EC, 2005/61/EC and 2005/62/EC (henceforth commonly referred to as the EU blood legislation) function in practice, against a backdrop of significant scientific and organisational developments (internationalisation, commercialisation) that have taken place in the European blood and blood components sector over the past decade. 
Poleg tega, da se s tem poročilom izpolnjujejo zakonske obveznosti, je v njem prikazano, kako Direktiva 2002/98/ES ter izvedbene direktive 2004/33/ES, 2005/61/ES in 2005/62/ES (v nadaljnjem besedilu skupaj: zakonodaja EU o krvi) delujejo v praksi glede na znaten znanstveni in organizacijski razvoj (internacionalizacija, komercializacija) v sektorju krvi in komponent krvi v zadnjem desetletju.
Safety and quality of blood depends on the implementation of a combination of three pillars: donor screening for deferral criteria, donor testing and, where possible, pathogen inactivation techniques. 
Varnost in kakovost krvi sta odvisni od izvajanja kombinacije treh stebrov: presejalni test darovalcev glede na merila za odklon, testiranje darovalcev in, kadar je to mogoče, tehnike inaktivacije patogenov.
Also the inspection approaches vary significantly towards mobile and satellite sites, hospital blood banks, plasma collection centres and potential third country players. 
Pristopi k inšpekcijskim pregledom se znatno razlikujejo tudi pri mobilnih in satelitskih enotah, transfuzijskih bankah v bolnišnicah, centrih za zbiranje krvne plazme in morebitnih akterjih iz tretjih držav.
Although the definition of serious adverse reaction (SAR) in Directive 2002/98/EC, Article 3, gives equal importance to SAR in donors and in recipients, the current requirements refer only to reporting of SAR in recipients. 
Čeprav opredelitev hude neželene reakcije iz člena 3 Direktive 2002/98/ES daje enak pomen hudim neželenim reakcijam pri darovalcih in prejemnikih, se sedanje zahteve nanašajo samo na poročanje o hudih neželenih reakcijah pri prejemnikih.
The main causes leading to deferrals of candidate donors reported by Member States were low haemoglobin levels (putting at risk the health of the donor) as well as risk of transmission of infectious diseases, (sexual) risk behaviours, travel, medication and other medical reasons (putting the health of the recipient at risk). 
Glavni vzroki za odklon kandidatov za darovalce, o katerih so poročale države članice, so bili nizka raven hemoglobina (ki ogroža zdravje darovalca) ter nevarnost prenosa nalezljivih bolezni, tvegano (spolno) vedenje, potovanje, jemanje zdravil in drugi zdravstveni razlogi (ki ogrožajo zdravje prejemnika).
The authorities interact effectively with the RAB system, although many mention a need to improve communication of the information from RAB to the local blood establishments, which needs to be accomplished at national level. 
Organi učinkovito sodelujejo prek sistema RAB, čeprav številni navajajo, da je treba izboljšati pošiljanje informacij lokalnim transfuzijskim ustanovam od RAB, kar je treba doseči na nacionalni ravni.
Whilst overall Member States seem to correctly implement the provisions concerning inspections, a number of Member States reported difficulties related to staffing, which makes compliance with the required 2-year inspection interval challenging. 
Medtem ko je videti, da države članice na splošno ustrezno izvajajo določbe glede inšpekcijskih pregledov, je več držav članic poročalo o kadrovskih težavah, zaradi česar je težko izpolniti zahteve v zvezi z dveletnimi inšpekcijskimi pregledi.
Most countries organise root cause analyses to understand the reasons behind SARE, however there is a generally reported interest in developing this approach further, in particular to address the challenge of involving local professionals and hospitals in these analyses. 
Večina držav organizira analize izvornega vzroka, da bi razumele razloge za hude neželene reakcije in dogodke, vendar na splošno poročajo o interesu za nadaljnji razvoj tega pristopa, zlasti za spopadanje z izzivom, da bi v take analize vključili lokalne strokovnjake in bolnišnice.
Rules for export of plasma for fractionation are usually less restrictive, although practice was reported of plasma export for contract fractionation of derivatives which are subsequently to be used for patients only in the country of collection. 
Pravila o izvozu krvne plazme za frakcioniranje so običajno manj omejevalna, čeprav se poroča o praksi izvoza krvne plazme za pogodbeno frakcioniranje derivatov, ki se nato uporabijo samo za paciente v državi zbiranja.
To engage these local stakeholders, countries mention the use of audits and programmes such as the implementation of patient blood management (PBM) (for which there is currently a tendered study on-going under the Union's Third Health Programme). 
Države za vključitev teh lokalnih deležnikov navajajo uporabo revizij in programov, kot je izvajanje upravljanja krvi pacientov (glede katerega trenutno v okviru tretjega progama zdravja Unije poteka študija, ki se izvaja na podlagi javnega razpisa).
EU legislation defines the minimum serological testing for human immunodeficiency virus (HIV) 1/2, hepatitis B and hepatitis C to be carried out for every whole blood and apheresis donation. 
Zakonodaja EU opredeljuje minimalno serološko testiranje na virus človeške imunske pomanjkljivosti (HIV) 1/2, hepatitis B in hepatitis C, ki ga je treba opraviti pri vsakem darovanju polne krvi in darovanju z uporabo afereze.
The full analysis of the Member States' replies to the 2013 implementation survey and the 2014 survey on the implementation of the VUD principle is included in the two Staff Working Documents accompanying this Report. 
Celotna analiza odgovorov držav članic na anketo o izvajanju iz leta 2013 in anketo o izvajanju načela PBD iz leta 2014 je vključena v dva delovna dokumenta služb Komisije, priložena temu poročilu.
In around half of the Member States, donors have their travel costs reimbursed and get time off work in the public and private sector. 
V približno polovici držav članic so darovalcem povrnjeni potni stroški, v javnem in zasebnem sektorju pa jim je odobren tudi dopust.
The regular meetings of the expert sub-group on blood and blood components (which is part of the Competent Authorities on Substances of Human Origin Expert Group - CASoHO E01718) allow for sharing best practices and clarification of common difficulties encountered at national and EU level. 
Redna srečanja strokovne podskupine za kri in komponente krvi (ki je del strokovne skupine pristojnih organov za snovi človeškega izvora - CASoHO E01718) omogočajo izmenjavo dobrih praks in pojasnjevanje pogostih težav, do katerih pride na nacionalni ravni in ravni EU.
The EU is significantly reliant on importation of plasma for the manufacture of plasma derived medicinal products, mainly from the United States. 
EU je precej odvisna od uvoza krvne plazme za izdelavo zdravil iz krvne plazme, predvsem iz ZDA.
The role of common assessments by ECDC and the Commission was recognised in this context, e.g. when developing a preparedness plan to help blood establishments address the seasonal outbreaks of West Nile Virus in some southern EU countries. 
V tem okviru je bila priznana vloga skupnih ocenjevanj Evropskega centra za preprečevanje in obvladovanje bolezni (ECDC) in Komisije, na primer pri razvoju načrta pripravljenosti na pomoč transfuzijskim ustanovam pri spopadanju z izbruhi virusa zahodnega Nila v nekaterih južnih državah EU.
Replacement donors, i.e. donors that are encouraged to make donations to replace those being used for a relative or friend, are reported as important for maintaining supply in five countries. 
Po poročanju so nadomestni darovalci, tj. darovalci, ki jih spodbujajo k darovanju za nadomestitev krvi, ki se je uporabila za sorodnika ali prijatelja, pomembni za vzdrževanje dobave v petih državah.
In their responses to the implementation survey, several countries suggested making syphilis testing mandatory at EU level, while some suggest making NAT testing for HIV and hepatitis mandatory, despite the reservations mentioned by other countries. 
Več držav je v svojih odgovorih na anketo o izvajanju predlagalo obvezno testiranje na sifilis na ravni EU, nekatere pa predlagajo obvezno testiranje na HIV in hepatitis z NAT, in to kljub zadržkom, ki jih navajajo druge države.
Some countries foresee compensation for loss of earnings in some circumstances, e.g. one Member State foresees this for plasma apheresis donations. 
Nekatere države predvidevajo nadomestilo za izgubo dohodka v določenih okoliščinah, ena od držav članic pa to na primer predvideva za darovanje krvne plazme z aferezo.
These include standards for verifying equivalent safety and quality standards, which in half of the Member States go beyond the requirements of the EU blood legislation, e.g. adding requirements for the use of the more sensitive nucleic acid testing (NAT) now available as a routine test for hepatitis and HIV screening. 
Ta vključujejo standarde za preverjanje enakovrednih standardov glede varnosti in kakovosti, ki v polovici držav članic presegajo zahteve zakonodaje EU o krvi, na primer dodatne zahteve za uporabo občutljivejšega testiranja z nukleinsko kislino (NAT), ki je zdaj na voljo kot redni presejalni test za hepatitis in HIV.
Additional screening and testing may reduce, but cannot completely eliminate, the possibility of a transmission from donor to recipient. 
Dodatni presejalni test in testiranje lahko zmanjšata možnost prenosa z darovalca na prejemnika, vendar je ne moreta povsem izločiti.
Other eligibility criteria that several countries would wish to reflect on relate to the history of malignancy, donor risk behaviour and haemoglobin levels. 
Druga merila za ustreznost, o katerih bi želelo razmisliti več držav, se nanašajo na preteklo malignost, tvegano vedenje darovalca in ravni hemoglobina.
Inactivation techniques are mainly used for plasma although pathogen inactivation of platelets is likely to be more common going forward. 
Tehnike inaktivacije se večinoma uporabljajo za krvno plazmo, čeprav bo v prihodnosti inaktivacija patogenov pri trombocitih verjetneje pogostejša.
Donor screening for eligibility. 
Presejalni test darovalcev glede ustreznosti.
About two thirds of the countries mention that blood establishments also apply more sensitive nucleic acid testing (NAT), along with serological testing, although several countries also raised questions regarding the cost-benefit ratio of this relatively costly testing technique. 
Približno dve tretjini držav navaja, da transfuzijske ustanove poleg serološkega testiranja uporabljajo tudi občutljivejše testiranje z nukleinsko kislino (NAT), čeprav je nekaj držav odprlo vprašanja glede stroškovne učinkovitosti te razmeroma drage tehnike testiranja.
Support for the Implementation of the Blood Directives 
Podpora pri izvajanju direktiv o krvi
All Member States reported that the same rules on traceability apply to blood establishments and hospital blood banks, allowing tracing of blood and blood components from donor to recipient and vice versa. 
Vse države članice poročajo, da se ista pravila o sledljivosti uporabljajo za transfuzijske ustanove in transfuzijske banke v bolnišnicah, kar omogoča sledenje krvi in komponent krvi od darovalca do prejemnika in obratno.
Plasma and plasma derivatives can have a longer shelf-life and as fractionation plants exist only in twelve Member States, both plasma (the starting material) and plasma derivatives (the end product) are frequently exchanged across borders, within the EU and with third (non-EU) countries. 
Krvna plazma in derivati krvne plazme imajo lahko daljši rok uporabe, in ker obrati za frakcioniranje obstajajo samo v 12 državah članicah, se krvna plazma (vhodni material) in derivati krvne plazme (končni izdelek) pogosto prenašajo prek meja znotraj EU in s tretjimi državami (ki niso v EU).
Men having sex with men (MSM) is the most commonly reported sexual risk exclusion criterion due to the higher incidence of infections such as HIV within this population. 
Spolni odnosi med moškimi je najpogosteje navedeno merilo za izključitev zaradi spolnega tveganja, ker je v tej populaciji večja pojavnost okužb, kot je HIV.
It is common practice to provide refreshments to donors (27 countries) and to give them small tokens such as pin badges, pens, towels, t-shirts and mugs (24 countries). 
Običajna praksa je, da darovalci dobijo okrepčila (27 držav) in majhna darila, kot so značke, pisala, brisače, majice in skodelice (24 držav).
In the Eurobarometer survey on Blood and Cell and Tissue Donation, only 12% of EU citizens reported that they thought compensation additional to the costs related to donation was acceptable, when donating blood or plasma. 
V anketi Eurobarometra o darovanju krvi, celic in tkiv je samo 12 % državljanov EU navedlo, da je nadomestilo poleg stroškov v zvezi z darovanjem sprejemljivo pri darovanju krvi ali krvne plazme.
Nonetheless, the voluntary reporting of SAR in donors has increased, suggesting the Member States' increasing interest in the protection of living donors. 
Vendar se je prostovoljno poročanje o hudih neželenih reakcijah pri darovalcih kljub temu povečalo, kar kaže na povečan interes držav članic za zaščito živih darovalcev.
Twenty one Member States have dedicated vigilance officer(s) in place. 
Enaindvajset držav članic ima imenovane posebne uradnike za vigilanco.
In half of the countries, the blood establishments either determine, or are involved in determining, the value of the compensations and incentives, while in one-third of the countries the national blood competent authorities are involved. 
V polovici držav transfuzijske ustanove določijo vrednost nadomestil in spodbud ali pa so vključene v njihovo določanje, medtem ko so v eni tretjini držav v to vključeni nacionalni pristojni organi za kri.
This overarching Report is a summary, drawing from the replies to questionnaires that the Commission sent to Member States in 2012 (verification of the completeness of transposition), 2013 (implementation survey), and 2014 (implementation of the VUD principle) and follows up on the Report in 2006 and the Commission Communication in 2010, as well as on the two Reports on the application of the principle of VUD for blood and blood components issued in 2006 and 2011. 
To krovno poročilo je povzetek, ki temelji na odgovorih na vprašalnike, ki jih je Komisija poslala državam članicam leta 2012 (preverjanje popolnosti prenosa), leta 2013 (anketa o izvajanju), in leta 2014 (izvajanje načela PBD), ter sledi poročilu iz leta 2006 in sporočilu Komisije iz leta 2010 ter poročiloma o uporabi načela PBD za kri in komponente krvi, izdanima leta 2006 oziroma leta 2011.
No additional testing was reported for plasma collection, compared with collection of whole blood donations. 
V zvezi z zbiranjem krvne plazme ni bilo sporočeno nobeno dodatno testiranje v primerjavi z zbiranjem polne krvi.
Since the survey was conducted, changes in national policies have been reported by some countries during the bi-annual meetings of Competent Authorities; the trend is to move from permanent to temporary (usually 12 months) deferral for MSM. 
Od izvedbe ankete so nekatere države na dveletnih srečanjih pristojnih organov poročale o spremembah nacionalnih politik; trend je prehajanje s trajnega odklona na začasni (običajno 12-mesečni) odklon zaradi spolnih odnosov med moškimi.
The VUD survey shows that Member States overall comply with Article 20 of Directive 2002/98/EC requiring them to take the necessary measures to encourage VUD. 
Anketa o PBD je pokazala, da države članice na splošno ravnajo v skladu s členom 20 Direktive 2002/98/ES, ki zahteva, da sprejmejo potrebne ukrepe za spodbujanje prostovoljnega in brezplačnega darovanja.
There is diversity between Member States in organisation (e.g. desk-based versus on-site), and outcome (i.e. classification and follow-up of deficiencies) of inspections. 
Med državami članicami obstajajo razlike glede organizacije (npr. dokumentacijski pregled v primerjavi s pregledom na kraju samem) in rezultatov (tj. razvrščanje in nadaljnje spremljanje pomanjkljivosti) inšpekcijskih pregledov.
Seven countries do not recover all plasma from whole blood donations for plasma fractionation into derivatives. 
Sedem držav ne dobi nazaj vse krvne plazme v primeru darovanja polne krvi za frakcioniranje krvne plazme v derivate.
In conclusion, this Report reveals an overall adequate level of application of the current quality and safety requirements of the EU blood legislation. 
To poročilo kaže, da se obstoječe zahteve glede kakovosti in varnosti iz zakonodaje EU o krvi na splošno ustrezno uporabljajo.
The reported picture seems not to be complete, with some inconsistencies between the information provided by countries whose citizens travel to donate and those who have donors coming from another Member State to donate. 
Videti je, da sporočena slika ni popolna, saj obstajajo nedoslednosti med informacijami iz držav, katerih državljani dajejo kri v tujini, in tistih, v katere prispejo darovalci iz druge države članice, da bi dali kri.
In order to manage demand and supply of blood and blood components, almost all countries have policies in place that combine annual forecasting with weekly monitoring. 
Skoraj vse države imajo za upravljanje povpraševanja in ponudbe krvi in komponent krvi vzpostavljene politike, ki združujejo letno napovedovanje s tedenskim spremljanjem.
Whole blood and blood components such as platelets and red blood cells have a limited shelf-life and are rarely exchanged between Member States, with the exception of rare emergency or humanitarian situations. 
Polna kri in komponente krvi, kot so trombociti in eritrociti, imajo omejen rok uporabe in si jih države članice redko izmenjujejo, razen v redkih nujnih primerih ali v primeru humanitarne pomoči.
Safety and quality of the blood supply is an important issue for EU citizens, with 56% of respondents to the Eurobarometer survey on Blood and Cell and Tissue Donation citing the risk of contracting a disease as a major concern when accepting donated substances. 
Varnost in kakovost dobave krvi je pomembno vprašanje za državljane EU, pri čemer je 56 % tistih, ki so ogovorili na anketo Eurobarometra o darovanju krvi, celic in tkiv, tveganje prenosa bolezni navedlo kot glavno skrb pri sprejetju darovanih snovi.
Where appropriate, data gathered through other channels and supporting the findings of the two surveys (e.g. exchanges with the national blood competent authorities during the bi-annual meetings with the Commission, mandatory annual reporting to the Commission of serious adverse reactions and events (SARE), alerts launched in the Rapid Alerts for Blood (RAB) platform, a study mapping the economic landscape of the sector and more recently a Eurobarometer survey as well as outputs of EU-funded projects were also taken into account. 
Kadar je bilo to ustrezno, so bili upoštevani tudi podatki, zbrani po drugih poteh in v podporo ugotovitvam obeh anket (npr. izmenjava informacij s pristojnimi nacionalnimi organi za kri na dveletnih srečanjih s Komisijo, obvezno letno poročanje Komisiji o hudih neželenih reakcijah in dogodkih, opozorila, poslana prek platforme za hitro obveščanje o krvi (RAB), študija o ekonomskem okolju v sektorju in novejša anketa Eurobarometra ter rezultati projektov, ki jih je financirala EU).
While not mandatory, two-thirds of countries have put in place donor self-exclusion systems. 
Dve tretjini držav sta vzpostavili sisteme za samoizključitev darovalca, čeprav tak sistem ni obvezen.
Fig. 6: Main causes leading to deferrals/country 
Slika 6: Glavni vzroki za odklon po državah
A common reason for these recalls is information received from the donor regarding his/her health situation and made available after the donation event. 
Pogost vzrok za odpoklic so informacije, ki jih darovalec predloži v zvezi s svojim zdravstvenim stanjem in ki so dane na voljo po darovanju.
In addition, thematic/focused inspections, inspections following SARE and desk-based assessments are organised. 
Poleg tega so organizirani tematski/usmerjeni inšpekcijski pregledi, inšpekcijski pregledi po hudih neželenih reakcijah in dogodkih ter dokumentacijska ocenjevanja.
In this context, it is challenging for MS to apply a requirement for the exclusive importation of plasma sourced from voluntary and unpaid donors. 
V teh okoliščinah države članice težko uporabijo zahtevo po izključnem uvozu krvne plazme, ki jo darovalci dajo prostovoljno in brezplačno.
However blood competent authorities in one third of the countries do not believe that all blood establishments are reporting SARE. 
Vendar pristojni organi za kri v eni tretjini držav ne verjamejo, da vse transfuzijske ustanove poročajo o hudih neželenih reakcijah in dogodkih.
Implementation of the EU blood legislation 
Izvajanje zakonodaje EU o krvi
These two areas are often cause for general alerts in the blood sector, as demonstrated since the launch of the Commission managed Rapid Alert System for Blood (RAB), where a number of alerts relating to emerging disease risks with relevance to blood donor selection or testing and to medical device defects that were important in blood collection or processing were shared among the national blood competent authorities. 
Ti dve področji sta pogosto vzrok za splošni preplah v sektorju krvi, kot se je pokazalo od uvedbe sistema za hitro obveščanje o krvi (RAB), ki ga upravlja Komisija in v okviru katerega so si nacionalni pristojni organi za kri izmenjali več opozoril v zvezi s nevarnostmi nastajajočih bolezni, pomembnih pri izbiri krvodajalcev ali njihovem testiranju, ter v zvezi z okvarami medicinskih pripomočkov, pomembnih pri zbiranju ali predelavi krvi.
Five countries reported having donations by donors from abroad, while six countries reported having citizens that travel to donate abroad. 
Pet držav je poročalo, da so pri njih kri dali darovalci iz tujine, šest pa jih je poročalo o državljanih, ki dajejo kri v tujini.
Notification of serious adverse reactions and events (SARE). 
Obveščanje o hudih neželenih reakcijah in dogodkih.
All Member States except Hungary reported having a SARE notification system in place, in the majority of them based on the practical guidance developed in co-operation with the Member States for the compilation of the online annual SARE report. 
Vse države članice, razen Madžarske, so poročale, da imajo vzpostavljen sistem za obveščanje o hudih neželenih reakcijah in dogodkih, večinoma na podlagi praktičnih navodil, oblikovanih v sodelovanju z državami članicami, za pripravo spletnega letnega poročila o hudih neželenih reakcijah in dogodkih.
Transposition of EU Blood legislation 
Prenos zakonodaje EU o krvi
The difference in purchasing power between Member States might be one factor which explains the diverging views on what is or is not an incentive to donate. 
Eden od dejavnikov, ki pojasnjuje različna mnenja o tem, kaj je in kaj ni spodbuda za darovanje, je lahko razlika v kupni moči med državami članicami.
Levels of inspector empowerment and training were regularly commented upon in the replies to the implementation survey. 
V odgovorih na anketo o izvajanju so bile redno navedene pripombe o stopnjah pooblastitve in usposabljanja inšpektorjev.