FrancophonIA/Publications_Medical_Domain_UE huggingface dataset:
English: Additionally, for cases in which tissues/cells from one donor will be used for both transplantation and manufacturing of ATMP, consideration should be given on how to best exchange relevant data between the pharmacovigilance and biovigilance systems (e.g. donation of cells from a living donor which may be found to develop a tumour after donating cells to an ATMP manufacturer or recipient developing a tumour/communicable disease following therapy with donated cells from a donor who may have donated cells transplanted in another recipient).
Danish: Desuden gælder for tilfælde, hvor væv/celler fra en donor vil blive anvendt i forbindelse med både transplantation og fremstilling af lægemidler til avanceret terapi (LTAT), at man bør gøre sig overvejelser om, hvordan man bedst kan udveksle relevante oplysninger mellem systemerne til lægemiddelovervågning og bioberedskab (f.eks. donation af celler fra en levende donor, der udvikler en tumor efter donation af celler til LTAT-fabrikanten, eller recipienten udvikler en tumor/overførbar sygdom efter behandling med celler, der er doneret af en donor, der kan have doneret celler transplanteret til en anden recipient).
English: Quality and safety of tissues and cells
Danish: Kvalitet og sikkerhed af væv og celler
English: The findings of the VUD survey suggest that Member States should collect more information on the day-to-day practices vis-à-vis donors in both procurement organisations and tissue establishments, especially when these operators are responsible for deciding the type and/or value of the compensation provided to donors.
Danish: Resultaterne af undersøgelsen om frivillig og vederlagsfri donation tyder på, at medlemsstaterne bør indsamle flere oplysninger om den daglige praksis over for donorer i såvel udtagningsorganer som vævscentre, navnlig når disse operatører er ansvarlige for at beslutte, hvilken type og/eller værdi af kompensation donorer skal have.
English: Number of accredited/designated/authorised/licensed tissue establishments per type of human tissues and cells (comparative data; data submitted by 27 Member States and two EEA countries)
Danish: Figur 4 Antal akkrediterede/udpegede/godkendte vævscentre og vævscentre, der er udstedt licens til pr. type humane væv og celler (sammenlignelige data; data indsendt af 27 medlemsstater og to EØS-lande)
English: This report shows that Member States overall comply with Article 12 of Directive 2004/23/EC requiring Member States to take the necessary measures to endeavour to ensure VUD of tissues and cells.
Danish: Denne rapport viser, at medlemsstaterne generelt overholder artikel 12 i direktiv 2004/23/EF, der pålægger medlemsstaterne at træffe de nødvendige foranstaltninger til at forsøge at sikre frivillig og vederlagsfri donation af væv og celler.
English: Furthermore, besides procurement of replacement tissues, haematopoietic stem cells and reproductive cells, some Member States also reported a significant number of procurement organisations carrying out procurement of tissue and cells to be used for manufacturing of advanced therapy medicinal products (ATMP) (Fig. 3).
Danish: Desuden indberettede visse medlemsstater ud over udtagning af erstatningsvæv, hæmatopoietiske stamceller og kønsceller også et betydeligt antal udtagningsorganisationer, der foretager udtagning af væv og celler, der skal anvendes til fremstilling af lægemidler til avanceret terapi (figur 3).
English: Issues to be addressed include transparency of the decisions regarding donor compensation, the type and value of the compensations for donors, especially for the situations when such decisions were conveyed to procurement organisations or tissue establishments.
Danish: Der skal tages fat om følgende emner: gennemsigtighed af afgørelser om donorers kompensation, typen og værdien af kompensation til donorer, navnlig med henblik på situationer, hvor disse beslutninger blev meddelt udtagningsorganer og vævscentre.
English: All Member States, and also Liechtenstein and Norway provided answers to the survey on the implementation of the VUD principle.
Danish: Alle medlemsstater samt Liechtenstein og Norge besvarede spørgeskemaet om gennemførelsen af princippet om frivillig og vederlagsfri donation.
English: Number of procurement organisations (POs) reported by the EU and EEA countries
Danish: Figur 3 Antal udtagningsorganisationer (PO'er) indberettet af EU- og EØS-landene
English: The current survey showed that in addition to the requirements in the Directive 2006/17/EC, the more stringent selection criteria required by Member States are usually justified for local reasons, such as the increased prevalence of a certain disease.
Danish: Udvælgelse og evaluering af donorer Den nuværende undersøgelse har vist, at foruden kravene i direktiv 2006/17/EF, så er de strengere udvælgelseskriterier, som medlemsstaterne kræver, som regel begrundet i lokale forhold, f.eks. øget forekomst af en bestemt sygdom.
English: Where appropriate data gathered through other channels and supporting the findings of the two surveys (e.g. exchanges with the national 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 Tissues and Cells (RATC) platform, Eurobarometer survey exploring the views of EU citizens on tissue and cell donation and the output of a number of relevant EU-funded projects and studies) were also taken into account.
Danish: I givet fald blev oplysninger, der er indsamlet via andre kanaler og støtter resultaterne af de to undersøgelser (f.eks. i forbindelse med kontakt med de nationale kompetente myndigheder i de halvårlige møder med Kommissionen, den obligatoriske årlige rapportering til Kommissionen om alvorlige bivirkninger og uønskede hændelser (SARE), indberetninger, der blev iværksat i forbindelse med platformen for det hurtige varslingssystem for væv og celler (RATC), Eurobarometerundersøgelsen om holdningen hos EU's borgere om donation af væv og celler og resultatet af en række relevante EU-finansierede projekter og undersøgelser), også taget i betragtning.
English: In most of the Member States compliance with the requirements for tissue and cell procurement set by Directive 2006/17/EC is verified by the competent authorities when performing inspections, but also by auditing procurement organisations and centres of human application.
Danish: Udtagning af væv og celler I de fleste medlemsstater kontrolleres overholdelse af kravene til udtagningen af væv og celler fastsat i direktiv 2006/17/EF af de kompetente myndigheder, når de udfører inspektioner, men også ved at revidere udtagningsorganisationer og centre for anvendelse på mennesker.
English: The data provided, even though incomplete and sometimes not precisely defined, confirm that increasing volumes of human tissues and cells are imported from or exported to third countries (Fig. 7).
Danish: Import/eksport af humane væv og celler til/fra tredjelande Selv om de afgivne oplysninger er ufuldstændige og til tider ikke er præcist defineret, bekræfter de, at de stigende mængder af humane væv og celler importeres fra eller eksporteres til tredjelande (figur 7).
English: In line with the requirements in Article 10 of Directive 2004/23/EC, national registers of tissues establishments appear to be available in most of the responding Member States.
Danish: Register over vævscentre samt rapporteringsforpligtelser I overensstemmelse med kravene i artikel 10 i direktiv 2004/23/EF synes nationale registre over vævscentre at være mulige i de fleste af de medlemsstater, der har svaret.
English: It has to be noted that similar to donor selection, more stringent testing requirements introduced by some Member States are sometimes perceived by healthcare professionals ordering tissues or cells from other Member States as barriers hampering development and the cross-border movement of tissues and cells between Member States.
Danish: Det skal bemærkes, at i lighed med donorudvælgelse opfattes de strengere krav til testning, der er indført af visse medlemsstater, til tider som barrierer for udviklingen og den grænseoverskridende transport af væv og celler mellem medlemsstaterne af sundhedspersoner, der bestiller væv eller celler fra andre medlemsstater.
English: Fig. 7.
Danish: Figur 7
English: Verification by the competent authorities of the implementation of the VUD principle in tissue establishments is focused on inspecting documentation related to donor consent.
Danish: De kompetente myndigheders kontrol af gennemførelsen af princippet om frivillig og vederlagsfri donation i vævscentre fokuserer på kontrol af dokumentation vedrørende donorsamtykke.
English: Diverse practices related to the implementation of the requirements of Article 4 of Directive 2006/86/EC were reported.
Danish: Godkendelse af processer til forarbejdning af væv og celler Der blev indberettet forskellig praksis i forbindelse med gennemførelsen af kravene i artikel 4 i direktiv 2006/86/EF.
English: It is noted that an additional support on training of tissue establishment personnel was given through EU-funded projects such as European Quality System for Tissue Banking (EQSTB) and European Good Tissue Practices (EuroGTPs).
Danish: Det skal bemærkes, at der gennem EU-finansierede projekter som f.eks. det europæiske kvalitetssikringssystem for vævsbanker (EQSTB) og gode europæiske praksisser for væv (EuroGTP'er) blev ydet yderligere støtte til uddannelse af personale ved vævscentre.
English: The present implementation survey confirmed that Member States are trying to ensure an appropriate level of training for their tissue establishment personnel, and the compliance with the requirements of Directive 2004/23/EC is systematically verified during inspections and also before granting authorisation/accreditation/licence to tissue establishments.
Danish: Kvalitetsstyring, ansvarlig person og personale Denne gennemførelsesundersøgelse bekræftede, at medlemsstaterne forsøger at sikre en passende uddannelse af personalet i deres vævscentre, og at opfyldelsen af kravene i direktiv 2004/23/EF systematisk kontrolleres under inspektioner og før der udstedes en tilladelse/godkendelse/licens til vævscentrene.
English: [2: Detailed Member States' replies (as well as replies from Norway and Liechtenstein) can be accessed at http://ec.europa.eu/health/blood_tissues_organs/key_documents/][3: In a number of cases clarification requests were sent to Member States.
Danish: [2: Detaljerede svar fra medlemsstaterne (samt svar fra Norge og Liechtenstein) kan ses på adressen http://ec.europa.eu/health/blood_tissues_organs/key_documents/.
English: As regards the implementation of the VUD principle, the Commission survey showed that Member States overall comply with Article 12 of Directive 2004/23/EC requiring them to take the necessary measures to encourage VUD.
Danish: Hvad angår gennemførelsen af princippet om frivillig og vederlagsfri donation, så viste Kommissionens undersøgelse, at medlemsstaterne generelt overholder artikel 12 i direktiv 2004/23/EF, der forpligter dem til at træffe de nødvendige foranstaltninger for at tilskynde frivillig og vederlagsfri donation.
English: Overall, the survey showed that regardless of the consent system, all responding countries have put measures in place for verifying donor consent.
Danish: Samtykke, beskyttelse af personoplysninger og tavshedspligt Samlet set viste undersøgelsen, at uanset hvilken samtykkeordning der er, så har alle de deltagende lande truffet foranstaltninger for at kontrollere donors samtykke.
English: The high number of procurement organisations shows that this activity is well developed across the Union.
Danish: Tilsyn med udtagning af humane væv og celler Det store antal udtagningsorganisationer er et tegn på, at denne aktivitet er veludviklet i hele Unionen.
English: Tissue establishments' status (public vs. private)/type of tissue (2011 data; data submitted by 25 Member States and one EEA country)
Danish: Figur 5 Vævscentres status (offentlig eller privat)/type væv (tal fra 2011; data indsendt af 25 medlemsstater og et EØS-land)
English: [7: Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L102, 07.04.2004, p. 48).
Danish: [7: Europa-Parlamentets og Rådets direktiv 2004/23/EF af 31. marts 2004 om fastsættelse af standarder for kvaliteten og sikkerheden ved donation, udtagning, testning, behandling, præservering, opbevaring og distribution af humane væv og celler (EUT L 102 af 7.4.2004, s. 48).
English: As demonstrated by the Member State replies, there are important cross-border movements of human tissues and cells within the EU and EEA countries (Fig. 8).
Danish: Distribution af væv og celler til anvendelse på mennesker Som det fremgår af medlemsstaternes svar, er der vigtige grænseoverskridende overførsler af humane væv og celler i EU og EØS-landene (figur 8).
English: ][9: Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L294, 25.10.2006, p.
Danish: ][9: Kommissionens direktiv 2006/86/EF af 24. oktober 2006 om gennemførelse af Europa-Parlamentets og Rådets direktiv 2004/23/EF for så vidt angår krav til sporbarhed, indberetning af alvorlige bivirkninger og uønskede hændelser og visse tekniske krav til kodning, behandling, præservering, opbevaring og distribution af humane væv og celler (EUT L 294 af 25.10.2006, s.
English: As the EU legislation in the tissue and cell 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.
Danish: Der er mange forskelle mellem medlemsstaterne i de tilgange, som de har truffet vedrørende gennemførelse, da EU's lovgivning vedrørende væv og celler ikke danner grundlag for en fuldstændig harmonisering, og eftersom direktiver giver medlemsstaterne en vis margen med hensyn til, hvordan de vil sikre deres gennemførelse.
English: [22: Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (OJ L 93, 9.4.2015, p. 56). ]
Danish: [22: Kommissionens direktiv (EU) 2015/566 af 8. april 2015 om gennemførelse af direktiv 2004/23/EF for så vidt angår procedurerne til kontrol af tilsvarende kvalitets- og sikkerhedsstandarder for importerede væv og celler (EUT L 93 af 9.4.2015, s. 56). ]
English: The analysis of the annual SARE reports submitted by the Member States demonstrates notable efforts to comply with the requirements in Article 7 of Directive 2006/86/EC.
Danish: Indberetning af alvorlige bivirkninger og alvorlige uønskede hændelser (SARE) Analysen af de årlige SARE-rapporter, som medlemsstaterne har indsendt, viser en betydelig indsats for at opfylde kravene i artikel 7 i direktiv 2006/86/EF.
English: ][8: Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (OJ L38, 9.2.2006, p. 40).
Danish: ][8: Kommissionens direktiv 2006/17/EF af 8. februar 2006 om gennemførelse af Europa-Parlamentets og Rådets direktiv 2004/23/EF for så vidt angår visse tekniske krav til donation, udtagning og testning af humane væv og celler (EUT L 38 af 9.2.2006, s. 40).
English: b. Volume of tissues and cells (units) exported in 2011 (data reported by 11 Member States)
Danish: b. Mængden af væv og celler (enheder) eksporteret i 2011 (data indberettet af 11 medlemsstater)
English: Support for the implementation of the EU tissue and Cell Directives
Danish: Støtte til gennemførelsen af EU's direktiver om væv og celler
English: Other responsibilities of tissues and cells competent authorities in the reporting EU Member States and EEA countries (2011 data)
Danish: Figur 2 Andre ansvarsområder for de kompetente myndigheder med ansvar for væv og celler i de indberettende EU-medlemsstater og EØS-lande (data for 2011)
English: The importance of inspections was highlighted again in the context of compliance with the requirements in the Directive 2006/86/EC, as the most frequent approach to verify their implementation.
Danish: Modtagelse af væv og celler, forarbejdning, oplagring, mærkning og emballering Betydningen af inspektioner blev fremhævet igen i forbindelse med overholdelsen af kravene i direktiv 2006/86/EF som den mest almindelige metode til at kontrollere kravenes gennemførelse.
English: Tissues and cells competent authorities in the reporting EU Member States and EEA countries (2011 data)
Danish: Figur 1 Kompetente myndigheder med ansvar for væv og celler i de indberettende EU-medlemsstater og EØS-lande (data for 2011)
English: a. Volume of tissues and cells (units) distributed from one MS to other EU MS and/or EEA countries in 2011 (Data reported by 18 countries)
Danish: a. Mængden af væv og celler (enheder) leveret fra en medlemsstat til andre EU-medlemsstater og/eller EØS-lande i 2011 (data indberettet fra 18 lande)
English: Non-reproductive tissues and cells.
Danish: Somatiske væv og celler.
English: [13: Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (OJ L 93, 9.4.2015, p.
Danish: [13: Kommissionens direktiv (EU) 2015/565 om ændring af direktiv 2006/86/EF for så vidt angår visse tekniske krav til kodning af humane væv og celler (EUT L 93 af 9.4.2015, s.
English: b. Volume of tissues and cells (units) received by MS from other EU MS and/or EEA countries in 2011 (Data reported by 15 Member States)
Danish: b. Mængden af væv og celler (enheder) modtaget af en medlemsstat fra andre EU-medlemsstater og/eller EØS-lande i 2011 (data indberettet fra 15 lande)
English: a. Volume of tissues and cells (units) imported in 2011 (data reported by 15 Member States)
Danish: a. Mængden af væv og celler (enheder) indført i 2011 (data indberettet af 15 medlemsstater)
English: OJ L 93, 9.4.2015, p. 43-55][15: EU Tissue establishment compendium is part of the EU Coding platform that was introduced by the Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.]
Danish: ][15: EU's vævscenterkompendium er en del af EU's kodningsplatform, der blev indført ved direktiv (EU) 2015/565 om ændring af direktiv 2006/86/EF for så vidt angår visse tekniske krav til kodning af humane væv og celler.]
English: Implementation of the EU tissues and cells legislation
Danish: Gennemførelse af EU's lovgivning om væv og celler
English: 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.
Danish: De to arbejdsdokumenter fra Kommissionens tjenestegrene, som ledsager denne rapport, indeholder en fuldstændig analyse af medlemsstaternes svar på gennemførelsesundersøgelsen fra 2013 og undersøgelsen fra 2014 om gennemførelse af princippet om frivillig og vederlagsfri donation.
English: Good practices developed by the EU-funded initiatives were also included by the Council of Europe in a dedicated Guide to the Quality and Safety of Tissues and Cells.
Danish: Europarådets særskilte vejledning om kvaliteten og sikkerheden af væv og celler inkluderede også god praksis udviklet af EU-finansierede initiativer.
English: [12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_en.pdf ]
Danish: [12: http://ec.europa.eu/health/blood_tissues_organs/docs/manual_da.pdf. ]
English: EN 3 EN
Danish: DA 3 DA
English: These reasons are still valid.
Danish: Disse grunde gør stadig sig gældende.
English: Problems that the initiative aims to tackle
Danish: Problemer, som initiativet sigter på at imødegå
English: The Commission will bear the limited costs.
Danish: Kommissionen vil afholde de begrænsede omkostninger.
English: The political response was to adopt a White Paper on Food Safety in January 2000.
Danish: Den politiske reaktion var at vedtage en hvidbog om fødevaresikkerhed i januar 2000.
English: Risk communication was also found not to be effective enough.
Danish: Risikokommunikation blev også anset for ikke at være tilstrækkeligt effektiv.
English: The Commission open public consultation is published on:
Danish: Kommissionens åbne offentlige høring er offentliggjort på:
English: Member States may nominate nationals of other Member States.
Danish: Medlemsstaterne kan indstille statsborgere fra andre medlemsstater.
English: The Authority shall carry out its activities with a high level of transparency.
Danish: Autoriteten udfører sine aktiviteter med en høj grad af åbenhed.
English: In addition, the role of the Management Board is focussed on administration and finances.
Danish: Derudover er bestyrelsens rolle fokuseret på administration og finanser.
English: Reasons for action at European level (ex-ante)
Danish: Begrundelse for handling på EU-plan (ex ante)
English: Applicants and in particular small- and medium-sized enterprises do not always have a clear understanding of these specifications.
Danish: Ansøgere, navnlig små og mellemstore virksomheder, har ikke altid en klar forståelse af disse specifikationer.
English: Therefore experience and knowledge exist on this substance or product.
Danish: Derfor findes der erfaring og viden om dette stof eller produkt.
English: Each Member State shall nominate at least 12 scientific experts.
Danish: Hver medlemsstat indstiller mindst 12 videnskabelige eksperter.
English: Appropriate provisions are included to protect the rights of commercial applicants.
Danish: Der er medtaget passende bestemmelser for at beskytte kommercielle ansøgeres rettigheder.
English: The Commission shall ensure the regular review of the application of this Regulation.
Danish: Kommissionen sikrer en regelmæssig revision af anvendelsen af denne forordning.
English: Such measures are therefore not expected to have significant socio-economic and environmental impacts that are clearly identifiable ex ante.
Danish: Sådanne foranstaltninger forventes derfor ikke at ville få nogen væsentlige socioøkonomiske og miljømæssige virkninger, som klart kan identificeres på forhånd.
English: (22) Food safety is a sensitive matter of prime interest for all Union citizens.
Danish: (22) Fødevaresikkerhed er et følsomt anliggende af største interesse for alle Unionens borgere.
English: It shall apply from [18 months after its entry into force], except for the following provisions:
Danish: Den anvendes fra den [18 months after its entry into force] bortset fra følgende bestemmelser:
English: framework 5 ‘Administrative expenditure'
Danish: ramme 5 "Administrationsudgifter"
English: Business and civil society stakeholders are of the same mind.
Danish: De interesserede parter fra erhvervslivet og civilsamfundet deler den opfattelse.
English: The proposal also provides for a better organisation of the Panels' work.
Danish: Forslaget giver også mulighed for en bedre tilrettelæggelse af panelernes arbejde.
English: (e) The Management Board shall ensure that the broadest possible geographical distribution is achieved in the final appointments.
Danish: e) Bestyrelsen sikrer, at der opnås den bredest mulige geografiske fordeling i forbindelse med de endelige udpegelser.
English: Since duly justified confidential information is protected, incentives for innovation should remain unchanged.
Danish: Eftersom behørigt begrundede fortrolige oplysninger beskyttes, bør incitamenterne til innovation forblive uændrede.
English: (a) Article 1(2) shall apply from 1st July 2022.
Danish: a) Artikel 1, stk. 2, anvendes fra den 1. juli 2022.
English: These controls shall be organised in cooperation with the competent authorities of the Member States.
Danish: Denne kontrol tilrettelægges i samarbejde med de kompetente myndigheder i medlemsstaterne.
English: The following factors have an impact on this:
Danish: Følgende faktorer har indflydelse på dette:
English: The findings of the evaluation shall be made public."
Danish: Resultaterne af evalueringen offentliggøres."
English: Those implementing acts shall be adopted in accordance with Article 58(2).
Danish: Sådanne gennemførelsesretsakter vedtages i overensstemmelse med artikel 58, stk. 2.
English: from candidate countries[46: Candidate countries and, where applicable, potential candidates from the Western Balkans.]
Danish: fra kandidatlande[46: Kandidatlande og, efter omstændighederne, potentielle kandidatlande på Vestbalkan.]
English: Transitions measures are provided.
Danish: Der fastsættes overgangsforanstaltninger.
English: It underlined that this lack should be addressed in future policy development, for instance by making better coordinated use of existing reporting requirements.
Danish: Det understregedes, at denne mangel bør tages op i forbindelse med kommende politiske udvikling, f.eks. ved at koordinere anvendelsen af de eksisterende indberetningskrav bedre.
English: In particular a series of measures will be put in place such as:
Danish: Navnlig vil der blive indført en række foranstaltninger, bl.a.:
English: The register shall be managed by the Authority.
Danish: Registret forvaltes af autoriteten.
English: - the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation;
Danish: - reglerne om omkostningers støtteberettigelse vil blive forenklet i overensstemmelse med finansforordningens bestemmelser
English: The regulatory regime on food safety needs to be strong to ensure its credibility and effectiveness.
Danish: Regelsættet inden for fødevaresikkerhed er nødt til at være stærkt for at sikre dets troværdighed og effektivitet.
English: Subsidiarity (for non-exclusive competence)
Danish: Nærhedsprincippet (for områder, der ikke er omfattet af enekompetence)
English: [51: Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and the European Fisheries Fund (EFF).]
Danish: [51: Angår især strukturfondene, Den Europæiske Landbrugsfond for Udvikling af Landdistrikterne (ELFUL) og Den Europæiske Fiskerifond (EFF).]
English: […] [XX.YY.YY.YY] […] […] YES/
Danish: […] [XX.YY.YY.YY] […] […] JA/
English: (e) be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.
Danish: e) være tilgængelig, også for dem, der ikke er direkte involveret i processen, idet der tages hensyn til fortrolighed og beskyttelse af personoplysninger.
English: (15) It is essential to ensure the efficient operation of the Authority and to improve the sustainability of its expertise.
Danish: (15) Det er vigtigt at sikre autoritetens effektive drift og forbedre bæredygtigheden af dens ekspertise.
English: Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be made public:
Danish: Uanset stk. 2 og 3 skal følgende oplysninger dog offentliggøres:
English: Implementation with a start-up period from 2020 to 2022
Danish: Iværksættelse med en indkøringsperiode fra 2020 til 2022
English: Moreover, a strict application of the rules on conflict of interests provided in the proposal will be ensured.
Danish: Derudover vil der blive sikret en stringent anvendelse af de bestemmelser om interessekonflikter, der er indeholdt i forslaget.
English: The impact in terms of costs and resources needed is mostly on EFSA.
Danish: Indvirkningen med hensyn til omkostninger og påkrævede ressourcer vil hovedsageligt berøre EFSA.
English: Added value of Union involvement (it may result from different factors, e.g. coordination gains, legal certainty, greater effectiveness or complementarities).
Danish: Merværdien ved en indsats fra EU's side (kan skyldes forskellige faktorer, f.eks. fordele ved koordination, retssikkerhed, større effektivitet eller komplementaritet).
English: framework 3 Security and Citizenship
Danish: ramme 3 Sikkerhed og unionsborgerskab
English: Direct management by the Commission through
Danish: Direkte forvaltning ved Kommissionen via
English: It is proportionate to harmonise these rules while preserving, where needed, the specific balance of interests in sectoral legislations.
Danish: Det er rimeligt at harmonisere disse regler og samtidig bevare, hvor det er nødvendigt, den specifikke afvejning af interesser i sektorspecifik lovgivning.
English: Public access to the dossiers
Danish: Offentlig adgang til dossiererne
English: Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council.
Danish: Disse beføjelser bør udøves i overensstemmelse med Europa-Parlamentets og Rådets forordning (EU) nr. 182/2011.
English: X bodies referred to in Articles 208 and 209;
Danish: X de organer, der er omhandlet i artikel 208 og 209
English: Risk communication is an essential part of the risk analysis process.
Danish: Risikokommunikation er en væsentlig del af risikoanalyseprocessen.
English: Setting up the EFSA has given Union measures a sounder scientific basis.
Danish: Oprettelsen af EFSA har givet Unionens foranstaltninger et mere solidt videnskabeligt grundlag.
English: (i) A high level of scientific expertise;
Danish: i) videnskabelig ekspertise på et højt niveau
English: Impact on the European Food Safety Authority (EFSA)
Danish: Indvirkning på Den Europæiske Fødevaresikkerhedsautoritet (EFSA)
English: Title 2: Infrastructure and operating expenditure Commitments (1a)
Danish: Afsnit 2: Infrastruktur- og driftsudgifter Forpligtelser (1a)
English: Payments (2a)
Danish: Betalinger (2 a)
English: In particular, there has been a decrease in the number of candidates applying to be members of the Scientific Panels.
Danish: Der har navnlig været et fald i antallet af personer, der ansøger om at blive medlemmer af ekspertpanelerne.
English: The results of all consultation activities are summarised in the synopsis report.
Danish: Resultaterne af alle høringerne er sammenfattet i den sammenfattende rapport.
English: from EFTA countries[45: EFTA: European Free Trade Association. ]
Danish: fra EFTAlande[45: EFTA: Den Europæiske Frihandelssammenslutning. ]
English: In parallel, the Commission's Scientific Advice Mechanism has been asked to prepare an opinion on the authorisation process of plant protection products.
Danish: Sideløbende hermed er Kommissionens mekanisme for videnskabelig rådgivning blevet bedt om at udarbejde en udtalelse om godkendelsesproceduren for plantebeskyttelsesmidler.
English: Activity: [General Food Law]
Danish: Aktivitet: [Den generelle fødevarelovgivning]
English: Policy area: [Food Safety]
Danish: Politikområde: [Fødevaresikkerhed]
English: "The number of members in each Scientific Panel within the maximum provided for in paragraph 5g.
Danish: "antallet af medlemmer i hvert af ekspertpanelerne inden for det maksimum, der er fastsat i stk. 5g".
English: However, issues of compliance with the applicable standards may arise in some cases and this is why national systems are in place to verify such compliance.
Danish: Der kan imidlertid i visse tilfælde opstå problemer med at overholde de gældende standarder, og derfor er der indført nationale systemer til verifikation af en sådan overholdelse.
English: The delegation of power referred to in Article 8(c) may be revoked at any time by the European Parliament or by the Council.
Danish: Den i artikel 8c omhandlede delegation af beføjelser kan til enhver tid tilbagekaldes af Europa-Parlamentet eller Rådet.
English: Those items referred to in the first subparagraph shall be made public on a dedicated section of the Authority's website.
Danish: De punkter, der er omhandlet i første afsnit, offentliggøres i et særligt afsnit på autoritetens websted.
English: (a) the name and address of the applicant;
Danish: a) ansøgerens navn og adresse
English: Citizens demand that the risk assessment process in the area of food law (and the decision-making based on it) be more transparent.
Danish: Borgerne efterspørger, at risikovurderingsprocessen inden for fødevarelovgivningen (og beslutningstagningen baseret på den) skal være mere gennemsigtig.
English: 1) improve and clarify the rules on transparency
Danish: 1) at forbedre og præcisere reglerne om gennemsigtighed
English: The estimated impact on expenditure and staffing for the years 2021 and beyond in this legislative financial statement is added for illustrative purpose and does not pre-judge the next multiannual financial framework.
Danish: Den anslåede virkning for udgifterne og personalet fra 2021 og fremover i denne finansieringsoversigt er tilføjet som illustration og foregriber ikke den næste flerårige finansielle ramme.
English: (c) information on the complete composition of a plant protection product.
Danish: c) oplysninger om et plantebeskyttelsesmiddels komplette sammensætning."
English: The reasons underlying differences in the assessments and conclusions of scientific bodies should be better communicated to the public in order to facilitate their understanding.
Danish: De underliggende årsager til forskelle i vurderinger og konklusioner fra videnskabelige organer bør formidles bedre til offentligheden, således at de bliver lettere at forstå.
English: (19) In the case of applications to request the renewal of an authorisation, the authorised substance or product has already been on the market for several years.
Danish: (19) Ved ansøgninger om fornyelse/forlængelse af en godkendelse har det godkendte stof eller produkt allerede været på markedet i flere år.
English: To ensure the transparency of this process, the advice of the Authority should be made public.
Danish: For at sikre denne proces' åbenhed bør autoritetens rådgivning offentliggøres.
English: Please note that inflation adjustments to the figures mentioned in the tables below, need to be considered as from the year 2023 onwards.
Danish: Bemærk venligst, at inflationsjusteringer af tallene i nedenstående tabeller må påregnes fra 2023 og fremefter.
English: The Commission shall report to the European Parliament, the Council and the Management Board on the evaluation findings.
Danish: Kommissionen aflægger rapport til Europa-Parlamentet, Rådet og bestyrelsen om resultaterne af evalueringen.
English: Further measures should also be put in place to ensure that scientific experts have the means to act independently.
Danish: Der bør ligeledes indføres yderligere foranstaltninger for at sikre, at de videnskabelige eksperter har midlerne til at handle uafhængigt.
English: (g) the annual report of its activities;
Danish: g) den årlige aktivitetsberetning
English: [2: Food law authorisations cover different subject matters: substances, products, health claims and processes but for the ease of reading, the reference to substances in the text covers all.]
Danish: [2: Godkendelser i henhold til fødevarelovgivningen omfatter forskellige emner (stoffer, produkter, sundhedsanprisninger og processer), men for at lette læsningen dækker henvisningen til stoffer i teksten dem alle.]
English: (25) It is therefore necessary to strengthen the transparency of the risk assessment process in a proactive manner.
Danish: (25) Det er derfor nødvendigt at styrke åbenheden i risikovurderingsprocessen på en proaktiv måde.
English: Type[47: Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).]
Danish: Type[47: Resultater er de produkter og tjenesteydelser, der skal leveres (f.eks. antal finansierede studenterudvekslinger, antal km bygget vej osv.).]
English: This is because companies going to laboratories outside the Union would take the risk to be perceived as evading the rules.
Danish: Dette skyldes, at virksomheder, der benytter laboratorier uden for Unionen, ville risikere, at dette opfattes som omgåelse af reglerne.
English: X The proposal is compatible with the current multiannual financial framework and may entail the use of special instruments as defined in Council Regulation (EU, Euratom) No 1311/2013.
Danish: X Forslaget er foreneligt med indeværende flerårige finansielle ramme, men kan medføre anvendelse af særlige instrumenter som anført i Rådets forordning (EU, Euratom) nr. 1311/2013.
English: In addition to members and alternate members referred to in paragraph 1, the Management Board shall include:
Danish: Ud over de medlemmer og suppleanter, der er omhandlet i stk. 1, omfatter bestyrelsen:
English: This should have a positive impact since experience from other Union agencies demonstrates that this model ensures efficient supervision of the functioning of agencies and coordinated views between the Union and national level.
Danish: Dette burde få en positiv effekt, idet erfaringerne fra andre EU-agenturer viser, at denne model sikrer effektiv overvågning af agenturernes funktion og koordinering af synspunkter på henholdsvis EU-plan og nationalt plan.
English: (h) requests from the European Parliament, the Commission or a Member State for scientific opinions which have been refused or modified and the justifications for the refusal or modification.
Danish: h) anmodninger fra Europa-Parlamentet, Kommissionen eller en medlemsstat om ekspertudtalelser, som er blevet afslået eller ændret samt begrundelserne for afslaget eller ændringen
English: N° of requests for access to documents addressed to EFSA and the Commission.
Danish: Antal anmodninger om aktindsigt til dokumenter, der er sendt til EFSA og Kommissionen.
English: Not later than five years after the date referred to in Article [entry into force of the Regulation amending the GFL], and every five years thereafter, the Commission shall assess the Authority's performance in relation to its objectives, mandate, tasks, procedures and location, in accordance with Commission guidelines.
Danish: Senest fem år efter den dato, der henvises til i artikel [entry into force of the Regulation amending the GFL], og derefter hvert femte år vurderer Kommissionen autoritetens resultater i forhold til dens mål, mandat, opgaver og placering i overensstemmelse med Kommissionens retningslinjer.
English: The main objectives of this initiative are to update the GFL Regulation so as to:
Danish: Hovedformålet med dette initiativ er at ajourføre forordningen om fødevarelovgivning med henblik på:
English: (f) ensure appropriate exchange of information with interested parties in relation to risks associated with the agri-food chain.
Danish: f) sikre en passende udveksling af oplysninger med interesserede parter med hensyn til de risici, der er forbundet med fødevarekæden.
English: (a) ensure that accurate, appropriate and timely information is interactively exchanged, based on the principles of transparency, openness, and responsiveness;
Danish: a) sikre, at nøjagtige, hensigtsmæssige og rettidige oplysninger udveksles interaktivt på grundlag af principperne om gennemsigtighed, åbenhed og imødekommenhed
English: (c) four members with the right to vote representing civil society and food chain interests namely, one from consumers organisations, one from environmental non-governmental organisations, one from farmers organisations and one from industry organisations.
Danish: c) fire medlemmer med stemmeret, der repræsenterer civilsamfundet og interesser i fødevarekæden, dvs. et medlem fra forbrugerorganisationer, et fra ikkestatslige organisationer på miljøområdet, et fra landbrugsorganisationer og et fra brancheorganisationer.
English: Member States appreciate that the challenges in relation to food safety, in an environment with very high levels of trade and a complex food supply chain, require a strong Union regulatory system.
Danish: Medlemsstaterne anerkender, at udfordringerne i tilknytning til fødevaresikkerhed i en situation med meget omfattende handel og en kompleks fødevareforsyningskæde kræver et stærkt regelsæt på EU-plan.
English: SPECIFIC OBJECTIVE No 2 .
Danish: Specifikt mål nr.
English: Its primary mission is to provide scientific advice at the request of the Commission, Member States and the European Parliament and on its own motion.
Danish: Dets hovedopgave er at yde videnskabelig rådgivning både på anmodning af Kommissionen, medlemsstaterne og Europa-Parlamentet og på eget initiativ.
English: There are no negative impacts in the duration of authorisation procedures since this is a parallel activity.
Danish: Der er ingen negative virkninger på godkendelsesprocedurernes varighed, idet der er tale om en parallel aktivitet.
English: The current term of office of the Scientific Committee and Panel members shall be prolonged until that date.
Danish: Den nuværende mandatperiode for medlemmerne af det videnskabelige udvalg og ekspertpanelet forlænges indtil denne dato.
English: It ensures that action can be taken at Union level where there are exceptional circumstances of serious controversies or conflicting results.
Danish: Dette sikrer, at der kan træffes foranstaltninger på EU-plan i tilfælde af ekstraordinære omstændigheder med alvorlig uenighed eller modstridende resultater.
English: Please indicate the planned recruitment date and adapt the amount accordingly (if recruitment occurs in July, only 50 % of the average cost is taken into account) and provide further explanations in an annex.
Danish: Det planlagte ansættelsestidspunkt angives, beløbet tilpasses i overensstemmelse hermed (hvis ansættelsen finder sted i juli, opføres kun 50 % af de gennemsnitlige udgifter), og der redegøres nærmere i et bilag.
English: The notification obligation under paragraph 1, also applies to Union laboratories carrying out those studies.
Danish: Underretningspligten i henhold til stk. 1 gælder også EU-laboratorier, der gennemfører disse undersøgelser.
English: There should be no negative impact for innovation from the measures on the reliability and robustness of studies.
Danish: Der påregnes ingen negative virkninger for innovationen fra foranstaltningerne på undersøgelsernes pålidelighed og robusthed.
English: In addition to monitoring compliance, DG SANTE identifies and disseminates good practices in collaboration with the agencies.
Danish: Foruden overvågning af overholdelsen fastlægger og udbreder GD SANTE god praksis i samarbejde med agenturerne.
English: That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Danish: Fristen forlænges med to måneder på Europa-Parlamentets eller Rådets initiativ."
English: The Commission shall adopt the general plan for risk communication within [two years from the date of application of this Regulation] and shall keep it updated, taking into account technical and scientific progress and experience gained.
Danish: Kommissionen vedtager den generelle plan for risikokommunikation senest den [two years from the date of application of this Regulation] og holder den ajourført, idet der tages hensyn til den tekniske og videnskabelige udvikling og de opnåede erfaringer."
English: It has also strengthened the cooperation with national and international scientific bodies as well as the exchange of information between Member States, the Commission and EFSA itself.
Danish: Den har også styrket samarbejde med nationale og internationale videnskabelige organer og udvekslingen af oplysninger mellem medlemsstaterne, Kommissionen og EFSA.
English: They also seriously undermined public confidence in the Union food safety regulatory framework.
Danish: De har også undergravet befolkningens tillid til EU's lovgivningsmæssige rammer for fødevaresikkerhed.
English: [43: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
Danish: [43: Forklaringer vedrørende forvaltningsmetoder og henvisninger til finansforordningen findes på webstedet BudgWeb: https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx.]
English: A number of impacts were however considered during the preparation process as follows:
Danish: En række konsekvenser blev imidlertid taget i betragtning i forberedelsesprocessen.
English: (f) its scientific studies in accordance with Articles 32 and 32e;
Danish: f) sine videnskabelige undersøgelser i overensstemmelse med stk. 32 og 32e
English: Access shall be based at the minimum on a system requiring two factor authentication or providing an equivalent level of security.
Danish: Adgangen skal som minimum være baseret på et system, der kræver tofaktorautentificering, eller som giver et tilsvarende sikkerhedsniveau.
English: Globally, all these measures will also contribute to an increased involvement of stakeholders in the risk assessment system and thus to a more effective risk communication.
Danish: Globalt set vil alle disse foranstaltninger også bidrage til en øget inddragelse af interessenter i risikovurderingssystemet og dermed til en mere effektiv risikokommunikation.
English: (e) promote appropriate involvement of all interested parties; and,
Danish: e) fremme en passende inddragelse af alle interesserede parter og
English: EFSA has in place and strictly monitors its rules on "independence" and "conflict of interest"; Control method(s) envisaged
Danish: EFSA har indført og overvåger nøje sine regler om "uafhængighed" og "interessekonflikt"; Påtænkt(e) kontrolmetode(r)
English: Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY
Danish: Forslag/initiativ gældende fra [DD/MM]ÅÅÅÅ til [DD/MM]ÅÅÅÅ
English: To address these issues, the Commission has come up with a wide ranging and ambitious proposal requiring a significant increase in the resources available to the EFSA to enable it to discharge its existing and proposed new responsibilities.
Danish: For at behandle disse emner har Kommissionen udarbejdet et vidtrækkende og ambitiøst forslag, der vil kræve en væsentlig forhøjelse af bevillingerne til EFSA, for at den skal kunne varetage sine eksisterende og foreslåede nye ansvarsområder.
English: The fourth measure provides for controls and audits by Commission inspectors in relation to studies.
Danish: Den fjerde foranstaltning fastsætter, at Kommissionens inspektører foretager kontrol og audit i forbindelse med undersøgelser.
English: Fundamental rights
Danish: Grundlæggende rettigheder
English: Member States were consulted in a meeting of the Expert Group on the General Food Law on 5 March 2018.
Danish: Medlemsstaterne blev hørt på et møde i ekspertgruppen om den generelle fødevarelovgivning den 5. marts 2018.
English: (a) Where urgent action is essential to protect public health, animal health or the environment, such as in emergency situations, the Authority may disclose the information referred to paragraphs 2 and 3; and,
Danish: a) Hvis en øjeblikkelig indsats er vigtig for at beskytte folkesundheden, dyresundheden eller miljøet, f.eks. i nødsituationer, kan autoriteten offentliggøre de oplysninger, der er omhandlet i stk. 2 og 3, og
English: As quickly as possible and within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint those members.
Danish: Hurtigst muligt og inden tre måneder efter fremsendelsen kan Europa-Parlamentet tilkendegive sin holdning over for Rådet, der herefter udpeger disse medlemmer.
English: European stakeholder organisations representing farmers, cooperatives, the food industry, retailers, consumers, professionals and civil society were consulted at an ad hoc meeting of the Advisory Group on the Food Chain, Animal and Plant Health on 5 February 2018.
Danish: Europæiske interesseorganisationer, der repræsenterer landbrugere, kooperativer, fødevareindustrien, detailhandlere, forbrugere, fagfolk og civilsamfundet, blev hørt på et ad hoc-møde i Den Rådgivende Gruppe for Fødevarekæden, Dyresundhed og Plantesundhed den 5. februar 2018.
English: At the same time, the proposal is expected to ensure the long-term sustainability of EFSA's capacity of scientific expertise.
Danish: Samtidig forventes forslaget at sikre den langsigtede bæredygtighed af EFSA's videnskabelige ekspertise.