FrancophonIA/ELRC3.0 huggingface dataset:
English: I would like to begin by congratulating the Executive Director, his staff, the scientific committees and all working parties for their outstanding performance in 2006.
Danish: Jeg vil gerne indlede med at lykønske den administrerende direktør, personalet, de videnskabelige udvalg og alle arbejdsgrupper for deres fremragende indsats i 2006.
English: The decisions and actions arising from the management review are incorporated in planning directives, annual work programme and budget.
Danish: De beslutninger og handlinger, som følger af ledelsesrevisionen, er indføjet i planlægningsdirektiverne, det årlige arbejdsprogram og budgettet.
English: Other initiatives for improving the safety of veterinary medicines included:
Danish: Øvrige initiativer til forbedring af veterinærlægemidlers sikkerhed omfattede:
English: Average assessment time quicker than in 2005
Danish: Kortere gennemsnitlig vurderingstid end i 2005
English: These monographs were released for public consultation prior to being finalised.
Danish: Disse monografier blev frigivet til offentlig høring, inden den endelige færdiggørelse.
English: The network is in place, connecting regulatory authorities in the European Economic Area, including the two new EU Member States, Bulgaria and Romania.
Danish: Netværket er på plads og forbinder tilsynsmyndighederne i Det Europæiske Økonomiske Samarbejdsområde, herunder de to nye EU-medlemsstater Bulgarien og Rumænien.
English: 1.3 Information and communication
Danish: 1.3 Information og kommunikation
English: These products potentially benefit some 1.6 million European patients suffering from 24 different rare conditions.
Danish: Disse lægemidler kan hjælpe omkring 1,6 millioner patienter i EU, som lider af 24 forskellige sjældne sygdomme.
English: EMEA/88802/2007/EN/FINAL
Danish: EMEA/230189/2007/DA/ENDELIG
English: Monitoring the new legal tools relating to risk-management, in particular risk-management plans.
Danish: Overvågning af de nye retlige redskaber vedrørende risikostyring, navnlig risikostyringsplaner.
English: As always, I am grateful to the national competent authorities for the scientific resources they have made available to the EMEA.
Danish: Jeg er som altid taknemmelig for de videnskabelige ressourcer, som de nationale kompetente myndigheder stiller til rådighed for EMEA.
English: Testing results showed that the majority of the products were of high quality.
Danish: Resultaterne af afprøvningerne viste, at hovedparten af lægemidlerne var af høj kvalitet.
English: The changes brought about by the revised pharmaceutical legislation had a fundamental impact on the structure and organisation of the Management Board.
Danish: De ændringer, som følger af den reviderede lægemiddellovgivning, havde en afgørende indvirkning på bestyrelsens struktur og organisation.
English: The European Commission adopts its decisions with the assistance of a standing committee composed of representatives of the Member States.
Danish: Europa-Kommissionen træffer de endelige afgørelser i samråd med et stående udvalg sammensat af repræsentanter for medlemsstaterne.
English: The Agency is responsible for implementing the EU telematics strategy agreed by the European Commission, Member States and the EMEA.
Danish: Agenturet er ansvarligt for at gennemføre EU's telematikstrategi, som er aftalt mellem EuropaKommissionen, medlemsstaterne og EMEA.
English: 6.2 Integrated quality-management at the Agency
Danish: 6.2 Agenturets integrerede kvalitetsstyring
English: Thanks to the newly streamlined procedure, the SAWP was able to complete these scientific-advice procedures more quickly than in previous years.
Danish: Takket være den nye strømlinede procedure kunne SAWP afslutte procedurerne for videnskabelig rådgivning hurtigere end i de foregående år.
English: In addition, a project has also been running to prepare such summaries for products approved prior to 2006.
Danish: Derudover har der også kørt et projekt vedrørende forberedelsen af sådanne sammendrag for produkter, der er godkendt inden 2006.
English: The number of withdrawn applications (20) was the lowest in the past 6 years.
Danish: Antallet af tilbagekaldte ansøgninger (20) var det laveste i de seneste seks år.
English: This success has been recognised by all of the Agency's stakeholders.
Danish: Disse gode resultater har opnået anerkendelse fra alle agenturets partnere.
English: A new system of revenue (invoicing) was introduced and implemented successfully.
Danish: Der blev med succes indført og gennemført et nyt faktureringssystem.
English: This document provides a summary of the EMEA annual report for 2006.
Danish: Dette dokument indeholder et sammendrag af EMEA's årsberetning for 2006.
English: The concept of risk-management plans (RMPs) was fully implemented in 2006 as part of the new legislative provisions of Regulation (EC) No 726/2004.
Danish: Begrebet risikostyringsplaner (RMP) blev fuldt gennemført i 2006 som del af de nye lovbestemmelser i forordning (EF) nr. 726/2004.
English: They provides for the extension of marketing authorisations granted by one Member State to one or more other Member States identified by the applicant.
Danish: Procedurerne giver mulighed for at udvide markedsføringstilladelser udstedt af en medlemsstat til at gælde i en eller flere andre medlemsstater udpeget af ansøgeren.
English: 2006 was also the first full year in which the Management Board operated in its full composition.
Danish: 2006 var også det første hele driftsår for bestyrelsen i dens fulde sammensætning.
English: It is once again my pleasure to introduce to you our report on the activities and achievements of the European Medicines Agency in the past year.
Danish: Jeg har nok engang fornøjelsen af at præsentere vores årsberetning om Det Europæiske Lægemiddelagenturs aktiviteter og resultater i det forgangne år.
English: The EMEA Management Board met four times in 2006, under chairman Hannes Wahlroos, from Finland, and vice-chairman Jytte Lyngvig, from Denmark.
Danish: EMEA's bestyrelse mødtes fire gange i løbet af 2006 under ledelse af formand Hannes Wahlroos fra Finland og næstformand Jytte Lyngvig fra Danmark.
English: Implementation and further development of risk-management plans
Danish: Gennemførelse og videreudvikling af risikostyringsplaner
English: Eight applications were withdrawn by applicants before an opinion could be adopted.
Danish: Otte ansøgninger blev trukket tilbage af ansøgerne, inden der kunne vedtages en udtalelse.
English: 117 companies from 17 countries across the EU were assigned SME status, including an encouragingly high number of micro enterprises (24%), many of which were university spin-off companies.
Danish: 117 virksomheder fra 17 lande i EU fik tildelt SMV-status, heraf et opmuntrende højt antal mikrovirksomheder (24 %), hvoraf mange er opstået i universitetsmiljøet.
English: Keen interest expressed by patients' and consumers' organisations
Danish: Stor interesse fra patient- og forbrugerorganisationer
English: Sensory organs
Danish: De sensoriske organer
English: At the end of 2006, new European legislation aimed at promoting the development of medicines for children was adopted.
Danish: Der blev ved udgangen af 2006 vedtaget en ny europæisk lovgivning, som har til formål at fremme udviklingen af lægemidler til børn.
English: The Agency has continued its contribution to the promotion of research and development in Europe.
Danish: Agenturet fortsatte sit arbejde med at fremme forskning og udvikling i Europa.
English: There were 25 applications relating to the more complex type-II variations.
Danish: Der blev indgivet 25 ansøgninger om mere komplekse type II-ændringer.
English: First year of the EMEA SME Office: supporting innovation among Europe's SMEs
Danish: Det første driftsår for EMEA's SMV-kontor: Støtte til innovation blandt Europas SMV'er
English: The decentralised procedure and the mutual recognition procedure apply to the majority of conventional medicinal products.
Danish: Den decentraliserede procedure og den gensidige anerkendelsesprocedure gælder for størsteparten af de traditionelle lægemidler.
English: Contributing to the European Technology Platform for Global Animal Health
Danish: Støtte til den europæiske teknologiplatform for global dyresundhed
English: By saying this I would also like to take this opportunity to thank all the Board members for their contributions to the work of the Board.
Danish: Jeg vil i samme åndedrag benytte mig af lejligheden til at takke alle bestyrelsesmedlemmerne for deres bidrag til bestyrelsens arbejde.
English: By the end of 2006, the Agency employed a total of 497 staff.
Danish: Agenturet havde ved udgangen af 2006 497 medarbejdere.
English: Most of those not reviewed related to active substances whose safety profile was well known.
Danish: De fleste af de planer, der ikke blev behandlet, vedrørte aktive stoffer, hvor sikkerhedsprofilen er kendt.
English: 300 originated within the EU.
Danish: 300 af indberetningerne stammer fra EU-lande.
English: 1.4 European medicines network Sharing expertise and competence-development in the network
Danish: 1.4 Det europæiske lægemiddelnetværk Udveksling af ekspertise og kompetenceudvikling i netværket
English: The Board encourages the Agency to continue its good work and to remain alert in view of the threat levels.
Danish: Bestyrelsen opfordrer agenturet til at fortsætte det gode arbejde og bevare fokus på trusselsniveauerne.
English: Project status at the end of 2006
Danish: Projektstatus ved udgangen af 2006
English: ** A new method has been used as of 2006 to present the number of ICSRs received/expected over time.
Danish: ** Fra og med 2006 er en ny metode taget i brug til at vise antallet af ICSR, som modtages/forventes modtaget.
English: The Committee for Orphan Medicinal Products (COMP) adopted 81 positive opinions.
Danish: Udvalget for Lægemidler til Sjældne Sygdomme (COMP) vedtog 81 positive udtalelser.
English: Procedures for reporting into EudraVigilance Veterinary were considerably enhanced during the year.
Danish: Procedurerne for indberetning til EudraVigilance Veterinary blev forbedret væsentligt i løbet af året.
English: These recommendations are to be included in the risk-management plans of all pandemic-influenza vaccines.
Danish: Disse henstillinger skal medtages i risikostyringsplanerne for alle vacciner mod pandemisk influenza.
English: * The figures for 2004 and 2005 have been revised to taken into account the reports submitted for non-centrally authorised products.
Danish: * Tallene for 2004 og 2005 er blevet revideret, så der tages højde for indberetninger indsendt for decentralt godkendte lægemidler.
English: Reviewing business processes to rationalise them and make them more efficient and less timeconsuming, while improving or at least maintaining the quality of the work undertaken, was emphasised in 2006 at all levels of the EMEA's operations.
Danish: Gennemgang af forretningsprocesserne for at effektivisere dem og gøre dem mindre tidskrævende, samtidig med at det arbejde, der udføres, enten forbedres eller holdes på samme niveau, blev fremhævet i 2006 på alle niveauer af EMEA's aktiviteter.
English: European Risk-Management Strategy (ERMS) for medicines for human use
Danish: Den europæiske risikostyringsstrategi (ERMS) for humanmedicinske lægemidler
English: 1.7 Tackling antimicrobial resistance
Danish: 1.7 Håndtering af antimikrobiel resistens
English: In July 2006, the Agency implemented a new framework for the provision of scientific advice.
Danish: I juli 2006 gennemførte agenturet nye rammebestemmelser for videnskabelig rådgivning.
English: In the SME Office's first year of operation:
Danish: Resultater i løbet af SMV-kontorets første driftsår:
English: To pick out just a few notable achievements in core business areas:
Danish: Her skal blot nævnes et par eksempler på bemærkelsesværdige resultater inden for agenturets centrale forretningsområder:
English: Totals:
Danish: I alt:
English: In December 2006, the HMPC presented to the European Commission a comprehensive overview of its activities and achievements since its establishment in September 2004.
Danish: HMPC fremlagde i december 2006 en omfattende oversigt over dets aktiviteter og resultater siden oprettelsen i september 2004 for Europa-Kommissionen.
English: of Directive 2001/83/EC
Danish: i direktiv 2001/83/EF
English: 8 companies submitted marketing-authorisation applications.
Danish: Otte virksomheder indsendte ansøgninger om markedsføringstilladelse.
English: This required no fee or formal application, provided the scientific criteria allowing such extrapolations were met.
Danish: Ekstrapoleringen krævede ingen gebyrer eller formelle ansøgninger, forudsat de videnskabelige kriterier, der gør det muligt at foretage sådanne ekstrapoleringer, blev opfyldt.
English: Number of quality defects reported,
Danish: Antal indberetninger om kvalitetsfejl,
English: Of the 681 such opinions adopted, 60% related to safety and efficacy, and 40% related to quality changes.
Danish: Ud af disse 681 vedtagne udtalelser vedrørte 60 % sikkerhed og effektivitet, og 40 % var kvalitetsændringer.
English: These included the first ‘opinions on any scientific matter', under Article 5(3) of Regulation (EC) No 726/2004.
Danish: Disse vedtagne udtalelser omfattede også de første "udtalelser om videnskabelige spørgsmål" i henhold til artikel 5, stk. 3, i forordning (EF) nr. 726/2004.
English: Pharmacovigilance in the veterinary sector in the EU is undergoing changes triggered by the new legislation.
Danish: Lægemiddelovervågningen i veterinærsektoren i EU er under forandring som følge af den nye lovgivning.
English: New indications broaden scope of existing medicines
Danish: Nye indikationer udvider anvendelsesområdet for eksisterende lægemidler
English: Over 145 companies, including 6 veterinary companies, submitted applications for SME status to the Agency.
Danish: Mere end 145 virksomheder, heraf 6 veterinærvirksomheder, indsendte ansøgninger til agenturet om at få tildelt SMV-status.
English: of Regulation (EC) No 726/2004
Danish: i forordning (EF) nr. 726/2004
English: Despite the operational challenges and increased workload this entailed, the Agency was able to achieve all the main objectives it had set itself for the year, and once more delivered good performance results across the entire spectrum of its activities.
Danish: På trods af de operationelle udfordringer og den øgede arbejdsbyrde, som dette medførte, opfyldte agenturet alle de vigtigste mål, det havde sat for året, og formåede nok engang at skabe gode resultater inden for alle dets aktivitetsområder.
English: The EMEA continued its work on improving the availability of medicines.
Danish: EMEA fortsatte sin indsats for at forbedre adgangen til lægemidler.
English: The scheme is part of the Agency's strategy to improve the availability of such medicines.
Danish: Ordningen er en del af agenturets strategi til at forbedre adgangen til denne form for lægemidler.
English: The core system was in testing as at the end of 2006.
Danish: Det grundlæggende system blev afprøvet i slutningen af 2006.
English: In addition, the Agency made proposals for topics of public-health interest, such as pharmacovigilance, to be included in the project.
Danish: Derudover foreslog agenturet, at emner af interesse for folkesundheden, såsom lægemiddelovervågning, inkluderes i projektet.
English: Further work is being done to better define minor uses and limited markets, in order to facilitate use of the guidelines and to allow for a harmonised implementation across the EU.
Danish: Der arbejdes desuden på at indføre en bedre definition af mindre udbredte sygdomme og begrænsede markeder for at gøre det lettere at anvende retningslinjerne og muliggøre en harmoniseret gennemførelse i hele EU.
English: The Agency also attended meetings with the European Commission Directorate-General for Research to prepare the funding of research on off-patent medicines.
Danish: Agenturet deltog endvidere i møder med Europa-Kommissionens Generaldirektorat for Forskning med henblik på at forberede finansieringen af forskning i ikke-patenterede lægemidler.
English: Contra-indications, class labelling and warnings
Danish: Kontraindikationer, klassificering og advarsler
English: This was the first procedure conducted under the new pharmacovigilance provision of Article 78 of Directive 2001/82/EC, as amended.
Danish: Denne var den første procedure, der blev gennemført under den nye bestemmelse om lægemiddelovervågning i artikel 78 i direktiv 2001/82/EF, som ændret.
English: A meeting with stakeholders held early in the year confirmed the successful removal of the legalisation step previously performed by the European Commission's UK representation.
Danish: På et møde med agenturets partnere i starten af året bekræftedes den vellykkede afskaffelse af det trin, som tidligere var blevet gennemført af Europa-Kommissionens repræsentation i Det Forenede Kongerige.
English: Neurology/CNS
Danish: Neurologi/CNS
English: 2.4 Post-authorisation activities Number of variation applications up by almost one third
Danish: 2.4 Aktiviteter efter godkendelse Antallet af ansøgninger om ændringer steg med næsten en tredjedel
English: A total of 10 referrals were made to the CVMP in 2006 in the framework of the mutual-recognition procedure.
Danish: CVMP modtog i 2006 i alt 10 henvisninger inden for rammerne af den gensidige anerkendelsesprocedure.
English: The majority of new indications related to medicinal products approved for the treatment of various forms of cancer.
Danish: Størsteparten af de nye indikationer vedrørte lægemidler, der er godkendt til behandling af forskellige former for kræftsygdomme.
English: The number of requests is expected to continue to grow as more marketing-authorisation applications are submitted.
Danish: Antallet af anmodninger forventes at stige i takt med, at der indgives flere ansøgninger om markedsføringstilladelse.
English: This overview is intended to support the Commission with the preparation of its report to the European Parliament and to the Council concerning the application of the relevant legislative provisions relating to traditional herbal medicinal products.
Danish: Denne oversigt har til formål at hjælpe Kommissionen med udarbejdelsen af Kommissionens rapport til Europa-Parlamentet og Rådet vedrørende anvendelsen af de relevante lovbestemmelser vedrørende traditionelle plantelægemidler.
English: Summary of the twelfth annual report of the EMEA
Danish: Sammendrag af den 12. årsberetning for EMEA
English: In addition, the Agency made a successful start with the SME Office, which provides assistance to small and medium-sized enterprises involved in the development of medicines in Europe.
Danish: Derudover har agenturet haft succes med oprettelsen af SMV-kontoret, der yder bistand til små og mellemstore virksomheder, som er involveret i udviklingen af lægemidler i Europa.
English: The launch of the database is a first step towards providing public access to comprehensive and up-to-date information about all authorised medicines in the European Union.
Danish: Databasen er første skridt i retning af at give offentligheden adgang til omfattende og opdaterede oplysninger om alle godkendte lægemidler i Den Europæiske Union.
English: PIM (Product Information Management - a process that supports the electronic exchange of product information between applicants and the EMEA, as well as the review of this information).
Danish: PIM (produktinformationsstyring - en proces, som støtter den elektroniske udveksling af produktinformation mellem ansøgere og EMEA, samt behandling af disse informationer).
English: Management and internal-control systems are part of EMEA governance and are consolidated in an integrated management system at the Agency.
Danish: Styrings- og interne kontrolsystemer indgår i EMEA's virksomhedsledelse og er konsolideret i et integreret styringssystem i agenturet.
English: The good progress observed in 2005 with EudraVigilance continued in 2006.
Danish: De gode fremskridt, der i 2005 blev gjort i forbindelse med gennemførelsen af EudraVigilance, fortsatte i 2006.
English: The system for the centralised procedure is nearly complete, with adjustments for postauthorisation procedures being planned for early 2007.
Danish: Systemet for den centraliserede procedure er næsten færdigt, men der er planlagt justeringer af procedurerne efter godkendelse i starten af 2007.
English: The successes we were able to achieve were due to the smooth operation of the European network as a whole, and in particular to the outstanding work of our scientific committees, working parties and secretariat personnel.
Danish: Vores gode resultater skyldtes i høj grad det europæiske netværk, der fungerede upåklageligt, samt ikke mindst det fremragende arbejde i vores videnskabelige udvalg, arbejdsgrupper og sekretariater.
English: The full EMEA annual report for 2006 was adopted by the Management Board on 8 March 2007, and is available on the EMEA website:
Danish: EMEA's fulde årsberetning for 2006 blev vedtaget af bestyrelsen den 8. marts 2007 og kan ses på agenturets websted:
English: On 15 December 2005, the EMEA launched an ‘SME Office' to provide financial and administrative assistance to micro, small and medium-sized enterprises (SMEs), with the aim of promoting innovation and the development of new human and veterinary medicinal products by SMEs.
Danish: Den 15. december 2005 oprettede EMEA et såkaldt SMV-kontor, der skal yde finansiel og administrativ bistand til mikrovirksomheder og små og mellemstore virksomheder (SMV'er) med henblik på at fremme SMV'ernes innovation og udvikling af nye humanmedicinske og veterinærlægemidler.
English: At the end of 2006, EudraVigilance contained a total of 677,976 individual-case-safety reports (ICSRs), corresponding to 409,138 individual cases.
Danish: Ved udgangen af 2006 indeholdt EudraVigilance i alt 677 976 individuelle sikkerhedsindberetninger (ICSR), hvilket svarer til 409 138 individuelle sager.
English: In 2006, information on 14 withdrawals and 7 refusals was published.
Danish: Der blev i 2006 offentliggjort 14 tilbagekaldelser og 7 afslag.
English: New applications (by medicinal product) New applications (by active substance)
Danish: Nye ansøgninger (pr. lægemiddel) Nye ansøgninger (pr. aktivt stof)
English: As part of this, an ad hoc working group was created to re-define the Management Board's role and responsibilities.
Danish: Der er som led i denne proces blevet nedsat en ad hoc-arbejdsgruppe, der havde til opgave at omdefinere bestyrelsens rolle og ansvarsområder.
English: The number of such procedures finalised in 2006 was also greater, with a total of 32 opinions being adopted.
Danish: Antallet af afsluttede procedurer var også større i 2006, hvor der i alt blev vedtaget 32 udtalelser.
English: Recommendations for a core pharmacovigilance plan for pandemic-influenza vaccines were developed and approved in 2006.
Danish: Henstillinger vedrørende en central lægemiddelovervågningsplan for pandemiske influenzavacciner blev udarbejdet og godkendt i 2006.
English: We also contributed towards stimulating research and development of new medicines through our involvement in the Innovative Medicines Initiative and the European Technology Platform for Global Animal Health, but in particular through the dedicated support provided to small and medium-sized companies by our SME Office, which, in its first year of operation, generated even greater interest than had been expected.
Danish: Vi bidrog også til at fremme forskning og udvikling af nye lægemidler gennem vores deltagelse i initiativet vedrørende innovative lægemidler og den europæiske teknologiplatform for global dyresundhed samt ikke mindst gennem den dedikerede støtte til små og mellemstore virksomheder fra vores SMV-kontor, som i sit første driftsår skabte endnu større interesse end forventet.
English: 53 related to food-producing animals (mainly cattle, pigs and horses), following treatment of 2,251 animals, of which 559 showed suspected adverse reactions.
Danish: 53 vedrørte dyr bestemt til levnedsmiddelproduktion (hovedsageligt kvæg, grise og heste), efter behandling af i alt 2 251 dyr, hvoraf 559 viste tegn på formodede bivirkninger.
English: 1.5 Better medicines for children
Danish: 1.5 Bedre lægemidler til børn