FrancophonIA/ELRC3.0 huggingface dataset:
English: In 2004, total compensation was 32 233 000 about one third of the Agencys total budget.
Danish: I 2004 udgjorde denne godtgørelse i alt 32 233 000 EUR - svarende til ca. en tredjedel af agenturets samlede budget.
English: The decentralised procedure (or mutual recognition procedure) applies to the majority of conventional medicinal products and is based upon the principle of mutual recognition of national authorisations.
Danish: Den decentraliserede procedure (eller gensidige anerkendelsesprocedure) anvendes for størsteparten af de traditionelle lægemidler og er baseret på princippet om gensidig anerkendelse af nationale godkendelser.
English: In addition, a management audit based on ISO 9004:2000 was conducted.
Danish: Der blev desuden gennemført en ledelsesrevision baseret på ISO 9004:2000.
English: Special attention was paid to improving communication between the stakeholders and to increasing transparency and understanding.
Danish: Der blev lagt særlig vægt på at forbedre kommunikationen mellem de involverede parter og skabe større åbenhed og gensidig forståelse.
English: Applications are submitted directly to the EMEA.
Danish: Ansøgninger indgives direkte til EMEA.
English: In this context, the CVMP, its processes, records and working practices were audited in October 2004.
Danish: I denne forbindelse blev CVMP og dets processer, registreringer og arbejdsmetoder revideret i oktober 2004.
English: Title IV of the new Regulation entered into force on 20 May 2004.
Danish: Afsnit IV i den nye forordning trådte i kraft den 20. maj 2004.
English: This legislation is particularly relevant for biotechnology-derived products, which means that there is likely to be an increasing number of such applications in the coming years.
Danish: Denne lovgivning er særlig relevant for produkter, der er udviklet ved bioteknologi, hvilket betyder, at der kan forventes et stigende antal af den slags ansøgninger i de kommende år.
English: • The first production version of EudraVigilance Veterinary was released at the end of 2004
Danish: • Den første produktionsversion af EudraVigilance Veterinary blev frigivet i slutningen af 2004
English: This number is 31 % higher than the figure for 2003, and 27.5 % higher than the forecast number of 40.
Danish: Det er 31 % flere end i 2003 og 27,5 % flere end det forventede tal på 40.
English: 1 EMEA in the European system
Danish: 1 EMEA i det europæiske system
English: • HIV/AIDS (3 new combinations of products)
Danish: • hiv/aids (3 nye kombinationer af produkter)
English: The existing procedures were updated to take account of the consequences of the EU enlargement and the revision of the pharmaceutical legislation.
Danish: De nuværende procedurer blev ajourført for at tage højde for virkningerne af EU-udvidelsen og revisionen af lægemiddellovgivningen.
English: 1.5 Transparency and communication
Danish: 1.5 Åbenhed og kommunikation
English: The Management Board met for the first time in its new configuration on 24 May 2004 at an extraordinary meeting.
Danish: Bestyrelsen mødtes første gang i sin nye sammensætning den 24. maj 2004 til et ekstraordinært møde.
English: In addition, an extraordinary meeting was held in December in order to discuss safety concerns relating to SSRIs and SNRIs (see section 2.5).
Danish: Der blev desuden afholdt et ekstraordinært møde i december, hvor man drøftede problemerne vedrørende SSRI og SNRI (jf. punkt 2.5).
English: The new Member State authorities were connected to the EudraVigilance Gateway and are actively involved in the joint implementation activities at Community level.
Danish: Myndighederne i de nye medlemsstater blev koblet op til EudraVigilance Gateway og deltager aktivt i de fælles implementeringsaktiviteter på EU-plan.
English: The Legal Affairs Sector brings together the legal resources of the Agency into one specialised group in response to the increasing demand for legal services.
Danish: Den juridiske sektion samler agenturets juridiske ressourcer i en specialiseret gruppe for at imødekomme den voksende efterspørgsel efter juridisk bistand.
English: In 2004, the EMEA also published guidance for parallel distributors.
Danish: I 2004 offentliggjorde EMEA desuden en vejledning for paralleldistributører.
English: ECD will be used by many applications that require directory information, starting first of all with MMS Phase III
Danish: ECD skal anvendes af mange applikationer, der kræver adresseoplysninger, begyndende med MMS Fase III
English: 18 174 reports were received from EU sources and 46 012 were from outside the EU.
Danish: 18 174 indberetninger hidrørte fra kilder i EU og 46 012 fra kilder uden for EU.
English: The authorities make scientific resources available in the form of a network of more than 3 500 European experts who assist the Agency in the performance of its scientific tasks.
Danish: Myndighederne stiller videnskabelige ressourcer til rådighed i form af et netværk af over 3 500 europæiske eksperter, som bistår agenturet i udførelsen af dets videnskabelige opgaver.
English: In 2004, the Agency had a record 25 551 visitors.
Danish: Agenturet havde i 2004 et rekordhøjt antal besøgende: 25 551.
English: Annex 12 Guidelines and working documents in 2004
Danish: Bilag 12 Retningslinjer og arbejdsdokumenter i 2004
English: Each Committee member has an alternate.
Danish: Hvert udvalgsmedlem har en suppleant.
English: A revised template was introduced to facilitate the collection of relevant data.
Danish: Der er indført et revideret format for at lette indsamlingen af relevante data.
English: The parallel distribution activity was marked by two major changes in 2004:
Danish: Sagerne om paralleldistribution var præget af to væsentlige ændringer i 2004:
English: This initiative started in 2002, and the Agency is now preparing summaries for medicinal products designated in previous years.
Danish: Dette initiativ startede i 2002, og agenturet er i færd med at udarbejde resumeer for de lægemidler, der blev udpeget i årene forud.
English: The certificate of compliance is valid throughout the European Community.
Danish: Certifikatet er gyldigt i hele EU.
English: Seven applications were withdrawn by applicants prior to an opinion being given.
Danish: 7 ansøgninger blev trukket tilbage af ansøgerne, før der blev afgivet udtalelse.
English: In 2005, new Community legislation will introduce a requirement for risk management plans in relation to certain medicines with important (established or potential) risks.
Danish: Med den nye EU-lovgivning indføres der i 2005 krav om risikostyringsplaner i forbindelse med visse lægemidler med væsentlige (konstaterede eller potentielle) risici.
English: This has been addressed by the Road Map, in which proposals have been made concerning the future cooperation of the network.
Danish: Der er dog taget højde herfor i "køreplanen", der indeholder forslag vedrørende netværkets fremtidige samarbejde.
English: My particular thanks go to the Executive Director of the Agency and his staff for their support and cooperation on the work of the Management Board.
Danish: En særlig tak skal rettes til agenturets administrerende direktør og hans medarbejdere for deres støtte og samarbejdsvilje i forbindelse med bestyrelsens arbejde.
English: There were no referral procedures under Articles 36 or 37.
Danish: Der var ingen henvisninger baseret på artikel 36 eller 37.
English: A selection of centrally authorised products is included in each annual programme.
Danish: Et udvalg af centralt godkendte produkter indgår i de enkelte årlige programmer.
English: In 2004, the VMRFG provided answers to a wide range of questions from both Member States and Industry on a number of different regulatory issues.
Danish: I 2004 besvarede VMRFG en lang række spørgsmål fra både medlemsstater og industrien om forskellige forskriftsmæssige emner.
English: The Board now has one representative per Member State (and no longer two), two representatives of the European Parliament, two representatives of the European Commission and, for the first time, two representatives of patients organisations and one representative each of doctors and veterinarians organisations.
Danish: Bestyrelsen har nu en repræsentant fra hver medlemsstat (i stedet for tidligere to), to repræsentanter for Europa-Parlamentet, to repræsentanter for Europa-Kommissionen og - for første gang - to repræsentanter for patientorganisationerne og en repræsentant for henholdsvis lægernes og dyrlægernes organisationer.
English: No scientific advice (n=171)
Danish: Ingen videnskabelig rådgivning(n=171)
English: Consumers expect that residues be avoided as far as possible, and, where not possible, that they be safe.
Danish: Forbrugerne forventer, at man i videst muligt omfang undgår restkoncentrationer, og at de, såfremt de ikke helt kan undgås, ikke indebærer nogen risiko for mennesker.
English: Product defects and deviations
Danish: Produktfejl og afvigelser
English: At the time of writing of this report, testing was completed and results reported for 31 products.
Danish: I skrivende stund var afprøvningerne afsluttet og resultaterne indberettet for 31 produkter.
English: • This is a new requirement, on which specification work was initiated
Danish: • Dette er et nyt krav, man er begyndt at udarbejde specifikationer for
English: The Committee re-elected Dr Daniel Brasseur as chairman and Dr Eric Abadie as vicechairman.
Danish: Udvalget genvalgte Dr. Daniel Brasseur til formand og Dr. Eric Abadie til næstformand.
English: Mutual recognition agreements (MRAs) between the European Community (EC) and partner (third) countries include specific annexes regarding medicinal products and GMP.
Danish: Gensidige anerkendelsesaftaler mellem EU og partner(tredje)lande indeholder særlige bilag om lægemidler og GMP.
English: A Community marketing authorisation is valid throughout the EU and a centrally authorised medicinal product is by definition identical in all Member States.
Danish: En EU-markedsføringstilladelse er gyldig i hele EU, og et centralt godkendt lægemiddel er per definition identisk i alle medlemsstater.
English: The majority (>90 %) of results received show that the products were of high quality and complied with their authorised specifications.
Danish: Hovedparten (over 90 %) af de indberettede resultater viser, at produkterne var af høj kvalitet og i overensstemmelse med de godkendte specifikationer.
English: Training profiles were proposed for a range of job profiles at all levels within the Agency.
Danish: Der blev foreslået efteruddannelsesprofiler for en række stillinger på alle niveauer i agenturet.
English: The remaining provisions will come into force 18 months later, on 20 November 2005.
Danish: De øvrige bestemmelser bliver gældende 18 måneder senere, dvs. fra den 20. november 2005.
English: The summarised comparative budget statements for 2003 to 2005 are as follows: (Amounts expressed in euro)
Danish: Komparative sammendrag af budgetoversigter for perioden 2003 - 2005: (Alle beløb er angivet i euro)
English: The Agency will publish the required analysis and assessment on its website once it has been adopted by the Management Board.
Danish: Agenturet har til hensigt at offentliggøre den krævede analyse og vurdering på sit websted, når den er vedtaget af bestyrelsen.
English: The EMEA Code of Conduct was revised in 2004 in order to clarify the meaning of some sections.
Danish: EMEA's adfærdskodeks blev revideret i 2004 for at tydeliggøre indholdet af visse afsnit.
English: The new legislation introduced a simplified registration procedure for traditional herbal medicinal products.
Danish: Med den nye lovgivning er der indført en forenklet registreringsprocedure for traditionelle plantelægemidler.
English: • A first iteration forming the basis of the first production system restricted to data on products that have been approved using the centralised procedure was completed and demonstrated at the end of 2004
Danish: • En første iteration, der danner grundlag for det første produktionssystem, begrænset til data om produkter, der er godkendt efter den centraliserede procedure, blev færdiggjort og demonstreret i slutningen af 2004
English: 50 % fee reduction for inspections
Danish: 50 % gebyrnedsættelse for inspektioner
English: • User requirements for the database were drawn up in line with additional requirements resulting from the terms of Regulation (EC) No 726/2004, G10 recommendations and Council conclusions
Danish: • Brugerkrav til databasen blev fastlagt i overensstemmelse med de yderligere krav, der følger af forordning (EF) nr. 726/2004, G10-anbefalingerne og Rådets konklusioner
English: Impact of scientific advice (n=48) on proportion of approvals over time
Danish: Effekten af videnskabelig rådgivning (n=48) for andelen af godkendelser over tid
English: The provision of interpretation was reviewed and tailored to real needs, and thus interpretation days were reduced by 68 % compared to the previous year.
Danish: Leveringen af tolkning blev revideret og tilpasset de reelle behov, hvorved antallet af dage med tolkning blev reduceret med 68 % i forhold til året før.
English: Geographical distribution at EMEA - 31 December 2004
Danish: Personalets geografiske fordeling i EMEA - 31. december 2004
English: Following an exchange of views with IFAH-Europe in 2004, the procedure and guidance for prospective applicants to request scientific advice has been considerably amended, which appears to be resulting in more applications.
Danish: Efter en nyttig udveksling af synspunkter med IFAH-Europe i 2004 er proceduren og vejledningen for potentielle ansøgere, der ønsker videnskabelig rådgivning, blevet væsentligt forbedret, hvilket tilsyneladende resulterer i flere anmodninger.
English: This represents a 40 % increase in activity when compared to 2003, and indicates that companies developing medicines for rare diseases have a high level of interest in receiving support and advice during the research and development phase.
Danish: Det er en stigning på 40 % i forhold til 2003 og tyder på, at virksomheder, der udvikler lægemidler til sjældne sygdomme, er meget interesseret i at få støtte og rådgivning i forsknings- og udviklingsfasen.
English: The number of SUSARs received electronically was 7 984, of which 3 746 were from EU sources and 4 238 from outside the EU.
Danish: Antallet af elektronisk indberettede SUSAR var 7 984, hvoraf 3 746 hidrørte fra kilder i EU og 4 238 fra kilder uden for EU.
English: New Member States took part in the testing part of the programme from May 2004 onwards, as samples of certain products had already been taken from the market prior to accession.
Danish: Nye medlemsstater deltog i programmets afprøvningsdel fra og med maj 2004, da der allerede var taget stikprøver af visse produkter på markedet inden tiltrædelsen.
English: The new Rules of Procedure were discussed and adopted in July 2004.
Danish: Den nye forretningsorden blev drøftet og vedtaget i juli
English: • Revised the rules on public access to EMEA documents 16 December 2004
Danish: • revision af reglerne om aktindsigt i EMEA-dokumenter 16. december 2004
English: The group is made up of delegates from the EU, Iceland and Norway, and meets at the EMEA to coordinate Member States positions on topics relating to the mutual recognition procedure (MRP).
Danish: Gruppen består af delegerede fra EU, Island og Norge og mødes hos EMEA for at koordinere medlemsstaternes holdning til spørgsmål vedrørende den gensidige anerkendelsesprocedure (MRP).
English: The pilot phase will last one year, after which the experience and value of the programme will be reassessed.
Danish: Pilotfasen skal vare et år, hvorefter man atter vil vurdere erfaringerne med og udbyttet af programmet.
English: A comprehensive upgrade to the MMS was delivered both on time and within budget.
Danish: En omfattende opgradering af MMS blev gennemført rettidigt og inden for budgettet.
English: In order to protect public and animal health, it may become necessary to implement urgent measures such as the recall of one or more batches of a medicinal product during its marketing period.
Danish: For at beskytte folkesundheden og dyrs sundhed kan det være nødvendigt at træffe hasteforanstaltninger som f.eks. tilbagekaldelse af en eller flere batcher af et lægemiddel i løbet af markedsføringsperioden.
English: Much effort was devoted in 2004 to the establishment of a long-term vision and implementation strategy for the Agency.
Danish: Der blev i 2004 gjort en stor indsats for at opstille en langsigtet vision og implementeringsstrategi for agenturet.
English: The Agency also received 6 referrals under Articles 29 and 30.
Danish: Agenturet modtog også seks henvisninger baseret på artikel 29 og 30.
English: The other referral concerned the veterinary medicinal product Micotil 300 (tilmicosin).
Danish: Den anden sag vedrørte veterinærlægemidlet Micotil 300 (tilmicosin).
English: Work on the elaboration and construction phases will continue in
Danish: Arbejdet med udarbejdelses- og konstruktionsfaserne fortsætter i 2005
English: The CVMP agreed to set a harmonised withdrawal period, which is now adopted throughout the Community.
Danish: CVMP besluttede at fastsætte en ensartet tilbagekaldelsesperiode, der nu gælder i hele EU.
English: Other activities in 2004 focused on the quality and consistency of CVMP assessments for centrally authorised products.
Danish: Andre aktiviteter i 2004 fokuserede på kvaliteten af og sammenhængen i CVMP's vurderinger af centralt godkendte produkter.
English: The control framework of the Agency changed significantly with the adoption of the new EMEA quality policy and new internal control standards.
Danish: Rammerne for kontrollen i agenturet blev ændret markant med vedtagelsen af EMEA's nye kvalitetspolitik og nye interne kontrolstandarder.
English: • Integration of delegates from the new Member States
Danish: • integrering af de delegerede fra de nye medlemsstater
English: As a result of the enlargement and the increased number of documents being posted on the EMEA website, the number of external requests for information increased by 50 % over the previous year.
Danish: Som følge af udvidelsen og det faktum, at der lægges stadigt flere dokumenter ud på EMEA's websted, steg antallet af eksterne henvendelser om information med 50 % i forhold til året før.
English: An observer for the veterinary authority of one EEA-EFTA state participated in plenary sessions.
Danish: En repræsentant for veterinærmyndigheden i en EØS-EFTA-stat deltog som observatør i plenarmøderne.
English: A total of 5 925 delegate visits were reimbursed, leading to a 47 % increase in expenditure in 2004.
Danish: Der blev i 2004 ydet godtgørelse for i alt 5 925 besøg af delegerede, hvilket medførte en udgiftsstigning på 47 %.
English: The EMEA operates in partnership with the national competent authorities for human and veterinary medicinal products in the Member States and the EEA-EFTA countries Iceland, Liechtenstein and Norway.
Danish: EMEA fungerer i partnerskab med de nationale ansvarlige myndigheder for human- og veterinærmedicinske lægemidler i medlemsstaterne og EØS-EFTA-landene Island, Liechtenstein og Norge.
English: Denmark 3.57 % Estonia 0.77 % Finland 2.04 % France
Danish: Danmark 3,57 % Estland 0,77 % Finland 2,04 % Frankrig
English: And while the growth of the European network to 28 EEA-EFTA countries, 42 national competent authorities and a pool of over 3 500 national experts certainly placed increased pressure on the EMEA in its role as coordinator, the Agency was able to cope without any major difficulty.
Danish: Og selv om det faktum, at det europæiske netværk voksede til at omfatte 28 EØS-EFTA-lande, 42 nationale ansvarlige myndigheder og mere end 3 500 nationale eksperter, naturligvis lagde et øget pres på EMEA i dets egenskab af koordinator, klarede agenturet denne udfordring uden større vanskeligheder.
English: Annual reports for 32 products were prepared in 2004, each of which is prepared in cooperation with a rapporteur and co-rapporteur, and adopted by the CVMP.
Danish: Der blev i 2004 udarbejdet årsrapporter for 32 produkter, og hver enkelt rapport blev til i et samarbejde med en rapportør og en medrapportør og vedtaget af CVMP.
English: The main achievements are described briefly in the table below.
Danish: De vigtigste resultater er gengivet i skemaet nedenfor.
English: The EMEA component of the EudraVigilance project proceeded as planned in 2004.
Danish: EMEA-delen af EudraVigilance-projektet forløb som planlagt i 2004.
English: Two informal meetings were held in 2004, in Dublin and Scheveningen.
Danish: Der blev afholdt to uformelle møder i 2004, i henholdsvis Dublin og Scheveningen.
English: For the first time, the discharge for the implementation of the 2002 budget was given to the Executive Director by the European Parliament.
Danish: For første gang var det Europa-Parlamentet, der meddelte den administrerende direktør decharge for 2002-budgettet.
English: The accounts sector maintains the accounts, makes payments and collects revenue in accordance with the procedures laid down in the Financial Regulation.
Danish: Bogholderiet fører regnskaberne, foretager betalinger og indkasserer indtægter efter procedurerne i finansforordningen.
English: The EMEA actively contributed to the public consultation on proposals to replace the existing Regulation on the establishment of maximum residue limits.
Danish: EMEA medvirkede aktivt ved den offentlige høring om forslag til erstatning for den nuværende forordning om fastsættelse af maksimale grænseværdier for restkoncentrationer.
English: The unexpected withdrawal of certain medicinal products last year demonstrates in a concrete way how vulnerable EU pharmacovigilance efforts still are.
Danish: Det forhold, at visse lægemidler uventet blev trukket tilbage fra markedet sidste år, er et konkret bevis på, hvor sårbar EU-lægemiddelovervågningen stadigvæk er.
English: A 99.5 % availability of IT services was achieved and key projects were delivered on time and within budget.
Danish: Rådighedsgraden var 99,5 %, og vigtige projekter blev gennemført til tiden og inden for budgetterne.
English: In this context, I would like to draw attention to an important issue in the Road Map, which will further improve the interests of EU citizens and patients by means of medicines control: the reinforcement of pharmacovigilance coordination.
Danish: I denne forbindelse vil jeg henlede opmærksomheden på et vigtigt punkt i "køreplanen", som i endnu højere grad vil sikre EU-borgernes og patienternes interesser gennem bedre kontrol med lægemidler: den tættere koordinering af lægemiddelovervågningen.
English: The European Commission adopts its decision with the assistance of a standing committee composed of representatives of the Member States.
Danish: Europa-Kommissionen træffer den endelige afgørelse i samråd med et stående udvalg sammensat af repræsentanter for medlemsstaterne.
English: A wide range of changes are possible to alter or improve the medicinal product.
Danish: Der er mulighed for at foretage mange forskellige former for ændringer for at modificere eller forbedre lægemidlet.
English: Once an opinion has been given, the Agency posts a summary of opinion on its website.
Danish: Når der er afgivet udtalelse, lægger agenturet et resumé af udtalelsen ud på sit websted.
English: Sensory organs
Danish: Sensoriske organer
English: 1.6 EU institutions, agencies and international partners
Danish: 1.6 EU-institutioner, agenturer og internationale partnere
English: A new policy and procedure on the handling of conflicts of interests of scientific committee members and experts was adopted in March 2004.
Danish: I marts 2004 blev der vedtaget en ny politik og procedure for håndteringen af interessekonflikter hos medlemmerne af videnskabelige udvalg og eksperterne.
English: This exercise was conducted in a most transparent manner, with the recommendations being discussed and finalised at a workshop in which all organisations that had commented were invited to participate.
Danish: Hele arbejdet foregik i fuld åbenhed, og anbefalingerne blev drøftet og færdigredigeret på en workshop, hvori alle de organisationer, der havde fremsat kommentarer, var indbudt til at deltage.