FrancophonIA/ELRC3.0 huggingface dataset:
English: This, together with the automatic extension of European Commission decisions granting marketing authorisations for medicinal products to the 10 new Member States on the date of accession, and the implicit requirement that product information be available in all official languages of the European Union, increased the volume of translation work substantially.
Danish: Dette, i kombination med den automatiske udvidelse af Europa-Kommissionens afgørelser om markedsføringstilladelse for lægemidler til at omfatte de 10 nye medlemsstater med virkning fra tiltrædelsestidspunktet, og det deraf følgende krav om, at produktinformationerne skal foreligge på alle de officielle EU-sprog, øgede oversættelsesmængden ganske betydeligt.
English: • In 2004, the CHMP/EMEA initiated a revision of the European Commission Summary of Product Characteristics (SPC) Guideline, and agreement on sections 4.1 and 5.1 was reached.
Danish: • I 2004 påbegyndte CHMP/EMEA en revision af Europa-Kommissionens vejledning om produktresumeer, og man nåede til enighed om afsnit 4.1 og 5.1.
English: The EMEA ensures efficient support for the meetings it organises, providing facilities and services, and constantly improves the resources available.
Danish: EMEA yder effektiv assistance i forbindelse med de møder, agenturet selv arrangerer, ved at stille faciliteter og tjenester til rådighed og løbende forbedre de disponible ressourcer.
English: In 2004, the provision of scientific advice and protocol assistance was up by approximately 25 % in comparison to 2003.
Danish: I 2004 blev videnskabelig rådgivning og protokolbistand forøget med ca. 25 % i forhold til 2003.
English: • Two standards for electronic information exchange (the EU Module 1 Specification and the Application Form Specification) were adopted
Danish: • Der blev vedtaget to standarder for elektronisk informationsudveksling (EUmodul 1-specifikation og ansøgningsformularspecifikation)
English: On average, the COMP reached an opinion within 69 days and the Commission adopted a decision within 32 days.
Danish: I gennemsnit forelå udtalelsen fra COMP efter 69 dage og Kommissionens afgørelse efter 32 dage.
English: For example, within the EMEA, the implementation of an extensive firewall combined with the segmented 3-tier architecture ensures high levels of protection
Danish: F eks. er der inden for EMEA etableret en omfattende firewall kombineret med en segmenteret 3-lags arkitektur, der giver en meget høj beskyttelse
English: Flugestone acetate and norgestomet were placed in Annex III of Regulation (EEC) No 2377/90 in 2003, with provisional MRLs expiring in 2008.
Danish: Flugestone acetate og norgestomet blev i 2003 optaget i bilag III til forordning (EØF) nr. 2377/90 med foreløbige maksimale grænseværdier til udløb i 2008.
English: These groups continue to bring additional expertise into the European regulatory system.
Danish: Disse grupper tilfører fortsat EU-lovgivningssystemet værdifuld ekspertise.
English: In addition, the Board takes numerous decisions on Agency policies.
Danish: Desuden træffer bestyrelsen en lang række afgørelser om agenturets politik og strategi.
English: A total of 27 recruitment procedures were carried out in 2004.
Danish: Der blev gennemført i alt 27 ansættelsesprocedurer i 2004.
English: Arbitration procedures are initiated because of disagreement between Member States in the framework of the mutual recognition procedure (Article 33 of Directive 2001/82/EC).
Danish: Voldgiftsprocedurer indledes på grund af uenighed mellem medlemsstater i relation til den gensidige anerkendelsesprocedure (artikel 33 i direktiv 2001/82/EF).
English: MRA partners have agreed to work on harmonisation of operational aspects across the different agreements.
Danish: Aftalepartnerne har indvilget i at arbejde for en harmonisering af de operationelle aspekter af samtlige aftaler.
English: From 1 May 2004, the 10 new EU Member States were able to participate at the VMRFG meetings as full members of the group.
Danish: Fra den 1. maj 2004 kunne de ti nye medlemsstater deltage i VMRFG-møderne som fuldgyldige medlemmer af gruppen.
English: The Committee now has one member from each of the 25 EU Member States and one member each from Iceland and Norway.
Danish: Udvalget har nu et medlem fra hvert af de 25 EU-lande og et medlem fra henholdsvis Island og Norge.
English: Risk management strategy
Danish: Risikostyringsstrategi
English: The EMEA continued its interaction with the European Parliament, in particular with the Committee on the Environment, Public Health and Food Safety.
Danish: EMEA opretholdt kontakten med Europa-Parlamentet, især Udvalget for Miljø, Folkesundhed og Fødevaresikkerhed.
English: There were very few deviations from planned results, one notable exception being the slow implementation of EudraVigilance by Member States.
Danish: Der var meget få afvigelser fra de planlagte resultater - med medlemsstaternes langsomme implementering af EudraVigilance som en markant undtagelse.
English: Draft guidance documents were developed, including external guidance that will become publicly available in 2005.
Danish: Der blev udarbejdet udkast til retningslinjer samt en ekstern vejledning, der vil blive offentliggjort i 2005.
English: A new task for the EMEA stemming from the new Community legislation is to improve and optimise contacts with its various stakeholders to facilitate dialogue and communication.
Danish: En ny opgave for EMEA, der følger af den nye EU-lovgivning, bliver at forbedre og optimere kontakterne med de forskellige interesserede parter for at fremme dialogen og kommunikationen.
English: The implementation plan for the confidentiality arrangement, detailing the information and documents the two agencies will exchange and the process for monitoring the implementation of the plan itself, was published in October 2004.
Danish: Planen for ordningens konkrete gennemførelse med nærmere enkeltheder om de informationer og dokumenter, de to agenturer vil udveksle, og om tilsynet med gennemførelsen af selve planen blev offentliggjort i oktober 2004.
English: In 2004, 2 referrals were received; no arbitration was submitted.
Danish: I 2004 indkom der to henvisningssager; der blev ikke indbragt sager til voldgift.
English: As expected, the workload in dealing with product defects and deviations increased, mainly due to the greater number of centrally authorised products on the market and a growing awareness of Industry s responsibilities to keep the EMEA informed.
Danish: Som det var ventet, voksede antallet af sager om produktfejl og afvigelser, primært fordi der er kommet flere centralt godkendte produkter på markedet og på grund af voksende forståelse af industriens forpligtelse til at holde EMEA underrettet.
English: The CVMP took an average of 210 days for assessment of those new applications which received a Commission decision in 2004.
Danish: CVMP brugte gennemsnitligt 210 dage på at vurdere de nye ansøgninger, hvorom EuropaKommissionen traf afgørelse i 2004.
English: Scientific advice (n=48)
Danish: Videnskabelig rådgivning (n=48)
English: Ninety-four mutual recognition procedures were completed in 2004.
Danish: 49 gensidige anerkendelsesprocedurer blev afsluttet i 2004.
English: The procedure will be revised based on experience gained from the pilot phase in time for the introduction of the new Community legislation in November 2005.
Danish: Proceduren skal revideres på grundlag af erfaringerne fra pilotfasen, inden den nye EU-lovgivning træder i kraft i november 2005.
English: The EMEA is participating in ongoing discussions with DG Research to establish a European Technology Platform for Innovative Medicines.
Danish: EMEA deltager i løbende drøftelser med Generaldirektoratet for Forskning om etablering af en europæisk teknologiplatform for innovative lægemidler.
English: In 2004, the Board approved the revised rules on access to EMEA documents and the EMEA Code of Conduct, which are binding on all who participate in the work of the Agency.
Danish: I 2004 godkendte bestyrelsen de reviderede regler om adgang til EMEA-dokumenter og om EMEA's adfærdskodeks, som er bindende for alle, der deltager i agenturets arbejde.
English: The CVMP created a Scientific Advisory Group on Antimicrobials in 2004.
Danish: CVMP nedsatte i 2004 en videnskabelig rådgivende gruppe for antimikrobielle stoffer.
English: Meeting reimbursements increased by 38 % due to EU enlargement with a corresponding increase in the recording of new third parties.
Danish: Godtgørelserne for mødeaktiviteter steg med 38 % - som følge af EU's udvidelse - med en tilsvarende stigning i nye, registrerede tredjeparter.
English: Representatives attended from the VMRFG, IFAHEurope and the European Group for Generic Veterinary Products (EGGVP).
Danish: Der var tale om møder mellem repræsentanter for VMRFG, IFAH-Europe og European Group for Generic Veterinary Products (EGGVP).
English: It is expected that this initiative will increase the number of reports produced and, subsequently, strengthen the basis for evaluating the safety of authorised veterinary medicinal products.
Danish: Dette initiativ forventes at øge antallet af indberetninger og dermed skabe et mere solidt grundlag for vurderingen af sikkerheden ved godkendte veterinærlægemidler.
English: Parts of the Agency were refurbished in 2004.
Danish: Dele af agenturet blev nyindrettet i 2004.
English: 1 Applications to the EMEA which request that its refusal of an initial application for access to documents be reconsidered.
Danish: 1 Begæringer stilet til EMEA med anmodning om, at afvisning af en tidligere begæring om aktindsigt genbehandles.
English: 2004 was a very successful year for the IT sector from both operational and project-delivery points of view.
Danish: 2004 var et meget positivt år for IT-sektionen både ud fra et operationelt og et projektmæssigt synspunkt.
English: The effective coordination, management and resourcing of these projects led to their successful delivery.
Danish: Med en effektiv koordinering og forvaltning af disse projekter samt en hensigtsmæssig ressourceallokering kunne de føres til ende med godt resultat.
English: At the beginning of 2004 there were 3 old substances remaining for which MRLs had not been entirely completed: altrenogest, flugestone acetate and norgestomet.
Danish: I starten af 2004 var der tre "gamle" stoffer tilbage, for hvilke der ikke var fastsat endelige maksimale grænseværdier: altrenogest, flugestone acetate og norgestomet.
English: Overall performance for the year was very good, with regulatory timelines being met in almost all areas of activity.
Danish: Det samlede resultat af indsatsen i 2004 var særdeles godt, idet de lovfæstede tidsfrister kunne overholdes inden for næsten alle aktivitetsområder.
English: This figure includes 6 positive opinions for designated orphan medicinal products, and relates to a total of 29 new active substances.
Danish: Dette tal omfatter 6 positive udtalelser for udpegede lægemidler (sjældne sygdomme) og vedrører i alt 29 nye aktive stoffer.
English: The overall objectives were revised and published and a new testing scheme was agreed in principle.
Danish: De overordnede målsætninger blev revideret og offentliggjort, og der blev truffet en principbeslutning om et nyt afprøvningssystem.
English: • Neuropsychiatric disorders, such as epilepsy, depression, Parkinsons disease or severe pain (7 products)
Danish: • neuropsykiatriske lidelser såsom epilepsi, depression, Parkinsons syge eller stærke smerter (7 produkter)
English: I am confident that the next ten-year period will also prove to be a successful one for European cooperation.
Danish: Jeg er overbevist om, at det europæiske samarbejde også i det næste tiår vil kunne udvise vigtige resultater på dette felt.
English: Helping to bring medicines for rare diseases to the market
Danish: Støtte til at bringe lægemidler til sjældne sygdomme på markedet
English: Including validation time, the overall procedure took 102 days on average.
Danish: Medregner man valideringstiden, var den samlede sagsbehandlingstid gennemsnitligt 102 dage.
English: Human medicinal products only Currently excludes active substances, investigational medicinal products, medicinal gases
Danish: Kun humanmedicinske lægemidler, p.t. er aktive stoffer, testpræparater, medicinske gasser undtaget
English: Two national competent authorities and 21 pharmaceutical companies implemented the electronic transmission of ICSRs during 2004.
Danish: To nationale ansvarlige myndigheder og 21 medicinalvirksomheder indførte elektronisk fremsendelse af ICSR i 2004.
English: EMEA guidelines in 2004
Danish: EMEA-retningslinjer i 2004
English: I would like to begin by thanking the EMEA staff and scientific committees and working group members for the results achieved in 2004 in very challenging circumstances and at a time of many changes.
Danish: Jeg vil gerne indlede med at takke EMEA's medarbejdere og videnskabelige udvalg og medlemmerne af arbejdsgrupperne for de resultater, vi har opnået i 2004 under særdeles vanskelige vilkår.
English: Annex 6 National competent authority partners
Danish: Bilag 6 Partnere fra de nationale ansvarlige myndigheder
English: Legislative provisions implementing special measures for innovative medicines, technologies and therapies will help to provide more rapid access to medicines without compromising the safety of patients.
Danish: Særlige lovregler om innovative lægemidler, teknologier og behandlingsformer vil kunne give hurtigere adgang til lægemidler, uden at patienternes sikkerhed sættes på spil.
English: Integration of the new EU Member States
Danish: Integrering af de nye EU-lande
English: Preparations started for the full application of all provisions by 20 November 2005.
Danish: Forberedelserne til den fulde anvendelse af samtlige bestemmelser fra den 20. november 2005 er begyndt.
English: The three therapeutic areas where the number of applications was highest are oncology, HIV and diabetes.
Danish: De tre terapeutiske områder, der tegner sig for flest ansøgninger, er onkologi, hiv/aids og diabetes.
English: EDMS was successfully launched in September 2004 with an integrated helpdesk support service
Danish: EDMS blev lanceret med godt resultat i september 2004 med en integreret helpdesk- og supporttjeneste
English: The aim of this benchmarking system is to contribute to the development of a world-class regulatory system for medicinal products, based on a network of agencies operating to best-practice standards.
Danish: Formålet med dette benchmarking-system er at medvirke til etableringen af et verdensomspændende klassificeringssystem for lægemidler på grundlag af et netværk af agenturer og styrelser, der lever op til normerne for bedste praksis.
English: As a consequence of the new legislation, the Scientific Advice Working Group became a standing working party of the CHMP in May 2004.
Danish: Som følge af den nye lovgivning blev arbejdsgruppen vedrørende videnskabelig rådgivning i maj 2004 omdannet til en stående arbejdsgruppe under CHMP.
English: The EMEA received a total of 19 type-I variation applications (14 type-IA and 5 type-IB) less than half of the original 40 forecast.
Danish: EMEA modtog i alt 19 ansøgninger om type I-ændringer (14 type IA og 5 type IB - dvs. under halvdelen af de forventede 40).
English: Involving its partners and stakeholders in this consultation process allowed the EMEA to achieve a broad consensus on the best way forward for the Agency in an operating environment characterised by significant political, institutional, legislative and scientific developments.
Danish: Ved at inddrage sine samarbejdspartnere og relevante interessegrupper i denne høringsproces lykkedes det EMEA at skabe bred enighed om, hvad der er den bedste vej frem for agenturet i en situation, der er præget af store politiske, institutionelle, lovgivningsmæssige og videnskabelige forandringer.
English: The task of this group is to establish, together with the Member States, a cost-based reimbursement system for rapporteurship.
Danish: Denne gruppe har til opgave sammen med medlemsstaterne at fastlægge en omkostningsbaseret vederlagsordning for rapportørernes ydelser.
English: European experts list
Danish: Fortegnelse over europæiske eksperter
English: The EU enlargement, new scientific committee and new responsibilities of the EMEA arising from the parts of the new legislation that entered into force in 2004 generated a huge increase in the number of delegates and visitors coming to the Agency.
Danish: EU's udvidelse, det nye videnskabelige udvalg og EMEA's nye ansvarsområder, der følger af de dele af den nye lovgivning, der trådte i kraft i 2004, affødte en kraftig stigning i antallet af delegerede og besøgende til agenturet.
English: Its aim is to identify and report any potential safety issues relating to medicines and to prevent adverse drug reactions.
Danish: Formålet er at afdække og indberette eventuelle sikkerhedsrelaterede problemer med lægemidler og forebygge negative bivirkninger.
English: Following a comprehensive review of the EU's pharmaceutical legislative framework, which started in July 2001, the new European pharmaceutical legislation was published in the Official Journal of the European Union on 30 April 2004.
Danish: Efter den gennemgribende revision af grundlaget for EU's lægemiddellovgivning, som blev indledt i juli 2001, blev den nye EU-lægemiddellovgivning offentliggjort i Den Europæiske Unions Tidende den 30. april 2004.
English: • The Meeting Management System (MMS) was upgraded, including a new range of services.
Danish: • Mødestyringssystemet (MMS) blev opgraderet og kom til at omfatte flere nye værktøjer.
English: Type-II variations *The numbers include multiple procedures as stated at 31 December 2004.
Danish: Type II-ændringer *Tallene er fra den 31. december 2004 og omfatter også kombinerede procedurer.
English: Caitríona Fisher chaired the meetings during the Irish EU presidency and Truus Janse-de Hoog chaired the meetings during the Dutch EU presidency.
Danish: Caitríona Fisher ledede møderne som formand under det irske EUformandskab og afløstes af Truus Janse-de Hoog under det nederlandske EU-formandskab.
English: One-day individual implementation meetings were organised with each national competent authority to achieve better and more robust planning.
Danish: Der blev afholdt endags implementeringsmøder med hver enkelt national ansvarlig myndighed for at sikre en realistisk og fast planlægning.
English: Integrated quality management / audit
Danish: Integreret kvalitetsstyring/revision
English: The EMEA coordinated and chaired meetings of the Costing Group.
Danish: EMEA koordinerede og ledede møderne i gruppen vedrørende omkostningsberegning.
English: • The Agencys processes in relation to human medicines were further improved as a consequence of successful implementation of several short-term improvements, mainly stemming from the audit of the former CPMP conducted in 2003.
Danish: • Agenturets sagsbehandling vedrørende humanmedicinske lægemidler blev yderligere effektiviseret som resultat af implementeringen af flere forbedringer på kort sigt, som primært kunne tilskrives den revision af det tidligere CPMP, der blev foretaget i 2003.
English: Final appropriations for the 2003 budget.
Danish: Endelige bevillinger opført på budgettet for 2003.
English: This Committee will provide the Member States and the European institutions with the bestpossible scientific opinion on questions relating to herbal medicinal products.
Danish: Dette udvalg skal sikre medlemsstaterne og EU-institutionerne den bedst mulige videnskabelige ekspertise i spørgsmål vedrørende plantelægemidler.
English: Greater collaboration with non-EU authorities and increased dialogue with health organisations, academia and learned societies should facilitate a consistent regulatory approach for new technologies.
Danish: Et større samarbejde med myndighederne uden for EU og øget dialog med sundhedsorganisationer, forskere og videnskabelige kredse skulle gøre det lettere at opnå en ensartet lovgivningsmæssig tilgang til nye teknologier.
English: • Refurbishment of parts of the EMEA offices to accommodate new staff, telematics projects, and delegates and experts from the new Member States
Danish: • nyindretning af en del af EMEA's lokaler til brug for nye medarbejdere, telematikprojekter og delegerede og eksperter fra de nye medlemsstater.
English: Part A or B
Danish: Del A eller B
English: As part of the Agency s efforts to improve its structures and procedures, and as a follow-up to an audit of the former CPMP held in 2003, an EMEA action plan for the improvement of the Agency s core procedures and CHMP activities was developed.
Danish: Som led i agenturets bestræbelser på at forbedre sine strukturer og procedurer og som opfølgning på en revision af det tidligere CPMP, der blev gennemført i 2003, blev der udarbejdet en EMEAhandlingsplan for forbedringen af agenturets centrale procedurer og CHMP's aktiviteter.
English: To achieve 99.5 % availability for all IT services supporting the corporate activities of the EMEA
Danish: 99,5 % af alle IT-tjenester skal være til rådighed til støtte for EMEA's erhvervsrettede tjenester
English: The CVMP established the following standing and temporary working parties to assist its scientific assessment activities: Standing working parties
Danish: CVMP nedsatte følgende stående og midlertidige arbejdsgrupper til at bistå med de faglige vurderinger: Stående arbejdsgrupper
English: In addition to its ongoing work with the Commission services in 2004, the EMEA cooperated with other EU agencies, most notably the European Food Safety Authority (EFSA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).
Danish: Ud over den løbende kontakt med Kommissionens tjenestegrene i 2004 samarbejdede EMEA med andre agenturer, først og fremmest Den Europæiske Fødevaresikkerhedsautoritet (EFSA) og Det Europæiske Overvågningscenter for Narkotika og Narkotikamisbrug (EMCDDA).
English: This has been the overall experience since
Danish: Det har været det generelle indtryk siden 1998.
English: Considerable effort was made to prepare for the significant changes associated with the new legislation, which will come into full effect on 20 November 2005.
Danish: Der blev gjort en ihærdig indsats for at forberede de omfattende ændringer i forbindelse med den nye lovgivning, som træder i kraft i fuldt omfang den 20. november
English: Every holder of a manufacturing authorisation is required to implement an effective procedure for the recall of defective products.
Danish: Alle indehavere af en markedsføringstilladelse er forpligtet til at følge en effektiv procedure for tilbagekaldelse af fejlbehæftede produkter.
English: A procurement plan for the whole Agency was compiled, providing a framework for tenders launched over the course of the year.
Danish: Der blev udarbejdet en samlet indkøbsplan for hele agenturet, som kan danne rammen om de udbud, der iværksættes i årets løb.
English: Following this, the EMEA decided to expedite the review of COX-2 inhibitors in the context of the ongoing procedure.
Danish: Herefter besluttede EMEA at fremskynde undersøgelsen af COX-2-hæmmere i forbindelse med den igangværende procedure.
English: Cooperation between the EMEA and the World Health Organization (WHO) was strengthened during 2004.
Danish: Samarbejdet mellem EMEA og WHO blev intensiveret i 2004.
English: A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Danish: EMEA har efterhånden udgivet en bred vifte af dokumenter, herunder pressemeddelelser, generelt informationsmateriale, årsberetninger og arbejdsprogrammer.
English: This is a 36 % increase compared to the previous year.
Danish: Det er en stigning på 36 % i forhold til året før.
English: One application involved collaboration with the Food and Drug Administration (FDA) on a parallel protocol assistance procedure, which was also subject to a follow-up procedure.
Danish: Den ene anmodning indebar samarbejde med US Food and Drug Administration (FDA) om en parallel procedure for protokolbistand, som også omfattede en opfølgningsprocedure.