FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommendations were the outcome of an extensive external consultation exercise with the Agency's partners and stakeholders.
Danish: Henstillingerne var et resultat af en omfattende ekstern høringsøvelse med deltagelse af agenturets partnere og aktører.
English: Initiatives in the areas of risk detection, risk assessment, risk minimisation and risk communication
Danish: Initiativer inden for risikosporing, risikovurdering, risikominimering og risikokommunikation
English: As anticipated, 2005 was quite an extraordinary year for the European Medicines Agency.
Danish: 2005 var som forventet et ganske usædvanligt år for Det Europæiske Lægemiddelagentur.
English: The Agency was given responsibility for implementing the EU telematics strategy agreed by the European Commission, Member States and the EMEA.
Danish: Agenturet fik ansvaret for at gennemføre EU's telematikstrategi, som er aftalt mellem EuropaKommissionen, medlemsstaterne og EMEA.
English: By August 2005, 500 GMP inspections had been completed since the start of the operation of the centralised procedure.
Danish: Inden august 2005 var der blevet foretaget 500 GMP-inspektioner siden indførelsen af den centraliserede procedure.
English: In addition, I would like to thank the Member States' competent authorities, which, together with the EMEA, form the core regulatory network for medicinal products.
Danish: Jeg vil desuden benytte lejligheden til at takke medlemsstaternes kompetente myndigheder, som sammen med EMEA udgør det grundlæggende lægemiddelreguleringsnetværk.
English: These stakeholders reported electronically a total of 144,786 individual case safety reports (ICSRs) originating from within and outside the EU.
Danish: Disse parter foretog i alt 144 786 elektroniske individuelle sikkerhedsindberetninger (ICSR) både fra tredjelande og EU-lande.
English: Thomas Lönngren was unanimously appointed by the Management Board to serve in this demanding post for another five-year period, from 2006 to 2010.
Danish: Bestyrelsen udnævnte enstemmigt Thomas Lönngren til at varetage denne krævende stilling for en ny femårig periode fra 2006 til 2010.
English: The list was submitted to the Commission in May 2005 to serve as basis for a list of essential substances, which is provided for by the new legislation .
Danish: Denne liste blev fremsendt til Kommissionen i maj 2005 med henblik på at fungere som basis for en liste over væsentlige stoffer, som fastsættes i den nye lovgivning.
English: The Management Board has been closely following the progress of the European innovation and technology platform, especially in the area of veterinary medicines.
Danish: Bestyrelsen har nøje fulgt udviklingen i den europæiske innovations- og teknologiplatform, navnlig inden for veterinærlægemidler.
English: An initial prototype was demonstrated to the responsible implementation group in December.
Danish: I december 2005 blev den første prototype fremlagt for den ansvarlige gennemførelsesgruppe.
English: Management and internal-control systems are part of EMEA corporate governance and are consolidated in an integrated management system at the EMEA.
Danish: Styrings- og interne kontrolsystemer indgår i EMEA's virksomhedsledelse og er konsolideret i et integreret styringssystem i EMEA.
English: At the same time, it provides new tools for strengthened protection of public health.
Danish: Den indfører samtidig nye redskaber til en øget beskyttelse af folkesundheden.
English: The overall volume of pre- and post-authorisation applications received was high, but the Agency was able to handle its tasks successfully.
Danish: Det samlede antal ansøgninger om markedsføringstilladelser før og efter godkendelse var stort, men agenturet var i stand til at håndtere sine opgaver med succes.
English: In addition, there were 74 type-II variations relating to special warnings and precautions for use.
Danish: Derudover var der 74 type II-ændringer vedrørende særlige advarsler og forholdsregler ved brug.
English: This has been achieved by rationalisation of human resources and further process automation.
Danish: Dette kunne lade sig gøre ved at rationalisere personaleressourcerne og øge automatiseringen af procedurerne.
English: Strengthening the Agency's interaction with European industry associations representing the innovative, generic and self-medication industries
Danish: Styrkelse af agenturets interaktion med europæiske industriorganisationer, som repræsenterer industrier, der fremstiller innovative, generiske lægemidler og lægemidler til selvmedicinering
English: A special group (ERMS facilitation group) was set up to oversee the delivery of these key objectives through the development of a rolling work plan for 2005-2007.
Danish: Der blev nedsat en særlig gruppe til at overvåge opfyldelsen af disse hovedmål gennem udvikling af en rullende arbejdsplan for 2005-2007.
English: Suspension of a centrally authorised hexavalent vaccine due to concerns over the level of longterm protection offered by one of its components
Danish: Suspension af en centralt godkendt heksavalent vaccine som følge af bekymringer over en af komponenternes langsigtede beskyttelsesniveau
English: The majority of results show that the products were of high quality and complied with their specifications.
Danish: Hovedparten af de indberettede resultater viste, at lægemidlerne var af høj kvalitet og i overensstemmelse med deres specifikationer.
English: The evaluation period for the pandemic variation is then expected to be very short, typically less than one week.
Danish: Evalueringsperioden for den pandemiske variant kan dermed afkortes betydeligt og vil typisk komme til at ligge på en uge.
English: An action plan to further progress the European risk management strategy (ERMS) was published in May 2005, covering a number of key aspects including:
Danish: I maj 2005 blev der offentliggjort en handlingsplan for fremme af den europæiske risikostyringsstrategi (ERMS), som omfattede en række vigtige aspekter, herunder:
English: During 2005, the Agency provided guidance in preparation for the entry into force of the revised legislation.
Danish: I løbet af 2005 udarbejdede agenturet en vejledning i forbindelse med den reviderede lovgivnings ikrafttræden.
English: I know I can rely on your continuing commitment as we bring the EMEA forward into its second decade.
Danish: Jeg ved, jeg kan regne med jeres fortsatte støtte nu, hvor EMEA går ind i sit andet tiår.
English: Work on the completion of phase 2a of EudraCT, the European Clinical Trails registration database, was delayed due to unforeseen difficulties with the final steps of the upgrade to version
Danish: Arbejdet med at færdiggøre fase 2a af EudraCT, den europæiske database over kliniske undersøgelser, blev forsinket på grund af uforudsete vanskeligheder med den afsluttende opgradering af basen til version 3.0.0.
English: The 11th year of operation of the European Medicines Agency (EMEA) was eventful.
Danish: Det Europæiske Lægemiddelagenturs (EMEA) 11. driftsår var begivenhedsrigt.
English: The EMEA provided full secretariat and administrative support to the work of the two coordination groups.
Danish: EMEA stillede sit sekretariat og sin administration til rådighed for de to koordineringsgruppers arbejde.
English: As the EU institutions progressed their discussions in 2005 on new EU legislation on medicines for children, over half of the designation opinions in 2005 were for conditions that affect children.
Danish: Da EU-institutionerne i 2005 afviklede deres drøftelser om den nye EU-lovgivning for lægemidler til børn, vedrørte over halvdelen af udtalelserne om udpegning i 2005 sygdomme, som påvirker børn.
English: the successful launch of the Agency's SME Office, which provides specific assistance to the smaller companies that are so often at the cutting edge of medicinal technologies development;
Danish: den vellykkede lancering af agenturets SMV-kontor, som yder særlig bistand til de mindre virksomheder, der så ofte er banebrydende inden for medicinsk teknologiudvikling,
English: The strategy includes earlier and more frequent involvement of experts particularly on rare diseases and new therapies.
Danish: Denne nye strategi omfatter tidligere og hyppigere inddragelse af eksperter, især i forbindelse med sjældne sygdomme og nye behandlingsformer.
English: The year 2005 was the first full year of operation of the Committee on Herbal Medicinal Products (HMPC), following its inaugural meeting in September 2004.
Danish: 2005 var det første hele år for aktiviteterne i Udvalget for Plantelægemidler (HMPC) efter dets stiftende møde i september 2004.
English: To further improve the management of translations, the Management Board adopted a revised EMEA translation policy in September 2005.
Danish: For yderligere at forbedre styringen af oversættelser vedtog bestyrelsen i september 2005 en revideret oversættelsespolitik for EMEA.
English: In years to come, the EMEA will need further top-quality expertise and will be increasingly reliant on the Member States and their authorities to offer this.
Danish: EMEA vil i de kommende år få brug for mere ekspertise og vil i stadig højere grad skulle søge denne ekspertise hos medlemsstaterne og deres myndigheder.
English: Strengthening interaction with patients' and consumers' organisations
Danish: Styrkelse af samarbejdet med patient- og forbrugerorganisationer
English: 5 INSPECTIONS
Danish: 5 INSPEKTIONSVIRKSOMHED
English: Now, with a decade of very solid progress behind it, and a good long-term plan in place to guide its forward evolution, the Agency is in better shape than ever to pursue its mission for the protection and promotion of health in Europe.
Danish: Med et årtis særdeles solide fremskridt bag sig og en god langsigtet plan for den fremtidige udvikling er agenturet nu i bedre form end nogensinde til at varetage sin opgave, som er at beskytte og fremme sundheden i Europa.
English: The EMEA will be involved in the issues of relative effectiveness and provision of information to patients.
Danish: EMEA vil blive involveret i spørgsmålene om relativ effektivitet og formidling af information til patienter.
English: Improvements to scientific and other business practices helped the Agency to deliver very good performance results for the year.
Danish: Forbedret videnskabelig og anden praksis medvirkede til, at agenturet kunne præstere særdeles gode resultater i årets løb.
English: The Agency made continuous improvements to its processes and interfaces with partners in the European network and ensures the logistics of the benchmarking of medicines agencies of 28 EU/EEA countries.
Danish: Agenturet forbedrede løbende sine processer og sit samarbejde med partnerne i det europæiske netværk og sikrer logistikken i benchmarkingen af lægemiddelstyrelserne i 28 EU/EØS-lande.
English: Only 32 reports related to food-producing animals.
Danish: Kun 32 indberetninger vedrørte dyrearter beregnet til levnedsmiddelproduktion.
English: Summary of the annual report of the European Medicines Agency
Danish: Sammendrag af årsberetningen for Det Europæiske Lægemiddelagentur
English: EudraGMP: Work on the development of this system, the Community database of manufacturing authorisations and of certificates of good manufacturing practice, began.
Danish: EudraGMP: Arbejdet med at udvikle dette system, som er EU's database over fremstillingstilladelser og certifikater for god fremstillingspraksis, blev påbegyndt.
English: The training profiles aim for a continuous system of competence development and help to identify outstanding training needs.
Danish: Disse uddannelsesprofiler har til formål at sikre et vedvarende system for kompetenceudvikling og bidrage til at identificere særlige uddannelsesbehov.
English: In the beginning of 2005, the Agency published its long-term strategy, the ‘European Medicines Agency Road Map to 2010: Preparing the Ground for the Future'.
Danish: Agenturet offentliggjorde i begyndelsen af 2005 sin langsigtede strategi "European Medicines Agency Road Map to 2010: Preparing the Ground for the Future" (Det Europæiske Lægemiddelagenturs køreplan frem til 2010: Forberedelse til fremtiden).
English: The Committee concluded in November 2005 that, based on the available evidence, no action to protect consumer safety or animal safety was necessary.
Danish: I november 2005 konkluderede udvalget, at det på baggrund af de foreliggende oplysninger ikke var nødvendigt at træffe foranstaltninger til yderligere sikring af forbruger- og dyresikkerheden.
English: Despite the increasing number of requests, the average issuing time has remained within procedural limits.
Danish: På trods af det stigende antal ansøgninger om markedsføringstilladelser holdt den gennemsnitlige udstedelsestid sig inden for de fastsatte tidsgrænser.
English: While only few scientific advice applications for MUMS products have been received since the scheme was introduced in October 2003, industry have confirmed high interest.
Danish: Selv om der kun er modtaget få ansøgninger om videnskabelig rådgivning i forbindelse med MUMS, efter at ordningen blev indført i oktober 2003, har industrien vist stor interesse.
English: The Agency contributed to the development of a proposed regulation on advanced therapies.
Danish: Agenturet bidrog til udarbejdelsen af et udkast til forordning om avancerede behandlingsformer.
English: The extrapolations are carried out without specific applications or payment of fees, provided the criteria detailed in the relevant CVMP guideline are met, thus ensuring consumer safety.
Danish: Ekstrapoleringerne udføres, uden at der foreligger særlige ansøgninger og uden opkrævning af gebyrer under forudsætning af, at de kriterier, der beskrives nærmere i de relevante CVMP-retningslinjer, er opfyldt og forbrugersikkerheden garanteret.
English: A survey of SMEs was carried out in 2005 to understand their specific needs and expectations, and a first meeting with SME stakeholder organisations was held to discuss the results.
Danish: Der blev i 2005 gennemført en undersøgelse af SMV'er for at forstå deres særlige behov og forventninger, og det første møde med interesseorganisationer for SMV'erne blev afholdt for at drøfte resultaterne af undersøgelsen.
English: In 2005, the Agency discussed implementation plans for electronic reporting with major partners in the veterinary pharmaceutical industry.
Danish: I 2005 drøftede agenturet gennemførelsen af planer for elektronisk indberetning med de største partnere i veterinærlægemiddelindustrien.
English: 3.2.3 Maximum residue limits
Danish: 3.2.3 Maksimalgrænseværdier for restkoncentrationer
English: Contributions were made to the Innovative Medicines Initiative (IMI), the development of the European Technology Platform on Global Animal Health (ETPGAH), and the establishment of priorities for rare diseases.
Danish: Der blev ydet bidrag til initiativet vedrørende innovative lægemidler (IMI), udviklingen af den europæiske teknologiplatform for global dyresundhed (ETPGAH) og oprettelsen af en prioritetsliste for sjældne sygdomme.
English: The number of applications for variations to marketing authorisations increased once again in 2005.
Danish: Antallet af ansøgninger om ændringer af markedsføringstilladelsen steg atter i 2005.
English: As part of the revised pharmaceutical legislation, all new applications for marketing authorisation and applications for major changes to existing authorisations must be accompanied by a risk management plan.
Danish: Som en del af den reviderede lægemiddellovgivning skal alle nye ansøgninger om markedsføringstilladelser for store ændringer af eksisterende tilladelser ledsages af en risikostyringsplan.
English: This development will greatly enhance the ability of the EMEA to evaluate the safety of medicines.
Danish: Denne udvikling vil i høj grad øge EMEA's muligheder for at evaluere lægemiddelsikkerheden.
English: In addition, 67 sponsors conducting clinical trials within the European Economic Area (EEA) were reporting suspected unexpected serious adverse reactions (SUSARs) to the EudraVigilance Clinical Trial Module (EVCTM).
Danish: Herudover indberettede 67 sponsorer, som udfører kliniske undersøgelser inden for Det Europæiske Økonomiske Samarbejdsområde (EØS), formodede uventede alvorlige bivirkninger (SUSAR) til EudraVigilance-modulet for kliniske undersøgelser (EVCTM).
English: As a result, the Agency was immediately able to embrace its new responsibilities and begin offering an extended range of services in support of European efforts to bring innovative new medicines to the market.
Danish: Som følge heraf kunne agenturet umiddelbart påtage sig sit nye ansvar og begynde at tilbyde en bredere vifte af tjenesteydelser til støtte for de europæiske bestræbelser på at bringe nye innovative lægemidler på markedet.
English: the implementation of procedures for greater (and in some cases free) provision of early-stage scientific advice to companies developing ‘breakthrough' medicines;
Danish: gennemførelsen af procedurerne for mere omfattende (og i visse tilfælde gratis) videnskabelig rådgivning på et tidligt tidspunkt for virksomheder, som udvikler ‘banebrydende' lægemidler,
English: In 2005 this included the annual management review, which aims to ensure that management tools are effective and suitable in relation to the Agency's needs, and a self-assessment carried out in the context of the EU benchmarking system in order to improve the EMEA management system.
Danish: Dette system omfattede i 2005 en årlig ledelsesrevision, som har til formål at sikre, at ledelsesværktøjerne er effektive og afstemte til agenturets behov, og en selvevaluering, som udføres inden for rammerne af EU's benchmarking-system, med henblik på at forbedre EMEA's styringssystem.
English: A new strategy for providing scientific advice
Danish: En ny strategi for videnskabelig rådgivning
English: The SME Office has the sole remit of offering assistance to SMEs.
Danish: SMV-kontoret har alene til opgave at yde administrativ bistand til SMV'er.
English: The Agency made good progress with national competent authorities in further developing and implementing the 2003 European risk management strategy (ERMS) that looks at how to better identify and manage safety issues.
Danish: Agenturet har sammen med de nationale kompetente myndigheder gjort store fremskridt inden for udvikling og gennemførelse af den europæiske risikostyringsstrategi for 2003 (ERMS), som behandler måder til forbedring af fastlæggelsen og håndteringen af sikkerhedsspørgsmål.
English: In addition to its own internal activities, the EMEA also cooperated in 2005 with the European Commission Directorate-General for Research in the context of the ‘Innovative Medicines Initiative' of the 7th Framework Programme for research, technological development and demonstration activities (2007-2013).
Danish: Ved siden af sine egne interne aktiviteter samarbejdede EMEA i 2005 også med EuropaKommissionens Generaldirektorat for Forskning om initiativet vedrørende innovative lægemidler i det syvende rammeprogram for forskning, teknologisk udvikling og demonstration (2007-2013).
English: A number of important actions were carried out, aimed at improving electronic reporting of post-authorisation safety information, improving the exchange of safety information within the EU, and ensuring adequate surveillance and harmonised action.
Danish: Der blev gennemført en række vigtige aktioner, som havde til formål at forbedre den elektroniske indberetning af sikkerhedsoplysninger efter godkendelse samt forbedre udvekslingen af sikkerhedsoplysninger inden for EU og sikre passende overvågning og harmoniserede foranstaltninger.
English: 13 EU TELEMATICS STRATEGY AND INFORMATION TECHNOLOGY
Danish: 13 EU'S TELEMATIKSTRATEGI OG INFORMATIONSTEKNOLOGI
English: The SME Office aims to facilitate communication with SMEs through dedicated personnel within the Agency who respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs.
Danish: SMV-kontoret har til formål at lette kommunikationen med SMV'er gennem agenturets hertil ansatte personale, som besvarer praktiske og proceduremæssige spørgsmål, overvåger ansøgninger og organiserer workshopper og uddannelsesforløb for SMV'er.
English: This policy put in place a framework for the checking of translations of product information by the national competent authorities, and set up a financial compensation scheme.
Danish: Med denne politik fastsættes rammerne for de nationale kompetente myndigheders kontrol af oversættelser af produktinformation, og der indføres en godtgørelsesordning.
English: There was a similar increase in the number of finalised post-authorisation procedures, particularly those for type-II variations.
Danish: Der var en tilsvarende stigning i antallet af procedurer efter godkendelse, navnlig procedurer for type II-ændringer.
English: A total of 880 suspected signals, concerning 87 products, were detected and investigated.
Danish: Der blev opfanget og undersøgt i alt 880 formodede signaler, som vedrørte 87 produkter.
English: Once adopted products containing the listed substances can be used by veterinarians for the treatment of horses under the conditions of the ‘cascade principle' providing a minimum 6-month withdrawal period is applied.
Danish: Når denne liste er vedtaget, kan produkter, der indeholder de anførte stoffer, bruges af dyrlæger til behandling af heste i henhold til betingelserne i henhold til "kaskadeprincippet" under forudsætning af, at princippet om en tilbageholdelsestid på seks måneder anvendes.
English: The Agency dealt with a number of major safety issues in 2005, involving both centrally and noncentrally authorised medicines for human use, including:
Danish: Agenturet behandlede en lang række vigtige sikkerhedsspørgsmål i 2005, som vedrørte centralt og decentralt godkendte humanmedicinske lægemidler, herunder:
English: the introduction of new measures to accelerate the assessment of medicines that are of critical importance to public health.
Danish: indførelsen af nye foranstaltninger med sigte på at fremskynde vurderingen af lægemidler, som er af afgørende betydning for folkesundheden.
English: Work began in 2005 on implementing this new provision, which will require plans to identify any known or potential risks associated with the medicinal product concerned.
Danish: Arbejdet med at gennemføre denne nye bestemmelse blev indledt i 2005, og den kræver planer til at identificere enhver kendt eller potentiel risiko forbundet med det pågældende lægemiddel.
English: To address the specific needs of smaller companies, an additional, simple electronic reporting form was developed for use at Member State level by smaller marketing authorisation holders.
Danish: For at imødekomme mindre firmaers særlige behov blev der udviklet en supplerende enkel indberetningsformular, som skal anvendes i medlemsstaterne af mindre indehavere af markedsføringstilladelser.
English: The Agency also developed guidelines and concept papers designed to improve the consistency of safety data assessments.
Danish: Agenturet udarbejdede desuden retningslinjer og oplæg, som sigter på at gøre vurderingerne af sikkerhedsoplysninger mere sammenhængende.
English: Good progress was made with the implementation of EudraVigilance in 2005, with 23 national competent authorities and 105 marketing authorisation holders reporting electronically to the EudraVigilance Post-Authorisation Module (EVPM).
Danish: Der blev i 2005 gjort gode fremskridt med gennemførelsen af EudraVigilance, idet 23 nationale kompetente myndigheder og 105 indehavere af markedsføringstilladelser foretog elektroniske indberetninger til EudraVigilance Post-Authorisation Module (EVPM).
English: Competitiveness of the European pharmaceutical industry in the context of the ‘Lisbon Agenda' remains high on the political agenda.
Danish: Den europæiske lægemiddelindustris konkurrenceevne er i overensstemmelse med Lissabondagsordenen fortsat en politisk prioritering.