FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety of veterinary medicines in the post-authorisation phase and the need to implement and further improve a risk-management approach to this important issue will continue to be a high priority for the Agency in 2007.
Danish: Veterinærlægemidlers sikkerhed i fasen efter godkendelse og behovet for at gennemføre og yderligere forbedre en risikostyringsstrategi vedrørende dette vigtige emne vil forsat være et vigtigt prioriteret indsatsområde for agenturet i 2007.
English: To this end, the Agency has established a working group with healthcare professionals, which will prepare a framework for interaction with healthcare professionals' organisations.
Danish: Agenturet har til det formål nedsat en arbejdsgruppe bestående af sundhedspersonale, som har til opgave at udarbejde rammerne for interaktion med organisationer for sundhedspersonale.
English: The number of referrals triggered by safety concerns where there is a Community interest is expected to remain low, with only 1 predicted for 2007.
Danish: Antallet af henvisninger af sager, som skyldes sikkerhedshensyn, og som er af interesse for Fællesskabet, forventes at forblive lavt, med kun 1 i 2007.
English: The Agency expects to complete the remaining internal evaluation work and follow-up with new Member States in the context of the EC-Canada MRA, which will now include Bulgaria and Romania.
Danish: Agenturet forventer at færdiggøre de resterende interne vurderinger og opfølgning med nye medlemsstater inden for rammerne af den gensidige anerkendelsesaftale mellem EU og Canada, som nu også omfatter Bulgarien og Rumænien.
English: 5.3 Meetings and conferences at the EMEA
Danish: 5.3 Møder og konferencer i EMEA
English: The Agency will also liaise with responsible US institutions to exchange relevant information on veterinary medicines.
Danish: Agenturet vil også skabe kontakt til de ansvarlige institutioner i USA med henblik på udveksling af relevante informationer om veterinærlægemidler.
English: PIM (Product Information Management) (In pilot production)
Danish: PIM (produktinformationsstyring) (under udvikling som pilotprojekt)
English: Work will continue on implementing the vision outlined in the long-term strategies prepared by the EMEA and the national competent authorities.
Danish: Arbejdet med at gennemføre den vision, der er fastlagt i de langsigtede strategier, som er udarbejdet af EMEA og de nationale kompetente myndigheder, fortsættes.
English: To further advance the implementation of the revised legislation, the procedure for monitoring the actual placing on the market of authorised products will be implemented.
Danish: For yderligere at fremme gennemførelsen af den reviderede lovgivning vil proceduren for overvågning af godkendte produkters faktiske markedsføring blive gennemført.
English: The Agency will participate in the multi-beneficiary programme dedicated to supporting the participation of Croatia and Turkey in the work of certain Community agencies.
Danish: Agenturet vil deltage i flerlandeprogrammet, som har til formål at fremme Kroatiens og Tyrkiets deltagelse i visse EU-agenturers arbejde.
English: The office aims to facilitate communication with SMEs through dedicated personnel within the agency who will respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs.
Danish: Kontoret har til formål at lette kommunikationen med SMV'er gennem agenturets dedikerede personale, som besvarer praktiske eller proceduremæssige spørgsmål, overvåger ansøgninger og organisere workshopper og uddannelsesforløb for SMV'er.
English: However, the achievement of these targets is critically dependent on the availability of adequate bibliographic data and on resources made available at NCA level to support their review.
Danish: Opfyldelsen af disse mål afhænger imidlertid i høj grad af adgangen til relevante bibliografiske data og af de ressourcer, der stilles til rådighed på NCA-niveau til at gennemgå disse data.
English: It also deals with other emerging therapies and new technologies that are not within the scope of the upcoming regulation on advanced therapies and which will strongly influence the Agency's work in this field.
Danish: Det beskæftiger sig også med nye behandlingsformer og teknologier, som ikke er omfattet af den kommende forordning om avancerede behandlingsformer, og vil øve store indflydelse på Agenturet's arbejde indenfor dette område.
English: The number of meetings and increasing number of staff due to the growing responsibilities of the Agency made it necessary for the Agency to acquire additional office space in 2006.
Danish: Det stigende antal møder og det øgede antal ansatte som følge af agenturets nye ansvarsområder skabte i 2006 behov for større kontorlokaler.
English: The Agency will continue its successful and useful cooperation with the FDA and will introduce measures to deepen this cooperation by consolidating procedures for parallel scientific advice.
Danish: Agenturet vil videreføre sit velfungerende og nyttige samarbejde med FDA og indføre foranstaltninger til uddybning af dette samarbejde ved at konsolidere procedurerne for parallel videnskabelig rådgivning.
English: The Agency expects a significant increase in the number of arbitration and referral procedures in particular in the number of Article 29 arbitrations (relating to difference in opinions at the Member State level).
Danish: Agenturet forventer en markant stigning i antallet af voldgifter og henvisningsprocedurer, særlig inden for antallet af voldgifter i medfør af artikel 29 (om forskelle i medlemsstaternes udtalelser).
English: Conference, as well as work with the World Health Organization (for example, on medicinal products for use in developing countries), the Codex Alimentarius, the World Organisation for Animal Health, the US Food and Drug Administration (FDA) and the US Department of Agriculture.
Danish: ICH-konference samt samarbejde med Verdenssundhedsorganisationen (f.eks. om lægemidler til brug i udviklingslande), Codex Alimentarius, Verdensorganisationen for Dyresundhed, US Food and Drug Administration (FDA) og det amerikanske landbrugsministerium.
English: The large number of applications received in 2006 will have a significant impact on the workload in 2007 since procedures run over several months.
Danish: De mange ansøgninger, som blev indsendt i 2006, har stor betydning for arbejdsbyrden i 2007, eftersom procedurerne kan strække sig over flere måneder.
English: A production system is anticipated that will be able to make available sets of controlled terms, subject to the establishment of a formal process for the control of such terms.
Danish: Der er planer om et produktionssystem, som kan give adgang til udvalgte termer under forudsætning af, at der indføres en formel proces til kontrol af disse termer.
English: Special EU contribution for orphan medicinal products 6,110 5.59 7,400 5.34 6,000 3.88 Contribution from EEA
Danish: Særligt EU-tilskud til lægemidler til sjældne sygdomme 6 110 5,59 7 400 5,34 6 000 3,88 Bidrag fra EØS
English: Close collaboration between the EMEA, the European Directorate for the Quality of Medicines and the national authorities in the programme continues to prove invaluable in assuring effective and continued post-marketing surveillance of the quality of medicines.
Danish: Et tæt samarbejde mellem EMEA, Det Europæiske Direktorat for Lægemiddelkvalitet og de nationale myndigheder i forbindelse med programmet er fortsat af uvurderlig betydning med hensyn til at sikre en effektiv og løbende overvågning af lægemidlers kvalitet efter markedsføring.
English: A significant task for the Agency in 2007 is to implement the paediatric medicines regulation by ensuring effective cooperation between the Scientific Advice Working Party and the new Paediatric Committee.
Danish: En vigtig opgave for agenturet i 2007 bliver at gennemføre forordningen om pædiatriske lægemidler ved at sikre et effektivt samarbejde mellem arbejdsgruppen vedrørende videnskabelig rådgivning og det nye pædiatriske udvalg.
English: In addition to the new tools we have already implemented, we want to work with Member State authorities and academic centres on establishing networks of experts to run intensive drug-monitoring programmes that will actively study the safety of targeted medicines.
Danish: Ud over de nye redskaber, vi allerede har implementeret, ønsker vi at samarbejde med medlemsstaternes myndigheder og akademiske centre om oprettelse af ekspertnetværk, der skal stå for intensive lægemiddelovervågningsprogrammer, som har til formål aktivt at undersøge sikkerheden vedrørende målrettede lægemidler.
English: The number of submissions for scientific advice for veterinary medicines will increase to 16 for 2007.
Danish: Antallet af anmodninger om videnskabelig rådgivning vedrørende veterinærlægemidler vil i 2007 stige til 16.
English: Firstly, the Agency will further improve the EudraVigilance database and individual case safety reporting.
Danish: For det første, vil Agenturet forbedre EudraVigilance-databasen og sikkerhedsrapporteringen i de enkelte sager.
English: During 2007, it is anticipated that the high-level design will be completed, that the system will be prototyped, and that work on the first production version will be initiated.
Danish: Det forventes, at det højt specialiserede design er færdigt i løbet af 2007, at systemet kan laves som prototype, og at arbejdet med den første produktionsversion påbegyndes.
English: Document management and publishing Meeting management and conferences Project management
Danish: Styring og offentliggørelse af dokumenter Mødestyring og konferencer Projektstyring
English: The Agency will introduce additional information-technology tools to track applications for veterinary scientific advice, and will measure the level of satisfaction with the new procedure in order to make additional improvements, if needed.
Danish: Agenturet vil indføre supplerende informationsteknologiske redskaber til sporing af anmodninger om videnskabelig rådgivning vedrørende veterinærlægemidler, og det vil måle tilfredsheden med den nye procedure, så det om nødvendigt kan foretage yderligere forbedringer.
English: In addition, it will develop the concept of the ‘multistrain' dossier to promote authorisation of vaccines against antigenically variable viruses such as avian influenza, bluetongue and foot-and-mouth disease.
Danish: Det vil desuden udvikle et "flerstammet" dossier til fremme af godkendelser af vacciner mod antigent variable vira som f.eks. fugleinfluenza, bluetongue og mund- og klovesyge.
English: The Agency forecasts the number of serious adverse reaction reports will rise to well over 400, with 64 PSURs4 being submitted (54 were submitted in 2006).
Danish: Agenturet forudser, at antallet af indberetninger om alvorlige bivirkninger vil stige til over 400, og at der vil blive indsendt 64 PSUR'er4 (mod 54 i 2006).
English: − Operate and increase the effectiveness of marketing authorisation procedures for facilitating availability of medicines, while maintaining the highest quality standards.
Danish: − Gennemføre samt øge effektiviteten af markedsføringstilladelsesprocedurerne til fremme af adgangen til lægemidler samtidig med, at de højeste kvalitetsstandarder bevares.
English: It will continuously assess the prioritisation of projects and activities to accommodate a considerably increased volume of activity, and effect improvements where necessary to ensure that high standards are maintained.
Danish: Det vil fortsat vurdere prioriteringen af projekter og aktiviteter for at muliggøre en væsentlig stigning i aktiviteterne og udvirke forbedringer på de områder, hvor det er nødvendigt for at sikre opretholdelse af høje standarder.
English: − Strengthen cooperation on pharmacovigilance, EU telematics, scientific advice, support to SMEs and communication;
Danish: − Styrkelse af samarbejdet omkring lægemiddelovervågning, EU's telematikstrategi, videnskabelig rådgivning, støtte til SMV'er og kommunikation
English: Availability or lack thereof will have a direct impact on the productivity of the HMPC in 2007 and beyond.
Danish: Denne adgang vil have direkte betydning for HMPC's produktivitet i 2007 og frem.
English: In addition to four outsourced contracts (switchboard/reception; audiovisual technicians; security guarding; and catering), the Agency will consider outsourcing reprographics and ancillary services in 2007.
Danish: Ud over fire udliciterede kontrakter (omstilling/reception, audiovisuelle teknikere, sikkerhedsvagter og catering) overvejer agenturet at udlicitere reprografiske og dertil knyttede tjenester i 2007.
English: The Agency expects that a total of 13 arbitrations/referrals will be submitted to the CVMP in 2007three more than in 2006 - including twelve referrals following mutual recognition and decentralised procedures.
Danish: Agenturet forventer, at der i alt vil blive indsendt 13 voldgifts-/henvisningssager til CVMP i 2007, hvilket er tre mere end i 2006, herunder 12 henvisninger som følge af gensidige anerkendelsesprocedurer eller decentraliserede procedurer.
English: − Further implement the EMEA transparency measures and increase the openness of the Agency's activities to underpin its corporate governance;
Danish: − Yderligere gennemførelse af EMEA's gennemsigtighedsforanstaltninger og etablering af større åbenhed omkring agenturets aktiviteter for at understøtte dets selskabsledelse ("corporate governance")
English: − Continue to apply a proactive approach to safety of medicines by initiating early assessment of the safety prior to authorisation, by monitoring implementation of risk-management plans after marketing authorisation, and by supervising the updating of such plans throughout the lifecycle of the product;
Danish: − Fortsat anvendelse af en proaktiv tilgang til lægemiddelsikkerhed ved at foretage en tidlig vurdering af sikkerheden inden godkendelse, ved at kontrollere gennemførelsen af risikostyringsplaner efter tildeling af markedsføringstilladelse og ved at overvåge opdateringen af disse planer i løbet af hele produktets livscyklus
English: EudraCT-Paediatrics Database (At inception)
Danish: EudraCT-Paediatrics Database (ved at blive indført)
English: Subject to successful conclusion of pilot activities for both new marketing authorisation applications and post-authorisation activities, the system will go into full production during the year.
Danish: Hvis pilotaktiviteterne for både de nye ansøgninger om markedsføringstilladelser og aktiviteter efter godkendelse er en succes, vil systemet blive sat i produktion i løbet af året.
English: One or two new releases of both the review and light authoring systems are anticipated.
Danish: Der forventes at blive frigivet to nye udgaver af både revisions- og forfattersystemerne.
English: The Agency expects that the overall number of applications for veterinary medicinal products will remain at around 14 applications in 2007.
Danish: Agenturet forventer, at det samlede antal ansøgninger for veterinærlægemidler vil forblive på cirka 14 ansøgninger i 2007.
English: The detection, evaluation and tracking of potential safety issues will be reinforced through the availability of the EudraVigilance Data Warehouse and Analysis System.
Danish: Detektering, evaluering og sporing af potentielle sikkerhedsproblemer vil blive styrket gennem adgangen til EudraVigilance datawarehousing og analysesystem.
English: The strategy aims to increase efficiency and enhance transparency, and to support and facilitate the operation of procedures established by legislation.
Danish: Denne strategi har til formål at øge effektiviteten og gennemsigtigheden samt støtte og fremme anvendelsen af de procedurer, der er indført i medfør af lovgivningen.
English: * With the implementation of the mandatory electronic reporting of ICSRs and the EudraVigilance Data Warehouse and Analysis System, a new method has been developed to present the number of ICSRs received/expected over time.
Danish: * Sammen med indførelsen af den obligatoriske elektroniske indberetning af ICSR og EudraVigilance datawarehousing og analysesystem er der udviklet en ny metode til fremlæggelse af det antal ICSR, der er modtaget/forventes indsendt over en vis periode.
English: Work will continue on improving the cost-effectiveness of arrangements for working parties, including a review of their mandates, the distribution of work, and the support provided by the secretariat.
Danish: Der vil fortsat blive arbejdet på at forbedre omkostningseffektiviteten i forbindelse med arbejdsgruppernes arrangementer, herunder en evaluering af deres mandater, arbejdsdelingen og sekretariatets støtte.
English: EudraGMP (In final testing)
Danish: EudraGMP (i sidste afprøvning)
English: In addition to evaluation of applications for MRLs, the Agency will provide assistance to the Commission with the review of Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of MRLs for veterinary medicinal products in foodstuffs of animal origin.
Danish: Ud over at vurdere ansøgninger om MRL vil agenturet bistå Kommissionen med at revidere forordning (EØF) nr. 2377/90 om fastsættelse af maksimalgrænseværdier for restkoncentrationer af veterinærmedicinske præparater i animalske levnedsmidler.
English: 3.3 Sampling and testing
Danish: 3.3 Stikprøveudtagning og afprøvning
English: − Further stimulate complementarities in the network and develop adequate work-sharing and resource-planning activities across the network;
Danish: − Yderligere fremme af komplementariteten i netværket samt udvikling af en passende arbejdsdeling og aktiviteter til ressourceplanlægning over netværket
English: Plasma master file (PMF).
Danish: Masterfiler vedrørende plasma (Plasma master file (PMF)).
English: The Agency establishes maximum residue limits (MRLs) for pharmacologically active substances used in veterinary medicinal products, to provide for the safe use of foodstuffs of animal origin, including meat, fish, milk, eggs and honey.
Danish: Agenturet fastsætter maksimale grænseværdier for restkoncentrationer (MRL) for farmakologisk aktive stoffer i veterinærmedicinske præparater for at garantere sikker brug af animalske levnedsmidler, herunder kød, fisk, mælk, æg og honning.
English: The Agency issues certificates of medicinal products to support the work of health authorities outside the European Union, in particular in developing countries.
Danish: Agenturet udsteder certifikater for lægemidler for at støtte sundhedsmyndigheder i lande uden for EU, navnlig i udviklingslandene.
English: It will also address aspects relating to data quality and stakeholders' compliance with expedited reporting timelines.
Danish: Det vil desuden behandle forhold vedrørende datakvalitet og de berørte parters overholdelse af fremskyndede indberetningsfrister.
English: 5.1 Infrastructure services at the EMEA
Danish: 5.1 Infrastrukturtjenester i EMEA
English: This intensification must be supported by improved cost-effectiveness of the Agency's operations and further improvement of its quality assurance systems.
Danish: Denne intensivering skal understøttes af en forbedret omkostningseffektivitet i forbindelse med agenturets aktiviteter og yderligere forbedringer af dets kvalitetssikringssystemer.
English: Regular releases throughout the year are foreseen, putting into place reporting against the requested pre-defined queries for pharmacovigilance (in respect of both human and veterinary products).
Danish: Løbende frigivelser i løbet af året med indførelse af indberetninger på grundlag af de foruddefinerede spørgsmål vedrørende lægemiddelovervågning (både med hensyn til human- og veterinærmedicinske lægemidler).
English: The Agency expects that the number of applications in the post-authorisation area of veterinary medicines will remain largely unchanged.
Danish: Agenturet forventer, at antallet af ansøgninger vedrørende veterinærlægemidler i fasen efter godkendelse vil forblive stort set uændret.
English: The Agency will continue its work in respect of, and maintain readiness for, a potential influenza pandemic, including through training and simulation activities and measures to promote the authorisation through the centralised procedure of safe and effective vaccines for control of avian influenza in birds.
Danish: Agenturet vil fortsætte sit arbejde og holde sig i beredskab for så vidt angår en potentiel influenzapandemi, bl.a. gennem uddannelses- og simuleringsaktiviteter og foranstaltninger til at fremme godkendelse via den centraliserede procedure af sikre og effektive vacciner mod fugleinfluenza.
English: Innovation and research are the primary driving forces for new medicines, and, consequently, motors for improved public and animal health.
Danish: Innovation og forskning er de vigtigste drivkræfter bag nye lægemidler og medvirker dermed også til at fremme folke- og dyresundheden.
English: The Agency will take part in the work of the Pharmaceutical Forum, and will continue the development of the EudraPharm database, containing information about centrally authorised products.
Danish: Agenturet vil deltage i lægemiddelforummets arbejde og fortsætte udviklingen af EudraPharmdatabasen, som indeholder oplysninger om centralt godkendte produkter.
English: The number of type-I and II variations will change in line with the growing number of centrally authorised products.
Danish: Der vil komme flere type I- og II-ændringer som følge af det stigende antal centralt godkendte lægemidler.
English: The Agency is facing a steady intensification of activities relating to the evaluation and supervision of medicinal products.
Danish: Agenturet står over for at skulle intensivere sine aktiviteter vedrørende evaluering og overvågning af lægemidler.
English: In addition to its evaluation of orphan-designation applications, the Agency will collaborate with international partners, particularly through increased provision of protocol assistance in parallel with the US Food and Drug Administration.
Danish: Ud over agenturets evaluering af ansøgninger om udpegelse af lægemidler til sjældne sygdomme vil det samarbejde med internationale partnere, navnlig gennem øget protokolbistand parallelt med US Food and Drug Administration.
English: − Support further initiatives, once identified, to facilitate greater availability of veterinary medicines, particularly through measures to assist companies submitting applications for veterinary medicines which have limited markets or which are intended for diseases with regional distribution.
Danish: − Støtte til yderligere initiativer, så snart de er identificeret, for at fremme en bedre adgang til veterinærlægemidler, navnlig gennem foranstaltninger til at hjælpe virksomheder med at indsende ansøgninger vedrørende veterinærlægemidler, som der kun er et begrænset marked for, eller som er beregnet til regionalt udbredte sygdomme.
English: Scientific advice and protocol assistance are key areas of activity for the Agency, in particular with respect to fostering new innovative technologies and therapies and as a means to facilitate and improve earlier availability of medicinal products.
Danish: Videnskabelig rådgivning og protokolbistand er blandt agenturets hovedaktiviteter, navnlig for så vidt angår udvikling af nye innovative teknologier og behandlingsformer og som redskab til at fremme og forbedre en tidligere adgang til lægemidler.
English: By developing these initiatives, the EMEA aims to promote the appropriate use of medicines and further contribute to patient safety.
Danish: EMEA ønsker gennem udviklingen af disse initiativer at fremme en hensigtsmæssig anvendelse af lægemidler og yderligere bidrage til patientsikkerheden.
English: The level of access will take into account the requirement to guarantee personal data protection as well as the commercial confidentiality of some of the data stored in EudraVigilance.
Danish: Adgangsniveauet skal fastsættes i henhold til kravet om beskyttelse af personoplysninger samt fortroligheden af de kommercielle data, der er gemt i EudraVigilance.
English: It will develop, with the Commission and Member States, guidelines for transparency of the paediatric clinical-trials database.
Danish: Det vil i samarbejde med Kommissionen og medlemsstaterne udarbejde retningslinjer for gennemsigtighed i databasen over kliniske pædiatriske undersøgelser).