FrancophonIA/ELRC3.0 huggingface dataset:
English: The enlargement of the European Union on 1 May 2004 and the preparation for the implementation of the new Community legislation were permanent items on the MRFG agenda.
Danish: EU's udvidelse den 1. maj 2004 og forberedelsen og gennemførelsen af den nye EU-lægemiddellovgivning var faste punkter på MRFG's dagsorden.
English: The EMEA agreed with the European Association of Euro-Pharmaceutical Companies (EAEPC) to put in place a joint performance indicator exercise to monitor the operation of the procedure.
Danish: EMEA vedtog sammen med European Association of Euro-Pharmaceutical Companies (EAEPC) at indføre en fælles præstationsindikator for at kunne følge med i, hvordan proceduren fungerer.
English: The Agency remained committed to and participated in the two international conferences on harmonisation of technical requirements for the registration of human and veterinary pharmaceuticals (ICH and VICH respectively) in 2004.
Danish: Agenturet var også i 2004 stærkt engageret i de to internationale konferencer om harmonisering af tekniske krav til registreringen af henholdsvis human- og veterinærmedicinske lægemidler (ICH og VICH).
English: In 2004, work continued towards establishing common costing methodologies for calculating the cost of scientific services provided by the national competent authorities to the EMEA.
Danish: Arbejdet fortsatte i 2004 med at fastlægge fælles omkostningsberegningsmetoder for de videnskabelige ydelser, de nationale ansvarlige myndigheder leverer til EMEA.
English: Once finalised, these training profiles will help to establish a common competency standard among EMEA staff.
Danish: Når disse efteruddannelsesprofiler ligger helt klar, vil de kunne anvendes til at fastlægge en fælles kompetencestandard for EMEA's personale.
English: Having completed the implementation of the data centre, the EMEA 3-tier architecture was implemented in 2004 with fully integrated security as the foundation platform for all new applications
Danish: Efter at datacentret var færdigt, etablerede man i 2004 3-lags arkitekturen i EMEA med fuldt integreret sikkerhed som basisplatform for alle nye applikationer
English: The operational and technical work of the EMEA is reported in Chapter 2 on medicines for human use, Chapter 3 on veterinary medicines and Chapter 4 on inspection activities.
Danish: EMEA's konkrete og tekniske opgaver er beskrevet i kapitel 2 om humanmedicinske lægemidler, kapitel 3 om veterinærlægemidler og kapitel 4 om inspektionsvirksomhed.
English: • Both the phase-1 registration system (known as EudraCT) and the EudraVigilance Clinical Trials Module were successfully deployed
Danish: • Både fase 1-registreringssystemet (med betegnelsen EudraCT) og EudraVigilance-modulet for kliniske forsøg blev sat i gang uden problemer
English: 6.2 Information technology at the EMEA
Danish: 6.2 Informationsteknologi i EMEA
English: The role of these groups is to advise the CHMP on specific questions addressed to them by the Committee.
Danish: Disse grupper har til opgave at rådgive CHMP i specifikke spørgsmål, de får forelagt af udvalget.
English: Annex 14 EMEA contact points
Danish: Bilag 14 EMEA's kontaktpunkter
English: European product index (mutual recognition procedure)
Danish: Europæisk lægemiddelindeks (gensidig anerkendelse)
English: These two groups contribute to the harmonisation of inspection-related procedures across the EU and develop guidance documents.
Danish: De to grupper deltog i arbejdet med at harmonisere inspektionsrelaterede procedurer i hele EU og udarbejde skriftlige vejledninger.
English: This total includes 3 applications for biosimilar products and 6 multiple applications.
Danish: I dette samlede tal indgår 3 ansøgninger for bioækvivalente produkter og 6 kombinerede ansøgninger.
English: IT completed testing of IP-based videoconferencing over the Internet successfully and used it in several Eudranet TIG meetings.
Danish: IT-sektionen færdiggjorde afprøvningen af IP-baserede videokonferencer via Internettet med godt resultat og benyttede det ved flere møder med Eudranettelematikimplementeringsgruppen.
English: The quality and safety of products derived from human plasma rely both on the source plasma material and the further manufacturing processes.
Danish: Kvaliteten af og sikkerheden ved produkter fremstillet på basis af humant plasma afhænger dels af kildeplasmamaterialet, dels af de efterfølgende fremstillingsprocesser.
English: Having implemented 2 large data storage arrays in the new EMEA data centre, IT has ensured that the Agency s processing and storage capabilities are aligned to its workload for the next 5 years
Danish: Efter at have implementeret to store datalagersæt i det nye EMEA-datacenter, har IT-sektionen sikret, at agenturets databehandlings- og lagerkapacitet er tilstrækkelig til at dække behovene de næste fem år
English: EudraVigilance is the EU s data processing network and management system for monitoring adverse drug reactions.
Danish: EudraVigilance er EU's databehandlingsnetværk og styringssystem for tilsynet med bivirkninger.
English: Human and veterinary medicinal products and recognition of official batch control of biologicals
Danish: Human- og veterinærmedicinske lægemidler og anerkendelse af officiel batchkontrol af biologiske produkter
English: • The EMEA, together with the Inspections Telematics Implementation Group, began to work on the deployment of an inspections database which comprises information about all inspections activities carried out in the European system
Danish: • EMEA begyndte sammen med inspektionssektionens telematikimplementeringsgruppe at arbejde på at oprette en database over inspektioner, som skal indeholde oplysninger om alle inspektionsaktiviteter, der gennemføres inden for det europæiske system.
English: The EMEA/CHMP Working Party with Patients Organisations reviewed the comments and contributions received following the release for consultation of the paper Recommendations and proposals for action (CPMP/5819/04) in April 2004.
Danish: EMEA/CHMP-arbejdsgruppen med deltagelse af patientorganisationer gennemgik de kommentarer og bidrag, der indkom, efter at oplægget Recommendations and proposals for action (CPMP/5819/04) var blevet sendt til høring i april 2004.
English: • The total number of new applications for marketing authorisation received in 2004 was higher than initially planned, particularly for those concerning non-orphan products.
Danish: • Det samlede antal nye ansøgninger om markedsføringstilladelser i 2004 var større end forventet, især for produkter, der ikke vedrører sjældne sygdomme.
English: Following the entry into force of parts of the new pharmaceutical legislation in May 2004, the Committee for Medicinal Products for Human Use (CHMP) replaced the Committee for Proprietary Medicinal Products (CPMP).
Danish: Da visse dele af den nye lægemiddellovgivning trådte i kraft i maj 2004, erstattede Udvalget for Humanmedicinske Lægemidler (CHMP) Udvalget for Farmaceutiske Specialiteter (CPMP).
English: Mutual recognition procedure
Danish: Gensidig anerkendelsesprocedure
English: To implement one common and standard directory of all parties involved in the EU pharmaceutical regulatory process
Danish: En fælles standardiseret adresseliste over alle de parter, der er involveret i EU's lovgivningsproces vedrørende lægemidler
English: Guideline on adjuvants in vaccines Released for consultation in March
Danish: Guideline on adjuvants in vaccines Sendt til høring i marts 2004
English: Arbitration procedures (either under Article 29 of Directive 2001/83/EC or Article 6(12) of Commission Regulation (EC) No 1084/2003) are initiated because of disagreement between Member States in the framework of the mutual recognition procedure.
Danish: Voldgiftsprocedurer (i henhold til enten artikel 29 i direktiv 2001/83/EF eller artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003) indledes på grund af uenighed mellem medlemsstater inden for rammerne af den gensidige anerkendelsesprocedure.
English: This includes activities relating to pharmacovigilance information (periodic safety update reports), follow-up measures, specific obligations, annual re-assessments (annual reports) and renewal applications.
Danish: Det omfatter aktiviteter vedrørende oplysning om lægemiddelovervågning (periodisk opdaterede sikkerhedsindberetninger), opfølgningsforanstaltninger, særlige forpligtelser, årlige revurderinger (årsrapporter) og ansøgninger om fornyelse af markedsføringstilladelser.
English: A European public assessment report (EPAR) is published once the Commission has adopted a final marketing authorisation decision.
Danish: Der offentliggøres en såkaldt European Public Assessment Report (EPAR), når Kommissionen har truffet endelig afgørelse om markedsføringstilladelse.
English: Old substances are those which were on the market prior to the entry into force of Regulation (EEC) No 2377/90 and for which there are still some outstanding issues to address.
Danish: "Gamle" stoffer er stoffer, som var på markedet, før forordning (EØF) nr. 2377/90 trådte i kraft, og som fortsat er forbundet med problemer.
English: This is the highest number of positive opinions adopted in any year since orphan medicinal product legislation was implemented in 2000.
Danish: Det er det højeste antal positive udtalelser i et enkelt år, siden lovgivningen om lægemidler til sjældne sygdomme trådte i kraft i 2000.
English: The CHMP gave 2 opinions on referrals under Article 29 and 2 opinions on referrals under Article 30.
Danish: CHMP afgav to udtalelser vedrørende henvisninger i henhold til artikel 29 og to udtalelser vedrørende henvisninger i henhold til artikel 30.
English: Nello MARTINI (Alternate: Silvia FABIANI)
Danish: Nello MARTINI (suppleant: Silvia FABIANI)
English: Referrals are initiated either in order to obtain harmonisation within the Community of the conditions of authorisation for products already authorised by the Member States (Article 34 of Directive 2001/82/EC), or in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment (Articles 35 and 40 of Directive 2001/82/EC).
Danish: Indbringelser iværksættes enten for at opnå harmonisering inden for EU af vilkårene for tilladelse til markedsføring af lægemidler, der allerede er godkendt af medlemsstaterne (artikel 34 i direktiv 2001/82/EF), eller i sager, der berører EU's interesser eller vedrører sikkerheden for menneskers og dyrs sundhed eller miljøet (artikel 35 og 40 i direktiv 2001/82/EF).
English: There has been an increase in the number of applications during each of the past five years.
Danish: Antallet af ansøgninger har været stigende i de seneste fem år.
English: • The CVMP adopted its Position paper regarding availability of products for minor uses and minor species (EMEA/CVMP/477/03/Final) detailing the strategy to be taken in advancing the greater availability of medicines in the veterinary sector.
Danish: • CVMP vedtog et holdningsdokument vedrørende adgangen til lægemidler til mindre udbredte sygdomme og mindre arter (EMEA/CVMP/477/03/Final) med en detaljeret redegørelse for den fremtidige strategi for at give øget adgang til lægemidler i veterinærsektoren.
English: The Ad hoc GMP Inspectors Group was appointed as the Telematics Implementation Group (TIG) for the Community GMP database in May 2004, and a preliminary implementation plan was drawn up.
Danish: Ad hoc-gruppen af GMP-inspektører blev i maj 2004 udpeget til at være telematikimplementeringsgruppe for EU's GMP-database, og der blev udarbejdet en foreløbig implementeringsplan.
English: • Harrie J J SEEVERENS (Netherlands)
Danish: • Harrie J J Seeverens (Nederlandene)
English: Number of certificates
Danish: Antal certifikater
English: The Agency ensures full compliance with all regulatory and quality requirements in the areas of document and records management.
Danish: Agenturet sikrer fuld overholdelse af alle lovfæstede og kvalitetsmæssige krav til dokument- og sagsstyring.
English: Management changes in 2004 included the implementation of an integrated management policy for the Agency, the extension of internal audits to include the functioning of the scientific committees, and the establishment of an Audit Advisory Committee.
Danish: Af ledelsesmæssige ændringer i 2004 kan nævnes implementeringen af en integreret ledelsesstrategi for agenturet, udvidelse af interne revisioner til at omfatte de videnskabelige udvalg samt nedsættelse af et rådgivende revisionsudvalg.
English: The Agency also participated in international activities of the Codex Alimentarius, the World Organisation for Animal Health (OIE) and the European Directorate for the Quality of Medicines (EDQM)/European Pharmacopoeia.
Danish: Agenturet deltog også i det internationale arbejde under Codex Alimentarius, World Organisation for Animal Health (OIE) og Det Europæiske Direktorat for Lægemiddelkvalitet (EDQM)/Den Europæiske Farmakopé.
English: MRLs established for cattle were extrapolated for three substances; in one case to goats, in a second case to sheep and in a third case to all mammalian species.
Danish: Der blev foretaget ekstrapolering af de maksimale grænseværdier for restkoncentrationer af tre stoffer i kvæg: i det ene tilfælde til geder, i det andet tilfælde til får og i det tredje tilfælde til alle pattedyr.
English: Back-up copies of all EMEA data are held in secure off-site locations.
Danish: Backup-kopier af alle EMEA-data opbevares på sikre steder uden for organisationen.
English: The new pharmaceutical legislation also gives the Executive Director, in liaison with the Committee for Medicinal Products for Human Use (CHMP), the responsibility of setting up the administrative structures and procedures allowing the development of scientific advice for companies and sponsors.
Danish: Den nye lægemiddellovgivning giver den administrerende direktør sammen med Udvalget for Humanmedicinske Lægemidler (CHMP) ansvaret for etableringen af de administrative strukturer og procedurer for leveringen af videnskabelig rådgivning til virksomheder og sponsorer.
English: EudraVigilance version 7.0 was launched in May 2004, including a Clinical Trial module (EVCTM) to support the electronic reporting of suspected unexpected serious adverse reactions (SUSARs) occurring during clinical trials.
Danish: EudraVigilance version 7.0 blev lanceret i maj 2004 og omfattede et modul for kliniske undersøgelser (EVCTM) til at understøtte den elektroniske indberetning af formodede uventede alvorlige bivirkninger (SUSAR), der konstateres ved kliniske undersøgelser.
English: Treatment of idiopathic Parkinsons disease (PD) in patients with end-of-dose fluctuations
Danish: Treatment of idiopathic Parkinson's disease (PD) in patients with end-of-dose fluctuations
English: • The EMEA/CHMP Working Group with Patients Organisations finalised its Recommendations and proposals for action after extensive consultation.
Danish: • EMEA/CHMP-arbejdsgruppen med deltagelse af patientorganisationer færdiggjorde sine anbefalinger og forslag efter en omfattende høring.
English: It includes the work of the Agency s Management Board, its partnership with national competent authorities and European institutions, and other general aspects of the EMEA, including transparency and the Agency s international activities.
Danish: Kapitlet omhandler arbejdet i agenturets bestyrelse, dets partnerskab med de nationale ansvarlige myndigheder og europæiske institutioner samt andre generelle aspekter af EMEA's virke, herunder åbenhed og internationale aktiviteter.
English: This represents an increase of 10 % over 2003.
Danish: Det er en stigning på 10 % i forhold til 2003.
English: A system of activity-based budgeting was developed, with details included in the budget reports to the Management Board and to the budgetary authority.
Danish: Der er udviklet et system med aktivitetsbaseret budgetplanlægning, der bl.a. indebærer mere detaljerede regnskabsrapporter til bestyrelsen og budgetmyndigheden.
English: Referral procedures under Article 30 of Directive 2001/83/EC are mainly initiated in order to obtain harmonisation within the Community of the conditions of authorisation for products already authorised by the Member States.
Danish: Henvisning af sager i henhold til artikel 30 i direktiv 2001/83/EF sker primært med det formål at opnå harmonisering inden for EU af vilkårene for tilladelse for produkter, der allerede er godkendt af medlemsstaterne.
English: 100 % fee reduction for protocol assistance
Danish: 100 % gebyrnedsættelse for protokolbistand
English: A new working party was created in 2004, following the entry into force of Title IV of Regulation (EC) No 726/2004: the Scientific Advice Working Party, responsible for all requests for scientific advice relating to product development.
Danish: Der blev nedsat en ny arbejdsgruppe i 2004, da afsnit IV i forordning (EF) nr. 726/2004 trådte i kraft: arbejdsgruppen vedrørende videnskabelig rådgivning, der skal tage sig af alle anmodninger om videnskabelig rådgivning vedrørende produktudvikling.
English: In accordance with the EMEA Financial Regulation, the Agency is required to publish an analysis and assessment of its annual activity report together with its annual report.
Danish: I henhold til finansforordningen for EMEA er agenturet forpligtet til sammen med årsberetningen at offentliggøre en analyse og vurdering af beretningen om årets aktiviteter.
English: The contributions that industry associations are making to this technology platform will help to find solutions to clear bottlenecks during the development of new medicines.
Danish: De relevante brancheorganisationer vil med deres bidrag til denne teknologiplatform være med til at finde løsninger på problemerne med åbenbare flaskehalse under udviklingen af nye lægemidler.
English: This means that the collection, testing, storage and transportation of human plasma are major factors in the quality assurance of the manufacture of plasma-derived products.
Danish: Det er ensbetydende med, at indsamlingen, testningen, opbevaringen og transporten af humant plasma er vigtige faktorer i kvalitetssikringen af fremstillingen af disse produkter.
English: European Public Assessment Reports are published as soon as possible after receipt of the respective Commission Decision in line with the procedure for human medicines.
Danish: De såkaldte European Public Assessment Reports (EPAR) offentliggøres hurtigst muligt efter modtagelsen af den respektive kommissionsafgørelse efter samme procedure som for humanmedicinske lægemidler.
English: EC subsidy/EEA contribution
Danish: EU-tilskud/EØS-bidrag
English: Five applications for scientific advice were received in 2004.
Danish: Der indkom fem anmodninger om videnskabelig rådgivning i 2004.
English: They allow EU Member States and the MRA partner to mutually recognise the conclusions of inspections of manufacturers carried out by the respective inspection services of the other party and the manufacturers' certification of the conformity of each batch to its specifications without re-control at import.
Danish: De gør det muligt for EU-landene og partnerlandene gensidigt at anerkende dels konklusionerne af de inspektioner af medicinalvirksomheder, der er udført af den anden parts respektive inspektionstjenester, dels producenternes certificering af hver enkelt batchs overensstemmelse med specifikationerne uden at skulle kræve fornyet kontrol ved import.
English: The EMEA received 38 quality defect reports concerning human medicinal products and 2 defect reports for veterinary medicinal products.
Danish: EMEA modtog 38 indberetninger af kvalitetsfejl ved humanmedicinske lægemidler og 2 indberetninger vedrørende veterinærlægemidler.
English: Biotechnology Quality Pre-clinical Clinical
Danish: Bioteknologi Kvalitet Præ-klinisk Klinisk
English: Such substances are evolving partly through the development of new products, while others are old molecules for which no MRLs had previously been established or which had previously not been used as veterinary medicines.
Danish: Disse stoffer fremkommer til dels i forbindelse med udviklingen af nye produkter, og er til dels allerede kendte stoffer, for hvilke der ikke tidligere er fastsat maksimale grænseværdier, eller som ikke tidligere har været anvendt i veterinærlægemidler.
English: Transparent and public rules of conduct reinforce the Agency s reliability in the eyes of the general public.
Danish: Åbne og offentligt tilgængelige etiske regler styrker agenturets troværdighed over for befolkningen.
English: The primary institutional partner of the EMEA is the European Commission, in particular the Directorate-General for Enterprise and Industry.
Danish: EMEA's vigtigste institutionelle partnere er Europa-Kommissionen, primært Generaldirektoratet for Erhvervspolitik.
English: After two years of decline, 2004 saw a recovery in the number of applications submitted to the EMEA for products containing new active substances.
Danish: Efter to års fald kunne der i 2004 atter konstateres en stigning i antallet af ansøgninger til EMEA for produkter indeholdende nye aktive stoffer.
English: The total number of requests for protocol assistance (PA) was 35, of which 32 were finalised.
Danish: Der indkom i alt 35 anmodninger om protokolbistand, hvoraf 32 blev færdigbehandlet.
English: This more than triples the number requested in 2003 and results from an increase in the number of applications, the impact of applications for biosimilar medicinal products, and a number of inspections for pharmacovigilance purposes.
Danish: Det er mere end en tredobling i forhold til 2003 og skyldes en stigning i antallet af ansøgninger, effekten af ansøgninger for bioækvivalente lægemidler og en række inspektioner vedrørende lægemiddelovervågning.
English: # Denotes an orphan medicinal product designated under Regulation (EC) No 121/2000.
Danish: # Betegner et lægemiddel til sjældne sygdomme, som er udpeget i henhold til forordning (EF) nr. 121/2000.
English: All changes that are made to the terms of authorisation of a centrally authorised medicinal product throughout its life have to be approved by the Community.
Danish: Alle ændringer, der foretages i vilkårene for en markedsføringstilladelse for et centralt godkendt lægemiddel i hele dets levetid, skal godkendes af EU.
English: The workload arising from the handling of periodic safety updates, follow-up measures and specific obligations decreased slightly compared to 2003, owing partly to a decrease in the number of marketing authorisation applications received at the EMEA in the years 2002 and 2003.
Danish: Arbejdsmængden i relation til behandling af periodiske opdaterede sikkerhedsindberetninger, opfølgningsforanstaltninger og særlige forpligtelser blev en smule mindre i forhold til 2003, hvilket til dels skyldes, at EMEA modtog færre ansøgninger om markedsføringstilladelser i 2002 og 2003.
English: The enlargement of the European Union to 25 Member States on 1 May 2004 and the entry into force of the new pharmaceutical legislation, which introduced a fourth scientific committee and new scientific groups, led to a considerable increase in the number of meetings organised, in the number of meeting days, and in the number of delegates to be reimbursed.
Danish: EU's udvidelse til 25 medlemsstater den 1. maj 2004 og den nye lægemiddellovgivnings ikrafttræden, som betød, at der skulle nedsættes et fjerde videnskabeligt udvalg og nye videnskabelige grupper, indebar en betydelig stigning i mødeaktiviteten, dvs. antallet af møder, mødedage og delegerede, der skulle have godtgjort omkostninger.
English: As a joint effort, a revised mandate of the Pharmacovigilance Working Party was agreed upon.
Danish: Der blev i fællesskab vedtaget et revideret mandat for arbejdsgruppen vedrørende lægemiddelovervågning.
English: At the conclusion of the scientific evaluation, undertaken in 210 days within the Agency, the opinion of the scientific committee is transmitted to the European Commission to be transformed into a single market authorisation applying to the whole European Union.
Danish: Efter den faglige vurdering, der foretages af agenturet senest 210 dage efter modtagelse af ansøgningen, fremsendes det videnskabelige udvalgs udtalelse til Europa-Kommissionen, hvor den udmøntes i én enkelt markedsføringstilladelse, der gælder i hele EU.