natgillin/translations-raw huggingface dataset:
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.
Predložiti jim mora tudi pregledno poročilo o izvajanju zahtev Direktive, zlasti glede inšpekcijske in kontrolnih ukrepov.
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.
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.
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.
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.
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.
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.
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.
Opozoriti je treba, da povezave vsebujejo prvotne odgovore držav članic, medtem ko so v poročilu upoštevane posodobljene informacije, ki so jih poslale države članice.
These policies involve players at multiple levels, national competent authorities as well as local clinicians.
Te politike vključujejo akterje na več ravneh, nacionalne pristojne organe in lokalne klinične zdravnike.
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.
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.
The service contract aims to develop best practices, which could allow for a significant reduction of blood demand for many treatments.
Namen naročila storitev je razviti dobre prakse, ki bi lahko omogočile znatno zmanjšanje potrebe po krvi pri številnih zdravljenjih.
From an EU perspective, the relevant question is whether blood collected from these donors might have a different safety and quality profile (see below).
Z vidika EU je pomembno vprašanje, ali ima lahko kri, zbrana od teh darovalcev, drugačne lastnosti glede varnosti in kakovost (glej spodaj).
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.
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.
In almost all countries, the inspections of blood establishments overlap with inspections in other areas.
Skoraj v vseh državah se inšpekcijski pregledi transfuzijskih ustanov prekrivajo z inšpekcijskimi pregledi na drugih področjih.
A limited number of countries report surpluses for some blood components which indicates the potential for cross-border agreements.
Omejeno število držav poroča o presežku nekaterih komponent krvi, kar kaže na možnost čezmejnih sporazumov.
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.
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.
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.
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.
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.
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.
In contrast, 47-48% considered that receiving refreshments, free blood testing or a free physical check-up were acceptable.
Nasprotno jih je 47 %-48 % menilo, da je sprejemljivo prejetje okrepčil, brezplačno testiranje krvi ali brezplačen zdravniški pregled.
The practical application of the VUD principle varies across the Union.
Praktična uporaba načela PBD se po Uniji razlikuje.
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".
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.
Most countries have additional supportive measures in place, primarily focused on promoting VUD or defining compensation and incentives (see below).
Večina držav je sprejela dodatne podporne ukrepe, ki so osredotočeni predvsem na spodbujanje PBD ali opredelitev nadomestil in spodbud (glej spodaj).
Overall, Member States expressed interest in an increased level of donor protection and in an overview of additional national eligibility criteria in order to increase transparency and mutual trust in exchanges.
Na splošno so države članice izrazile zanimanje za povečano stopnjo zaščite darovalcev in pregled dodatnih nacionalnih meril za ustreznost, da bi izboljšale preglednost in medsebojno zaupanje pri izmenjavah.
The 2013 implementation survey was answered by all Member States and also by two EEA countries, Liechtenstein and Norway.
Na anketo o izvajanju iz leta 2013 so odgovorile vse države članice in dve državi EGP, in sicer Lihtenštajn in Norveška.
Fig. 2: Overlapping inspection schemes
Slika 2: Prekrivajoči se inšpekcijski programi
Countries identify an increase of the maximum donor age as the most promising initiative to improve the supply of blood and blood components.
Države ugotavljajo, da je povečanje najvišje dovoljene starosti darovalca najobetavnejša pobuda za izboljšanje dobave krvi in komponent krvi.
Countries also see value in further centralisation of laboratory test results at EU level to facilitate benchmarking against average EU rates of positivity.
Državam se zdi koristna tudi nadaljnja centralizacija rezultatov laboratorijskih testov na ravni EU za lažjo primerjavo s povprečnimi stopnjami pozitivnosti v EU.
The global growth of utilisation of plasma derivatives, particularly intravenous immunoglobulin (IVIG), requires a growing number of donations.
Zaradi splošne rasti uporabe derivatov krvne plazme, zlasti intravenskih imunoglobulinov (IVIG), je potrebno vse večje število darovalcev.
Projects such as EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP and the on-going joint action VISTART provide strong support to Member States in their efforts to implement the requirements of the blood directives.
Projekti, kot so EUBIS, CATIE, DOMAINE, Optimal Blood Use, EU-Q-Blood-SOP in trenutni skupni ukrep VISTART, so državam članicam v veliko oporo pri prizadevanjih za izvajanje zahtev direktiv o krvi.
Ten countries reported facilitating donations by donors from abroad by providing donor questionnaires in different languages.
Deset držav je poročalo o tem, da so olajšale darovanje za darovalce iz tujine z zagotovitvijo vprašalnikov za darovalce v različnih jezikih.
These differences facilitate successful integration of the requirements into national legislation but in some cases they may limit the mutual acceptance of authorisations with consequences for potential cross-border movement of blood and blood components.
Te razlike omogočajo uspešno vključitev zahtev v nacionalno zakonodajo, vendar lahko v nekaterih primerih omejijo vzajemno priznavanje odobritev, kar pomeni posledice za morebitni čezmejni prenos krvi in komponent krvi.
Fig. 5: Policy setting to ensure effective use of blood, blood components and plasma derivatives
Slika 5: Oblikovanje politike za zagotovitev učinkovite uporabe krvi, komponent krvi in derivatov krvne plazme
Eight countries reported regular shortages of one or more blood components in the survey.
V anketi je osem držav poročalo o rednem pomanjkanju ene ali več komponent krvi.
Many countries are largely supplied with plasma derivatives by just one supplier, either public or private.
Številne države večinoma dobivajo derivate krvne plazme od enega samega dobavitelja, javnega ali zasebnega.
However, Member States' perceptions of what is considered compensation and incentive vary.
Vendar se razlage držav članic, kaj se šteje za nadomestilo in spodbudo, razlikujejo.
There is considerable heterogeneity across the EU, with certain practices perceived as compensation in one country and as incentives in another.
V EU obstaja precejšnja raznolikost, pri čemer se nekatere prakse v eni državi štejejo za nadomestilo, v drugi pa za spodbudo.
However, the Report also points to some gaps and difficulties in relation to the application and enforcement of the existing provisions (e.g. definitions, provisions for donor safety, inspections framework), some due to different approaches taken by the Member States and others due to technological advances and changing risks observed since the legislation was adopted.
Vendar poročilo kaže tudi na nekatere vrzeli in težave v zvezi z uporabo in izvrševanjem obstoječih določb (npr. opredelitve, določbe o varnosti darovalcev, okvir inšpekcijskih pregledov), pri čemer so nekatere posledica različnih pristopov držav članic, druge pa tehnološkega napredka in sprememb v tveganjih, ugotovljenih od sprejetja zakonodaje.
Sixteen reported discouraging such donations by requiring a local ID document or a proof or local residence.
Šestnajst jih je poročalo o odvračanju od takega darovanja z zahtevo po lokalnem osebnem dokumentu ali dokazilu o lokalnem prebivališču.
In addition, and in accordance with Article 20(2) of the Directive 2002/98/EC, Member States have to submit to the Commission reports on the application of the principle of voluntary and unpaid donation (VUD) every three years.
Poleg tega morajo države članice v skladu s členom 20(2) Direktive 2002/98/ES Komisiji vsaka tri leta predložiti poročila o uporabi načela prostovoljnega in brezplačnega darovanja (PBD).
Most common are awareness building campaigns for specific donor groups, such as students, or events such as the World Blood Donor Day (WHO, 14 June) or Thalassemia day (8 May in Greece and Cyprus).
Najpogostejše so kampanje ozaveščanja za posebne skupine darovalcev, kot so študenti, ali dogodki, kot sta svetovni dan krvodajalcev (SZO, 14. junij) ali dan talasemije (8. maj v Grčiji in na Cipru).
Fig. 1: Additional fields of competence for national blood competent authorities
Slika 1: Dodatna področja pristojnosti za nacionalne pristojne organe za kri
In half of the countries one authority is responsible for the entire oversight of the blood sector, whereas in others the tasks are divided amongst two or three authorities (based on duties, e.g. accreditation/authorisation versus inspections/vigilance, or based on the allocation of tasks between federal and regional levels).
V polovici držav je en organ odgovoren za celoten nadzor nad sektorjem krvi, v drugih pa so naloge razdeljene med dva ali tri organe (glede na naloge, npr. akreditacija/odobritev v primerjavi z inšpekcijskim pregledom/vigilanco, ali glede na razdelitev nalog med zvezno in regionalno ravnjo).
While many countries report having data on imported volumes, it is difficult to draw conclusions in the absence of a harmonised data collection system on import and export volumes.
Čeprav številne države poročajo, da imajo podatke o količini uvoza, je iz njih težko sklepati, ker ni usklajenega sistema zbiranja podatkov o količinah uvoza in izvoza.
In contrast to blood components for transfusion, the demand for plasma derivatives is steadily increasing (around 6% per year) which also generates import flows from third countries into the EU.
Povpraševanje po derivatih krvne plazme v nasprotju s komponentami krvi za transfuzijo stalno narašča (za približno 6 % letno), kar tudi ustvarja uvozne tokove iz tretjih držav v EU.
The ageing EU population could exacerbate supply challenges, leading both to increased demand and reduced numbers of eligible donors.
Zaradi staranja prebivalstva EU se lahko izzivi glede dobave povečajo, saj to pomeni povečano povpraševanje in zmanjšano število ustreznih darovalcev.
Seventeen Member States reported having penalties in place, addressing different situations such as making financial gain or collection of donations without consent.
Sedemnajst držav članic je poročalo, da so pri njih uvedene kazni za različne primere, kot je pridobivanje finančne koristi ali zbiranje darovanj brez soglasja.
All Member States, Liechtenstein and Norway also provided answers to the survey on the implementation of the principle of VUD.
Vse države članice ter Lihtenštajn in Norveška so predložili tudi odgovore na anketo o izvajanju načela PBD.
As regards the risk of transmission of communicable diseases thorough blood and blood components, the collaboration with ECDC proved extremely valuable.
Kar zadeva tveganje prenosa nalezljivih bolezni prek krvi in komponent krvi, se je sodelovanje z Evropskim centrom za preprečevanje in obvladovanje bolezni (ECDC) izkazalo za izredno dragoceno.
Many countries reported in 2013 on the feasibility/appropriateness of deferring donors on the grounds of sexual risk behaviour and about two-thirds of the countries have national guidance in place.
Leta 2013 so številne države poročale o izvedljivosti/ustreznosti odklona darovalcev zaradi tveganega (spolnega) vedenja, približno dve tretjini držav pa ima glede tega sprejeta nacionalna navodila.
Sixteen countries report having pathogen inactivation technologies in place.
Šestnajst držav poroča, da imajo vzpostavljene tehnologije inaktivacije patogenov.
Other Member States reported to be negotiating agreements for fractionation, while one reported having difficulties finding a partner to carry out fractionation.
Druge države članice so poročale, da se pogajajo o sporazumih o frakcioniranju, medtem ko je ena poročala, da ima težave pri iskanju partnerja za izvajanje frakcioniranja.
In the vast majority of Member States, the authorities for blood are also responsible for the oversight of other sectors (e.g. organs, tissues, cells and/or medicinal products), which can be beneficial for achieving greater efficiency and coherence.
V veliki večini držav članic so organi za kri odgovorni tudi za nadzor nad drugimi sektorji (npr. organi, tkiva, celice in/ali zdravila), kar je lahko koristno z vidika učinkovitosti in skladnosti.
Additionally, the distinction between import/export from/to third countries and distribution from/to other EU Member States is not consistently applied.
Poleg tega ni doslednega razlikovanja med uvozom v tretje države oz. izvozom iz njih ter razdeljevanjem iz drugih držav članic EU in vanje.
Therefore, information provided by the donor contributes to an accurate assessment of all risks associated to the transfusion of blood and blood components and the clinical application of plasma derivatives.
Zato informacije, ki jih predloži darovalec, prispevajo k točni oceni vseh tveganj v zvezi s transfuzijo krvi in komponent krvi ter klinično uporabo derivatov krvne plazme.
For the purpose of the survey, "compensation" was defined as "reparation strictly limited to making good the expenses and inconveniences related to the donation" and "incentive" was defined as "inducement or stimulus for donation with a view to seeking financial gain or comparable advantage", but even with these (non-binding) definitions Member States reached divergent classifications.
Za namene ankete je bilo „nadomestilo" opredeljeno kot „odškodnina, strogo omejena na povračilo stroškov in kompenzacijo za neprijetnosti v zvezi z darovanjem", „spodbuda" pa kot „stimulacija ali motivacija za darovanje za pridobitev finančne koristi ali podobne ugodnosti", vendar so države članice kljub tem (nezavezujočim) opredelitvam uporabile različne razvrstitve.
A majority of countries report having policies to also optimise the clinical use of plasma derivatives, with a small number of countries having national prioritisation strategies to ensure supply to those patient groups who are highly dependent on treatment with these products.
Večina držav poroča, da imajo tudi politike za optimiziranje klinične uporabe derivatov krvne plazme, majhno število držav pa ima nacionalne strategije za prednostno razvrščanje za zagotovitev dobave tistim skupinam pacientov, ki so močno odvisni od zdravljenja s temi pripravki.
The majority of Member States have rules to authorise and control import of blood and blood components for transfusion, while only about half have such rules for plasma for fractionation.
Večina držav članic ima pravila za odobritev in kontrolo uvoza krvi in komponent krvi za transfuzijo, medtem ko jih ima taka pravila za krvno plazmo za frakcioniranje samo približno polovica.
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.