FrancophonIA/ELRC3.0 huggingface dataset:
English: Two informal meetings were held in 2004: one in Cork, in May, under the Irish presidency, and one in Rotterdam, in November, under the Dutch presidency.
Danish: Der blev desuden i 2004 afholdt to uformelle møder, et i Cork i maj under det irske formandskab og et i Rotterdam i november under det nederlandske formandskab.
English: Good relations were maintained with Industry, academia and other stakeholders, while cooperation with and support from the European Commission and Parliament were also extremely good.
Danish: De gode relationer til industrien, videnskabelige kredse og andre interessegrupper blev opretholdt, og samarbejdet med og støtten fra Europa-Kommissionen og Europa-Parlamentet var ligeledes særdeles godt.
English: So far, 15 companies, mainly EU-based, have contacted the EMEA expressing interest in the procedure.
Danish: Foreløbig har 15 virksomheder, hvoraf hovedparten er hjemmehørende i EU, kontaktet EMEA og givet udtryk for interesse for en sådan procedure.
English: Meetings management system (MMS)
Danish: Mødestyringssystemer (MMS)
English: For product defect and other quality-related matters:
Danish: Spørgsmål vedrørende produktfejl og andre kvalitetsrelaterede spørgsmål:
English: They are intended to guarantee a consistent level of internal control of all business activities throughout the Agency, whether their financial impact is direct or indirect.
Danish: Formålet er at sikre ensartet og konsekvent intern kontrol med alle agenturets forretningsmæssige aktiviteter, uanset om de har direkte eller indirekte finansielle konsekvenser.
English: Previous annual reports and other reference documents are available from the EMEA website:
Danish: Tidligere årsberetninger og andre referencedokumenter er tilgængelige på EMEA's websted:
English: In some cases where the applicant has been unable to address these questions and the dossier was heading for a negative opinion, this has led to the withdrawal of the application.
Danish: I visse tilfælde, hvor ansøgeren ikke var i stand til at besvare spørgsmålene tilfredsstillende, og resultatet kunne forventes at blive en negativ udtalelse, blev ansøgningen trukket tilbage.
English: One product was not renewed and, therefore, its marketing authorisation expired in 2004.
Danish: Et produkt fik ikke fornyet godkendelsen, og markedsføringstilladelsen udløb således i 2004.
English: In addition to the members appointed by the European Commission and the European Parliament, the new Board will also have representatives from doctors and patients organisations.
Danish: Ud over de bestyrelsesmedlemmer, der udpeges af Europa-Kommissionen og Europa-Parlamentet, vil den nye bestyrelse også omfatte repræsentanter for læge- og patientorganisationer.
English: The EU s revised pharmaceutical legislation and the expansion of the total number of Member States to 25 brought about changes to the composition of the Management Board.
Danish: EU's reviderede lægemiddellovgivning og udvidelsen af antallet af medlemsstater til 25 indebar også ændringer i bestyrelsens sammensætning.
English: The CVMP adopted 10 positive opinions for veterinary medicines, including 8 vaccines.
Danish: CVMP vedtog ti positive udtalelser for veterinærlægemidler, herunder otte vacciner.
English: As regards core operations, 2004 was an extremely active year for the EMEA.
Danish: Hvad angår kerneaktiviteterne, var 2004 et særdeles travlt år for EMEA.
English: Positive Withdrawn prior to opinion Negative
Danish: Positiv Tilbagekaldelse før udtalelsen Negativ
English: A commitment was made in 2003 to implement a large number of projects in 2004.
Danish: Der blev i 2003 givet tilsagn om gennemførelse af et større antal projekter i 2004.
English: The new products that received a positive opinion in 2004 will benefit patients in the following areas:
Danish: De nye produkter, der fik en positiv udtalelse i 2004, er beregnet til behandling af patienter inden for følgende sygdomsområder:
English: The European system offers two routes for authorisation of medicinal products.
Danish: Det europæiske system består af to procedurer for godkendelse af lægemidler.
English: 253 periodic safety update reports (PSURs) were reviewed in 2004.
Danish: 253 periodiske opdaterede sikkerhedsindberetninger (PSUR) blev gennemgået i 2004.
English: 5 EU telematics strategy
Danish: 5 EU's telematikstrategi
English: I am pleased to report that the integration of the 10 new Member States into the European regulatory network was successful beyond all expectations thanks to excellent preparatory work conducted in the years leading up to the EU enlargement.
Danish: Det er mig en glæde at kunne meddele, at de ti nye medlemsstaters integrering i EU's regelværk lykkedes i en grad, der langt oversteg forventningerne - takket være det glimrende forberedende arbejde, der fandt sted i årene op til selve udvidelsen.
English: This should facilitate the future introduction of risk management plans as foreseen in the new Community legislation and compliance with the ICH E2E concept of pharmacovigilance planning.
Danish: Det skulle lette den kommende indførelse af risikostyringsplaner, der er forudset i den nye EU-lovgivning, og overholdelsen af ICH E2E-konceptet for planlægningen af lægemiddelovervågning.
English: Storage capability in the data centre
Danish: Lagerkapacitet i datacentret
English: A total of 87 requests were received and 77 were finalised.
Danish: Agenturet modtog i alt 87 anmodninger, og 77 anmodninger blev færdigbehandlet.
English: The Agency carried out sampling and testing activities as planned.
Danish: Agenturet gennemførte aktiviteterne i forbindelse med stikprøveudtagning og afprøvning som planlagt.
English: The work for final MRLs for these two substances is well underway and is likely to be completed in 2005.
Danish: Undersøgelserne med henblik på endelige maksimale grænseværdier for disse to stoffer er godt i gang og forventes afsluttet i 2005.
English: Rapid procedure for updating product information
Danish: Hasteprocedure for ajourføring af produktinformation
English: The PAT team held 5 meetings in 2004 and established contacts with 3 pharmaceutical companies.
Danish: PAT-gruppen holdt fem møder i 2004 og tog kontakt til tre medicinalvirksomheder.
English: The Management Board adopted the EMEA quality policy in March 2004, with a revision in June 2004.
Danish: Bestyrelsen vedtog EMEA's kvalitetspolitik i marts 2004 med en revision i juni 2004.
English: • EudraNet II in operation by May 2004
Danish: • EudraNet II kunne tages i brug inden maj 2004
English: If food animals are treated with medicines, residues may remain in the food produced by or from them.
Danish: Hvis dyr, hvis produkter anvendes til menneskeføde, behandles med lægemidler, kan der være restkoncentrationer i de fødevarer, der produceres fra eller af dem.
English: Topics included risk management strategies, pharmacovigilance and the implementation of the European telematics strategy.
Danish: Blandt emnerne var risikostyringsstrategier, lægemiddelovervågning og implementeringen af den europæiske telematikstrategi.
English: A hepatitis A and B vaccine had its use extended to children aged 1 to 5 years.
Danish: En vaccine mod hepatitis A og B fik udvidet anvendelsesmulighederne til at omfatte børn i alderen 1 til 5 år.
English: Work relating to the improvement of various aspects of the management of referral procedures, which started in 2003, continued throughout 2004.
Danish: Arbejdet med at forbedre forskellige aspekter af forvaltningen af henvisningsprocedurerne, der blev indledt i 2003, fortsatte i hele 2004.
English: Version 2.1.1 adopted in July 2004
Danish: Version 2.1.1 vedtaget i juli 2004
English: International partners
Danish: Internationale partnere
English: Pharmacovigilance involves a process of continuous monitoring of medicinal products on the market.
Danish: Lægemiddelovervågning indebærer løbende tilsyn med lægemidler på markedet.
English: The Agency continually strives to improve the structures and procedures of the scientific evaluation of medicinal products.
Danish: Agenturet arbejder løbende på at forbedre strukturerne og procedurerne for den faglige vurdering af lægemidler.
English: Discussions were ongoing to bring about further development and improvements in the services provided.
Danish: Der blev løbende ført drøftelser om yderligere forbedringer og videreudvikling af de tjenesteydelser, der tilbydes.
English: Support to sponsors
Danish: Støtte til sponsorer
English: The EU enlargement in May 2004, with the accession of 10 new Member States, had a significant impact on the EU, its institutions and agencies.
Danish: EU's udvidelse i maj 2004 med ti nye medlemsstater havde store konsekvenser både for EU og for dets institutioner og agenturer.
English: The HMPWP continued its work in 2004 until the inauguration of the HMPC in September 2004.
Danish: HMPWP fortsatte sit arbejde i 2004, indtil HMPC var blevet nedsat i september 2004.
English: The volume of the third parties database grew significantly in 2004, with over 1 000 parties added.
Danish: Databasen over tredjeparter blev betragteligt udvidet i 2004, idet der blev tilføjet over 1 000 nye tredjeparter.
English: For half of the applications, the clock stop was over 200 days, while for others it was shorter in a number of cases, as short as 50 or 60 days.
Danish: For halvdelen af ansøgningernes vedkommende var "uret sat i stå" i mere end 200 dage, men for andre var det langt mindre - i visse tilfælde helt ned til 50-60 dage.
English: EMEA contact points and reference documents
Danish: EMEA's kontaktpunkter og referencedokumenter
English: In 2004, the EMEA validated 402 initial parallel distribution notifications and finalised 373 initial notifications.
Danish: I 2004 validerede EMEA 402 indledende anmeldelser af paralleldistribution og færdigbehandlede 373 sådanne anmeldelser.
English: The resulting long-term strategy is one that takes a realistic view of the challenges facing the Agency and the EU regulatory system as a whole, while offering viable proposals as to how those challenges can be met.
Danish: Den langsigtede strategi, der blev resultatet, forholder sig realistisk til de udfordringer, agenturet og EU-lovgivningssystemet som helhed står overfor, og indeholder samtidig konkrete forslag til, hvordan disse udfordringer skal klares.
English: The constant monitoring of the safety of medicines after authorisation ( pharmacovigilance ) is an important part of the work of the national competent authorities and the EMEA.
Danish: Den fortløbende overvågning af lægemidlers sikkerhed efter godkendelse (‘lægemiddelovervågning') er en vigtig del af de nationale ansvarlige myndigheders og EMEA's arbejde.
English: On 1 May 2004, the new Regulations and Rules applicable to officials and other servants of the European Communities entered into force.
Danish: Den 1. maj 2004 trådte den nye vedtægt for tjenestemand og øvrige ansatte i De Europæiske Fællesskaber i kraft.
English: In addition, the EMEA participated in the eleventh International Conference of Drug Regulatory Authorities (ICDRA), in Madrid.
Danish: EMEA deltog desuden i den ellevte internationale konference for myndigheder med ansvar for narkotikalovgivningen (ICDRA) i Madrid.
English: Of the medicinal products having received a positive opinion, some were more notable in terms of therapeutic progress:
Danish: Af de lægemidler, der fik en positiv udtalelse, var nogle særligt bemærkelsesværdige på grund af behandlingsmæssige nyskabelser:
English: Adopted by the Management Board on 10 March 2005
Danish: Vedtaget af bestyrelsen den 10. marts 2005
English: Recommendations and advice provided include general public-health issues relating to veterinary medicinal products.
Danish: Anbefalingerne og rådgivningen omfatter også generelle spørgsmål af betydning for folkesundheden i relation til veterinærlægemidler.
English: European surveillance strategy
Danish: Den europæiske overvågningsstrategi
English: • A pilot data-warehousing and business intelligence system was put in place
Danish: • Der blev etableret et forsøgsmæssigt data warehousing- og business intelligence-system
English: Products placed on the market in one Member State can be marketed in any other part of the Community by a parallel distributor independent of the marketing authorisation holder.
Danish: Produkter, der er bragt på markedet i en medlemsstat, kan markedsføres i en anden del af EU via en ‘paralleldistributør', der er uafhængig af indehaveren af markedsføringstilladelsen.
English: The Committee on Herbal Medicinal Products (HMPC) held its inaugural meeting on 23 September 2004.
Danish: Udvalget for Plantelægemidler (HMPC) afholdt sit første møde den 23. september 2004.
English: In 2004, several marketing authorisations were extended in order to provide more treatment options for children.
Danish: I 2004 blev flere markedsføringstilladelser udvidet for at give flere behandlingsmuligheder for børn.
English: In 2004, annual reports of the sampling and testing results were produced for the first time, starting with the 2003 programme.
Danish: I 2004 blev der for første gang udarbejdet årsrapporter om resultaterne af stikprøveudtagninger og afprøvninger begyndende med programmet for 2003.
English: The batch certificate format has been adapted to include investigational medicinal products and active substances.
Danish: Batch-certifikatets udformning er blevet tilpasset til at omfatte testpræparater og aktive stoffer.
English: Elements of the new legislation which came into force in 2004 include:
Danish: Blandt de elementer i den nye lovgivning, der trådte i kraft i 2004, kan nævnes:
English: 3.9 Management and organisation of the CVMP
Danish: 3.9 Ledelse og organisering af CVMP
English: Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect not more than five in 10 000 people in the European Union.
Danish: Lægemidler til sjældne sygdomme er beregnet til diagnosticering, forebyggelse eller behandling af livstruende eller kronisk invaliderende sygdomstilstande, der forekommer hos højst fem ud af 10 000 personer i EU.
English: The first meeting of the new Committee, which for the first time included representatives from the 10 new EU Member States as full members, took place from 1 3 June 2004.
Danish: Det nye udvalgs første møde, hvori repræsentanter for de ti nye EU-lande for første gang deltog som fuldgyldige medlemmer, fandt sted den 1.-3. juni 2004.
English: Surpluses in one budget year are returned to the Commission, where they are earmarked to compensate for shortfalls in fee income in following budget years.
Danish: Overskud i et regnskabsår tilbageføres til Kommissionen, hvor det øremærkes til at dække manglende gebyrindtægter i følgende regnskabsår.
English: Where the original national authorisation cannot be recognised, the points in dispute are submitted to the EMEA for arbitration.
Danish: Hvis den oprindelige nationale godkendelse ikke kan anerkendes, forelægges tvisten for EMEA til voldgift.
English: A further 40 % increase in the number of travel and hotel bookings for reimbursed delegates occurred, as well as a 20 % increase in hotel booking requirements for non-reimbursed delegates.
Danish: Der var desuden tale om en stigning på 40 % i antallet af rejse- og hotelreservationer for de delegerede, der modtog godtgørelse, samt en stigning på 20 % i anmodninger om hotelreservationer for delegerede, der ikke modtog godtgørelse.
English: First contacts were established during 2004 with the new European Centre for Disease Prevention and Control (ECDC).
Danish: Der blev desuden i 2004 etableret en første kontakt til Det Europæiske Center for Sygdomsforebyggelse og -kontrol (ECDC).
English: IT maintained high service levels throughout 2004, achieving more than 99.5 % availability to corporate users
Danish: IT opretholdt et højt serviceniveau i hele 2004 med en rådighedsgrad på over 99,5 % for brugerne i erhvervslivet
English: This report covers activities of the EMEA in 2004.
Danish: Den foreliggende beretning dækker EMEA's aktiviteter i 2004.
English: • 85 % of all national competent aurthorities were connected to EudraNet II at the end of 2004
Danish: • 85 % af alle de nationale ansvarlige myndigheder var koblet på EudraNet II
English: Number of variation applications in excess of 1 000 for the first time
Danish: For første gang indkom der over 1 000 ændringsansøgninger
English: Greater level of satisfaction with the quality of dossiers
Danish: Større tilfredshed med sagsmaterialets kvalitet
English: This document provides the procedures to implement Article 58 of Regulation (EC) No 726/2004 and was released for external consultation in November 2004.
Danish: Denne vejledning omhandler procedurerne for implementering af artikel 58 i forordning (EF) nr. 726/2004 og blev i november 2004 sendt ud i ekstern høring.
English: Treatment of stress urinary incontinence in women
Danish: Pending Treatment of stress urinary incontinence in women
English: In 2004, the Agency began to implement a series of transparency policy measures adopted by the Management Board in October 2003.
Danish: Agenturet begyndte i 2004 at gennemføre en række foranstaltninger i relation til den åbenhedspolitik, bestyrelsen vedtog i oktober 2003.
English: Three Article 6(12) referrals were withdrawn.
Danish: Tre henvisninger baseret på artikel 6, stk. 12, blev trukket tilbage.
English: • Two exercises ultimately aimed at enabling the automatic transfer of data between competent authorities and EU Telematiics systems were initiated
Danish: • Der blev påbegyndt to øvelser med det endelige mål at give mulighed for automatisk overførsel af data mellem ansvarlige myndigheder og EUtelematiksystemer
English: Summary of indication
Danish: Resumé af indikation
English: The policy aims to assist the effective planning, operation and control of processes within the Agency, and to continually improve its interaction with partners in the European network.
Danish: Sigtet med denne politik er at opnå en mere effektiv planlægning og drift og bedre kontrol med processerne inden for agenturet samt løbende at forbedre samspillet med partnere i det europæiske netværk.
English: The European Union telematics strategy for pharmaceuticals is agreed between Member States, the EMEA and the European Commission, and aims to increase efficiency, enhance transparency and provide support for the procedures set out in European legislation.
Danish: EU's telematikstrategi for lægemidler aftales mellem medlemsstaterne, EMEA og EuropaKommissionen og tager sigte på at forbedre effektiviteten og skabe større åbenhed samt understøtte de procedurer, der er fastsat i EU-lovgivningen.
English: Summary reports are published on the EMEA website within 14 days of publication in the Official Journal of a Commission Regulation amending the Annexes to Council Regulation (EEC) No 2377/90.
Danish: På EMEA's websted offentliggøres kortfattede redegørelser inden 14 dage efter offentliggørelsen i Den Europæiske Unions Tidende af en kommissionsafgørelse om ændring af bilagene til Rådets forordning (EØF) nr. 2377/90.
English: Prior to May 2004, the new Member States participated voluntarily in simplified mutual recognition procedures under the Collaboration Agreement between Veterinary Drug Registration Institutions (CAVDRI) of European Union Associated Countries.
Danish: Før maj 2004 deltog de nye medlemsstater på frivillig basis i forenklede gensidige anerkendelsesprocedurer i henhold til samarbejdsaftalen mellem Veterinary Drug Registration Institutions (CAVDRI) i de EU-associerede lande.
English: It is essential to improve EMEA coordination on the collection and evaluation of adverse effects data for medicinal products.
Danish: Det er absolut nødvendigt at forbedre EMEA's koordinering af indsamlingen og vurderingen af bivirkningsdata for lægemidler.
English: The EMEA set up a pre-accession linguistic review process for 199 human and 41 veterinary centrally authorised products in the 9 new EU languages.
Danish: Før udvidelsen foretog EMEA sproglig revision for 199 humanmedicinske og 41 veterinærmedicinske centralt godkendte produkter på de 9 nye EU-sprog.
English: 126 annual reports were reviewed and reported to the COMP in 2004.
Danish: I 2004 blev 126 årsrapporter gennemgået og indberettet til COMP.
English: The evaluation process serves to ensure that medicinal products reaching the EU marketplace have a favourable risk/benefit balance for patients.
Danish: Evalueringsprocessen tjener til at sikre, at lægemidler, der forhandles på EU-markedet, udviser en positiv balance mellem risici og fordele for patienterne.
English: Article 58 of the Regulation responds to the need to give scientific assistance to non-member countries in the context of cooperation with the WHO whilst at the same time allowing rapid access to important new medicines for those countries.
Danish: Artikel 58 i forordningen tager højde for behovet for videnskabelig bistand til tredjelande i forbindelse med samarbejdet med WHO og gør det samtidigt muligt for disse lande hurtigt at få adgang til nye lægemidler.
English: • Implementation of the new staff regulations
Danish: • gennemførelse af en ny personalevedtægt
English: Actions have focused on revision and strengthening of the quality assurance system, establishing clear roles and tasks for the working parties, and revising the policy on the handling of conflicts of interests.
Danish: De konkrete foranstaltninger har været centreret omkring revision og styrkelse af kvalitetssikringssystemet, fastlæggelse af klare roller og opgaver for arbejdsgrupperne samt revision af politikken for håndtering af interessekonflikter.
English: • EudraVigilance in the veterinary sector for electronic reporting of adverse reactions became fully operational on 1 January 2005.
Danish: • EudraVigilance i veterinærsektoren til elektronisk indberetning af bivirkninger blev fuldt operationel den 1. januar 2005.
English: These vaccines contain no adjuvant and should result in less injection-site reactions in vaccinated cats
Danish: Disse vacciner indeholder ingen hjælpestoffer og skulle medføre færre reaktioner omkring injektionsstedet hos de vaccinerede katte.
English: This allows innovations of the pharmaceutical industry to reach healthcare services and patients in the EU market faster than before.
Danish: Den betyder, at nyskabelser fra lægemiddelindustrien hurtigere end før kan nå ud til sundhedsvæsener og patienter på EU's marked.
English: Medical conditions affecting children only Medical conditions affecting both children and adults Medical conditions affecting adults only
Danish: Sygdomme, der kun berører børn Sygdomme, der berører både børn og voksne Sygdomme, der kun berører voksne
English: Participation in the development of the third phase of an automated meetings management system (MMS) to manage the meeting process as a whole was effective.
Danish: Deltagelsen i udviklingen af tredje fase af et automatisk mødestyringssystem til at styre mødeprocessen gav generelt et positivt udkomme.
English: • Implementation of new and modified accounting practices in line with the reform of the Commission
Danish: • indførelse af en ny regnskabspraksis i tråd med reformen af Kommissionen
English: A key part of the plan is a pilot programme under which companies can request parallel scientific advice from the two agencies.
Danish: Et vigtigt led i planen er et pilotprogram, som går ud på, at virksomheder kan anmode om parallel videnskabelig rådgivning fra de to parter.
English: If so, the CHMP adopts a positive opinion that is reflected in a European Public Assessment Report and makes a recommendation to the European Commission that a marketing authorisation be granted for that product.
Danish: I bekræftende fald afgiver CHMP en positiv udtalelse, der afspejles i en European Public Assessment Report, og henstiller til Europa-Kommissionen, at der gives markedsføringstilladelse for det pågældende produkt.
English: To maintain the MMS and implement a range of new services in MMS Phase III
Danish: Vedligehold af MMS og implementering af en række nye tjenester i MMS Fase II