qanastek/ELRC-Medical-V2 huggingface dataset:
English: In any event, the number of penalties imposed is very low.
Translation (en-da): Under alle omstændigheder er antallet af pålagte sanktioner meget lavt.
English: These are of particular importance given the numerous technological developments in the field in recent years.
Translation (en-da): Dette er særlig af betydning i betragtning af de mange teknologiske udviklinger på dette område i de seneste år.
English: Obligations of Member State competent authorities
Translation (en-da): Forpligtelser for medlemsstaternes kompetente myndigheder
English: Significant progress has been made in many areas, also through the active support by Commission funded projects and other initiatives.
Translation (en-da): Der er gjort betydelige fremskridt på mange områder, også gennem aktiv støtte af kommissionsfinansierede projekter og andre initiativer.
English: The application of selection criteria should be transparent and subject to continuous evaluation in order to minimize safety risks.
Translation (en-da): Anvendelsen af udvælgelseskriterier bør være gennemsigtig og underkastet løbende evaluering for at minimere sikkerhedsrisici.
English: [11: Case C-29/14, judgment pronounced on 11 June 2015.
Translation (en-da): [11: Sag C-29/14, dom af 11. juni 2015.
English: It was also suggested that the full list of these more stringent requirements could be made available by the Commission.
Translation (en-da): Det blev også foreslået, at Kommissionen kan offentliggøre den fulde liste over disse strengere krav.
English: No problems were reported regarding the implementation of the provisions related to data protection.
Translation (en-da): Der blev ikke rapporteret om problemer vedrørende gennemførelsen af bestemmelserne om databeskyttelse.
English: Concerning joint inspections by authorities from more than one Member State, a small number have been organised in recent years.
Translation (en-da): For så vidt angår fælles inspektioner med deltagelse af myndigheder fra mere end en medlemsstat, er der blevet afholdt et lille antal af disse i de seneste år.
English: Legend: ART = assisted reproductive technologies
Translation (en-da): Forklaring: ART = assisteret reproduktionsteknologi
English: Another important issue highlighted by some Member States was the need to foster harmonisation of the inspection practices in the Member States.
Translation (en-da): Et andet vigtigt spørgsmål, der blev fremhævet af nogle medlemsstater, var behovet for at fremme harmoniseringen af inspektionspraksis i medlemsstaterne.
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-da): Det er vigtigt at bemærke, at hyperlinksene indeholder de oprindelige svar fra medlemsstaterne, mens rapporten afspejler medlemsstaternes ajourførte oplysninger.
English: In some Member States the sector is fully controlled by public organisations, whilst in others private operators make a significant contribution (Fig. 5).
Translation (en-da): I nogle medlemsstater er sektoren fuldstændigt kontrolleret af offentlige organisationer, mens private operatører i andre yder et væsentligt bidrag (fig. 5).
English: The gaps and difficulties identified suggest that a further in-depth evaluation might be useful.
Translation (en-da): De konstaterede mangler og problemer viser, at en mere indgående evaluering kunne være nyttig.
English: Donor selection and evaluation
Translation (en-da): Udvælgelse og evaluering af donorer
English: In 2015 the MS concerned has adopted new legislation for the ART sector and is in process of implementing it.]
Translation (en-da): I 2015 vedtog den pågældende medlemsstat ny lovgivning for ART-sektoren, og den er i færd med at gennemføre denne lovgivning.]
English: Other practices include compensation for the inconveniences related to the donation.
Translation (en-da): Andre praksisser omfatter kompensation for ulemper i forbindelse med donationen.
English: As a consequence, pursuant to Article 258 TFEU, the Commission has brought action against one Member State to the Court of Justice, and launched an infringement proceeding against another Member State, which is ongoing.
Translation (en-da): Som følge heraf har Kommissionen i henhold til artikel 258 i TEUF anlagt sag mod en medlemsstat ved Domstolen, og den har iværksat en traktatbrudsprocedure mod en medlemsstat, som endnu ikke er afsluttet.
English: The overall aim of the annual reporting, to identify the most frequent causes of SARE and provide appropriate corrective measures, has not yet been fully achieved.
Translation (en-da): Det overordnede mål med den årlige rapportering, nemlig at identificere de hyppigste årsager til SARE og at yde passende afhjælpende foranstaltninger, er endnu ikke opfyldt fuldt ud.
English: The implementation survey was answered by all Member States except Greece, and also by two EEA countries, Liechtenstein and Norway.
Translation (en-da): Gennemførelsesundersøgelsen blev besvaret af alle medlemsstater med undtagelse af Grækenland, og også af to EØS-lande, Liechtenstein og Norge.
English: Their outcome was in general satisfying and in particular allowed bringing expertise where this might be missing within the own Member State.
Translation (en-da): Resultaterne heraf var generelt tilfredsstillende, og det gjorde det navnlig muligt at bringe ekspertise ind, hvor en sådan kunne mangle i medlemsstaten.
English: Reproductive cells (ART sector).
Translation (en-da): Kønsceller (ART-sektoren).
English: If donor payment were allowed, some individuals could find the monetary remuneration so important that they might hide relevant medical and/or behavioural information.
Translation (en-da): Hvis betaling af donorer var tilladt, kunne nogle personer finde den monetære aflønning så vigtig, at de skjulte relevante medicinske og/eller adfærdsmæssige oplysninger.
English: It should be highlighted that several Member States indicated that there is no national legal requirement for organising national follow-up registries for living donors.
Translation (en-da): Det bør fremhæves, at flere medlemsstater anførte, at der ikke findes noget nationalt retligt krav om at organisere nationale opfølgningsregistre vedrørende levende donorer.
English: Designation of competent authority or authorities responsible for the implementation of Directive 2004/23/EC
Translation (en-da): Udpegning af kompetente myndigheder med ansvar for gennemførelsen af direktiv 2004/23/EF
English: At the end of 2011, 2047 tissue establishments were authorised in the EU, showing an almost 20% increase compared to the 2008 data (Fig. 4).
Translation (en-da): Ved udgangen af 2011 var der 2047 godkendte vævscentre i EU, hvilket er en stigning på næsten 20 % sammenlignet med oplysningerne for 2008 (fig. 4).
English: The penalties foreseen in national legislation, their criteria for implementation and their effective implementation can differ significantly between Member States.
Translation (en-da): Sanktioner Sanktionerne fastsat i national lovgivning, kriterierne for gennemførelse og deres effektive gennemførelse kan variere betydeligt mellem medlemsstaterne.
English: It has to be highlighted that, irrespective of the organisational set up in each country, it is important that authorities have appropriate resources at their disposal in order to ensure their independence from economic operators, in the sector and from other influences.
Translation (en-da): Det skal understreges, at det uanset den organisatoriske opbygning i hvert land er vigtigt, at myndighederne har passende ressourcer til deres rådighed med henblik på at sikre deres uafhængighed af økonomiske operatører i sektoren og af andre påvirkninger.
English: However, Member States interpretation of what is considered compensation and incentive vary.
Translation (en-da): Medlemsstaternes fortolkning af, hvad der betragtes som kompensation og incitamenter, varierer imidlertid.
English: (Total POs = 4825; 2011 data)
Translation (en-da): (PO'er i alt = 4825; data fra 2011)
English: Even though only trained personnel are allowed to provide appropriate information to donors, this information has been standardised at national level in a small number of countries.
Translation (en-da): Selv om kun uddannet personale får lov til at udarbejde passende oplysninger til donorer, så er disse oplysninger blevet standardiseret på nationalt plan i et lille antal lande.
English: A majority also supported European legislation to ensure the safety and quality of blood, tissues and cells.
Translation (en-da): Et flertal støttede også europæisk lovgivning til sikring af sikkerheden og kvaliteten af blod, væv og celler.
English: There is no harmonisation in defining or applying such penalties, therefore it is difficult to evaluate whether similar measures are applied by all the Member States in case of a specific breach of the legislation in this area.
Translation (en-da): Der er ingen harmonisering vedrørende fastlæggelsen eller anvendelsen af sådanne sanktioner, og det er derfor vanskeligt at vurdere, hvorvidt lignende foranstaltninger anvendes af alle medlemsstater i tilfælde af en specifik tilsidesættelse af lovgivningen på dette område.
English: The differences in purchasing power between Member States might also explain why a measure is considered a "compensation" in one country and an "incentive" in another.
Translation (en-da): Forskellene i de enkelte medlemsstaters købekraft kan også forklare, hvorfor en foranstaltning anses for at være "kompensation" i ét land og "incitament" i et andet.
English: More generally speaking, it was difficult to assess how divisions of tasks impacts oversight of the sector, especially as some of the national competent authorities did not provide precise/complete information.
Translation (en-da): Mere generelt er det vanskeligt at vurdere, dels hvordan opgavefordelingen påvirker tilsynet med sektoren, især da nogle af de nationale kompetente myndigheder ikke forelagde nøjagtige/fuldstændige oplysninger.
English: In terms of inspection outcomes, mostly minor shortcomings were recorded with few suspensions and revocations of authorisations (Fig. 6).
Translation (en-da): Med hensyn til resultaterne af inspektionerne blev der for det meste registreret mindre mangler med få suspenderinger og tilbagekaldelser af tilladelser (fig. 6).
English: These consist mainly in providing administrative support for the funeral and ensuring full or partial coverage of the cost of the funeral/burial/cremation.
Translation (en-da): Denne består hovedsagelig af administrativ støtte til begravelsen og sikring af fuldstændig eller delvis dækning af omkostningerne til begravelsen/jordfæstelsen/kremeringen.
English: Wherever accreditation and inspections are undertaken by different authorities, a good communication and coordination between respective authorities needs to be ensured.
Translation (en-da): Når akkreditering og inspektioner gennemføres af forskellige myndigheder, er det nødvendigt at sikre en god kommunikation og koordinering mellem de forskellige myndigheder.
English: However, the tissue establishment reports are not always publicly available, mainly due to different interpretations of this provision by the Member States authorities.
Translation (en-da): Vævscenterrapporterne er imidlertid ikke altid offentligt tilgængelige, hvilket først og fremmest skyldes, at medlemsstaternes myndigheder har forskellige fortolkninger af denne bestemmelse.
English: This may suggest a role for the EU in supporting Member States to develop national sufficiency policies although the exact impact of such policies on cross-border exchanges and the supply of starting materials for medicinal product manufacture would need to be carefully analysed.
Translation (en-da): Dette kan betyde, at EU har en rolle med hensyn til at hjælpe medlemsstaterne med at udvikle nationale tilstrækkelighedspolitikker, selv om den præcise indvirkning af sådanne politikker på grænseoverskridende udvekslinger og udbuddet af udgangsmateriale til fremstilling af lægemidler ville skulle analyseres nøje.
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 2004/23/EC and its implementing Directives.
Translation (en-da): Kommissionen vil overveje, om der er behov for en evaluering for at vurdere relevansen, effektiviteten, virkningsgraden, sammenhængen og merværdien for EU af direktiv 2004/23/EF og dets gennemførelsesdirektiver.
English: However, some difficulties in interpretation, implementation and enforcement of the legislation have been identified, which in some cases could be explained by the scientific and technological advances since its adoption.
Translation (en-da): Imidlertid er der blevet konstateret nogle problemer med fortolkning, gennemførelse og håndhævelse af lovgivningen, hvilket i nogle tilfælde kan forklares ved den videnskabelige og teknologiske udvikling siden vedtagelsen.
English: Several Member States suggested that a common list of diagnostic tests (panel) for some genetic diseases may be valuable for increasing safety in the EU ART sector.
Translation (en-da): Flere medlemsstater foreslog, at en fælles liste over diagnostiske test (paneltest) for visse genetiske sygdomme kan være værdifuld for at øge sikkerheden i EU's ART-sektor.
English: It should be noted that, although much has been achieved and reporting improves every year, challenges related to under-reporting by organisations responsible for human application and the lack of accurate data remain.
Translation (en-da): Det skal bemærkes, at selv om der er opnået meget, og indberetningerne forbedres hvert år, så er der fortsat udfordringer i forbindelse med underrapportering af organisationer med ansvar for anvendelse på mennesker og mangel på præcise data..
English: Developing more detailed requirements for these activities as part of GTP was supported by several national competent authorities for tissues and cells.
Translation (en-da): Udarbejdelsen af mere detaljerede krav til disse aktiviteter som et led i GTP blev støttet af flere nationale kompetente myndigheder for væv og celler.
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 human tissue and cells for clinical application.
Translation (en-da): Siden 2003 er en række projekter blevet finansieret under de flerårige programmer for Unionens indsats inden for sundhedsområdet vedrørende humane væv og celler til klinisk anvendelse.
English: All Member States replied to the transposition questionnaire.
Translation (en-da): Alle medlemsstaterne besvarede spørgeskemaet om gennemførelse i praksis.
English: Reimbursement of costs linked to travel and medication based on actual costs/receipts are among the most commonly used type of compensation for living donors.
Translation (en-da): Godtgørelse af udgifter til rejser og medicin baseret på faktiske omkostninger og kvitteringer er blandt de mest anvendte former for kompensation til levende donorer.
English: As regards the risk of transmission of communicable diseases thorough tissues and cells, the collaboration with ECDC proved extremely valuable.
Translation (en-da): For så vidt angår risikoen for spredning af overførbare sygdomme gennem væv og celler, har samarbejdet med ECDC vist sig yderst værdifuldt.
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 group meetings to EU-funded projects.
Translation (en-da): Europa-Kommissionen har støttet gennemførelsen af lovgivningen i medlemsstaterne ved at fremme aktiv deltagelse af nationale kompetente myndigheder i en række aktioner, fra halvårlige møder med ekspertgrupper til EU-finansierede projekter.
English: Projects such as EUSTITE, EuroGTP, SOHO V&S, and the on-going joint actions ARTHIQS and VISTART have provided a strong support to Member States in their efforts to implement the requirements of the EU tissue and cell legislation.
Translation (en-da): Projekter, såsom EUSTITE, EuroGTP, SOHO V&S og de igangværende fælles aktioner ARTHIQS og VISTART har ydet medlemsstaterne en stærk støtte i deres indsats for at gennemføre kravene i EU's lovgivning om væv og celler.
English: All reporting Member States have appointed competent authorities for tissues and cells.
Translation (en-da): Alle indberettende medlemsstater har udpeget kompetente myndigheder for væv og celler.
English: It was underlined that Member States introducing more stringent safety and quality requirements should inform the other Member States and EEA countries, as well as the Commission, regarding these measures, in a transparent manner.
Translation (en-da): Det blev understreget, at medlemsstater, der indfører strengere krav til sikkerhed og kvalitet, på en gennemsigtig måde bør underrette de øvrige medlemsstater og EØS-landene samt Kommissionen om disse foranstaltninger.
English: 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 on the cross-border movement of tissues and cells.
Translation (en-da): Disse forskelle fremmer en vellykket integrering af kravene i national lovgivning, men i nogle tilfælde kan de begrænse den gensidige accept af godkendelser med konsekvenser for den grænseoverskridende bevægelighed for væv og celler.
English: An important issue is how and by whom the decision concerning the value and form of compensations for tissue and cell donors is taken.
Translation (en-da): Et vigtigt spørgsmål er, hvordan og af hvem afgørelsen træffes om værdien og formen for kompensation for vævs- og celledonorer.
English: Therefore information provided by the donor or his/her family contributes to an accurate assessment of all risks associated to the application of donated tissues or cells.
Translation (en-da): Derfor bidrager oplysninger fra donoren eller dennes familie til en nøjagtig vurdering af alle risici forbundet med anvendelsen af donerede væv eller celler.
English: The Commission is also required to provide the European Parliament and the Council with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and monitoring.
Translation (en-da): Kommissionen skal desuden give Europa-Parlamentet og Rådet en oversigtsrapport om gennemførelsen af kravene i direktivet, navnlig kravene vedrørende inspektion og kontrol.
English: It is also interesting to highlight the split between private and public ownership of tissue establishments.
Translation (en-da): Det er også interessant at se på opdelingen mellem offentlige og privatejede vævscentre.
English: Overall, the implementation of the EU tissues and cells legislation by the Member States is considered adequate and the legislation has resulted in the establishment of a network of competent authorities that oversee the sector through authorisation, inspection, and vigilance.
Translation (en-da): Overordnet set anses medlemsstaternes gennemførelse af EU's lovgivning om væv og celler for at være tilstrækkelig, og lovgivningen har ført til oprettelse af et netværk af kompetente myndigheder, der fører tilsyn med sektoren gennem godkendelser, inspektion og overvågning.
English: This may suggest that tissue establishments are striving to comply with the EU quality and safety requirements, but it may also indicate under-enforcement, e.g. in countries which have never reported any shortcomings.
Translation (en-da): Dette kan tyde på, at vævscentrene stræber efter at opfylde EU's kvalitets- og sikkerhedskrav, men det kan også betyde, at håndhævelsen ikke er tilstrækkelig, f.eks. i lande, der aldrig har meddelt nogle mangler.
English: Only in a small number of Member States is the value of the compensation provided to tissue and cell donors connected to national economic indicators (e.g. monthly income, purchasing capacity).
Translation (en-da): Kun i få medlemsstater er værdien af den kompensation, der ydes til vævs- og celledonorer, knyttet til nationale økonomiske indikatorer (f.eks. månedlig indkomst, købekraft).
English: In spite of this, both the Commission and national competent authorities for tissues and cells acknowledge that there is still a high degree of under-reporting requiring careful consideration when analysing the data.
Translation (en-da): Til trods herfor anerkender både Kommissionen og de nationale kompetente myndigheder for væv og celler, at der stadig er en høj grad af underrapportering, der kræver omhyggelige overvejelser, når data analyseres.
English: This may also explain why some Member States have not put in place a coherent policy to ensure national sufficiency at least for some type of tissues or cells.
Translation (en-da): Dette kan også forklare, hvorfor nogle medlemsstater ikke har indført en sammenhængende politik til sikring af den nationale forsyning, i hvert fald for nogle typer væv eller celler.
English: Additional tests required by Member States are usually justified for local reasons, like e.g. the increased prevalence of a certain infectious disease.
Translation (en-da): Supplerende test, der kræves af medlemsstaterne, er normalt begrundet i lokale forhold, som f.eks. den øgede forekomst af visse smitsomme sygdomme.
English: Several of the selection criteria, as well as the tasks of the responsible persons in Member States with more stringent requirements, have been subject to discussion during the bi-annual national competent authority meetings.
Translation (en-da): Flere af udvælgelseskriterierne samt de opgaver, der påhviler de ansvarlige personer i medlemsstater med strengere krav, er blevet drøftet under de halvårlige møder mellem de nationale kompetente myndigheder.
English: Only 17 Member States reported having guiding principles regarding the possibility to compensate tissue and cell donors, but in many cases these principles were just a description of the practices allowed at national level.
Translation (en-da): Kun 17 medlemsstater har oplyst, at de har vejledende principper vedrørende muligheden for at kompensere vævs- og celledonorer, men i mange tilfælde var disse principper blot en beskrivelse af fremgangsmåder tilladt på nationalt plan.
English: Outcome of tissue establishment inspections performed in 2011
Translation (en-da): Figur 6 Resultatet af inspektioner af vævscentre udført i 2011
English: Some mixed models have emerged where, for example, the private sector may take the role of a third party for processing or storage, with all donation, promotion and distribution activities remaining in public hands.
Translation (en-da): Der er opstået nogle blandede modeller, hvor f.eks. den private sektor kan påtage sig rollen som tredjepart med henblik på forarbejdning eller oplagring, mens alle aktiviteter i forbindelse med donation, markedsføring og distribution forbliver på offentlige hænder.
English: It has to be underlined that countries which reported difficulties in implementing the donation identification system were either developing a central allocation system for identifiers or were waiting for the adoption of the implementing legislation introducing a Single European Code for tissues and cells.
Translation (en-da): Det skal understreges, at lande, der rapporterede om vanskeligheder ved indførelsen af donationsidentifikationssystemet enten var ved at udvikle en central tildelingsordning for identifikatorer eller afventede vedtagelsen af den gennemførelseslovgivning, der vil indføre en fælles europæisk kode for væv og celler.